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[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Rules and Regulations]
[Pages 53967-54162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21050]

[[Page 53967]]

Vol. 77

Tuesday,

No. 171

September 4, 2012

Part II

Department of Health and Human Services

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45 CFR Part 170

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Centers for Medicare & Medicaid Services

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42 CFR Parts 412, 413, and 495

Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program--Stage 2; Health Information Technology: Standards, 
Implementation Specifications, and Certification Criteria for 
Electronic Health Record Technology, 2014 Edition; Revisions to the 
Permanent Certification Program for Health Information Technology; 
Final Rules

Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / 
Rules and Regulations

[[Page 53968]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412, 413, and 495

[CMS-0044-F]
RIN 0938-AQ84

Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Stage 2

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule specifies the Stage 2 criteria that eligible 
professionals (EPs), eligible hospitals, and critical access hospitals 
(CAHs) must meet in order to qualify for Medicare and/or Medicaid 
electronic health record (EHR) incentive payments. In addition, it 
specifies payment adjustments under Medicare for covered professional 
services and hospital services provided by EPs, eligible hospitals, and 
CAHs failing to demonstrate meaningful use of certified EHR technology 
(CEHRT) and other program participation requirements. This final rule 
revises certain Stage 1 criteria, as finalized in the July 28, 2010 
final rule, as well as criteria that apply regardless of Stage.

DATES: Effective dates: This final rule is effective on November 5, 
2012, with the exception of the definition of ``meaningful EHR user'' 
in Sec.  495.4 and the provisions in Sec.  495.6(f), Sec.  495.6(g), 
Sec.  495.8, Sec.  495.102(c), and part 495 subpart D, which are 
effective September 4, 2012.
    Applicability dates: Sections 495.302, 495.304, and 495.306 are 
applicable beginning payment year 2013.

FOR FURTHER INFORMATION CONTACT: Elizabeth Holland, (410) 786-1309, or 
Robert Anthony, (410) 786-6183, EHR Incentive Program issues or 
Administrative appeals process issues. David Koppel, (410) 786-3255, 
for Medicaid Incentive Program issues. Frank Szeflinski, (303) 844-
7119, for Medicare Advantage issues. Travis Broome, (214) 767-4450, 
Medicare payment adjustment issues. Douglas Brown, (410) 786-0028, or 
Maria Michaels, (410) 786-2809 for Clinical quality measures issues.

SUPPLEMENTARY INFORMATION:

Acronyms

ARRA American Recovery and Reinvestment Act of 2009
AAC Average Allowable Cost (of CEHRT)
ACO Accountable Care Organization
AIU Adopt, Implement, Upgrade (CEHRT)
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CCN CMS Certification Number
CDS Clinical Decision Support
CEHRT Certified Electronic Health Record Technology
CFR Code of Federal Regulations
CHIP Children's Health Insurance Program
CHIPRA Children's Health Insurance Program Reauthorization Act of 
2009
CMS Centers for Medicare & Medicaid Services
CPOE Computerized Provider Order Entry
CQM Clinical Quality Measure
CY Calendar Year
EHR Electronic Health Record
EP Eligible Professional
EPO Exclusive Provider Organization
FACA Federal Advisory Committee Act
FFP Federal Financial Participation
FFY Federal Fiscal Year
FFS Fee-For-Service
FQHC Federally Qualified Health Center
FTE Full-Time Equivalent
FY Fiscal Year
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIE Health Information Exchange
HIT Health Information Technology
HITPC Health Information Technology Policy Committee
HIPAA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical 
Health Act
HMO Health Maintenance Organization
HOS Health Outcomes Survey
HPSA Health Professional Shortage Area
HRSA Health Resource and Services Administration
IAPD Implementation Advance Planning Document
ICR Information Collection Requirement
IHS Indian Health Service
IPA Independent Practice Association
IT Information Technology
LOINC Logical Observation Identifiers and Codes System
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAO Medicare Advantage Organization
MCO Managed Care Organization
MITA Medicaid Information Technology Architecture
MMIS Medicaid Management Information Systems
MSA Medical Savings Account
NAAC Net Average Allowable Cost (of CEHRT)
NCQA National Committee for Quality Assurance
NCVHS National Committee on Vital and Health Statistics
NPI National Provider Identifier
NPRM Notice of Proposed Rulemaking
ONC Office of the National Coordinator for Health Information 
Technology
PAHP Prepaid Ambulatory Health Plan
PAPD Planning Advance Planning Document
PCP Primary Care Provider
PECOS Provider Enrollment, Chain, and Ownership System
PFFS Private Fee-For-Service
PHO Physician Hospital Organization
PHR Personal Health Record
PHS Public Health Service
PHSA Public Health Service Act
PIHP Prepaid Inpatient Health Plan
POS Place of Service
PPO Preferred Provider Organization
PQRS Physician Quality Reporting System
PSO Provider Sponsored Organization
RHC Rural Health Clinic
RPPO Regional Preferred Provider Organization
SAMHSA Substance Abuse and Mental Health Services Administration
SMHP State Medicaid Health Information Technology Plan
TIN Tax Identification Number

Table of Contents

I. Executive Summary and Overview
    A. Executive Summary
    1. Purpose of Regulatory Action
    a. Need for the Regulatory Action
    b. Legal Authority for the Regulatory Action
    2. Summary of Major Provisions
    a. Stage 2 Meaningful Use Objectives and Measures
    b. Reporting on Clinical Quality Measures (CQMs)
    c. Payment Adjustments and Exceptions
    d. Modifications to Medicaid EHR Incentive Program
    e. Stage 2 Timeline Delay
    3. Summary of Costs and Benefits
    B. Overview of the HITECH Programs Created by the American 
Recovery and Reinvestment Act of 2009
II. Provisions of the Proposed Regulations and Analysis of and 
Responses to Public Comments
    A. Definitions Across the Medicare FFS, Medicare Advantage, and 
Medicaid Programs
    1. Uniform Definitions
    2. Meaningful EHR User
    3. Definition of Meaningful Use
    a. Considerations in Defining Meaningful Use
    b. Changes to Stage 1 Criteria for Meaningful Use
    c. State Flexibility for Stage 2 of Meaningful Use
    d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
    (1) Discussion of Whether Certain EPs, Eligible Hospitals or 
CAHs can meet all Stage 2 Meaningful Use Objectives Given 
Established Scopes of Practice
    (2) EPs Practicing in Multiple Practices/Locations
    (3) Discussion of the Reporting Requirements of the Measures 
Associated with the Stage 2 Meaningful Use Objectives
    B. Reporting on Clinical Quality Measures Using Certified EHRs 
Technology by Eligible Professionals, Eligible Hospitals, and 
Critical Access Hospitals
    1. Time Periods for Reporting Clinical Quality Measures
    2. Certification Requirements for Clinical Quality Measures

[[Page 53969]]

    3. Criteria for Selecting Clinical Quality Measures
    4. Clinical Quality Measures for Eligible Professionals
    a. Statutory and Other Considerations
    b. Clinical Quality Measures for Eligible Professionals for CY 
2013
    c. Clinical Quality Measures for Eligible Professionals 
Beginning With CY 2014
    5. Reporting Methods for Clinical Quality Measures for Eligible 
Professionals
    a. Reporting Methods for Medicaid EPs
    b. Reporting Methods for Medicare EPs in CY 2013
    c. Reporting Methods for Medicare EPs Beginning With CY 2014
    d. Group Reporting Option for Medicare and Medicaid Eligible 
Professionals Beginning With CY 2014
    6. Clinical Quality Measures for Eligible Hospitals and Critical 
Access Hospitals
    a. Statutory and Other Considerations
    b. Clinical Quality Measures for Eligible Hospitals and CAHs for 
FY 2013
    7. Reporting Methods for Eligible Hospitals and Critical Access 
Hospitals
    a. Reporting Methods in FY 2013
    b. Reporting Methods Beginning With FY 2014
    c. Electronic Reporting of Clinical Quality Measures for 
Medicaid Eligible Hospitals
    C. Demonstration of Meaningful Use and Other Issues
    1. Demonstration of Meaningful Use
    a. Common Methods of Demonstration in Medicare and Medicaid
    b. Methods for Demonstration of the Stage 2 Criteria of 
Meaningful Use
    c. Group Reporting Option of Meaningful Use Core and Menu 
Objectives and Associated Measures for Medicare and Medicaid EPs 
Beginning With CY 2014
    2. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    3. Hospital-Based Eligible Professionals
    4. Interaction With Other Programs
    D. Medicare Fee-for-Service
    1. General Background and Statutory Basis
    2. Payment Adjustment Effective in CY 2015 and Subsequent Years 
for EPs Who Are Not Meaningful Users of CEHRT for an Applicable 
Reporting Period
    a. Applicable Payment Adjustments in CY 2015 and Subsequent 
Calendar Years for EPs Who Are Not Meaningful Users of CEHRT
    b. EHR Reporting Period for Determining Whether an EP Is Subject 
to the Payment Adjustment for CY 2015 and Subsequent Calendar Years
    c. Exception to the Application of the Payment Adjustment to EPs 
in CY 2015 and Subsequent Calendar Years
    d. HPSA Bonus Technical Change
    e. Payment Adjustment Not Applicable to Hospital-Based EPs
    3. Incentive Market Basket Adjustment Effective in FY 2015 and 
Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR 
Users for an Applicable Reporting Period
    a. Applicable Market Basket Adjustment for Eligible Hospitals 
Who Are Not Meaningful EHR Users for FY 2015 and Subsequent FYs
    b. EHR Reporting Period for Determining Whether a Hospital is 
Subject to the Market Basket Adjustment for FY 2015 and Subsequent 
FYs
    c. Exception to the Application of the Market Adjustment to 
Hospitals in FY 2015 and Subsequent FYs
    d. Application of Market Basket Adjustment in FY 2015 and 
Subsequent FYs to a State Operating Under a Payment Waiver Provided 
by Section 1814(B)(3) of the Act
    4. Reduction of Reasonable Cost Reimbursement in FY 2015 and 
Subsequent Years for CAHs That Are Not Meaningful EHR Users
    a. Applicable Reduction of Reasonable Cost Payment Reduction in 
FY 2015 and Subsequent Years for CAHs That Are Not Meaningful EHR 
Users
    b. EHR Reporting Period for Determining Whether a CAH Is Subject 
to the Applicable Reduction of Reasonable Cost Payment in FY 2015 
and Subsequent Years
    c. Exception to the Application of Reasonable Cost Payment 
Reductions to CAHs in FY 2015 and Subsequent FYs
    5. Administrative Review Process of Certain Electronic Health 
Record Incentive Program Determinations
    E. Medicare Advantage Organization Incentive Payments
    1. Definition (Sec.  495.200)
    2. Identification of Qualifying MA Organizations, MA-EPs and MA-
Affiliated Eligible Hospitals (Sec.  495.202)
    3. Incentive Payments to Qualifying MA Organizations for 
Qualifying MA EPs and Qualifying MA-Affiliated Eligible Hospitals 
(Sec.  495.204)
    a. Amount Payable to a Qualifying MA Organization for Its 
Qualifying MA EPs
    b. Increase in Incentive Payment for MA EPs Who Predominantly 
Furnish Services in a Geographic Health Professional Shortage Area 
(HPSA)
    4. Avoiding Duplicate Payments
    5. Payment Adjustments Effective in 2015 and Subsequent MA 
Payment Adjustment Years (Sec.  495.211).
    6. Reconsideration Process for MA Organizations
    F. Revisions and Clarifications to the Medicaid EHR Incentive 
Program
    1. Net Average Allowable Costs
    2. Eligibility Requirements for Children's Hospitals
    3. Medicaid Professionals Program Eligibility
    a. Calculating Patient Volume Requirements
    b. Practices Predominately
    4. Medicaid Hospital Incentive Payment Calculation
    a. Discharge Related Amount
    b. Acute Care Inpatient Bed Days and Discharges for the Medicaid 
Share and Discharge- Related Amount
    c. Hospitals Switching States
    5. Hospital Demonstrations of Meaningful Use--Auditing and 
Appeals
    6. State Flexibility for Stage 2 of Meaningful Use
    7. State Medicaid Health Information Technology Plan (SMHP) and 
Implementation Advance Planning Document (IAPD)
    a. Frequency of Health Information Technology (HIT) 
Implementation Advanced Planning Document (IAPD) Updates
    b. Requirements of States Transitioning From HIT Planning 
Advanced Planning Documents (P-APDs) to HIT IAPDs
III. Waiver of Delay in Effective Date
IV. Collection of Information Requirements
    A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  
495.6 and Sec.  495.8)
    B. ICRs Regarding Qualifying MA Organizations (Sec.  495.210)
    C. ICRs Regarding State Medicaid Agency and Medicaid EP and 
Hospital Activities (Sec.  495.332 Through Sec.  495.344)
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    1. Overall Effects
    a. Regulatory Flexibility Analysis and Small Entities
    (1) Number of Small Entities
    (2) Conclusion
    b. Small Rural Hospitals
    c. Unfunded Mandates Reform Act
    d. Federalism
    2. Effects on Eligible Professionals, Eligible Hospitals, and 
CAHs
    a. Background and Assumptions
    b. Industry Costs and Adoption Rates
    c. Costs of EHR Adoption for EPs
    d. Costs of EHR Adoption for Eligible Hospitals
    3. Medicare Incentive Program Costs
    a. Medicare Eligible Professionals (EPs)
    b. Medicare Eligible Hospitals and CAHs
    c. Critical Access Hospitals (CAHs)
    4. Medicaid Incentive Program Costs
    a. Medicaid EPs
    b. Medicaid Hospitals
    5. Benefits For All EPs and All Eligible Hospitals
    6. Benefits to Society
    7. General Considerations
    8. Summary
    9. Explanation of Benefits and Savings Calculations
    D. Accounting Statement
    E. Conclusion

Regulations Text

I. Executive Summary and Overview

A. Executive Summary

1. Purpose of Regulatory Action
a. Rationale for the Regulatory Action
    In this final rule the Secretary of the Department of Health and 
Human Services (the Secretary) will specify Stage 2 criteria beginning 
in 2014 that eligible professionals (EPs), eligible hospitals, and 
critical access hospitals (CAHs) must meet in order to qualify for an 
incentive payment, as well as introduce changes to the program timeline 
and detail Medicare payment adjustments. Recommendations on Stage 2 
criteria from the Health IT

[[Page 53970]]

Policy Committee (HITPC), a Federal Advisory Committee that coordinates 
industry and provider input regarding the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Programs were substantially 
adopted, with consideration of current program data for the Medicare 
and Medicaid EHR Incentive Programs. Our current program data is 
derived from two sources. First, data elements from the registration 
and attestation process of those providers who have already registered 
and attested to Stage 1 of meaningful use. This includes demographic 
information about the provider, the Certified EHR Technology (CEHRT) 
used by the provider and their performance on the meaningful use 
objectives and measures. Second, we have information from thousands of 
questions providers submitted about the EHR Incentive Programs. These 
questions provide insights into the difficulties faced by providers and 
also into the areas of the EHR Incentive Programs that warrant 
additional clarification.
b. Legal Authority for the Regulatory Action
    The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5) amended Titles XVIII and XIX of the Social Security Act (the 
Act) to authorize incentive payments to EPs, eligible hospitals, and 
CAHs, and Medicare Advantage (MA) organizations to promote the adoption 
and meaningful use of CEHRT.
    Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act 
provide the statutory basis for the Medicare incentive payments made to 
meaningful EHR users. These statutory provisions govern EPs, Medicare 
Advantage (MA) organizations (for certain qualifying EPs and hospitals 
that meaningfully use CEHRT), subsection (d) hospitals and critical 
access hospitals (CAHs) respectively. Sections 1848(a)(7), 1853(l) and 
(m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward 
payment adjustments, beginning with calendar or fiscal year 2015, for 
EPs, MA organizations, subsection (d) hospitals and CAHs that are not 
meaningful users of CEHRT for certain associated reporting periods.
    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory 
basis for Medicaid incentive payments. (There are no payment 
adjustments under Medicaid). For a more detailed explanation of the 
statutory basis for the EHR incentive payments, see the Stage 1 final 
rule (75 FR 44316 through 44317).
2. Summary of Major Provisions
a. Stage 2 Meaningful Use Objectives and Measures
    In the Stage 1 final rule we outlined Stage 1 meaningful use 
criteria, we finalized a separate set of core objectives and menu 
objectives for EPs, eligible hospitals and CAHs. EPs and hospitals must 
meet the measure or qualify for an exclusion to all 15 core objectives 
and 5 out of the 10 menu objectives in order to qualify for an EHR 
incentive payment. In this final rule, we maintain the same core-menu 
structure for the program for Stage 2. We are finalizing that EPs must 
meet the measure or qualify for an exclusion to 17 core objectives and 
3 of 6 menu objectives. We are finalizing that eligible hospitals and 
CAHs must meet the measure or qualify for an exclusion to 16 core 
objectives and 3 of 6 menu objectives. Nearly all of the Stage 1 core 
and menu objectives are retained for Stage 2. The ``exchange of key 
clinical information'' core objective from Stage 1 was re-evaluated in 
favor of a more robust ``transitions of care'' core objective in Stage 
2, and the ``Provide patients with an electronic copy of their health 
information'' objective was removed because it was replaced by a ``view 
online, download, and transmit'' core objective. There are also 
multiple Stage 1 objectives that were combined into more unified Stage 
2 objectives, with a subsequent rise in the measure threshold that 
providers must achieve for each objective that has been retained from 
Stage 1.
b. Reporting on Clinical Quality Measures (CQMs)
    EPs, eligible hospitals, and CAHs are required to report on 
specified clinical quality measures in order to qualify for incentive 
payments under the Medicare and Medicaid EHR Incentive Programs. This 
final rule outlines a process by which EPs, eligible hospitals, and 
CAHs will submit CQM data electronically, reducing the associated 
burden of reporting on quality measures for providers. EPs will submit 
9 CQMs from at least 3 of the National Quality Strategy domains out of 
a potential list of 64 CQMs across 6 domains. We are recommending a 
core set of 9 CQMs focusing on adult populations with a particular 
focus on controlling blood pressure. We are also recommending a core 
set of 9 CQMs for pediatric populations. EPs should report on these 
recommended CQMs if they are representative of their clinical practice 
and patient population. Eligible hospitals and CAHs will submit 16 CQMs 
from at least 3 of the National Quality Strategy domains out of a 
potential list of 29 CQMs across 6 domains. For the Medicare EHR 
Incentive Program, EPs, eligible hospitals, and CAHs in their first 
year of demonstrating meaningful use must submit their CQM data via 
attestation, and those beyond their first year must submit their CQM 
data electronically via a CMS-designated transmission method. For EPs, 
this includes an aggregate electronic submission or a patient-level 
electronic submission through the method specified by the Physician 
Quality Reporting System (PQRS) that would provide one submission for 
credit in both the PQRS and Medicare EHR Incentive Program. For 
eligible hospitals and CAHs, this includes an aggregate electronic 
submission or a patient-level data submission through the method 
similar to the Medicare EHR Incentive Program Electronic Reporting 
Pilot, which is proposed for extension in the CY 2013 Hospital 
Outpatient Prospective Payment System (OPPS) proposed rule (July 30, 
2012, 77 FR 45188). For electronic submissions, patient-level data must 
be submitted using the Quality Reporting Data Architecture (QRDA) 
Category I format, and aggregate-level data must be submitted using the 
QRDA Category III format.
c. Payment Adjustments and Exceptions
    Medicare payment adjustments are required by statute to take effect 
in 2015. We are finalizing a process by which payment adjustments will 
be determined by a prior reporting period. Therefore, we specify that 
EPs and eligible hospitals that are meaningful EHR users in 2013 will 
avoid payment adjustment in 2015. Also, if such providers first meet 
meaningful use in 2014, they will avoid the 2015 payment adjustment, if 
they are able to demonstrate meaningful use at least 3 months prior to 
the end of the calendar (for EPs) or fiscal year (for eligible 
hospitals) and meet the registration and attestation requirement by 
July 1, 2014 (for eligible hospitals) or October 1, 2014 (for EPs).
    We also are finalizing exceptions to these payment adjustments. 
This final rule outlines four categories of exceptions based on (1) the 
lack of availability of internet access or barriers to obtaining IT 
infrastructure; (2) a time-limited exception for newly practicing EPs 
or new hospitals that will not otherwise be able to avoid payment 
adjustments; (3) unforeseen circumstances such as natural disasters 
that will be handled on a case-by-case basis; and (4) (EP only) 
exceptions due to a combination of clinical features

[[Page 53971]]

limiting a provider's interaction with patients or, if the EP practices 
at multiple locations, lack of control over the availability of CEHRT 
at practice locations constituting 50 percent or more of their 
encounters.
d. Modifications to Medicaid EHR Incentive Program
    We are expanding the definition of what constitutes a Medicaid 
patient encounter, which is a required eligibility threshold for the 
Medicaid EHR Incentive Programs. We include encounters for individuals 
enrolled in a Medicaid program, including Title XXI-funded Medicaid 
expansion encounters (but not separate Children's Health Insurance 
Programs (CHIPs)). We also specify flexibility in the lookback period 
for patient volume to be over the 12 months preceding attestation, not 
tied to the prior calendar year.
    We are also making eligible approximately 12 additional children's 
hospitals that have not been able to participate to date, despite 
meeting all other eligibility criteria, because they do not have a CMS 
Certification Number since they do not bill Medicare.
    These changes would take effect beginning with payment year 2013.
e. Stage 2 Timeline Delay
    Lastly, we are finalizing a delay in the implementation of the 
onset of Stage 2 criteria. In the Stage 1 final rule, we established 
that any provider who first attested to Stage 1 criteria in 2011 would 
begin using Stage 2 criteria in 2013. This final rule delays the onset 
of those Stage 2 criteria until 2014, which we believe provides the 
needed time for vendors to develop CEHRT. We are also introducing a 
special 3-month EHR reporting period, rather than a full year of 
reporting, for providers attesting to either Stage 1 or Stage 2 in 2014 
in order to allow time for providers to implement newly certified 
CEHRT. In future years, providers who are not in their initial year of 
demonstrating meaningful use must meet criteria for 12-month reporting 
periods. The 3-month reporting period allows providers flexibility in 
their first year of meeting Stage 2 without warranting any delay for 
Stage 3. This policy is consistent with CMS's commitment to ensure that 
Stage 3 occurs on schedule (implemented by 2016).
3. Summary of Costs and Benefits
    This final rule is anticipated to have an annual effect on the 
economy of $100 million or more, making it an economically significant 
rule under the Executive Order and a major rule under the Congressional 
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis 
that to the best of our ability presents the costs and benefits of the 
final rule. The total Federal cost of the Medicare and Medicaid EHR 
Incentive Programs between 2014 and 2019 is estimated to be $15.4 
billion (these estimates include net payment adjustments for Medicare 
providers who do not achieve meaningful use in 2015 and subsequent 
years in the amount of $2.1 billion). In this final rule we have not 
quantified the overall benefits to the industry, nor to EPs, eligible 
hospitals, or CAHs participating in the Medicare and Medicaid EHR 
Incentive Programs. Information on the costs and benefits of adopting 
systems specifically meeting the requirements for the EHR Incentive 
Programs has not yet been collected and information on costs and 
benefits overall is limited. Nonetheless, we believe there are 
substantial benefits that can be obtained by eligible hospitals and 
EPs, including reductions in medical recordkeeping costs, reductions in 
repeat tests, decreases in length of stay, increased patient safety, 
and reduced medical errors. There is evidence to support the cost-
saving benefits anticipated from wider adoption of EHRs.

TABLE 1--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the HITECH EHR Incentive Program. (Fiscal year)--
                                                                      (in Billions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Medicare eligible                   Medicaid eligible
                            Fiscal year                             ------------------------------------------------------------------------    Total
                                                                         Hospitals       Professionals       Hospitals       Professionals
--------------------------------------------------------------------------------------------------------------------------------------------------------
2014...............................................................              $2.1              $1.9              $0.6              $0.5        $5.10
2015...............................................................               1.8               1.9               0.4               0.8         4.90
2016...............................................................               1.2               0.6               0.5               0.8         3.10
2017...............................................................               0.2               0.1               0.5               0.7         1.50
2018...............................................................              -0.1              -0.2               0.1               0.7         0.50
2019...............................................................               0.0              -0.2               0.0               0.5         0.30
--------------------------------------------------------------------------------------------------------------------------------------------------------

B. Overview of the HITECH Programs Created by the American Recovery and 
Reinvestment Act of 2009

    The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5) amended Titles XVIII and XIX of the Social Security Act (the 
Act) to authorize incentive payments to EPs, eligible hospitals, and 
CAHs, and Medicare Advantage (MA) Organizations to promote the adoption 
and meaningful use of CEHRT. In the July 28, 2010 Federal Register (75 
FR 44313 through 44588) we published a final rule entitled ``Medicare 
and Medicaid Programs; Electronic Health Record Incentive Program,'' 
that specified the Stage 1 criteria that EPs, eligible hospitals, and 
CAHs must meet in order to qualify for an incentive payment, 
calculation of the incentive payment amounts, and other program 
participation requirements (hereinafter referred to as the Stage 1 
final rule). (For a full explanation of the amendments made by ARRA, 
see the Stage 1 final rule (75 FR 44316).) In that final rule, we also 
detailed that the Medicare and Medicaid EHR Incentive Programs will 
consist of 3 different stages of meaningful use requirements.
    For Stage 1, CMS and the Office of the National Coordinator for 
Health Information Technology (ONC) worked closely to ensure that the 
definition of meaningful use of CEHRT and the standards and 
certification criteria for CEHRT were coordinated. Current ONC 
regulations may be found at 45 CFR part 170.
    For Stage 2, CMS and ONC again worked together to align our 
regulations.
    In the March 7, 2012 Federal Register (77 FR 13698), we published a 
proposed rule that specified the potential Stage 2 criteria that EPs, 
eligible hospitals, and CAHs would have to meet in order to qualify for 
Medicare and/or Medicaid EHR incentive payments (hereinafter referred 
to as the Stage 2 proposed rule). In addition, the proposed rule --(1) 
proposed payment adjustments under Medicare for covered professional 
services and hospital services provided

[[Page 53972]]

by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful 
use of CEHRT and other program participation requirements; and (2) 
proposed the revision of certain Stage 1 criteria, as well as criteria 
that apply regardless of stage.
    In the April 18, 2012 Federal Register (77 FR 23193), we published 
a document that corrected typographical and technical errors in the 
March 7, 2012 Stage 2 proposed rule.
    Simultaneously in the March 7, 2012 Federal Register (77 FR 13832), 
ONC published its notice of proposed rulemaking titled Health 
Information Technology: Standards, Implementation Specifications, and 
Certification Criteria for Electronic Health Record Technology, 2014 
Edition; Revisions to the Permanent Certification Program for Health 
Information Technology. The notice of proposed rulemaking proposed 
revisions to the initial set of standards, implementation 
specifications, and certification criteria in ONC's July 28, 2010 final 
rule as well as the adoption of new standards, implementation 
specifications, and certification criteria.
    We urge those interested in this final rule to also review the ONC 
final rule on standards and implementation specifications for CEHRT. 
Readers may also visit http://www.cms.hhs.gov/EHRincentiveprograms and 
http://healthit.hhs.gov for more information on the efforts at the 
Department of Health and Human Services (HHS) to advance HIT 
initiatives.

II. Provisions of the Proposed Regulations and Analysis of and 
Responses to Public Comments

    We received approximately 6,100 items of timely correspondence in 
response to our Stage 2 proposed rule published in the March 7, 2012 
Federal Register. We received some comments that were outside the scope 
of the proposed rule and therefore are not addressed in this final 
rule. Summaries of the timely public comments that are within the scope 
of the Stage 2 proposed rule and our responses to those comments are 
set forth in the various sections of this final rule under the 
appropriate headings. We have generally organized those sections by 
stating our proposals, summarizing and responding to the timely public 
comments received, and describing our final policy.

A. Definitions Across the Medicare FFS, Medicare Advantage, and 
Medicaid Programs

1. Uniform Definitions
    As discussed in the proposed rule, in the Stage 1 final rule, we 
finalized many uniform definitions for the Medicare FFS, Medicare 
Advantage (MA), and Medicaid EHR incentive programs. These definitions 
are set forth in part 495 subpart A of the regulations, and we proposed 
to maintain most of these definitions, including, for example, 
``Certified EHR Technology (CEHRT),'' ``Qualified EHR,'' ``Payment 
Year,'' and ``First, Second, Third, Fourth, Fifth, and Sixth Payment 
Year.'' We noted in the Stage 2 proposed rule that our definitions of 
``CEHRT'' and ``Qualified EHR'' incorporate the definitions adopted by 
ONC, and to the extent that ONC's definitions are revised, our 
definitions would also incorporate those changes. For these 
definitions, we refer readers to ONC's standards and certification 
criteria final rule that is published elsewhere in this issue of the 
Federal Register.
    We did not receive any comments on our proposal and will continue 
to use the existing definitions in part 495 subpart A, except where 
stated otherwise in this final rule.
    We stated that we would revise the descriptions of the EHR 
reporting period to clarify that providers who are demonstrating 
meaningful use for the first time would have an EHR reporting period of 
90 days regardless of payment year. We proposed to add definitions for 
the applicable EHR reporting period that would be used in determining 
the payment adjustments, as well as a definition of a payment 
adjustment year.
    A summary of the comments pertaining to the EHR reporting period, 
the applicable EHR reporting period for determining the payment 
adjustments, and the definition of a payment adjustment year, as well 
as our responses to those comments, can be found in sections II.A.3.a 
and II.D.2 of this final rule.
2. Meaningful EHR User
    We proposed to include clinical quality measure reporting as part 
of the definition of ``meaningful EHR user'' under Sec.  495.4 instead 
of as a separate meaningful use objective under Sec.  495.6.
    Comment: A few commenters suggested that this change would create 
confusion, but the majority supported this change to alleviate 
confusion caused by the current situation. Many comments discussed the 
specifics of clinical quality measures.
    Response: We appreciate the support expressed for the proposal. We 
continue to believe that separating clinical quality measures from the 
meaningful use objectives and measures in Sec.  495.6 will reduce 
confusion and finalize the change as proposed. We address comments on 
the specifics of clinical quality measures in section II.B of this 
final rule. While clinical quality measure reporting will no longer be 
listed as a separate objective and measure in Sec.  495.6, as it is now 
incorporated in the definition of meaningful EHR user in Sec.  495.4, 
it remains a condition for demonstrating meaningful use.
    We proposed to revise the third paragraph of the definition of 
meaningful EHR user at Sec.  495.4 to refer specifically to the payment 
adjustments and read as follows: ``(3) To be considered a meaningful 
EHR user, at least 50 percent of an EP's patient encounters during an 
EHR reporting period for a payment year (or during an applicable EHR 
reporting period for a payment adjustment year) must occur at a 
practice/location or practices/locations equipped with CEHRT.'' We did 
not receive any comments on this revision and we are finalizing it as 
proposed.
3. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
    In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the 
Congress identified the broad goal of expanding the use of EHRs through 
the concept of meaningful use. Section 1903(t)(6)(C) of the Act also 
requires that Medicaid providers adopt, implement, upgrade or 
meaningfully use CEHRT if they are to receive incentives under Title 
XIX. CEHRT used in a meaningful way is one piece of the broader HIT 
infrastructure needed to reform the health care system and improve 
health care quality, efficiency, and patient safety. This vision of 
reforming the health care system and improving health care quality, 
efficiency, and patient safety should inform the definition of 
meaningful use.
    As we explained in our Stage 1 meaningful use rule and again in our 
Stage 2 proposed rule, we seek to balance the sometimes competing 
considerations of health system advancement (for example, improving 
health care quality, encouraging widespread EHR adoption, promoting 
innovation) and minimizing burdens on health care providers given the 
short timeframe available under the HITECH Act.

[[Page 53973]]

    Based on public and stakeholder input received during our Stage 1 
rule, we laid out a phased approach to meaningful use. Such a phased 
approach encompasses reasonable criteria for meaningful use based on 
currently available technology capabilities and provider practice 
experience, and builds up to a more robust definition of meaningful use 
as technology and capabilities evolve. The HITECH Act acknowledges the 
need for this balance by granting the Secretary the discretion to 
require more stringent measures of meaningful use over time. 
Ultimately, consistent with other provisions of law, meaningful use of 
CEHRT should result in health care that is patient centered, evidence-
based, prevention-oriented, efficient, and equitable.
    Under this phased approach to meaningful use, we update the 
criteria of meaningful use through staggered rulemaking. We published 
the Stage 1 final rule (75 FR 44314) on July 28, 2010, and this rule 
finalizes the criteria and other requirements for Stage 2. We currently 
are planning at least one additional update, and anticipate finalizing 
the Stage 3 criteria through additional rulemaking in early 2014 with 
Stage 3 starting in 2016. The stages represent an initial graduated 
approach to arriving at the ultimate goal.
     The Stage 1 meaningful use criteria, consistent with other 
provisions of Medicare and Medicaid law, focused on electronically 
capturing health information in a structured format; using that 
information to track key clinical conditions and communicating that 
information for care coordination purposes (whether that information is 
structured or unstructured, but in structured format whenever 
feasible); implementing clinical decision support tools to facilitate 
disease and medication management; using EHRs to engage patients and 
families and reporting clinical quality measures and public health 
information. Stage 1 focused heavily on establishing the 
functionalities in CEHRT that will allow for continuous quality 
improvement and ease of information exchange. By having these 
functionalities in CEHRT at the onset of the program and requiring that 
the EP, eligible hospital or CAH become familiar with them through the 
varying levels of engagement required by Stage 1, we believe we created 
a strong foundation to build on in later years. Though some 
functionalities were optional in Stage 1, all of the functionalities 
are considered crucial to maximize the value to the health care system 
provided by CEHRT. We encouraged all EPs, eligible hospitals and CAHs 
to be proactive in implementing all of the functionalities of Stage 1 
in order to prepare for later stages of meaningful use, particularly 
functionalities that improve patient care, the efficiency of the health 
care system and public and population health. The specific criteria for 
Stage 1 of meaningful use are discussed in the Stage 1 final rule, 
published on July 28, 2010 (75 FR 44314 through 44588). We are 
finalizing certain changes to the Stage 1 criteria in section II.A.3.b. 
of this final rule.
     Stage 2: We stated in the Stage 2 proposed rule that our 
Stage 2 goals, consistent with other provisions of Medicare and 
Medicaid law, would expand upon the Stage 1 criteria with a focus on 
ensuring that the meaningful use of EHRs supports the aims and 
priorities of the National Quality Strategy. Specifically, Stage 2 
meaningful use criteria would encourage the use of health IT for 
continuous quality improvement at the point of care and the exchange of 
information in the most structured format possible. Our proposed Stage 
2 meaningful use requirements included rigorous expectations for health 
information exchange including: more demanding requirements for e-
prescribing; incorporating structured laboratory results; and the 
expectation that providers will electronically transmit patient care 
summaries with each other and with the patient to support transitions 
in care. Increasingly robust expectations for health information 
exchange in Stage 2 and Stage 3 would support the goal that information 
follows the patient. In addition, as we forecasted in the Stage 1 final 
rule, we proposed that nearly every objective that was optional for 
Stage 1 would be part of the core for Stage 2.
     Stage 3: We anticipate that Stage 3 meaningful use 
criteria will focus on: promoting improvements in quality, safety and 
efficiency leading to improved health outcomes; focusing on decision 
support for national high priority conditions; patient access to self-
management tools; access to comprehensive patient data through robust, 
secure, patient-centered health information exchange; and improving 
population health. For Stage 3, we currently intend to propose higher 
standards for meeting meaningful use. For example, we intend to propose 
that every objective in the menu set for Stage 2 be included in Stage 3 
as part of the core set. While the use of a menu set allows providers 
flexibility in setting priorities for EHR implementation and takes into 
account their unique circumstances, we maintain that all of the 
objectives are crucial to building a strong foundation for health IT 
and to meeting the objectives of the HITECH Act. In addition, as the 
capabilities of HIT infrastructure increase, we may raise the 
thresholds for these objectives in both Stage 2 and Stage 3.
    In the Stage 1 final rule (75 FR 44323), we published the following 
Table 2 with our expected timeline for the stages of meaningful use.

                                     Table 2--Stage of Meaningful Use Criteria by Payment Year as Finalized in 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Payment year
         First payment year         --------------------------------------------------------------------------------------------------------------------
                                              2011                    2012                    2013                   2014                   2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011...............................  Stage 1...............  Stage 1...............  Stage 2..............  Stage 2..............  TBD
2012...............................  ......................  Stage 1...............  Stage 1..............  Stage 2..............  TBD
2013...............................  ......................  ......................  Stage 1..............  Stage 1..............  TBD
2014...............................  ......................  ......................  .....................  Stage 1..............  TBD
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We proposed changes to this timeline as well as its extension 
beyond 2014. As we explained in the Stage 2 proposed rule, under the 
timeline used in Table 2, an EP, eligible hospital, or CAH that became 
a meaningful EHR user for the first time in 2011 would need to begin 
their EHR reporting period for Stage 2 on January 1, 2013 (EP) or 
October 1, 2012 (eligible hospital or CAH). The HITPC recommended we 
delay by 1 year the start of Stage 2 for providers who became 
meaningful EHR users in 2011. We stated in the proposed rule that Stage 
2 of meaningful use would require changes to both technology and 
workflow that cannot reasonably be expected to be completed in the time

[[Page 53974]]

between the publication of the final rule and the start of the EHR 
reporting periods as listed in Table 2. We noted the similar concerns 
we have heard from other stakeholders and agreed that, based on our 
proposed definition of meaningful use for Stage 2, providers could have 
difficulty implementing these changes in time. Therefore, we proposed a 
1-year extension of Stage 1 of meaningful use for providers who 
successfully demonstrated meaningful use for 2011. Our proposed 
timeline through 2021, which we finalize in this rule with a notation 
of the special EHR reporting period in 2014, is displayed in Table 3. 
We refer readers to section II.D.2 of this final rule for a discussion 
of the applicable EHR reporting period that will be used to determine 
whether providers are subject to payment adjustments.

                                             Table 3--Stage of Meaningful Use Criteria by First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Stage of meaningful use
                  First payment year                  --------------------------------------------------------------------------------------------------
                                                         2011     2012     2013     2014     2015     2016     2017     2018     2019     2020     2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.................................................        1        1        1       *2        2        3        3      TBD      TBD      TBD      TBD
2012.................................................  .......        1        1       *2        2        3        3      TBD      TBD      TBD      TBD
2013.................................................  .......  .......        1       *1        2        2        3        3      TBD      TBD      TBD
2014.................................................  .......  .......  .......       *1        1        2        2        3        3      TBD      TBD
2015.................................................  .......  .......  .......  .......        1        1        2        2        3        3      TBD
2016.................................................  .......  .......  .......  .......  .......        1        1        2        2        3        3
2017.................................................  .......  .......  .......  .......  .......  .......        1        1        2        2        3
--------------------------------------------------------------------------------------------------------------------------------------------------------
*3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at state option) for Medicaid EPs. All
  providers in their first year in 2014 use any continuous 90-day EHR reporting period.

    We explained in the proposed rule that the Medicare EHR incentive 
program and the Medicaid EHR incentive program have different rules 
regarding the number of payment years available, the last year for 
which incentives may be received, and the last payment year for 
initiating the program. The last year for which an EP and an eligible 
hospital or CAH can begin receiving Medicare incentive payments is 2014 
and 2015 respectively. These providers would begin in Stage 1 of 
meaningful use. Medicaid EPs and eligible hospitals can receive a 
Medicaid EHR incentive payment for ``adopting, implementing, and 
upgrading'' (AIU) to CEHRT for their first payment year, which is not 
reflected in Table 3. For example, a Medicaid EP who earns an incentive 
payment for AIU in 2013 would have to meet Stage 1 of meaningful use in 
his or her next 2 payment years (2014 and 2015). The applicable payment 
years and the incentive payments available for each program are 
discussed in the Stage 1 final rule.
    If we anticipate future criteria beyond Stage 3 of meaningful use, 
we expect to update Table 3 in the rulemaking for Stage 3, which 
remains on schedule for implementation in 2016.
    Comment: We received numerous comments, which represented a 
significant majority of all comments received, on the timing of the 
stages of meaningful use. Commenters asserted that the timeline is too 
aggressive and will result in many providers being unable to meet Stage 
2 of meaningful use, particularly those who first attested in 2011 and 
2012. The most common justification for this claim was the lack of 
sufficient time between the publication of this final rule and the time 
when a provider who first attested to meaningful use in 2011 or 2012 
would have to begin Stage 2 of meaningful use. Some commenters 
suggested that the time was insufficient regardless of resource 
constraints, while others suggested that currently vendors of CEHRT 
lack the necessary capacity to make the necessary upgrades to their 
CEHRT products and implement them for their customers in time. 
Commenters also pointed to competing priorities and demands on provider 
time and resources, such as the transition to ICD-10, the various 
programs and policies under the Affordable Care Act and other 
priorities that diminish the time and resources that can be devoted to 
reaching Stage 2 of meaningful use. Commenters offered several 
suggestions on how to increase the time available between publication 
of this final rule and the EHR reporting periods in 2014. The 
suggestions included using a shorter than full year EHR reporting 
period in 2014, delaying the start of Stage 2 until 2015 and using a 
shorter than full year EHR reporting period in 2015, and delaying the 
start of Stage 2 until 2015 with a full year EHR reporting period. 
Several commenters suggested a minimum of 18 months is needed, while 
others suggested longer periods.
    Response: While our proposal would provide more than a year between 
the publication of this final rule and the first day any provider would 
start their EHR reporting period in 2014 for any stage of meaningful 
use, we agree that additional time to demonstrate meaningful use in 
2014 would be helpful to providers, many of whom will need to upgrade 
to new technology as well as ensure they are able to meet all of the 
objectives and measures for Stage 2. In considering what would be an 
appropriate length of time between publication of this final rule and 
the start of the EHR reporting periods for providers in 2014 for either 
Stage 2 or Stage 1, we weighed two primary factors against the comments 
calling for a delay. The first is that by delaying Stage 2 until 2015, 
the movement towards improved outcomes that is the main goal of 
meaningful use would be put off by a full year. This full-year delay 
would have a ripple effect through the timeline of the stages as 
providers move along their own timelines across the stages of 
meaningful use. For this reason, we will not delay Stage 2 until 2015, 
but instead we are using a 3-month EHR reporting period in 2014 as the 
first year any provider would attest to Stage 2. The second 
consideration is the data integrity of meaningful use attestations and 
clinical quality measure submissions, especially as it relates to our 
efforts towards alignment with other programs such as PQRS, Medicare 
Shared Savings Program (SSP), and potentially others. The more robust 
data set provided by a full year reporting period offers more 
opportunity for alignment than the data set provided by a shorter 
reporting period, especially compared across years. By altering the 
reporting period from year to year the data is less comparable from 
year to year. However, we agree with commenters that the use of a 
shorter EHR reporting period in 2014 is necessary to allow sufficient 
time for vendors to upgrade their CEHRT and for

[[Page 53975]]

providers to implement it. In an effort to preserve some data validity 
with similar Medicare quality measurement programs, we are finalizing 
3-month quarter EHR reporting periods in 2014 for certain providers 
that are beyond their first year of meaningful use, rather than any 
continuous 90-day period within the year as for first-time meaningful 
users. For more information on alignment with other programs, we refer 
readers to our discussion on clinical quality measures (see section 
II.B.1. of this final rule).
    While commenters generally suggested a shorter EHR reporting period 
for the start of Stage 2 in any year rather than just Stage 2 in 2014, 
we believe that most of the reasons for a shorter period are due to the 
time constraints for vendor certification, upgrades and provider 
implementation between publication of this final rule and the beginning 
of Stage 2 in 2014. Any provider starting Stage 2 after 2014 will have 
more time and therefore most of the constraints are lifted. We 
acknowledge that not all constraints go away, but we believe that the 
balance is sufficiently shifted such that the concerns of data validity 
and program alignment outweigh the few remaining concerns with a full 
year EHR reporting period for the provider's first year of Stage 2 if 
it is after 2014. In addition, since ONC's 2014 Edition certification 
is for all EHR systems, regardless of the stage of meaningful use the 
provider using that system is in, there are far fewer implementation 
concerns after 2014. For example, if a provider begins Stage 2 in 2015, 
that provider would have been required to use CEHRT (that was certified 
to the 2014 Edition EHR certification criteria) for the previous year 
(2014) for Stage 1.
    Finally, we considered that for the Medicaid EHR incentive program, 
EPs work exclusively with the states as they must choose between either 
the Medicare or Medicaid EHR incentive program. We do not know whether 
shifting from an EHR reporting period of any continuous 90 days to a 3-
month quarter will provide any alignment benefits for Medicaid EPs, and 
it could introduce system complexity for Medicaid agencies. Therefore, 
we are maintaining flexibility for states to allow Medicaid EPs to 
select any continuous 90-day EHR reporting period during 2014 as 
defined by the state Medicaid program, or, if the state so chooses, any 
3-month calendar quarter in 2014. As nearly all hospitals participate 
in both Medicare and Medicaid, we are using the 3-month quarter EHR 
reporting period for all hospitals to align both programs.
    After consideration of the public comments received, we are 
modifying our proposal with regard to the EHR reporting periods for 
EPs, eligible hospitals and CAHs that attest to meaningful use for 2014 
for their first year of Stage 2 or their second year of Stage 1. Our 
final policy is as follows: For 2014, Medicare EPs will attest using an 
EHR reporting period of January 1, 2014 through March 31, 2014; April 
1, 2014 through June 30, 2014; July 1, 2014 through September 30, 2014; 
or October 1, 2014 through December 31, 2014. For 2014, Medicare and 
Medicaid eligible hospitals and CAHs will attest using an EHR reporting 
period of October 1, 2013 through December 31, 2013; January 1, 2014 
through March 31, 2014; April 1, 2014 through June 30, 2014; or July 1, 
2014 through September 30, 2014. Medicaid EPs will attest using an EHR 
reporting period of any continuous 90-day period between January 1, 
2014 and December 1, 2014 as defined by the state Medicaid program, or, 
if the state so chooses, any 3-month calendar quarter in 2014.
b. Changes to Stage 1 Criteria for Meaningful Use
    We proposed the following changes to the objectives and associated 
measures for Stage 1:
     Computerized Provider Order Entry (CPOE)--In 2013 (CY for 
EPs, FY for eligible hospitals/CAHs), we proposed that providers in 
Stage 1 could use the alternative denominator of the number of 
medication orders created by the EP or in the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period (for further explanation of this alternative 
denominator, see the discussion of the CPOE objective in the Stage 2 
criteria section at II.A.3.d. of this final rule).
    A provider seeking to meet Stage 1 in 2013 can use either the 
denominator defined in the Stage 1 final rule or the alternative 
denominator to calculate the percentage for the CPOE measure. We also 
proposed to require the alternative denominator for Stage 1 beginning 
in 2014.
    Comment: Commenters both supported and opposed the new denominator 
for CPOE. Those supporting the proposed denominator did so for its 
simplicity and greater accuracy for measuring actual CPOE usage. Those 
opposing the proposed denominator did so either because they were 
concerned with the burden associated with counting paper or other 
orders that are never entered into the EHR or because of the potential 
higher performance required by the proposed denominator.
    Response: We proposed the alternative denominator to alleviate the 
burden associated with measurement, not to create a higher performance 
threshold. As we stated in the proposed rule, feedback from many 
providers indicated that the alternative denominator was more easily 
measurable. In response to concerns from commenters, we are finalizing 
the alternative denominator for this measure and specify that providers 
at any year in Stage 1 may elect to use either the denominator defined 
in the Stage 1 final rule or the alternative denominator to calculate 
the percentage for the CPOE measure. In response to comments, we are 
not requiring that the alternative denominator be used beginning in 
2014, which will give providers who may find it difficult to measure 
the flexibility to continue to use the denominator defined in the Stage 
1 final rule.
     Vital Signs--For the objective of record and chart changes 
in vital signs, the proposed Stage 2 measure would allow an EP to split 
the exclusion and exclude blood pressure only or height/weight only 
(for more detail, see the discussion of this objective in the Stage 2 
criteria section at II.A.3.d. of the final rule). We proposed an 
identical change to the Stage 1 exclusion as well, starting in CY 2013. 
We also proposed changing the age limitations on vital signs for Stage 
2 (for more detail, see the discussion of this objective in the Stage 2 
criteria section). We proposed an identical change to the age 
limitations on vital signs for Stage 1, starting in 2013 (CY for EPs, 
FY for eligible hospitals/CAHs). These changes to the exclusion and age 
limitations were proposed as an alternative in 2013 to the current 
Stage 1 requirements but required for Stage 1 beginning in 2014.
    Comment: While some commenters suggested that these changes would 
be confusing, most commenters supported the changes and indicated that 
they would provide added flexibility for providers who seek to 
incorporate the recording of this data into their clinical workflow. 
These commenters also noted that the age change reflects best clinical 
practices. Some commenters suggested removing BMI and growth charts 
from the measure since there are no best practices on BMI for patients 
under 3 years of age and since providers who would not record height 
and weight would not be able to provide BMI or growth charts.
    Response: We appreciate the support for these changes and finalize 
them as proposed. We also note that BMI and

[[Page 53976]]

growth charts are not required to meet this measure but are instead a 
capability provided by CEHRT. Providers who claim the exclusion for 
height and weight will not have data for CEHRT to create either BMI or 
growth charts and this will not affect their ability to meet the 
measure of this objective.
    Comment: Some commenters requested clarification on whether 
providers who provide ancillary services and do not normally record any 
of these elements as part of their regular scope of practice can claim 
the exclusion.
    Response: If a provider believes that height and weight and/or 
blood pressure are relevant to their scope of practice, they must 
record those data elements and cannot qualify for the exclusion. We 
believe that most providers who provide ancillary services can meet the 
measure of this objective by obtaining this information from a 
referring provider and recording the necessary data in their CEHRT.
    Comment: Some providers asked for clarification on whether 
providers who only occasionally record height and weight and/or blood 
pressure are still permitted to claim the exclusions for this measure.
    Response: We recognize that there are situations in which certain 
providers may only record height and weight and/or blood pressure for a 
very limited number of patients (for example, high-risk surgical 
patients or patients on certain types of medication) but do not 
normally regard these data as relevant to their scope of practice. When 
a provider does not believe that height and weight and/or blood 
pressure are typically relevant to their scope of practice but still 
records these vital signs only in exceptional circumstances, the 
provider is permitted to claim the exclusions for this measure.
    After consideration of the public comments received, we are 
finalizing the changes to vital signs as proposed. We are making 
technical corrections to the regulation text at Sec.  495.6(d)(8) and 
Sec.  495.6(f)(7) to clarify these are alternatives in 2013 and 
required beginning in 2014.
     Exchange Key Clinical Information--As noted in the 
proposed rule, the objective of ``capability to exchange key clinical 
information'' has been surprisingly difficult for providers to 
understand, which has made the objective difficult for most providers 
to achieve. We solicited comment on several options for this objective 
that we believed would reduce or eliminate the burden associated with 
this objective or increase the value of the objective. The first option 
we considered was removal of this objective. The second option was to 
require that the test be successful. The third option was to eliminate 
the objective, but require that providers select either the Stage 1 
medication reconciliation objective or the Stage 1 summary of care at 
transitions of care and referrals objective from the menu set. The 
fourth option was to move from a test to one case of actual electronic 
transmission of a summary of care document for a real patient either to 
another provider of care at a transition or referral or to a patient 
authorized entity. We proposed the first option to remove this 
objective and measure from the Stage 1 core set beginning in 2013 (CY 
for EPs, FY for eligible hospitals/CAHs), but we also stated we would 
evaluate all four options in light of the public comments we received.
    Comment: While we received feedback and support from commenters on 
all of the proposed options, the majority of commenters supported the 
elimination of this objective for Stage 1. Some commenters instead 
supported a more exact definition of data exchange for this measure, 
and other commenters supported additional elements or additional 
requirements for exchange to be included as part of the measure. Other 
proposals included implementing a system that would allow case-by-case 
reporting of data exchange that would allow CMS to measure successes 
and failures by provider, vendor, and other elements.
    Response: We appreciate the many suggestions from commenters on 
clarifying data exchange and/or adding requirements to the measure. We 
also appreciate the suggestion of a case-by-case reporting system for 
data exchange. However, we are concerned that all of these options 
would not alleviate but actually increase the burden of this measure 
for providers by requiring them to document and submit substantially 
greater information than is currently required by attestation. While 
such a burden may be justified, we do not believe it is in this case 
because the Stage 2 requirements for actual electronic exchange of 
summary of care records create sufficient incentive to begin testing in 
Stage 1 without there being an explicit meaningful use requirement to 
do so. Because of these concerns and in reaction to the opinion of most 
commenters, we are finalizing the removal of this objective and measure 
for Stage 1 beginning in 2013. Although some commenters suggested 
removing this objective earlier, we do not believe the timing of 
publication of this final rule would allow us to implement such a 
change and allow consistent reporting for all providers in 2012. 
Therefore, this objective and measure will be removed from the Stage 1 
criteria beginning in 2013 (CY for EPs, FY for eligible hospitals and 
CAHs).
     View Online, Download, and Transmit--We proposed for Stage 
2 a new method for making patient information available electronically, 
which would enable patients to view online, download, and transmit 
their health information and hospital admission information. We discuss 
in the Stage 2 criteria section at II.A.3.d the ``view online, 
download, and transmit'' objectives for EPs and hospitals. We noted in 
the proposed rule that starting in 2014, CEHRT would no longer be 
certified to the Stage 1 EP and hospital core objectives of providing 
patients with electronic copies of their health information (Sec.  
495.6(d)(12) and (f)(11)) or the Stage 1 hospital core objective of 
providing patients with electronic copies of their discharge 
instructions upon request (Sec.  495.6(f)(12)), nor would it support 
the Stage 1 EP menu objective of providing patients with timely 
electronic access to their health information (Sec.  495.6(e)(5)). 
Therefore starting in 2014, for Stage 1, we proposed to replace these 
objectives with the new ``view online, download and transmit'' 
objectives.
    Comment: There were a number of commenters who asked for 
clarifications regarding the requirements of these objectives. Other 
commenters raised concerns regarding the implementation of these 
objectives in both Stage 1 and Stage 2.
    Response: We discuss the clarifications and concerns raised by 
commenters in our Stage 2 criteria at II.A.3.d regarding these 
objectives. Please refer to those discussions for additional 
information.
    Comment: Some commenters supported this change while other 
commenters disagreed with it. Those who disagreed with the proposed 
change indicated that providers would not be ready to implement online 
access to health information in Stage 1, and that it was unlikely that 
providers could convince more than 50 percent of patients to sign up 
for online access within the Stage 1 reporting period. These commenters 
suggested eliminating all of the Stage 1 objectives for providing 
electronic copies of health information or discharge summaries and not 
replacing these objectives with the ``view, download, and transmit'' 
objectives.
    Response: We disagree that the Stage 1 objectives for providing 
patients with electronic copies of their health information and 
discharge instructions should be eliminated without replacing

[[Page 53977]]

these objectives with the ``view online, download, and transmit'' 
objectives. We believe patient access to their health information is an 
important aspect of patient care and engagement, and we further believe 
that the capabilities of CEHRT in 2014 and beyond will enable providers 
to make this information available online in a way that does not impose 
a significant burden on providers.
    We note that only the first measure of the ``view online, download, 
and transmit'' objectives would be required for Stage 1. This means 
that providers would only have to make information available online to 
view online, download, and transmit for more than 50 percent of all 
unique patients during the EHR reporting period in order to meet the 
measure. We further clarify that providers are only required to make 
this information available online to view online, download, and 
transmit and that patients who do not access the information or would 
not affect whether or not the provider is able to meet the measure. For 
Stage 1, providers are not required to meet the second measure of more 
than 5 percent of patients view online, download, or transmit to a 
third party their health or hospital admission information. Providers 
are only required to meet the second measure of the objectives in Stage 
2. However, the exclusions for these objectives are available for 
providers in Stage 1. Therefore, we are finalizing our proposal to 
replace the existing Stage 1 EP and hospital objectives listed above 
with the ``view online, download, and transmit'' objectives beginning 
in 2014 for Stage 1. We are making a technical correction to the 
regulations text to clarify that the existing Stage 1 objective at 
Sec.  495.6(f)(11) is being replaced. We clarify in Table 4 the four 
existing Stage 1 objectives that are being replaced. We are also making 
a technical correction to the regulation text to remove the existing 
exclusion for the objective at Sec.  495.6(f)(12)(iii) beginning in 
2014 because the objective that this exclusion applies to is being 
replaced.
     Removing CQM Reporting from Stage 1 Objectives--We 
proposed a revised definition of a meaningful EHR user at Sec.  495.4 
which would incorporate the requirement to submit clinical quality 
measures, as discussed in section II.A.2 of this final rule. We also 
proposed to remove the objective to submit clinical quality measures 
from Sec.  495.6 beginning in 2013 for Stage 1 to conform with this 
change in the definition of a meaningful EHR user.
    Comment: While some commenters indicated that this change would be 
confusing, most commenters supported this change.
    Response: We appreciate the support of commenters and believe that 
removing the objective will actually alleviate confusion. Therefore, as 
discussed earlier in II.A.2. of this final rule, we are finalizing as 
proposed, the revised definition of a meaningful EHR user at Sec.  
495.4 to include clinical quality measure submission, as well as the 
removal of this objective from Sec.  495.6 beginning in 2013.
     Public Health Objectives--For the Stage 1 public health 
objectives, beginning in 2013, we proposed to add ``except where 
prohibited'' to the regulation text in order to encourage all EPs, 
eligible hospitals, and CAHs to submit electronic immunization data, 
even when not required by state/local law. Therefore, if they are 
authorized to submit the data, they should do so even if it is not 
required by either law or practice. There are a few instances where 
some EPs, eligible hospitals, and CAHs are prohibited from submitting 
to a state/local immunization registry. For example, in sovereign 
tribal areas that do not permit transmission to an immunization 
registry or when the immunization registry only accepts data from 
certain age groups (for example, adults).
    Comment: Some commenters supported this change while others 
disagreed with it. A number of commenters interpreted the proposed 
addition of language as a change to either the measure of the 
objectives or the exclusions that are currently in place.
    Response: As noted in the proposed rule, the addition of this 
language was intended to ensure that providers who are not required by 
law or practice to submit data would do so and to make it clear that 
EPs, eligible hospitals, and CAHs that are prohibited from submitting 
data would not be required to submit such data. Immunizations was used 
as a descriptive example in the proposed rule, but this change applies 
to all Stage 1 public health objectives. The exclusions provided for 
these objectives in Stage 1 are not affected by the addition of this 
language and remain in place for all providers. Therefore, we are 
finalizing the addition of this language as proposed.
     Menu Set Exclusions Policy--We proposed to change the 
policy on menu set exclusions for Stage 1 beginning in 2014. Please see 
section II.A.3.d. of this final rule for a discussion of the proposal 
and our final policy.
 Electronic Prescribing
    Comment: We received comments pointing out that we proposed a new 
exclusion for electronic prescribing objective for Stage 2 regarding 
the availability of pharmacies that can accept electronic 
prescriptions. These commenters noted that if this exclusion was not 
also made available for Stage 1 then it would create a strange scenario 
where an EP might have to electronically prescribe during their 2 years 
of Stage 1 and then meet an exclusion in Stage 2.
    Response: We agree that it makes no sense to apply this exclusion 
to e-prescribing in Stage 2, but not in Stage 1. We consider it an 
oversight of our proposed rule that we did not include that exclusion 
in our proposed changes to the Stage 1 criteria. We are finalizing an 
exclusion for the e-prescribing objective in Stage 2 for any EP who 
does not have a pharmacy within their organization and there are no 
pharmacies that accept electronic prescriptions within 10 miles of the 
EP's practice location at the start of his/her EHR reporting period. We 
are also finalizing the addition of this exclusion to Stage 1 starting 
in CY 2013.

                        Table 4--Stage 1 Changes
------------------------------------------------------------------------
                                                         Effective year
       Stage 1 objective             Final changes           (CY/FY)
------------------------------------------------------------------------
Use CPOE for medication orders  Change: Addition of an  2013 [dash]
 directly entered by any         alternative measure     Onward
 licensed healthcare             More than 30 percent    (Optional).
 professional who can enter      of medication orders
 orders into the medical         created by the EP or
 record per state, local and     authorized providers
 professional guidelines.        of the eligible
                                 hospital's or CAH's
                                 inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period are recorded
                                 using CPOE.

[[Page 53978]]

 
Generate and transmit           Change: Addition of an  2013--Onward
 permissible prescriptions       additional exclusion    (Required).
 electronically (eRx).           Any EP who: does not
                                 have a pharmacy
                                 within their
                                 organization and
                                 there are no
                                 pharmacies that
                                 accept electronic
                                 prescriptions within
                                 10 miles of the EP's
                                 practice location at
                                 the start of his/her
                                 EHR reporting period.
Record and chart changes in     Change: Addition of     2013 Only
 vital signs.                    alternative age         (Optional).
                                 limitations More than
                                 50 percent of all
                                 unique patients seen
                                 by the EP or admitted
                                 to the eligible
                                 hospital's or CAH's
                                 inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period have blood
                                 pressure (for
                                 patients age 3 and
                                 over only) and height
                                 and weight (for all
                                 ages) recorded as
                                 structured data.
Record and chart changes in     Change: Addition of     2013 Only
 vital signs.                    alternative             (Optional).
                                 exclusions.
                                Any EP who
                                (1) Sees no patients 3
                                 years or older is
                                 excluded from
                                 recording blood
                                 pressure;
                                (2) Believes that all
                                 three vital signs of
                                 height, weight, and
                                 blood pressure have
                                 no relevance to their
                                 scope of practice is
                                 excluded from
                                 recording them;
                                (3) Believes that
                                 height and weight are
                                 relevant to their
                                 scope of practice,
                                 but blood pressure is
                                 not, is excluded from
                                 recording blood
                                 pressure; or
                                (4) Believes that
                                 blood pressure is
                                 relevant to their
                                 scope of practice,
                                 but height and weight
                                 are not, is excluded
                                 from recording height
                                 and weight.
Record and chart changes in     Change: Age             2014--Onward
 vital signs.                    limitations on          (Required).
                                 height, weight and
                                 blood pressure.
                                More than 50 percent
                                 of all unique
                                 patients seen by the
                                 EP or admitted to the
                                 eligible hospital's
                                 or CAH's inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period have blood
                                 pressure (for
                                 patients age 3 and
                                 over only) and height
                                 and weight (for all
                                 ages) recorded as
                                 structured data.
Record and chart changes in     Change: Changing the    2014--Onward
 vital signs.                    age and splitting the   (Required).
                                 EP exclusion.
                                Any EP who
                                (1) Sees no patients 3
                                 years or older is
                                 excluded from
                                 recording blood
                                 pressure;
                                (2) Believes that all
                                 three vital signs of
                                 height, weight, and
                                 blood pressure have
                                 no relevance to their
                                 scope of practice is
                                 excluded from
                                 recording them;
                                (3) Believes that
                                 height and weight are
                                 relevant to their
                                 scope of practice,
                                 but blood pressure is
                                 not, is excluded from
                                 recording blood
                                 pressure; or
                                (4) Believes that
                                 blood pressure is
                                 relevant to their
                                 scope of practice,
                                 but height and weight
                                 are not, is excluded
                                 from recording height
                                 and weight.
Capability to exchange key      Change: Objective is    2013--Onward
 clinical information (for       no longer required.     (Required).
 example, problem list,
 medication list, medication
 allergies, and diagnostic
 test results), among
 providers of care and patient
 authorized entities
 electronically.
Report ambulatory (hospital)    Change: Objective is    2013--Onward
 clinical quality measures to    incorporated directly   (Required).
 CMS or the states.              into the definition
                                 of a meaningful EHR
                                 user and eliminated
                                 as an objective under
                                 Sec.   495.6.
EP and Hospital Objectives:     Change: Replace these   2014--Onward
 Provide patients with an        four objectives with    (Required).
 electronic copy of their        the Stage 2 objective
 health information (including   and one of the two
 diagnostics test results,       Stage 2 measures..
 problem list, medication
 lists, medication allergies,
 discharge summary,
 procedures) upon request.
                                EP Objective: Provide
                                 patients the ability
                                 to view online,
                                 download, and
                                 transmit their health
                                 information within 4
                                 business days of the
                                 information being
                                 available to the EP..
                                EP Measure: More than
                                 50 percent of all
                                 unique patients seen
                                 by the EP during the
                                 EHR reporting period
                                 are provided timely
                                 (within 4 business
                                 days after the
                                 information is
                                 available to the EP)
                                 online access to
                                 their health
                                 information subject
                                 to the EP's
                                 discretion to
                                 withhold certain
                                 information.

[[Page 53979]]

 
Hospital Objective: Provide     Hospital Objective:
 patients with an electronic     Provide patients the
 copy of their discharge         ability to view
 instructions at time of         online, download, and
 discharge, upon request.        transmit information
                                 about a hospital
                                 admission.
EP Objective: Provide patients  Hospital Measure: More
 with timely electronic access   than 50 percent of
 to their health information     all patients who are
 (including lab results,         discharged from the
 problem list, medicatiion       inpatient or
 lists, and allergies) within    emergency department
 4 business days of the          (POS 21 or 23) of an
 information being available     eligible hospital or
 to the EP..                     CAH have their
                                 information available
                                 online within 36
                                 hours of discharge.
Public Health Objectives:       Change: Addition of     2013--Onward
                                 ``except where          (Required).
                                 prohibited'' to the
                                 objective regulation
                                 text for the public
                                 health objectives
                                 under Sec.   495.6.
------------------------------------------------------------------------
                         Stage 1 Policy Changes
------------------------------------------------------------------------
Meeting an exclusion for a      Meeting an exclusion    2014--Onward
 menu set objective counts       for a menu set          (Required).
 towards the number of menu      objective does not
 set objectives that must be     count towards the
 satisfied to meet meaningful    number of menu set
 use.                            objectives that must
                                 be satisfied to meet
                                 meaningful use..
------------------------------------------------------------------------

c. State Flexibility for Stage 2 of Meaningful Use
    We proposed to offer states flexibility under the Medicaid 
incentive program with the public health measures in Stage 2, similar 
to that of Stage 1, subject to the same conditions and standards as the 
Stage 1 flexibility policy. This applies to the public health measures 
as well as the measure to generate lists of specific conditions to use 
for quality improvement, reduction of disparities, research or 
outreach. We clarify that our proposal included the existing public 
health measures from Stage 1 as well as the new public health measures 
proposed for Stage 2.
    In addition, we stated that whether a state moved an objective to 
the core or left it in the menu, states may also specify the means of 
transmission of the data or otherwise change the public health measure, 
as long as it does not require EHR functionality above and beyond that 
which is included in the 2014 ONC EHR certification criteria.
    We solicited comments on extending state flexibility as described 
for Stage 2 of meaningful use and whether this remains a useful tool 
for state Medicaid agencies.
    Comment: Commenters requested clarification of the requirement that 
states cannot require EHR functionality above and beyond that which is 
included in the 2014 ONC EHR certification criteria. These commenters 
point out that the Stage 2 public health measures require capabilities 
beyond that which is included in the 2014 ONC EHR certification 
criteria already.
    Response: We assume commenters are referring to transmission 
methods which are not included in 2014 Edition EHR certification 
criteria adopted by ONC for public health objectives (immunizations, 
electronically reportable lab results, syndromic surveillance, cancer 
registries and specialized registries). This limitation applies only to 
those capabilities and standards included in 2014 ONC EHR certification 
criteria for a given public health objective. For example, a state 
could not require a different standard than the one included in 2014 
ONC EHR certification criteria. In cases where the 2014 ONC EHR 
certification criteria are silent, such as the means of transmission 
for a given public health objective, the state may propose changes to 
public health measures.
    Comment: Several commenters supported extending state flexibility 
with meaningful use for Stage 2, but requested that CMS provide a 
clearer definition of state flexibility. Commenters suggested that it 
would be helpful to EPs and eligible hospitals if states follow a 
common timeline for establishing state-specific requirements.
    Response: We appreciate these comments and would like to clarify 
that the state flexibility for Stage 2 remains defined the same way as 
it is defined in Stage 1 at Sec.  495.316 (d)(2) and Sec.  495.322 
(f)(2). Given that states are launching their programs at different 
times and are therefore at different stages in the program lifecycle 
and process, at this time we do not support the development of a common 
timeline for establishing state-specific requirements. The parameters 
remain the same as for Stage 1 and providers are subject to the 
requirements found in Sec.  495.332. CMS approval of states' requests 
will include a review of the outlined elements.
    After consideration of the public comments received, we are 
finalizing these provisions as proposed.
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
    We proposed to continue the Stage 1 concept of a core set of 
objectives and a menu set of objectives for Stage 2. In the Stage 1 
final rule (75 FR 44322), we indicated that for Stage 2, we expected to 
include the Stage 1 menu set objectives in the core set. We proposed to 
follow that approach for our Stage 2 core set with two exceptions. We 
proposed to keep the objective of ``capability to submit electronic 
syndromic surveillance data to public health agencies'' in the menu set 
for EPs. Our experience with Stage 1 is that very few public health 
agencies have the ability to accept non-emergency or non urgent care 
ambulatory syndromic surveillance data electronically and those that do 
are less likely to support EPs than hospitals; therefore we do not 
believe that current infrastructure supports moving this objective to 
the core set for EPs. We also proposed to keep the objective of 
``record advance directives'' in the menu set for eligible hospitals 
and CAHs. As we stated in our Stage 1 final rule (75 FR 44345), we have 
continuing concerns that there are potential conflicts between storing 
advance directives and existing state laws.
    We proposed new objectives for Stage 2, some of which would be part 
of the

[[Page 53980]]

Stage 2 core set and others would make up the Stage 2 menu set, as 
discussed below with each objective. We proposed to eliminate certain 
Stage 1 objectives for Stage 2, such as the objective for testing the 
capability to exchange key clinical information. We proposed to combine 
some of the Stage 1 objectives for Stage 2. For example, the objectives 
of maintaining an up-to-date problem list, active medication list, and 
active medication allergy list would not be separate objectives for 
Stage 2. Instead, we proposed to combine these objectives with the 
objective of providing a summary of care record for each transition of 
care or referral by including them as required fields in the summary of 
care.
    We proposed a total of 17 core objectives and 5 menu objectives for 
EPs. We proposed that an EP must meet the criteria or an exclusion for 
all of the core objectives and the criteria for 3 of the 5 menu 
objectives. This is a change from our current Stage 1 policy where an 
EP could reduce the number of menu set objectives that the EP would 
otherwise need to meet by the number of menu set objectives that the EP 
could exclude. We noted the feedback we received on Stage 1 from 
providers and health care associations leads us to believe that most 
EPs had difficulty understanding the concept of deferral of a menu 
objective in Stage 1. Therefore, we proposed this change for Stage 2, 
as well as for Stage 1 beginning in 2014, to make the selection of menu 
objectives easier for EPs. We also proposed this change because we are 
concerned that under the current Stage 1 requirements some EPs could 
select and exclude menu objectives when there are other menu objectives 
they can legitimately meet, thereby making it easier for them to 
demonstrate meaningful use than EPs who attempt to legitimately meet 
the full complement of menu objectives. Although we provided the 
ability to do this in the selection of Stage 1 menu objectives through 
2013, we stated that EPs participating in Stage 1 and Stage 2 starting 
in 2014 should focus solely on those objectives they can meet rather 
than those for which they have an exclusion. In addition, we noted the 
exclusions for the Stage 2 menu objectives that we believe would 
accommodate EPs who are unable to meet certain objectives because of 
scope of practice. However, just as we signaled in our Stage 1 
regulation, we stated our intent to propose in our next rulemaking that 
every objective in the menu set for Stage 2 (as described later in this 
section) be included in Stage 3 as part of the core set.
    We explained that in the case where an EP meets the criteria for 
the exclusions for 3 or more of the Stage 2 menu objectives, the EP 
would have more exclusions than the allowed deferrals. EPs in this 
situation would attest to an exclusion for 1 or more menu objectives in 
his or her attestation to meaningful use. In doing so, the EP would be 
attesting that he or she also meets the exclusion criteria for all of 
the menu objectives that he or she did not choose. We stated that the 
same policy would also apply for the Stage 1 menu objectives for EPs 
beginning in 2014.
    We proposed a total of 16 core objectives and 4 menu objectives for 
eligible hospitals and CAHs for Stage 2. We proposed that an eligible 
hospital or CAH must meet the criteria or an exclusion for all of the 
core objectives and the criteria for 2 of the 4 menu objectives. We 
proposed that the policy for exclusions for EPs discussed in the 
preceding paragraph would also apply to eligible hospitals and CAHs for 
Stage 1 beginning in 2014 and for Stage 2.
    We received many comments on the appropriateness of individual 
objectives placement in the core or menu set. We discuss these comments 
below for each individual objective.
    Comment: Commenters expressed concern over the small number of 
objectives in the menu set. They were concerned that the small number 
of objectives limited the usefulness of the menu set to providers.
    Response: Stage 2 does contain a more specialized and smaller menu 
set than Stage 1. We see this as a natural result of moving up the 
staged path towards improved outcomes and adding fewer new objectives. 
We also see specialization as necessary for meaningful use to be 
applicable to all EPs. Due to comments received we are adding two 
objectives for hospitals and one for EPs which will be in the menu, as 
further explained later in this section.
    After consideration of the public comments received, we finalize 
the concept of a core and menu set for Stage 2.
    We finalize a total of 17 core objectives and 6 menu objectives for 
EPs for Stage 2. We finalize that an EP must meet the criteria or an 
exclusion for all of the core objectives and the criteria for 3 of the 
6 menu objectives unless an exclusion can be claimed for more than 3 of 
the menu objectives in which case the criteria for the remaining non-
excluded objectives must be met.
    We finalize a total of 16 core objectives and 6 menu objectives for 
eligible hospitals and CAHs for Stage 2. We finalize that an eligible 
hospital or CAH must meet the criteria or an exclusion for all of the 
core objectives and the criteria for 3 of the 6 menu objectives.
    We also finalize our proposal to change the menu set exclusions 
policy for Stage 1. Beginning in 2014, qualifying for an exclusion from 
a menu set objective will no longer reduce the number of menu set 
objectives that an EP or hospital must otherwise satisfy to demonstrate 
meaningful use for Stage 1. There is an exception for EPs who meet the 
criteria to exclude five or more of the menu set objectives, in which 
case the EP must meet the criteria for all of the remaining non-
excluded menu set objectives. This exception would not be applicable to 
hospitals due to the number of hospital menu set objectives that 
include exclusions.
(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs Can 
Meet All Stage 2 Meaningful Use Objectives Given Established Scopes of 
Practice
    We noted in the proposed rule that we do not believe that any of 
the proposed new objectives for Stage 2 make it impossible for any EP, 
eligible hospital or CAH to meet meaningful use. Where scope of 
practice may prevent an EP, eligible hospital or CAH from meeting the 
measure associated with an objective, we discussed the barriers and 
included exclusions in our descriptions of the individual objectives. 
We proposed to include new exclusion criteria when necessary for new 
objectives, continue the Stage 1 exclusions for Stage 2, and continue 
the option for EPs and hospitals to defer some of the objectives in the 
menu set unless they meet the exclusion criteria for more objectives 
than they can defer as explained previously.
    We recognized in the proposed rule that at the time of publication, 
our data (derived internally from attestations) only reflected the 
meaningful use attestations from Medicare providers. There have been no 
significant changes in the data derived from meaningful use 
attestations since the publication of the proposed rule.
    We did not receive any comments on this provision.
(2) EPs Practicing in Multiple Practices/Locations
    We proposed for Stage 2 to continue our policy that to be a 
meaningful EHR user, an EP must have 50 percent or more of his or her 
outpatient encounters during the EHR reporting period at a practice/
location or practices/locations equipped with CEHRT. An EP who does not 
conduct at least 50 percent of their patient encounters in any one 
practice/location would have to meet the 50

[[Page 53981]]

percent threshold through a combination of practices/locations equipped 
with CEHRT. We gave the following in the proposed rule example: if the 
EP practices at a federally qualified health center (FQHC) and within 
his or her individual practice at 2 different locations, we would 
include in our review all 3 of these locations, and CEHRT would have to 
be available at one location or a combination of locations where the EP 
has 50 percent or more of his or her patient encounters. If CEHRT is 
only available at one location, then only encounters at this location 
would be included in meaningful use assuming this one location 
represents 50 percent or more of the EP's patient encounters. If CEHRT 
is available at multiple locations that collectively represent 50 
percent or more of the EP's patient encounters, then all encounters 
from those locations would be included in meaningful use.
    In the proposed rule we stated that we have received many inquiries 
on this requirement since the publication of the Stage 1 final rule. We 
define patient encounter as any encounter where a medical treatment is 
provided and/or evaluation and management services are provided. This 
includes both individually billed events and events that are globally 
billed, but are separate encounters under our definition. We define a 
practice/location as equipped with CEHRT if the record of the patient 
encounter that occurs at that practice/location is created and 
maintained in CEHRT. This can be accomplished in three ways: CEHRT 
could be permanently installed at the practice/location, the EP could 
bring CEHRT to the practice/location on a portable computing device, or 
the EP could access CEHRT remotely using computing devices at the 
practice/location. Although it is currently allowed under Stage 1 for 
an EP to create a record of the encounter without using CEHRT at the 
practice/location and then later input that information into CEHRT that 
exists at a different practice/location, we do not believe this process 
takes advantage of the value CEHRT offers. We proposed not to allow 
this practice beginning in 2013. We have also received inquiries 
whether the practice locations have to be in the same state, to which 
we clarify that they do not. Finally, we received inquiries regarding 
the interaction with hospital-based EP determination. The determination 
of whether an EP is hospital-based or not occurs prior to the 
application of this policy, so only nonhospital-based eligible 
professionals are included. Furthermore, this policy, like all 
meaningful use policies for EPs, only applies to outpatient settings 
(all settings except the inpatient and emergency department of a 
hospital).
    Comment: Some commenters suggested that for EPs practicing in 
multiple locations that meaningful use attestations should be limited 
to just reporting on meaningful use for the most prevalent location due 
to the difficulty in aggregating data across locations.
    Response: We continue to believe that for the core measures, 
aggregating data is not overly burdensome. We allow the numerators and 
denominators calculated by CEHRT to be summed across an EP's various 
practice locations.
    Comment: We received request for clarification on what to do when 
an EP is practicing in multiple locations that select different menu 
objectives to pursue, and the EP does not control this selection.
    Response: An EP who does not have the same menu objectives 
implemented across each of their practice locations equipped with CEHRT 
would attest to the three menu objectives that represent the greatest 
number of their patient encounters. For example, if six menu objectives 
are implemented between two locations, an EP would attest to the three 
menu objectives implemented at the location where they have the 
greatest number of encounters during the EHR reporting period. For 
measures that utilize a percentage threshold, they can limit the 
denominator to the location or locations that pursued that menu 
objective.
    After consideration of the public comments received, we are 
finalizing the proposed provisions with the modifications previously 
discussed.
(3) Discussion of the Reporting Requirements of the Measures Associated 
With the Stage 2 Meaningful Use Objectives
    In our experience with Stage 1, we found the distinction between 
limiting the denominators of certain measures to only those patients 
whose records are maintained using CEHRT, but including all patients in 
the denominators of other measures, to be complicated for providers to 
implement. We proposed to remove this distinction for Stage 2 and 
instead include all patients in the denominators of all of the measures 
associated with the meaningful use objectives for Stage 2. We believe 
that by the time an EP, eligible hospital, or CAH has reached Stage 2 
of meaningful use all or nearly all of their patient population should 
be included in their CEHRT, making this distinction no longer relevant.
    Comment: We received comments that maintain that this distinction 
is still necessary for Stage 2 because there are situations where 
significant patient records may still be maintained outside of CEHRT. 
Examples provided by commenters include worker's compensation or other 
special contracts for certain patients, specialized departments or 
units in a hospital for which CEHRT is not tailored and patient 
requests to keep their records on paper.
    Response: We continue to believe that nearly all patient records 
will be stored in CEHRT by the time a provider reaches Stage 2. 
However, we acknowledge that if this assertion is correct then there is 
no practical consequence of maintaining the distinction, while if it is 
not, removing the distinction could have adverse impacts on providers.
    After consideration of the comments, we are not finalizing our 
proposed change. Instead, we maintain the distinction between measures 
that include only those patients whose records are maintained using 
CEHRT and measures that include all patients. Providers may limit the 
denominator to those patients whose records are maintained using CEHRT 
for measures with a denominator other than unique patients seen by the 
EP during the EHR reporting period or unique patients admitted to the 
eligible hospital's or CAH's inpatient or emergency department during 
the EHR reporting period.
    Comment: Some commenters suggested that the denominators should be 
limited to either just Medicare-covered patients for those 
participating in the Medicare EHR Incentive Program or just Medicaid-
covered patients for those participating in the Medicaid EHR Incentive 
Program. Commenters presented two arguments in favor of this 
suggestion. First, that requiring a provider to include all patients 
was more burdensome than including just Medicare-covered or Medicaid-
covered patients and that this burden was not offset by the incentive 
payments that are based (for Medicare only) on charges submitted to 
Medicare. Second, that if identifiable patient data was included in 
Medicare or Medicaid meaningful use reporting for patient not covered 
by Medicare or Medicaid this would raise serious privacy concerns and 
possibly require patient consent. Other commenters were supportive of 
current denominators that does not account for payers.

[[Page 53982]]

    Response: We discussed the burden differences between all patients 
versus patients differentiated by payer in our Stage 1 final rule (75 
FR44332). We continue to believe that it is highly unlikely that 
providers will use different record keeping systems based on payer. 
Where there are differences in patient populations such as age we 
account for them directly in the measure not indirectly with payer as a 
generalized proxy. The burden of breaking out the patients by payer for 
purposes of meaningful use measurement would have only increased from 
the publication of the Stage 1 final rule as measurement tools have 
been designed and implemented to measure patients regardless of payer. 
If at a future date, the demonstration of meaningful use includes the 
submission of identifiable patient data we will certainly address the 
privacy implications of that requirement. However, the Stage 1 
objectives and measures and Stage 2 objectives and measures included in 
this final rule do not require the submission of identifiable patient 
information. We are not making any changes to this policy in this final 
rule.
    We proposed new objectives that could increase reporting burden. To 
minimize the burden, we proposed to create a uniform set of 
denominators that would be used for all of the Stage 2 meaningful use 
objectives, as discussed later.
    Many of our meaningful use objectives use percentage-based measures 
if appropriate. To provide a check on the burden of reporting of 
meaningful use, we proposed for Stage 2 to use 1 of 4 denominators for 
each of the measures associated with the meaningful use objectives. We 
focused on denominators because the action that moves something from 
the denominator to the numerator usually requires the use of CEHRT by 
the provider. These actions are easily tracked by the technology.
    The four proposed denominators for EPs are--
     Unique patients seen by the EP during the EHR reporting 
period (stratified by age or previous office visit);
     Number of orders (medication, labs, radiology);
     Office visits, and
     Transitions of care/referrals.
    Comment: We received many comments supporting our efforts to 
minimize the variety of denominators. Some commenters argued that any 
variation (such as by age or orders of different types) should be 
considered separate denominators.
    Response: We appreciate the support for our proposal to minimize 
the variety of denominators. Our base of four denominators are only 
modified by information that must be entered into CEHRT in order to 
meet meaningful use; therefore, we believe that such modifications 
represent a small burden and are in keeping with our overall goal in 
minimizing the variety of denominators.
    In the proposed rule, we stated that the term ``unique patient'' 
means that if a patient is seen or admitted more than once during the 
EHR reporting period, the patient only counts once in the denominator. 
Patients seen or admitted only once during the EHR reporting period 
will count once in the denominator. A patient is seen by the EP when 
the EP has an actual physical encounter with the patient in which they 
render any service to the patient. A patient seen through telemedicine 
will also still count as a patient ``seen by the EP.'' In cases where 
the EP and the patient do not have an actual physical or telemedicine 
encounter, but the EP renders a minimal consultative service for the 
patient (like reading an EKG), the EP may choose whether to include the 
patient in the denominator as ``seen by the EP'' provided the choice is 
consistent for the entire EHR reporting period and for all relevant 
meaningful use measures. For example, a cardiologist may choose to 
exclude patients for whom they provide a one-time reading of an EKG 
sent to them from another provider, but include more involved 
consultative services as long as the policy is consistent for the 
entire EHR reporting period and for all meaningful use measures that 
include patients ``seen by the EP.'' EPs who never have a physical or 
telemedicine interaction with patients must adopt a policy that 
classifies at least some of the services they render for patients as 
``seen by the EP,'' and this policy must be consistent for the entire 
EHR reporting period and across meaningful use measures that involve 
patients ``seen by the EP''--otherwise, these EPs will not be able to 
satisfy meaningful use, as they will have denominators of zero for some 
measures. In cases where the patient is seen by a member of the EP's 
clinical staff the EP can include or not include those patients in 
their denominator at their discretion as long as the decision applies 
universally to all patients for the entire EHR reporting period and the 
EP is consistent across meaningful use measures. In cases where a 
member of the EP's clinical staff is eligible for the Medicaid EHR 
incentive in their own right (for example, nurse practitioners (NPs) 
and certain physician assistants (PA)), patients seen by NPs or PAs 
under the EP's supervision can be counted by both the NP or PA and the 
supervising EP as long as the policy is consistent for the entire EHR 
reporting period.
    Comment: While generally supporting the concept of a unique patient 
as a good tool to address the fact that not all meaningful use 
objectives need be addressed at every patient encounter or rendering of 
medical service, some commenters expressed concern about the ability to 
identify unique patients across CEHRTs in situations where an EP 
practices at multiple locations or in situations where an EP might 
switch CEHRT during an EHR reporting period.
    Response: We agree that determining unique patients across CEHRTs 
is difficult. When aggregating performance on meaningful use measures 
across multiple practice locations using different CEHRTs we do not 
require that it be determined that a patient seen at one location was 
not also seen at another location. While this could result in the same 
patient appearing more than once in the denominator of unique patients 
seen, we believe that the burden of seeking out these patients is 
greater than any gain in measurement accuracy. Furthermore, it is not 
possible for a provider to increase only the numerator with this policy 
as any increase in the numerator would also increase the denominator. 
Accordingly, we are adopting a final policy that will give EPs who 
practice at multiple locations or switch CEHRT during the EHR reporting 
period some flexibility as to the method for counting unique patients 
in the denominators. We leave it up to the EP to decide for the EHR 
reporting period whether to count a unique patient across all locations 
equipped with different CEHRT (for example, 1 patient seen at 3 
locations with different CEHRT counts once) or at each location 
equipped with CEHRT (for example, 1 patient seen at 3 locations with 
different CEHRT counts thrice). In cases where a provider switches 
CEHRT products at a single location during the EHR reporting period, 
they also have the flexibility to count a patient as unique on each 
side of the switch and not across it (for example, 1 patient seen 
before the switch and after the switch could be counted once or twice). 
EPs in these scenarios must choose one of these methods for counting 
unique patients and apply it consistently throughout the entire EHR 
reporting period.
    With the flexibility for EPs practicing in multiple locations using 
different CEHRT or switching CEHRT during the

[[Page 53983]]

EHR reporting period, we otherwise finalize our description of ``unique 
patient'' as proposed.
    We proposed that an office visit is defined as any billable visit 
that includes: (1) Concurrent care or transfer of care visits; (2) 
consultant visits; or (3) prolonged physician service without direct, 
face-to-face patient contact (for example, telehealth). A consultant 
visit occurs when a provider is asked to render an expert opinion/
service for a specific condition or problem by a referring provider. 
The visit does not have to be individually billable in instances where 
multiple visits occur under one global fee.
    Comment: We received comments requesting that we establish a list 
of billing codes that constitute an office visit for purposes of 
clarity.
    Response: We continue to believe that the use of a list of billing 
codes would inappropriately limit the discretion of EPs that we have 
built into this measure. We finalize as proposed our description of an 
office visit and emphasize that there is room for EP discretion in this 
definition and that the most important consideration in utilizing that 
discretion is that the policy apply for the entire EHR reporting period 
and across all patients.
    We proposed to describe transitions of care as the movement of a 
patient from one setting of care (hospital, ambulatory primary care 
practice, ambulatory specialty care practice, long-term care, home 
health, rehabilitation facility) to another. Currently, the meaningful 
use measures that use transitions of care require there to be a 
receiving provider of care to accept the information. Therefore, a 
transition home without any expectation of follow-up care related to 
the care given in the prior setting by another provider is not a 
transition of care for purpose of Stage 2 meaningful use measures as 
there is no provider recipient. A transition within one setting of care 
does not qualify as a transition of care. Referrals are cases where one 
provider refers a patient to another, but the referring provider 
maintains their care of the patient as well. Please note that a 
``referral'' as defined here and elsewhere in this final rule is only 
intended to apply to the EHR Incentive Programs and is not applicable 
to other Federal regulations.
    Comment: We have received many comments that determining when a 
transition of care occurs is very difficult under our current Stage 1 
rule, particularly when the provider is on the receiving end of the 
transition of care. Commenters suggest that the only reliable way to 
know if a patient saw another provider is to ask the patient at each 
encounter and even then this is not guaranteed. Several suggestions 
were presented to make the definition more precise on both the 
receiving and transitioning side. They were as follows:--
     Discharges for eligible hospitals/CAHs and referrals to 
other providers who do not share the same CEHRT as the EP are very 
clearly identified and should be the focus of the numerator/
denominator.
     A transition within one setting of care does not qualify 
as a transition of care. Referral is defined as care ``where one 
provider refers a patient to another, but the referring provider 
maintains their care of the patient as well.''
     A patient is referred to another provider (for EPs) or a 
patient is discharged (for eligible hospitals).
     Sharing data with health plans.
    Response: In reviewing the comments, we agree that a refinement of 
our transitions of care definition is needed. We also agree with the 
suggestions to point to specific events that identify a transition of 
care has occurred without relying entirely on asking the patient. 
Therefore, we revise our description of transitions of care for the 
purpose of defining the denominator. For an EP who is on the receiving 
end of a transition of care or referral, (currently used for the 
medication reconciliation objective and measure), the denominator 
includes first encounters with a new patient and encounters with 
existing patients where a summary of care record (of any type) is 
provided to the receiving provider. The summary of care record can be 
provided either by the patient or by the referring/transiting provider 
or institution. We believe that both of these situations would create 
information in the CEHRT that can be automatically recorded. For an EP 
who is initiating a patient transfer to another setting and/or 
referring a patient to another provider, (currently used for providing 
summary of care documents at transitions of care), the initiating/
referring EP would count the transitions and/or referrals that were 
ordered by the EP in the measure denominator. If another provider also 
sees the same patient, only the EP who orders the transition/referral 
would need to account for this transition for the purpose of this 
measure. EPs are not responsible for including patient-initiated 
transitions and referrals that were not ordered by the EP. For example, 
if the EP creates an order for admission to a nursing home, this 
transition of care would be counted in the EP's measure denominator. If 
one of the EP's patients is admitted to a nursing home by another 
provider, this transition would only have to be counted by the EP who 
creates the order and not necessarily by other EPs who care for the 
patient. We want to emphasize that these transitions of care/referral 
descriptions have been developed for purposes of reducing the provider 
measurement burden for the EHR Incentive Program and do not necessarily 
apply to other programs or regulations. We also clarify that these 
descriptions are minimum requirements. An EP can include in the 
denominator transitions of care and referrals that fit the broader 
descriptions of these terms, but are not one of the specific events 
described previously.
    The four proposed denominators for eligible hospitals and CAHs 
are--
     Unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department during the EHR reporting period 
(stratified by age);
     Number of orders (medication, labs, radiology);
     Inpatient bed days; and
     Transitions of care.
    We noted in the proposed rule that our explanation of ``unique 
patients'' and ``transitions of care'' for EPs would also apply for 
eligible hospitals and CAHs.
    Comment: Commenters suggested a problem with unique patients could 
arise if a hospital switched CEHRT during the EHR reporting period.
    Response: Our final policy on EPs who switch CEHRT during the EHR 
reporting period counting unique patients in the denominator would also 
apply for hospitals in the same situation.
    Comment: We have received many comments that determining when a 
transition of care occurs is very difficult under our Stage 1 
regulations, particularly when the provider is on the receiving end of 
the transition of care. Commenters suggest that the only reliable way 
to know if a patient saw another provider is to ask the patient at each 
encounter and even then this is not guaranteed. Several suggestions 
were presented to make the definition more precise on both the 
receiving and transitioning side, which we summarized previously in the 
discussion of the proposed denominators for EPs.
    Response: For the same reasons as discussed for EPs, we agree that 
pointing to specific occurrences is needed to accurately measure this 
denominator. For transitions of care when the hospital is on the 
receiving end, (currently used for the medication reconciliation 
objective and measure), we include all admissions to the inpatient and 
emergency departments.

[[Page 53984]]

For transitions of care when the hospital is transitioning the patient, 
(currently used for providing summary of care documents at transitions 
of care), we include all discharges from the inpatient department and 
after admissions to the emergency department when follow-up care is 
ordered by an authorized provider of the hospital. As with EPs, these 
are the minimum events that must be included in the denominator for the 
transitions of care measure. Hospitals can include additional 
transitions of care that match the full description of transitions of 
care, but are not one of these specific events.
    We proposed that admissions to the eligible hospital or CAH can be 
calculated using one of two methods currently available under Stage 1 
of meaningful use. The observation services method includes all 
patients admitted to the inpatient department (POS 21) either directly 
or through the emergency department and patients who initially present 
to the emergency department (POS 23) and receive observation services. 
Details on observation services can be found in the Medicare Benefit 
Policy Manual, Chapter 6, Section 20.6. Patients who receive 
observation services under both the outpatient department (POS 22) and 
emergency department (POS 23) should be included in the denominator 
under this method. The all emergency department method includes all 
patients admitted to the inpatient department (POS 21) either directly 
or through the emergency department and all patients receiving services 
in the emergency department (POS 23).
    Comment: Commenters expressed near universal support for the 
continuance of the two options in defining an admission to the 
emergency department.
    Response: We continue to believe that not all information required 
by meaningful use may be relevant to all encounters in the emergency 
department and that this decision is best left to the hospital; 
therefore, we are finalizing this as proposed.
    We proposed that inpatient bed days are the admission day and each 
of the following full 24-hour periods during which the patient is in 
the inpatient department (POS 21) of the hospital. For example, a 
patient admitted to the inpatient department at noon on June 5th and 
discharged at 2 p.m. on June 7th will be admitted for 2-patient days: 
the admission day (June 5th) and the 24 hour period from 12 a.m. on 
June 6th to 11:59 p.m. on June 6th.
    We did not receive comments on this proposal. This denominator is 
not used by the proposed meaningful use objectives and measures nor the 
finalized objectives and measures.
    As discussed later in this section, we are including the menu 
objective for hospitals of ``Provide structured electronic lab results 
to ambulatory providers''. The measure associated with the objective 
uses a denominator that was not included in our proposal. The 
denominator is the number of electronic lab orders received by the 
hospital from ambulatory providers. For this objective, we use the same 
description of ``laboratory services'' as for our Stage 2 CPOE 
objective: any service provided by a laboratory that could not be 
provided by a nonlaboratory. We also use the definition of 
``laboratory'' at Sec.  493.2 as for the Stage 2 CPOE objective. Any 
order for a laboratory service will be considered a lab order. For the 
order to be considered received electronically, it must be received by 
the hospital utilizing an electronic transmission method and not 
through methods such as physical electronic media, electronic fax, 
paper document or telephone call.
    After consideration of public comments, we are finalizing the 
following denominators for EPs:
     Unique patients seen by the EP during the EHR reporting 
period (stratified by age or previous office visit);
     Number of orders (medication, labs, radiology);
     Office visits; and
     Transitions of care/referrals including at a minimum one 
of the following:
    + + When the EP is the recipient of the transition or referral, 
first encounters with a new patient and encounters with existing 
patients where a summary of care record (of any type) is provided to 
the receiving EP;
    ++ When the EP is the initiator of the transition or referral, 
transitions and referrals ordered by the EP.
    We are finalizing the following denominators for eligible hospitals 
and CAHs:
     Unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department during the EHR reporting period 
(stratified by age);
     Number of orders (medication, labs, radiology);
     Transitions of care including at a minimum one of the 
following:
    ++ When the hospital is the recipient of the transition or 
referral, all admissions to the inpatient and emergency departments,
    ++ When the hospital is the initiator of the transition or 
referral, all discharges from the inpatient department and after 
admissions to the emergency department when follow-up care is ordered 
by authorized providers of the hospital; and
     Electronic lab orders received by the hospital from 
ambulatory providers.
(4) Discussion of the Relationship of Meaningful Use to CEHRT
    We proposed to continue our policy of linking each meaningful use 
objective to certification criteria for CEHRT. As with Stage 1, EPs, 
eligible hospitals, and CAHs must use the capabilities and standards 
that are certified to meet the objectives and associated measures for 
Stage 2 of meaningful use. In meeting any objective of meaningful use, 
an EP, eligible hospital or CAH must use the capabilities and standards 
that are included in certification. We noted that in some instances, 
meaningful use objectives and measures require use that is not directly 
enabled by certified capabilities and/or standards. In these cases, the 
EP, eligible hospital and CAH is responsible for meeting the objectives 
and measures of meaningful use, but the way they do so is not 
constrained by the capabilities and standards of CEHRT. In the proposed 
rule we gave the following example: in e-Rx and public health 
reporting, CEHRT applies standards to the message being sent and 
enables certain capabilities for transmission in 2014; however, to 
actually engage in e-Rx or public health reporting many steps must be 
taken outside of these standards and capabilities such as contacting 
both parties and troubleshooting issues that may arise through the 
normal course of business.
    Comment: We received many comments that expressed confusion of when 
the capabilities and standards included in certification must be used 
and when they do not.
    Response: Nearly all of these comments were objective-specific, so 
we address them at the referenced objective. With each measure we 
include a universal statement on the applicability of the specific 
standards and capabilities included in the 2014 edition of 
certification criteria for EHR technologies and, if applicable, 
specific allowances for that measure.
    After consideration of the public comments received, we are 
finalizing these provisions as proposed.
(5) Discussion of the Relationship Between a Stage 2 Meaningful Use 
Objective and Its Associated Measure
    We proposed to continue our Stage 1 policy that regardless of any 
actual or perceived gaps between the measure of an objective and full 
compliance with the objective (such as a measure threshold of less than 
100 percent or a

[[Page 53985]]

measure designed to account for circumstances where 100 percent 
compliance in not the intention of the objective), meeting the criteria 
of the measure means that the provider has met the objective for Stage 
2.
    We did not receive any comments and we are finalizing these 
provisions as proposed.
(6) Objectives and Their Associated Measures
(a) Objectives and Measures Carried Over (Modified or Unmodified) From 
Stage 1 Core Set to Stage 2 Core Set
    Proposed Objective: Use computerized provider order entry (CPOE) 
for medication, laboratory and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per state, local and professional guidelines to create the first 
record of the order.
    In the proposed rule, we outlined the following benefits of CPOE. 
CPOE improves quality and safety by allowing clinical decision support 
at the point of the order and therefore influences the initial order 
decision. CPOE improves safety and efficiency by automating aspects of 
the ordering process to reduce the possibility of communication and 
other errors. Consistent with the recommendations of the HIT Policy 
Committee, we proposed to expand the orders included in the objective 
to medication (which was included in Stage 1), laboratory, and 
radiology. We believe that the expansion to laboratory and radiology 
furthers the goals of the CPOE objective, that such orders are commonly 
included in CPOE roll outs and that inclusion of the entry of these 
orders using CPOE is a logical step in the progression of meaningful 
use. We note that this does not require the electronic transmission of 
the order.
    We proposed to continue to define CPOE as the provider's use of 
computer assistance to directly enter medical orders (for example, 
medications, consultations with other providers, laboratory services, 
imaging studies, and other auxiliary services) from a computer or 
mobile device. The order is then documented or captured in a digital, 
structured, and computable format for use in improving safety and 
efficiency of the ordering process. We further proposed that the CPOE 
function of CEHRT must be used by the ordering provider or licensed 
healthcare professionals under his or her direction to create the first 
record of that order, or it would not count as CPOE. As this proposed 
objective limits the use of CPOE to the creation of the first record of 
the order (a more restrictive standard than in Stage 1), we invited 
public comment on whether the stipulation that the CPOE function be 
used only by licensed healthcare professionals remains necessary or if 
CPOE can be expanded to include non-licensed healthcare professionals 
such as scribes.
    Comment: Commenters focused primarily on CPOE's value as the 
trigger for clinical decision support interventions. It was suggested 
the term be revised from computerized provider order entry to 
computerized order evaluation. This focus led to the suggestion by 
several commenters that as long as the ordering providers ``signs'' or 
otherwise authorizes the order before it is carried out this should 
count for CPOE. These commenters maintain that meaningful use should 
not dictate any of the processes that lead up to this authorization 
including who enters the order into CEHRT nor what types of record of 
the order may exist prior to entry into CEHRT.
    Response: We agree that CPOE as the trigger for CDS interventions 
is the primary value creating function of CPOE. However, we disagree 
that it is the only one. We believe automating aspects of and/or 
eliminating steps in the ordering process prior to final authorization 
of the order does reduce communication and other errors. Furthermore, 
it is our understanding from both commenters and our own experiences 
with CEHRT that many EHRs use the entry of the order as the trigger for 
CDS interventions and either display them again at authorization or do 
not display them at all at authorization. For these reasons, we 
continue to focus the definition and measurement of CPOE on when and by 
whom the order is entered into CEHRT and not on when it is authorized 
by the ordering provider in CEHRT.
    Comment: Commenters stated that the authentication of verbal orders 
is already covered by the conditions of participation for hospitals at 
42 CFR482.24(c)(1)(iii) which states that ``[a]ll verbal orders must be 
authenticated based upon Federal and state law. If there is no state 
law that designates a specific timeframe for the authentication of 
verbal orders, verbal orders must be authenticated within 48 hours.'' 
Meaningful use should adopt this same standard.
    Response: We are not adopting this standard for two reasons. First, 
as this is in an incentive program, we do not believe it is logical to 
base a requirement for meaningful use solely on a condition of 
participation. Hospitals already must comply with the conditions of 
participation, so we believe as an incentive program meaningful use 
should be incentivizing behavior beyond the conditions of 
participation. Second, as discussed later, we are not limiting the 
communication of orders prior to CPOE to verbal orders so there is not 
a direct corollary between this condition of participation and our 
description of CPOE. Section 482.23(c)(2) also speaks to verbal orders. 
First, it states, ``If verbal orders are used, they are to be used 
infrequently. Second, it states, ``When verbal orders are used, they 
must only be accepted by persons who are authorized to do so by 
hospital policy and procedures consistent with Federal and state law.'' 
We discuss who may enter the order later in comment and response, but 
reiterate our position that meaningful use should incentivize behavior 
that benefits patients beyond that required by the conditions of 
participation.
    Comment: Commenters objected to our proposal to change our policy 
regarding CPOE from ``the CPOE function should be used the first time 
the order becomes part of the patient's medical record and before any 
action can be taken on the order'' to ``the order created using the EHR 
must be the first record of that order or it would not count as CPOE''. 
The commenters stressed that if they used a process that created a 
record of the order that was not part of the patient's medical record, 
then the proposed policy requiring this record not be retained is not 
advisable. The commenters asserted that even if it was not part of the 
patient's medical record the initial record of the order could be used 
for quality control purposes.
    Response: Our proposed policy change was intended as an evolution 
from the Stage 1 requirements for CPOE. However, after reviewing the 
comments received, we agree that requiring an electronic or written 
order that is not created using the CPOE function of CEHRT to not be 
retained in order for it to count as CPOE could have unforeseen and 
possibly detrimental consequences for quality control. We continue to 
believe that our original proposal would have increased CPOE's ability 
to improve safety and efficiency and encourage all providers to 
streamline the ordering process to minimize the number of steps 
involved. However, we do not have sufficient information to determine 
whether the gains of the proposal are greater than or less than the 
potential cost of not retaining written or electronic orders issued 
before the use of the CPOE function. Therefore, we are not finalizing 
the proposed revised

[[Page 53986]]

description of when the CPOE function must be utilized during the 
ordering process and instead finalize our existing Stage 1 description 
that the CPOE function should be used the first time the order becomes 
part of the patient's medical record and before any action can be taken 
on the order. Based on the questions we have received on CPOE to date, 
the limiting criterion is the first time the order becomes part of the 
patient's medical record rather than the limitation of before any 
action can be taken on the order. The provider must make the 
determination as to what constitutes the patient's medical record and 
what does not based on their existing policies and applicable state and 
Federal law. Our only requirements in this regard are that the 
determination be made by the provider prior to the start of the EHR 
reporting period and be uniformly applied.
    Comment: We have received many comments on who can enter the order 
into CEHRT for it to count as CPOE. Four possibilities received comment 
support. First, only the ordering provider be able to enter the order 
into CEHRT. Second, any licensed healthcare professional who can enter 
orders into the medical record per state, local and professional 
guidelines can enter the order into CEHRT. This is the current policy 
which was proposed to continue. Third, an expansion to any licensed, 
certified or appropriately credentialed healthcare professional (some 
commenters replaced medical assistant with healthcare professional) who 
can enter orders into the medical record per state, local and 
professional guidelines. Fourth, an expansion to allow anyone, 
including those commonly referred to as scribes, enter the orders into 
the medical record per state, local and professional guidelines. We 
also note that there was some confusion among commenters as to our 
current limitation and proposal of any licensed healthcare professional 
using CPOE to create the first entry of the order into the patient's 
medical record as we received many comments suggesting that nurses 
should be able to enter the orders. We clarify that nurses who are 
licensed and can enter orders into the medical record per state, local 
and professional guidelines may enter the order into CEHRT and have it 
count as CPOE.
    Response: As we did not revise our description of when in the 
ordering process the CPOE function must be used, we are inclined to not 
revise our description of who may enter it into CEHRT. However, we are 
particularly concerned with CPOE usage by EPs in this regard. Many EPs 
practice without the assistance of other licensed healthcare 
professionals. These EPs in their comments urged the expansion 
indicated in the third possibility of credentialed healthcare 
professionals/medical assistants. We believe that this expansion is 
warranted and protects the concept that the CDS interventions will be 
presented to someone with medical knowledge as opposed to a layperson. 
The concept of credentialed healthcare professionals is over broad and 
could include an untold number of people with varying qualifications. 
Therefore, we finalize the more limited description of including 
credentialed medical assistants. The credentialing would have to be 
obtained from an organization other than the employing organization. 
Our responses to earlier comments factored into this decision as well. 
Based on the public comments received, questions submitted by the 
public on Stage 1 and demonstrations of CEHRT we have participated in, 
it is apparent that the prevalent time when CDS interventions are 
presented is when the order is entered into CEHRT, and that not all 
EHRs also present CDS when the order is authorized (assuming such a 
multiple step ordering process is in place). This means that the person 
entering the order could be required to enter the order correctly, 
evaluate CDS either using their own judgment or through accurate relay 
of the information to the ordering provider, and then either make a 
change to the order based on the CDS intervention or bypass the 
intervention. We do not believe that a layperson is qualified to do 
this, and as there is no licensing or credentialing of scribes, there 
is no guarantee of their qualifications.
    Comment: We received comments on a particular category of orders 
referred to as ``protocol'' or ``standing'' orders. The defining 
characteristic of these orders is that they are not created due to a 
specific clinical determination by the ordering provider for a given 
patient, but rather are pre-determined for patients with a given set of 
characteristics (for example, administer medication X and order lab Y 
for all patients undergoing a certain procedure or refills for given 
medication). Commenters maintain that these orders require special 
treatment in regards to when they are entered into CEHRT and who enters 
them. Commenters indicate that administrative staff should be allowed 
to enter them, but not override any CDS interventions that may appear.
    Response: We agree that this category of orders warrant different 
considerations than orders that are due to a specific clinical 
determination by the ordering provider for a specific patient. We 
therefore allow providers to exclude orders that are predetermined for 
a given set of patient characteristics or for a given procedure from 
the calculation of CPOE numerators and denominators. Note this does not 
require providers to exclude this category of orders from their 
numerator and denominator. We foresee two circumstances where a 
provider would not want to exclude this category of orders. The first 
is that they disagree that these type of orders warrant different 
considerations and therefore enter them according to our description of 
CPOE. The second is providers who are unable to separate them from 
other orders in their calculation of the denominator and numerator.
    Comment: Commenters mostly support the expansion to the laboratory 
and radiology orders. Three concerns were raised. First, commenters 
believed that as laboratory and radiology orders were new additions 
they should have a lower threshold than medication orders. Second, 
commenters desired a more descriptive definition on what constitutes a 
laboratory and particularly a radiology order. Third, commenters 
suggested that laboratory and radiology orders should be delayed for 
EPs until more laboratory and radiology providers could receive the 
order electronically.
    Response: We discuss the measure separately later in this section 
and address the comments on the threshold there. We describe laboratory 
services as any service provided by a laboratory that could not be 
provided by a non-laboratory. Laboratory is defined at 42 CFR 493.2 as: 
``a facility for the biological, microbiological, serological, 
chemical, immunohematological, hematological, biophysical, cytological, 
pathological, or other examination of from the human body for the 
purpose of providing information for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of, human beings. These examinations also include procedures to 
determine, measure, or otherwise describe the presence or absence of 
various substances or organisms in the body. Facilities only collecting 
or preparing specimens (or both) or only serving as a mailing service 
and not performing testing are not considered laboratories.'' We 
describe radiologic services as any imaging service that uses 
electronic product radiation. Electronic product radiation is defined 
at 21 CFR 1000.3 as: ``any ionizing or nonionizing electromagnetic or 
particulate radiation, or [a]ny sonic, infrasonic, or ultrasonic wave 
that is emitted from an electronic product as the result of the 
operation of an electronic circuit in such product.''

[[Page 53987]]

If the provider desires to include other types of imaging services that 
do not rely on electronic product radiation they may do so as long as 
the policy is consistent across all patients and for the entire EHR 
reporting period. Finally, as we discuss in the next comment and 
response, electronic transmission of the order is not a requirement for 
CPOE.
    Comment: Some commenters stated that while CPOE is a commonly 
understood function in the hospital setting, in the ambulatory setting 
its use is more ambiguous. For medication orders, the difference 
between CPOE for the medication and e-prescribing the medication is 
more subtle. The expansion to laboratory and radiology further 
complicates this in the ambulatory setting as most laboratory and 
radiology orders are sent to a third party which may or may not be able 
to receive such orders electronically.
    Response: While we agree that the concept of CPOE is a more 
definitive action in the ordering process in the hospital setting, we 
believe that it is still integral to the ambulatory setting and serves 
the same purposes in both settings as a trigger for CDS interventions 
and as a way to increase the efficiency and safety of the ordering 
process. CPOE is the entry of the order into the patient's EHR that 
uses a specific function of CEHRT. It is not how that order is filled 
or otherwise carried out. For medications, on the ambulatory side CPOE 
feeds into e-prescribing, and on the hospital side electronic 
medication administration record may be used, but neither of these are 
requirements for CPOE. For example, a medication could be entered into 
CEHRT using CPOE and then be electronically transmitted to a pharmacy. 
This would be both CPOE and e-prescribing. However, a medication could 
be entered into CEHRT using CPOE and then a printed copy of the 
prescription could be generated by CEHRT and given to the patient. This 
would still be CPOE, but not e-prescribing. Similarly, whether the 
ordering of laboratory or radiology services using CPOE in fact results 
in the order being transmitted electronically to the laboratory or 
radiology provider does not dictate whether CPOE was met. CPOE is a 
step in a process that takes place in both hospital and ambulatory 
settings, and we continue to believe it is relevant to both settings.
    After consideration of the public comments received, we are 
modifying this objective for EPs as Sec.  495.6(j)(1)(i) and for 
eligible hospitals and CAHs at Sec.  495.6(l)(1)(i) to use the same 
language as Stage 1 (with the addition of laboratory and radiology 
orders), as we did not finalize our proposed changes to when the order 
must be entered: ``Use computerized provider order entry (CPOE) for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per state, local, and professional guidelines.''
    Proposed Measure: More than 60 percent of medication, laboratory, 
and radiology orders created by the EP or authorized providers of the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period are recorded using CPOE.
    In Stage 1 of meaningful use, we adopted a measure of more than 30 
percent of all unique patients with at least one medication in their 
medication list seen by the EP or admitted to the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period have at least one medication order entered using 
CPOE. In the Stage 1 final rule, we adopted a threshold of 60 percent 
for this measure for Stage 2.
    In our proposed rule, we discussed how our experience with Stage 1 
has shown that the denominator of all orders created by the EP or in 
the hospital would not be unduly burdensome for providers and creates a 
better measurement for CPOE usage, particularly for EPs who 
infrequently order medications. We explained that the denominator 
recommended by the HITPC of ``patients with at least one type of 
order'' is a proxy measure for the number of orders issued. We asked 
for comments on whether the barriers to collecting information for our 
proposed denominator would be greater in a hospital or ambulatory 
setting. We also requested that commenters suggest different 
denominators or measures and encouraged any commenter proposing an 
alternative denominator to discuss whether the proposed threshold or an 
alternative threshold should be used for this measure and to include 
any exclusions they believe are necessary based on their alternative 
denominator.
    We also stated in our proposed rule that we believed providers do 
not roll out CPOE for only one order type, but rather for a package of 
order types. The HITPC had recommended a percentage threshold for 
laboratory orders, but a yes/no attestation of one order for radiology 
(not for both laboratory and radiology, as we mistakenly stated in the 
proposed rule). We also expressed concerns in the proposed rule about 
the possibility that an EP, eligible hospital or CAH could create a 
test environment to issue the one order and not roll out the capability 
widely or at all. For these reasons, we proposed a percentage threshold 
for all three types of orders: medication, laboratory, and radiology.
    Comment: Commenters both supported and opposed the new denominator 
for CPOE. Those supporting the proposed denominator did so for its 
simplicity and greater accuracy for measuring actual CPOE usage. 
Commenters that opposed the proposed denominator did so for one of two 
reasons. Either they were concerned with the burden associated with 
counting paper or other orders that are never entered into CEHRT or 
they were concerned that the proposed denominator requires much higher 
performance of CPOE usage. For example, in the hospital setting an 
inpatient might have 20 orders during a stay. Under the proposed 
denominator, 13 of those orders would have to be entered using CPOE, 
while under the current denominator only one order would have to be 
entered using CPOE. A few commenters opposed the new denominator for 
both reasons.
    Response: In regards to the perceived higher performance of CPOE 
usage required by switching from the Stage 1 denominator to the Stage 2 
proposed denominator, the sole purpose of the proxy measure for CPOE 
used in Stage 1 was to alleviate the measurement burden, not create a 
lower level of CPOE usage than implied by the percentage threshold. 
Therefore, as a more accurate measure is possible, it should reflect 
the percentage of CPOE use indicated by the established thresholds. In 
regards to the burden of the measure, we had stated in our proposed 
rule that the reason we believed we could move to the proposed 
denominator was feedback from many providers indicating that they could 
in fact measure the proposed denominator. In addition due to problems 
associated with the proxy for EPs who have comprehensive medication 
lists for their patients, but were not the ordering provider for many 
of those medications some EPs were having to use an alternative measure 
issued through guidance (https://questions.cms.gov/faq.php?id=5005&faqId=3257) that allowed them to only include patients 
with medications the EP had ordered. We assume in determining the 
measures of meaningful use that the patient's medical record conforms 
to existing Federal and state laws, which we believe would generally 
require that all orders issued by a provider for a patient become part 
of the patient's medical record (for example, 42 CFR 482.24(c)(2)(vi)). 
Therefore, the concept that some orders do not become part of

[[Page 53988]]

the CEHRT means that the provider is maintaining patient medical 
records both electronically in CEHRT and outside of CEHRT using either 
paper charts or another electronic system. When a provider starts their 
first Stage 2 EHR reporting period, they will have been using CEHRT for 
at least 15 months. In our proposed rule, we have stated our belief 
that most providers would have fully transitioned patients' medical 
records to CEHRT by the time they start Stage 2. However, as discussed 
previously, we are leaving open the option for limiting certain 
measures to only those records maintained in CEHRT. As this is one of 
those measures, there is no reason to change the measure to accommodate 
patient records not maintained in CEHRT as provider can choose to not 
include records not maintained in CEHRT in the denominator. Thus, we 
finalize the denominator as proposed.
    Comment: Commenters requested clarification on whether the measure 
puts all medication, laboratory and radiology orders in the same 
denominator and therefore it was potentially possible to meet the 60 
percent threshold without CPOE being used 60 percent of the time for 
one or more order type, up to and including the possibility that CPOE 
may never be used for one or more order type. Many commenters suggested 
that if all orders were in the same denominator this was not a good 
measure of the expansion of CPOE to laboratory and radiology and that 
the orders should be broken out separately. Only a few commenters 
suggested that the denominator should be the aggregate of all three 
types of orders.
    Response: We agree with the commenters that an aggregate 
denominator does not best reflect our expansion to laboratory and 
radiology and therefore create a separate denominator for each order 
type. This is consistent with the suggestions of the majority of 
commenters and most accurately reflects the use of CPOE. While CPOE 
does not require the electronic transmission of the order, many CEHRT 
will be linked to the technology systems that manage medication, as 
well as those for laboratories and radiology departments. These systems 
may be different thereby presenting unique challenges for each order 
type that could result in differing roll out times and utilization 
rates. In addition, a provider with a high number of one order type 
compared to others may even be able to reach a combined threshold 
without implementing CPOE for one or more of the order types. This 
would negate the benefits of expanding CPOE to these order types. We 
have exclusionary criteria for those providers who so infrequently 
issue an order type that it is not practical to implement CPOE for that 
order type.
    Comment: We received several suggestions on the percentage 
threshold for medication orders to reduce it below 60 percent. The 
suggestions ranged from 50 percent to 30 percent. Two reasons were 
given. First, that 60 percent was simply too high. Second, that the 
proposed denominator made 30 percent a much higher bar than it was when 
the proxy was in place and the threshold should not be raised until we 
have data based on the proposed denominator.
    Response: As we stated previously, the purpose of the proxy 
denominator was not to create a lower bar than CPOE usage at 30 
percent, but to address measurement burden. While we agree that the 
information generated using the proxy denominator for CPOE is different 
from the finalized denominator, this is only true in a limited set of 
circumstances, especially for EPs. For it to be different at all, a 
provider must have ordered more than one medication for a patient 
during the EHR reporting period. Furthermore, this is most likely 
limited to providers who see a patient on more than one occasion. We 
believe it would be highly unlikely that a provider would use CPOE to 
order one medication and then not use it to order another during the 
same encounter or admission. For these reasons, we believe that while 
not a perfect correlation the information gained through Stage 1 
attestations. The Stage 1 attestations provide a reasonable basis on 
which to set the Stage 2 thresholds. We believe it is reasonable to 
expect the actual use of CPOE to increase from 30 percent in Stage 1 to 
60 percent in Stage 2 and consist with the expectations that were 
finalized in the Stage 1 regulations. Therefore, for medication orders, 
we finalize the threshold at 60 percent.
    Comment: Some commenters maintain that the addition of laboratory 
and radiology orders to CPOE is a new function and should not be 
introduced at the same threshold.
    Response: Based on the same logic supporting the 60 percent 
threshold for medication orders (that is, 30 percent is reasonable when 
CPOE is first introduced for an order type, and 60 percent in the next 
stage following CPOE introduction), we agree with the commenters that 
the thresholds should be different. We finalize a threshold of 30 
percent for each laboratory and radiology orders.
    After consideration of the public comments received, we are 
splitting the proposed measure into three measures and changing the 
threshold for radiology and laboratory orders at Sec.  495.6(j)(1)(ii) 
for EPs and Sec.  495.6(l)(1)(ii) for eligible hospitals and CAHs.
     More than 60 percent of medication orders created by the 
EP or authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using CPOE.
     More than 30 percent of laboratory orders created by the 
EP or authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using CPOE.
     More than 30 percent of radiology orders created by the EP 
or authorized providers of the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period 
are recorded using CPOE.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(1).
    As discussed in the comment and response section, an EP, eligible 
hospital or CAH can limit the denominators to only include medication, 
laboratory and radiology orders for patients whose records are 
maintained using CEHRT.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of medication orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 60 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
    Exclusion: Any EP who writes fewer than 100 medication orders 
during the EHR reporting period.
     Denominator: Number of radiology orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 30 
percent in order

[[Page 53989]]

for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 radiology orders during 
the EHR reporting period.
     Denominator: Number of laboratory orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 30 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
    Exclusion: Any EP who writes fewer than 100 laboratory orders 
during the EHR reporting period.
    An EP through a combination of meeting the thresholds and/or 
exclusions must satisfy all three measures for this objective.
    A hospital must meet the thresholds for all three measures.
    Proposed EP Objective: Generate and transmit permissible 
prescriptions electronically (eRx).
    In the proposed rule, we noted that the use of electronic 
prescribing has several advantages over having the patient carry the 
prescription to the pharmacy or directly faxing a handwritten or 
typewritten prescription to the pharmacy. When the EP generates the 
prescription electronically, CEHRT can recognize the information and 
can provide decision support to promote safety and quality in the form 
of adverse interactions and other treatment possibilities. The CEHRT 
can also provide decision support that promotes the efficiency of the 
health care system by alerting the EP to generic alternatives or to 
alternatives favored by the patient's insurance plan that are equally 
effective. Transmitting the prescription electronically promotes 
efficiency and safety through reduced communication errors. It also 
allows the pharmacy or a third party to automatically compare the 
medication order to others they have received for the patient. This 
comparison allows for many of the same decision support functions 
enabled at the generation of the prescription, but bases them on 
potentially greater information.
    We proposed to continue to define prescription as the authorization 
by an EP to dispense a drug that will not be dispensed without such 
authorization. This includes authorization for refills of previously 
authorized drugs. We proposed to define a permissible prescription as 
all drugs meeting the definition of prescription not listed as a 
controlled substance in Schedules II-V http://www.deadiversion.usdoj.gov/schedules/index.html. Although the Drug 
Enforcement Administration's (DEA) interim final rule on electronic 
prescriptions for controlled substances (75 FR 16236) removed the 
Federal prohibition to electronic prescribing of controlled substances, 
some challenges remain including more restrictive state law and 
widespread availability of products both for providers and pharmacies 
that include the functionalities required by the DEA's regulations. We 
asked for public comments as to whether over the counter (OTC) 
medicines will be routinely electronically prescribed and proposed to 
continue to exclude them from the definition of a prescription.
    In our proposed rule we discussed several different workflow 
scenarios are possible when an EP prescribes a drug for a patient. 
First, the EP could prescribe the drug and provide it to the patient at 
the same time, and sometimes the EP might also provide a prescription 
for doses beyond those provided concurrently. Second, the EP could 
prescribe the drug, transmit it to a pharmacy within the same 
organization, and the patient would obtain the drug from that pharmacy. 
Third, the EP could prescribe the drug, transmit it to a pharmacy 
independent of the EP's organization, and the patient would obtain the 
drug from that pharmacy. Although each of these scenarios would result 
in the generation of a prescription, the transmission of the 
prescription would vary. In the first situation, there is no 
transmission. In the second situation, the transmission may be the 
viewing of the generation of the prescription by another person using 
the same CEHRT as the EP, or it could be the transmission of the 
prescription from the Certified EHR Technology used by the EP to 
another system used by the same organization in the pharmacy. In the 
third situation, the EP's Certified EHR Technology transmits the 
prescription outside of their organization either through a third party 
or directly to the external pharmacy. These differences in 
transmissions create differences in the need for standards. We proposed 
that only the third situation would require standards to ensure that 
the transmission meets the goals of electronic prescribing. In the 
first two scenarios one organization has control over the whole 
process. In the third scenario, the process is divided between 
organizations. In that situation, standards can ensure that despite the 
lack of control the whole process functions reliably. To have 
successfully e-prescribed, we proposed that the EP needs to use CEHRT 
as the sole means of creating the prescription, and when transmitting 
to an external pharmacy that is independent of the EP's organization 
such transmission must use standards adopted for EHR technology 
certification.
    We did not receive any public comments on this objective, 
therefore, we are finalizing this objective at Sec.  495.6(j)(2)(i) as 
proposed.
    Proposed EP Measure: More than 65 percent of all permissible 
prescriptions written by the EP are compared to at least one drug 
formulary and transmitted electronically using CEHRT.
    We proposed a new exclusion for Stage 2 that would allow EPs to 
exclude this objective if no pharmacies within 25 miles of an EP's 
practice location at the start of his/her EHR reporting period accept 
electronic prescriptions. This is 25 miles in any straight line from 
the practice location independent of the travel route from the practice 
location to the pharmacy. We stated that EP's practicing at multiple 
locations would be eligible for the exclusion if any of their practice 
locations that are equipped with CEHRT meet this criteria. An EP would 
not be eligible for this exclusion if he or she is part of an 
organization that owns or operates its own pharmacy within the 25-mile 
radius regardless of whether that pharmacy can accept electronic 
prescriptions from EPs outside of the organization. We also proposed an 
exclusion for EPs who write fewer than 100 prescriptions during the EHR 
reporting period.
    Comment: Most commenters agreed with the exclusion of controlled 
substances in the denominator. They were concerned about industry 
readiness as well as potentially conflicting state regulations. Other 
commenters expressed concerns that specialists (that is, surgeons, 
psychiatrists) who write prescriptions that are not permissible (that 
is, controlled substances) would not be able to meet the measure.
    Response: We agree with the commenters and will continue to exclude 
controlled substances from the denominator. However, we are also adding 
an alternative denominator to provide additional flexibility for EPs 
who are able to electronically prescribe controlled substances and want 
to count these prescriptions in the measure.
    Comment: Most commenters did not support the inclusion of OTC 
medicines in this objective, as OTC medicines are not usually intended 
for the pharmacy to fill. Those commenters who did support it noted 
that OTC medicines are

[[Page 53990]]

prescribed often times because it allows patients to use their health 
care spending accounts to pay for the cost.
    Response: After consideration of public comments, we agree with the 
majority of commenters in that OTC medicines should not be included as 
a part of this objective. While some OTC medicines are ordered by the 
EP, the low prevalence of such occurrences means the costs of including 
them in both measurement and actual e-prescribing outweighs any benefit 
of inclusion.
    Comment: Most commenters thought the proposed threshold was too 
high or just right. Those who thought it was too high expressed 
concerns about the abilities of mail-order pharmacies to accept 
electronic subscriptions. Some commenters suggested lowering the 
threshold to 50 percent. Other commenters expressed concerns that 
patients may prefer a paper prescription and suggested excluding those 
patients from the denominator. The commenters who thought the proposed 
threshold was ``just right'' noted that most EPs who successfully 
demonstrated meaningful use for Stage 1 far exceeded the Stage 1 
threshold of 40 percent.
    Response: Preliminary analysis of Stage 1 meaningful use 
attestation data shows that those EPs who successfully attested for 
this measure exceeded the 40 percent threshold--many reporting 
thresholds of 80-100 percent. However, the Surescripts Q4 2011 Report 
suggests that close to 40 percent of physicians who began e-prescribing 
in 2008 meet the 65 percent threshold. This report only represents the 
earliest adopters. Based on public comments, we believe the 65 percent 
threshold we proposed may be unattainable for many EPs and question 
whether any real difference in provider behavior is achieved with a 65 
percent threshold versus a 50 percent threshold. This lower threshold 
also accounts for patients who may prefer a paper prescription, rather 
than having their prescription sent to a pharmacy electronically. After 
consideration of public comments, we are finalizing the threshold for 
this measure at 50 percent.
    Comment: Most commenters supported comparing prescriptions written 
by the EP to a drug formulary, but not without concern. Many noted that 
drug formularies are not always readily available, are linked to 
specific payers, or may not otherwise be readily available.
    Response: After review of the public comments, we realize this 
measure needs to be further clarified. We recognize that not every 
patient will have a formulary that is relevant for him or her. 
Therefore, we require not that the CEHRT check each prescription 
against a formulary relevant for a given patient, but rather that the 
CEHRT check each prescription for the existence of a relevant 
formulary. If a relevant formulary is available, then the information 
can be provided. We believe that this initial check is essentially an 
on or off function for the CEHRT and should not add to the measurement 
burden. Therefore, with this clarification of the check we are 
referring to, we are finalizing the drug formulary check as a component 
of this measure. We look forward to the day when a relevant formulary 
is available for every patient. We also modified the measure to use the 
word ``query'' instead of ``compare'' because it better explains the 
process in which the EP uses the CEHRT to consult the information 
provided in the formulary.
    Comment: Many commenters expressed concerns about patients who 
request paper copies of their prescriptions and how they would be 
accounted for in this measure. Commenters also expressed concerns about 
patients who prefer to use mail-order pharmacies that do not accept 
eRx.
    Response: We have accounted for patient preferences by lowering the 
threshold for this measure from 65 percent to 50 percent.
    Comment: Many commenters expressed concerns that the word 
``permissible'' was omitted from the proposed exclusion for EPs who 
write fewer than 100 prescriptions during the EHR reporting period.
    Response: We agree with commenters in that we inadvertently omitted 
the word ``permissible'' from this exclusion. After consideration of 
public comments, we are finalizing this exclusion as ``EPs who write 
fewer than 100 permissible prescriptions during the EHR reporting 
period.''
    Comment: Many commenters supported this exclusion but expressed 
concerns about how it was proposed and would be implemented. Some 
commenters suggested reducing the radius to 10 miles or less in urban 
areas and leaving it at 25 miles in rural areas. Other commenters 
suggested revising this exclusion for EPs where less than 20 percent of 
pharmacies e-prescribe within a 25-mile radius of their office. Other 
commenters expressed concerns that there may only be a limited number 
of pharmacies in their geographic area that can accept prescriptions 
electronically. Yet others suggested including a grace period for EPs 
in areas where no pharmacies e-prescribe at the beginning of their EHR 
reporting period, but later begin accepting eRx.
    Response: We appreciate the commenters' concerns about this 
exclusion. We agree with commenters in that a 25-mile radius may be too 
large. We believe the 10-mile radius is more reasonable as it takes the 
country's geographic diversity (urban, suburban, rural areas) into 
account. We are therefore finalizing that if no pharmacies within a 10-
mile radius of an EP's practice location at the start of the EHR 
reporting period accept electronic prescriptions, the EP would qualify 
for this exclusion, unless the EP is part of an organization that owns 
or operates a pharmacy within the 10-mile radius. As for patient 
preference, we agree with commenters that not all patients will want to 
go to a particular pharmacy just because they accept electronic 
prescriptions. However, we believe we accounted for patient preference 
by lowering the threshold for the measure to 50 percent.
    After consideration of public comments, we are revising the measure 
at Sec.  495.6(j)(2)(ii) to read: ``More than 50 percent of all 
permissible prescriptions, or all prescriptions, written by the EP are 
queried for a drug formulary and transmitted electronically using 
CEHRT.''
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(b)(3) and 45 CFR 170.314(a)(10).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of prescriptions written for drugs 
requiring a prescription in order to be dispensed other than controlled 
substances during the EHR reporting period; or
    Number of prescriptions written for drugs requiring a prescription 
in order to be dispensed during the EHR reporting period.
     Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary and transmitted electronically 
using CEHRT.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
    Exclusions: Any EP who: (1) Writes fewer than 100 permissible 
prescriptions during the EHR reporting period; or (2) does not have a 
pharmacy within their organization and there are no pharmacies that 
accept electronic prescriptions within 10 miles of the EP's practice 
location at the start of his/her EHR reporting period.
    Consolidated Objective: Maintain an up-to-date problem list of 
current and active diagnoses.

[[Page 53991]]

    Consolidated Objective: Maintain active medication list.
    Consolidated Objective: Maintain active medication allergy list.
    For Stage 2, we proposed to consolidate the objectives for 
maintaining an up-to-date problem list, active medication list, and 
active medication allergy list with the Stage 2 objective for providing 
a summary of care for each transition of care or referral. We stated 
that we continue to believe that an up-to-date problem list, active 
medication list, and active medication allergy list are important 
elements to be maintained in CEHRT. However, the continued 
demonstration of their meaningful use in Stage 2 would be required by 
other objectives focused on the transitioning of care of patients 
removing the necessity of measuring them separately. Providing this 
information is critical to continuity of care, so we proposed to add 
these as required fields in the summary of care for the following Stage 
2 objective: ``The EP, eligible hospital or CAH who transitions their 
patient to another setting of care or provider of care or refers their 
patient to another provider of care should provide a summary care 
record for each transition of care or referral.'' We stated that EPs 
and hospitals would have to ensure the accuracy of these fields when 
providing the summary of care, which we believe would ensure a high 
level of compliance in maintaining an up-to-date problem list, active 
medication list, and active medication allergy list for patients. The 
required standards for these fields are discussed in the ONC standards 
and certification final rule published elsewhere in this issue of the 
Federal Register.
    Comment: Overall, we received very few comments on our proposal to 
consolidate the up-to-date problem list, active medication list, and 
active medication allergy list objectives. Some commenters opposed our 
proposal as they believe it would detract from the importance of these 
items. However, the vast majority of those who commented on this 
proposal supported the consolidation of these objectives.
    Response: After consideration of public comments, we are finalizing 
the consolidation of these objectives as proposed for the reasons 
discussed in the proposed rule. The objectives of maintaining an up-to-
date problem list, active medication list, and active medication 
allergy list will be consolidated with the Stage 2 objective for 
providing a summary of care for each transition of care or referral.
    Proposed EP Objective: Record the following demographics: preferred 
language, gender, race and ethnicity, and date of birth.
    Proposed Eligible Hospital/CAH Objective. Record the following 
demographics: preferred language, gender, race and ethnicity, date of 
birth, and date and preliminary cause of death in the event of 
mortality in the eligible hospital or CAH.
    We proposed to continue the policy that EPs, eligible hospitals and 
CAHs collect baseline demographic data for all unique patients in the 
EHR using OMB standards for race and ethnicity. The proposed rule 
outlines some of the numerous benefits from recording basic patient 
demographic information in the EHR, including improved patient-centered 
care and management of the health of populations. In response to 
multiple comments from the Stage 1 final rule regarding the preliminary 
cause of death data element required for eligible hospitals and CAHs, 
we clarified the following; this element is the preliminary cause of 
death recorded by the hospital and is not required to be amended when 
additional information becomes available, there is no specified 
timeframe for recording this element, and we invited additional public 
comment regarding these clarifications in the proposed rule. We also 
asked for public comment on the burden and ability to include 
additional measures of disability status, gender identity and/or sexual 
orientation.
    Comment: We received many comments suggesting CMS differentiate 
between the terms sex and gender. One commenter provided the definition 
that the term sex is used in recording vital health statistics that 
describe the physiological characteristics at time of birth. The term 
gender incorporates behaviors, roles, and expectations corresponding to 
an individual's sex and is generally self reported.
    Response: We appreciate this clarification and will incorporate the 
change in terminology for the final rule using the term sex instead of 
gender in EP, eligible hospital and CAH objectives for recording 
demographics. This change in terminology aligns with vital statistic 
reporting and the HHS final demographic data collection standards 
published October 31, 2011.
    Comment: Several commenters indicated that the collection of race 
and ethnicity demographic information can be sensitive and patients may 
be unwilling or uncomfortable reporting this information to the 
individual collecting demographic data. Other comments supported CMS 
clarification in the Stage 1 final rule that providers can be allowed 
to account for patients who decline to provide elements of demographic 
information. Additional comments suggested that a single system 
parameter be developed to identify states that prohibit data reporting 
should be available to the EHR.
    Response: If a patient declines to provide information of ethnicity 
or race or if capturing a patient's ethnicity or race is prohibited by 
state law, this should be duly noted as structured data in the EHR and 
this would still count as an entry for the purpose of meeting this 
measure. A study by the Agency for Healthcare Research and Quality 
(AHRQ) states that current state prohibitions on the collection of 
ethnicity and race apply to health plans' collection of data at the 
time of enrollment. Title VI of the Civil Rights Act of 1964 permits 
health care organizations to collect race, ethnicity, and preferred 
language patient data for the purpose of quality improvement.
    Comment: Several commenters suggested that CMS use the same 
definition for race and ethnicity as the Centers for Disease Control 
and Prevention (CDC) and the United States Census Bureau. Other 
commenters were concerned about the need to collect data granular 
enough to identify differences between subpopulations and aligned 
across government programs.
    Response: We recognize that the CDC has developed codes that allow 
for the mapping of more detailed race and ethnicity categories such as 
those maintained by the U.S. Bureau of the Census to the less detailed 
OMB standard. We appreciate that providers may need to collect more 
granular demographic data to manage their patient populations. For 
purposes of achieving Stage 2 of meaningful use, we will continue to 
rely on the OMB standard as a minimum standard for the collection of 
race and ethnicity data. EPs, eligible hospitals, and CAHs who wish to 
collect more granular level data on patient race and ethnicity may do 
so as long as they can map the data to 1 of the 5 races included in the 
existing OMB standards. The standards associated with the meaningful 
use objectives and measures are discussed further in the ONC standards 
and certification criteria final rule and we refer readers to that 
regulation published elsewhere in this issue of the Federal Register.
    Comment: Many commenters agreed with the need to incorporate 
disability status in EHR technology. However, it was also clear that 
several of these commenters varied in their definition of disability 
with interpretations that ranged from physical, mental, occupational, 
and economic disability

[[Page 53992]]

status. Commenters also differed regarding the most appropriate 
location for the capture and storage of disability status data elements 
within the EHR. Suggestions for where to incorporate disability status 
data varied (for example; from the demographic objective, to physician 
notes, and/or the problem list component of the summary of care 
document). Another commenter suggested that the demographic objective 
should be limited to collecting data with static values and the active 
problem list, electronic notes and/or care summary documents that are 
continually updated would be more appropriate for recording changes in 
patient disability status.
    Response: We wish to clarify that the term disability status used 
in the proposed rule was meant to be all-encompassing by incorporating 
both the concepts of physical and cognitive disabilities as well as the 
concept of functional status limitations that impact an individual's 
capability to perform activities in different environments. This latter 
concept incorporates metrics useful for planning and coordination 
across care settings. Commenters varied in their responses regarding 
the level of consensus on measurement standards for each of these 
health status measures. Since publishing the proposed rule we have 
learned that significant progress has been made regarding the capture 
of functional status into the consolidated clinical document 
architecture (C-CDA) standard for summary of care records. The C-CDA 
Implementation Guide provides the following examples that may be 
incorporated under functional status; assessments of a patient's 
language, vision, hearing, activities of daily living, behavior, 
general function, mobility, self-care status, physical state and 
cognitive function.\1\ The C-CDA standards support the exchange of 
clinical documents between those involved in the care of a patient and 
allow for the re-use of clinical data for clinical care giving, public 
health reporting, quality monitoring, patient safety and clinical 
trials. This inclusion is addressed more fully under the discussion of 
the transition of care objective in this final rule.
---------------------------------------------------------------------------

    \1\ Implementation Guide for CDA Release 2.0 (US REALM) July 
2012, (copyright) 2012 Health Level Seven, Inc. Ann Arbor, MI.
---------------------------------------------------------------------------

    We strongly support the adoption, implementation and meaningful use 
of CEHRT for all individuals and the reduction of barriers for persons 
with disabilities. In finalizing this rule, we also considered the 
operational challenges that could result from the lack of consensus 
noted by many commenters to incorporate a physical disability standard 
measure in the demographic section of CEHRT at this time. As a result, 
we will not require the collection of disability status data under the 
demographic objective for Stage 2 of meaningful use. However, we 
suggest that providers examine the questions developed by the HHS as 
required by section 4302 of the Affordable Care Act. The questions 
resulted from an interagency process and are closely aligned to the 
Census Bureau's American Community Survey and the International 
Classification of Disability. These questions may be found on the HHS 
Web site at http://minorityhealth.hhs.gov/templates/content.aspx?ID=9232#1. The answers to these questions could be 
incorporated as functional status or other data elements in the C-CDA 
summary of care document mentioned above and discussed more fully in 
the transition of care objective later in this rule.
    We will continue to work with ONC, other federal agencies and seek 
the advice of the HIT Policy Committee to explore further how 
disability status could be included in meaningful use Stage 3.
    Comments: Many commenters supported the proposed inclusion of 
recording gender identity and/or sexual orientation as part of the 
demographic objective. Other commenters suggested that the collection 
of this information is extremely sensitive and could be considered 
offensive for some patients especially when collected by administrative 
staff. Still other commenters did not see the clinical significance of 
collecting and recording this information in the demographic section of 
the EHR. Others commenters were against recording gender identity and/
or sexual orientation because they did not consider this would provide 
additional clinical benefit. Still others suggested that the reporting 
of gender identity or sexual orientation be optional and up to 
individual clinician judgment whether or not it is appropriate to 
collect this information.
    Similar to the comments for the proposed inclusion of disability 
status, commenters noted both the data collection challenges and data 
reporting burden. Many commenters were opposed to the mandatory 
collection of all three additional measures for Stage 2 of meaningful 
use and suggested that reporting could be optional.
    Response: Considering the lack of consensus for the definition of 
the concept of gender identity and/or sexual orientation as well as for 
a standard measure of the concept and where it would be most 
appropriate to store the data within the EHR, we will await further 
development of a consensus for the goal and standard of measurement for 
gender identity and/or sexual orientation. Additionally, we note that 
many commenters raised concerns as to whether such data collection is 
necessary for all EPs, eligible hospital, and CAH regardless of 
specialty.
    Comments: Several additional measures were suggested under the 
demographic objective including; measuring the level of access to and 
use of the internet, measuring computer literacy, and measuring 
standardized occupation using established industry codes.
    Response: We appreciate the numerous comments suggesting additional 
demographic information that will allow providers to improve the 
quality of individual patient centered care as well as population 
health. We may consider these suggestions further in the development of 
Stage 3 of meaningful use.
    Comment: A minority of commenters recommended removing the 
preliminary cause of death element altogether from the eligible 
hospital/CAH objective. Others suggested that the eligible hospital/CAH 
measure for preliminary cause of death be modified to simply capture 
whether or not the patient had a cause of death recorded, regardless of 
when that information was entered into the EHR, because the preliminary 
cause of death may often be inaccurate since by law the coroner or 
medical examiner makes the final determination for the patient's death 
certificate.
    Response: We appreciate the suggestion for measure simplification. 
However, for this measure we want to respect the existing hospital 
workflow where a clinician evaluates the patient to pronounce the 
death. This preliminary cause of death is documented by the clinician 
in the patient's chart. We recognize that these workflows may change as 
EHR technology develops and becomes more widely adopted and the 
exchange of health information is able to link to vital statistic 
reporting. However, for the time being the measure of preliminary cause 
of death under the demographic objective will remain unchanged.
    After consideration of the public comments received, we are 
modifying the meaningful use objective at Sec.  495.6(j)(3)(i) of our 
regulations as follows: EPs ``Record all of the following demographics: 
Preferred language, sex, race, ethnicity, and date of birth.''
    After consideration of the public comments received, we are 
modifying the meaningful use objective at Sec.  495.6(l)(2)(i) of our 
regulations as

[[Page 53993]]

follows: Eligible hospitals and CAHs ``Record all of the following 
demographics: Preferred language, sex, race, ethnicity, date of birth, 
date and preliminary cause of death in the event of mortality in the 
eligible hospital or CAH.''
    Proposed Measure: More than 80 percent of all unique patients seen 
by the EP or admitted to the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period 
have demographics recorded as structured data.
    Comment: Most commenters were supportive of the increased threshold 
for this measure.
    Response: Our analysis of the meaningful use data for Stage 1 found 
that over 90 percent of EPs, eligible hospitals and CAHs were able to 
successfully report the demographic measure. Therefore, based on 
comments and actual performance data we do not foresee a burden in 
increasing the measure threshold from more than 50 percent in Stage 1 
to greater than 80 percent in Stage 2.
    After consideration of public comments, we are finalizing this 
measure for EPs at Sec.  495.6(j)(3)(ii) and for eligible hospitals and 
CAHs at Sec.  495.6(l)(2)(ii) as proposed.
    We further specify that in order to meet this objective and measure 
an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(3).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of unique patients seen by 
the EP or admitted to an eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of patients in the 
denominator who have all the elements of demographics (or a specific 
notation if the patient declined to provide one or more elements or if 
recording an element is contrary to state law) recorded as structured 
data.
     Threshold: The resulting percentage must be more 
than 80 percent in order for an EP, eligible hospital or CAH to meet 
this measure.
    If a patient declines to provide one or more demographic elements 
this can be noted in the CEHRT and the EP or hospital may still count 
the patient in the numerator for this measure. The required elements 
and standards for recording demographics and noting omissions because 
of state law restrictions or patients declining to provide information 
will be discussed in the ONC standards and certification rule, 
published elsewhere in this issue of the Federal Register.
    Proposed Objective: Record and chart changes in the following vital 
signs: height/length and weight (no age limit); blood pressure (ages 3 
and over); calculate and display body mass index (BMI); and plot and 
display growth charts for patients 0-20 years, including BMI.
    We proposed to continue our policy objective from Stage 1 to 
collect and record basic vital sign data for patients across health 
care settings. In the proposed rule, we outlined the benefits of 
documenting basic vital signs including that the data provides 
important clinical information on both the patient's current condition 
as well as the ability to track changes in patient status over time. 
For Stage 2, we proposed to remove the age restrictions on recording 
height/length and weight, and also proposed to remove the age 
restrictions on calculating and displaying BMI and growth charts. In 
addition, we proposed to modify the Stage 1 blood pressure guideline to 
align with the American Academy of Pediatrics guideline recommendations 
to measure blood pressure for children 3 years of age and older. We 
also proposed to continue our exclusions policy from Stage 1 (with 
modifications, as discussed below) for EPs who believe that recording 
and charting vital signs is outside the scope of their practice.
    Comment: Several commenters questioned why all providers need to 
collect vital sign data when this information should be available from 
a robust health information exchange across providers.
    Response: We will continue the Stage 1 meaningful use policy that 
any method of obtaining height, weight and blood pressure is acceptable 
for the purpose of this objective as long as the information is 
recorded as structured data in the CEHRT. As stated in the proposed 
rule, the vital sign information can be entered into the patient's 
medical record in a number of ways including: direct entry by the EP, 
eligible hospital, or CAH; entry by a designated individual from the 
EP, eligible hospital, or CAH's staff; data transfer from another 
provider electronically, through an HIE or through other methods; or 
data entered directly by the patient through a portal or other means. 
Some of these methods are more accurate than others, and it is up to 
the EP or eligible hospital to determine the level of accuracy needed 
to care for their patient and how best to obtain this information. We 
also look forward to the time when a more robust health information 
exchange network will allow providers to share relevant data across 
settings and/or alert providers when additional data should be 
obtained.
    Comment: We received comments requesting that CMS include a 
statement clarifying which specialties would be included or excluded 
from this objective.
    Response: We appreciate commenter's efforts to clarify this 
objective. However, we will continue our more general policy from Stage 
1 (with modifications, as explained later) of allowing EPs to exclude 
this objective if they believe recording and charting changes in vital 
signs is not relevant to their scope of practice. We cannot define the 
scope of practice and/or interventions necessary for each individual 
patient and will continue to rely on provider determinations based on 
individual patient circumstances. Consider a hypothetical example of an 
elderly patient with multiple chronic conditions that includes 
depression. When the patient is seen by his behavioral healthcare 
provider to manage his depression, it is up to that provider to 
determine whether it would be medically necessary to record and chart 
the patient's weight in order to manage the patient's care.
    After consideration of public comments, we are finalizing this 
objective for EPs at Sec.  495.6(j)(4)(i) and for eligible hospitals 
and CAHs at Sec.  495.6(l)(3)(i) as proposed.
    Proposed Measure: More than 80 percent of all unique patients seen 
by the EP or admitted to the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period 
have blood pressure (for patients age 3 and over only) and height/
length and weight (for all ages) recorded as structured data.
    We proposed to split the exclusions from Stage 1 such that an EP 
could choose to record height/length and weight only and exclude blood 
pressure, or record blood pressure only and exclude height/length and 
weight. We encouraged comments on this split and whether it should go 
both ways. We proposed to increase the threshold from more than 50 
percent to more than 80 percent for this measure.
    Comment: Several commenters agreed with the policy that height/
length, weight, and blood pressure do not each need to be updated by a 
provider neither at every patient encounter nor even once per patient 
seen during the EHR reporting period.
    Response: We will maintain our policy from Stage 1 that it is up to 
the EP or hospital to determine whether height/length, weight, and 
blood

[[Page 53994]]

pressure each need to be updated, the level of accuracy needed to care 
for their patient, and how best to obtain the vital sign information 
that will allow for the right care for each patient.
    Comment: Another commenter suggested that CMS clarify that the 
growth charts and BMI are not part of the actual measure for this 
objective.
    Response: We clarify that to satisfy the measure of this objective, 
the CEHRT must have the capability to calculate BMI and produce growth 
charts for patients as appropriate. Since BMI and growth charts are 
only produced when height/length and weight vital sign data are 
captured in the CEHRT, the measure is limited to these data elements.
    Overall commenters supported the added flexibility of our proposal 
to split the exclusion and allow EPs to record blood pressure only or 
height/length and weight only. Our analysis of the meaningful use data 
for Stage 1 found that over 90 percent of EPs, eligible hospitals and 
CAHs were able to successfully report the vital signs measure. We did 
not propose additional measure elements that could increase the 
reporting burden at this time.
    After consideration of the public comments received, we are 
finalizing this measure as proposed for EPs at Sec.  495.6(j)(4)(ii) 
and for eligible hospitals and CAHs at Sec.  495.6(l)(3)(ii).
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(4). The ability to calculate 
the measure is included in CEHRT.
    To calculate the percentage, CMS and ONC have worked together to 
define the following:
     Denominator: Number of unique patients seen by the EP or 
admitted to an eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period.
     Numerator: Number of patients in the denominator who have 
at least one entry of their height/length and weight (all ages) and/or 
blood pressure (ages 3 and over) recorded as structured data.
     Threshold: The resulting percentage must be more than 80 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
     Exclusions: Any EP who sees no patients 3 years or older 
is excluded from recording blood pressure. Any EP who believes that all 
3 vital signs of height/length, weight, and blood pressure have no 
relevance to their scope of practice is excluded from recording them. 
Any EP who believes that height/length and weight are relevant to their 
scope of practice, but blood pressure is not, is excluded from 
recording blood pressure. Any EP who believes that blood pressure is 
relevant to their scope of practice, but height/length and weight are 
not, is excluded from recording height/length and weight.
    Proposed Objective: Record smoking status for patients 13 years old 
or older.
    We stated in the proposed rule that accurate information on smoking 
status provides context to a high number and wide variety of clinical 
decisions, such as immediate needs for smoking cessation or long-term 
outcomes for chronic obstructive pulmonary disease. Cigarette smoking 
is a key component to the current Million Hearts Initiative (http://millionhearts.hhs.gov). We did not propose rules on who may record 
smoking status or how often the record should be updated. In addition, 
we proposed to continue the age limitation at 13 years old. We also 
requested comments specifically on the possible inclusion of other 
forms of tobacco use and second hand smoke.
    Comment: We have received comments that assert that the objective 
is not relevant to a significant number of EPs due to their scope of 
practice and that it is redundant to the clinical quality measure 
``National Quality Forum (NQF) 28: Preventive Care and Screening: 
Tobacco Use: Screening and Cessation Intervention''. Some of the 
comments suggest that it should be eliminated and those EPs for whom it 
is relevant select the CQM.
    Response: We disagree that the proposed objective and the clinical 
quality measure identified by commenters serve the same purpose and 
therefore only one should be included. The objective seeks to ensure 
that information on smoking status is included in the patient's record. 
Furthermore, that the information is stored in a structured format so 
that it can automatically be identified by CEHRT as smoking status for 
possible reporting or exchanging. We also note that the clinical 
quality measure only focuses on patients 18 years or older, while the 
objective focuses on patients 13 years or older. In addition, many 
quality measures related to smoking are coupled with follow-up actions 
by the provider such as counseling. We consider those follow-up actions 
to be beyond the scope of what we hope to achieve for this objective 
and would move the objective beyond the scope of practice for many 
providers. We disagree that the objective is not relevant to EPs seeing 
patient 13 years old or older. We note that this is intended to inform 
the provider. The frequency of when the information is updated, detail 
beyond the standard included in certification of EHR technology and 
many other factors discussed later are all left up to the provider to 
decide and fit to their scope of practice and their patient population.
    Comment: We received conflicting suggestions in comments regarding 
the age limitation. These comments can be divided into those suggesting 
a lower age (as low as 8 to 12), those supporting 13 years old and 
those who believe it should be raised to 18 to match the clinical 
quality measures associated with smoking.
    Response: It is apparent from the comments that the appropriate age 
for smoking status is an elusive target highly dependent on the 
situation. For example, it was suggested in comments that the age be 
lowered for patients meeting certain characteristics such as parents 
who smoke or other risk factors, while remaining at 13 for other 
patients. In our review of the public comments, we do not believe a 
consensus has been reached on a different age limitation than our Stage 
1 age limitation of 13 years old and therefore finalize the age 
limitation as proposed. As with other meaningful use objectives and 
measures, this represents a minimum requirement. We encourage each and 
every provider to evaluate whether their scope of practice and/or 
patient population calls for collecting smoking status on patients 
younger than 13 or more detailed information than required by this 
objective.
    Comment: There continues to be strong support for expanding smoking 
to other forms of tobacco use. Commenters note that other types of 
tobacco use are supported by the clinical quality measure ``NQF 28: 
Preventive Care and Screening: Tobacco Use: Screening and Cessation 
Intervention''.
    Response: We refer readers to ONC's standards and certification 
criteria final rule that is published elsewhere in this issue of the 
Federal Register for discussions on the adoption of a standard that 
would support other types of tobacco use. As ONC did not adopt a 
standard supporting other forms of tobacco use, we do not expand the 
objective.
    Comment: Some commenters expressed strong support for the inclusion 
of second-hand smoke either as part of this objective or as a separate 
objective.
    Response: We agree with the importance of collecting second-hand 
smoke information for many EPs and hospitals. However, as with other 
forms of tobacco use, there is not a standard on which to base the 
requirement of

[[Page 53995]]

collection of this information as structured data.
    After consideration of the public comments received, we are 
finalizing this objective as proposed for EPs as Sec.  495.6(j)(5)(i) 
and for eligible hospitals and CAHs at Sec.  495.6(l)(4)(i).
    Proposed Measure: More than 80 percent of all unique patients 13 
years old or older seen by the EP or admitted to the eligible 
hospital's or CAH's inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period have smoking status recorded as 
structured data.
    In our proposed rule, based on Stage 1 data showing performance on 
this measure far exceeded the measure threshold of more than 50 
percent, we proposed a threshold of more than 80 percent for this 
measure for Stage 2 of meaningful use.
    Comment: We received comments asking for clarification on what must 
be recorded in the EHR and how often for the numerator to be met.
    Response: Information on smoking status must be present as 
structured data using the standard specified at 45 CFR 170.314(a)(11). 
There is no requirement that the smoking status be entered into the 
record by a specific person or category of persons, there is no 
requirement that smoking status be entered into the CEHRT already in 
the terminology of the standard and there is no requirement on how 
frequently this information be updated. A patient indicating how many 
packs he smokes a day on a new patient questionnaire which is then 
entered by an administrative person and mapped in the CEHRT to one of 
the responses in the standard is valid for this measure. A physician 
could also ask a patient detailed questions to determine if the patient 
is a current smoker, input the information into the CEHRT, and select 
one of the responses of the standard. ONC has provided a mapping of 
SNOMED CT[supreg] ID to the descriptions at 45 CFR 170.314(a)(11).
    Comment: We received a few comments on the threshold. Most were 
supportive, while others believe it should remain at 50 percent.
    Response: Due to our analysis of performance on this measure from 
Stage 1 and the support received from commenters, we are finalizing the 
threshold as proposed.
    After consideration of public comments, we are finalizing this 
measure as proposed for EPs at Sec.  495.6(j)(5)(ii) and for eligible 
hospitals and CAHs at Sec.  495.6(l)(4)(ii).
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(11).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of unique patients age 13 or older 
seen by the EP or admitted to an eligible hospital's or CAH's inpatient 
or emergency departments (POS 21 or 23) during the EHR reporting 
period.
     Numerator: The number of patients in the denominator with 
smoking status recorded as structured data.
     Threshold: The resulting percentage must be more than 80 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
     Exclusion: Any EP, eligible hospital, or CAH that neither 
sees nor admits any patients 13 years old or older.
    CQM Reporting as a Stage 2 Objective--We proposed to add CQM 
reporting to the definition of ``meaningful EHR user'' under Sec.  
495.4 instead of including it as a separate objective under Sec.  
495.6. Accordingly, we did not propose a CQM reporting objective for 
EPs and hospitals as part of the Stage 2 criteria under Sec.  495.6.
    Comment: While some commenters indicated that this change would be 
confusing, most commenters supported this change.
    Response: We appreciate the support of commenters and believe 
including CQM reporting in the definition of ``meaningful EHR user'' 
under Sec.  495.4 will actually alleviate confusion. Therefore, we are 
not finalizing an objective related to the reporting of CQMs in the 
Stage 2 criteria for meaningful use under Sec.  495.6. Although CQM 
reporting is not listed as a separate objective and measure under Sec.  
495.6, it remains a condition for demonstrating meaningful use.
    Consolidated Objective: Implement drug-drug and drug-allergy 
interaction checks.
    For Stage 2, we proposed to make the objective for ``Implement 
drug-drug and drug-allergy checks'' one of the measures of the core 
objective for ``Use clinical decision support to improve performance on 
high-priority health conditions.'' We noted our belief that automated 
drug-drug and drug-allergy checks provide important information to 
advise the provider's decisions in prescribing drugs to a patient. 
Because this functionality provides important clinical decision support 
that focuses on patient health and safety, we proposed to include this 
functionality as part of the objective for using clinical decision 
support.
    We discuss comments regarding this consolidation in the discussion 
of the clinical decision support objective.
    Proposed Objective: Use clinical decision support to improve 
performance on high-priority health conditions.
    We proposed to modify the clinical decision support (CDS) objective 
for Stage 2 such that CDS would be used to improve performance on high-
priority health conditions. We stated it would be left to the 
provider's clinical discretion to select the most appropriate CDS 
interventions for their patient population. We also proposed that the 
CDS interventions selected must be related to five or more of the 
clinical quality measures (CQMs) on which providers would be expected 
to report. The goal of the proposed CDS objective is for providers to 
implement improvements in clinical performance for high-priority health 
conditions that will result in improved patient outcomes.
    Comment: A few commenters voiced concern regarding the maturity of 
the development of clinical decision support systems. Others voiced a 
misconception that not all CEHRT includes pre-built CDS interventions 
where both capabilities and content are vendor supplied. The commenter 
went on to clarify that the CDS interventions must be specific to each 
provider's requirements. Still others commented on the CMS change in 
terminology from CDS ``rules'' to CDS ``interventions'' increases the 
range of available interventions.
    Response: We recognize commenters' concerns regarding the maturity 
of CDS systems. Closely linked to the development of EHRs, there are 
multiple factors impacting the evolution of CDS systems including; the 
increasing availability and sophistication of information technology in 
clinical settings, the increasing pace of publication of new evidence-
based guidelines for clinical practice and the continual evaluation and 
improvements of CDS.\2\ We clarify that all CEHRT includes CDS 
interventions. The companion ONC standards and certification criteria 
final rule published elsewhere in this issue of the Federal Register 
includes further information regarding the criteria necessary to 
implement CDS in CEHRT

[[Page 53996]]

for Stage 2 of meaningful use. With each incremental phase of 
meaningful use, CDS systems progress in their level of sophistication 
and ability to support patient care. For Stage 2 of meaningful use, it 
is our expectation that at a minimum, providers will select clinical 
decision support interventions to drive improvements in the delivery of 
care for the high-priority health conditions relevant to their patient 
population. Continuous quality improvement requires an iterative 
process in the implementation and evaluation of selected CDS 
interventions that will allow for ongoing learning and development. In 
this final rule, we will consider a broad range of CDS interventions 
that improve both clinical performance and the efficient use of 
healthcare resources in measuring providers' ability to demonstrate the 
meaningful use of CEHRT for Stage 2.
---------------------------------------------------------------------------

    \2\ Study Protocol for the Effects of computerized clinical 
decision support systems on practitioner performance and patient 
outcome: Methods of a decision-maker-researcher partnership 
systematic review. R Brian Haynes*, Nancy L Wilczynski and the 
Computerized Clinical Decision Support System (CCDSS) Systematic 
Review Team. IMPLEMENTATION SCIENCE 2010, 5:12.
---------------------------------------------------------------------------

    After consideration of the public comments received, we are 
finalizing this objective as proposed for EPs at Sec.  495.6(j)(6)(i) 
and for eligible hospitals and CAHs at Sec.  495.6(l)(5)(i).
    Proposed Measure: We proposed two measures for EPs, eligible 
hospitals and CAHs for this objective. Both of the measures must be met 
in order for the provider to satisfy this objective:
    1. Implement five clinical decision support interventions related 
to five or more clinical quality measures at a relevant point in 
patient care for the entire EHR reporting period; and
    2. The EP, eligible hospital, or CAH has enabled and implemented 
the functionality for drug-drug and drug-allergy interaction checks for 
the entire EHR reporting period.
    We proposed to make the Stage 1 objective for ``implement drug-drug 
and drug-allergy interaction checks'' one of the measures of the CDS 
objective for Stage 2. Based on the HIT Policy Committee's 
recommendation, we proposed that each CDS intervention must enable 
providers to review all of the following attributes for the 
intervention: developer of the intervention, bibliographic citation, 
funding source of the intervention, and the release or revision date of 
each intervention. The ONC standards and certification criteria final 
rule published elsewhere in this issue of the Federal Register provides 
additional information regarding the incorporation of the CDS in CEHRT. 
We proposed that providers must implement the CDS intervention at a 
relevant point in patient care when the intervention can influence 
clinical decisionmaking before an action is taken on behalf of the 
patient. We proposed that providers must implement five CDS 
interventions that they believe will result in improvement in 
performance for five or more of the clinical quality measures on which 
they report. If none of the clinical quality measures is applicable to 
an EP's scope of practice, the EP should implement a CDS intervention 
that he or she believes will be effective in improving the quality, 
safety, or efficiency of patient care.
    Comment: Many commenters noted that at least one of the CDS 
interventions implemented should be tied to efficiency goals (for 
example, reducing the overuse of high-cost procedures).
    Response: While we believe that it is entirely possible for a CDS 
intervention to improve both the quality of care and improve healthcare 
efficiency, we agree with the suggestion that at least one intervention 
could be tied directly to improving the efficient use of healthcare 
resources. In considering whether a CDS intervention increases 
healthcare efficiency, providers can consider improvements in any 
healthcare process. Some examples, of CDS interventions that may lead 
to improvements in healthcare efficiency include, alerts when duplicate 
tests, procedures or treatments are ordered for the same patient, using 
clinical guidelines for direct patient care processes, documentation 
templates to reduce variability in recording and alerting when outside 
of specified parameters, and using evidence based pre-specified order 
sets for blood products. Therefore, we are modifying the proposed CDS 
measure such that four of the CDS interventions are related to four or 
more CQMs, and the fifth CDS intervention should be related to 
improving healthcare efficiency. We clarify that any of the five CDS 
interventions may be related to both CQMs and improving healthcare 
efficiency.
    Comment: Various comments were received in response to the proposed 
number of CDS interventions that are related to five or more CQMs. One 
commenter noted the potential for improved provider reporting and user 
efficiencies due to the inherent measure associations. Several 
commenters welcomed this improved alignment of CQM measures and 
reporting between the EHR Incentive Program and other CMS quality 
programs. Other commenters expressed the difficult burden for 
specialists and others who may not be able to identify sufficient CQMs 
related to their patient population. Still other comments suggested 
that providers could easily implement double the number of proposed CDS 
interventions.
    Response: Overall comments were supportive of the proposed number 
of CDS interventions and of aligning these interventions with CQM 
reporting. If none of the clinical quality measures are applicable to 
an EP's scope of practice, the EP should implement a clinical decision 
support intervention that he or she believes will be effective in 
improving the quality, safety or efficiency of patient care. We believe 
that the proposed clinical quality measures for eligible hospitals and 
CAHs would provide ample opportunity for implementing clinical decision 
support interventions related to high-priority health conditions.
    Comment: Commenters also supported continuing the requirement for 
providers to enable and implement drug-drug and drug-allergy 
interaction checks for the entire reporting period under the new CDS 
measure. An AHA Survey indicated that 73 percent of hospitals could 
perform the drug/drug and drug/allergy check, as well as at least one 
additional clinical decision support function in the Fall of 2011.
    Response: We appreciate the commenters' overall support for 
consolidating this Stage 1 objective into one of the required clinical 
decision support measures. We also agree that drug-drug and drug-
allergy interaction checks are important CDS tools contributing to 
improvements in patient safety and the overall quality of patient care.
    Comment: Additional comments addressed concerns regarding the point 
at which professionals will be able to exercise clinical judgment about 
the CDS intervention before action is taken on behalf of the patient. 
The specific concern is that some interventions are only triggered when 
an action is about to be taken, and proposed that CMS revise this 
criterion to ``before or at the time an action is taken.''
    Response: We agree with the commenter that providers should be 
allowed the flexibility to determine the most appropriate CDS 
intervention and timing of the CDS. The CDS measure for EPs, eligible 
hospitals and CAHs allows this flexibility by allowing the 
implementation at a ``relevant point in patient care.'' We clarify that 
the CDS implementation criterion which allow for CDS implementation at 
a relevant point in patient care includes interventions that may occur 
before or at the time an action is taken in the care delivery process.
    Comment: Several commenters expressed concern with ``alert 
fatigue'' associated with increased use of clinical decision support 
interventions. These commenters cited studies that suggest

[[Page 53997]]

that multiple alerts may be disabled or ignored resulting in adverse 
effects in the quality of care and patient safety.
    Response: We recognize that ``alert fatigue'' is a potential 
occurrence with the increased use of some types of clinical decision 
support interventions. However, meaningful use seeks to leverage the 
capabilities of CEHRT to improve patient care. The selection of CDS 
interventions should weigh both the potential for unintended 
consequences including alert fatigue against the benefits of each CDS 
intervention, and the appropriate selection of an intervention type 
that interferes minimally with the provider's clinical workflow and 
cognitive burden. We believe such determinations are best left to 
providers. CDS is included as a meaningful use objective because we 
believe that the overall benefit of CDS is to improve patient safety 
and the quality of care. Therefore, we will continue to require the 
implementation of clinical decision support interventions in order to 
achieve meaningful use. Finally, as defined in the ONC standards and 
certification criteria final rule published elsewhere in this issue of 
the Federal Register, CDS is ``not simply an alert, notification, or 
explicit care suggestion.'' While some alerts may be helpful and 
necessary, we encourage EPs and hospitals to consider the selection of 
CDS interventions that are not alerts in order to reduce the burden of 
alert fatigue. Examples of non-alert CDS may include patient or disease 
specific order sets, referential decision support (presentation or 
availability of clinical reference information such as diagnostic 
guidance, dosing guidelines, or lab value interpretation assistance, or 
patient or disease specific documentation forms/templates that remind 
the provider to capture essential historical or physical exam findings 
for a patient with a certain condition). A common example of a CDS 
form/template would be a documentation form that is presented for 
patients with diabetes that includes a required section for the 
diabetic foot exam, where the same form would be presented for patients 
without diabetes and with the diabetic foot exam section removed.
    Comment: Several commenters requested the flexibility to be able to 
change CDS interventions at any point during the reporting period so 
that in effect they would not be implementing the CDS intervention 
during the entire reporting period. Commenters cited provider 
uncertainty at the beginning of a reporting period of which CQMs they 
will ultimately report during the attestation process (for example, due 
to low counts for the measures). Many commenters requested the 
additional flexibility for providers to be permitted to implement CDS 
interventions relevant to any of the finalized panel of clinical 
quality measures specific to the provider type, even if the provider 
ultimately chooses different clinical quality measures to report. 
Commenters requested the opportunity to change CDS interventions during 
the reporting period and not be penalized for the CDS measure that 
requires the intervention during the entire reporting period. 
Commenters also wanted clarification whether they have to align CDS 
interventions with the same CQM measures reported for meaningful use.
    Response: We expect providers to align CDS interventions with CQMs 
to the extent possible, although we recognize that providers may not 
know at the beginning of a reporting period which CQMs they will end up 
selecting to report. Based on the comments, we clarify that EPs and 
hospitals may implement CDS interventions that are related (as defined 
in the proposed rule) to any of the clinical quality measures for EPs 
and hospitals, respectively, and that are finalized for the EHR 
Incentive Program for the relevant year of reporting. In other words, 
providers are not required to implement CDS interventions that are 
related to the specific CQMs that they choose to report for that year. 
Providers who are not able to identify CQMs that apply to their scope 
of practice or patient population may implement CDS interventions that 
they believe are related to high-priority health conditions relevant to 
their patient population and will be effective in improving the 
quality, safety or efficiency of patient care. We will require 
providers to implement a minimum of five CDS interventions for the 
entire EHR reporting period. The provider may switch between CDS 
interventions or modify them during the EHR reporting period as long as 
a minimum of five are implemented for the entire EHR reporting period. 
We expect that providers may choose to implement a greater number of 
interventions from which they can select five interventions that have 
been enabled for the entire EHR reporting period when they attest to 
meaningful use.
    Comment: Several providers recommend to be allowed to use their 
clinical judgment regarding which clinical decision support 
interventions would best benefit patients within the scope of their 
practice.
    Response: We thank providers for this comment and want to clarify 
that in Stage 1; CMS allowed providers significant leeway in 
determining the clinical support interventions most relevant to their 
scope of practice. In Stage 2, we will continue to provide the 
flexibility for providers to identify high-priority health conditions 
that are most appropriate for CDS. As we stated in the proposed rule, 
for Stage 2 we will not require the provider to demonstrate actual 
improvements in performance on clinical quality measures for this 
objective. Because CQMs focus on high-priority health conditions by 
definition, to the extent possible, four of the five CDS interventions 
that are implemented must be related to CQMs. Providers are also 
reminded that the CDS interventions selected for Stage 2 represent only 
a floor. We expect that providers will implement many CDS 
interventions, and providers are free to choose interventions in any 
domain that is a priority to the EP, eligible hospital or CAH.
    Comment: Several commenters voiced concern that CDS interventions 
must be predetermined at the beginning of an EHR reporting period but 
providers do not have to choose CQMs until the end of the attestation 
reporting period. There is concern that providers will be unable to 
change the CDS interventions if they decide to change the related CQMs 
in a reporting period.
    Response: We proposed alignment with CQMs to facilitate provider 
reporting and measurement, but as we clarified earlier, providers are 
allowed the flexibility to implement CDS interventions that are related 
to any of the CQMs that are finalized for the EHR Incentive Program. 
They are not limited to the CQMs they choose to report. Providers who 
are not able to identify CQMs that apply to their scope of practice or 
patient population may implement CDS interventions that they believe 
are related to high-priority health conditions relevant to their 
patient population and will be effective in improving the quality, 
safety or efficiency of patient care. These high priority conditions 
must be determined prior to the start of the EHR reporting period in 
order to implement the appropriate CDS to allow for improved 
performance. We require a minimum number of CDS interventions, and 
providers must determine whether a greater number of CDS interventions 
are appropriate for their patient populations.
    Comment: Commenters supported the inclusion of drug-drug and drug-
allergy checks noting that they are critical to ensuring the safety of 
the medications prescribed for patients, and agree with the inclusion 
of this measure. Other commenters noted the lack of an for EPs

[[Page 53998]]

who do not prescribe medications and thus would not be able to meet 
this core set objective.
    Response: We received similar feedback after publication of the 
Stage 1 final rule and after careful consideration of the comments, we 
will allow an exclusion to this measure for EPs that write fewer than 
100 medication orders during the EHR reporting period. We did not 
include this exclusion as a change to Stage 1 as this is primarily an 
implementation of a function of CEHRT and there is no requirement to 
update CEHRT in 2013. This exclusion aligns with the exclusion under 
the objective CPOE for medication orders discussed earlier in this 
rule.
    Comment: There were several comments regarding the implementation 
of CDS and the attributes required for each intervention. Commenters 
did not believe that the information requested in order to support the 
inclusion of CDS attributes would be available to many providers, 
particularly for providers in a group practice. Commenters also 
requested clarification whether these attributes would be required for 
drug-drug and drug-allergy interactions. Other commenters requested 
additional clarification regarding the extent that CDS attributes are 
required when the interventions result from self-generated evidence. 
Other comments addressed provider concerns regarding the need to 
purchase additional expensive vendor products and upgrades to 
incorporate these requirements.
    Response: We appreciate the many comments for the proposed CDS 
attributes. We clarify that the need for inclusion of attributes for 
each CDS intervention also applies to drug-drug and drug-allergy 
interventions as well as interventions based on self-generated 
evidence. The companion ONC standards and certification criteria final 
rule published elsewhere in this issue of the Federal Register further 
describes CEHRT requirements for these CDS attributes in order to 
ensure that all users of CEHRT will have access to this new 
functionality. After consideration of the public comments and for the 
reasons discussed earlier, we are modifying the measures for EPs at 
Sec.  495.6(j)(6)(ii) and for eligible hospitals and CAHs at Sec.  
495.6(l)(5)(ii) as follows:
     Implement five clinical decision support interventions 
related to four or more clinical quality measures at a relevant point 
in patient care for the entire EHR reporting period. Absent four 
clinical quality measures related to an EP, eligible hospital or CAH's 
scope of practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions . It 
is suggested that one of the five clinical decision support 
interventions be related to improving healthcare efficiency.
     The EP, eligible hospital, or CAH has enabled and 
implemented the functionality for drug-drug and drug-allergy 
interaction checks for the entire EHR reporting period.
    Exclusion: For the second measure, any EP who writes fewer than 100 
medication orders during the EHR reporting period.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(8) and (a)(2).
    Replaced Objective: Provide patients with an electronic copy of 
their health information.
    Replaced Objective: Provide patients with an electronic copy of 
their discharge instructions.
    For Stage 2, we did not propose the Stage 1 meaningful use 
objectives for EPs and hospitals to provide patients with an electronic 
copy of their health information and discharge instructions upon 
request. As we stated in the proposed rule, the HIT Policy Committee 
recommended that these objectives be combined with the objectives for 
view online, download, and transmit. We agreed with the HIT Policy 
Committee and proposed to replace the Stage 1 objectives above with 
objectives and measures for Stage 2 that would enable patients to view 
online and download their health information and hospital admission 
information. We stated that continued online access to such information 
is more useful and provides greater accessibility over time and in 
different health care environments than a single electronic 
transmission or a one-time provision of an electronic copy, especially 
when that access is coupled with the ability to download a 
comprehensive point in time record.
    We received no comments that supported the retention of these 
objectives for Stage 2. Therefore, we are finalizing the replacement of 
these objectives for EPs, eligible hospitals, and CAHs as proposed. 
Please refer to the discussions later in this rule regarding view 
online, download, and transmit objectives for both EPs and eligible 
hospitals and CAHs for more information about the Stage 2 objectives 
that replace these Stage 1 objectives.
    Proposed EP Objective: Provide clinical summaries for patients for 
each office visit.
    In the proposed rule, we outlined the following benefits of 
providing clinical summaries for patients for each office visit: A 
summary of an office visit provides patients and their families with a 
record of the visit. This record can prove to be a vital reference for 
the patient and their caregivers about their health and actions they 
should be taking to improve their health. Without this reference, the 
patient must either recall each detail of the visit, potentially 
missing vital information, or contact the provider after the visit. 
Certified EHR technology enables the provider to create a summary 
easily and in many cases instantly. This capability removes nearly all 
of the barriers that exist when using paper records.
    As noted in the proposed rule, clinical summaries for each office 
visit are important because without this reference the patient must 
either recall each detail of the visit, potentially missing vital 
information, or contact the provider after the visit. We also noted 
that this is a meaningful use requirement, which does not override an 
individual's broader right under HIPAA to access his or her health 
information. Providers must continue to comply with all applicable 
requirements under the HIPAA Privacy Rule, including the access 
provisions of 45 CFR 164.524. However, none of the HIPAA access 
requirements preclude an EP from releasing electronic copies of 
clinical summaries to their patients as required by this meaningful use 
provision. For Stage 2, we proposed this as a core objective for EPs.
    Comment: Some commenters believed that this objective should be 
eliminated because the same information would be made available through 
the objective to ``Provide patients the ability to view online, 
download, and transmit their health information.'' Other commenters 
suggested combining these objectives with a concomitant rise in the 
measure threshold.
    Response: While it is true that there may be overlap between the 
information in the clinical summary and the information made available 
through the objective to ``Provide patients the ability to view online, 
download, and transmit their health information,'' we believe the 
clinical summary after an office visit serves a different purpose than 
online access to health information. A summary of an office visit 
provides patients and their families with a record of the visit and 
specific lab tests or specific follow-up actions and treatment related 
to the visit. While this information is certainly part of the patient's 
overall electronic health record, the clinical summary serves to 
highlight information that is relevant to the patient's care at that 
particular

[[Page 53999]]

moment. Therefore, we decline to eliminate or combine the objective.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for EPs at Sec.  495.6(j)(11)(i) as proposed.
    Proposed EP Measure: Clinical summaries provided to patients within 
24 hours for more than 50 percent of office visits.
    In the proposed rule, we proposed to maintain several policies 
regarding this objective from Stage 1. As we stated, for purposes of 
meaningful use, an EP could withhold information from the clinical 
summary if they believe substantial harm may arise from its disclosure 
through an after-visit clinical summary. An EP could also choose 
whether to offer the summary electronically or on paper by default, but 
at the patient's request must make the other form available. The EP 
could select any modality (for example, online, CD, USB) as their 
electronic option and would not have to accommodate requests for 
different modalities. We also stated in the proposed rule that we do 
not believe it would be appropriate for an EP to charge the patient a 
fee for providing the summary. Finally, we stated that when a single 
consolidated summary is provided for an office visit that lasts for 
several consecutive days, or for an office visit where a patient is 
seen by multiple EPs, that office visit must be counted only once in 
both the numerator and denominator of the measure. We are finalizing 
all of these policies for Stage 2 as proposed.
    Comment: Many commenters suggested that the measure should be 
changed from ``24 hours'' to ``1 business day.'' Other commenters 
believed that this timeframe was too short, especially for specialty 
providers who might not come into the office every day, and suggested 
either changing the timeframe to 48 hours or reverting to the 72-hour 
measure of Stage 1. Another commenter noted that delays past 24 hours 
can sometimes occur outside of the provider's control--for example, in 
the case of new patients where the provider might not have access to 
adequate previous records.
    Response: We believe that Certified EHR technology enables the 
provider to create a summary with the required information easily and 
in most cases instantly. The feedback we have received on this 
objective in Stage 1 through discussions with providers indicates that 
most providers make this clinical summary available as patients leave 
the office visit, and we expect this workflow to continue for most 
providers. Therefore a longer timeframe of 48 or 72 hours should not be 
necessary for providing clinical summaries. We also note that the 
clinical summary contains information relevant to the patient's office 
visit and therefore the EP should not need to include information from 
previous records for most patients. However, we believe the threshold 
of more than 50 percent of office visits allows EPs to meet the measure 
of this objective despite these challenges for a small number of 
patients. We also agree that the measure should be changed from ``24 
hours'' to ``1 business day'' since all providers may not have staff 
available to issue clinical summaries prior to the close of a work week 
or the beginning of a Federal holiday. Therefore, we are finalizing the 
change from ``24 hours'' to ``1 business day.''
    Comment: A number of commenters raised questions regarding the 
provision of the clinical summary. They asked whether the summary 
should be given automatically to each patient or whether offering the 
summary at the end of an office visit was sufficient to meet the 
measure. Commenters also asked whether patients who refused a copy of 
the clinical summary should be counted in the numerator of the measure.
    Response: It is the intention of this objective that clinical 
summaries be automatically given to patients within 1 business day of 
an office visit. However, we do recognize that some patients may 
decline a physical copy of their clinical summary. In the event that a 
clinical summary is offered to and subsequently declined by the 
patient, that patient may still be included in the numerator of the 
measure. We note that the clinical summary must be offered to the 
patient; a passive indication of the clinical summary's availability 
(for example, a sign at the reception desk, a note in form, etc.) would 
not serve as offering the clinical summary and those patients could not 
be counted in the numerator of the measure. However, the clinical 
summary does not necessarily need to be printed before being offered to 
the patient.
    Comment: Commenters asked whether making clinical summaries 
available on a patient portal or as part of the objective to ``Provide 
patients the ability to view online, download, and transmit their 
health information'' would meet the measure of this objective. Some 
commenters suggested that patients should be permitted to demand an 
electronic copy of clinical summaries where an EP has chosen to provide 
them in hard copy form.
    Response: We are continuing our policy from Stage 1 that the 
clinical summary can be provided through a patient portal or through 
other electronic means to satisfy this measure. A clinical summary 
provided through the same means that the provider makes other patient 
information available to meet the objective to ``Provide patients the 
ability to view online, download, and transmit their health 
information'' would also meet the measure of this objective. As stated 
previously, an EP can choose whether to offer the summary 
electronically or on paper by default, but at the patient's request 
must make the other form available. The EP could select any modality 
(for example, online, CD, USB) as their electronic option and would not 
have to accommodate requests for different electronic modalities.
    Comment: Some commenters suggested that this measure should be 
based on the number of unique patients seen by the EP instead of office 
visits. Other commenters suggested that the threshold for the measure 
should be reduced.
    Response: We do not agree that the measure should be based on 
unique patients. The purpose of the clinical summary is to provide 
patients and their authorized representatives with a record of an 
office visit and specific lab tests or specific follow-up actions and 
treatment related to that visit. Nor do we agree that the percentage 
threshold of this measure should be reduced. We note that the threshold 
for this measure in Stage 1 was also 50 percent; any reduction would 
constitute a step backward for the meaningful use of this capability.
    Comment: Some commenters suggested that EPs should be permitted to 
charge a fee for provision of a clinical summary.
    Response: Because the clinical summary is meant to summarize the 
office visit and any lab tests, follow-up actions, or treatments 
related to that visit, we do not believe it is appropriate for an EP to 
charge patients additional fees for its provision. Also, because this 
is a meaningful use requirement for the incentivized provider and not a 
response to a patient request, we do not believe it is appropriate for 
an incentivized provider to charge the patient. This is consistent with 
our position for this objective in Stage 1 (75 FR 44358).
    Comment: Commenters suggested that clinical summaries provided to 
patient-authorized representatives should also be counted for this 
measure.
    Response: We agree that the provision of a clinical summary to a 
patient-authorized representative should also be counted, and we have 
amended the measure accordingly.

[[Page 54000]]

    Comment: Many commenters believed that the list of required 
elements to be included in the clinical summary was excessive and not 
useful to the patient. Commenters suggested that the list be shortened 
or left to the provider's discretion. Additionally, many commenters 
asked for clarification on whether certain fields could be left blank 
and still permit the EP to meet the measure of this objective. Finally, 
a number of commenters suggested that this objective should focus on 
whether the summary is provided and not on required information since 
CEHRT cannot distinguish between information not provided in a clinical 
summary because it is not relevant or because a provider has exercised 
discretion to withhold it.
    Response: This measure is focused on the provision of the clinical 
summary. The clinical summary represents a patient's current care and 
health as a snapshot in time. When provided, we believe it can 
significantly improve a patient's overall awareness of the care they 
are receiving as well as any conditions they may need to manage between 
office visits. The required information listed at the end of this 
section are provided as a way to standardize and prioritize for the 
purposes of EHR technology certification the minimum amount of 
information that must be available to EPs to select. Further, we 
believe that the information in this minimum list is the most 
applicable and beneficial to improving patient care. This is a list of 
information, not a particular structure or format for the summary 
handed to the patient.
    We have no requirements on the design of the summary just the 
information that must be present if it is in the CEHRT. The design of 
the summary should reflect the context of the visit. For example, the 
information of future appointments, referrals to other providers, 
future scheduled tests, and clinical instructions could all appear in a 
section of the summary called ``Next steps''. If all of these 
information areas were empty then ``next steps'' could just be none and 
all the feeding information elements would be covered. Alternatively, 
if the summary is provided on letterhead that includes the office 
location and the provider's name that information does not have to be 
repeated in the text of the summary. We cannot emphasize enough that 
this is required information for the summary not a particular required 
structure for the summary. We do not believe that the list of required 
information imposes an undue burden on providers because CEHRT will be 
able to automatically generate the clinical summary with at least all 
of the required information. In ONC's rule it has included in the 
certification criterion that correlates to this objective the 
capability for end-users to customize (for example, edit) the clinical 
summary to make it more relevant to the patient encounter.
    In circumstances where there is no information available to 
populate one or more of the fields previously listed, either because 
the EP can be excluded from recording such information (for example, 
vital signs) or because there is no information to record (for example, 
no medication allergies or laboratory tests), an indication that the 
information is not available in the clinical summary would meet the 
measure of this objective. The feedback we have received on this 
objective in Stage 1 through discussions with providers indicates that 
the absence of information in the clinical summary sometimes offers an 
opportunity for reconciliation of misinformation; for example, if ``no 
medication allergies'' is listed but the patient has one, he or she may 
communicate that to the provider, thus improving the quality of the 
data in the EHR. We do note that the measure of this objective already 
focuses on provision of the clinical summary and is not specific to the 
information which is provided within the clinical summary; the list of 
required elements is meant to standardize the information given to 
patients, not to create an additional measure for the objective.
    We also refer providers to our discussion of what constitutes an 
office visit. Many of the concerns we have heard regarding this summary 
are the result of misunderstandings about what constitutes an office 
visit. For example, in some cases removing sutures or giving allergy 
shots do not represent an office visit if that is the only service 
provided.
    Comment: Commenters asked for clarification on ``current problem 
list and any updates,'' ``current medication list and any updates,'' 
and ``current medication allergy list and any updates,'' since updates 
would be included in any current problem list. They suggested 
simplifying these requirements to ``current problem list;'' ``current 
medication list;'' and ``current medication allergy list''.
    Response: We agree that including the language ``and any updates'' 
is redundant since a current problem, medication, or medication allergy 
list would already include updated information. We are amending this 
language in the list of required elements below. However, the clinical 
summary should include both a current problem list and any diagnosis 
specifically related to the office visit as separate fields. The 
diagnosis related to the office visit should be expressed in the 
``Reason for the patient's visit'' field, though it may also be 
included in the current problem list. We note that this is consistent 
documentation available in the Consolidated Clinical Document 
Architecture (CDA), which defines the ``Reason for the patient's 
visit'' field as the provider's description of the reason for visit and 
the ``Chief complaint field'' as the patient's own description.
    Comment: Commenters asked for clarification on ``vital signs and 
any updates'' and suggested simplifying this requirement to ``Vitals 
taken during visit''.
    Response: While we agree that vital signs taken during the visit 
would be most useful in the clinical summary, we also recognize that 
all vital signs may not be updated at each office visit. Therefore, we 
are amending this language to ``Vital signs taken during the visit (or 
other recent vital signs)'' in the list of required elements below.
    Comment: Commenters asked us to clarify if the requirement relating 
to the inclusion of laboratory test results applies only to test 
results available at the time of the office visit or to test results 
that become available after the clinical summary is issued.
    Response: By laboratory test results, we mean for the clinical 
summary to include results that are available at the time the clinical 
summary is issued to the patient. As we stated in the proposed rule, 
clinical summaries can quickly become out of date due to information 
not available to the EP at the end of the visit. The most common 
example of this is laboratory test results. We believe that EPs should 
make this information known to the patient when the results are 
available, but do not require that a new clinical summary must be 
issued when information needs to be updated.
    Comment: Commenters asked us to clarify if the list of diagnostic 
tests pending indicates diagnostic tests that have been scheduled or 
diagnostic tests for which results are not yet available.
    Response: Diagnostic tests pending refers to diagnostic tests that 
have been performed but for which results are not yet available. 
Laboratory or diagnostic tests that have been scheduled but not yet 
performed should be recorded under ``Future scheduled tests'' in the 
list of required elements later in this section.
    Comment: Some commenters asked us to define clinical instructions. 
Other commenters asked if the instructions included as part of the care 
plan were

[[Page 54001]]

redundant with the ``clinical instructions'' element in the list of 
required information.
    Response: By clinical instructions we mean care instructions for 
the patient that are specific to the office visit. Although we 
recognize that these clinical instructions at times may be identical to 
the instructions included as part of the care plan, we also believe 
that care plans may include additional instructions that are meant to 
address long-term or chronic care issues, whereas clinical instructions 
specific to the office visit may be related to acute patient care 
issues. Therefore, we maintain these as separate items in the list of 
required elements later.
    Comment: A commenter noted that future appointments and future 
scheduled tests might be stored in a scheduling system that is separate 
from CEHRT and suggested that if the information is not available in 
CEHRT that the EP be excluded from having to provide it as part of the 
clinical summary.
    Response: As noted previously, in circumstances where there is no 
information available to populate one or more of the fields previously 
listed, either because the EP can be excluded from recording such 
information (for example, vital signs) or because there is no 
information to record (for example, no medication allergies or 
laboratory tests), an indication that the information is not available 
in the clinical summary would meet the measure of this objective. This 
would also be true if the information is not accessible through CEHRT.
    Comment: Commenters asked for clarification regarding demographics 
``maintained by EP.'' Specifically, they asked whether the EP was 
required to enter demographics or whether these could be maintained by 
a member of his or her staff.
    Response: By demographics we mean the demographics maintained 
within CEHRT. We do not intend to specify that only the EP can enter 
such information into the EHR; demographic information can be entered 
into CEHRT by any person or through any electronic interface with 
another system. Therefore, we are amending the language to 
``Demographic information maintained within CEHRT'' in our list of 
required elements later in this section.
    Comment: In regard to the inclusion of ``care plan field'' in the 
list of required information, some commenters believed that the wording 
was overly prescriptive since CEHRT could utilize multiple fields to 
structure care plans. Other commenters requested a more detailed 
definition of care plan.
    Response: We agree that the language proposed could be viewed as 
prescriptive, and we do not intend to limit the inclusion of the care 
plan to a single field. Therefore, we are amending the language to 
``Care plan field(s), including goals and instructions'' in our list of 
required elements below. However, we decline to provide an alternate 
definition that would limit the information in the care plan. We 
believe that the definition we proposed in the proposed rule is 
sufficient to allow for the inclusion of a variety of care plans in the 
clinical summary. For purposes of the clinical summary, we define a 
care plan as the structure used to define the management actions for 
the various conditions, problems, or issues. A care plan must include 
at a minimum the following components: problem (the focus of the care 
plan), goal (the target outcome) and any instructions that the provider 
has given to the patient. A goal is a defined target or measure to be 
achieved in the process of patient care (an expected outcome).
    Comment: Some commenters asked for clarification about what is 
meant by patient decision aids.
    Response: By patient decision aids we mean any educational resource 
or tool that the provider believes can inform patient decisions about 
their own care. An example is an educational handout on the pros and 
cons of having surgery for a particular condition.
    Comment: Some commenters noted that because EHRs capture medical 
data, they will produce clinical summaries with medical terminology, 
whereas patients should receive summaries with nonmedical terminology 
and descriptions of both medications and lab test results that are easy 
to read and contain actionable items.
    Response: While we agree that clinical summaries with nonmedical 
terminology and extended descriptions would be most beneficial to 
patients, we also believe that the utility of this objective must be 
balanced against the potential burden it places on EPs. Since clinical 
summaries can be automatically generated from existing data in CEHRT, 
this removes significant workflow barriers to providing a summary for 
patients. We believe that requiring providers or their staff to render 
all information in the clinical summary into nonmedical terms at this 
time would impose a significant burden on providers and reduce the 
number of clinical summaries that providers make available to patients, 
thereby reducing the effectiveness of this objective. However, we note 
that most of the information that is required as part of the clinical 
summary should be easily understandable by most patients. Also, there 
is nothing to prevent an EP from providing additional information if he 
or she believes it would be more effective for the overall quality of 
patient care. We further note that we anticipate that the capabilities 
of CEHRT may soon allow for the provision of non-medical terminology 
and extended descriptions and we are considering adding this 
requirement in future stages of meaningful use.
    Comment: One commenter noted that the clinical summary contains a 
vast amount of protected health information (PHI) which could be 
compromised if patients discard the clinical summary insecurely. The 
commenter suggested requiring the clinical summary only for those 
patients who affirm they want it to eliminate any provider 
responsibility for security of the information.
    Response: We do not believe that making protected health 
information available to patients in any way compromises either 
patients or providers. On the contrary, we believe that offering this 
information is critical to improving the overall quality of patient 
care by offering specific follow-up instructions, test results, and 
care plan information to patients so that they can actively participate 
in their own care. We believe that providers can take steps to inform 
patients about the need to securely dispose of PHI, and we further note 
that making clinical summaries available electronically through an 
online portal or other means can be used to keep such PHI secure. 
Therefore, we decline to change the measure for this objective.
    After consideration of the public comments, we are finalizing the 
meaningful use measure for EPs as ``Clinical summaries provided to 
patients or patient-authorized representatives within 1 business day 
for more than 50 percent of office visits'' at Sec.  495.6(j)(11)(ii).
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(e)(2).
    We clarify that the following information (or an indication that 
there is no information available) is required to be part of the 
clinical summary for Stage 2:
     Patient name.
     Provider's name and office contact information.
     Date and location of the visit.
     Reason for the office visit.
     Current problem list.
     Current medication list.
     Current medication allergy list.

[[Page 54002]]

     Procedures performed during the visit.
     Immunizations or medications administered during the 
visit.
     Vital signs taken during the visit (or other recent vital 
signs).
     Laboratory test results.
     List of diagnostic tests pending.
     Clinical instructions.
     Future appointments.
     Referrals to other providers.
     Future scheduled tests.
     Demographic information maintained within CEHRT (sex, 
race, ethnicity, date of birth, preferred language).
     Smoking status
     Care plan field(s), including goals and instructions.
     Recommended patient decision aids (if applicable to the 
visit).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of office visits conducted by the EP 
during the EHR reporting period.
     Numerator: Number of office visits in the denominator 
where the patient or a patient-authorized representative is provided a 
clinical summary of their visit within 1 business day.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
     Exclusion: Any EP who has no office visits 
during the EHR reporting period.
    Removed Objective: Capability to exchange key clinical information.
    In Stage 2, we proposed to move to actual use cases of electronic 
exchange of health information through the following objective: ``The 
EP, eligible hospital or CAH who transitions their patient to another 
setting of care or provider of care or refers their patient to another 
provider of care should provide summary care record for each transition 
of care or referral.'' We also proposed to remove this objective for 
Stage 1 as well, but requested comments on other options. Please refer 
to the section titled ``Changes to Stage 1'' at II.A.3.b. of this final 
rule for details of the options considered. We are finalizing the 
removal of this objective as proposed in favor of the more robust, 
actual use case of electronic exchange through a summary of care record 
following each transition of care or referral. We believe that this 
actual use case is not only easier for providers to understand but it 
is also more beneficial because it contributes directly to the care of 
the patient through enhanced coordination between providers. A prudent 
provider will be preparing and testing to conduct actual exchange prior 
to the start of Stage 2 during their Stage 1 EHR reporting periods.
    Proposed Objective: Protect electronic health information created 
or maintained by the CEHRT through the implementation of appropriate 
technical capabilities.
    In the proposed rule, we outlined the following benefits of 
protecting health information: Protecting electronic health information 
is essential to all other aspects of meaningful use. Unintended and/or 
unlawful disclosures of personal health information could diminish 
consumers' confidence in EHRs and electronic health information 
exchange. Ensuring that health information is adequately protected and 
secured will assist in addressing the unique risks and challenges that 
may be presented by electronic health records.
    Comment: A number of commenters supported the continued inclusion 
of this objective, yet several commenters requested the elimination of 
this objective as redundant to HIPAA regulations.
    Response: We believe that it is crucial that EPs, eligible 
hospitals, and CAHs evaluate the privacy and security implications of 
CEHRT as part of the EHR Incentive Programs, particularly as they 
pertain to 45 CFR 164.308(a)(1) and the protection and safeguarding of 
personal health information in general. Therefore, we retain this 
objective and measure for meaningful use in the final rule.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for EPs at Sec.  495.6(j)(16)(i) and eligible 
hospitals and CAHs at Sec.  495.6(l)(15)(i) as proposed.
    Proposed Measure: Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data at rest in accordance with 
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), 
and implement security updates as necessary and correct identified 
security deficiencies as part of the provider's risk management 
process.
    In the proposed rule, we explained that this measure is the same as 
in Stage 1 except that we specifically address the encryption/security 
of data is that is stored in CEHRT (data at rest). Due to the number of 
breaches reported to HHS involving lost or stolen devices, the HIT 
Policy Committee recommended specifically highlighting the importance 
of an entity's reviewing its encryption practices as part of its risk 
analysis. We agree that this is an area of security that appears to 
need specific focus. Recent HHS analysis of reported breaches indicates 
that almost 40 percent of large breaches involve lost or stolen 
devices. Had these devices been encrypted, their data would have been 
secured. It is for these reasons that we specifically call out this 
element of the requirements under 45 CFR 164.308(a)(1) for the 
meaningful use measure. We did not propose to change the HIPAA Security 
Rule requirements, or require any more than is required under HIPAA. We 
only emphasize the importance of an EP or hospital including in its 
security risk analysis an assessment of the reasonable and 
appropriateness of encrypting electronic protected health information 
as a means of securing it, and where it is not reasonable and 
appropriate, the adoption of an equivalent alternative measure.
    We proposed this measure because the implementation of CEHRT has 
privacy and security implications under 45 CFR 164.308(a)(1). A review 
must be conducted for each EHR reporting period and any security 
updates and deficiencies that are identified should be included in the 
provider's risk management process and implemented or corrected as 
dictated by that process.
    In the proposed rule, we emphasized that our discussion of this 
measure and 45 CFR 164.308(a)(1) is only relevant for purposes of the 
meaningful use requirements and is not intended to supersede what is 
separately required under HIPAA and other rulemaking. Compliance with 
the HIPAA requirements is outside of the scope of this rulemaking. 
Compliance with 42 CFR Part 2 and state mental health privacy and 
confidentiality laws is also outside the scope of this rulemaking. EPs, 
eligible hospitals or CAH affected by 42 CFR Part 2 should consult with 
the Substance Abuse and Mental Health Services Administration (SAMHSA) 
or state authorities.
    Comment: Some commenters asked if the Stage 2 requirements for this 
objective contradict earlier Stage 1 requirements and HIPAA 
regulations. Specifically, the addition of addressing encryption/
security of data at rest to the measure was raised as a concern.
    Response: We do not believe that the Stage 2 measure of this 
objective contradicts either the Stage 1 measure or current HIPAA 
regulations. As noted in the proposed rule, this measure is the same as 
in Stage 1 except that we specifically highlight the encryption/
security of data that is stored in CEHRT (data at rest). Recent HHS 
analysis of reported breaches indicates that almost 40 percent of large 
breaches (breaches affecting 500 or more individuals) involve lost or 
stolen devices. Had these

[[Page 54003]]

devices been encrypted, their data would have been secured. It is for 
these reasons that we specifically call out this requirement under 45 
CFR 164.308(a)(1). We did not propose to change the HIPAA Security Rule 
requirements, or require any more under this measure than is required 
under HIPAA. We only emphasize the importance of an EP or hospital 
including in its security risk analysis an assessment of the reasonable 
and appropriateness of encrypting electronic protected health 
information as a means of securing it, and where it is not reasonable 
and appropriate, the adoption of an equivalent alternative measure.
    Comment: Several commenters asked for clarification of what 
constitutes an acceptable security risk analysis. Commenters also asked 
if the security risk analysis required in the measure should apply to 
health data stored in data centers with physical security.
    Response: We did not propose to change the HIPAA Security Rule 
requirements or impose additional requirements under this measure than 
those required under HIPAA. A review must be conducted for each EHR 
reporting period and any security updates and deficiencies that are 
identified should be included in the provider's risk management process 
and implemented or corrected as dictated by that process. We refer 
providers to the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data at rest in accordance with 
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), 
of the HIPAA Security Rule for compliance. The HHS Office for Civil 
Rights (OCR) has issued guidance on conducting a security risk 
assessment pursuant to the HIPAA Security Rule (http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). The 
scope of the security risk analysis for purposes of this meaningful use 
measure applies only to data created or maintained by CEHRT. This 
measure does not apply to data centers that are not part of CEHRT. 
However, we note that such data centers may be subject to the security 
requirements under 45 CFR 164.308(a)(1) and refer providers to the 
HIPAA Security Rule for compliance information.
    Comment: One commenter asked if the measure of the objective 
required hospitals to report on data encryption methods.
    Response: No, eligible hospitals and CAHs are not required to 
report to CMS or the states on specific data encryption methods used. 
However, they are required to address the encryption/security of data 
at rest in accordance with requirements under 45 CFR 164.312(a)(2)(iv) 
and 45 CFR 164.306(d)(3).
    Compliance with 42 CFR Part 2 and state mental health privacy and 
confidentiality laws is also outside the scope of this rulemaking. EPs, 
eligible hospitals or CAH affected by 42 CFR Part 2 should consult with 
the Substance Abuse and Mental Health Services Administration (SAMHSA) 
or state authorities.
    We are making a change in this final rule to the language of ``data 
at rest'' to specify our intention of data that is stored in CEHRT. 
After consideration of the public comments, we are finalizing the 
meaningful use measure as ``Conduct or review a security risk analysis 
in accordance with the requirements under 45 CFR 164.308(a)(1), 
including addressing the encryption/security of data stored in CEHRT in 
accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 
164.306(d)(3), and implement security updates as necessary and correct 
identified security deficiencies as part of the provider's risk 
management process'' for EPs ``at Sec.  495.6(j)(16)(ii) and eligible 
hospitals and CAHs at Sec.  495.6(l)(15)(ii).
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(d)(1) through 170.314(d)(8).
    (b) Objectives and Measures Carried Over (Modified or Unmodified) 
from Stage 1 Menu Set to Stage 2 Core Set
    We signaled our intent in the Stage 1 final rule to move the 
objectives from the Stage 1 menu set to the Stage 2 core set. The HIT 
Policy Committee also recommended that we move all of these objectives 
to the core set for Stage 2. We proposed to include in the Stage 2 core 
set all of the objectives and associated measures from the Stage 1 menu 
set, except for the objective ``capability to submit electronic 
syndromic surveillance data to public health agencies'' for EPs, which 
will remain in the menu set for Stage 2. As discussed later, we also 
proposed to modify and combine some of these objectives and associated 
measures for Stage 2--
    Consolidated Objective: Implement drug formulary checks.
    For Stage 2, we proposed to include this objective within the core 
objective for EPs ``Generate and transmit permissible prescriptions 
electronically (eRx)'' and the menu objective for eligible hospitals 
and CAHs of ``Generate and transmit permissible discharge prescriptions 
electronically (eRx).'' We believe that drug formulary checks are most 
useful when performed in combination with e-prescribing, where such 
checks can allow the EP or hospital to increase the efficiency of care 
and benefit the patient financially. We address the comments related to 
these proposals and state our final policy in the discussions of the 
eRx objectives for EPs and hospitals.
    Proposed Objective: Incorporate clinical lab test results into 
CEHRT as structured data.
    We propose to continue the policy from Stage 1 to incorporate 
clinical lab test results into CEHRT as structured data. We believe 
this measure contributes to the exchange of health information between 
providers of care, facilitates the sharing of information with patients 
and their designated representatives, and may reduce order entry errors 
which will contribute to patient care improvements.
    We did not receive any comments for this objective. We are 
finalizing the meaningful use objective for EPs at Sec.  495.6(j)(7)(i) 
and eligible hospitals and CAHs at Sec.  495.6(l)(6)(i) as proposed.
    Proposed Measure: More than 55 percent of all clinical lab tests 
results ordered by the EP or by authorized providers of the eligible 
hospital or CAH for patients admitted to its inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period whose results 
are either in a positive/negative or numerical format are incorporated 
in CEHRT as structured data.
    We proposed to increase the measure threshold from more than 40 
percent for Stage 1 to more than 55 percent for Stage 2. We also 
solicited public comment regarding the feasibility of continuing to 
account for individual lab tests separately from group and panel tests. 
In addition, we solicited comment on whether standards and other 
capabilities would allow for the expansion of this measure to include 
all quantitative lab results.
    Comment: Many of the commenters voiced their concern that not all 
EHRs are capable of splitting out individual test results from panel 
tests and that it would not be feasible to require this for Stage 2 of 
meaningful use. Other commenters suggested modifying the current 
measure to use the number of laboratory test results in the EHR as the 
numerator and the total laboratory test results from the Lab 
Information System as the denominator. Others questioned the validity 
of the current measure that counts orders in the denominator and 
results in the numerator. Another comment is that not all providers 
have

[[Page 54004]]

access to a lab interface system and not all lab interfaces are 
compatible.
    Response: We appreciate the many comments and suggestions submitted 
regarding this measure which were carefully considered as we developed 
the final regulation. Some commenters questioned the measure validity 
suggesting that the measure is imperfect since the numerator and 
denominator are incongruent. However, in considering the broader policy 
goal underlying this measure (to incorporate lab results into CEHRT in 
a standard format) the measure needs to be broad enough to allow 
providers to incorporate laboratory orders and results from multiple 
service providers. By incorporating all lab orders (whether panel or 
individual) in the denominator, and all lab test results in the 
numerator, providers will be able to capture structured lab data from a 
broad range of provider laboratory information systems into the CEHRT. 
We understand that the most likely scenario is that the denominator of 
total lab orders (if panel orders are counted as one) will be less than 
the numerator of laboratory results because results are provided for 
each individual test rather than by panel. Therefore, it is highly 
unlikely that the measure would impact a provider's ability to meet the 
increased threshold in this scenario.
    Providers will need to continue to report individual lab test 
results recorded as structured data in the numerator, and in the 
denominator report all individual lab-tests ordered whether or not they 
are ordered individually or as part of a panel or group lab order. For 
example, one panel order of ten individual lab tests could be counted 
as 1 or 10 lab tests ordered in the denominator depending on the system 
that is used to incorporate this data into the CEHRT. We will monitor 
provider experience with this measure as technological capacity for the 
reporting and exchange of lab data continues to evolve.
    Comment: Other commenters mentioned uncertainty regarding the 
proper vocabulary to use for the incorporation of lab test results in a 
structured format. Several commenters went on to mention that there is 
not one current vocabulary that encompasses all types of tests. Another 
comment proposed that CMS work to amend the clinical laboratory 
improvement amendments (CLIA) to require hospital labs to report 
results in standard vocabulary such as the Logical Observation 
Identifiers Names and Codes System (LOINC) by the time Stage 2 is 
implemented in 2014.
    Response: We refer readers to the ONC standards and certification 
criteria final rule published elsewhere in this issue of the Federal 
Register for vocabulary specifications.
    Comment: Many commenters were confused by the clarification CMS 
provided in the proposed rule for expanding the measure to all 
quantitative results (all results that can be compared on as a ratio or 
on a difference scale). Comments were mixed on whether this measure 
should include all types of lab tests that produce quantitative 
results. One commenter suggested CMS should allow ordinal responses for 
the measure since that is what LOINC uses as the response rather than 
counting test results with either a positive, negative or numeric 
response since operationally, counting tests based on whether or not 
they have two allowed answer choices is difficult, where counting tests 
based on whether the LOINC code for them had a Scale of QN or Ord would 
be quite simple. Another commenter suggested most people would assume 
that ``numeric/quantitative tests'' would include decimals and whole 
numbers as well as results reported in a range (for example, >7.4 or 
quantitative tests that report 
whole or decimal numbers. The structured data for the numeric/
quantitative test results may include positive or negative affirmations 
and/or numerical format that would include a reference range of numeric 
results and/or ratios.
    Comment: Most commenters agreed that the increase measure threshold 
is appropriate. One commenter referenced a recent AHA survey that found 
``60 percent of hospitals could perform this function in Fall 2011 at 
the raised threshold''.
    Response: Our analysis of the Stage 1 attestation data shows that 
91.5 percent of EPs and 95 percent of eligible hospitals and CAHs were 
able to successfully demonstrate meaningful use for this measure. 
Therefore, combined with the AHA survey data results, we will adopt the 
proposed threshold of 55 percent or more for this measure.
    After consideration of the public comments received, we modify the 
measure for EPs at Sec.  495.6(j)(7)(ii) and eligible hospitals and 
CAHs at Sec.  495.6(l)(6)(ii) to:
    More than 55 percent of all clinical lab tests results ordered by 
the EP or by authorized providers of the eligible hospital or CAH for 
patients admitted to its inpatient or emergency department (POS 21 or 
23) during the EHR reporting period whose results are either in a 
positive/negative affirmation or numerical format are incorporated in 
CEHRT as structured data.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(b)(5).
     Denominator: Number of lab tests ordered during the EHR 
reporting period by the EP or by authorized providers of the eligible 
hospital or CAH for patients admitted to its inpatient or emergency 
department (POS 21 or 23) whose results are expressed in a positive or 
negative affirmation or as a number.
     Numerator: Number of lab test results which are expressed 
in a positive or negative affirmation or as a numeric result which are 
incorporated in CEHRT as structured data.
     Threshold: The resulting percentage must be more than 55 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
     Exclusion: Any EP who orders no lab tests where results 
are either in a positive/negative affirmation or numeric format during 
the EHR reporting period.
    There is no exclusion available for eligible hospitals and CAHs 
because we do not believe any hospital will ever be in a situation 
where its authorized providers have not ordered any lab tests for 
admitted patients during an EHR reporting period.
    Proposed Objective: Generate lists of patients by specific 
conditions to use for quality improvement, reduction of disparities, 
research, or outreach.
    In the proposed rule, we outlined the following benefits of 
generating lists of patients by specific conditions: Generating patient 
lists is the first step in proactive management of populations with 
chronic conditions and is critical to providing accountable care. The 
ability to look at a provider's entire population or a subset of that 
population brings insight that is simply not available when looking at 
patients individually. Small variations that are unnoticeable or seem 
insignificant on an individual basis can be magnified when multiplied 
across a population. A number of studies have shown that significant 
improvements result merely due to provider awareness of population 
level information. We believe that many EPs and eligible hospitals will 
use these reports in combination with one of the

[[Page 54005]]

selected quality measures and decision support interventions to improve 
quality for a high priority issue (for example, identify patients who 
are in the denominator for a measure, but not the numerator, and in 
need of an intervention). The capabilities and variables used to 
generate the lists are defined in the ONC standards and certification 
final rule published elsewhere in this issue of the Federal Register; 
not all capabilities and variables must be used for every list.
    We have combined the comments and responses for this objective with 
the measure below. After consideration of the public comments, we are 
finalizing the meaningful use objective for EPs at Sec.  495.6(j)(8)(i) 
and eligible hospitals and CAHs at Sec.  495.6(l)(7)(i) as proposed.
    Proposed Measure: Generate at least one report listing patients of 
the EP, eligible hospital, or CAH with a specific condition.
    We proposed to continue our Stage 1 policies for this measure. The 
objective and measure do not dictate the specific report(s) that must 
be generated, as the EP, eligible hospital, or CAH is best positioned 
to determine which reports are most useful to their care efforts. The 
report used to meet the measure can cover every patient or a subset of 
patients. We believe there is no EP, eligible hospital, or CAH that 
could not benefit their patient population or a subset of their patient 
population by using such a report to identify opportunities for quality 
improvement, reductions in disparities of patient care, or for purposes 
of research or patient outreach; therefore, we did not propose an 
exclusion for this measure. The report can be generated by anyone who 
is on the EP's or hospital's staff during the EHR reporting period. We 
also solicited comment on whether a measure that either increases the 
number and/or frequency of the patient lists will further the intent of 
this objective.
    Comment: Most commenters voiced support for the objective and 
measure and wish it to remain unchanged in the final rule, although 
some commenters stated that the measure should only require 
demonstration that a list can be created and not require a certain 
number of patient lists until the needs to create certain patient lists 
are better ascertained.
    Response: We appreciate the support for this objective, and we note 
that the measure of the objective remains unchanged from Stage 1. 
Demonstration only of the capability to generate lists of patients by 
specific conditions would represent a step backward from the Stage 1 
measure, therefore we do not agree that this would be an appropriate 
measure for Stage 2. We also believe there is ample evidence to support 
the use of patient lists in a variety of quality improvement efforts.
    Comment: Some commenters suggested that the measure requirements 
should be increased, either to require more than one report be 
generated during the EHR reporting period or to require that the report 
generated is linked to one of the EP's or eligible hospital's clinical 
decision support interventions. Another commenter suggested that the 
measure should indicate how the list should be used.
    Response: We believe that moving the objective from the menu set to 
the core represents an adequate increase for Stage 2. We also continue 
to believe that an EP, eligible hospital, or CAH is best positioned to 
determine which reports are most useful to their care efforts. 
Therefore, we do not propose to direct certain reports be created or 
link reports to clinical decision support interventions at this time.
    Comment: Some commenters suggested that lists should be generated 
according to specific clinical conditions or include specific elements, 
such as demographics, to aid analysis. One commenter wanted to know 
whether EPs retain flexibility in deciding the lists they generate, 
particularly in coordinating public health activities with state and 
local public health departments and Medicaid agencies. Another 
commenter suggested that the measure of the objective specify the 
continuous use of the report throughout the EHR reporting period.
    Response: As noted previously, we are continuing our policy from 
Stage 1 that an EP, eligible hospital, or CAH is best positioned to 
determine which reports are most useful to their care efforts. 
Therefore, we do not propose to direct certain reports be created, nor 
do we require that specific conditions or elements be required for the 
reports. Also, we do not set requirements for the frequency of use of 
the report.
    Comment: A commenter asked us to clarify whether the EP must 
generate the patient list or if the patient list could be generated by 
a member of the EP's staff in order to meet the measure.
    Response: For this and most meaningful use objectives, we do not 
specify how information must be entered into CEHRT or who must complete 
the required action to meet the measure. Therefore an EP or a member of 
the EP's staff could generate the list and meet this measure. The 
exception to this rule is for computerized provider order entry (CPOE) 
of medication, laboratory, and radiology orders, which must be entered 
by a licensed healthcare professional per state, local, and 
professional guidelines.
    After consideration of the public comments, we are finalizing the 
meaningful use measure for EPs at Sec.  495.6(j)(8)(ii) and eligible 
hospitals and CAHs at Sec.  495.6(l)(7)(ii) as proposed.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(14).
    Proposed EP Objective: Use clinically relevant information to 
identify patients who should receive reminders for preventive/follow-up 
care.
    In the proposed rule, we described the following benefits of this 
objective. By proactively reminding patients of preventive and follow-
up care needs, EPs can increase compliance. These reminders are 
especially beneficial when long time lapses may occur as with some 
preventive care measures and when symptoms subside, but additional 
follow-up care is still required.
    We also proposed to revise this objective for Stage 2 to ``Use 
clinically relevant information to identify patients who should receive 
reminders for preventive/follow-up care'' based on the HITPC 
recommendation. An EP should use clinically relevant information stored 
within the CEHRT to identify patients who should receive reminders. We 
believe that the EP is best positioned to decide which information is 
clinically relevant for this purpose.
    Comment: A commenter stated that the language in the proposed 
objective is in conflict with the proposed measure. The proposed 
objective is to ``Use clinically relevant information to identify 
patients who should receive reminders for preventive/follow-up,'' with 
no indication that the reminder be sent. However, the proposed measure 
refers to ``patient who had an office visit and were sent a reminder, 
per patient preference.''
    Response: We agree with the commenter that the objective as 
proposed only speaks to the identification of the need for the reminder 
and that the proposed measure requires that the reminder be sent. The 
value of this objective is created when the reminder is sent to the 
patient and therefore, we revise the objective accordingly.
    Comment: Commenters requested request clarification of the 
operative definition of ``reminder.'' Remembering to keep the 
appointment is an important first step to follow-up and preventive care 
and therefore should be counted.

[[Page 54006]]

    Response: We believe that reminders should be limited to new 
actions that need to be taken not of actions that are already taken. 
For example, a reminder to schedule your next mammogram is a reminder 
to take action, while a reminder that your next mammogram is scheduled 
for next week is a reminder of action already taken. If we were to 
allow for reminders of existing scheduled appointments then every 
provider could meet this objective and measure without any patient ever 
learning new information. So we clarify that reminders for preventive/
follow-up care should be for care that the patient is not already 
scheduled to receive. Reminders are not necessarily just to follow up 
with the reminding EP. Reminders for referrals or to engage in certain 
activities are also included in this objective and measure.
    After consideration of the public comments received, we are 
modifying the objective at Sec.  495.6(j)(9)(i) to ``Use clinically 
relevant information to identify patients who should receive reminders 
for preventive/follow-up care and send these patients the reminders, 
per patient preference.''
    Proposed EP Measure: More than 10 percent of all unique patients 
who have had an office visit with the EP within the 24 months prior to 
the beginning of the EHR reporting period were sent a reminder, per 
patient preference.
    In Stage 1, the measure of this objective was limited to more than 
20 percent of all patients 65 years old or older or 5 years old or 
younger. Rather than raise the threshold for this measure, the HIT 
Policy Committee recommended lowering the threshold but extending the 
measure to all active patients. We proposed to apply the measure of 
this objective to all unique patients who have had an office visit with 
the EP within the 24 months prior to the beginning of the EHR reporting 
period. We believe this not only identifies the population most likely 
to consist of active patients, but also allows the EP flexibility to 
identify patients within that population who can benefit most from 
reminders. We solicited comments on the appropriateness of this 
timeframe. We also recognize that some EPs may not conduct face-to-face 
encounters with patients but still provide treatment to patients. These 
EPs could be unintentionally prevented from meeting this core objective 
under the measure requirements, so we proposed an exclusion for EPs who 
have no office visits in order to accommodate such EPs. Patient 
preference refers to the method of providing the reminder.
    Comment: Commenters expressed concern that even with the proposed 
revisions many patients in the denominator might not require a 
reminder. One example given was some colonoscopies are done on a 
schedule of once every ten years. Another example provided was 
specialists who see some patients only for one-time consults. 
Suggestions by commenters to deal with patients in the denominator who 
do not require reminders involve either much more precise measurement 
such as tracking and following up when CEHRT identifies the need for a 
patient reminder, to specific exclusions of certain visit types in the 
measure or to move the requirement to the menu set. Others suggested 
that providers who do not typically send reminders be sent granted 
exclusions.
    Response: We agree that not every active patient will require a 
reminder during the EHR reporting period, which is why the threshold is 
far below 100 percent. We believe that a low threshold of 10 percent is 
the best way to account for the contextually specific reasons a patient 
might not be sent a reminder. We proposed an exclusion for EPs who 
would typically not send reminders, specifically those without office-
based visits. This may not include all providers who do not typically 
send reminders, but as an exclusion must contain definitive criteria we 
believe it is a good exclusion. We did not receive in comments precise 
criteria for an alternative exclusion.
    Comment: We received many comments as to what constitutes an active 
patient in a practice. Many voiced the opinion that given the 24 month 
look back period in a typical practice, many patients would have moved 
to another practice. One suggestion given for an alternate way to count 
patients was to change the definition of ``active patients'' to be 
either three or more visits in 24 months or two or more visits in 12 
months. Other commenters recommended that the time limitation be 
removed.
    Response: We proposed active patients as a method to limit the 
denominator to patients more likely to require a reminder. The goal is 
to limit the denominator as much as possible without excluding patients 
who should receive a reminder. After reviewing the comments, we change 
the look back to patients with at least two office visits in the last 
24 months. We believe this better establishes a relationship between 
the provider and the EP. This would account for those specialists that 
do not have continuing relationships with their patients, but rather 
hand their care back to the referring provider.
    Comment: Several commenters raised concerns with the requirement 
that it be per patient preference. They asked for clarification on the 
definition of ``per patient preference.'' Specifically commenters asked 
if patient preference referred to whether the patient wanted reminders 
or what method of communication they wanted to receive the reminders. 
Second, clarification is requested on how providers should document 
these preferences. Third, there is concern that an insufficient number 
of patients will have their preferences recorded at the start of the 
EHR reporting period and if so, any method of communication should 
suffice for those patients.
    Response: We clarify that patient preference is the method of 
communication that patients prefer to receive their reminders such as 
(but not limited to) by mail, by phone or by secure messaging. Given 
the look back period associated with this measure, we agree that it is 
not feasible to have all patient preferences recorded prior to the 
start of the EHR reporting period. Therefore, we clarify that reminders 
must be sent using the preferred communication medium only when it is 
known by the provider. This is limited to the type of communication 
(phone, mail, secure messaging, etc.) and does not extend to other 
constraints like time of day. Patients may decline to provide their 
preferred communication medium in which case the provider may select 
the communication medium. A patient may also decline to receive 
reminders. We believe that this will be rare enough that combined with 
the 10 percent through, patients declining to receive reminders will 
not affect the ability of an EP to meet this measure. It is our 
expectation that providers will begin to collect this information and 
that in the future as the look back period catches up to the 
publication of this final rule it will become possible to require that 
all reminders be sent per patient preference. We do not specify how 
things are documented beyond the capabilities and standards included in 
CEHRT.
    After consideration of the public comments received, we are 
modifying the measure at Sec.  495.6(j)(9)(ii) to ``More than 10 
percent of all unique patients who have had 2 or more office visits 
with the EP within the 24 months before the beginning of the EHR 
reporting period were sent a reminder, per patient preference when 
available.''
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(a)(14).

[[Page 54007]]

    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of unique patients who have 
had two or more office visits with the EP in the 24 months prior to the 
beginning of the EHR reporting period.
     Numerator: Number of patients in the denominator 
who were sent a reminder per patient preference when available during 
the EHR reporting period.
     Threshold: The resulting percentage must be more 
than 10 percent in order for an EP to meet this measure.
     Exclusion: Any EP who has had no office visits 
in the 24 months before the EHR reporting period.
    Proposed EP Objective: Provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    In the proposed rule, we stated that the goal of this objective was 
to allow patients easy access to their health information as soon as 
possible so that they can make informed decisions regarding their care 
or share their most recent clinical information with other health care 
providers and personal caregivers as they see fit. In addition, we 
noted that this objective aligns with the Fair Information Practice 
Principles (FIPPs),\3\ in affording baseline privacy protections to 
individuals.\4\ In particular, the principles include Individual Access 
(patients should be provided with a simple and timely means to access 
and obtain their individually identifiable information in a readable 
form and format). We indicated that this objective replaces the Stage 1 
core objective for EPs of ``Provide patients with an electronic copy of 
their health information (including diagnostic test results, problem 
list, medication lists, medication allergies) upon request'' and the 
Stage 1 menu objective for EPs of ``Provide patients with timely 
electronic access to their health information (including lab results, 
problem list, medication lists, and allergies) within 4 business days 
of the information being available to the EP.'' The HIT Policy 
Committee recommended making this a core objective for Stage 2 for EPs, 
and we agreed with their recommendation consistent with our policy of 
moving Stage 1 menu objectives to the core set for Stage 2. Consistent 
with the Stage 1 requirements, we noted that the patient must be able 
to access this information on demand, such as through a patient portal 
or personal health record (PHR). However, we noted that providers 
should be aware that while meaningful use is limited to the 
capabilities of CEHRT to provide online access there may be patients 
who cannot access their EHRs electronically because of their 
disability. Additionally, other health information may not be 
accessible. Finally, we noted that providers who are covered by civil 
rights laws must provide individuals with disabilities equal access to 
information and appropriate auxiliary aids and services as provided in 
the applicable statutes and regulations.
---------------------------------------------------------------------------

    \3\ In 1973, the Department of Health, Education, and Welfare 
(HEW) released its report, Records, Computers, and the Rights of 
Citizens, which outlined a Code of Fair Information Practices that 
will create ``safeguard requirements'' for certain ``automated 
personal data systems'' maintained by the Federal Government. This 
Code of Fair Information Practices is now commonly referred to as 
fair information practice principles (FIPPs) and established the 
framework on which much privacy policy will be built. There are many 
versions of the FIPPs; the principles described here are discussed 
in more detail in The Nationwide Privacy and Security Framework for 
Electronic Exchange of Individually Identifiable Health Information, 
December 15, 2008. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
    \4\ The FIPPs, developed in the United States nearly 40 years 
ago, are well-established and have been incorporated into both the 
privacy laws of many states with regard to government-held records 
and numerous international frameworks, including the development of 
the OECD's privacy guidelines, the European Union Data Protection 
Directive, and the Asia-Pacific Economic Cooperation (APEC) Privacy 
Framework.http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
---------------------------------------------------------------------------

    Comment: Some commenters suggested that this objective should be 
part of the menu set instead of a core objective for Stage 2. This 
would permit EPs who do not believe they can meet the measure at this 
time to select different objectives.
    Response: We do not agree that this objective should be part of the 
menu set. We proposed this objective as part of the core for EPs 
because it is intended to replace the previous Stage 1 core objective 
of ``Provide patients with an electronic copy of their health 
information upon request'' and the Stage 1 menu objective of ``Provide 
patients with timely electronic access to their health information.'' 
Although CEHRT will provide added capabilities for this objective, we 
do not believe the objective itself is sufficiently different from 
previous objectives to justify placing it in the menu set. Also, we 
believe that patient access to their electronic health information is a 
high priority for the EHR Incentive Programs and this objective best 
provides that access in a timely manner.
    Comment: Some commenters expressed the opinion that this objective 
should not be included as part of meaningful use and was more 
appropriately regulated under HIPAA and through the Office for Civil 
Rights.
    Response: We do not agree that this objective should not be 
included in meaningful use. Although we recognize that many issues 
concerning the privacy and security of electronic health information 
are subject to HIPAA requirements, we believe that establishing an 
objective to provide online access to health information is within the 
regulatory purview of the EHR Incentive Programs and consistent with 
the statutory requirements of meaningful use.
    Comment: Some commenters suggested that this objective should be 
combined with the objective to ``Provide clinical summaries for 
patients after each office visit'' since much of the information 
provided in these objectives is identical.
    Response: While it is true that there may be overlap between the 
information provided in the clinical summary and the information made 
available through this objective, we believe the clinical summary after 
an office visit serves a different purpose than online access to health 
information. A summary of an office visit provides patients and their 
families with a record of the visit and specific lab tests or specific 
follow-up actions and treatment related to the visit. While this 
information is certainly part of the patient's overall electronic 
health record, the clinical summary serves to highlight information 
that is relevant to the patient's care at that particular moment. 
Therefore, we decline to combine the two objectives.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for EPs at Sec.  495.6(j)(10)(i) as proposed.
    Proposed EP Measures: We proposed two measures for this objective, 
both of which must be satisfied in order to meet the objective:
    More than 50 percent of all unique patients seen by the EP during 
the EHR reporting period are provided timely (within 4 business days 
after the information is available to the EP) online access to their 
health information subject to the EP's discretion to withhold certain 
information.
    More than 10 percent of all unique patients seen by the EP during 
the EHR reporting period (or their authorized representatives) view, 
download or transmit to a third party their health information.
    Exclusions: Any EP who neither orders nor creates any of the 
information listed for inclusion as part of this measure may exclude 
both

[[Page 54008]]

measures. Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude only the second measure.
    As we stated in the proposed rule, transmission can be any means of 
electronic transmission according to any transport standard(s) (SMTP, 
FTP, REST, SOAP, etc.). However, the relocation of physical electronic 
media (for example, USB, CD) does not qualify as transmission although 
the movement of the information from online to the physical electronic 
media will be a download.
    Comment: Some commenters suggested that the timeframe for the first 
measure should be expanded to 7 days, since the data required to be 
provided in order to meet the measure of this objective would sometimes 
be incomplete only 4 days after the patient's visit. Other commenters 
suggested the timeline for the first measure should be shortened to 2 
business days or 24 hours.
    Response: We do not agree that the timeframe for the measure should 
be lengthened. In the Stage 1 menu objective of ``Provide patients with 
timely electronic access to their health information,'' we established 
the measure for providing access within 4 business days. Also, we 
believe that most of the information required by this measure, except 
for lab tests, will be readily available within the specified time 
period. However, we also believe that 24 hours or 2 business days would 
not provide adequate time to make all information available online. 
Therefore, we maintain the requirement of making information available 
within 4 business days.
    Comment: Some commenters asked for clarification on whether online 
access had to be made available using CEHRT or if the information could 
be made available through other means (patient portal, PHR, etc.).
    Response: Both of the measures for this objective must be met using 
CEHRT. Therefore, for the purposes of meeting this objective, the 
capabilities provided by a patient portal, PHR, or any other means of 
online access and that would permit a patient or authorized 
representative to view, download, or transmit their personal health 
information would have to be certified in accordance with the 
certification requirements adopted by ONC. We refer readers to ONC's 
standards and certification criteria final rule that is published 
elsewhere in this issue of the Federal Register.
    Comment: A commenter asked how long data should be made available 
online before it can be removed. In a related topic, another commenter 
asked which provider would be responsible for excluding data from 
sharing when multiple providers share CEHRT.
    Response: It is the goal of this objective to make available to the 
patient both current and historical health information. Therefore, we 
would anticipate that the data should be available online on an ongoing 
basis. However, an EP may withhold or remove information from online 
access if they believe substantial harm may arise from its disclosure 
online. In regard to withholding data and which provider should be 
responsible for making the determination when multiple providers share 
CEHRT, we would expect that providers sharing the CEHRT would make a 
joint determination regarding the information to be withheld. 
Therefore, we leave this decision to the providers' discretion.
    Comment: Some commenters asked for clarification on how access by 
the patient is defined.
    Response: We define access as having been given when the patient 
possesses all of the necessary information needed to view, download, or 
transmit their information. This could include providing patients with 
instructions on how to access their health information, the Web site 
address they must visit for online access, a unique and registered 
username or password, instructions on how to create a login, or any 
other instructions, tools, or materials that patients need in order to 
view, download, or transmit their information.
    Comment: Some commenters suggested that patients under the age of 
18 should not have the same access to the same information to which 
adult patients have access and requested a separate list of required 
elements for patients under the age of 18.
    Response: An EP may decide that online access is not the 
appropriate forum for certain health information for patients under the 
age of 18. Within the confines of the laws governing guardian access to 
medical records for patients under the age of 18, we would defer to the 
EP's judgment regarding which information should be withheld for such 
patients. In lieu of providing online access to patients under the age 
of 18, EPs could provide online access to guardians for patients under 
the age of 18, in accordance with state and local laws, in order to 
meet the measure of this objective. Providing online access to 
guardians in accordance to state and local laws would be treated the 
same as access for patients, and guardians could then be counted in the 
numerator of the measure. We recognize that state and local laws may 
restrict the information that can be made available to guardians, and 
in these cases such information can be withheld and the patient could 
still be counted in the numerator of the measure. No requirement of 
meaningful use supersedes any Federal, State or local law regarding the 
privacy of a person's health information.
    Comment: Some commenters suggested that specialists should transmit 
information to the patient's primary care provider rather than 
providing online access to information in order to reduce the number of 
portals a patient must visit, which could cause confusion.
    Response: We believe that much of this information will be 
transmitted between providers as part of the summary of care record 
following a transition of care. However, we also believe there is value 
to the patient in having online access to this information for all 
providers they visit, including specialists. Therefore, we maintain 
this measure for all EPs.
    Comment: Many commenters voiced objections to the second measure of 
this objective and the concept of providers being held accountable for 
patient actions. The commenters believed that while providers could be 
held accountable for making information available online to patients, 
providers could not control whether patients actually accessed their 
information. Many commenters also noted that the potential barriers of 
limited internet access, computer access, and patient engagement with 
health IT for certain populations (for example, rural, elderly, lower 
income, visually impaired, non-English-speaking, etc.) might make the 
measure impossible to meet for some providers. There were also a number 
of comments stating that metrics used to track views or downloads can 
be misleading and are not necessarily the most accurate measure of 
patient usage. Commenters suggested a number of possible solutions to 
allow providers to overcome these barriers, including eliminating the 
percentage threshold of the measure or requiring providers to offer and 
track patient access but not requiring them to meet a percentage 
measure in order to demonstrate meaningful use. However, some 
commenters believed that the measure was a reasonable and necessary 
step to ensure that providers had accountability for engagement of 
their patients in use of electronic health information and integration 
of it into clinical practice. In

[[Page 54009]]

addition, commenters pointed to the unique role that providers can play 
in encouraging and facilitating their patients' and their families' use 
of online tools.
    Response: While we recognize that EPs cannot directly control 
whether patients access their health information online, we continue to 
believe that EPs are in a unique position to strongly influence the 
technologies patients use to improve their own care, including viewing, 
downloading, and transmitting their health information online. We 
believe that EPs' ability to influence patients coupled with the low 
threshold of more than 10 percent of patients having viewed online, 
downloaded, or transmitted to a third party the patient's health 
information make this measure achievable for all EPs.
    We recognize that certain patient populations face greater 
challenges in online access to health information. We address the 
potential barrier of limited Internet access in the comment regarding a 
broadband exclusion below. We address the potential barrier to 
individuals with disabilities through ONC's rules requiring that EHRs 
meet web content accessibility standards. While we agree that excluding 
certain patient populations from this requirement would make the 
measure easier for EPs to achieve, we do not know of any reliable 
method to quantify these populations for each EP in such a way that we 
could standardize exclusions for each population. We also decline to 
eliminate the percentage threshold of this measure because we do not 
believe that a simple yes/no attestation for this objective is adequate 
to encourage a minimum level of patient usage. However, in considering 
the potential barriers faced by these patient populations, we agree 
that it would be appropriate to lower the proposed threshold of this 
measure to more than 5 percent of unique patients who view online, 
download, or transmit to a third party the patient's health 
information. In addition, we are concerned that blanket exclusions for 
certain disadvantaged populations could serve to extend existing 
disparities in electronic access to health information and violate 
civil rights laws. All entities receiving funds under this program are 
subject to civil rights laws. For more information about these laws and 
their requirements (see http://www.hhs.gov/ocr/civilrights/index.html). 
We believe that this lower threshold, combined with the broadband 
exclusion detailed in the response that follow, will allow all EPs to 
meet the measure of this objective.
    Comment: Some commenters suggested an alternate definition of the 
second measure based on the number of patients seen within the last 2 
years that access their health information online.
    Response: We believe that the current numerator and denominator for 
this measure encourage the active online access by patients of their 
health information. We further believe that broadening the time period 
of this measure to patients seen within the last 2 years does not 
encourage both EPs and current patients to use online access to health 
information in the active management of their care, which is one of the 
goals of the EHR Incentive Programs. Therefore, we decline to adopt 
this suggested alternate definition.
    Comment: Some commenters asked for clarification on how view is 
defined.
    Response: We define view as the patient (or authorized 
representative) accessing their health information online.
    Comment: Some commenters noted that the potential financial burden 
of implementing an online patient portal to provide patients online 
access to health information. These commenters noted the added time 
burden for staff in handling the additional patient use of online 
resources, which may increase costs through the hiring of additional 
staff, as well as the need to modify their existing workflow to 
accommodate additional online messages from patients. Some commenters 
also believed that there would be an additional cost for sharing 
content before standards exist for content types and formats.
    Response: We do not believe that implementing online access for 
patients imposes a significant burden on providers. While we note that 
in some scenarios it may be possible for an EP to receive reimbursement 
from private insurance payers for online messaging, we acknowledge that 
EPs are generally not reimbursed for time spent responding to 
electronic messaging. However, it is also true that EPs are generally 
not reimbursed for other widely used methods of communication with 
patients (for example, telephone). As we noted in the proposed rule, 
many providers have seen a reduction in time responding to inquires and 
less time spent on the phone through the use of health IT, including 
online messages from patients. We expect the same will be true for 
online access to health information by reducing continuous requests for 
health records, test results, and other pertinent patient information. 
Finally, we believe that the standards established for this objective 
by ONC will serve as a content standard that will allow this 
information to be more easily transmitted and uploaded to another 
certified EHR, thereby reducing additional costs.
    Comment: Some commenters noted that patient engagement could occur 
effectively with or without online access, and patients should be 
encouraged to use any method (for example, telephone, internet, 
traditional mail) that suits them. These commenters noted that 
engagement offline reduces both the need and value for engagement 
online.
    Response: We agree that patient engagement can occur effectively 
through a variety of media, and we also believe that electronic access 
to health information can be an important component of patient 
engagement. We do not believe that offline engagement reduces the need 
for online access, as patients may opt to access information in a 
variety of ways. Because of the variety of ways that patients/families 
may access information, we keep the threshold for this measure low. We 
also note that online access to health information can enhance offline 
engagement--for example, patients could download information from an 
office visit with their primary care provider to bring with them for a 
consult with a specialist--which is one of the primary goals of the EHR 
Incentive Programs.
    Comment: Some commenters expressed concern that vendors would not 
be able to make these capabilities available as part of CEHRT in time 
for the beginning of Stage 2.
    Response: Many CEHRT vendors already make patient portals available 
that would meet the certification criteria and standards required for 
this measure. In fact, many vendors have already incorporated these 
capabilities into their CEHRT products in order to meet the measure of 
the Stage 1 objective to ``Provide patients with timely electronic 
access to their health information.'' Although the Stage 2 measure 
requires some additional capabilities, we believe vendors will be able 
to make these capabilities available in time for the beginning of Stage 
2.
    Comment: Some commenters requested clarification on the exclusion 
regarding an EP ``who neither orders nor creates any of the information 
listed for inclusion as part of this measure may exclude both 
measures.'' Because the list of required elements for this measure 
includes the patient's name, provider's name, and office contact 
information, these commenters suggested that no EP could qualify for 
this exclusion.

[[Page 54010]]

    Response: We amend the wording of the exclusion to accommodate 
providers who do not order or create any of the information listed, 
except for patient name, provider name, and office contact information.
    Comment: Some commenters suggested that basing an exclusion on the 
broadband data available from the FCC Web site (www.broadband.gov) was 
suspect since the data originates from vendors.
    Response: The broadband data made available from the FCC was 
collected from over 3,400 broadband providers nationwide. This data was 
then subject to many different types of analysis and verification 
methods, from drive testing wireless broadband service across their 
highways to meeting with community leaders to receive feedback. 
Representatives met with broadband providers, large and small, to 
confirm data, or suggest changes to service areas, and also went into 
the field looking for infrastructure to validate service offerings in 
areas where more information was needed. Therefore, we believe the data 
is appropriate for the exclusion to this measure. We note that since 
publication of our proposed rule the Web site has changed to 
www.broadbandmap.gov and the speed used has changed from 4Mbps to 
3Mbps. We are updating our exclusion to reflect these changes.
    Comment: Some commenters believe that broadband exclusions should 
be based on the patients' locations instead of the providers, since 
county-level data may not be granular enough to capture all areas of 
low broadband availability within a particular region.
    Response: Although we agree that a broadband exclusion based 
primarily on the individual locations of each patient seen would be 
more accurate, we do not believe that there is any method of making 
this determination for every patient without placing an undue burden on 
the provider. We continue to believe that limited broadband 
availability in the EP's immediate practice area, coupled with the low 
threshold of this measure, adequately serves as an acceptable proxy for 
determining areas where online access can present a challenge for 
patients. Therefore, we retain the broadband exclusion as proposed.
    Comment: Some commenters requested a clarification of the required 
element of ``Any additional known care team members beyond the 
referring or transitioning provider and the receiving provider.''
    Response: With this element we mean for providers to indicate the 
names and contact information for any other health care professionals 
known to the EP. This could include referring providers, receiving 
providers, or any other provider inside or outside the EP's practice 
that provides care to the patient. We are amending the language for 
this required element to ``Any known care team members.''
    Comment: Some commenters suggested that growth charts should not be 
included for either download or transmission, since these charts are 
simply visualizations of the height and weight data elements.
    Response: We believe that growth charts can be a useful tool for 
both patients and providers, especially in instances where a patient 
may elect to download or transmit their health information to another 
provider. Therefore, we require them to be included to meet the measure 
of this objective.
    Comment: One commenter suggested that images should not be included 
in the list of required elements to be provided to patients online. 
They cited specific difficulties in image viewing online, as well as 
concerns over file size.
    Response: We note the commenter's concerns and further note that 
images are not among the required elements to meet the measure of this 
objective.
    After consideration of the public comments, we finalize the first 
meaningful use measure for EPs as proposed at Sec.  
495.6(j)(10)(ii)(A). We finalize the second meaningful use measure for 
EPs as ``More than 5 percent of all unique patients seen by the EP 
during the EHR reporting period (or their authorized representatives) 
view, download or transmit to a third party their health information'' 
at Sec.  495.6(j)(10)(ii)(B). We finalize the following exclusions for 
EPs at Sec.  495.6(j)(10)(iii): ``Any EP who neither orders nor creates 
any of the information listed for inclusion as part of both measures, 
except for ``Patient name'' and ``Provider's name and office contact 
information,'' may exclude both measures;'' ``Any EP that conducts 50 
percent or more of his or her patient encounters in a county that does 
not have 50 percent or more of its housing units with 3Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude only the 
second measure''.
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(e)(1).
    To calculate the percentage of the first measure for providing 
patient with timely online access to health information, CMS and ONC 
have worked together to define the following for this objective:
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator who 
have timely (within 4 business days after the information is available 
to the EP) online access to their health information.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
    For the second measure for reporting on the number of unique 
patients seen by the EP during the EHR reporting period (or their 
authorized representatives) who view, download or transmit health 
information, CMS and ONC have worked together to define the following 
for this objective:
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of unique patients (or their 
authorized representatives) in the denominator who have viewed online, 
downloaded, or transmitted to a third party the patient's health 
information.
     Threshold: The resulting percentage must be more than 5 
percent in order for an EP to meet this measure.
     Exclusions: Any EP who neither orders nor creates any of 
the information listed for inclusion as part of both measures, except 
for ``Patient name'' and ``Provider's name and office contact 
information,'' may exclude both measures. Any EP that conducts 50 
percent or more of his or her patient encounters in a county that does 
not have 50 percent or more of its housing units with 3Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude only the 
second measure.
    In order to meet this objective, the following information must be 
made available to patients electronically within 4 business days of the 
information being made available to the EP:
     Patient name.
     Provider's name and office contact information.
     Current and past problem list.
     Procedures.
     Laboratory test results.
     Current medication list and medication history.
     Current medication allergy list and medication allergy 
history.
     Vital signs (height, weight, blood pressure, BMI, growth 
charts).
     Smoking status.

[[Page 54011]]

     Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
     Care plan field(s), including goals and instructions, and
     Any known care team members including the primary care 
provider (PCP) of record.
    As we stated in the proposed rule, this is not intended to limit 
the information made available by the EP. An EP can make available 
additional information and still align with the objective. In 
circumstances where there is no information available to populate one 
or more of the fields previously listed, either because the EP can be 
excluded from recording such information (for example, vital signs) or 
because there is no information to record (for example, no medication 
allergies or laboratory tests), the EP may have an indication that the 
information is not available and still meet the objective and its 
associated measure. Please note that while some of the information made 
available through this measure is similar to the information made 
available in the summary of care document that must be provided 
following transitions of care or referrals, the list of information 
above is specific to the view online, download, and transmit objective. 
Patients and providers have different information needs and contexts, 
so CMS has established separate required fields for each of these 
objectives.
    Proposed Objective: Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    In the proposed rule, we explained that providing clinically 
relevant education resources to patients is a priority for the 
meaningful use of CEHRT. Based on our experience with this objective in 
Stage 1, we are clarifying that while CEHRT must be used to identify 
patient-specific education resources, these resources or materials do 
not have to be stored within or generated by the CEHRT. We are aware 
that there are many electronic resources available for patient 
education materials, such as through the National Library of Medicine, 
that can be queried via CEHRT (that is, specific patient 
characteristics are linked to specific consumer health content). The EP 
or hospital should utilize CEHRT in a manner where the technology 
suggests patient-specific educational resources based on the 
information stored in the CEHRT. Certified EHR technology is certified 
to use the patient's problem list, medication list, or laboratory test 
results to identify the patient-specific educational resources. The EP 
or hospital may use these elements or additional elements within CEHRT 
to identify educational resources specific to patients' needs. The EP 
or hospital can then provide these educational resources to patients in 
a useful format for the patient (such as, electronic copy, printed 
copy, electronic link to source materials, through a patient portal or 
PHR).
    In the Stage 1 final rule (75 FR 44359), we included the phrase 
``if appropriate'' in the objective so that the EP or the authorized 
provider in the hospital could determine whether the education resource 
was useful and relevant to a specific patient. Consistent with the 
recommendations of the HIT Policy Committee, we proposed to remove the 
phrase ``if appropriate'' from the objective for Stage 2 because we do 
not believe that any EP or hospital will have difficulty identifying 
appropriate patient-specific education resources for the low percentage 
of patients required by the measure of this objective.
    We also recognized that providing education materials at literacy 
levels and cultural competency levels appropriate to patients is an 
important part of providing patient-specific education. However, we 
continue to believe that there is not currently widespread availability 
of such materials and that such materials could be difficult for EPs 
and hospitals to identify for their patients.
    Comment: Many commenters sought clarification on the meaning of the 
term ``identified by CEHRT.'' They questioned how the CEHRT would 
identify resources and whether the education resources had to be stored 
in the CEHRT or if it could contain links to the materials.
    Response: We clarified in the proposed rule (77 FR 13720) that 
while CEHRT must be used to identify patient-specific education 
resources, these resources or materials do not have to be stored within 
or generated by the Certified EHR Technology. We refer readers to ONC's 
standards and certification criteria final rule that is published 
elsewhere in this issue of the Federal Register which describes the 
capabilities and standards that CEHRT must include. For patient-
specific education materials, this includes a general functional 
capability to identify educational materials as well as a capability to 
do so using the HL7 Context-aware Information Retrieval ``Infobutton'' 
standard. This measure requires that an EP or hospital use the 
capabilities CEHRT includes to identify patient education materials. To 
clarify, although CEHRT will include the ability to identify education 
materials using the HL7 Infobutton standard, such capability alone does 
not need to be used in order to be counted in the numerator (that is, 
the general capability to identify education materials also counts 
towards the numerator).
    After reviewing the public comments, we finalize the objective for 
EPs at Sec.  495.6(j)(12)(i) and for eligible hospitals and CAHs at 
Sec.  495.6(l)(9)(i) as proposed.
    Proposed EP Measure: Patient-specific education resources 
identified by Certified EHR Technology are provided to patients for 
more than 10 percent of all office visits by the EP.
    In the proposed rule, we noted that the Stage 1 measure for this 
objective for EPs was ``More than 10 percent of all unique patients 
seen by the EP are provided patient-specific education resources.'' 
Because we proposed this as a core objective for Stage 2, we proposed 
to modify the measure for EPs to ``Patient-specific education resources 
identified by CEHRT are provided to patients for more than 10 percent 
of all office visits by the EP.'' We recognized that some EPs may not 
conduct face-to-face encounters with patients but still provide 
treatment to patients. These EPs could be prevented from meeting this 
core objective under the previous measure requirements, so we proposed 
to alter the measure to account for office visits rather than unique 
patients seen by the EP. We also proposed an exclusion for EPs who have 
no office visits in order to accommodate such EPs.
    The resources will have to be those identified by CEHRT. If 
resources are not identified by CEHRT and provided to the patient then 
it will not count in the numerator. We do not intend through this 
requirement to limit the education resources provided to patient to 
only those identified by CEHRT. We proposed the threshold at only 10 
percent for this reason. We believe that the 10 percent threshold both 
ensures that providers are using CEHRT to identify patient-specific 
education resources and is low enough to not infringe on the provider's 
freedom to choose education resources and to which patients these 
resources will be provided. The education resources will need to be 
provided prior to the calculation and subsequent attestation to 
meaningful use.
    Comment: Many commenters expressed concerns about the availability 
of resources that would be available at the appropriate literacy level 
for their patient populations. Some stated that there is a dearth of 
low-literacy materials available as most education sites are geared 
toward

[[Page 54012]]

college-educated patients; others stated that most materials are 
designed to be appropriate for a broad spectrum of literacy levels. 
Some commenters expressed concerns about the lack of resources 
available for non-English speaking patients. Yet other commenters were 
unclear as to what appropriate sources of patient-specific education 
would be. Some commenters expressed concerns that another alert within 
the system may create physician fatigue.
    Response: We understand the commenters concerns that the 
educational materials identified by the CEHRT may not be appropriate 
for certain patients. To accommodate these concerns, we are maintaining 
the threshold for this measure at 10 percent. As we stated in our 
proposed rule and in the Stage 1 Final Rule, we account for these 
concerns by maintaining a low threshold for this objective.
    Comment: Some commenters expressed concerns that the CEHRT, not the 
provider, would ``choose'' which educational resources would be 
provided to the patient.
    Response: We cannot define the scope of practice and/or appropriate 
educational resources to be shared with each individual patient and 
will continue to rely on provider determinations based on individual 
patient circumstances.
    Comment: Many commenters were concerned that the denominator for 
the EP measure included the number of office visits by the EP during 
the EHR reporting period. Commenters agreed with the rationale that EPs 
might not have the opportunity to provide educational materials to a 
patient if the patient has not had an office visit with the EP, 
however, commenters also stated that if an EP has a series of office 
visits with a patient, it might not be appropriate to provide education 
at each visit (for example, a patient with heart disease or high blood 
pressure that would see the EP multiple times during the EHR reporting 
period). To avoid the potential for presenting redundant information to 
patients, commenters suggested that the denominator be based on unique 
patients with office visits. This is consistent with the denominator 
for eligible hospitals, as that denominator is based on unique patients 
admitted. Additionally, commenters noted that counting unique patients 
is more appropriate to account for patient-specific education resources 
that are not provided in the context of an office visit, such as 
reference materials available from a portal or PHR about a patient's 
medications, conditions, or lab results.
    Response: We agree with commenters in that counting unique patients 
with office visits during the EHR reporting period for EPs, rather than 
office visits, is a more appropriate denominator for this measure. A 
patient with a chronic disease, such as diabetes or heart disease, may 
have multiple office visits with an EP during the EHR reporting period. 
While providing educational resources for these patients is important, 
presenting the same materials each office visit may prove to be 
redundant. We encourage EPs to refer educational resources to their 
patients with multiple visits during the EHR reporting period at their 
discretion.
    Additionally, we do maintain that EPs with no office visits during 
the EHR reporting period can be excluded from this measure. Therefore, 
we are finalizing the denominator for this measure as the ``Number of 
unique patients with office visits seen by the EP during the EHR 
reporting period.''
    Comment: Most commenters agreed that 10 percent was a reasonable 
threshold for this measure as it was proposed.
    Response: We agree with commenters and are finalizing 10 percent as 
the threshold for this measure. It will remain unchanged from Stage 1.
    After reviewing the public comments, we are finalizing the measure 
for EPs at Sec.  495.6(j)(12)(ii) as ``Patient-specific education 
resources identified by CEHRT are provided to patients for more than 10 
percent of all unique patients with office visits seen by the EP during 
the EHR reporting period.''
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(a)(15).
    To calculate the percentage for EPs, CMS and ONC have worked 
together to define the following for this objective:
     Denominator: Number of unique patients with office visits 
seen by the EP during the EHR reporting period.
     Numerator: Number of patients in the denominator who were 
provided patient-specific education resources identified by the 
Certified EHR Technology.
     Threshold: The resulting percentage must be more than 10 
percent in order for an EP to meet this measure.
     Exclusion: Any EP who has no office visits during the EHR 
reporting period.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of all 
unique patients admitted to the eligible hospital's or CAH's inpatient 
or emergency departments (POS 21 or 23) are provided patient-specific 
education resources identified by Certified EHR Technology.
    After consideration of public comments, we are finalizing the 
measure for eligible hospitals and CAHs at Sec.  495.6(l)(9)(ii) as 
proposed.
    We further specify that in order to meet this objective and 
measure, an eligible hospital or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(15).
    To calculate the percentage for hospitals, CMS and ONC have worked 
together to define the following for this objective:
     Denominator: Number of unique patients admitted to the 
eligible hospital's or CAH's inpatient or emergency departments (POS 21 
or 23) during the EHR reporting period.
     Numerator: Number of patients in the denominator who are 
subsequently provided patient-specific education resources identified 
by CEHRT.
     Threshold: The resulting percentage must be more than 10 
percent in order for an eligible hospital or CAH to meet this measure.
    Proposed Objective: The EP, eligible hospital or CAH who receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant should perform medication reconciliation.
    In the proposed rule we outlined the following benefits of this 
objective. Medication reconciliation allows providers to confirm that 
the information they have on the patient's medication is accurate. This 
not only assists the provider in their direct patient care, it also 
improves the accuracy of information they provide to others through 
health information exchange.
    In the proposed rule, we noted that that when conducting medication 
reconciliation during a transition of care, the EP, eligible hospital 
or CAH that receives the patient into their care should conduct the 
medication reconciliation. We reiterated that the measure of this 
objective does not dictate what information must be included in 
medication reconciliation. Information included in the process of 
medication reconciliation is appropriately determined by the provider 
and patient. In the proposed rule we defined medication reconciliation 
as the process of identifying the most accurate list of all medications 
that the patient is taking, including name, dosage, frequency, and 
route, by comparing the medical record to an external list of 
medications obtained from a patient, hospital or other provider. We 
proposed that the electronic exchange of information is

[[Page 54013]]

not a requirement for medication reconciliation.
    Comment: Commenters requested that the definition of medication 
reconciliation should specifically mention over-the-counter 
medications, vitamins, herbal or other alternative care medications in 
the definition.
    Response: We believe our term medications is expansive and not 
limiting. We in no way limit what any provider chooses to include or 
not include in their conduct of a medication reconciliation. As we are 
focused on the use of CEHRT to assist in medication reconciliation it 
is not our intent to develop a definitive definition of what medication 
reconciliation is.
    Comment: Commenters stated that the objective is so reliant on 
health information exchange that it should not be moved to core until 
health information exchange capability increases.
    Response: Robust health information exchange is certainly of great 
assistance to medication reconciliation. However, it is not required 
for medication reconciliation. Nor is electronic health information 
exchange the only way EHRs can assist with medication reconciliation. 
So while we believe that medication reconciliation will become easier 
as health information exchange capability increases, it is not a 
prerequisite to performing medication reconciliation.
    After consideration of the comments received, we are finalizing 
this objective as proposed for EPs at Sec.  495.6(j)(13)(i) and for 
eligible hospitals and CAHs at Sec.  495.6(l)(10)(i).
    Proposed Measure: The EP, eligible hospital or CAH performs 
medication reconciliation for more than 65 percent of transitions of 
care in which the patient is transitioned into the care of the EP or 
admitted to the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23).
    In the proposed rule, we stated that although the HITPC recommended 
maintaining this threshold at 50 percent we believed that due to this 
measure's role in information exchange that we seek to promote through 
meaningful use a higher measure was appropriate. Based on the 
performance of providers in Stage 1, we proposed to raise the measure 
to 65 percent.
    Comment: If as stated in the proposed rule ``the majority chose to 
defer this measure in Stage 1,'' commenters asserted that this is 
insufficient information to justify raising the threshold to 65 percent 
and move the objective to core. Other commenters assert that any 
measure that moves from menu to core should maintain its Stage 1 
threshold regardless of the particular measure's rate of deferral.
    Response: After considering the arguments for lowering the 
threshold to 50 percent and the lack of robust data in support of the 
proposed threshold, we do lower the threshold to 50 percent. For this 
measure in particular, we agree that since most providers chose to 
defer this measure in Stage 1 the information available on performance 
from Stage 1 meaningful EHR users is not as robust as for other 
objectives and measures. We do not agree with the comment that all 
objectives that move from menu to core should maintain the same 
threshold. We believe such a blanket policy would be arbitrary and not 
properly account for the information available for each objective and 
measure. For example, if most Stage 1 meaningful EHR users had reported 
on this measure, there would be a robust data set of performance on 
which to judge a threshold. A blanket policy would ignore such 
information.
    Comment: The denominator of transitions of care during the EHR 
reporting period for which the provider is the receiving part of the 
transition is imprecise and therefore difficult to determine, 
especially when neither the transitioning provider or patient notifies 
the provider of the transition.
    Response: We addressed this comment earlier in this section in our 
discussion of meaningful use denominators and provided a minimum set of 
specific actions that would indicate a transition of care has occurred.
    Comment: While the objective speaks to relevant encounters, these 
are not included in the measure. This makes measurement difficult for 
those providers that conduct medication reconciliation at more than 
just transitions of care. If providers were allowed to include these 
encounters in the measure, measurement would both be easier and more 
representative of the actual use of CEHRT by the provider.
    Response: We continue to believe that what is a relevant encounter 
is to variable to be included in the measure for all providers. 
However, a provider who institutes a policy for medication 
reconciliation at encounters encompassing more than just the minimum 
actions defined by the transitions of care denominator can include 
those encounters in their denominator and if medication reconciliation 
is conducted at the encounter in the numerator as well.
    After consideration of the comments, we are modifying the threshold 
of the measure for EPs at Sec.  495.6(j)(13)(ii) and for eligible 
hospitals and CAHs at Sec.  495.6(l)(10)(ii). The EP, eligible hospital 
or CAH performs medication reconciliation for more than 50 percent of 
transitions of care in which the patient is transitioned into the care 
of the EP or admitted to the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23).
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(b)(4).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of transitions of care during the EHR 
reporting period for which the EP or eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) was the receiving 
party of the transition.
     Numerator: The number of transitions of care in the 
denominator where medication reconciliation was performed.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
     Exclusion: Any EP who was not the recipient of any 
transitions of care during the EHR reporting period.
    Proposed Objective: The EP, eligible hospital or CAH who 
transitions their patient to another setting of care or provider of 
care or refers their patient to another provider of care provides a 
summary care record for each transition of care or referral.
    In the proposed rule, we outlined the following benefits of this 
objective. By assuring lines of communication between providers caring 
for the same patient, all of the providers of care can operate with 
better information and more effectively coordinate the care they 
provide. Electronic health records, especially when linked directly or 
through health information exchanges, reduce the burden of such 
communication. The purpose of this objective is to ensure a summary of 
care record is provided to the receiving provider when a patient is 
transitioning to a new provider or has been referred to another 
provider while remaining under the care of the referring provider.
    In the proposed rule, we proposed to eliminate the Stage 1 
objective for the exchange of key clinical information for Stage 2 and 
instead include such information as part of the summary of care when it 
is a part of the patient's electronic record. We also proposed to 
incorporate two separate Stage 2 recommendations from the HIT Policy 
Committee as required fields in the summary of care record--

[[Page 54014]]

     Record care plan fields, including goals and instructions, 
for at least 10 percent of transitions of care; and
     Record team member, including primary care practitioner, 
for at least 10 percent of patients.
    ONC also proposed in their standards and certification criteria 
rule (77 FR 13848 to include these as standard fields required to 
populate the summary of care document so CEHRT will be able to include 
this information. We provided a description of a ``care plan'' as well 
as the minimum components it must include for purposes of meaningful 
use, although we recognized that the actual content would be dependent 
on the clinical context. We asked for comments on both our description 
of a care plan and whether a description is necessary for purpose of 
meaningful use.
    We proposed certain elements that are listed in the proposed rule 
(77 FR 13722) to be included in the summary care document. In 
circumstances where there is no information available on an element, 
either because the EP, eligible hospital or CAH can be excluded from 
recording such information or because there is no information to 
record, the EP, eligible hospital or CAH may leave the field(s) blank 
and still meet the objective and its associated measure.
    In addition, we proposed that all summary of care documents used to 
meet this objective must include the following:
     An up-to-date problem list of current and active 
diagnoses.
     An active medication list, and
     An active medication allergy list.
    We proposed that all summary of care documents must contain the 
most recent and up-to-date information on these three elements to count 
in the numerator. We proposed to define problem list as a list of 
current and active diagnoses. We solicited comment on whether the 
problem list should be extended to include, ``when applicable, 
functional and cognitive limitations'' or whether a separate list 
should be included for functional and cognitive limitations. We 
proposed to define an up-to-date problem list as a list populated with 
the most recent diagnoses known by the EP or hospital. We proposed to 
define active medication list as a list of medications that a given 
patient is currently taking. We proposed to define active medication 
allergy list as a list of medications to which a given patient has 
known allergies. We proposed to define allergy as an exaggerated immune 
response or reaction to substances that are generally not harmful. In 
the event that there are no current or active diagnoses for a patient, 
the patient is not currently taking any medications, or the patient has 
no known medication allergies, confirmation of no problems, no 
medications, or no medication allergies would satisfy the measure of 
this objective. Note that the inclusion and verification of these 
elements in the summary of care record replaces the Stage 1 objectives 
for ``Maintain an up-to-date problem list,'' ``Maintain active 
medication list,'' and ``Maintain active medication allergy list.''
    Comment: Commenters suggested that the required data for each type 
of referral and transitions varies and that rather than creating a list 
of elements, the provider should decide what is needed.
    Response: While we agree that tailoring the summary of care 
document for each referral and transition of care is desirable, we 
disagree that this means a list of basic elements that should be in 
each summary of care documents is not appropriate. We note that most 
organizations that try and tackle the issue of summary of care 
documents have required fields, core sets or other nomenclature for 
elements that they believe should be in all summary of care documents. 
For example, the CDA architecture used as the standard for the summary 
of care document contains required and optional fields. The American 
College of Physicians in their Neighborhood Model uses a core data set. 
None of these organizations intend for their list of elements to be 
limiting and nor do we intend our list to be limiting, but rather serve 
as a minimum. In our proposed rule we went further and said that if the 
provider does not have the information available to populate one or 
more of the fields listed, either because they can be excluded from 
recording such information (for example, vital signs) or because there 
is no information to record (for example, laboratory tests), the 
provider may leave the field(s) blank. The only exception to this is 
the problem list, medication list, and medication allergy list. 
Therefore, we are including a list of elements in this final rule.
    Comment: Commenters stated that their understanding is that if any 
of the fields specifically for problem list, medication list, or 
allergy list is blank (meaning no entry of problems, medications or 
allergies nor an indication that it is known by the provider that the 
patient has no problems, medication or allergies), the EP or hospital 
will not meet the measure, but that if any other information is blank, 
the EP or hospital will still meet the measure. Please clarify whether 
this is a correct understanding of the proposal.
    Response: This understanding of our proposed rule is generally 
correct. The problem list, medication list and medication allergy list 
must also either contain problems, medications and medication allergy 
or a specific notation that the patient has none. Leaving the field 
entirely blank with no entry whatsoever would not meet the measure. 
However, in cases where the provider does not have the information 
available to populate one or more of the other fields listed, either 
because they can be excluded from recording such information (for 
example, vital signs) or because there is no information to record (for 
example, laboratory tests), the provider may leave the field(s) blank. 
Note this does not allow a provider to disable a listed field from 
being generated by the CEHRT, but rather allows for when the CEHRT does 
not contain information on which to generate an entry for the field.
    Comment: Some commenters suggested the substitution of past medical 
history for historical problem list in the list of required elements, 
since past medical history could provide additional information 
valuable to patient care.
    Response: CMS' Evaluation and Management Services Guide defines a 
past medical history as the patient's past ``experiences with 
illnesses, operations, injuries and treatments'' (see http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf, p. 11). In 
our proposed rule, we referred to ``current and historical problem 
list'' as this is more concrete and standards based than the definition 
for past medical history. We believe the concept of past medical 
history is inclusive of current and historical problem list. We 
understand that providers are more familiar with the term past medical 
history and will evaluate expanding historical problem list to past 
medical history for Stage 3. However, for Stage 2, we are finalizing 
current and historical problem list. For summary of care documents at 
transitions of care we encourage providers to send a list of items that 
he or she believes to be pertinent and relevant to the patient's care, 
rather than a list of all problems, whether they are active or 
resolved, that have ever populated the problem list. While a current 
problem list should always be included, the provider can use his or her 
judgment in deciding which items historically present on the problem 
list, PMHx list (if it exists in CEHRT), or surgical history list are

[[Page 54015]]

included given the clinical circumstances.
    Comment: Commenters stated that it is too burdensome to determine 
whether the problem list, medication list and medication allergy list 
are included in each summary of care document.
    Response: We disagree that this is too burdensome. We note that in 
Stage 1 measuring the completeness of the problem list, medication list 
and medication allergy list is already a requirement. Summary of care 
documents are generated by the CEHRT based on the information available 
to it. Therefore, there are only two causes of error that would have to 
be discovered to make the determination of whether the problem list, 
medication list and medication allergy list are included. The problem 
list, medication list and medication allergy list do not contain 
information for a given patient and/or there is an error in the 
generation of the summary of care document. This discovery constitutes 
the burden of this measure. We have already noted that the ability to 
know whether the lists contain information is already a Stage 1 
measure. The second issue is prevalent in nearly every meaningful use 
measure that requires CEHRT to generate a measurement so that burden is 
already integral to meaningful use.
    Comment: Commenters stated that the different descriptions of 
problem list throughout the proposed rule create confusion. The four 
terms used are ``an up-to-date problem list of current and active 
diagnoses'', ``problem list'', ``Current problem list and any updates 
to it'' and ``problem list maintained by the hospital on the patient''. 
CMS should use this term uniformly. Furthermore, the limitation of the 
problem list to only current and active diagnoses is inconsistent with 
how problem lists are used and historical problems should also be 
included.
    Response: We only proposed one definition of the base term 
``problem list'', which is a list of current and active diagnoses. We 
then use descriptors to tailor the term to the objective in which it is 
being utilized. For example, ``up-to-date'' means that the problem list 
in the CEHRT is populated with the most recent diagnoses known by the 
EP or hospital. The description used for office visit summary ``Current 
problem list and any updates to it'' was intended to separate problems 
that were known before the visit and those that were determined during 
the visit. We agree that our limitation of the ``problem list'' to just 
current and active diagnoses is unnecessarily limiting. The C-CDA, 
which is the standard adopted for EHR technology certification, for 
summary of care documents states that ``at a minimum, all pertinent 
current and historical problems should be listed''. We revise our 
definition of ``problem list'' to include historical problems. This is 
a minimum. We do not limit the provider to just including diagnoses on 
the problem list. We agree that there should be just one definition of 
the base term ``problem list''; however, we disagree that the same list 
is appropriate for every case especially with the addition of the 
historical problems. Some objectives call for the current problem list 
which includes only those diagnoses of problems currently affecting the 
patient. Other objectives call for the current and historical problem 
list, which would include problems currently affecting the patient as 
well as those that have been resolved. For purposes of clarity, we are 
consolidating across all of the meaningful use objectives to just two 
descriptions of our term ``problem list'': ``current problem list'' and 
``current and historical problem list.'' This consolidation also 
removes the need for a separate item of past relevant diagnosis as 
these would be included in a historical problem list. We define active 
medication list as a list of medications that a given patient is 
currently taking. We define active medication allergy list as a list of 
medications to which a given patient has known allergies. We define 
allergy as an exaggerated immune response or reaction to substances 
that are generally not harmful. Information on problems, medications, 
and medication allergies could be obtained from previous records, 
transfer of information from other providers (directly or indirectly), 
diagnoses made by the EP or hospital, new medications ordered by the EP 
or in the hospital, or through querying the patient. In the event that 
there are no current or active diagnoses for a patient, the patient is 
not currently taking any medications, or the patient has no known 
medication allergies, confirmation of no problems, no medications, or 
no medication allergies would satisfy the measure of this objective.
    Comment: Many commenters recommended against any specification of 
problem list content regarding functional and cognitive limitations 
citing insufficient consensus around the appropriate classification of 
these functions. Commenters also stated that if included, functional 
and cognitive limitations should be further defined.
    Response: As noted earlier in this final rule under the demographic 
objective, we wish to clarify that both the concepts of physical and 
cognitive disabilities as well as the concept of functional limitations 
that impact an individual's capability to perform activities were 
included in our description of disability status for the purpose of 
this rule. The latter concept is a common metric for care planning and 
care coordination across settings because knowledge of a patient's 
abilities (for example, functional and/or cognitive status) are also 
necessary for clinical practice. While many commenters noted the lack 
of consensus for the terms and standards necessary to support the 
inclusion of disability, functional and cognitive status assessment and 
observations into the Consolidated CDA for summary of care records, we 
understand that this standard was updated to include section- and data-
entry level templates that can describe a patient's functional and 
cognitive status. However, we agree that there are insufficient 
definitions for disability, functional and cognitive status assessment 
and observations to include them as part of the problem list. 
Therefore, we are including ``functional status, including functional, 
cognitive and disability'' as a separate element in the summary of care 
document.
    Comment: In regard to the inclusion of ``care plan field'' in the 
list of required information, some commenters believed that the wording 
was overly prescriptive since CEHRT could utilize multiple fields to 
structure care plans. Other commenters requested a more detailed 
definition of care plan and/or the standards that are available or 
required.
    Response: We agree that the language proposed could be viewed as 
prescriptive, and we do not intend to limit the inclusion of the care 
plan to a single field. Therefore, we are amending the language to 
``Care plan field(s), including goals and instructions'' in our list of 
required elements below. However, we decline to provide an alternate 
definition that would limit the information in the care plan. We 
believe that the definition we proposed in the proposed rule is 
sufficient to allow for the inclusion of a variety of care plans in the 
clinical summary. For purposes of the clinical summary, we define a 
care plan as the structure used to define the management actions for 
the various conditions, problems, or issues. A care plan must include 
at a minimum the following components: Problem (the focus of the care 
plan), goal (the target outcome), and any instructions that the 
provider has given to the patient. A goal is a defined target or 
measure to be achieved in the process of patient care (an expected 
outcome).

[[Page 54016]]

    Comment: Commenters stated that while the care team members are 
clearly important data elements and key to clinical coordination, they 
recommended further research into true standards to support these 
elements before any requirements are imposed.
    Response: Our proposal is to include ``Any additional known care 
team members beyond the referring or transitioning provider and the 
receiving provider''. We believe that the ability to identify providers 
is well established. We note that there is no requirement to identify 
the role of each provider which we would agree are not well established 
beyond PCP and referring provider. We also note that this is only for 
cases when the other care team members are known by the transitioning 
provider. These allowances are sufficient to accommodate the current 
standard limitations and therefore we finalize as proposed.
    Comment: As referrals are included in the denominator as well as 
transitions of care, the summary of care document should include the 
reason for the referral.
    Response: We agree with this comment and add reason for referral 
for EPs. The reason for the referral is the clinical question the 
referring provider wants answered for a consultation or the procedure 
to be performed. If the consultation is more open ended, then a brief 
summary of the case details pertinent to referral suffices.
    After consideration of the comments, all summary of care documents 
used to meet this objective must include the following information if 
the provider knows it:
     Patient name.
     Referring or transitioning provider's name and office 
contact information (EP only).
     Procedures.
     Encounter diagnosis.
     Immunizations.
     Laboratory test results.
     Vital signs (height, weight, blood pressure, BMI).
     Smoking status.
     Functional status, including activities of daily living, 
cognitive and disability status.
     Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
     Care plan field, including goals and instructions.
     Care team including the primary care provider of record 
and any additional known care team members beyond the referring or 
transitioning provider and the receiving provider.
     Discharge instructions (Hospital Only).
     Reason for referral (EP only).
    In circumstances where there is no information available to 
populate one or more of the fields listed previously, either because 
the EP, eligible hospital or CAH can be excluded from recording such 
information (for example, vital signs) or because there is no 
information to record (for example, laboratory tests), the EP, eligible 
hospital or CAH may leave the field(s) blank and still meet the 
objective and its associated measure.
    In addition, all summary of care documents used to meet this 
objective must include the following in order to be considered a 
summary of care document for this objective:
     Current problem list (Providers may also include 
historical problems at their discretion),
     Current medication list, and
     Current medication allergy list.
    An EP or hospital must verify these three fields for current 
problem list, current medication list, and current medication allergy 
list are not blank and include the most recent information known by the 
EP or hospital as of the time of generating the summary of care 
document.
    After consideration of public comments, we are finalizing this 
objective for EPs at Sec.  495.6(j)(14)(i) and for eligible hospitals 
and CAHs at Sec.  495.6(l)(11)(i) as proposed.
    Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy 
both measures in order to meet the objective:
    The EP, eligible hospital or CAH that transitions or refers their 
patient to another setting of care or provider of care provides a 
summary of care record for more than 65 percent of transitions of care 
and referrals.
    The EP, eligible hospital or CAH that transitions or refers their 
patient to another setting of care or provider of care electronically 
transmits a summary of care record using CEHRT to a recipient with no 
organizational affiliation and using a different CEHRT vendor than the 
sender for more than 10 percent of transitions of care and referrals.
    First Measure: We proposed that if the provider to whom the 
referral is made or to whom the patient is transitioned has access to 
the medical record maintained by the referring provider, then the 
summary of care record would not need to be provided and that patient 
should not be included in the denominators of the measures of this 
objective. We stated in the proposed rule that different settings 
within a hospital using the same CEHRT would have access to the same 
information, so providing a clinical care summary for transfers within 
the hospital would not be necessary.
    Comment: If as stated in the proposed rule ``the majority chose to 
defer this measure in Stage 1'', commenters asserted this is 
insufficient information to justify raising the threshold to 65 percent 
and move the objective to core. Other commenters assert that any 
measure that moves from menu to core should maintain its Stage 1 
threshold regardless of the particular measure's rate of deferral.
    Response: After considering the arguments for lowering the 
threshold to 50 percent and the lack of a robust data set in support of 
the proposed threshold, we do lower the threshold to 50 percent. For 
this measure in particular, we agree that since most providers chose to 
defer this measure in Stage 1 the information available on performance 
from Stage 1 meaningful EHR users is not as robust as for other 
objectives and measures. We do not agree with the comment that all 
objectives that move from menu to core should maintain the same 
threshold. We believe such a blanket policy would be arbitrary and not 
properly account for the information available for each objective and 
measure. For example, if most Stage 1 meaningful EHR users had reported 
on this measure, there would be a robust data set of performance on 
which to judge a threshold. A blanket policy would ignore such 
information.
    Comment: Commenters questioned and requested clarification on 
situations where the recipient of the transition or referral is using 
the same instance of CEHRT or otherwise has access to the CEHRT of the 
transitioning or referring provider. Some of these commenters 
acknowledged our proposal to address this situation were also split 
between support for our proposal to exclude these from the denominator 
versus allowing them to be in the denominator and numerator of both 
measures. Also commenters expressed concern on whether this was a 
measurable constraint. Finally, commenters requested clarification on 
whether our proposal applied to one or both measures.
    Response: We proposed that if the provider to whom the referral is 
made or to whom the patient is transitioned has access to the medical 
record maintained by the referring provider, then the summary of care 
record would not need to be provided and that patient should not be 
included in the denominators of the measures of this objective. We 
believe that different settings within a hospital using CEHRT would 
have access to the same information, so providing a clinical care

[[Page 54017]]

summary for transfers within the hospital would not be necessary. This 
is a continuance of our current Stage 1 policy. In response to 
comments, this policy applies to both measures. We clarify the first 
sentence that access to the medical record could be through several 
mechanisms. Some providers will be in the same organization and share 
CEHRT outright. Other providers might grant remote access to their 
CEHRT to providers not sharing their same CEHRT. We do not limit the 
mechanisms through which access is granted. We disagree that this 
access should count in the denominator or numerator of either measure. 
A summary of care document generated by CEHRT conforms to specific 
standards and could in many cases be automatically integrated into the 
recipient's CEHRT. Access provides no such capability. For this reason, 
we finalize our policy of excluding these transitions and referrals 
from the denominator. However, if a transitioning or referring provider 
provides both access and a summary of care document to providers 
outside their organization and wishes to include them in their 
denominator and as appropriate their numerator, they can do so. 
Finally, while we agree that it some cases it may be difficult to 
determine whether the recipient has access to the sender's CEHRT. We do 
not believe that we should remove an accommodation due to measurement 
difficulties. It is acceptable for a provider to include these 
transitions and referrals in the denominator, but only if a summary of 
care document is provided would it count in the numerator.
    Comment: Commenters stated that there are some providers who may 
engage in a small number of transitions of care and referrals and the 
implementation burden of this objective is too high to require of those 
with only a small number. This is particularly true as the requirement 
for electronic health information exchange is introduced.
    Response: We have previously allowed for a more than zero, but less 
than 100 exclusion for our other objective requiring electronic health 
information exchange (eRx); therefore, in response to these comments we 
will apply that policy to this objective and measure as well and raise 
the exclusion from zero to less than 100 transitions of care and 
referrals. Transitions of care and referrals are additive so someone 
with 50 transitions of care and 75 referrals would not qualify for the 
exclusion.
    After consideration of public comments, we are revising the measure 
for EPs at Sec.  495.6(j)(14)(ii)(A) and for eligible hospitals and 
CAHs at Sec.  495.6(l)(11)(ii)(A) to ``The EP, eligible hospital or CAH 
that transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 50 
percent of transitions of care and referrals.''
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(b)(l) and (b)(2)(i).
    To calculate the percentage of the first measure, CMS and ONC have 
worked together to define the following for this objective:
     Denominator: Number of transitions of care and 
referrals during the EHR reporting period for which the EP or eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
was the transferring or referring provider.
     Numerator: The number of transitions of care and 
referrals in the denominator where a summary of care record was 
provided.
     Threshold: The percentage must be more than 50 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
     Exclusion: Any EP who transfers a patient to 
another setting or refers a patient to another provider less than 100 
times during the EHR reporting period is excluded from all three 
measures.
    Second Measure: For Stage 2, we proposed the additional second 
measure for electronic transmittal because we believe that the 
electronic exchange of health information between providers will 
encourage the sharing of the patient care summary from one provider to 
another and the communication of important information that the patient 
may not have been able to provide, which can significantly improve the 
quality and safety of referral care and reduce unnecessary and 
redundant testing. Use of common standards can significantly reduce the 
cost and complexity of interfaces between different systems and promote 
widespread exchange and interoperability. In acknowledgement of this, 
ONC has included certain transmission protocols in the proposed 2014 
Edition EHR certification criteria.
    These protocols would allow every provider with CEHRT to have the 
tools in place to share critical information when patients are 
discharged or referred, representing a critical step forward in 
exchange and interoperability. Accordingly, we proposed to limit the 
numerator for this second measure to only count electronic 
transmissions which conform to the transport standards proposed for 
adoption at 45 CFR 170.202 of the ONC standards and certification 
criteria rule.
    To meet the second measure of this objective, we proposed that a 
provider must use CEHRT to create a summary of care document with the 
required information according to the required standards and 
electronically transmit the summary of care document using the 
transport standards to which its CEHRT has been certified. No other 
transport standards beyond those proposed for adoption as part of 
certification would be permitted to be used to meet this measure.
    In the proposed rule, we acknowledged the benefits of requiring the 
use of consistently implemented transport standards nationwide, but at 
the same time want to be cognizant of any unintended consequences of 
this approach. ONC requested comments on whether equivalent alternative 
transport standards exist to the ones ONC proposes to exclusively 
permit for certification. These comments are addressed in the ONC 
standards and certification final rule published elsewhere in this 
issue of the Federal Register. We noted in the proposed rule that the 
use of USB, CD-ROM, or other physical media or electronic fax would not 
satisfy the measures for electronic transmittal of a summary of care 
record. We discussed in the proposed rule, in lieu of requiring solely 
the transmission capability and transport standard(s) included in a 
provider's CEHRT to be used to meet this measure, also permitting a 
provider to count electronic transmissions in the numerator if the 
provider electronically transmits summary of care records to support 
patient transitions using an organization that follows Nationwide 
Health Information Network (NwHIN) specifications (http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_resources/1194). This could include those organizations that are 
part of the NwHIN Exchange as well as any organization that is 
identified through a governance mechanism ONC would establish through 
regulation. We requested public comment on whether this additional 
flexibility should be added to our proposed numerator limitations.
    In the proposed rule we raised another potential concern that 
another transport standard emerges after CMS' and ONC's rules are 
finalized that is not adopted in a final rule by ONC as part of 
certification, but nonetheless accomplishes the objective in the same 
way. To mitigate this concern, ONC indicated in its proposed rule that 
it

[[Page 54018]]

would pursue an off-cycle rulemaking to add as an option for 
certification transport standards that emerge at any time after these 
proposed rules are finalized in order to keep pace with innovation and 
thereby allow other transport standards to be used and counted as part 
of this measure's numerator. We asked for comments on how these 
standards will further the goal of true health information exchange.
    Additionally, in order to foster standards based-exchange across 
organizational and vendor boundaries, we proposed to further limit the 
numerator by only permitting electronic transmissions to count towards 
the numerator if they are made to recipients that are--(1) not within 
the organization of the transmitting provider; and (2) do not have 
CEHRT from the same EHR vendor.
    We proposed these numerator limitations because, in collaboration 
with ONC, our experience has shown that one of the biggest barriers to 
electronic exchange is the adoption of numerous different transmission 
methods by different providers and vendors. Thus, we explained that it 
would be prudent for Stage 2 to include these more specific 
requirements and conformance to open, national standards as it will 
cause the market to converge on those transport standards that can best 
and most readily support electronic health information exchange and 
avoid the use of proprietary approaches that limit exchange among 
providers. We recognized that because the 2011 Edition EHR 
certification criteria did not include specific transport standards for 
transitions of care, some providers and vendors implemented their own 
methods for Stage 1 to engage in electronic health information 
exchange, some of which would no longer be an acceptable means of 
meeting meaningful use if this proposal were finalized.
    Therefore, in order to determine a reasonable balance that makes 
this measure achievable yet significantly advance interoperability and 
electronic exchange, we asked for comment on the following concerns 
stakeholders may have relative to the numerator limitations we proposed 
previously.
    We discussed a potential concern related to the feasibility of 
meeting this proposed measure if an insufficient number of providers in 
a given geographic location (because of upgrade timing or some other 
factor) have EHR technology certified to the transport standards ONC 
has proposed to adopt. For example, a city might have had a widely 
adopted health information exchange organization that still used 
another standard than those proposed for adoption by ONC. While it is 
not our intent to restrict providers who are engaged in electronic 
health information exchange via other transport standards, we believe 
requiring the use of a consistent transport standard could 
significantly further our overarching goals for Stage 2.
    We recognized that this limitation extends beyond the existing 
parameters set for Stage 1, which specified that providers with access 
to the same medical record do not include transitions of care or 
referrals among themselves in either the denominator or the numerator. 
We recognized that this limitation could severely limit the pool of 
eligible recipients in areas where one vendor or one organizational 
structure using the same EHR technology has a large market share and 
may make measuring the numerator more difficult. We sought comment on 
the extent to which this concern could potentially be mitigated with an 
exclusion or exclusion criteria that account for these unique 
environments. We believe the limitation on organizational and vendor 
affiliations is important because even if a network or organization is 
using the standards, it does not mean that a network is open to all 
providers. Certain organizations may find benefits, such as competitive 
advantage, in keeping their networks closed, even to those involved in 
the care of the same patient. We believe this limitation will help 
ensure that electronic transmission of the summary of care record can 
follow the patient in every situation.
    Even without the addition of the proposed exclusions under the 
proposed measure, CEHRT would need to be able to distinguish between 
(1) electronic transmissions sent using standards and those that are 
not, (2) transmission that are sent to recipients with the same 
organizational affiliation or not, and (3) transmissions that are sent 
to recipients using the same EHR vendor or not. ONC sought comment in 
their proposed certification rule as to the feasibility of this 
reporting requirement for CEHRT.
    Despite the possible unintended consequences of the parameters we 
proposed for the numerator, in the proposed rule we stated that we 
believed that these limitations would help ensure that electronic 
health information exchange proceeds at the pace necessary to 
accomplish the goals of meaningful use. We asked for comments on all 
these points and particularly suggestions that would both push 
electronic health information exchange beyond what is proposed and 
minimize the potential concerns expressed previously.
    The HIT Policy Committee recommended different thresholds for EPs 
and hospitals for the electronic transmission measure, with a threshold 
of only 25 instances for EPs. However, we proposed a percentage-based 
measure is attainable for both EPs and eligible hospitals/CAHs and 
better reflects the actual meaningful use of technology. It also 
provides a more level method for measurement across EPs. We asked for 
comments on whether there are significant barriers in addition to those 
discussed above to EPs meeting the 10 percent threshold for this 
measure.
    Comment: There were several comments that doubted that the 
technology will be ready for providers to meet this measure. They did 
not believe there is enough vendor support to create, customize, and 
implement the changes necessary to meet the new measure. Commenters 
expressed concern that many of the technologies, from EHRs to HIEs and 
transmission standards, needed to enable electronic health information 
exchange currently do not exist.
    Response: We disagree that it is premature to include this measure 
for Stage 2. We note that as an incentive program it is expected that 
the requirements will reach beyond what is commonplace today. Many 
organizations and providers are successfully engaged in electronic 
health information exchange today and by including this measure in 
meaningful use those established practices will be adopted by a greater 
number of providers.
    Comment: A commenter suggested that ONC's certification rule was 
the appropriate place to ensure cross-vendor interoperability, not the 
Stage 2 measures and objectives.
    Response: While we agree that meaningful use should be enabled by 
the capabilities included in certification, the concept of meaningful 
use is to incentivize the use of such capabilities not just the 
acquisition of them.
    Comment: Commenters expressed two concerns on the limitation on the 
numerator that limited it to recipients with no organizational 
affiliation and using a different CEHRT vendor. First, there was 
concern that in some markets an organization or CEHRT vendor may 
control such a significant share of the market that meeting 10 percent 
is not possible. Second, even if the 10 percent threshold was feasible 
in a given market, one organization or CEHRT vendor may have enough 
market share

[[Page 54019]]

that the provider's referral patterns would inappropriately be 
influenced to give preference to those using different CEHRT vendors or 
outside their organizations. Commenters support appropriate information 
exchange between all providers, where clinically relevant, regardless 
of provider affiliations, but have these concerns on our proposed 
measure for this objective. Commenters presented several different 
solutions including removing one or both limitations, replacing the 
limitations with an error reporting system for instances where 
electronic health information exchange fails, moving the limitations to 
the denominator and providing exclusions for areas of high vendor or 
organizational market penetrations.
    Response: We agree that the measure as proposed runs both risks 
stated by commenters. Of the solutions presented by commenters, one 
directly alleviates both of these concerns. In drafting the final rule, 
we considered moving the limitations from the numerator to the 
denominator of the measure, both concerns are addressed. For example, 
if a provider makes 500 referrals during the EHR reporting period, 400 
of which are to providers that either are affiliated with the same 
organization or use the same CEHRT vendor, then only 100 referrals are 
even eligible for the proposed numerator. This creates a bar that is 
much higher than 10 percent, as 50 percent of the eligible instances 
must be electronically transmitted to meet the proposed measure in this 
example, which we agree has the possibility of influencing referral 
patterns. However, applying the limitations of ``no organizational 
affiliation'' and ``different CEHRT vendor'' to the denominator instead 
of the numerator would result, in this example, in a denominator of 100 
referrals instead of 500 and a true 10 percent threshold. There would 
be no need to change referral patterns as there would be no negative 
effect on the threshold for having a referral partner either in the 
same organization or using the same CEHRT vendor. We firmly believe 
that this solution is the best measure of the type of health 
information exchange that we proposed to target and that is supported 
in principle by nearly all commenters. However, we are not including 
this solution in the final rule as explained in the response to the 
next set of comments. Instead, we are removing the organizational and 
vendor limitations from this measure solely due to the burden of making 
these determinations for measurement.
    Comment: Many commenters expressed concern over the ability to 
measure this objective especially the organization and vendor 
limitations. Commenters who were providers expressed concern over the 
ability of their CEHRT vendor to measure this objective, while vendors 
of CEHRT expressed concern over the ability of providers to measure the 
objective. Combined, it appears that neither the provider nor the 
vendor believed they could even measure on their own and had concerns 
on their partners on which they placed their hopes for measurement.
    Response: In the proposed rule we determined that the CEHRT would 
have to be able to make three determinations to successfully calculate 
the numerator for this measure: (1) Electronic transmissions sent using 
standards and those that are not; (2) transmissions that are sent to 
recipients with the same organizational affiliation or not; and (3) 
transmissions that are sent to recipients using the same EHR vendor or 
not. We stated that ONC will seek comment in their proposed 
certification rule as to the feasibility of this reporting requirement 
for certified EHR technologies. ONC received comments similar to ours 
that making the determinations for the numerator was infeasible 
particularly in regard to the organizational and vendor limitations. 
Therefore, we are removing the organizational and vendor limitations 
from this measure solely due to the burden of making these 
determinations for measurement. Commenters did not suggest difficulties 
with determining that the electronic transmission was sent using the 
specified standards. Therefore, we finalize the stipulation that CEHRT 
be used, including its accompanying standards for this measure 
(``measure 2'').
    However, we are not abandoning all efforts to ensure that cross 
vendor electronic exchange is possible for all meaningful EHR users in 
Stage 2. As discussed in the prior comment and response, the only 
reason we are not finalizing the stipulations on the denominator is the 
measurement burden. We believe that a third measure is needed that 
reduces the burden relative to the proposed measure, but still ensures 
that all providers have implemented CEHRT in a way that enables them to 
electronically exchange summary of care documents with a recipient 
using EHR technology designed by a different vendor. Therefore, we have 
added a third measure (``measure 3'') that requires providers to use 
their CEHRT to either--
     Conduct one or more successful electronic exchanges of a 
summary of care document, which is counted in measure 2 with a 
recipient who has EHR technology designed by a different EHR technology 
developer than the sender's EHR technology certified to 45 CFR 
170.314(b)(2); or
     Conduct one or more successful tests with the CMS 
designated test EHR during the EHR reporting period.
    For the first option in measure 3, the sender must verify that the 
recipient's technology used to receive the summary of care record was 
not designed by the same EHR technology developer that designed the 
sender's EHR technology certified to 45 CFR 170.314(b)(2).
    With respect to the second option in measure 3, and recognizing 
past difficulties and lessons learned from a ``test'' oriented measure 
in Stage 1, we have collaborated with ONC and NIST to initiate a 
project that would result in a public facing (hosted online) ``test 
EHR'' with which EPs, eligible hospitals, and CAHs could engage in 
electronic exchange. We expect that most providers will satisfy the 
first option in the normal course of meeting measure 2. However, in 
those rare instances where that does not occur this other second option 
would give every EP, eligible hospital, or CAH an alternative method to 
meet measure 3 with minimal burden by successfully testing electronic 
exchange with the CMS-designated test EHR. If this second option is 
used, we clarify that the use of test information about a fictional 
patient that would be identical in form to what would be sent about an 
actual patient (for example, ``dummy data'') must be used for the 
purposes of conducting a test with the CMS-designated test EHR. 
Providers that use the same EHR technology certified to 45 CFR 
170.314(b)(2) and share a network for which their organization either 
has operational control or license to use can conduct one test that 
covers all providers in the organization. For example, if a large group 
of EPs with multiple physical locations use the same EHR technology 
certified to 45 CFR 170.314(b)(2) and those locations are connected 
using a network that the group has either operational control of or 
license to use, then a single test would cover all EPs in that group. 
Similarly, if a provider uses an EHR technology that is hosted (cloud-
based) on the developer's network, then a single test would allow all 
EPs, eligible hospitals and CAHs using the EHR technology that is 
hosted (cloud-based) on the developer's network to meet the measure.
    While making this does impose a burden on the provider, we believe 
the burden is outweighed by the benefits of ensuring that every 
provider who

[[Page 54020]]

becomes a meaningful EHR user is capable of exchanging a summary of 
care document electronically regardless of who developed the sender's 
EHR and the recipient's EHR.
    We also seek to note for readers that while we have significantly 
reduced this objective's burden from what we proposed in measure 2, we 
continue to believe that making vendor to vendor standards-based 
exchange attainable for all meaningful EHR users is of paramount 
importance. In that regard, and as we look toward meaningful use Stage 
3, we will monitor the ease with which EPs, eligible hospitals, and 
CAHs engage in electronic exchange, especially across different vendors 
EHRs. If we do not see sufficient progress or that continued 
impediments exist such that our policy goals for standards-based 
exchange are not being met, we will revisit these more specific 
measurement limitations and consider other policies to strengthen the 
interoperability requirements included in meaningful use as well as 
consider other policies and regulations through which the Department 
could effect the outcome we seek. Finally, we also intend to consider 
future meaningful use requirements that increase expectations for 
standards-based exchange and make information that is exchanged more 
searchable and usable for a broad array of clinical purposes imperative 
to care improvement. We envision that these requirements would rely on 
metadata tagging as well as more dynamic methods of electronic health 
information exchange.
    Comment: Commenters expressed support for including in this 
measure's numerator electronic transmissions enabled by query-based 
exchange models, including organizations using NwHIN Exchange 
specifications. The commenters indicated that NwHIN Exchange 
specifications are appropriate for exchange use cases not covered as 
well by the Direct standards, and use of either standard should be 
counted. This is particularly important in cases where the summary is 
pulled instead of pushed. Providers and organizations that are part of 
the NwHIN Exchange or other organizations using these standards should 
receive credit for those exchanges in meeting interoperability 
measures.
    Response: In Stage 2, all providers should be able to use CEHRT to 
share summary of care records in a ``push'' manner to support safe 
transitions and informed referrals. ``Pull'' (query) transactions can 
also support these goals. By ``pull'' transactions we refer to 
instances where the receiving provider retrieves the summary of care 
document from a location outside their own CEHRT as opposed to ``push'' 
transactions where the referring or transitioning provider sends the 
summary of care document to the receiving provider. Thus, such 
transactions should be counted towards the numerator of the provider 
initiating the transitions or referrals when the recipient (the 
provider ``receiving'' the transition or referral) actually receives or 
downloads the patient's summary of care record relevant to the 
transition or referral. The act of uploading the summary of care record 
to a repository that can be queried by the recipient--without 
validation that this query in fact occurred will not be sufficient to 
count towards the numerator. While we acknowledge that there may not be 
a simple, universal way for this to be measured, we believe it is 
important to make this accommodation for those who elect to engage in 
this form of exchange. Therefore, we are revising the second measure to 
include in the sending provider's numerator instances where the 
recipient receives the summary of care record via exchange facilitated 
by an organization that is an NwHIN Exchange participant or in a manner 
that is consistent with the governance mechanism ONC establishes for 
the nationwide health information network. The referring or 
transitioning provider would use their CEHRT to generate a summary of 
care document and to provide it an organization that is a NwHIN 
Exchange participant or in a manner that is consistent with the 
governance mechanism ONC establishes for the nationwide health 
information network. More information on NwHIN Exchange participants is 
available at http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_exchange/1407. ONC issued a request for 
information regarding a governance mechanism for the nationwide health 
information network that is available at 77 FR 28543.
    After considering the comments received, we are modifying the 
second measure for EPs at Sec.  495.6(j)(14)(ii)(B) and for eligible 
hospitals and CAHs at Sec.  495.6(l)(11)(ii)(B) to ``The EP, eligible 
hospital or CAH that transitions or refers their patient to another 
setting of care or provider of care provides a summary of care record 
for more than 10 percent of such transitions and referrals either (a) 
electronically transmitted using CEHRT to a recipient or (b) where the 
recipient receives the summary of care record via exchange facilitated 
by an organization that is a NwHIN Exchange participant or in a manner 
that is consistent with the governance mechanism ONC establishes for 
the nationwide health information network.''
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(b)(l) and (b)(2).
    To calculate the percentage of the second measure, CMS and ONC have 
worked together to define the following for this objective:
     Denominator: Number of transitions of care and 
referrals during the EHR reporting period for which the EP or eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
was the transferring or referring provider.
     Numerator: The number of transitions of care and 
referrals in the denominator where a summary of care record was a) 
electronically transmitted using CEHRT to a recipient or b) where the 
recipient receives the summary of care record via exchange facilitated 
by an organization that is a NwHIN Exchange participant or in a manner 
that is consistent with the governance mechanism ONC establishes for 
the nationwide health information network. The organization can be a 
third-party or the sender's own organization.
     Threshold: The percentage must be more than 10 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
     Exclusion: Any EP who transfers a patient to 
another setting or refers a patient to another provider less than 100 
times during the EHR reporting period is excluded from all three 
measures.
    Third Measure: After considering the comments received, we are 
adding a third measure for EPs at Sec.  495.6(j)(14)(ii)(C) and for 
eligible hospitals and CAHs at Sec.  495.6(l)(11)(ii)(C) to ``An EP, 
eligible hospital or CAH must satisfy one of the two following 
criteria:
     Conducts one or more successful electronic exchanges of a 
summary of care document, which is counted in ``measure 2'' (for EPs 
the measure at Sec.  495.6(j)(14)(ii)(B) and for eligible hospitals and 
CAHs the measure at Sec.  495.6(l)(11)(ii)(B)) with a recipient who has 
EHR technology that was designed by a different EHR technology 
developer than the sender's EHR technology certified to 45 CFR 
170.314(b)(2); or
     Conducts one or more successful tests with the CMS 
designated test EHR during the EHR reporting period.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the

[[Page 54021]]

capabilities and standards of CEHRT at 45 CFR 170.314(b)(2).
     Exclusion: Any EP who transfers a patient to 
another setting or refers a patient to another provider less than 100 
times during the EHR reporting period is excluded from all three 
measures.
(c) Public Health Objectives
General Public Health Discussion
    In the proposed rule, due to similar considerations among the 
public health objectives, we discussed them together. Some Stage 2 
public health objectives are proposed to be in the core set while 
others are proposed to be in the menu set. Each objective is identified 
as either core or menu in the following discussion.
     Capability to submit electronic data to immunization 
registries or immunization information systems except where prohibited, 
and in accordance with applicable law and practice.
     Capability to submit electronic reportable laboratory 
results to public health agencies, except where prohibited, and in 
accordance with applicable law and practice.
     Capability to submit electronic syndromic surveillance 
data to public health agencies, except where prohibited, and in 
accordance with applicable law and practice.
     Capability to identify and report cancer cases to a state 
cancer registry except where prohibited, and in accordance with 
applicable law and practice.
     Capability to identify and report specific cases to a 
specialized registry (other than a cancer registry), except where 
prohibited, and in accordance with applicable law and practice.
    We proposed the following requirements, which will apply to all of 
the public health objectives and measures. We proposed that actual 
patient data is required for the meaningful use measures that include 
ongoing submission of patient data.
    We discussed in the proposed rule situations where PHAs partner 
with health information exchange (HIE) organizations to facilitate the 
submission of public health data electronically from EHRs. As we stated 
in guidance for Stage 1, (see FAQ 10764 at: https://questions.cms.hhs.gov) we clarified that such arrangements with HIE 
organizations, if designated by the PHA to simply transport the data, 
but not transforming content or message format (for example, HL7 
format), are acceptable for the demonstration of meaningful use. 
Alternatively, if the intermediary is serving as an extension of the 
EP, eligible hospital or CAH's CEHRT and performing capabilities for 
which certification is required (for example, transforming the data 
into the required standard), then that functionality must be certified 
in accordance with the certification program established by ONC. In 
this situation, the EP, eligible hospital or CAH must still ensure the 
accomplishment of ongoing submission of reports to the actual 
immunization information system or registry (whether performed by the 
intermediary or not), except in situations when the PHA has explicitly 
designated delivery of reports to the intermediary as satisfying these 
requirements.
    We proposed that an eligible provider is required to utilize the 
transport method or methods supported by the PHA in order to achieve 
meaningful use.
    Unlike in Stage 1, under our proposed Stage 2 criteria a failed 
submission will not meet the objective. An eligible provider must 
either have successful ongoing submission or meet an exclusion 
criterion.
    We stated in the proposed rule that we expect that CMS, CDC and 
PHAs will establish a process where PHAs will be able to provide 
letters affirming that the EP, eligible hospital or CAH was able to 
submit the relevant public health data to the PHA. This affirmation 
letter could then be used by the EP, eligible hospital or CAH for the 
Medicare and Medicaid meaningful use attestation systems, as well as in 
the event of any audit. We requested comments on challenges to 
implementing this strategy.
    We proposed to accept a yes/no attestation and information 
indicating to which PHA the public health data were submitted to 
support each of the public health meaningful use measures.
    Comment: Commenters asked for clarification of ongoing submission; 
additionally, due to the amount of time needed to prepare for 
submission of data, commenters asked for clarification on the timing to 
determine if a public health authority has the capacity to accept 
electronic data for ongoing submission. Other commenters noted that 
being ``in queue'' or in the process of validation for ongoing 
submission should count as meeting this measure. Commenters also noted 
that credit should be given for having moved into ongoing submission 
during Stage 1.
    Response: To clarify the timing issue, the EP or hospital must 
determine if the PHA has the capacity to accept electronic data using 
the specification prescribed by ONC for the public health information 
for the objectives of meaningful use within the first 60 days of the 
EHR reporting period. If the PHA does not have the capacity to accept 
reporting (including situations when the PHA accepts electronic data 
but states it lacks capacity to enroll the EP, eligible hospital or CAH 
during that reporting period), the EP or hospital can claim an 
exclusion for this measure related to the data that cannot be accepted. 
In determining whether the PHA has the capacity, CMS anticipates 
developing a centralized repository for this information, including a 
deadline for the PHA to submit information. If the PHA fails to provide 
information to this centralized repository by the deadline, the 
provider could claim the exclusion. In the event, that we are unable to 
develop a centralized repository, providers will make the determination 
of PHA capacity by working directly with the PHA as is currently the 
case for Stage 1 of meaningful use. If the PHA does have the capacity, 
the measure may be satisfied through any of the following general 
public health criteria:
     Ongoing submission was already achieved for an EHR 
reporting period in a prior year and continues throughout the current 
EHR reporting period using either the current standard at 45 CFR 
170.314(f)(1) and (f)(2) or the standards included in the 2011 Edition 
EHR certification criteria adopted by ONC during the prior EHR 
reporting period when ongoing submission was achieved.
     Registration with the PHA or other body to whom the 
information is being submitted of intent to initiate ongoing submission 
was made by the deadline (within 60 days of the start of the EHR 
reporting period) and ongoing submission was achieved.
     Registration of intent to initiate ongoing submission was 
made by the deadline and the EP or hospital is still engaged in testing 
and validation of ongoing electronic submission.
     Registration of intent to initiate ongoing submission was 
made by the deadline and the EP or hospital is awaiting invitation to 
begin testing and validation.
    The measure will not be met if the provider--
     Fails to register their intent by the deadline; or
     Fails to participate in the on-boarding process as 
demonstrated by failure to respond to the PHA written requests for 
action within 30 days on two separate occasions.
    Comment: Several commenters expressed concern that no data 
transport mechanism was included in the Stage 2 rule and/or EHR 
certification. Some expressed concern that the lack of a

[[Page 54022]]

standard may result in EPs paying more for interfaces than received in 
incentive payments. Other commenters supported including no transport 
mechanism to allow maximum flexibility for public health authorities.
    Response: While we understand the concern of supporting multiple 
transport mechanisms, in order for data to flow to public health 
authority, vendors must support the transport mechanism utilized by the 
public health authority to which the EP or hospital reports. Public 
health authorities have moved to standardize transport mechanisms where 
feasible, and Health Information Exchanges are often facilitating the 
transport of data to public health. We stand by our policy that allows 
public health authorities to dictate the transport mechanism in their 
jurisdiction. Further, we clarify that this is independent of the EHR 
certification criteria as EHR certification does not address transport 
for public health objectives.
    Comment: Commenters suggested that the expectation that public 
health agencies provide affirmation letters is too restrictive in 
accomplishing the goal of established a record of communication between 
the provider and the PHA. They maintain that there are simpler and less 
burdensome ways such as automated acknowledgment messages from 
immunization submissions.
    Response: We agree that our proposal requiring it must be a letter 
is too restrictive and revise our expectation to allow for any written 
communication (which may be in electronic format) from the PHA 
affirming that the EP, eligible hospital or CAH was able to submit the 
relevant public health data to the PHA.
    Comment: Commenters requested greater clarification on what is 
meant by ongoing submission. Some suggested that it be transitioned to 
a percentage measurement as with other objectives of meaningful use.
    Response: We do not agree that a transition to a percentage 
measurement best serves the public health objectives. First, a 
percentage measure would only be applicable to those engaged in ongoing 
submission, and as indicated in an earlier response, we are allowing 
four different situations to meet the measure. Second, we believe that 
the requirement to submit information would be under applicable law, 
the agreements between the provider and PHA, or through meaningful use 
which requires submissions except where prohibited, so it is not 
necessary for meaningful use to monitor the already mandated 
submission. For greater clarification, we describe successful ongoing 
submission as electronic submission of reportable data during the 
normal course of a provider's operations. This is not to say all data 
that is reportable is sent to the PHA. A provider who is submitting any 
reportable data during their normal course of their operations is 
engaged in ongoing submission. A provider that can only submit 
reportable data in a test environment or other circumstance that is not 
part of their normal operations would not be engaged in ongoing 
submission.
    Where a measure states ``in accordance with applicable law and 
practice,'' this reflects that some public health jurisdictions may 
have unique requirements for reporting and that some may not currently 
accept electronic data reports. In the former case, the proposed 
criteria for this objective will not preempt otherwise applicable state 
or local laws that govern reporting. In the latter case, EPs, eligible 
hospitals, and CAHs will be excluded from reporting.
    Comment: Several commenters requested the removal of ``except where 
prohibited'' from the objective, while others expressed support for 
this phrase. Those that did not support note that CMS does not have the 
authority to direct reporting if not required by law or regulations, 
while supporters applauded CMS for supporting reporting where allowed 
but not required by law. Several commenters suggested removing the 
phrase ``in accordance with applicable law,'' while other commenters 
wrote in support of the addition of the phrase.
    Response: We disagree with the commenters suggesting removal of 
these phrases and will keep them as part of the final rule. The phrase 
``except where prohibited'' is meant to allow exemptions from reporting 
for providers who cannot by law report to the public health authority 
within their jurisdiction. For example, a sovereign Indian Nation may 
not be permitted to report immunization registry data to the public 
health authority in their jurisdiction. The phrase is meant to 
encourage reporting if a provider is authorized to do so. The ``in 
accordance with applicable law'' phrase allows public health 
authorities to utilize their existing laws and regulations for 
reporting.
    Proposed Objective: Capability to submit electronic data to 
immunization registries or immunization information systems except 
where prohibited, and in accordance with applicable law and practice.
    We proposed to include this objective in the Stage 2 core set for 
EPs, eligible hospitals and CAHs as recommended by the HITPC. We 
discussed in the proposed rule that the Stage 1 objective and measure 
acknowledged that our nation's public health IT infrastructure is not 
universally capable of receiving electronic immunization data from 
CEHRT, either due to technical or resource readiness. Immunization 
programs, their reporting providers and federal funding agencies, such 
as the CDC, ONC, and CMS, have worked diligently since the passage of 
the HITECH Act in 2009 to facilitate EPs, eligible hospitals and CAHs 
ability to meet the Stage 1 measure. We proposed for Stage 2 to take 
the next step from testing to requiring actual submission of 
immunization data. In order to achieve improved population health, 
providers who administer immunizations must share that data 
electronically, to avoid missed opportunities or duplicative 
vaccinations. Stage 3 is likely to enhance this functionality to permit 
clinicians to view the entire immunization registry/immunization 
information system record and support bi-directional information 
exchange.
    We proposed that the threshold for Stage 2 should move from simply 
testing the electronic submission of immunization data (with follow-up 
submission if the test is successful) to ongoing submission. However, 
we asked for comments on the challenges that moving this objective from 
the menu set to the core set would present for EPs and hospitals.
    Comment: Some commenters suggested that the term immunization 
information systems was all encompassing making the inclusion of 
immunization registries redundant.
    Response: We agree that an information system could include 
registries; however, we do not believe that modifying the objective 
serves a distinct purpose and could confuse those accustomed to the 
term immunization registries.
    Comment: Commenters, although supportive of moving immunization 
registry reporting from menu to core, expressed concern that PHAs did 
not have the capacity to accept electronic data from additional 
providers.
    Response: We agree that not all PHAs will have the resources to 
onboard providers for immunization registry reporting. The final rule 
allows for an EP or hospital to be excluded from the measure if they 
operate in a jurisdiction for which no immunization registry is capable 
of accepting data. We further clarify that this exception applies not 
only if the technical capacity to receive the data does not exist, but 
also if the resources are not available within the

[[Page 54023]]

public health authority to initiate ongoing submission with the EP or 
hospital. We also permit (as earlier stated) an EP or hospital to meet 
the measure so long as they have registered to submit and are either 
still in the process of testing and validation (within the time limits 
established earlier), or are still awaiting an invitation to begin 
submission.
    Comment: Numerous commenters encouraged the inclusion of 
bidirectional exchange of data with immunization registries. Many 
commenters noted that the EP or eligible hospital cannot take advantage 
of rich data and clinical decision support contained within an 
immunization registry without bidirectional exchange.
    Response: While we agree that the need for bidirectional data 
exchange is clear, this measure aligns more with the goals of Stage 3 
meaningful use stated in the proposed rule. Additionally, the standards 
and mechanisms for bidirectional data exchange need to be more 
standardized across public health authorities.
    After consideration of the public comments received, we are 
finalizing this objective for EPs at Sec.  495.6(j)(15)(i) and for 
eligible hospitals and CAHs at Sec.  495.6(l)(12)(i) as proposed.
    Proposed Measure: Successful ongoing submission of electronic 
immunization data from CEHRT to an immunization registry or 
immunization information system for the entire EHR reporting period.
    Comment: Many commenters noted the lack of national standards for 
the collection of immunization data with specific examples such as CVS 
versus MVX coding vocabularies and also noted the need for centralized 
data collection at a national level. Commenters noted that the lack of 
standardization results in cost-prohibitive compliance with this 
measure.
    Response: We agree that during the implementation of Stage 1 
reporting of immunization data, the need for a more harmonized standard 
for immunization reporting was highlighted. To address this issue, the 
option of using version HL7 2.3.1 versus 2.5.1 for certification was 
removed and now only an HL7 2.5.1 message can be used for Stage 2 
reporting of immunization data. The implementation guide for HL7 2.5.1 
has been updated to remove much of the variability across states for 
immunization registry reporting. However, if EPs prior to CY 2014 and 
eligible hospitals and CAHs prior to FY2014 have achieved successful 
ongoing submission using EHR technology certified to the 2011 Edition 
EHR certification criteria (HL7 2.3.1 only) it is acceptable to 
continue this ongoing submission and meet the Stage 2 measure for as 
long as HL7 2.3.1 continues to be accepted by the immunizations 
information system or immunization registry. EPs and eligible hospitals 
and CAHs conducting submissions using HL7 2.5.1 will be able to get 
their arrangement certified to the 2014 Edition EHR certification 
criteria.
    After consideration of the public comments received, we are 
finalizing this measure at for EPs at 495.6(j)(15)(ii) and for eligible 
hospitals and CAHs at 495.6(l)(12)(ii) as proposed, but we modify the 
exclusions to conform with the general criteria for public health 
objectives and to address redundancy in two of the proposed exclusions. 
In the general criteria for public health objectives section we 
established a centralized repository of information about PHA capacity. 
If a PHA does not provide capacity information to this repository in 
time for it to be made available to providers at the start of their EHR 
reporting period, then the providers in that PHA's jurisdiction will 
meet the modified exclusion. We proposed two exclusions: (1) The EP, 
eligible hospital or CAH operates in a jurisdiction for which no 
immunization registry or immunization information system is capable of 
receiving electronic immunization data in the specific standards 
required for CEHRT at the start of their EHR reporting period; and (2) 
the EP, eligible hospital or CAH operates in a jurisdiction for which 
no immunization registry or immunization information system is capable 
of accepting the version of the standard that the EP, eligible hospital 
or CAH's CEHRT can send at the start of their EHR reporting period. In 
both cases the limitation is the ability of the immunization registry 
or immunization information system to receive immunization data in the 
standards required by ONC for EHR certification in 2014. Therefore, we 
are combining these exclusions.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(f)(1) and (f)(2). However, if EPs 
prior to CY 2014 and eligible hospitals and CAHs prior to FY 2014 have 
achieved successful ongoing submission using EHR technology certified 
to the 2011 Edition EHR certification criteria (HL7 2.3.1 only), it is 
acceptable to continue this ongoing submission and meet the Stage 2 
measure for as long as HL7 2.3.1 continues to be accepted by the 
immunizations information system or immunization registry. We note that 
our decision to continue to permit the use of EHR technology certified 
to the 2011 Edition EHR certification criteria is a special 
circumstance and emphasize that EPs, eligible hospitals, and CAHs will 
still need EHR technology certified to the 2014 Edition EHR 
certification criteria in order to meet the CEHRT definition beginning 
with the FY/CY 2014 EHR reporting period.
     Exclusions: Any EP, eligible hospital or CAH that meets 
one or more of the following criteria may be excluded from this 
objective: (1) The EP, eligible hospital or CAH does not administer any 
of the immunizations to any of the populations for which data is 
collected by their jurisdiction's immunization registry or immunization 
information system during the EHR reporting period; (2) the EP, 
eligible hospital or CAH operates in a jurisdiction for which no 
immunization registry or immunization information system is capable of 
accepting the specific standards required for CEHRT at the start of 
their EHR reporting period (3) the EP, eligible hospital or CAH 
operates in a jurisdiction where no immunization registry or 
immunization information system provides information timely on 
capability to receive immunization data; or (4) the EP, eligible 
hospital or CAH operates in a jurisdiction for which no immunization 
registry or immunization information system that is capable of 
accepting the specific standards required by CEHRT at the start of 
their EHR reporting period can enroll additional EPs, eligible 
hospitals or CAHs.
    The second exclusion will not apply if an entity designated by the 
immunization registry or immunization information system can receive 
electronic immunization data submissions. For example, if the 
immunization registry cannot accept the data directly or in the 
standards required by CEHRT, but if it has designated a Health 
Information Exchange to do so on their behalf and the Health 
Information Exchange is capable of accepting the information in the 
standards required by CEHRT, the provider could not claim the second 
exclusion.
    Proposed Eligible Hospital/CAH Objective: Capability to submit 
electronic reportable laboratory results to public health agencies, 
except where prohibited, and in accordance with applicable law and 
practice.
    We proposed that this objective is in the Stage 2 core set for 
eligible hospitals and CAHs. The same rationale for the

[[Page 54024]]

proposed changes between this proposed objective and that of Stage 1 
are discussed earlier under the immunization registry objective. Please 
refer to that section for details on our proposals in this regard.
    Comment: Commenters, although supportive of moving electronic 
laboratory reporting from menu to core, expressed concern that PHAs did 
not have the capacity to accept electronic data from additional 
providers.
    Response: We agree that not all PHAs will have the resources to 
onboard providers for electronic laboratory reporting. The final rule 
allows for an EP, eligible hospital or CAH to be excluded from the 
measure if they operate in a jurisdiction for which no public health 
authority is capable of accepting electronic laboratory data. We 
further clarify that this exception applies not only if the technical 
capacity to receive the data does not exist, but also if the resources 
are not available within the public health authority to initiate 
ongoing submission with the EP, eligible hospital or CAH. We also 
permit (as earlier stated) an EP, eligible hospital or CAH to meet the 
measure so long as they have registered to submit and are either still 
in the process of testing and validation, or are still awaiting an 
invitation to begin submission.
    Comment: Many commenters noted that lack of standards for reporting 
electronic laboratory data to public health authorities and also noted 
the variety of transport methods needed to support reporting to public 
health.
    Response: ONC has adopted an updated implementation guide for 
electronic laboratory reporting from EHR technology in its 2014 Edition 
EHR certification criteria. Additionally, the Centers for Disease 
Control and Prevention in coordination with the Council of State and 
Territorial Epidemiologists have created the national Reporting 
Condition Mapping Table (http://www.cdc.gov/EHRmeaningfuluse/rcmt.html) 
that provides further guidance on appropriate vocabularies usable for 
reportable conditions across the country for reporting of ELR data.
    Comment: Several commenters wrote in favor of expansion of this 
requirement to be inclusive of the surveillance of healthcare 
associated infections (HAI).
    Response: While we agree that the reporting of healthcare 
associated infections is a critical part of public health surveillance, 
the methods and standards for reporting this information require very 
different standards for electronic laboratory reporting of reportable 
conditions. This measure aligns more with the goals of Stage 3 
meaningful use.
    Comment: Numerous commenters suggested that Electronic Laboratory 
Reporting is outside the scope of EHRs and should be excluded from the 
objectives. These commenters note that laboratory information systems 
(LIMS) already have ELR capabilities, and most EHRs do not. One 
commenter expressed concern that reporting from both laboratories and 
providers may cause duplicate reporting of a single case. The same 
commenter stated that many LIMS systems already have functionality to 
identify which laboratory results need to be reported to public health, 
which EHRs do not, and that building that capability into EHRs would be 
duplicative and burdensome.
    Response: We disagree with the statement that ELR is ``outside the 
scope of EHRs and should be excluded'' because we share ONC's broad 
interpretation of the term EHR technology. Eligible Hospitals can 
choose to report data directly from any kind of EHR technology that has 
been certified to the certification criteria adopted by ONC. This could 
include EHR technology from a single EHR technology developer, a 
separate modularly certified component such as a LIMS certified as an 
EHR Module, or the technical capability offered by an HIE that is 
certified as an EHR Module for electronic laboratory reporting.
    After consideration of the public comments, we are finalizing this 
objective for eligible hospitals and CAHs at 495.6(l)(13)(i) as 
proposed.
    Proposed Eligible Hospital/CAH Measure: Successful ongoing 
submission of electronic reportable laboratory results from CEHRT to a 
public health agency for the entire EHR reporting period as authorized, 
and in accordance with applicable State law and practice.
    Please refer to the general public health discussion regarding use 
of intermediaries.
    Most comments received related to this measure have been addressed 
in the discussion of public health objectives in general or in the 
discussion of the objective associated with this measure.
    Comment: Commenters pointed out that the proposed measure includes 
the statement ``as authorized, and in accordance with applicable State 
law and practice.'' Some commenters believed the phrase was simply 
redundant to the objective and was inconsistent with the other public 
health measures. Other commenters expressed concern that the addition 
of the phrase implied a more restrictive measure than other public 
health measures particularly with the limit to state law as opposed to 
just law.
    Response: We agree with commenters that this phrase is redundant to 
the objective and may introduce confusion. Therefore, we are revising 
this measure to remove the phrase and make it consistent with the other 
public health measures.
    Based on consideration of those comments, we are modifying this 
measure for eligible hospitals and CAHs at Sec.  495.6(l)(13)(ii) to 
successful ongoing submission of electronic reportable laboratory 
results from CEHRT to a public health agency for the entire EHR 
reporting period.'' We also modify the exclusions to conform with the 
general criteria for public health objectives. In the general criteria 
for public health objectives, we plan to establish a centralized 
repository of PHA capacity information. If a PHA does not provide 
capacity information to this repository in time for it to be made 
available to providers at the start of their EHR reporting period, then 
the providers in that PHA's jurisdiction will meet the modified 
exclusion. If the repository is not established, the eligible hospital 
or CAH must consult their PHA jurisdiction for guidance.
    We further specify that in order to meet this objective and 
measure, an eligible hospital or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(f)(4).
     Exclusions: The eligible hospital or CAH that meets one or 
more of the following criteria may be excluded from this objective: (1) 
operates in a jurisdiction for which no public health agency is capable 
of receiving electronic reportable laboratory results in the specific 
standards required for Certified EHR Technology at the start of the EHR 
reporting period; (2) operates in a jurisdiction where no public health 
agency provides information timely on capability to receive electronic 
reportable laboratory results or (3) the eligible hospital or CAH 
operates in a jurisdiction for which no public health agency that is 
capable of accepting the specific standards required by CEHRT at the 
start of their EHR reporting period can enroll additional eligible 
hospitals or CAHs.
    Proposed Objective: Capability to submit electronic syndromic 
surveillance data to public health agencies except where prohibited, 
and in accordance with applicable law and practice.
    We proposed that this objective is in the Stage 2 core set for 
eligible hospitals and CAHs and the Stage 2 menu set for EPs. The Stage 
1 objective and measure

[[Page 54025]]

acknowledged that our nation's public health IT infrastructure is not 
universally capable of receiving syndromic surveillance data from 
CEHRT, either due to technical or resource readiness. Given public 
health IT infrastructure improvements and new implementation guidance, 
for Stage 2, we proposed that this objective and measure be in the core 
set for hospitals and in the menu set for EPs. It is our understanding 
from hospitals and the CDC that many hospitals already send syndromic 
surveillance data. The CDC has issued the PHIN Messaging Guide for 
Syndromic Surveillance: Emergency Department and Urgent Care Data 
[http://www.cdc.gov/ehrmeaningfuluse/Syndromic.html] as cited in the 
ONC final rule on EHR standards and certification. However, per the CDC 
and a 2010 survey completed by the Association of State and Territorial 
Health Officials (ASTHO), very few public health agencies are currently 
accepting syndromic surveillance data from ambulatory, non-hospital 
providers, and there is no corresponding implementation guide at the 
time of this final rule. CDC is working with the syndromic surveillance 
community to develop a new implementation guide for ambulatory and 
inpatient discharge reporting of syndromic surveillance information, 
which it expects will be available in the spring 2013. We anticipate 
that Stage 3 might include syndromic surveillance for EPs in the core 
set if the collection of ambulatory syndromic data becomes a more 
standard public health practice in the interim.
    The HIT Policy Committee recommended making this a core objective 
for Stage 2 for EPs and hospitals. However, we did not propose to adopt 
their recommendation for EPs. We specifically invited comment on the 
proposal to leave syndromic surveillance in the menu set for EPs, while 
requiring it in the core set for eligible hospitals and CAHs.
    Comment: Commenters noted that keeping the objective as menu for 
EPs is still problematic as most public health agencies are unable to 
accept the data. Commenters also expressed that for providers that are 
already reporting this objective, it makes sense to keep it as a menu 
set option.
    Response: We agree that although not all public health authorities 
are able to accept syndromic surveillance data from Eligible 
Professionals, since many EPs already report this measure and some 
public health authorities have the ability to accept this data, the 
measure will remain as a menu set option.
    Comment: Commenters noted that moving the objective as core is 
premature due to public health readiness. Commenters also expressed 
that for hospitals that have already reporting this objective, it makes 
sense to move the measure to core.
    Response: We agree that not all public health authorities are able 
to accept syndromic surveillance data from hospitals; however, our 
exclusion criteria addresses this situation. Since many hospitals 
already report this measure and many public health authorities have the 
ability to accept this data, the measure will remain as core. If there 
are no public health authorities for the hospitals to report syndromic 
surveillance data to, the hospital can claim an exemption.
    Comment: Many commenters noted that lack of standards for reporting 
syndromic surveillance data to public health authorities.
    Response: While a single national implementation guide exists for 
syndromic surveillance data of emergency department data from 
hospitals, currently an implementation guide does not exist for 
syndromic surveillance reporting from the eligible professional. The 
Centers for Disease Control and Prevention is working in conjunction 
with the International Society for Disease Surveillance and draft 
guidance is currently available for the reporting of ambulatory based 
syndromic surveillance.
    Comment: Several comments expressed concern about the level of 
reporting. Concern was expressed from entities with multiple locations 
that would need to report by facility or provider lever rather than as 
an organization.
    Response: Currently public health departments that collect 
syndromic surveillance data streamline the data collection process and 
collect data at an organization or facility level depending on the 
provider. Syndromic surveillance data is not collected at the provider 
level, although attestation would be at the provider level where 
reporting by a single organization or facility could count for multiple 
providers.
    After consideration of the public comments received, we are 
finalizing this objective for EPs in the menu set at Sec.  
495.6(k)(3)(i) and for eligible hospitals and CAHs in the core set at 
Sec.  495.6(l)(14)(i) as proposed.
    Proposed Measure: Successful ongoing submission of electronic 
syndromic surveillance data from CEHRT to a public health agency for 
the entire EHR reporting period.
    All comments received related to this measure have been addressed 
in the discussion of public health objectives in general or in the 
discussion of the objective associated with this measure. After 
consideration of these public comments, we are finalizing this measure 
as proposed for EPs in the menu set at Sec.  495.6(k)(3)(ii) and for 
eligible hospitals and CAHs in the core set at Sec.  495.6(l)(14)(ii) 
as proposed, but we modify the exclusions to conform with the general 
criteria for public health objectives and to address redundancy in two 
of the proposed exclusions. In the general criteria for public health 
objectives, we plan to establish a centralized repository of PHA 
capacity information. If a PHA does not provide capacity information to 
this repository in time for it to be made available to providers at the 
start of their EHR reporting period, then the providers in that PHA's 
jurisdiction will meet the modified exclusion. We proposed two 
exclusions: (1) The EP, eligible hospital, or CAH operates in a 
jurisdiction for which no public health agency is capable of receiving 
electronic syndromic surveillance data in the specific standards 
required for Certified EHR Technology at the start of their EHR 
reporting period; and (2) the EP, eligible hospital, or CAH operates in 
a jurisdiction for which no public health agency is capable of 
accepting the version of the standard that the EP's, eligible 
hospital's or CAH's CEHRT can send at the start of their EHR reporting 
period. In both cases the limitation is the ability of the PHA to 
receive syndromic surveillance data in the standards required by ONC 
for EHR certification in 2014. Therefore, we are combining these 
exclusions.
    We expect that the CDC will be issuing (in Spring 2013) the CDC 
PHIN Messaging Guide for Ambulatory Syndromic Surveillance and we may 
rely on this guide to determine which categories of EPs will not 
collect such information.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(f)(3). However, if EPs prior to CY 
2014 and eligible hospitals and CAHs prior to FY 2014 have achieved 
successful ongoing submission using EHR technology certified to the 
2011 Edition EHR certification criteria (HL7 2.3.1 only), it is 
acceptable to continue this ongoing submission and meet the Stage 2 
measure for as long as HL7 2.3.1 continues to be accepted by the PHA in 
that jurisdiction. We note that our decision to continue to permit the 
use of EHR technology certified to the 2011 Edition EHR certification 
criteria is a special circumstance and

[[Page 54026]]

emphasize that EPs, eligible hospitals, and CAHs will still need EHR 
technology certified to the 2014 Edition EHR certification criteria in 
order to meet the CEHRT definition beginning with the FY/CY 2014 EHR 
reporting period.
     Exclusions: Any EP, eligible hospital or CAH that meets 
one or more of the following criteria may be excluded from this 
objective: (1) the EP is not in a category of providers that collect 
ambulatory syndromic surveillance information on their patients during 
the EHR reporting period; (2) the eligible hospital or CAH does not 
have an emergency or urgent care department; (3) the EP, eligible 
hospital, or CAH operates in a jurisdiction for which no public health 
agency is capable of receiving electronic syndromic surveillance data 
in the specific standards required by CEHRT at the start of their EHR 
reporting period; (4) the EP, eligible hospital or CAH operates in a 
jurisdiction where no public health agency provides information timely 
on capability to receive syndromic surveillance data; or (5) the EP, 
eligible hospital or CAH operates in a jurisdiction for which no public 
health agency that is capable of accepting the specific standards 
required by CEHRT at the start of their EHR reporting period can enroll 
additional EPs, eligible hospitals or CAHs.
    As was described under the immunization registry measure, the third 
and fourth exclusions do not apply if the PHA has designated an HIE 
organization or other intermediary to collect this information on its 
behalf and that intermediary can do so in the specific Stage 2 
standards and/or the same standard as the provider's CEHRT. An urgent 
care department delivers ambulatory care, usually on an unscheduled, 
walk-in basis, in a facility dedicated to the delivery of medical care, 
but not classified as a hospital emergency department. Urgent care 
centers are primarily used to treat patients who have an injury or 
illness that requires immediate care but is not serious enough to 
warrant a visit to an emergency department. Often urgent care centers 
are not open on a continuous basis, unlike a hospital emergency 
department, which will be open at all times.
(d) New Core and Menu Set Objectives and Measures for Stage 2
    We proposed the following objectives for inclusion in the core set 
for Stage 2: ``Provide patients the ability to view online, download, 
and transmit information about a hospital admission'' and 
``Automatically track medication orders using an electronic medication 
administration record (eMAR)'' for hospitals; ``Use secure electronic 
messaging to communicate with patients'' for EPs. We proposed all other 
new objectives for inclusion in the menu set for Stage 2. While the HIT 
Policy Committee recommended making all objectives mandatory and 
eliminating the menu option, we believe a menu set is necessary for 
some of these new objectives in order to give providers an opportunity 
to implement new technologies and make changes to workflow processes 
and to provide maximum flexibility for providers in specialties that 
may face particular challenges in meeting new objectives.
    Proposed Objective: Imaging results and information are accessible 
through CEHRT.
    In the proposed rule, we outlined the following benefits for this 
objective. Making the image that results from diagnostic scans and 
accompanying information accessible through CEHRT increases the utility 
and efficiency of both the imaging technology and the CEHRT. The 
ability to share the results of imaging scans will likewise improve the 
efficiency of all health care providers and increase their ability to 
share information with their patients. This will reduce the cost and 
radiation exposure from tests that are repeated solely because a prior 
test is not available to the provider.
    We stated in the proposed rule that most of the enabling steps to 
incorporating imaging relate to the certification of EHR technologies. 
As with the objective for incorporating lab results, we encourage the 
use of electronic exchange to incorporate imaging results into the 
CEHRT, but in absence of such exchange it is acceptable to manually add 
the image and accompanying information to CEHRT.
    Comment: Some commenters expressed concerns over the ability of 
CEHRT to store the images.
    Response: We did not propose that CEHRT store the images. Storing 
the images natively in CEHRT is one way to make them accessible through 
CEHRT, but there are many other ways.
    Comment: Commenters stated that unless a HIE organization existed 
to facilitate imaging exchange, building out an unique interface for 
each imaging provider is cost prohibitive. Second, commenters were 
concerned that because stand-alone radiology centers are not subject to 
the EHR Incentive Program they may not agreeing to provide their images 
electronically to the provider through their EHR. These commenters 
therefore suggest that it is premature to include this objective.
    Response: We agree that many advances in infrastructure are needed 
to fully enable this objective. We believe that from publication of 
this final rule to the start of Stage 2 significant progress will be 
made in part due to the inclusion of this objective in Stage 2. We do 
agree that these improvements in infrastructure will vary based on 
local conditions such as the presence of HIEs, the willingness of 
radiology centers to link to EHRs, and other factors and note that is a 
primary reason for this being a menu objective. We will also consider 
these comments below in relation to setting the threshold for the 
measure.
    Comment: The resolution required for viewing imaging for diagnostic 
purposes requires specific hardware which would be cost prohibitive for 
all EPs. CMS should clarify that the image can be of any resolution.
    Response: We do not impose limitations on the resolution of the 
image. To the extent this is a concern, it would be a capability of 
CEHRT not a requirement of meaningful use.
    Comment: Commenters requested clarification on whether both the 
image itself and the accompanying results and information must be 
available, or just one or the other.
    Response: The objective as proposed was intended to convey that the 
image itself is the result and that narratives/explanations and other 
information would be the additional information. Due to the many 
comments we received requesting clarification, we are revising the 
objective for clarity.
    Comment: Commenters requested a more specific definition of 
imaging.
    Response: We believe that imaging is a well understood term in the 
provider community. However, we agree that a more specific definition 
is required for purposes of measuring meaningful use. We adopt the 
description of radiology services from the Stage 2 CPOE objective as 
the minimum description of imaging. Providers are free to use a more 
expansive definition of imaging.
    After review of the comments, we are revising the objective for EPs 
at 495.6 (k)(1)(i) and for eligible hospitals and CAHs at 
495.6(m)(2)(i) to ``Imaging results consisting of the image itself and 
any explanation or other accompanying information are accessible 
through CEHRT.''
    Proposed Measure: More than 40 percent of all scans and tests whose 
result is one or more images ordered by the EP or by an authorized 
provider of the eligible hospital or CAH for patients admitted to its 
inpatient or emergency department (POS 21 or 23) during the

[[Page 54027]]

EHR reporting period are accessible through CEHRT.
    For Stage 2, we did not propose the image or accompanying 
information (for example, radiation dose) be required to be structured 
data. Images and imaging results that are scanned into the CEHRT may be 
counted in the numerator of this measure. We defined accessible as 
either incorporation of the image and accompanying information into 
CEHRT or an indication in CEHRT that the image and accompanying 
information are available for a given patient in another technology and 
a link to that image and accompanying information. Incorporation of the 
image means that the image and accompanying information is stored by 
the CEHRT. We did not propose that meaningful use would impose any 
additional retention requirements on the image. A link to the image and 
accompanying information means that a link to where the image and 
accompanying information is stored is available in CEHRT. This link 
must conform to the certification requirements associated with this 
objective in the ONC final rule published elsewhere in this issue of 
the Federal Register. We encouraged comments on the necessary level of 
specification and what those specifications should be to define 
accessible and what constitutes a direct link.
    Comment: Commenters suggested that the proposed threshold of 40 
percent was too high given the dependency on the image provider and 
electronic exchange infrastructure discussed in the objective. The most 
popular suggested threshold was 10 percent. Commenters also suggested 
that an exclusion be created for providers who have no access to 
electronic images. A few of the commenters pointed to the lack of an 
imaging provider that could make electronic images available. Others 
were concerned that when a provider uses multiple imaging providers, 40 
percent might be too high of a threshold even if at least one imaging 
provider that could make electronic images available.
    Response: After reviewing the comments, we agree that 40 percent is 
too high of a threshold for this measure and revise it to 10 percent. 
Providers, especially EPs, may use many imaging providers, and we do 
not want an EP to have to defer this objective simply because they have 
three imaging providers, and the one allowing electronic access 
represents less than 40 percent of their orders. The comment regarding 
complete lack of an imaging provider that could make electronic images 
available speaks to the need for an exclusion. In considering an 
exclusion for those providers who have no access to electronic images, 
we take into account that it is a menu objective and also that there 
may be providers who fall into a situation where access is more than 
zero, but less than 10 percent. In regards to the menu, while it is 
true that a provider may defer this measure, the number of measures in 
the menu set are fewer and more specialized than in Stage 1. 
Furthermore, as an exclusion no longer counts towards meeting a menu 
objective, we are not concerned providers would choose this objective 
only to exclude it. For this reason, we are finalizing an exclusion for 
providers who have no access to electronic images. For those who cannot 
meet the 10 percent threshold even with access to an imaging provider 
who makes electronic images available, deferral remains a possibility 
as well as shifting more orders to imaging providers that do allow 
electronic access.
    Comment: Several commenters disagreed with the proposed exclusion 
for EPs and believed it was inconsistent with the objective. These 
commenters believe the objective is intended for EPs who order imaging, 
whether or not they interpret the imaging studies themselves. These 
commenters suggested changing the exclusion to ``Any EP who orders 
(less than 100/50/no) diagnostic scans or tests whose result is an 
image during the EHR reporting period''.
    Response: Our intention with the proposed exclusion was to 
distinguish between ordering providers who have need of the image and 
those that do not. Based on the comments the need to view the image 
depends on a combination of factors including previous experiences with 
the type of image, the imaging facility, the circumstances of the 
patient, whether a similar image has been ordered before for the 
patient and the reading clinician. Given the wide variety of factors, 
we agree that it is not possible to create a distinct line between 
ordering providers who need the image and those that do not. We believe 
this line can be partly drawn by adopting the exclusion recommended by 
comments with a high count of 100. This is both consistent with our 
other objectives and as a high number indicates a particular benefit to 
the provider as well as increasing the likelihood that factors align 
for the ordering provider to need the image.
    Comment: Commenters stated that the use of the term ``scan'' is 
confusing and unnecessary. Scan frequently applies to actions and 
concepts other than certain types of imaging procedures.
    Response: We agree that the term scan has multiple uses, as any 
scan would be an image and could be classified as a test. Therefore, we 
remove the word scan from the measure as duplicative.
    After reviewing the comments, we modify the measure for EPs at 
Sec.  495.6 (k)(1)(ii) and for eligible hospitals and CAHs at Sec.  
495.6(m)(2)(ii) to: More than 10 percent of all tests whose result is 
one or more images ordered by the EP or by an authorized provider of 
the eligible hospital or CAH for patients admitted to its inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
accessible through CEHRT.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(12).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this measure:
     Denominator: Number of tests whose result is one or more 
images ordered by the EP or by an authorized provider on behalf of the 
eligible hospital or CAH for patients admitted to its inpatient or 
emergency department (POS 21 and 23) during the EHR reporting period.
     Numerator: The number of results in the denominator that 
are accessible through CEHRT.
     Threshold: The resulting percentage must be more than 10 
percent in order to meet this measure.
     Exclusion: Any EP who orders less than 100 tests whose 
result is an image during the EHR reporting period; or
    Any EP who has no access to electronic imaging results at the start 
of the EHR reporting period.
    No access means that none of the imaging providers used by the EP 
provide electronic images and any explanation or other accompanying 
information that are accessible through their CEHRT at the start of the 
EHR reporting period.
    We solicited comments on a potential second measure for this 
objective that would encourage the exchange of imaging and results 
between providers. We considered a threshold of 10 percent of all scans 
and tests whose result is one or more images ordered by the EP or by an 
authorized provider of the eligible hospital or CAH for patients 
admitted to its inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period and accessible through CEHRT also be exchanged 
with another provider of care.
    Comment: While most commenters agree with the principle of exchange 
of images among providers of care, they nearly all agreed that this 
measure would be premature for Stage 2 due to

[[Page 54028]]

infrastructure concerns. Some suggested that it be considered for Stage 
3 as a logical next step from our proposed Stage 2 measure.
    Response: Given the comments, we are not including this measure in 
our final rule. We will consider the input provided when we develop our 
proposal for Stage 3.
    Proposed Objective: Record patient family health history as 
structured data
    In the proposed rule, we noted that every provider currently 
requests a family health history from the patient in order to obtain 
it. However, EHRs can allow the patient to contribute directly to the 
record and allow the record to be shared among providers, thereby 
greatly increasing the efficiency of collecting family health 
histories. Family health history is a major risk indicator for a 
variety of chronic conditions for which effective screening and 
prevention tools are available.
    Comment: Commenters generally supported the inclusion of recording 
family health history as a menu set measure for EPs, eligible hospitals 
and CAHs, while some suggested deferring the measure until Stage 3 when 
they expect more robust standards will be available. Some commenters 
also suggested family health history is best collected by primary care 
physicians, not hospitals. Others still suggested modifying this 
objective to allow for the use of unstructured data.
    Response: ONC has adopted standards requiring CEHRT to be able to 
use SNOMED-CT or the HL7 Pedigree standard to record a patient's family 
health history. We refer readers to ONC's standards and certification 
criteria final rule that is published elsewhere in this issue of the 
Federal Register. As a readily available standard is being adopted, we 
are maintaining this objective as proposed and including it in the menu 
set. We continue to believe that family history is part of regular 
physician and hospital workflow--even if it's collected at a very high 
level. While it may primarily be the physicians working in the hospital 
that consider this information, these same physicians typically use the 
hospital EHR when evaluating their hospitalized patients so having this 
information in the hospital EHR is just as important as having it in 
the physician's own EHR. We will also finalize the exclusion for EPs 
who have no office visits during the EHR reporting period to account 
for scope of practice concerns and the common collection of this 
information directly from patients.
    After consideration of public comments, we are finalizing this 
objective for EPs at Sec.  495.6 (k)(2)(i) and for eligible hospitals 
and CAHs at Sec.  495.6(m)(3)(i) as proposed.
    Proposed Measure: More than 20 percent of all unique patients seen 
by the EP, or admitted to the eligible hospital or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period 
have a structured data entry for one or more first-degree relatives.
    We proposed to adopt the definition of first degree relative used 
by the National Human Genome Research Institute of the National 
Institutes of Health. A first degree relative is a family member who 
shares about 50 percent of their genes with a particular individual in 
a family. First degree relatives include parents, offspring, and 
siblings. We considered other definitions, including those that address 
both affinity and consanguinity relationships and encourage comments on 
this definition. We noted that this is a minimum and not a limitation 
on the health history that can be recorded. We did not propose a time 
limitation on the indication that the family health history has been 
reviewed. The recent nature of this capability in EHRs will impose a de 
facto limitation on review to the recent past.
    We proposed an exclusion to this measure for EPs who have no office 
visits during the EHR reporting period. We believe that EPs who do not 
have office visits will not have the face-to-face contact with patients 
necessary to obtain family health history information.
    Comment: Many commenters wondered why recording family health 
history was limited to first-degree relatives. They noted that a 
patient's grandparents or other relatives may have equally relevant 
medical information that should be included in the EHR. Other 
commenters pointed out that not all patients may know their family 
health history, particularly patients who were adopted, and suggested 
including a code for ``unknown'' or ``not relevant.'' They noted that 
in some cultures, the patient may not be willing to provide the data or 
that the data they have may be unreliable (such as informal adoptions 
in Native American tribes).
    Response: While information about second degree relatives may be 
useful for some diagnoses and conditions, we believe collecting medical 
history from first degree relatives is the floor, not the ceiling and 
encourage providers to collect additional information as they see fit. 
Additionally, we understand concerns about patients who may not know 
their family history. In these situations, we would find it acceptable 
for the provider to record the patient's family history as ``unknown.'' 
Either a structured data entry of ``unknown'' or any structured data 
entry identified as part of the patient's family history and conforming 
to the standards of CEHRT at 45 CFR 170.314(a)(13) must be in the 
provider's CEHRT for the patient to count in the numerator.
    Comment: Some commenters suggested we introduce this measure with a 
lower threshold as this is a new requirement, but did not specify a 
threshold. They noted that providers who might have previously captured 
family history might not have that in a structured format or not coded 
against the standards chosen for CEHRT. This history would have to be 
redocumented.
    Response: We proposed a low threshold of 20 percent. As this 
measure is not reliant on other organizations and providers the way 
imaging is we do not believe that is necessary to lower the threshold 
further.
    Comment: Some commenters suggested this measure may not apply to 
certain specialty providers (for example, Urgent Care, Orthopedics) and 
suggested including an exclusion.
    Response: We proposed an exclusion to this measure for EPs who have 
no office visits during the EHR reporting period. We continue to 
believe that EPs who do not have office visits would not have the face-
to-face contact with patients necessary to obtain family health history 
information. However, this exclusion may not apply to certain specialty 
providers (like the aforementioned). We continue believe that recording 
family health history, regardless of specialty, is can be an important 
indicator for chronic conditions. Additionally, as this measure is 
being finalized as part of the menu set, providers are not required to 
report on this objective.
    After consideration of public comments, we are finalizing the 
measure for EPs at Sec.  495.6(k)(2)(ii) and for eligible hospitals and 
CAHs at Sec.  495.6(m)(3)(ii) to ``More than 20 percent of all unique 
patients seen by the EP, or admitted to the eligible hospital or CAH's 
inpatient or emergency department (POS 21 or 23), during the EHR 
reporting period have a structured data entry for one or more first-
degree relatives''.
    We are finalizing the exclusion as proposed at Sec.  
495.6(k)(2)(iii).
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(13).

[[Page 54029]]

    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of unique patients seen by 
the EP or admitted to the eligible hospital's or CAH's inpatient or 
emergency departments (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of patients in the 
denominator with a structured data entry for one or more first-degree 
relatives.
     Threshold: The resulting percentage must be more 
than 20 percent in order to meet this measure.
     Exclusion: Any EP who has no office visits 
during the EHR reporting period.
    Proposed EP Objective: Capability to identify and report cancer 
cases to a state cancer registry, except where prohibited, and in 
accordance with applicable law and practice.
    We outlined the following benefits of this objective in the 
proposed rule. Reporting to cancer registries by EPs would address 
current underreporting of cancer, especially certain types. In the past 
most cancers were diagnosed and/or treated in a hospital setting and 
data were primarily collected from this source. However, medical 
practice is changing rapidly and an increasing number of cancer cases 
are never seen in a hospital or are cared for primarily in the 
outpatient setting. Data collection from EPs presents new challenges 
since the infrastructure for reporting is less mature than it is in 
hospitals. Certified EHR technology can address this barrier by 
identifying reportable cancer cases and treatments to the EP and 
facilitating electronic reporting either automatically or upon 
verification by the EP.
    We proposed to include ``except where prohibited and in accordance 
with applicable law and practice'' because we want to encourage all EPs 
to submit cancer cases, even in rare cases where they are not required 
to by state/local law. Legislation requiring cancer reporting by EPs 
exists in 49 states with some variation in specific requirements, per 
the 2010 Council of State and Territorial Epidemiologists (CSTE) State 
Reportable Conditions Assessment (SRCA) (http://www.cste.org/dnn/ProgramsandActivities/PublicHealthInformatics/StateReportableConditionsQueryResults/tabid/261/Default.aspx).'' If EPs 
are authorized to submit, they should do so even if it is not required 
by either law or practice.'' In accordance with applicable law and 
practice'' reflects that some public health jurisdictions may have 
unique requirements for reporting, and that some may not currently 
accept electronic provider reports. In the former case, the proposed 
criteria for this objective would not preempt otherwise applicable 
state or local laws that govern reporting. In the latter case, eligible 
professionals would be exempt from reporting.
    Comment: Nearly all commenters who wrote in support of the 
objective stated that the rule would decrease reporting burden for EPs 
because cancer diagnosis reporting in mandatory in most states. One 
commenter noted that the rule may increase compliance with mandatory 
reporting by reducing time and effort needed to submit cancer diagnosis 
report. Also, it was noted that incorporation of cancer reporting in 
meaningful use Stage 2 for eligible providers will improve completeness 
and quality of cancer reporting. Conversely, several of the commenters 
who recommended moving the objective to Stage 3 or remove the objective 
completely stated that inclusion of this object would place undue 
burden on EPs, especially because primary care providers rarely report 
to cancer registries. A commenter noted that the necessary EHR 
functionality currently exists primarily in oncology specialty EHRs, 
and EPs may be required to purchase additional modules to meet this 
object, and further states that this would be cost-prohibitive to EPs 
who only rarely diagnose cancer. One commenter suggested that the 
detailed reporting requirements would be too time-consuming for most 
EPs. Another commenter questions if responsibility for reporting cases, 
or presumptive cases, would shift to primary care providers. Other 
commenters suggest that the objective should be removed until such time 
that a national central repository can be established to simplify 
point-to-point connections.
    Response: We agree that inclusion of this requirement is likely to 
reduce reporting burden for those already required to report to cancer 
registries. We also agree with commenters that this objective is not 
relevant to all providers. For those EPs who do not meet the proposed 
exclusion of not diagnosing or directly treating cancer, yet are not 
already under a requirement to report to cancer registries, we note 
that this is a menu objective and can be deferred. Between the proposed 
exclusions and the option to defer, we do not believe the measure 
imposes a reporting burden on providers who would not normally report 
to cancer registries.
    Comment: The objectives of specialized registries and cancer 
registries reporting should be combined.
    Response: In review of comments we found no compelling reason to 
change our proposal. No commenter disputed that the reporting to cancer 
registries has different level of existing reporting requirements and 
supporting standards than other specialized registries.
    Comment: One commenter suggested changing the final rule to read, 
``public health central cancer registry'' to clearly distinguish them 
from hospital-based cancer registries.
    Response: We agree that the term public health central cancer 
registry is better than just cancer registries and more inclusive than 
just state cancer registries as used in the proposed objective, but not 
the proposed measure.
    After consideration of the public comments received, we are 
modifying this objective for EPs at Sec.  495.6 (k)(4)(i) to 
``Capability to identify and report cancer cases to a public health 
central cancer registry, except where prohibited, and in accordance 
with applicable law and practice.''
    Proposed EP Measure: Successful ongoing submission of cancer case 
information from CEHRT to a cancer registry for the entire EHR 
reporting period.
    Comment: Commenters are concerned that under the proposed menu set 
providers will be required to choose one of: (1) Syndromic 
surveillance; (2) submitting to cancer registries; or (3) submitting to 
specialty registries if they do not meet the exclusions for all three. 
The commenters believe that CMS should be providing physicians with a 
legitimate selection of menu set measures from which to choose.
    Response: Stage 2 does contain a more specialized and smaller menu 
set than Stage 1. We see this as a natural result of moving up the 
staged path towards improved outcomes. We also see it as necessary for 
meaningful use to be applicable to all EPs. We use exclusions to ensure 
that only those EPs who create reportable data have the obligation 
under meaningful use to report it so this would not be a barrier to 
meeting meaningful use. Furthermore, we added an objective to the menu 
set in this final rule for EPs so it is no longer true that an EP would 
be required to pick one of the three menu objectives mentioned by 
commenters.
    After consideration of the public comments received, we are 
modifying this measure for EPs at Sec.  495.6 (k)(4)(ii) to 
``Successful ongoing submission of cancer case information from CEHRT 
to a public health central cancer registry for the entire EHR reporting 
period'' and modify the exclusions to conform with the general criteria 
for public health objectives.
    We further specify that in order to meet this objective and 
measure, an EP

[[Page 54030]]

must use the capabilities and standards of CEHRT 45 CFR 170.314(a), 
(c)(l), (f)(5), and (f)(6).
     Exclusions: Any EP that meets at least 1 of the following 
criteria may be excluded from this objective: (1) The EP does not 
diagnose or directly treat cancer; (2) the EP operates in a 
jurisdiction for which no public health agency is capable of receiving 
electronic cancer case information in the specific standards required 
for CEHRT at the beginning of their EHR reporting period; (3) the EP 
operates in a jurisdiction where no PHA provides information timely on 
capability to receive electronic cancer case information; (4) the EP 
operates in a jurisdiction for which no public health agency that is 
capable of receiving electronic cancer case information in the specific 
standards required for CEHRT at the beginning of their EHR reporting 
period can enroll additional EPs.
    Proposed EP Objective: Capability to identify and report specific 
cases to a specialized registry (other than a cancer registry), except 
where prohibited, and in accordance with applicable law and practice.
    In the proposed rule, we outlined the following benefits of this 
objective. We believe that reporting to registries is an integral part 
of improving population and public health. The benefits of this 
reporting are not limited to cancer reporting. We include cancer 
registry reporting as a separate objective because it is more mature in 
its development than other registry types, not because other reporting 
is excluded from meaningful use. We have included this objective to 
provide more flexibility in the menu objectives that EPs can choose. We 
believe that specialized registry reporting could provide many EPs with 
meaningful use menu option that is more aligned with their scope of 
practice.
    Comment: The overwhelming majority of individuals and groups who 
commented on this objective expressed concern about the lack of 
specificity of this objective. Their concerns include: (1) Lack of 
specificity of the potential types of registries make planning for 
vendors and EPs very difficult; (2) lack of information about who would 
define which registries may be included; (3) leaving dozens or hundreds 
of possibilities; (4) lack of clarity as to the definition of 
'specialized registry; (5) lack of standards for many registries; (6) 
or potential of needing to comply with standards not identified in the 
proposed rule; and (7) lack of public health readiness to accept data 
from EHRs.
    Response: The purpose of this objective and measure is to give 
meaningful use credit to those EPs who are engaged in ongoing 
submission with specialized registries. It is not expected that every 
EP will select this objective and measure from the menu nor even that 
every EP will have the capability to submit to a specialized registry. 
We are purposefully general in our description of specialized registry 
because we do not wish to exclude certain registries in an attempt to 
be more specific. The only limitation we place on our description of 
specialized registries is that the specialized registry cannot be 
duplicative of any of the other registries included in other meaningful 
use objectives and measures. This means that an EP cannot meet the 
immunization, syndromic surveillance or cancer objectives and this 
objective by reporting to the same registry. EPs who either do not wish 
to participate with a specialized registry or cannot overcome the 
barriers to doing so can defer or exclude this measure as their 
situation warrants.
    Comment: Commenters expressed support for expansion of the 
requirement to streamline and improve surveillance of healthcare-
associated infections (HAIs), with the goal of improving patient care 
and safety.
    Response: A registry that is focused on healthcare associated 
infections could certainly be considered a specialized registry.
    After consideration of the public comments received, we are 
finalizing this objective for EPs at Sec.  495.6 (k)(5)(i) as proposed.
    Proposed EP Measure: Successful ongoing submission of specific case 
information from CEHRT to a specialized registry for the entire EHR 
reporting period.
    Comment: Since the lack of specificity and named standards make it 
difficult to select this measure from the menu set, the actual viable 
measures available in the menu set are reduced to four and burdensome 
for providers who may need to pay for interfaces, costing the EPs extra 
time and money above the cost of the CEHRT.
    Response: Stage 2 does contain a more specialized and smaller menu 
set than Stage 1. We see this as a natural result of moving up the 
staged path towards improved outcomes. We also see it as necessary for 
meaningful use to be applicable to all EPs. We include exclusions that 
allow for those providers who do not create reportable data so every 
provider who would is required to report public health data would have 
public health data to report. Furthermore, we added an objective to the 
menu in this final rule for EPs so it is no longer true that an EP 
would be required to pick one of the three menu objectives. The purpose 
of this measure is to provide meaningful use credit to those providers 
engaged in the beneficial use of CEHRT of participating in specialized 
registries. Other EPs can either meet the exclusions or defer this 
objective and thereby avoid the burden of compliance with this 
objective.
    Comment: Given the large number of specialized registries, many of 
which have national scope, the exclusions are rendered meaningless.
    Response: We agree with this comment, and for purposes of the 
exclusion only, we limit it to registries sponsored by national 
specialty societies and specialized registries maintained by PHAs. We 
believe this provides needed limitations on the exclusions. This 
limitation does not apply to the specialized registries that can be 
used to satisfy the measure as the benefits are not limited only to 
reporting to registries operated by Public Health Agencies or national 
medical specialty organizations. Specialized registries operated by 
patient safety organizations and quality improvement organizations also 
enable knowledge generation or process improvement regarding the 
diagnosis, therapy and prevention of various conditions that affect a 
population.
    After consideration of the public comments received, we are 
finalizing this measure for EPs at Sec.  495.6 (k)(5)(ii) as proposed, 
but we modify the exclusions to conform with the general criteria for 
public health objectives and in response to comments.
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT 45 CFR 
170.314(f)(5) and (f)(6).
     Exclusions: Any EP that meets at least 1 of the 
following criteria may be excluded from this objective: (1) The EP does 
not diagnose or directly treat any disease associated with a 
specialized registry sponsored by a national specialty society for 
which the EP is eligible, or the public health agencies in their 
jurisdiction; (2) the EP operates in a jurisdiction for which no 
specialized registry sponsored by a public health agency or by a 
national specialty society for which the EP is eligible is capable of 
receiving electronic specific case information in the specific 
standards required by CEHRT at the beginning of their EHR reporting 
period; (3) the EP operates in a jurisdiction where no public health 
agency or national specialty society for which the EP is eligible 
provides information timely on capability to receive information into 
their specialized registries ; or (4) the EP

[[Page 54031]]

operates in a jurisdiction for which no specialized registry sponsored 
by a public health agency or by a national specialty society for which 
the EP is eligible that is capable of receiving electronic specific 
case information in the specific standards required by CEHRT at the 
beginning of their EHR reporting period can enroll additional EPs.
    Proposed EP Objective: Use secure electronic messaging to 
communicate with patients on relevant health information.
    In the proposed rule, we outlined the following benefits of using 
secure electronic messaging to communicate with patients: Electronic 
messaging (for example, email) is one of the most widespread methods of 
communication for both businesses and individuals. The inability to 
communicate through electronic messaging may hinder the provider-
patient relationship. Electronic messaging is very inexpensive on a 
transactional basis and allows for communication even when the provider 
and patient are not available at the same moment in time. The use of 
common email services and the security measures that may be used when 
they are sent may not be appropriate for the exchange of protected 
health information. Therefore, the exchange of health information 
through electronic messaging requires additional security measures 
while maintaining its ease of use for communication. While email with 
the necessary safeguards is probably the most widely used method of 
electronic messaging, for the purposes of meeting this objective, 
secure electronic messaging could also occur through functionalities of 
patient portals, PHRs, or other stand-alone secure messaging 
applications.
    We proposed this as a core objective for EPs for Stage 2. The 
additional time made available for Stage 2 implementation made possible 
the inclusion of some new objectives in the core set as proposed in the 
proposed rule. We chose to identify objectives that address critical 
priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html), with a 
focus on one for EPs and one for hospitals.
    For EPs, secure electronic messaging is critically important to two 
NQS priorities--
     Ensuring that each person/family is engaged as partners in 
their care; and
     Promoting effective communication and coordination of 
care.
    Secure messaging could make care more affordable by using more 
efficient communication vehicles when appropriate. Specifically, 
research demonstrates that secure messaging has been shown to improve 
patient adherence to treatment plans, which reduces readmission rates. 
Secure messaging has also been shown to increase patient satisfaction 
with their care. Secure messaging has been named as one of the top 
ranked features according to patients. Also, despite some trepidation, 
providers have seen a reduction in time responding to inquires and less 
time spent on the phone. We specifically sought comment on whether 
there may be special concerns with this objective in regards to 
behavioral health.
    Comment: Some commenters noted that patient engagement and enhanced 
patient-provider communications facilitated by an EHR are important 
goals, and secure messaging between EPs and patients is an appropriate 
objective to consider for Meaningful Use criteria.
    Response: We appreciate the commenters support of this objective 
and agree that electronic patient-provider communication is important 
to improving the overall quality of patient care.
    Comment: Some commenters suggested that this objective should be 
part of the menu set instead of a core objective for Stage 2. This 
would permit EPs who do not believe they can meet the measure at this 
time to select different objectives.
    Response: As we noted in the proposed rule, we placed this 
objective in the core because we believe it addresses critical 
priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html): 
Ensuring that each person/family is engaged as partners in their care; 
and promoting effective communication and coordination of care. We also 
believe that secure messaging could make care more affordable by using 
more efficient communication vehicles when appropriate. Specifically, 
research demonstrates that secure messaging has been shown to improve 
patient adherence to treatment plans, which reduces readmission rates 
(see Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008) ``Supporting 
the patient's role in guideline compliance: a controlled study'' 
American Journal of Managed Care 14(11):737-44; Gustafson DH, Hawkins 
R, Boberg E, Pingree S, Serlin RE, Graziano F, Chan CL (1999) ``Impact 
of a patient-centered, computer-based health information/support 
system'' American Journal of Preventive Medicine 16(1):1-9). Secure 
messaging has also been shown to increase patient satisfaction with 
their care (see Ralston JD, Carrell D, Reid R, Anderson M, Moran M, 
Hereford J (2007) ``Patient Web services integrated with a shared 
medical record: patient use and satisfaction'' Journal of the American 
Medical Informatics Association 14(6):798-806). Therefore, we are 
leaving this as a core objective for EPs for Stage 2.
    Comment: Several commenters responded to our question about whether 
there were special concerns about implementing this objective for 
behavioral health patients. These commenters indicated that they did 
not believe this objective posed a special concern and that it would 
help behavioral health patients obtain needed support from clinicians.
    Response: We appreciate the feedback from commenters regarding 
behavioral health.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for EPs at Sec.  495.6(j)(17)(i) as proposed.
    Proposed EP Measure: A secure message was sent using the electronic 
messaging function of CEHRT by more than 10 percent of unique patients 
seen by the EP during the EHR reporting period.
    Comment: Many commenters voiced objections to the measure of this 
objective and the concept of providers being held accountable for 
patient actions. The commenters believed that while providers could be 
held accountable for making electronic messaging capabilities available 
to patients and encouraging patients to use electronic messaging, they 
could not control whether patients actually utilized electronic 
messaging. However, some commenters believed that the measure was a 
reasonable and necessary step to require vendors to make electronic 
messaging tools more widely available and for providers to incorporate 
electronic messaging into clinical practice. In addition, commenters 
pointed to the unique role that providers can play in encouraging and 
facilitating their patients' and their families' use of secure 
messaging.
    Response: While we recognize that EPs cannot directly control 
whether patients use electronic messaging, we continue to believe that 
EPs are in a unique position to strongly influence the technologies 
patients use to improve their own care, including secure electronic 
messaging. We believe that EPs' ability to influence patients coupled 
with the low threshold make this measure achievable for all EPs.
    Comment: Other commenters did not object to the principle of 
providers

[[Page 54032]]

being held accountable for patient actions but noted that the potential 
barriers of limited internet access, computer access, and electronic 
messaging platforms for certain populations (for example, rural, 
elderly, lower income, visually impaired, non-English-speaking, etc.) 
might make the measure impossible to meet for some providers. 
Commenters suggested a number of possible solutions to allow providers 
to overcome these barriers: granting exclusions for certain patient 
populations, lowering the proposed threshold of the measure, or 
eliminating the percentage threshold of the measure.
    Response: We recognize that certain patient populations face 
greater challenges in utilizing electronic messaging. We address the 
potential barrier of limited internet access in the comment regarding a 
broadband exclusion below. While we agree that excluding certain 
patient populations from this requirement would make the measure easier 
for EPs to achieve, we do not know of any reliable method to quantify 
these populations for each EP in such a way that we could standardize 
exclusions for each population. In addition, we are concerned that 
blanket exclusions for certain disadvantaged populations could serve to 
extend existing disparities in electronic access to health information. 
We also decline to eliminate the percentage threshold of this measure 
because we do not believe that a simple yes/no attestation for 
implementation of electronic messaging is adequate to encourage a 
minimum level of patient usage. However, in considering the potential 
barriers faced by these patient populations, we agree that it would be 
appropriate to lower the proposed threshold of this measure to more 
than 5 percent of unique patients sending an electronic message. We 
believe that this lower threshold, combined with the broadband 
exclusion detailed in the response below, will allow all EPs to meet 
the measure of this objective.
    Comment: Several commenters suggested that the exclusion for FCC-
recognized areas with under 50 percent broadband availability, which 
was proposed in the objective to ``Provide patients the ability to view 
online, download, and transmit their health information,'' should be 
extended to the electronic messaging objective.
    Response: We agree that the infrastructure required for electronic 
messaging is similar to the infrastructure required for successful 
usage of an online patient portal as described in the objective to 
``Provide patients the ability to view online, download, and transmit 
their health information.'' Therefore, we believe an exclusion to this 
measure based on the availability of broadband is appropriate and are 
finalizing the exclusion in the language below. We note that since 
publication of our proposed rule the Web site has changed to 
www.broadbandmap.gov and the speed used has changed from 4Mbps to 
3Mbps. We updated our exclusion.
    Comment: Some commenters expressed concern about including all 
patients seen by the EP in the denominator and suggested limiting the 
denominator instead to patients who have indicated secure electronic 
messaging as their communication preference. Other commenters suggested 
the denominator should not be limited to patients seen by the EP and 
should also include patients who make inquiries or who attempt to make 
an appointment with the EP during the reporting period.
    Response: We do not agree that limiting the denominator to patients 
who have indicated secure electronic messaging as their communication 
preference is appropriate. The purpose of the measure is for EPs to 
promote wider use of electronic messaging as a regular communication 
vehicle for their patients, and we are concerned that limiting the 
denominator in the manner suggested would not lead to an increase in 
the promotion or usage of electronic messaging as an important 
communication vehicle between patients and providers. We also do not 
agree that expanding the denominator to patients not seen by the EP 
during the reporting period is appropriate. Another purpose of the 
measure is for secure messaging to include clinically relevant 
information, and we do not believe that patients seeking introductory 
information or making an appointment are likely to include clinically 
relevant information in secure messaging.
    Comment: Some commenters noted that patients whose only office 
visit with an EP occurs near the end of the reporting period might not 
be able to send an electronic message in time to be included in the 
numerator of the measure.
    Response: While we agree that patients with a single office visit 
near the end of the reporting period may not utilize electronic 
messaging and be eligible for inclusion in the numerator of the measure 
during the EHR reporting period, we believe that the threshold of this 
measure will be sufficiently low to permit EPs to meet the measure even 
without the participation of these patients.
    Comment: Several commenters requested clarification on the 
definition of a secure message.
    Response: We define a secure message as any electronic 
communication between a provider and patient that ensures only those 
parties can access the communication. This electronic message could be 
email or the electronic messaging function of a PHR, an online patient 
portal, or any other electronic means. However, we note that the secure 
message also must use the electronic messaging function of CEHRT in 
order to qualify for the measure of this objective.
    Comment: Some commenters suggested that EPs or patients should be 
permitted to use an electronic messaging function that is not part of 
CEHRT in order to meet the measure.
    Response: We believe that allowing patients to use multiple 
electronic messaging functions in order to communicate with the 
provider under this measure could create confusion for the EP and 
potentially lead to electronic messages that are missed or not 
responded to. We also believe that by encouraging patients to use the 
electronic messaging function that is part of CEHRT EPs can better 
ensure that electronic messages are sent securely to protect patient's 
health information. Finally, we are concerned that CEHRT would not be 
able to track electronic messaging that is not part of the EHR, which 
would place an extra burden for reporting on EPs in meeting this 
measure. For all of these reasons, we require that patients use the 
electronic messaging function that is part of CEHRT in order to be 
included in the measure of this objective.
    Comment: Commenters agreed with our decision not to include in the 
definition for this measure ``relevant health information.'' Commenters 
did not believe CEHRT could support the categorization of electronic 
messages in a way that would satisfy such a requirement.
    Response: We appreciate the support offered by commenters. As we 
stated in the proposed rule, the secure messages sent should contain 
relevant health information specific to the patient in order to meet 
the measure of this objective. We believe the EP is the best judge of 
what health information should be considered relevant in this context. 
We do not specifically include the term ``relevant health information'' 
in the measure because we believe the provider is best equipped to 
determine whether such information is included. We agree that it would 
be too great a burden for CEHRT to determine whether

[[Page 54033]]

the information in the secure message has such information.
    Comment: Some commenters expressed concerns that we did not propose 
to measure provider response to patient electronic messaging. These 
commenters believed that the proposed measure places too much focus on 
patient messaging and should instead focus on communication between 
patient and provider. Some commenters suggested that the measure be 
modified for responsiveness of an EP or staff to patient messaging 
rather than the proposed percentage of patients who send a secure 
message.
    Response: As we stated in the proposed rule, there is an 
expectation that the EP would respond to electronic messages sent by 
the patient, although we do not specify the method of response or 
require the EP to document his or her response for this measure. We 
decline to specify the method of provider response because we believe 
it is best left to the provider's clinical judgment to decide the 
course of action which should be taken in response to the patient's 
electronic message. An EP or staff member could decide that a follow-up 
telephone call or office visit is more appropriate to address the 
concerns raised in the electronic message. Therefore, we decline to 
alter the measure to include provider response.
    Comment: Commenters asked for clarification as to whether the EP 
had to respond personally to electronic messaging or whether members of 
the EP's staff could respond. Commenters also asked for clarification 
regarding whether or not messages sent by a patient-authorized 
representative would be recorded in this measure.
    Response: There is not an expectation that the EP must personally 
respond to electronic messages to the patient. Just as an EP's staff 
respond to telephone inquiries or conduct office visits on behalf of 
the EP, staff could also respond to electronic messages from the 
patient. We also intend for electronic messages sent by a patient-
authorized representative to be included in the measure of this 
objective and have modified the language of the measure below 
accordingly.
    Comment: Some commenters raised concerns regarding the security of 
electronic messaging, specifically citing instances where family 
members might have access to the patient's account or elderly patients 
who would not know how to use a computer and would have to give account 
access to a caregiver. Other commenters raised concerns regarding their 
liability in providing access to such information or in responding to 
an electronic message.
    Response: We do not believe that secure electronic messaging poses 
greater risks to exposure of protected health information than other 
mediums such as telephone messaging, paper records, etc. In some cases 
secure electronic messaging can provide even greater protection of 
health information. We note that many patients grant access to health 
information to family members and caregivers to facilitate care, and we 
expect the same access to continue with secure electronic messaging. 
Nor do we believe that secure electronic messaging exposes providers to 
greater liability (for example, in areas of privacy protection or 
malpractice) than other mediums such as telephone, mail, paper records, 
etc. Previous research has demonstrated that better patient-provider 
communication reduces the likelihood of malpractice claims being filed.
    Comment: Some commenters noted that the potential financial burden 
of implementing securing messaging as a part of their clinical or 
administrative workflow. These commenters noted that EPs are not 
reimbursed for the time spent responding to electronic messages and 
that it can be time consuming for an EP to have multiple exchanges with 
a patient via email.
    Response: We do not believe that implementing electronic messaging 
imposes a significant burden on providers. While we note that in some 
scenarios it may be possible for an EP to receive reimbursement from 
private insurance payers for online messaging, we acknowledge that EPs 
are generally not reimbursed for time spent responding to electronic 
messaging. However, it is also true that EPs are generally not 
reimbursed for other widely used methods of communication with patients 
(for example, telephone). As we noted in the proposed rule, many 
providers have seen a reduction in time responding to inquires and less 
time spent on the phone through the use of electronic messaging. In 
addition, we note that EPs themselves do not have to respond to 
electronic messages personally and can delegate this task to staff, 
just as many EPs currently delegate telephone exchanges with patients 
to staff.
    After consideration of the public comments, we are finalizing the 
meaningful use measure for EPs as ``A secure message was sent using the 
electronic messaging function of CEHRT by more than 5 percent of unique 
patients (or their authorized representatives) seen by the EP during 
the EHR reporting period'' at Sec.  495.6(j)(17)(ii) and the exclusion 
for EPs as ``Any EP who has no office visits during the EHR reporting 
period, or any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 3Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period'' at Sec.  495.6(j)(17)(iii).
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(e)(3).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of unique patients seen by 
the EP during the EHR reporting period.
     Numerator: The number of patients or patient-authorized 
representatives in the denominator who send a secure electronic message 
to the EP that is received using the electronic messaging function of 
CEHRT during the EHR reporting period.
     Threshold: The resulting percentage must be more than 5 
percent in order for an EP to meet this measure.
     Exclusion: Any EP who has no office visits during the EHR 
reporting period, or any EP who conducts 50 percent or more of his or 
her patient encounters in a county that does not have 50 percent or 
more of its housing units with 3Mbps broadband availability according 
to the latest information available from the FCC on the first day of 
the EHR reporting period.
    Proposed Eligible Hospital/CAH Objective: Automatically track 
medications from order to administration using assistive technologies 
in conjunction with an electronic medication administration record 
(eMAR).
    In the proposed rule, we outlined the following benefits of 
automatically tracking medications with eMAR: eMAR increases the 
accuracy of medication administration thereby increasing both patient 
safety and efficiency. The HIT Policy Committee has recommended the 
inclusion of this objective for hospitals in Stage 2, and we proposed 
this as a core objective for eligible hospitals and CAHs. The 
additional time made available for Stage 2 implementation makes 
possible the inclusion of some new objectives in the core set. eMAR is 
critically important to making care safer by reducing medication errors 
which may make care more affordable. eMAR has been shown to lead to 
significant improvements in medication-related adverse events within 
hospitals with associated decreases in cost. eMAR cuts

[[Page 54034]]

in half the adverse drug event (ADE) rates for non-timing medication 
errors, according to a study published in the New England Journal of 
Medicine (Poon et al., 2010, Effect of Bar-Code Technology on the 
Safety of Medication Administration http://www.nejm.org/doi/abs/10.1056/NEJMsa0907115?query=NC). A study done to evaluate cost-benefit 
of eMAR (Maviglia et al., 2007, Cost-Benefit Analysis of a Hospital 
Pharmacy Bar Code Solution http://archinte.ama-assn.org/cgi/content/full/167/8/788) demonstrated that associated ADE cost savings allowed 
hospitals to break even after 1 year and begin reaping cost savings 
going forward.
    We proposed to define eMAR as technology that automatically 
documents the administration of medication into CEHRT using electronic 
tracking sensors (for example, radio frequency identification (RFID)) 
or electronically readable tagging such as bar coding). The specific 
characteristics of eMAR for the EHR Incentive Programs will be further 
described in the ONC standards and certification criteria final rule 
published elsewhere in this issue of the Federal Register.
    By its very definition, eMAR occurs at the point of care so we did 
not propose additional qualifications on when it must be used or who 
must use it.
    Comment: Some commenters suggested that this should be a menu 
objective for Stage 2.
    Response: As we stated in the proposed rule, we believe that eMAR 
is critically important to making care safer by reducing medication 
errors which may also make care more affordable. eMAR has been shown to 
lead to significant improvements in medication-related adverse events 
within hospitals with associated decreases in cost. Therefore, we 
believe that the benefits to patient safety from eMAR warrant the 
inclusion of this as a Stage 2 core objective for eligible hospitals 
and CAHs.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for eligible hospitals and CAHs at Sec.  
495.6(l)(16)(i) as proposed.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of 
medication orders created by authorized providers of the eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period are tracked using eMAR.
    Comment: A number of commenters questioned whether the measure 
should apply to at least one instance of the administration of a dose 
connected with a medication order or whether each individual dose 
connected with a medication order should be included in the measure. 
Some commenters believed that a single instance of administration of a 
dose should constitute fulfillment of the measure, while others 
believed that all doses administered rather than orders administered 
would be a more precise and meaningful measurement.
    Response: We believe that including each individual dose connected 
with a medication order through this measure could yield denominators 
that are very large. However, we believe that the benefits to patient 
safety from eMAR are seen when all doses of a medication order are 
tracked. Therefore, we clarify that we include in the numerator of this 
objective medication orders for which all doses are tracked using eMAR, 
and we are amending the measure language below to reflect this 
clarification. If a medication is ordered but not all doses of the 
medication are tracked using eMAR, then that order may not be included 
in the numerator of the measure.
    Comment: Some commenters raised the concern that certain rural and 
low volume hospitals might face undue financial burden in implementing 
this objective and proposed an exclusion for hospitals with either a 
limited number of inpatient beds or a low average inpatient volume. 
Some commenters suggested there should be an exclusion for very small 
hospitals for whom eMAR could be a prohibitively expensive undertaking. 
Other commenters noted that the difficulties in implementing eMAR were 
outweighed by the significant benefits to patient safety.
    Response: We agree with commenters who suggested that the potential 
benefits to patient safety of eMAR are significant. While we agree that 
certain hospitals may face challenges in implementing eMAR on a wider 
scale, we believe that the low threshold for this measure lessens the 
burden associated with implementation of eMAR for most rural and low 
volume hospitals. We also note that CEHRT will include eMAR 
capabilities, so the primary barrier to implementation for most 
hospitals will be workflow.
    However, we are also concerned that very small hospitals may have 
local technical support and training issues that may make an automated 
eMAR solution actually less effective than other approaches. We also 
believe that very small hospitals will have fewer health care 
professionals involved in the process of medication administration and 
fewer patients for whom duplicative orders could present an issue, 
which would also make an eMAR solution less effective. Therefore, we 
believe these hospitals would not benefit from eMAR as much as larger 
facilities and are finalizing an exclusion for these hospitals. Any 
hospital with an average daily inpatient census of fewer than 10 
patients may be excluded from meeting the measure of this objective. 
For purposes of this exclusion, we define an average daily inpatient 
census as the total number of patients admitted during the previous 
calendar year divided by 365 (or 366 if the previous calendar year is a 
leap year).
    Comment: Some commenters stated that the percentage threshold of 
this measure should be replaced with the implementation of eMAR in one 
ward or unit of the hospital to limit burdensome measurement 
requirements. Other commenters argued that changing the measure to one 
ward or unit of the hospital would introduce ambiguity regarding what 
constitutes a ward or unit, while a percentage threshold would allow 
hospitals the flexibility to implement eMAR capabilities on a limited 
basis.
    Response: We believe that the low threshold of this objective does 
not impose burdensome measurement requirements on hospitals, especially 
since we do not anticipate a significant difference in the way CEHRT 
will measure eMAR usage regardless of where it is implemented. We agree 
that limiting the measure to implementation in a single ward or unit 
could introduce ambiguity regarding the precise definition of ward or 
unit, especially since some hospitals combine the locations and 
workflows of certain units. We further note that the percentage 
threshold does allow hospitals to implement eMAR in a limited capacity, 
and that a hospital could potentially meet the low measure of this 
objective by implementing in a single ward or unit or by implementing 
in several smaller wards or units that combine to yield more than 10 
percent of medication orders created during the EHR reporting period. 
We believe the percentage measure of this objective yields maximum 
flexibility for a hospital to implement eMAR in a way that is 
clinically relevant to its individual workflow.
    Comment: Some commenters requested clarification on whether eMAR 
could be implemented solely in portions of an inpatient department or 
solely in portions of an emergency department in order to meet the 
measure, as opposed to implementing eMAR in both the inpatient and 
emergency departments.

[[Page 54035]]

    Response: As stated previously, we have attempted to provide 
maximum flexibility for a hospital to implement eMAR in a way that is 
clinically relevant to its individual workflow. Therefore, we do not 
require that eMAR is implemented in both inpatient and emergency 
departments in order to meet this measure, only that more than 10 
percent of medication orders created by authorized providers of either 
the inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are tracked using eMAR. Hospitals could implement eMAR 
in the inpatient department, the emergency department, or both 
departments in order to meet the threshold of this measure.
    After consideration of the public comments, we modify the 
meaningful use measure as ``More than 10 percent of medication orders 
created by authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period for which all doses are tracked using eMAR'' for 
eligible hospitals and CAHs at Sec.  495.6(l)(16)(ii) and finalize the 
exclusion as ``Any eligible hospital or CAH with an average daily 
inpatient census of fewer than 10 patients'' at Sec.  
495.6(l)(16)(iii).
    We further specify that in order to meet this objective and 
measure, an eligible hospital or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(16).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of medication orders created 
by authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the 
denominator for which all doses are tracked using eMAR.
     Threshold: The resulting percentage must be more 
than 10 percent in order for an eligible hospital or CAH to meet this 
measure.
     Exclusion: Any hospital with an average daily 
inpatient census of fewer than ten (10) patients.
    Proposed Eligible Hospital/CAH Objective: Generate and transmit 
permissible discharge prescriptions electronically (eRx)
    In the proposed rule, we outlined the following benefits of 
electronic prescribing: The use of electronic prescribing has several 
advantages over having the patient carry the prescription to the 
pharmacy or directly faxing a handwritten or typewritten prescription 
to the pharmacy. When the hospital generates the prescription 
electronically, CEHRT can recognize the information and can provide 
decision support to promote safety and quality in the form of adverse 
interactions and other treatment possibilities. The CEHRT can also 
provide decision support that promotes the efficiency of the health 
care system by alerting the EP to generic alternatives or to 
alternatives favored by the patient's insurance plan that are equally 
effective. Transmitting the prescription electronically promotes 
efficiency and safety through reduced communication errors. It also 
allows the pharmacy or a third party to automatically compare the 
medication order to others they have received for the patient. This 
comparison allows for many of the same decision support functions 
enabled at the generation of the prescription, but bases them on 
potentially greater information.
    We have combined the comments and responses for this objective with 
the measure below. After consideration of the public comments, we are 
finalizing the meaningful use objective for eligible hospitals and CAHs 
at Sec.  495.6(m)(4)(i) as proposed.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of 
hospital discharge medication orders for permissible prescriptions (for 
new or changed prescriptions) are compared to at least one drug 
formulary and transmitted electronically using CEHRT.
    Comment: Most commenters voiced support for this as a menu set 
item, with some commenters noting that the threshold for this measure 
should remain low for Stage 2 because of the difficulty of using 
electronic prescribing for all prescriptions, including controlled 
substances.
    Response: We appreciate the support for this objective, and we note 
that the measure of the objective for eligible hospitals and CAHs for 
Stage 2 is set at more than 10 percent of all discharge medication 
orders for permissible prescriptions. We believe this sets a 
sufficiently low threshold that would allow most hospitals to achieve 
this measure and eliminates the inclusion of controlled substances, 
which are not included as permissible prescriptions for the purposes of 
this measure.
    Comment: Most commenters noted that distinguishing new and altered 
prescriptions from refills would be unnecessarily burdensome for 
hospitals.
    Response: Although we had initially proposed to limit this measure 
to only new and altered prescriptions because we believed that 
hospitals would not issue refill prescriptions, we agree with the 
commenters that distinguishing refills from new and altered 
prescriptions could be unnecessarily burdensome for hospitals. 
Therefore, we are not imposing this limitation and include new, 
altered, and refill prescriptions in the measure of discharge 
medication orders for permissible prescriptions.
    Comment: Some commenters expressed concerns about patient requests 
for paper prescriptions instead of electronic prescriptions.
    Response: We believe that the more than 10 percent of discharge 
medication orders threshold is sufficiently low to accommodate patient 
requests for paper prescriptions and still allow most, if not all, 
hospitals to meet the measure of this objective.
    Comment: Some commenters asked whether prescriptions electronically 
transmitted to in-house pharmacies should be included in the measure 
and if the standards specified by ONC for this measure would apply to 
these transmissions.
    Response: We are continuing the policy from Stage 1 that 
prescriptions transmitted electronically within an organization (the 
same legal entity) would be counted in the measure and would not need 
to use the standards specified by ONC for this objective. However, a 
hospital's CEHRT must meet all applicable certification criteria and be 
certified as having the capability of meeting external transmission 
requirements. In addition, the EHR that is used to transmit 
prescriptions within the organization would need to be CEHRT.
    The hospital would include in the numerator and denominator both 
types of electronic transmission (those within and outside the 
organization) for the measure of this objective. We further clarify 
that for purposes of counting discharge prescriptions ``generated and 
transmitted electronically,'' we considered the generation and 
transmission of prescriptions to occur simultaneously if the prescriber 
and dispenser are the same person and/or are accessing the same record 
in an integrated EHR to create an order in a system that is 
electronically transmitted to an internal pharmacy.
    Comment: Some commenters asked for clarification regarding whether 
drug-formulary checks had to be enabled for the entire EHR reporting 
period, as required by the Stage 1 measure.
    Response: No. The Stage 1 objective for drug-formulary checks has 
been combined with this Stage 2 objective for generating and 
transmitting permissible discharge prescriptions electronically. 
Although the measure of the Stage 1 objective required the capability 
for

[[Page 54036]]

drug-formulary checks to be enabled for the entire reporting period, 
the measure of the Stage 2 objective specifies drug-formulary checks 
should be performed for more than 10 percent of hospital discharge 
medication orders for permissible prescriptions. We recognize that not 
every patient will have a formulary that is relevant for him or her. 
Therefore, we require not that the EHR check each prescription against 
a formulary relevant for a given patient, but rather that the EHR check 
each prescription for the existence of a relevant formulary. If a 
relevant formulary is available, then the information can be provided. 
We believe that this initial check is essentially an on or off function 
for the EHR and should not add to the measurement burden. Therefore, 
with this clarification of the check we are referring to, we are 
finalizing the drug formulary check as a component of this measure. We 
look forward to the day when a relevant formulary is available for 
every patient. We modified the measure to use the word query instead of 
compare.
    Comment: Some commenters asked whether the measure of this 
objective applied to inpatient departments, emergency departments, or 
both.
    Response: We specify that the measure of this objective applies to 
medication orders for patients discharged from either the inpatient 
(POS 21) department, the emergency department, or both the inpatient 
and emergency departments of an eligible hospital or CAH during the EHR 
reporting period.
    Comment: One commenter asked for clarification of whether a patient 
for whom no relevant drug formularies are available could be counted in 
the numerator of the measure if the discharge prescription for that 
patient is generated and transmitted electronically. Another commenter 
suggested that patients for whom no relevant formularies are available 
should not be counted in the measure.
    Response: As noted in the proposed rule, we believe that the 
inclusion of the comparison to at least one drug formulary enhances the 
efficiency of the healthcare system when clinically appropriate and 
cheaper alternatives may be available. In the event that a relevant 
formulary is unavailable for a particular patient and medication 
combination, a discharge prescription that is generated and 
electronically transmitted should still be included in the numerator of 
the measure. We do not agree that prescriptions for patients for whom 
relevant formularies are unavailable should be excluded from this 
measure.
    Comment: Several commenters believed that the exclusion based on 
the availability of a pharmacy capable of receiving electronic 
prescriptions within 25 miles of the hospital's location was not 
adequate for all areas, particularly rural areas. Some commenters 
suggested that 10 miles is a more appropriate distance.
    Response: We appreciate the commenters' concerns about this 
exclusion. As stated in the proposed rule, we recognize that certain 
areas may not have widespread availability of electronic prescribing in 
all pharmacies, we believe that most hospitals will be able to fulfill 
electronic prescriptions through an internal pharmacy. However, we 
agree with commenters that basing the exclusion on a 25-mile radius 
could place a significant burden on patients to travel to fill 
prescriptions, especially in rural areas. Therefore, we are finalizing 
a 10-mile radius at the start of the EHR reporting period. Hospitals 
that do not have an internal pharmacy and that are located 10 miles 
from a pharmacy that can receive electronic prescriptions at the start 
of the EHR reporting period would be able to claim the exclusion for 
this measure. We also believe that the low threshold of more than 10 
percent of discharge prescriptions transmitted electronically would 
make it possible for all hospitals to meet this measure.
    Comment: Some commenters requested for clarification of whether 
CEHRT would provide the capability to determine the availability of a 
pharmacy capable of receiving electronic prescriptions within 25 miles 
of the hospital's location.
    Response: CEHRT will not provide the capability to determine 
whether a hospital meets the exclusion for this measure. As stated in 
the previous response, we are finalizing the exclusion for the 
availability of a pharmacy capable of receiving electronic 
prescriptions within 10 miles of the hospital's location. Therefore, 
eligible hospitals and CAHs may use their own resources to make a 
determination regarding the availability of a pharmacy capable of 
receiving electronic prescriptions within 10 miles of the hospital's 
location.
    After consideration of the public comments, we modify the 
meaningful use measure for eligible hospitals and CAHs as ``More than 
10 percent of hospital discharge medication orders for permissible 
prescriptions (for new, changed, and refilled prescriptions) are 
queried for a drug formulary and transmitted electronically using 
CEHRT'' at Sec.  495.6(m)(4)(ii) and we modify the exclusion for 
eligible hospitals and CAHs at Sec.  495.6(m)(4)(iii) by changing the 
radius from 25 miles to 10 miles.
    We further specify that in order to meet this objective and 
measure, an eligible hospital or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(10) and (b)(3).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Denominator: Number of new, changed, or refill 
prescriptions written for drugs requiring a prescription in order to be 
dispensed other than controlled substances for patients discharged 
during the EHR reporting period.
     Numerator: The number of prescriptions in the 
denominator generated, queried for a drug formulary and transmitted 
electronically.
     Threshold: The resulting percentage must be more 
than 10 percent in order for an eligible hospital or CAH to meet this 
measure.
     Exclusion: Any eligible hospital or CAH that 
does not have an internal pharmacy that can accept electronic 
prescriptions and is not located within 10 miles of any pharmacy that 
accepts electronic prescriptions at the start of their EHR reporting 
period.
    Proposed Eligible Hospital/CAH Objective: Provide patients the 
ability to view online, download, and transmit information about a 
hospital admission.
    In the proposed rule, we noted that studies have found that 
patients engaged with computer based information sources and decision 
support show improvement in quality of life indicators, patient 
satisfaction and health outcomes. (Ralston, Carrell, Reid, Anderson, 
Moran, & Hereford, 2007) (Gustafson, Hawkins, Bober, S, Graziano, & CL, 
1999) (Riggio, Sorokin, Moxey, Mather, Gould, & Kane, 2009) (Gustafson, 
et al., 2001). In addition, we noted that this objective aligns with 
the FIPPs,\5\ in affording baseline privacy protections to individuals. 
We stated that we believe this information is integral to the 
Partnership for Patents initiative and reducing hospital readmissions. 
While this objective does not require all of the information sources 
and decision support used in these studies, having a set of basic 
information available advances these initiatives. The ability to have 
this information online means it is always retrievable by the patient, 
while the download function ensures that the patient can take the 
information with them when secure internet access is not

[[Page 54037]]

available. However, providers should be aware that while meaningful use 
is limited to the capabilities of CEHRT to provide online access, there 
may be patients who cannot access their EHRs electronically because of 
their disability. Additionally, other health information may not be 
accessible. Finally, we noted that providers who are covered by civil 
rights laws must provide individuals with disabilities equal access to 
information and appropriate auxiliary aids and services as provided in 
the applicable statutes and regulations.
---------------------------------------------------------------------------

    \5\ Ibid.
---------------------------------------------------------------------------

    We proposed this as a core objective for hospitals for Stage 2. We 
also specified in the proposed rule the information that must be made 
available as part of the objective, although we noted hospitals could 
choose to provide additional information (77 FR 13730).
    Comment: Some commenters suggested that this objective should be 
part of the menu set instead of a core objective for Stage 2. This 
would permit eligible hospitals and CAHs that do not believe they can 
meet the measure at this time to select different objectives.
    Response: We do not agree that this objective should be part of the 
menu set. We proposed this objective as part of the core for eligible 
hospitals and CAHs because it is intended to replace the previous Stage 
1 core objective of ``Provide patients with an electronic copy of their 
health information upon request'' and the Stage 1 core objective of 
``Provide patients with an electronic copy of their discharge 
information.'' Although CEHRT will provide added capabilities for this 
objective, we do not believe the objective itself is sufficiently 
different from previous objectives to justify placing it in the menu 
set. Also, we believe that patient access to their discharge 
information is a high priority for the EHR Incentive Programs and this 
objective best provides that access in a timely manner.
    Comment: Some commenters expressed the opinion that this objective 
should not be included as part of meaningful use and was more 
appropriately regulated under HIPAA and through the Office for Civil 
Rights.
    Response: We do not agree that this objective should not be 
included in meaningful use. Although we recognize that many issues 
concerning the privacy and security of information online are subject 
to HIPAA requirements, we believe that establishing an objective to 
provide online access to health information is within the regulatory 
purview of the EHR Incentive Programs and consistent with the statutory 
requirements of meaningful use.
    After consideration of the public comments, we are finalizing the 
meaningful use objective for eligible hospitals and CAHs at Sec.  
495.6(l)(8)(i) as proposed.
    Proposed Eligible Hospital/CAH Measure: There are 2 measures for 
this objective, both of which must be satisfied in order to meet the 
objective.
    More than 50 percent of all patients who are discharged from the 
inpatient or emergency department (POS 21 or 23) of an eligible 
hospital or CAH have their information available online within 36 hours 
of discharge.
    More than 10 percent of all patients who are discharged from the 
inpatient or emergency department (POS 21 or 23) of an eligible 
hospital or CAH view, download or transmit to a third party their 
information during the EHR reporting period.
    Comment: A commenter questioned how long data should be made 
available online before it can be removed.
    Response: It is the goal of this objective to make available to the 
patient both current and historical health information regarding 
hospital discharges. Therefore, we would anticipate that the data 
should be available online on an ongoing basis. However, an eligible 
hospital or CAH may withhold or remove information from online access 
for purposes of meaningful use if they believe substantial harm may 
arise from its disclosure online.
    Comment: Some commenters asked for clarification on whether online 
access had to be made available using CEHRT or if the information could 
be made available through other means (patient portal, PHR, etc.).
    Response: Both of the measures for this objective must be met using 
CEHRT. Therefore, for the purposes of meeting this objective, the 
capabilities provided by a patient portal, PHR, or any other means of 
online access and that would permit a patient or authorized 
representative to view, download, or transmit their personal health 
information would have to be certified in accordance with the 
certification requirements adopted by ONC. We refer readers to ONC's 
standards and certification criteria final rule that is published 
elsewhere in this issue of the Federal Register.
    Comment: Some commenters asked for clarification on how access by 
the patient is defined.
    Response: We define access as having been given when the patient 
possesses all of the necessary information needed to view, download, or 
transmit their discharge information. This could include providing 
patients with instructions on how to access their health information, 
the Web site address they must visit for online access, a unique and 
registered username or password, instructions on how to create a login, 
or any other instructions, tools, or materials that patients need in 
order to view, download, or transmit their discharge information.
    Comment: Some commenters suggested that patients under the age of 
18 should not have the same access to the same information to which 
adult patients have access and requested a separate list of required 
elements for patients under the age of 18.
    Response: An eligible hospital or CAH may decide that online access 
is not the appropriate forum for certain health information for 
patients under the age of 18. Within the confines of the laws governing 
guardian access to medical records for patients under the age of 18, we 
would defer to the eligible hospital's or CAH's judgment regarding 
which information should be withheld for such patients. In lieu of 
providing online access to patients under the age of 18, eligible 
hospitals or CAHs could provide online access to guardians for patients 
under the age of 18, in accordance with state and local laws, in order 
to meet the measure of this objective. Providing online access to 
guardians in accordance to state and local laws would be treated the 
same as access for patients, and guardians could then be counted in the 
numerator of the measure. We recognize that state and local laws may 
restrict the information that can be made available to guardians, and 
in these cases such information can be withheld and the patient could 
still be counted in the numerator of the measure.
    Comment: Many commenters voiced objections to the second measure of 
this objective and the concept of providers being held accountable for 
patient actions. The commenters believed that while providers could be 
held accountable for making information available online to patients, 
providers could not control whether patients actually accessed their 
information. Many commenters also noted that the potential barriers of 
limited internet access, computer access, and patient engagement with 
health IT for certain populations (for example, rural, elderly, lower 
income, non-English-speaking, etc.) might make the measure impossible 
to meet for some providers. There were also a number of comments 
stating that metrics used to track views or downloads can be misleading 
and are not necessarily the most accurate measure of patient usage. 
Commenters suggested a number of possible solutions to allow providers 
to overcome these barriers, including

[[Page 54038]]

eliminating the percentage threshold of the measure or requiring 
providers to offer and track patient access but not requiring them to 
meet a percentage measure in order to demonstrate meaningful use. 
However, some commenters believed that the measure was a reasonable and 
necessary step to ensure that providers had accountability for 
engagement of their patients in use of electronic health information 
and integration of it into clinical practice. In addition, commenters 
pointed to the unique role that providers can play in encouraging and 
facilitating their patients' and their families' use of online tools.
    Response: While we recognize that eligible hospitals and CAHs 
cannot directly control whether patients access their health 
information online, we continue to believe that eligible hospitals and 
CAHs are in a unique position to strongly influence the technologies 
patients use to improve their own care, including viewing, downloading, 
and transmitting their health information online. We believe that the 
eligible hospital's or CAH's ability to influence patients coupled with 
the low threshold of more than 10 percent of patients who view online, 
download, or transmit to a third party their information make this 
measure achievable for all eligible hospitals and CAHs.
    We recognize that certain patient populations face greater 
challenges in online access to information. We address the potential 
barrier of limited internet access in the comment regarding a broadband 
exclusion below. We address the potential barrier to individuals with 
disabilities through ONC's rules requiring that EHRs meet disability 
accessibility standards. While we agree that excluding certain patient 
populations from this requirement would make the measure easier for 
eligible hospitals and CAHs to achieve, we do not know of any reliable 
method to quantify these populations for each eligible hospital and CAH 
in such a way that we could standardize exclusions for each population. 
We also decline to eliminate the percentage threshold of this measure 
because we do not believe that a simple yes/no attestation for this 
objective is adequate to encourage a minimum level of patient usage. 
However, in considering the potential barriers faced by these patient 
populations, we agree that it would be appropriate to lower the 
proposed threshold of this measure to more than 5 percent of unique 
patients who view online, download, or transmit to a third party their 
information. In addition, we are concerned that blanket exclusions for 
certain disadvantaged populations could serve to extend existing 
disparities in electronic access to information and violate civil 
rights laws. All entities receiving funds under this program are 
subject to civil rights laws. For more information about these laws and 
their requirements (see  http://www.hhs.gov/ocr/civilrights/index.html). We believe that this lower threshold, combined with the 
broadband exclusion detailed in the response later in this section, 
will allow all eligible hospitals and CAHs to meet the measure of this 
objective.
    Comment: Some commenters suggested making the numerator and 
denominator language for this measure consistent with the language used 
for this measure for EPs.
    Response: We agree that there are some slight variations in 
language between the measure for EPs and the measure for hospitals. To 
the extent possible, we have harmonized the language between both.
    Comment: Some commenters asked for clarification on how view is 
defined.
    Response: We define view as the patient (or authorized 
representative) accessing their health information online.
    Comment: Some commenters noted that the potential financial burden 
of implementing an online patient portal to provide patients online 
access to discharge information. These commenters noted the added time 
burden for staff in handling the additional patient use of online 
resources, which may increase costs through the hiring of additional 
staff, as well as the need to modify their existing workflow to 
accommodate potential online messages from patients. Some commenters 
also believed that there would be an additional cost for sharing 
content before standards exist for content types and formats.
    Response: As noted in the proposed rule, studies have found that 
patients engaged with computer based information sources and decision 
support show improvement in quality of life indicators, patient 
satisfaction and health outcomes (see Rosenberg SN, Shnaiden TL, Wegh 
AA, Juster IA (2008) ``Supporting the patient's role in guideline 
compliance: a controlled study'' American Journal of Managed Care 
14(11):737-44; Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE, 
Graziano F, Chan CL (1999) ``Impact of a patient-centered, computer-
based health information/support system'' American Journal of 
Preventive Medicine 16(1):1-9; Ralston JD, Carrell D, Reid R, Anderson 
M, Moran M, Hereford J (2007) ``Patient web services integrated with a 
shared medical record: patient use and satisfaction'' Journal of the 
American Medical Informatics Association 14(6):798-806). We believe 
that the information provided as part of this measure is integral to 
the Partnership for Patents initiative and reducing hospital 
readmissions. We do not believe that implementing online access for 
patients imposes a significant burden, financial or otherwise, on 
providers. While we note that in some scenarios it may be possible for 
an eligible hospital or CAH to receive reimbursement from private 
insurance payers for online messaging, we acknowledge that eligible 
hospitals and CAHs are generally not reimbursed for time spent 
responding to electronic messaging. However, it is also true that 
eligible hospitals and CAHs are generally not reimbursed for other 
widely used methods of communication with patients (for example, 
telephone). In addition, it will be part of the capability of CEHRT to 
automatically populate most of the list of required elements to meet 
this measure, which significantly reduces the administrative burden of 
providing this information. Finally, we believe that the standards 
established for this objective by ONC will serve as a content standard 
that will allow this information to be more easily transmitted and 
uploaded to another certified EHR, thereby reducing the cost of sharing 
information.
    Comment: Some commenters noted that patient engagement could occur 
effectively with or without online access, and patients should be 
encouraged to use any method (for example, telephone, internet, 
traditional mail) that suits them. These commenters noted that 
engagement offline reduces both the need and value for engagement 
online.
    Response: We agree that patient engagement can occur effectively 
through a variety of media, and we also believe that electronic access 
to discharge information can be an important component of patient 
compliance and improving longitudinal care. We do not believe that 
offline engagement reduces the need for online access, as patients may 
opt to access information in a variety of ways. Because of the variety 
of ways that patients/families may access information, we keep the 
threshold for this measure low. Measuring other means of accessing 
health information is beyond the scope of the EHR Incentive Programs. 
We also note that online access to health information can enhance 
offline engagement--for example, patients could download information 
from a hospital admission

[[Page 54039]]

to bring with them for a consult on follow-up care--which is one of the 
primary goals of the EHR Incentive Programs.
    Comment: Some commenters expressed concern that vendors would not 
be able to make these capabilities available as part of CEHRT in time 
for the beginning of Stage 2.
    Response: Many CEHRT vendors already make patient portals available 
that would meet the certification criteria and standards required for 
this measure. Although the Stage 2 eligible hospital/CAH measure 
requires some additional required elements and fields capabilities, we 
believe vendors will be able to make these capabilities available in 
time for the beginning of Stage 2.
    Comment: Some commenters suggested that basing the exclusion on the 
broadband data available from the FCC Web site (www.broadband.gov) was 
suspect since the data originates from vendors.
    Response: The broadband data made available from the FCC was 
collected from over 3,400 broadband providers nationwide. This data was 
then subject to many different types of analysis and verification 
methods, from drive testing wireless broadband service across their 
highways to meeting with community leaders to receive feedback. 
Representatives met with broadband providers, large and small, to 
confirm data, or suggest changes to service areas, and also went into 
the field looking for infrastructure to validate service offerings in 
areas where more information was needed. Therefore, we believe the data 
is appropriate for the exclusion to this measure. We note that since 
publication of our proposed rule the Web site has changed to 
www.broadbandmap.gov and the speed used has changed from 4Mbps to 
3Mbps. We are updating our exclusion to reflect these changes.
    Comment: Some commenters believe that broadband exclusions should 
be based on the patients' locations instead of the providers, since 
county-level data may not be granular enough to capture all areas of 
low broadband availability within a particular region.
    Response: Although we agree that a broadband exclusion based 
primarily on the individual locations of each patient seen would be 
more accurate, we do not believe that there is any method of making 
this determination for every patient without placing an undue burden on 
the provider. We continue to believe that limited broadband 
availability in the eligible hospital's or CAH's immediate practice 
area, coupled with the low threshold of this measure, adequately serves 
as an acceptable proxy for determining areas where online access can 
present a challenge for patients. Therefore, after consideration of the 
public comments received, we are finalizing the broadband exclusion as 
proposed.
    Comment: Some commenters suggested that the required element of 
``Problem list maintained by the hospital on the patient'' should be 
made consistent with the required element in the objective of the same 
name and changed to ``Problem list.'' Other commenters asked for 
clarification of ``Relevant past diagnoses known by the hospital'' and 
how this element differs from ``Problem list.''
    Response: We agree that this language should be made standard. By 
``Relevant past diagnoses known by the hospital'' we mean to indicate 
historical entries in the patient's problem list. Therefore, we are 
eliminating the ``Relevant past diagnoses'' element and modifying the 
problem list element to ``Current and past problem list'' in the list 
of required elements below.
    Comment: Some commenters suggested that displaying all historical 
medications for each patient under the required element of ``Medication 
list maintained by the hospital on the patient (both current admission 
and historical)'' would be too burdensome for hospitals. These 
commenters suggested amending the required element to only the active 
medication list maintained by CEHRT. They also expressed confusion over 
the use of the term ``current admission'' since the information for 
this measure would be posted after the patient's discharge.
    Response: We believe that just as providing a historical problem 
list for the patient can be useful, so too can providing a historical 
list of all medications. To clarify the intention of this objective, we 
are modifying the language in the list of required elements below to 
read ``Active medication list and medication history. Current admission 
referred to the admission and subsequent discharge that places the 
patient in the denominator for this measure.
    Comment: Some commenters suggested that ``Laboratory test results 
(available at discharge)'' could result in a large number of test 
results that could be confusing to patients. They suggested limiting 
this required element to a subset of lab results of a particular type 
or lab results from the last 24 hours of admission.
    Response: We believe that a list of all laboratory test results can 
be beneficial to longitudinal care, therefore, we decline to modify 
this required element either by type of lab result or by any time 
period beyond those lab test results available at discharge.
    Comment: Some commenters suggested that the required element of 
``Care transition summary and plan for next provider of care (for 
transitions other than home)'' should be made consistent with the 
required element in the objective of the same name and changed to 
``Care plan field, including goals and instructions.'' Some commenters 
also suggested that care transition plans are more appropriate for 
providers than patients.
    Response: By ``care transition summary and plan for next provider 
of care'' we mean for eligible hospitals and CAHs to include both the 
care plan field(s), including goals and instructions, and a copy of the 
summary of care document that hospitals must generate and provide for 
the core objective of ``The eligible hospital or CAH that transitions 
their patient to another setting of care or provider of care or refers 
their patient to another provider of care should provide summary care 
record for each transition of care or referral.'' While we believe that 
the summary of care documents are best exchanged directly with the 
provider to whom the hospital is transitioning care or referring the 
patient, we also believe that providing an electronic copy with 
discharge information will ensure that the provider can easily access 
the information after the transition of referral. We have modified the 
language in the list of required elements below to reflect this.
    After consideration of the public comments received, we are 
finalizing the first meaningful use measure for eligible hospitals and 
CAHs at Sec.  495.6(l)(8)(ii)(A) as proposed. We are modifying the 
second meaningful use measure for eligible hospitals and CAHs to be 
``More than 5 percent of all patients (or their authorized 
representatives) who are discharged from the inpatient or emergency 
department (POS 21 or 23) of an eligible hospital or CAH view, download 
or transmit to a third party their information during the EHR reporting 
period'' at Sec.  495.6(l)(8)(ii)(B), and the exclusion for eligible 
hospitals and CAHs at Sec.  495.6(l)(8)(iii) as ``Any eligible hospital 
or CAH that is located in a county that does not have 50 percent or 
more of its housing units with 3Mbps broadband availability according 
to the latest information available from the FCC on the first day of 
the EHR reporting period is excluded from the second measure.''
    We further specify that in order to meet this objective and 
measure, an

[[Page 54040]]

eligible hospital or CAH must use the capabilities and standards of 
CEHRT at 45 CFR 170.314(e)(1).
    To calculate the percentage of the first measure for providing 
patients timely access to discharge information, CMS and ONC have 
worked together to define the following for this objective:
     Denominator: Number of unique patients discharged from an 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period.
     Numerator: The number of patients in the denominator whose 
information is available online within 36 hours of discharge.
     Threshold: The resulting percentage must be more than 50 
percent in order for an eligible hospital or CAH to meet this measure.
    To calculate the percentage of the second measure for reporting on 
the number of unique patients discharged from an eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period (or their authorized representatives) who view, 
download or transmit health information, CMS and ONC have worked 
together to define the following for this objective:
     Denominator: Number of unique patients discharged from an 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period.
     Numerator: The number of unique patients (or their 
authorized representatives) in the denominator who have viewed online, 
downloaded, or transmitted to a third party the discharge information 
provided by the eligible hospital or CAH.
     Threshold: The resulting percentage must be more than 5 
percent in order for an eligible hospital or CAH to meet this measure.
     Exclusion: Any eligible hospital or CAH will be excluded 
from the second measure if it is located in a county that does not have 
50 percent or more of its housing units with 3Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period.
    The following information must be available to satisfy the 
objective and measure:
     Patient name.
     Admit and discharge date and location.
     Reason for hospitalization.
     Care team including the attending of record as well as 
other providers of care.
     Procedures performed during admission.
     Current and past problem list.
     Current medication list and medication history.
     Current medication allergy list and medication allergy 
history.
     Vital signs at discharge.
     Laboratory test results (available at time of discharge).
     Summary of care record for transitions of care or 
referrals to another provider.
     Care plan field(s), including goals and instructions.
     Discharge instructions for patient.
     Demographics maintained by hospital (sex, race, ethnicity, 
date of birth, preferred language).
     Smoking status.
    As noted in the proposed rule, this is not intended to limit the 
information made available by the hospital. A hospital can make 
available additional information and still align with the objective. 
Please note that while some of the information made available through 
this measure is similar to the information made available in the 
summary of care document that must be provided following transitions of 
care or referrals, the list of information above is specific to the 
view online, download, and transmit objective. Patients and providers 
have different information needs and contexts, so CMS has established 
separate required fields for each of these objectives.
    Proposed Eligible Hospital/CAH Objective: Record whether a patient 
65 years old or older has an advance directive.
    In our proposed rule, we noted that the HIT Policy Committee 
recommended making this a core objective and also requiring eligible 
hospitals and CAHs to either store an electronic copy of the advance 
directive in the CEHRT or link to an electronic copy of the advance 
directive. However, we proposed to maintain this objective as part of 
the menu set for Stage 2, and we did not propose the requirement of an 
electronic copy or link to the advance directive. As we stated in our 
Stage 1 final rule (75 FR 44345), we have continuing concerns that 
there are potential conflicts between storing advance directives and 
existing state laws. Also, we believe that because of state law 
restrictions, an advance directive stored in an EHR may not be 
actionable. Finally, we believe that eligible hospitals and CAHs may 
have other methods of satisfying the intent of this objective at this 
time, although we recognize that these workflows may change as EHR 
technology develops and becomes more widely adopted. Therefore, we did 
not propose to adopt the HIT Policy Committee's recommendations for 
this objective.
    The HIT Policy Committee has also recommended the inclusion of this 
objective for EPs in Stage 2. In our Stage 1 final rule (75 FR 44345), 
we indicated our belief that many EPs will not record this information 
under current standards of practice and will only require information 
about a patient's advance directive in rare circumstances. We continue 
to believe this is the case and that creating a list of specialties or 
types of EPs that will be excluded from the objective will be too 
cumbersome and still might not be comprehensive. Therefore, we did not 
propose the recording of the existence of advance directives as an 
objective for EPs in Stage 2. However, we solicited public comment on 
this decision and encouraged commenters to address specific concerns 
regarding scope of practice and ease of compliance for EPs. And we note 
that nothing in this rule compels the use of advance directives.
    Comment: While some commenters supported the HIT Policy Committee's 
recommendations, many recommended that we keep this measure as part of 
the menu set. We received several comments about a link or copy of the 
advance directives, and these commenters generally supported our 
proposal of not including this as part of the objective.
    Response: While we appreciate the commenters support and the 
HITPC's reiteration of their recommendation, neither the HITPC nor 
other commenters provided new information that would address our 
concerns regarding conflicting state laws.
    Comment: While most commenters agreed that this objective should 
not be extended to EPs at this time, a select few suggested adding it 
as part of the menu set.
    Response: We are not extending this objective to EPs. Our belief 
that many EPs would not record this information under current standards 
of practice was supported by commenters. Also, we continue to believe 
that creating a list of specialties or types of EPs that would be 
excluded from the objective would be too cumbersome and would not be 
comprehensive.
    After consideration of public comments, we are finalizing this 
objective for eligible hospitals and CAHs at Sec.  495.6(m)(1)(i) as 
proposed.
    Proposed Eligible Hospital/CAH Measure: More than 50 percent of all 
unique patients 65 years old or older admitted to the eligible 
hospital's or CAH's inpatient department (POS 21) during the EHR 
reporting period have

[[Page 54041]]

an indication of an advance directive status recorded as structured 
data.
    In the proposed rule, we explained that the calculation of the 
denominator for the measure of this objective is limited to unique 
patients age 65 or older who are admitted to an eligible hospital's or 
CAH's inpatient department (POS 21). Patients admitted to an emergency 
department (POS 23) should not be included in the calculation. As we 
discussed in our Stage 1 final rule (75 FR 44345), we believe that this 
information is a level of detail that is not practical to collect on 
every patient admitted to the eligible hospital's or CAH's emergency 
department, and therefore, have limited this measure only to the 
inpatient department of the hospital.
    Comment: A commenter indicated that nearly 70 percent of hospitals 
could meet this measure in Fall 2011.
    Response: Data collected from Stage 1 attestations shows that less 
than 15 percent of hospitals deferred this measure.
    After consideration of public comments, we are finalizing this 
measure for eligible hospitals and CAHs at Sec.  495.6(m)(1)(ii) as 
proposed. We are maintaining the exclusion for any eligible hospital or 
CAH that admits no patients age 65 years old or older during the EHR 
reporting period.
    We further specify that in order to meet this objective and 
measure, an EP must use the capabilities and standards of CEHRT at 45 
CFR 170.314(a)(17).
     Denominator: Number of unique patients age 65 or older 
admitted to an eligible hospital's or CAH's inpatient department (POS 
21) during the EHR reporting period.
     Numerator: The number of patients in the denominator who 
have an indication of an advance directive status entered using 
structured data.
     Threshold: The resulting percentage must be more than 50 
percent in order for an eligible hospital or CAH to meet this measure.
     Exclusion: Any eligible hospital or CAH that admits no 
patients age 65 years old or older during the EHR reporting period.
(f) HIT Policy Committee Recommended Objectives Discussed in the 
Proposed Rule Without Proposed Regulation Text
    We did not propose these objectives for Stage 2 as explained at 
each objective, but we solicited comments on whether these objectives 
should be incorporated into Stage 2.
    Hospital Objective: Provide structured electronic lab results to 
eligible professionals.
    Although the HITPC recommended this as a core objective for Stage 2 
for hospitals, we did not propose this objective for the following 
reasons as explained in the proposed rule. Although hospital labs 
supply nearly half of all lab results, they are not the predominant 
vendors for providers who do not share or cannot access their 
technology. Independent and office laboratories provide over half of 
the labs in this market. We stated that we were concerned that imposing 
this requirement on hospital labs would unfairly disadvantage them in 
this market. Furthermore, not all hospitals offer these services so it 
would create a natural disparity in meaningful use between those 
hospitals offering these services and those that do not. Finally, all 
other aspects of meaningful use in Stage 1 and Stage 2 focus on the 
inpatient and emergency departments of a hospital. This objective is 
not related to these departments, and in fact excludes services 
provided in these departments. We asked for comments on both the pros 
and cons of this objective and whether it should be considered for this 
final rule as recommended by the HITPC.
    Comment: Nearly all of the commenters that supported the inclusion 
of this objective based their support wholly or in part on the concept 
that the benefits of hospitals providing structured electronic lab 
results outweigh the costs of doing so. They point to specific 
benefits, such as making it more likely that EPs will be able to meet 
the meaningful use measure of incorporating clinical lab-test results 
into CEHRT as structured data, as well as more general benefits of 
structured electronic results.
    Response: The large number of commenters in support of this 
objective and the associated benefits they identified make a compelling 
case for inclusion. In particular, inclusion of this objective will 
enable EPs to incorporate laboratory test results into the CEHRT as 
structured data, which in turn adds to the ability of CEHRT to provide 
CDS and to calculate clinical quality measures. In addition, this 
objective will improve consistency in the market by incentivizing the 
use of the uniform standard for laboratory exchange transactions 
included in CEHRT as established in ONC's certification criteria at 
(ONC reference once available). However, the benefits identified are 
somewhat tempered by the makeup of the commenters supporting the 
inclusion of this objective, who are usually those who stand to benefit 
(EPs, patient advocates and others), whereas those who did not support 
inclusion are usually those who would bear the burden (hospitals and 
vendors). We summarize and respond to the comments in opposition later. 
However, due to the strong disagreements among commenters about the 
inclusion of this objective, and also concern for market impact 
discussed in the comments later, we will include it in the menu set of 
Stage 2 and not in the core set as recommended by the HITPC and 
supported by some of the commenters.
    Comment: Several commenters questioned the applicability of this 
objective to meaningful use. Most stated that it was not applicable for 
several reasons. First, commenters asserted it is beyond the statutory 
authority of the Medicare EHR Incentive Program, which is established 
in sections of the statute that govern payment for hospital inpatient 
services, whereas laboratory services are paid under a different 
payment system. Second, as meaningful use is currently constrained to 
the inpatient and emergency departments, it would be inconsistent to 
expand it to include lab results for patients that are not admitted to 
either the inpatient or emergency department of the hospital. Third, 
systems used by hospitals to process and send laboratory results are 
not traditionally considered part of CEHRT, and including those systems 
in CEHRT could have many unintended consequences and costs.
    Response: We believe the statute supports a definition of 
meaningful use that is not limited to actions taken within the 
inpatient department of a hospital. The meaningful use incentive 
payments and payment adjustments for Medicare eligible hospitals are 
established in sections of the Act that are under the hospital 
inpatient prospective payment system (IPPS) (sections 1886(n) and 
1886(b)(3)(B)(ix) of the Act, respectively). However, the statutory 
definition of a ``meaningful EHR user'' under section 1886(n)(3) of the 
Act does not constrain the use of CEHRT to the inpatient department of 
the hospital. The definition requires in part that an eligible hospital 
must use CEHRT ``for the electronic exchange of health information to 
improve the quality of health care, such as promoting care 
coordination'' (section 1886(n)(3)(A)(ii)), which the objective of 
providing structured electronic lab results to ambulatory providers 
would support. Moreover, the majority of hospital objectives for Stages 
1 and 2 of meaningful use take into account actions performed in the 
emergency department as well as the inpatient department. In the Stage 
1 final rule, we indicated that we may consider

[[Page 54042]]

applying the Stage 2 criteria more broadly to all hospital outpatient 
settings beyond the emergency department (75 FR 44322). One of the 
primary reasons not to include outpatient settings in meaningful use 
for hospitals is the potential for overlap with settings where EPs 
typically would use CEHRT. We believe there is minimal risk of such 
overlap with this objective, as it involves a function that is 
controlled by the hospital, and for which EPs are a recipient and not a 
provider of information. In regards to the third reason identified by 
commenters, CEHRT and meaningful use already include the ability to 
report electronic lab results to public health agencies, so 
consequences and costs of such inclusion should have already occurred. 
The impact of including these systems in certification is addressed in 
the ONC regulation published elsewhere in this issue of the Federal 
Register.
    Comment: A few commenters supported this objective because they 
believe that hospital labs have lagged behind independent labs in 
providing electronic results.
    Response: We agree that hospital lab reporting should be included 
as a menu set objective, but without actual data demonstrating lags by 
hospitals in laboratory exchange with ambulatory providers, we do not 
find this to be a compelling reason to include the objective as part of 
the core set.
    Comment: Commenters believed this objective is inappropriate 
because the meaningful use regulations do not apply to commercial 
clinical laboratories, leading to an adverse market impact for 
hospitals in competition with others that process laboratory results 
for physician offices. The operational impacts of this objective are 
significant. In the absence of functional health information exchanges, 
hospitals would need to create and maintain separate, system-to-system 
interfaces with each physician office that receives laboratory results 
electronically, at considerable cost and effort. The transition to 
using standardized code sets in laboratories that must continue to 
function is challenging and burdensome, particularly for small 
hospitals.
    Response: For these reasons, we include this objective and measure 
in the menu set. Those hospitals that see competitive benefits in 
providing electronic lab results to ambulatory providers may wish to 
select this as a menu set objective. Those who believe that building 
out the capability to provide electronic lab results is not beneficial 
in their competitive market environments can defer the objective. 
Similarly, those hospitals that consider the burden too high can defer 
this objective.
    After consideration of public comments, we are including this 
objective in the menu set for eligible hospitals and CAHs at Sec.  
495.6(m)(6)(i) as ``Provide structured electronic lab results to 
ambulatory providers.''
    For each objective, we outline the benefits expected from that 
objective. We did not include these benefits in our proposed rule and 
we are adding them to this final rule. Hospitals sending structured lab 
results electronically to EPs using CEHRT and in accordance with 
designated standards will directly enhance the ability of EPs to meet 
meaningful use objectives, including incorporating laboratory test 
results into the EHR as structured data, generating lists of patients 
with particular conditions, utilizing clinical decision support, and 
enhancing the ability to calculate clinical quality measures. The 
addition of this objective will help improve consistency in the market, 
in contrast to today's environment in which inconsistencies in 
interface requirements are hindering the delivery of structured 
hospital lab results to ambulatory EHRs. This objective will also 
benefit hospitals by creating a uniform standard for laboratory 
exchange transactions, which will eliminate variation, reducing 
interface costs and time to deploy.
    Hospital Measure: Hospital labs send (directly or indirectly) 
structured electronic clinical lab results to the ordering provider for 
more than 40 percent of electronic lab orders received.
    The measure for this objective recommended by the HIT Policy 
Committee is that 40 percent of clinical lab test results 
electronically sent by an eligible hospital or CAH will need to be done 
so using the capabilities CEHRT. This measure requires that in 
situations where the electronic connectivity between an eligible 
hospital or CAH and an EP is established, the results electronically 
exchanged are done so using CEHRT. To facilitate the ease with which 
this electronic exchange may take place, ONC proposed that for 
certification, ambulatory EHR technology will need to be able to 
incorporate lab test results formatted in the same standard and 
implementation specifications to which inpatient EHR technology will 
need to be certified as being able to create.
    Comment: Some commenters who support this objective raised concerns 
that small hospitals might not be able to comply due to the burden 
involved and suggest an unspecified exclusion for them.
    Response: By including this objective as a menu set item, those 
hospitals that view lab reporting to ambulatory practices as too 
burdensome can defer this measure.
    Comment: Some commenters supporting the measure indicated that they 
would like to see hospital reference labs that are already providing 
electronic lab results to ordering providers ``grandfathered'' into the 
measure.
    Response: There are two reasons that a hospital providing 
electronic lab results already would need special consideration. First, 
they are not using the standards of CEHRT where available. Second, they 
may not have gotten the system they use certified. As it is meaningful 
use of CEHRT we do not believe that we should include exceptions to the 
use of CEHRT in meaningful use. We do not believe that providers must 
``rip and replace'' existing systems. Existing systems that support the 
standards of CEHRT can be certified for inclusion and those that do not 
support the standards can defer the objective until they upgrade to the 
standards of CEHRT.
    Comment: Commenters expressed concern that if the objective is 
included in meaningful use that the threshold is unattainable. They 
noted that for a hospital to send electronic lab results the EP must be 
able to receive electronic results and that current adoption rates do 
not indicate that 40 percent of EPs will be able to receive electronic 
lab results.
    Response: The measure uses a denominator of electronic lab orders 
received so this consideration is already built into the measure. 
However, we do agree with commenters that 40 percent is a high 
threshold for this completely new measure as it is dependent on 
electronic health exchange. For the final measure we reduce the 
threshold to 20 percent. While we considered lowering the threshold to 
10 percent, the denominator limitation that the lab order must be 
received electronically already limits the measure to those ordering 
providers capable of submitting electronic orders and implies at least 
some electronic health information exchange has been established 
between the hospital and the ordering provider.
    After considering the comments, we are finalizing this measure for 
eligible hospitals and CAHs at Sec.  495.6(m)(6)(ii) as ``Hospital labs 
send structured electronic clinical lab results to the ordering 
provider for more than 20 percent of electronic lab orders received.''

[[Page 54043]]

    In order to be counted in the numerator, the hospital would need to 
use CEHRT to send laboratory results to the ambulatory provider in a 
way that has the potential for electronic incorporation of those 
results as structure data. Methods that have no potential for automatic 
incorporation such as ``portal view'' do not count in the numerator. We 
further specify that in order to meet this objective and measure, an 
EP, eligible hospital, or CAH must use the capabilities and standards 
of CEHRT at 45 CFR 170.314(b)(6).
     Denominator: The number of electronic lab orders received.
     Numerator: The number of structured clinical lab results 
sent to the ordering provider.
     Threshold: The resulting percentage must be greater than 
20 percent.
    EP Objective/Measure: Record patient preferences for communication 
medium for more than 20 percent of all unique patients seen during the 
EHR reporting period.
    We proposed that this requirement is better incorporated with other 
objectives that require patient communication and is not necessary as a 
standalone objective.
    Commenters were supportive of the incorporation of this objective 
and we continue to believe that it is better incorporated; therefore, 
we are finalizing this provision as proposed.
    Objective/Measure: Record care plan goals and patient instructions 
in the care plan for more than 10 percent of patients seen during the 
reporting period.
    We proposed that this requirement is better incorporated with other 
objectives that require summary of care documents and is not necessary 
as a standalone objective.
    Commenters were supportive of the incorporation of this objective 
as proposed and we continue to believe that it is better incorporated; 
therefore, we are finalizing this provision as proposed.
    Objective/Measure: Record health care team members (including at a 
minimum PCP, if available) for more than 10 percent of all patients 
seen during the reporting period; this information can be unstructured.
    We proposed that this requirement is better incorporated with other 
objectives that require summary of care documents and is not necessary 
as a standalone objective.
    Commenters were supportive of the incorporation of this objective 
as proposed and we continue to believe that it is better incorporated; 
therefore, we are finalizing as proposed.
    Objective/Measure: Record electronic notes in patient records for 
more than 30 percent of office visits.
    In the proposed rule, we encouraged public comment regarding the 
inclusion of this objective/measure. We noted that narrative entries 
are considered an important component of patient records and complement 
the structured data captured in CEHRT. We also noted our understanding 
that electronic notes are already widely used by providers and 
therefore may not need to include this as a meaningful use objective.
    Comment: Commenters agreed that existing technology has the 
capability to capture notes in an electronic form for inclusion in the 
patient record. Other commenters mentioned that not all CEHRT in use 
currently include the capability to incorporate narrative clinical 
documentation.
    Response: We reiterate the statement in the proposed rule regarding 
the important contribution of narrative clinical documentation in the 
patient record. In light of the comments that not all CEHRT currently 
has the capability to incorporate this clinical documentation, we agree 
to incorporate this functionality to record electronic notes as an 
additional menu objective for Stage 2 of meaningful use. The ONC 
standards and certification criteria final rule associated with this 
objective/measure is published elsewhere in this issue of the Federal 
Register. We believe that inclusion of electronic patient notes to the 
meaningful use menu objectives is another incremental step towards 
maximizing the potential of EHR technology.
    Comment: The HIT Policy Committee commented that this objective/
measure should apply to both EPs, eligible hospitals and CAHs because 
some certified EHRs do not have clinical documentation and because they 
believe that a complete record (including progress notes) is required 
to deliver high quality, efficient care.
    Response: We agree and are adopting this objective in the menu set 
for Stage 2 for EPs, eligible hospitals and CAHs in order to allow 
providers access to the most accurate and complete patient information 
available electronically to support quality of care efforts across 
patient care settings.
    Comment: A commenter suggested that if this objective/measure 
becomes part of the final rule it will require a clear definition of 
how notes are defined and who may create, edit and sign them in order 
to be included in the measure numerator. Other commenters requested 
clarification of the term electronic note and whether it would include 
nursing notes, flow sheets, operative reports, discharge summaries, 
consults, etc. in addition to basic progress notes.
    Response: For this objective, we have determined that any EP as 
defined for the Medicare or Medicaid EHR Incentive Programs, or an 
authorized provider of the eligible hospital's or CAH's inpatient or 
emergency departments (POS 21 or 23) may author, edit, and provide an 
electronic signature for the electronic notes in order for them to be 
considered for this measure. We further define electronic notes as 
electronic progress notes for the purpose of this measure. We will rely 
on providers own determinations and guidelines defining when progress 
notes are necessary to communicate individual patient circumstances and 
for coordination with previous documentation of patient observations, 
treatments and/or results in the electronic health record.
    Comment: Many commenters agreed with the inclusion of the text 
searchable certification requirement and agreed that portions of 
clinical notes are already being collected electronically. The HIT 
Policy Committee recommended inclusion of this measure because some 
certified EHRs do not have clinical documentation, and believe that the 
benefit of a complete patient record, including progress notes, is 
required to deliver high quality, efficient care. Several commenters 
were opposed to the inclusion of this additional measure in order to 
limit the number of reporting objectives.
    Response: Based on the multiple reasons stated in this preamble we 
agree with the benefits of including the electronic progress notes 
measure in the menu set for the Stage 2 meaningful use objectives. We 
envision continued technological advances in the capture and processing 
of text and diagrammatic data such as research of natural language 
processing. We also believe there is added value in collecting both 
narrative data and structured data in the EHR and using that 
information to track key clinical conditions and communicating that 
information for care coordination purposes. Therefore, we are including 
this objective/measure to record electronic notes in the patient 
records for more than 30 percent of office visits or unique patients 
admitted to an eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) as was originally recommended by the HITPC.
    After consideration of public comments, we are finalizing this 
objective for EPs at Sec.  495.6 (k)(6)(i) and for eligible hospitals 
and CAHs at Sec.  495.6(m)(5)(i) as ``Record electronic notes in 
patient records.''

[[Page 54044]]

    We are adding the measure for EPs at Sec.  495.6(k)(6)(ii) and for 
eligible hospitals and CAHs at Sec.  495.6(m)(5)(ii) of our regulations 
to include this new measure:
    EP Menu Measure: Enter at least one electronic progress note 
created, edited and signed by an EP for more than 30 percent of unique 
patients with at least one office visit during the EHR reporting 
period. Electronic progress notes must be text-searchable. Non-
searchable notes do not qualify, but this does not mean that all of the 
content has to be character text. Drawings and other content can be 
included with searchable text notes under this measure.
    Eligible Hospital/CAH Menu Measure: Enter at least one electronic 
progress note created, edited and signed by an authorized provider of 
the eligible hospital's or CAH's inpatient or emergency department (POS 
21 or 23) for more than 30 percent of unique patients admitted to the 
eligible hospital or CAH's inpatient or emergency department during the 
EHR reporting period. Electronic progress notes must be text-
searchable. Non-searchable notes do not qualify, but this does not mean 
that all of the content has to be character text. Drawings and other 
content can be included with searchable text notes under this measure.
    We further specify that in order to meet this objective and 
measure, an EP, eligible hospital, or CAH must use the capabilities and 
standards of CEHRT at 45 CFR 170.314(a)(9).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for these measures:
     Denominator: Number of unique patients with at least one 
office visit during the EHR reporting period for EPs or admitted to an 
eligible hospital or CAH's inpatient or emergency department (POS 21 or 
23) during the EHR reporting period.
     Numerator: The number of unique patients in the 
denominator who have at least one electronic progress note from an 
eligible professional or authorized provider of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) recorded as 
text-searchable data.
     Threshold: The resulting percentage must be more than 30 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.

                                    Table B5--Stage 2 Objectives and Measures
----------------------------------------------------------------------------------------------------------------
                                                      Stage 2 objectives
                                      --------------------------------------------------
   Health outcomes policy priority                               Eligible hospitals and      Stage 2 measures
                                        Eligible professionals            CAHs
----------------------------------------------------------------------------------------------------------------
                                                    CORE SET
----------------------------------------------------------------------------------------------------------------
Improving quality, safety,             Use computerized         Use computerized         More than 60 percent of
 efficiency, and reducing health        provider order entry     provider order entry     medication, 30 percent
 disparities.                           (CPOE) for medication,   (CPOE) for medication,   of laboratory, and 30
                                        laboratory and           laboratory and           percent of radiology
                                        radiology orders         radiology orders         orders created by the
                                        directly entered by      directly entered by      EP or authorized
                                        any licensed             any licensed             providers of the
                                        healthcare               healthcare               eligible hospital's or
                                        professional who can     professional who can     CAH's inpatient or
                                        enter orders into the    enter orders into the    emergency department
                                        medical record per       medical record per       (POS 21 or 23) during
                                        state, local and         state, local and         the EHR reporting
                                        professional             professional             period are recorded
                                        guidelines.              guidelines.              using CPOE.
                                       Generate and transmit    .......................  More than 50 percent of
                                        permissible                                       all permissible
                                        prescriptions                                     prescriptions, or all
                                        electronically (eRx).                             prescriptions written
                                                                                          by the EP and queried
                                                                                          for a drug formulary
                                                                                          and transmitted
                                                                                          electronically using
                                                                                          CEHRT.
                                       Record the following     Record the following     More than 80 percent of
                                        demographics:            demographics:            all unique patients
                                        Preferred        Preferred        seen by the EP or
                                        language.                language.                admitted to the
                                        Sex...........   Sex...........   eligible hospital's or
                                        Race..........   Race..........   CAH's inpatient or
                                        Ethnicity.....   Ethnicity.....   emergency department
                                        Date of birth.   Date of birth.   (POS 21 or 23) during
                                                                 Date and         the EHR reporting
                                                                 preliminary cause of     period have
                                                                 death in the event of    demographics recorded
                                                                 mortality in the         as structured data.
                                                                 eligible hospital or
                                                                 CAH..
                                       Record and chart         Record and chart         More than 80 percent of
                                        changes in vital         changes in vital         all unique patients
                                        signs:                   signs:                   seen by the EP or
                                        Height/length.   Height/length.   admitted to the
                                        Weight........   Weight........   eligible hospital's or
                                        Blood pressure   Blood pressure   CAH's inpatient or
                                        (age 3 and over).        (age 3 and over).        emergency department
                                        Calculate and    Calculate and    (POS 21 or 23) during
                                        display BMI.             display BMI.             the EHR reporting
                                        Plot and         Plot and         period have blood
                                        display growth charts    display growth charts    pressure (for patients
                                        for patients 0-20        for patients 0-20        age 3 and over only)
                                        years, including BMI.    years, including BMI.    and height/length and
                                                                                          weight (for all ages)
                                                                                          recorded as structured
                                                                                          data.

[[Page 54045]]

 
                                       Record smoking status    Record smoking status    More than 80 percent of
                                        for patients 13 years    for patients 13 years    all unique patients 13
                                        old or older.            old or older.            years old or older
                                                                                          seen by the EP or
                                                                                          admitted to the
                                                                                          eligible hospital's or
                                                                                          CAH's inpatient or
                                                                                          emergency departments
                                                                                          (POS 21 or 23) during
                                                                                          the EHR reporting
                                                                                          period have smoking
                                                                                          status recorded as
                                                                                          structured data.
                                       Use clinical decision    Use clinical decision    1. Implement five
                                        support to improve       support to improve       clinical decision
                                        performance on high-     performance on high-     support interventions
                                        priority health          priority health          related to four or
                                        conditions.              conditions.              more clinical quality
                                                                                          measures at a relevant
                                                                                          point in patient care
                                                                                          for the entire EHR
                                                                                          reporting period.
                                                                                          Absent four clinical
                                                                                          quality measures
                                                                                          related to an EP,
                                                                                          eligible hospital or
                                                                                          CAH's scope of
                                                                                          practice or patient
                                                                                          population, the
                                                                                          clinical decision
                                                                                          support interventions
                                                                                          must be related to
                                                                                          high-priority health
                                                                                          conditions. It is
                                                                                          suggested that one of
                                                                                          the five clinical
                                                                                          decision support
                                                                                          interventions be
                                                                                          related to improving
                                                                                          healthcare efficiency.
                                                                                         2. The EP, eligible
                                                                                          hospital, or CAH has
                                                                                          enabled and
                                                                                          implemented the
                                                                                          functionality for drug
                                                                                          and drug allergy
                                                                                          interaction checks for
                                                                                          the entire EHR
                                                                                          reporting period.
                                       Incorporate clinical     Incorporate clinical     More than 55 percent of
                                        lab-test results into    lab-test results into    all clinical lab tests
                                        Certified EHR            Certified EHR            results ordered by the
                                        Technology as            Technology as            EP or by authorized
                                        structured data.         structured data.         providers of the
                                                                                          eligible hospital or
                                                                                          CAH for patients
                                                                                          admitted to its
                                                                                          inpatient or emergency
                                                                                          department (POS 21 or
                                                                                          23) during the EHR
                                                                                          reporting period whose
                                                                                          results are either in
                                                                                          a positive/negative
                                                                                          affirmation or
                                                                                          numerical format are
                                                                                          incorporated in
                                                                                          Certified EHR
                                                                                          Technology as
                                                                                          structured data.
                                       Generate lists of        Generate lists of        Generate at least one
                                        patients by specific     patients by specific     report listing
                                        conditions to use for    conditions to use for    patients of the EP,
                                        quality improvement,     quality improvement,     eligible hospital or
                                        reduction of             reduction of             CAH with a specific
                                        disparities, research,   disparities, research,   condition.
                                        or outreach              or outreach.
                                       Use clinically relevant  .......................  More than 10 percent of
                                        information to                                    all unique patients
                                        identify patients who                             who have had two or
                                        should receive                                    more office visits
                                        reminders for                                     with the EP within the
                                        preventive/follow-up                              24 months before the
                                        care and send these                               beginning of the EHR
                                        patients the reminder,                            reporting period were
                                        per patient preference.                           sent a reminder, per
                                                                                          patient preference
                                                                                          when available.
                                                                Automatically track      More than 10 percent of
                                                                 medications from order   medication orders
                                                                 to administration        created by authorized
                                                                 using assistive          providers of the
                                                                 technologies in          eligible hospital's or
                                                                 conjunction with an      CAH's inpatient or
                                                                 electronic medication    emergency department
                                                                 administration record    (POS 21 or 23) during
                                                                 (eMAR).                  the EHR reporting
                                                                                          period for which all
                                                                                          doses are tracked
                                                                                          using eMAR.

[[Page 54046]]

 
Engage patients and families in their  Provide patients the     .......................  1. More than 50 percent
 health care.                           ability to view                                   of all unique patients
                                        online, download, and                             seen by the EP during
                                        transmit their health                             the EHR reporting
                                        information within 4                              period are provided
                                        business days of the                              timely (within 4
                                        information being                                 business days after
                                        available to the EP.                              the information is
                                                                                          available to the EP)
                                                                                          online access to their
                                                                                          health information
                                                                                          subject to the EP's
                                                                                          discretion to withhold
                                                                                          certain information.
                                                                                         2. More than 5 percent
                                                                                          of all unique patients
                                                                                          seen by the EP during
                                                                                          the EHR reporting
                                                                                          period (or their
                                                                                          authorized
                                                                                          representatives) view,
                                                                                          download, or transmit
                                                                                          to a third party their
                                                                                          health information.
                                                                Provide patients the     1. More than 50 percent
                                                                 ability to view          of all patients who
                                                                 online, download, and    are discharged from
                                                                 transmit information     the inpatient or
                                                                 about a hospital         emergency department
                                                                 admission.               (POS 21 or 23) of an
                                                                                          eligible hospital or
                                                                                          CAH have their
                                                                                          information available
                                                                                          online within 36 hours
                                                                                          of discharge.
                                                                                         2. More than 5 percent
                                                                                          of all patients (or
                                                                                          their authorized
                                                                                          representatives) who
                                                                                          are discharged from
                                                                                          the inpatient or
                                                                                          emergency department
                                                                                          (POS 21 or 23) of an
                                                                                          eligible hospital or
                                                                                          CAH view, download or
                                                                                          transmit to a third
                                                                                          party their
                                                                                          information during the
                                                                                          reporting period.
                                       Provide clinical         .......................  Clinical summaries
                                        summaries for patients                            provided to patients
                                        for each office visit.                            or
                                                                                          patient[dash]authorize
                                                                                          d representatives
                                                                                          within 1 business day
                                                                                          for more than 50
                                                                                          percent of office
                                                                                          visits.
                                       Use Certified EHR        Use Certified EHR        Patient-specific
                                        Technology to identify   Technology to identify   education resources
                                        patient-specific         patient-specific         identified by CEHRT
                                        education resources      education resources      are provided to
                                        and provide those        and provide those        patients for more than
                                        resources to the         resources to the         10 percent of all
                                        patient.                 patient.                 unique patients with
                                                                                          office visits seen by
                                                                                          the EP during the EHR
                                                                                          reporting period.
                                                                                         More than 10 percent of
                                                                                          all unique patients
                                                                                          admitted to the
                                                                                          eligible hospital's or
                                                                                          CAH's inpatient or
                                                                                          emergency departments
                                                                                          (POS 21 or 23) are
                                                                                          provided patient-
                                                                                          specific education
                                                                                          resources identified
                                                                                          by Certified EHR
                                                                                          Technology.
                                       Use secure electronic    .......................  A secure message was
                                        messaging to                                      sent using the
                                        communicate with                                  electronic messaging
                                        patients on relevant                              function of Certified
                                        health information.                               EHR Technology by more
                                                                                          than 5 percent of
                                                                                          unique patients (or
                                                                                          their authorized
                                                                                          representatives) seen
                                                                                          by the EP during the
                                                                                          EHR reporting period.

[[Page 54047]]

 
Improve care coordination............  The EP who receives a    The eligible hospital    The EP, eligible
                                        patient from another     or CAH who receives a    hospital or CAH
                                        setting of care or       patient from another     performs medication
                                        provider of care or      setting of care or       reconciliation for
                                        believes an encounter    provider of care or      more than 50 percent
                                        is relevant should       believes an encounter    of transitions of care
                                        perform medication       is relevant should       in which the patient
                                        reconciliation.          perform medication       is transitioned into
                                                                 reconciliation.          the care of the EP or
                                                                                          admitted to the
                                                                                          eligible hospital's or
                                                                                          CAH's inpatient or
                                                                                          emergency department
                                                                                          (POS 21 or 23).
                                       The EP who transitions   The eligible hospital    1. The EP, eligible
                                        their patient to         or CAH who transitions   hospital, or CAH that
                                        another setting of       their patient to         transitions or refers
                                        care or provider of      another setting of       their patient to
                                        care or refers their     care or provider of      another setting of
                                        patient to another       care or refers their     care or provider of
                                        provider of care         patient to another       care provides a
                                        provides a summary       provider of care         summary of care record
                                        care record for each     provides a summary       for more than 50
                                        transition of care or    care record for each     percent of transitions
                                        referral.                transition of care or    of care and referrals.
                                                                 referral.               2. The EP, eligible
                                                                                          hospital or CAH that
                                                                                          transitions or refers
                                                                                          their patient to
                                                                                          another setting of
                                                                                          care or provider of
                                                                                          care provides a
                                                                                          summary of care record
                                                                                          for more than 10% of
                                                                                          such transitions and
                                                                                          referrals either--(a)
                                                                                          electronically
                                                                                          transmitted using
                                                                                          CEHRT to a recipient
                                                                                          or (b) where the
                                                                                          recipient receives the
                                                                                          summary of care record
                                                                                          via exchange
                                                                                          facilitated by an
                                                                                          organization that is a
                                                                                          NwHIN Exchange
                                                                                          participant or in a
                                                                                          manner that is
                                                                                          consistent with the
                                                                                          governance mechanism
                                                                                          ONC establishes for
                                                                                          the nationwide health
                                                                                          information network.
                                                                                         3. An EP, eligible
                                                                                          hospital or CAH must
                                                                                          satisfy one of the two
                                                                                          following criteria:
                                                                                         (A) Conducts one or
                                                                                          more successful
                                                                                          electronic exchanges
                                                                                          of a summary of care
                                                                                          document, as part of
                                                                                          which is counted in
                                                                                          ``measure 2'' (for EPs
                                                                                          the measure at Sec.
                                                                                          495.6(j)(14)(ii)(B)
                                                                                          and for eligible
                                                                                          hospitals and CAHs the
                                                                                          measure at Sec.
                                                                                          495.6(l)(11)(ii)(B))
                                                                                          with a recipient who
                                                                                          has EHR technology
                                                                                          that was developed
                                                                                          designed by a
                                                                                          different EHR
                                                                                          technology developer
                                                                                          than the sender's EHR
                                                                                          technology certified
                                                                                          to 45 CFR
                                                                                          170.314(b)(2); or
                                                                                         (B) Conducts one or
                                                                                          more successful tests
                                                                                          with the CMS
                                                                                          designated test EHR
                                                                                          during the EHR
                                                                                          reporting period.
Improve population and public health.  Capability to submit     Capability to submit     Successful ongoing
                                        electronic data to       electronic data to       submission of
                                        immunization             immunization             electronic
                                        registries or            registries or            immunization data from
                                        immunization             immunization             Certified EHR
                                        information systems      information systems      Technology to an
                                        except where             except where             immunization registry
                                        prohibited, and in       prohibited, and in       or immunization
                                        accordance with          accordance with          information system for
                                        applicable law and       applicable law and       the entire EHR
                                        practice.                practice.                reporting period.

[[Page 54048]]

 
                                                                Capability to submit     Successful ongoing
                                                                 electronic reportable    submission of
                                                                 laboratory results to    electronic reportable
                                                                 public health            laboratory results
                                                                 agencies, except where   from Certified EHR
                                                                 prohibited, and in       Technology to public
                                                                 accordance with          health agencies for
                                                                 applicable law and       the entire EHR
                                                                 practice.                reporting period.
                                                                Capability to submit     Successful ongoing
                                                                 electronic syndromic     submission of
                                                                 surveillance data to     electronic syndromic
                                                                 public health            surveillance data from
                                                                 agencies, except where   Certified EHR
                                                                 prohibited, and in       Technology to a public
                                                                 accordance with          health agency for the
                                                                 applicable law and       entire EHR reporting
                                                                 practice.                period.
Ensure adequate privacy and security   Protect electronic       Protect electronic       Conduct or review a
 protections for personal health        health information       health information       security risk analysis
 information.                           created or maintained    created or maintained    in accordance with the
                                        by the Certified EHR     by the Certified EHR     requirements under 45
                                        Technology through the   Technology through the   CFR 164.308(a)(1),
                                        implementation of        implementation of        including addressing
                                        appropriate technical    appropriate technical    the encryption/
                                        capabilities.            capabilities.            security of data
                                                                                          stored in CEHRT in
                                                                                          accordance with
                                                                                          requirements under 45
                                                                                          CFR 164.312(a)(2)(iv)
                                                                                          and 45 CFR
                                                                                          164.306(d)(3), and
                                                                                          implement security
                                                                                          updates as necessary
                                                                                          and correct identified
                                                                                          security deficiencies
                                                                                          as part of the
                                                                                          provider's risk
                                                                                          management process.
----------------------------------------------------------------------------------------------------------------
                                                    MENU SET
----------------------------------------------------------------------------------------------------------------
Improving quality, safety,             .......................  Record whether a         More than 50 percent of
 efficiency, and reducing health                                 patient 65 years old     all unique patients 65
 disparities.                                                    or older has an          years old or older
                                                                 advance directive.       admitted to the
                                                                                          eligible hospital's or
                                                                                          CAH's inpatient
                                                                                          department (POS 21)
                                                                                          during the EHR
                                                                                          reporting period have
                                                                                          an indication of an
                                                                                          advance directive
                                                                                          status recorded as
                                                                                          structured data.
                                       Imaging results          Imaging results          More than 10 percent of
                                        consisting of the        consisting of the        all tests whose result
                                        image itself and any     image itself and any     is one or more images
                                        explanation or other     explanation or other     ordered by the EP or
                                        accompanying             accompanying             by an authorized
                                        information are          information are          provider of the
                                        accessible through       accessible through       eligible hospital or
                                        Certified EHR            Certified EHR            CAH for patients
                                        Technology.              Technology.              admitted to its
                                                                                          inpatient or emergency
                                                                                          department (POS 21 and
                                                                                          23) during the EHR
                                                                                          reporting period are
                                                                                          accessible through
                                                                                          Certified EHR
                                                                                          Technology.
                                       Record patient family    Record patient family    More than 20 percent of
                                        health history as        health history as        all unique patients
                                        structured data.         structured data.         seen by the EP or
                                                                                          admitted to the
                                                                                          eligible hospital or
                                                                                          CAH's inpatient or
                                                                                          emergency department
                                                                                          (POS 21 or 23) during
                                                                                          the EHR reporting
                                                                                          period have a
                                                                                          structured data entry
                                                                                          for one or more first-
                                                                                          degree relatives.
                                                                Generate and transmit    More than 10 percent of
                                                                 permissible discharge    hospital discharge
                                                                 prescriptions            medication orders for
                                                                 electronically (eRx).    permissible
                                                                                          prescriptions (for
                                                                                          new, changed, and
                                                                                          refilled
                                                                                          prescriptions) are
                                                                                          queried for a drug
                                                                                          formulary and
                                                                                          transmitted
                                                                                          electronically using
                                                                                          Certified EHR
                                                                                          Technology.

[[Page 54049]]

 
                                       Record electronic notes  Record electronic notes  Enter at least one
                                        in patient records.      in patient records.      electronic progress
                                                                                          note created, edited
                                                                                          and signed by an
                                                                                          eligible professional
                                                                                          for more than 30
                                                                                          percent of unique
                                                                                          patients with at least
                                                                                          one office visit
                                                                                          during the EHR
                                                                                          reporting period.
                                                                                         Enter at least one
                                                                                          electronic progress
                                                                                          note created, edited
                                                                                          and signed by an
                                                                                          authorized provider of
                                                                                          the eligible
                                                                                          hospital's or CAH's
                                                                                          inpatient or emergency
                                                                                          department (POS 21 or
                                                                                          23) for more than 30
                                                                                          percent of unique
                                                                                          patients admitted to
                                                                                          the eligible hospital
                                                                                          or CAH's inpatient or
                                                                                          emergency department
                                                                                          during the EHR
                                                                                          reporting period.
                                                                                          Electronic progress
                                                                                          notes must be text-
                                                                                          searchable. Non-
                                                                                          searchable notes do
                                                                                          not qualify, but this
                                                                                          does not mean that all
                                                                                          of the content has to
                                                                                          be character text.
                                                                                          Drawings and other
                                                                                          content can be
                                                                                          included with
                                                                                          searchable text notes
                                                                                          under this measure.
                                                                Provide structured       Hospital labs send
                                                                 electronic lab results   structured electronic
                                                                 to ambulatory            clinical lab results
                                                                 providers.               to the ordering
                                                                                          provider for more than
                                                                                          20 percent of
                                                                                          electronic lab orders
                                                                                          received.
Improve Population and Public Health.  Capability to submit     .......................  Successful ongoing
                                        electronic syndromic                              submission of
                                        surveillance data to                              electronic syndromic
                                        public health                                     surveillance data from
                                        agencies, except where                            Certified EHR
                                        prohibited, and in                                Technology to a public
                                        accordance with                                   health agency for the
                                        applicable law and                                entire EHR reporting
                                        practice.                                         period.
                                       Capability to identify   .......................  Successful ongoing
                                        and report cancer                                 submission of cancer
                                        cases to a public                                 case information from
                                        health central cancer                             CEHRT to a public
                                        registry, except where                            health central cancer
                                        prohibited, and in                                registry for the
                                        accordance with                                   entire EHR reporting
                                        applicable law and                                period.
                                        practice.
                                       Capability to identify   .......................  Successful ongoing
                                        and report specific                               submission of specific
                                        cases to a specialized                            case information from
                                        registry (other than a                            Certified EHR
                                        cancer registry),                                 Technology to a
                                        except where                                      specialized registry
                                        prohibited, and in                                for the entire EHR
                                        accordance with                                   reporting period.
                                        applicable law and
                                        practice.
----------------------------------------------------------------------------------------------------------------

B. Reporting on Clinical Quality Measures Using Certified EHR 
Technology by Eligible Professionals, Eligible Hospitals, and Critical 
Access Hospitals

    The following sections address CQMs reporting requirements using 
CEHRT. These include: EHR technology certification requirements; 
criteria for CQM selection; time periods for reporting CQMs; issues 
related to specifications for CQMs and transmission formats; reporting 
options and CQMs for EPs; reporting methods for EPs; reporting options 
and CQMs for eligible hospitals and CAHs; and reporting methods for 
eligible hospitals and CAHs.
1. Time Periods for Reporting CQMs
    This section addresses the reporting periods and submission periods 
as they relate to reporting CQMs only. For a summary of the reporting 
and submission periods proposed for CQMs, please refer to Table 5 in 
the Stage 2 proposed rule (77 FR 13742).
    We proposed that the reporting period for CQMs, which is the period 
during which data collection or measurement for CQMs occurs, would 
continue to track with the EHR reporting periods for the meaningful use 
objectives and measures:
     EPs: January 1 through December 31 (calendar year).
     Eligible Hospitals and CAHs: October 1 through September 
30 (federal fiscal year).
     EPs, eligible hospitals, and CAHs in their first year of 
meaningful use for Stage 1, any continuous 90-day period within the 
calendar year (CY) or federal fiscal year (FY), respectively.

[[Page 54050]]

    To avoid a payment adjustment, Medicare EPs and eligible hospitals 
that are in their first year of demonstrating meaningful use in the 
year immediately preceding any payment adjustment year would have to 
ensure that their 90-day EHR reporting period ends at least 3 months 
before the end of the CY or FY, and that all submission is completed by 
October 1 or July 1, respectively. For more information on payment 
adjustments, see section II.D. of this final rule.
    The submission period is the time during which EPs, eligible 
hospitals, and CAHs may submit CQM information. We proposed the 
submission period for CQM data generally would be the 2 months 
immediately following the end of the EHR reporting period as follows:
     EPs: January 1 through February 28.
     Eligible Hospitals and CAHs: October 1 through November 
30.
     EPs, eligible hospitals, and CAHs in their first year of 
Stage 1: Anytime after the end of their 90-day EHR reporting period 
until the end of the 2 months immediately following the end of the CY 
or FY, respectively. However, for purposes of avoiding the payment 
adjustments, Medicare EPs and eligible hospitals that are in their 
first year of demonstrating meaningful use in the year immediately 
preceding a payment adjustment year must submit their CQM data no later 
than October 1 (EPs) or July 1 (eligible hospitals) of such preceding 
year.
    Comment: Several commenters stated that the first year of a new 
stage for reporting CQMs should only require a 90-day or 180-day 
reporting period instead of a 365-day reporting period.
    Response: We agree that vendors, EPs, eligible hospitals, and CAHs 
may need more time to develop, test, and implement EHR technology 
certified to the 2014 Edition EHR certification criteria and to be able 
to meet the CQM reporting requirements that we proposed beginning in 
2014. Therefore, for the reasons discussed in this section, we are 
modifying the reporting periods for CQMs in 2014 to match the EHR 
reporting periods that we are finalizing for 2014. By using 3-month 
quarters as the reporting periods in 2014 for providers that are beyond 
their first year of demonstrating meaningful use instead of requiring a 
full year as proposed, we allow vendors and health care providers as 
much as 9 months more time to program, develop, and implement CEHRT, 
and meet the requirements for meaningful use in 2014. We note that the 
3-month quarter reporting period is only applicable for 2014. For 2015 
and subsequent years, we are finalizing our proposal of a full year 
reporting period for EPs, eligible hospitals and CAHs that are beyond 
their first year of demonstrating meaningful use. We have selected 3-
month quarters rather than any continuous 90-day period to promote more 
ready comparisons of data. This is particularly important for eligible 
hospitals and CAHs since many of the CQMs that we are finalizing for 
2014 and subsequent years are also used in the CMS Hospital IQR 
Program. We have indicated our desire to transition the CMS Hospital 
IQR Program to collecting EHR-based quality data. Having data from 
hospitals for comparable quarter timeframes as used for the CMS 
Hospital IQR Program will be beneficial for comparing chart abstracted 
data with data derived from CEHRT and will facilitate data collection 
mode for potential future usage for Hospital Compare public reporting 
and the CMS Hospital Value Based Purchasing programs.
    After consideration of the public comments received, we are 
finalizing the reporting and submission periods as follows. The 
reporting period for CQMs generally will be the same as an EP's, 
eligible hospital's, or CAH's respective EHR reporting period for the 
meaningful use objectives and measures, with the exceptions discussed 
later in this section. Please note that Medicare EPs who choose to 
report CQMs through the options we are finalizing that rely on other 
CMS programs (namely, Option 2--PQRS (see section II.B.6.c. of this 
final rule) and the group reporting options--Physician Quality 
Reporting System (PQRS) and Accountable Care Organizations (ACOs) (see 
section II.B.6.d. of this final rule) would be subject to the reporting 
periods for CQMs established for those programs. As an example using CY 
2014, for Medicare EPs who choose to submit CQMs under Option 2 (PQRS 
EHR Reporting Option) for purposes of satisfying the CQM reporting 
component of meaningful use, the reporting periods for the PQRS EHR 
reporting that fall within CY 2014 would apply. Medicaid EPs and 
eligible hospitals must submit CQM data for a reporting period that is 
the same as their EHR reporting period using the reporting methods and 
submission periods specified by their state Medicaid agency.
    In 2013, the reporting period for CQMs will continue to be an EP's, 
eligible hospital's or CAH's respective EHR reporting period. The 
submission period will be the 2 months immediately following the end of 
the CY or FY, respectively (EPs: January 1 through February 28, 2014; 
eligible hospitals and CAHs: October 1 through November 30, 2013). EPs, 
eligible hospitals and CAHs in their first year of meaningful use may 
submit CQM data anytime after the end of their 90-day EHR reporting 
period until the end of the 2 months immediately following the end of 
the CY or FY, respectively.
    Beginning in 2014 and in subsequent years, for EPs, eligible 
hospitals and CAHs that are in their first year of meaningful use, the 
reporting period for CQMs will be their respective 90-day EHR reporting 
period, and they must submit CQM data by attestation. The submission 
period will be anytime after the end of their respective 90-day EHR 
reporting period until the end of the 2 months immediately following 
the end of the CY or FY, respectively. However, for purposes of 
avoiding a payment adjustment, Medicare EPs and eligible hospitals that 
are in their first year of demonstrating meaningful use in the year 
immediately preceding a payment adjustment year must submit their CQM 
data no later than October 1 (EPs) or July 1 (eligible hospitals) of 
such preceding year. We note that these deadlines do not apply to CAHs. 
For more details on submission deadlines specific to CAHs, please refer 
to section II.D.4. of this final rule.
    Beginning in 2014 and in subsequent years, EPs, eligible hospitals 
and CAHs that are beyond their first year of meaningful use must 
electronically submit CQM data unless the Secretary lacks the capacity 
to accept electronic submission. In the unlikely event that the 
Secretary does not have the capacity to accept electronic submission, 
then consistent with sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) 
of the Act, we would continue to accept attestation as a method of 
reporting CQMs. We would inform the public of this fact by publishing a 
notice in the Federal Register and providing instructions on how CQM 
data should be submitted to us. For additional details on the reporting 
methods for EPs, please refer to sections II.B.6.c. and II.B.6.d. of 
this final rule, and for the reporting methods for eligible hospitals 
and CAHs, please refer to section II.B.8.b. of this final rule. The 
reporting periods for CQMs in 2014 for EPs, eligible hospitals, and 
CAHs that are beyond their first year of meaningful use are as follows:
     EPs, eligible hospitals and CAHs may report CQM data for 
the full CY or FY 2014, respectively, if desired. Alternatively, they 
may report CQM data for the 3-month quarter(s) that is/are their 
respective EHR reporting period.

[[Page 54051]]

++ For EPs, the 3-month quarters are as follows:
    --January 1, 2014 through March 31, 2014
    --April 1, 2014 through June 30, 2014
    --July 1, 2014 through September 30, 2014
    --October 1, 2014 through December 31, 2014
++ For eligible hospitals and CAHs, the 3-month quarters are as 
follows:
    --October 1, 2013 through December 31, 2013
    --January 1, 2014 through March 31, 2014
    --April 1, 2014 through June 30, 2014
    --July 1, 2014 through September 30, 2014

    In all cases of electronic submission, the submission period will 
be the 2 months immediately following the end of the CY or FY, 
respectively. This submission period will apply regardless of whether 
an EP, eligible hospital or CAH reports CQM data for the full CY or FY, 
respectively, or only for a 3-month quarter:
     EPs: January 1, 2015 through February 28, 2015.
     Eligible Hospitals and CAHs: October 1, 2014 through 
November 30, 2014.
    The reporting periods for CQMs in 2015 and in subsequent years for 
EPs, eligible hospitals, and CAHs that are beyond their first year of 
meaningful use will be the full CY or FY, respectively. For EPs, we 
expect to accept a single annual submission. For eligible hospitals and 
CAHs, we expect to align with the submission frequency of the Hospital 
IQR program for electronic reporting of CQMs.
    We summarize the reporting and submission periods beginning with 
CY/FY 2014 for EPs, eligible hospitals, and CAHs reporting CQMs via 
attestation in Table 5 and reporting CQMs electronically in Table 6.

  Table 5--Reporting and Submission Periods for EPs, Eligible Hospitals
   and CAHs in Their First Year of Meaningful Use Submitting CQMs via
                  Attestation Beginning With CY/FY 2014
------------------------------------------------------------------------
                                 Reporting period  Submission period for
                                for first year of      first year of
         Provider type            meaningful use       meaningful use
                                    (Stage 1)            (Stage 1)*
------------------------------------------------------------------------
EP............................  90 consecutive     Anytime immediately
                                 days.              following the end of
                                                    the 90[dash]day
                                                    reporting period,
                                                    but no later than
                                                    February 28 of the
                                                    following calendar
                                                    year.
Eligible Hospital/CAH.........  90 consecutive     Anytime immediately
                                 days.              following the end of
                                                    the 90[dash]day
                                                    reporting period,
                                                    but no later than
                                                    November 30 of the
                                                    following fiscal
                                                    year.
------------------------------------------------------------------------
*For purposes of avoiding a payment adjustment, Medicare EPs and
  eligible hospitals that are in their first year of demonstrating
  meaningful use in the year immediately preceding a payment adjustment
  year must submit their CQM data no later than October 1 (EPs) or July
  1 (eligible hospitals) of such preceding year.

    Table 6--Reporting and Submission Periods for EPs, Eligible Hospitals and CAHs Beyond Their First Year of
                     Meaningful Use Submitting CQMs Electronically Beginning With CY/FY 2014
----------------------------------------------------------------------------------------------------------------
                                                                  Reporting period for    Submission period for
                                                                  subsequent years of      subsequent years of
            Provider type                 Optional reporting     meaningful use  (stage   meaningful use  (stage
                                           period in 2014*          1 and subsequent         1 and subsequent
                                                                        stages)                  stages)*
----------------------------------------------------------------------------------------------------------------
EP...................................  Calendar year quarter:   1 calendar year          2 months following the
                                       January 1-March 31.....   (January 1-December      end of the reporting
                                       April 1-June 30........   31).                     period (January 1-
                                       July 1-September 30....                            February 28).
                                       October 1-December 31..
Eligible Hospital/CAH................  Fiscal year quarter....  1 Fiscal year (October   2 months following the
                                       October 1-December 31..   1-September 30).         end of the reporting
                                       January 1-March 31.....                            period (October 1-
                                       April 1-June 30........                            November 30).
                                       July 1-September 30....
----------------------------------------------------------------------------------------------------------------
*NOTE: The optional quarter reporting periods have the same submission period as a full year reporting period
  for electronic submission.

2. EHR Technology Certification Requirements for Reporting of CQMs
    ONC adopts certification criteria for EHR technology and proposed a 
2014 Edition of certification criteria in a proposed rule (77 FR 
13832). As such, we proposed to require that CEHRT, as defined by ONC, 
must be used by EPs, eligible hospitals, and CAHs to satisfy their CQM 
reporting requirements (77 FR 13743). We proposed that CQM reporting 
methods could include the following:

 Aggregate reporting methods (EPs, eligible hospitals, and 
CAHs):
    ++ Attestation
    ++ Electronic submission
 Patient-level reporting methods:
    ++ The PQRS EHR reporting option, the group reporting options for 
PQRS, the Medicare SSP or Pioneer ACOs (note: these are reporting 
methods for EPs)
    ++ The manner similar to the 2012 Medicare EHR Incentive Program 
Electronic Reporting Pilot for Eligible Hospitals and CAHs.
    For the attestation and aggregate electronic reporting methods, we 
proposed that EPs, eligible hospitals, and CAHs must only submit CQMs 
that their EHR technology had been certified to ``incorporate and 
calculate'' (45 CFR 170.314(c)(2) in ONC's rule). For example, if an 
EP's CEHRT was certified to calculate CQMs 1 through 
9, and the EP submitted CQMs 1 through 8 and 
25, the EP would not have met the meaningful use requirement 
for reporting CQMs because his/her CEHRT was not certified to calculate 
CQM 25. For the attestation and aggregate electronic reporting 
methods, we proposed that CEHRT must be certified to the ``reporting'' 
certification criterion proposed for adoption by ONC at 45 CFR 
170.314(c)(3) and which focused on

[[Page 54052]]

EHR technology's capability to create and transmit a standard aggregate 
XML-based file that CMS can electronically accept.
    Comment: Most commenters supported the requirement that EHR 
technology certified to the 2014 Edition EHR certification criteria 
should be able to capture, accurately calculate and transmit CQM data. 
Many of these commenters pointed out EHR technology certified to the 
2011 Edition EHR certification criteria did not produce accurate 
results and was not explicitly tested and certified for accurate CQM 
calculation. As a result of experiences in Stage 1, some commenters 
recommended requiring that EHR technologies be able to calculate all 
measures finalized by CMS in order to be certified rather than 
requiring only one CQM to be certified, as was proposed by ONC to 
satisfy the Base EHR definition. Others supported EHR technology's 
output of data to another product for calculation or output in the 
Quality Reporting Data Architecture (QRDA) format. Many commenters also 
supported consistency among EHR technologies based on certification and 
adequate testing of the systems during certification, including use of 
test data. One commenter recommended closer oversight of vendors by ONC 
and a remediation process for vendors who do not properly implement 
CEHRT.
    Many commenters stated that the specific XML-based format required 
by CMS for CQM reporting should be incorporated into ONC's 
certification criteria. One commenter suggested that all vendors focus 
on codified data collection and provide complete CCD extractions to 
another system (such as PopHealth) and allow that system to manage the 
calculations and data tables as well as provide the extraction of data 
for a QRDA report, stating that this method would save time and money 
because it would not require testing each individual EHR product. 
Another commenter supported the use of CQM definitions that include 
standards for technical and electronic specifications that allow for 
interoperability across EHRs and consistent use among end users.
    Response: Comments on EHR technology certification requirements are 
outside the scope of this final rule and are addressed in ONC's 
Standards and Certification Criteria (S&CC) final rule published 
elsewhere in this issue of the Federal Register. ONC has addressed the 
CQM requirements for the Base EHR definition, the standards necessary 
for the submission of CQM data to CMS, and has made other conforming 
revisions to the proposed certification criteria in response to public 
comments received.
    Comment: Several commenters stated that it was unrealistic to 
expect the transition to EHR technology certified to the 2014 Edition 
EHR certification criteria to be feasible for all EPs and all eligible 
hospitals and CAHs at the same time. These commenters explained that 
EHR vendors would need to develop, test, distribute upgraded products, 
and provide user support for a large number of clients in a short 
amount of time. Furthermore, EPs, eligible hospitals, and CAHs would 
need to devote time and resources as well as have qualified staff to 
purchase and implement the upgraded technology, including testing the 
system and training staff, which may include designing new clinical 
workflows. The commenters requested a more reasonable approach to 
transitioning to the upgraded technology that would ensure proper 
implementation and avoid compromising patient safety.
    Response: We acknowledge that the transition to upgraded EHR 
technology will be a challenge for all parties involved. Due to several 
interrelated factors addressed by ONC and CMS to relieve regulatory 
burden in our respective final rules, we have respectively included 
certain new flexibilities for EPs, eligible hospitals, and CAHs in 
order to allow for a more reasonable transition to the upgraded 
technology. ONC has decided to finalize a more flexible CEHRT 
definition for the EHR reporting periods in FY/CY 2013, which would 
permit EPs, eligible hospitals, and CAHs to use EHR technology that has 
been certified only to the 2014 Edition EHR certification criteria.
    For EPs, eligible hospitals, and CAHs that seek to use EHR 
technology certified only to the 2014 Edition EHR certification 
criteria in FY/CY 2013, we note that EHR technology certified to these 
criteria reflect the new set of CQMs we adopt in this rule for 
reporting beginning with FY/CY 2014. We also note that the reporting 
requirements in FY/CY 2013 are otherwise the same as for FY/CY 2011 and 
2012, including reporting on the CQMs that were finalized in the July 
28, 2010 Stage 1 final rule. For EPs, the reporting schema for CY 2013 
will remain 3 core or alternate core CQMs, and 3 additional CQMs, as 
explained in section II.B.5.b. of this final rule. We note that EHR 
technology certified to the 2014 Edition certification criteria will 
exclude the three CQMs that we are removing from the list of EP CQMs 
for reporting beginning in CY 2014 (NQF 0013, 0027, 0084). NQF 0013 is 
in the list of core CQMs in the Stage 1 final rule, but just as in the 
case where one of the core CQMs would not apply to an EP's scope of 
practice or unique patient population, EPs can select one CQM from the 
list of alternate core CQMs to replace NQF 0013. Therefore, in order to 
meet the CQM reporting criteria for meaningful use in CY 2013, EPs who 
seek to use EHR technology certified only to the 2014 Edition EHR 
certification criteria could only select from CQMs that are included in 
both the Stage 1 and Stage 2 final rules. For eligible hospitals and 
CAHs, the reporting schema for FY 2013 will remain all 15 of the CQMs 
finalized for reporting in FYs 2011 and 2012 because all CQMs that were 
included in the Stage 1 final rule are also included in the Stage 2 
final rule.
    Comment: Most commenters stated that CQM exceptions (allowable 
reason for non-performance of a quality measure for patients that meet 
the denominator criteria and do not meet the numerator criteria) should 
be incorporated into the CQM certification requirements. Many 
commenters also stated that EPs should not be penalized if it is later 
determined that a vendor has not met the certification requirement as 
it would be burdensome and expensive to then purchase additional 
certified modules and modify workflows after an existing EHR is 
determined to be non-certified. The same commenters believed that EPs 
should have an exemption from CQM reporting requirements of meaningful 
use until measures have been tested and vendors have shown they have 
met the certification requirements.
    Some commenters requested delaying implementation of CQMs that 
require information from Labor and Delivery information systems until 
they are certified. One commenter stated that EHR technology should be 
based on the 2011 Edition EHR certification criteria. Another commenter 
stated that very few vendors are providing QI measure data integrity 
and error-checking algorithms, citing the information in FAQ 10839 
which includes that CMS does not require providers to record all 
clinical data in their CEHRT but that providers should report the CQM 
data exactly as it is generated as output from CEHRT.
    Response: We do not agree with the suggestion that EHR technology 
should based on the 2011 Edition EHR certification criteria. The 2014 
Edition EHR certification criteria are significantly enhanced compared 
to 2011 Edition and we believe that it is important for EPs, eligible 
hospitals and CAHs to adopt, implement, and use

[[Page 54053]]

EHR technology based on the updated certification criteria. We expect 
that the enhancements in the 2014 Edition certification criteria will 
address the accuracy of outputs from CEHRT.
    We agree generally with the rest of the comments. All CQMs included 
in this final rule will have electronic specifications available at or 
around the time of publication. Certification requirements are outside 
the scope of this rule. We refer readers to ONC's S&CC final rule 
published elsewhere in this issue of the Federal Register for 
information of certification requirements for items such as CQM 
exceptions. We discuss the testing of CQM specifications in section 
II.B.4. of this final rule. We encourage EPs, eligible hospitals and 
CAHs to refer to the Certified HIT Products List when selecting an EHR 
product (http://oncchpl.force.com/ehrcert). We also encourage EPs, 
eligible hospitals, and CAHs to discuss their intent to participate in 
the EHR Incentive Programs with their vendors, and for vendors to 
communicate intentions related to certification of a product with EPs, 
eligible hospitals or CAHs.
    After consideration of the public comments received, we are 
finalizing the proposals related to EHR technology certification 
requirements for reporting of CQMs subject to the discussion earlier. 
They include:
     The data reported to CMS for CQMs must originate from an 
EP's, eligible hospital's, or CAH's CEHRT that has been certified to 
``capture and export'' in accordance with 45 CFR 170.314(c)(1) and 
``electronic submission'' in accordance with 45 CFR 170.314(c)(3).
     For attestation and the aggregate electronic reporting 
methods, the only CQMs that can be reported are those for which an 
EP's, eligible hospital's, or CAH's CEHRT has been certified to 
``import and calculate'' in accordance with 45 CFR 170.314(c)(2).
     In FY/CY 2013, if an EP, eligible hospital, or CAH seeks 
to use EHR technology certified only to the 2014 Edition EHR 
certification criteria for reporting CQMs, they can only report those 
CQMs that are included in both the Stage 1 and Stage 2 final rules. For 
EPs, this would exclude the option of reporting NQF 0013, 0027, 0084 
from the CQMs in the Stage 1 final rule. Since NQF 0013 is a core CQM 
in the Stage 1 final rule, EPs would select one of the alternate core 
CQMs to replace it. All 15 CQMs for eligible hospitals and CAHs in the 
Stage 1 final rule are included in the Stage 2 final rule.
3. Criteria for Selecting CQMs
    We solicited comment on a wide-ranging list of 125 potential CQMs 
for EPs and 49 potential CQMs for eligible hospitals and CAHs. We 
stated that we expected to finalize only a subset of these proposed 
CQMs. We discussed several criteria that we used to select the proposed 
CQMs.
    In the proposed rule, we stated our commitment to align quality 
measurement and reporting among our programs (for example, IQR, PQRS, 
CHIPRA, ACO programs). We noted that our alignment efforts focus on 
several fronts including using the same measures for different 
programs, standardizing the measure development and electronic 
specification processes across CMS programs, coordinating quality 
measurement stakeholder involvement efforts, and identifying ways to 
minimize multiple submission requirements and mechanisms. In the 
proposed rule, we gave the example that we are working toward allowing 
CQM data submitted via CEHRT by EPs, eligible hospitals and CAHs to 
apply to other CMS quality reporting programs. A longer-term vision 
would be hospitals and clinicians reporting through a single, aligned 
mechanism for multiple CMS programs. We stated our belief that the 
alignment options proposed for PQRS/EHR Incentive Program would be a 
first step toward such a vision.
    Comment: There was strong support for aligning CQMs and reporting 
mechanisms across multiple quality reporting programs as well as 
alignment with the goals of the National Quality Strategy and the HIT 
Policy Committee recommendations. However, some commenters addressed 
utility of the CQMs within the EHR Incentive Program as follows:
     Removal of measures that are not included under other 
quality reporting programs.
     Alignment in other areas such as specifications, reporting 
methods and to whom measures are reported.
     Concern that the penalties that will be applied in 2015, 
given the many problems that were encountered implementing Stage 1 
CQMs.
     Administrative burden required by multiple submission 
requirements and multiple reporting mechanisms. Where possible, one 
commenter encouraged CMS to promote and/or mandate similar action for 
state, accreditation body, and private payer reporting.
    Response: We appreciate the comments received and have made every 
effort to accommodate the concerns by aligning quality reporting for 
EPs with the PQRS EHR Reporting Option and establishing an 
infrastructure for eligible hospitals and CAHs that could be used by 
IQR and other hospital reporting programs to electronically report 
CQMs.
    We continue to explore how data intermediaries and state Medicaid 
Agencies could participate in and further enable these quality 
measurement and reporting alignment efforts, while meeting the needs of 
multiple Medicare and Medicaid programs (for example, ACO programs, 
Dual Eligible initiatives, Medicaid shared savings efforts, CHIPRA and 
Affordable Care Act measure sets). Through these efforts, we intend to 
lessen provider burden and harmonize with our data exchange priorities.
    In addition to statutory requirements for EPs (see section 
II.B.5.a. of this final rule), eligible hospitals (see sections 
II.B.7.a. of this final rule), and CAHs (see section II.B.7.a. of this 
final rule), we relied on other criteria to select the proposed CQMs 
for EPs, eligible hospitals, and CAHs such as measures that can be 
technically implemented within the capacity of the CMS infrastructure 
for data collection, analysis, and calculation of reporting and 
performance rates. This includes measures that are ready for 
implementation, such as those with developed specifications for 
electronic submission that have been used in the EHR Incentive Program 
or other CMS quality reporting initiatives, or that will be ready soon 
after the expected publication of the final rule in 2012. This also 
includes measures that can be most efficiently implemented for data 
collection and submission.
    Comment: There were several comments on infrastructure regarding 
quality measures, the selection of quality measures, challenges of 
implementing EHRs and the lack of coordination between measure 
developers and software vendors. These comments included the following:
     CQMs require data that is not coded in a structured format 
within the EHRs and thus require significant resources and effort, 
including specialized coding and training, in order to build CQMs 
within the EHR systems that can produce accurate results.
     CMS should only include measures which have been 
sufficiently field tested and validated. The National Qualify Forum's 
(NQF) Quality Data Model (QDM) and Measure Authoring Tool (MAT) have 
not been sufficiently tested to ensure valid and accurate EHR CQM 
calculations.
     A general lack of communication between vendors and 
measure stewards.

[[Page 54054]]

    There were also several comments providing additional 
recommendations for selecting quality measures, including CQMs that:
     Can be automatically abstracted from an EHR.
     Rely on data that is considered viable and accurate.
     Definitively support quality care improvement.
     Align with current quality programs.
    Response: The CQMs that we are finalizing for reporting beginning 
with 2014 have either undergone feasibility testing in EHR systems and 
clinical settings or were finalized in the Stage 1 final rule for 
reporting in 2011 and 2012 and specifications have been updated based 
on experiences with reporting those CQMs. In addition, ONC's 2014 
Edition certification criteria explicitly require that the data 
elements be captured for certification (see 45 CFR 170.314(c), as 
discussed in ONC's final rule). We have taken into account the 
recommendations of commenters in our selection of the CQMs finalized 
for reporting beginning in 2014, and we are finalizing measures that 
align with current clinical quality programs as well as definitively 
support quality care improvements.
    Comment: Commenters pointed out the limitations of current CQMs in 
addressing longitudinal patient care management and population health.
    Response: We are finalizing CQMs for EPs, eligible hospitals, and 
CAHs that will have electronic specifications available at or around 
the time of publication of the final rule and also meet the selection 
criteria described in this rule. We agree with the importance of the 
clinical quality measurement goals mentioned by the commenters and are 
working with measure stewards and measure developers to create a 
broader set of electronic CQMs that would address these goals.
    We also identified the following as criteria used in selecting 
CQMs:
     CQMs that can be technically implemented within the 
capacity of the CMS infrastructure for data collection, analysis, and 
calculation of reporting and performance rates. This includes CQMs that 
are ready for implementation, such as those with developed 
specifications for electronic submission that have been used in the EHR 
Incentive Program or other CMS quality reporting initiatives, or that 
will be ready soon after the expected publication of the final rule in 
2012. This also includes CQMs that can be most efficiently implemented 
for data collection and submission.
     CQMs that support CMS and HHS priorities for improved 
quality of care for people in the United States, which are based on the 
March 2011 report to the Congress, ``National Strategy for Quality 
Improvement in Health Care'' (National Quality Strategy, NQS) (http://www.healthcare.gov/law/resources/reports/nationalqualitystrategy032011.pdf) and the Health Information 
Technology Policy Committee's (HITPC's) recommendations (http://healthit.hhs.gov/portal/server.pt?open=512&objID=1815&parentname=CommunityPage&parentid=7&mode=2&in_hi_userid=11113&cached=true).
     CQMs that address known gaps in quality of care, such as 
measures in which performance rates are currently low or for which 
there is wide variability in performance, or that address known drivers 
of high morbidity and/or cost for Medicare and Medicaid.
     CQMs that address areas of care for different types of EPs 
(for example, Medicare- and Medicaid-eligible physicians, and Medicaid-
eligible nurse-practitioners, certified nurse-midwives, dentists, 
physician assistants).
    In an effort to align the CQMs used within the EHR Incentive 
Program with the goals of CMS and HHS, the NQS, and the HITPC's 
recommendations, we have assessed all proposed CQMs against six domains 
based on the NQS's six priorities, which were further developed by the 
HITPC Workgroups, as follows:
     Patient and Family Engagement. These are CQMs that reflect 
the potential to improve patient-centered care and the quality of care 
delivered to patients. They emphasize the importance of collecting 
patient-reported data and the ability to impact care at the individual 
patient level as well as the population level through greater 
involvement of patients and families in decision making, self care, 
activation, and understanding of their health condition and its 
effective management.
     Patient Safety. These are CQMs that reflect the safe 
delivery of clinical services in both hospital and ambulatory settings 
and include processes that would reduce harm to patients and reduce 
burden of illness. These measures should enable longitudinal assessment 
of condition-specific, patient-focused episodes of care.
     Care Coordination. These are CQMs that demonstrate 
appropriate and timely sharing of information and coordination of 
clinical and preventive services among health professionals in the care 
team and with patients, caregivers, and families in order to improve 
appropriate and timely patient and care team communication.
     Population and Public Health. These are CQMs that reflect 
the use of clinical and preventive services and achieve improvements in 
the health of the population served and are especially focused on the 
leading causes of mortality. These are outcome-focused and have the 
ability to achieve longitudinal measurement that will demonstrate 
improvement or lack of improvement in the health of the US population.
     Efficient Use of Healthcare Resources. These are CQMs that 
reflect efforts to significantly improve outcomes and reduce errors. 
These CQMs also impact and benefit a large number of patients and 
emphasize the use of evidence to best manage high priority conditions 
and determine appropriate use of healthcare resources.
     Clinical Processes/Effectiveness. These are CQMs that 
reflect clinical care processes closely linked to outcomes based on 
evidence and practice guidelines.
    We solicited comments on these domains, and whether they would 
adequately align with and support the breadth of CMS and HHS activities 
to improve quality of care and health outcomes.
    Comment: Many commenters supported the NQS initiative. Many 
commenters stated that the domains were imprecise and some CQMs can be 
placed in multiple domains. Some commenters recommended that the Care 
Coordination domain include pre- and post-acute care providers and that 
the CQMs be carefully assigned to the appropriate domains.
    Response: We appreciate the supportive comments with respect to the 
NQS. We agree with commenters that certain CQMs do not fit in only a 
single domain. When we considered CQMs for selection, we also 
considered to what extent a domain is already represented in the 
meaningful use objectives and measures, which use performance 
thresholds. For example, in the area of care coordination, to be a 
meaningful EHR user, a provider must provide a summary of care record 
for more than 50 percent of their transitions of care and referrals. In 
addition, in the area of patient and family engagement, to be a 
meaningful EHR user a provider must make patients' health information 
available to them and potentially their caregivers and families and is 
responsible for ensuring that at least 5 percent of their patients or 
their

[[Page 54055]]

caregivers and families actually access that information. For these 
reasons, we are relaxing the requirement to report CQMs in each domain 
as discussed in section II.B.5.c. of this final rule for EP reporting 
requirements and II.B.7.c. of this final rule for eligible hospital and 
CAH reporting requirements.
    We stated in the proposed rule that we also considered the 
recommendations of the Measure Applications Partnership (MAP) for 
inclusion of CQMs. The MAP is a public-private partnership convened by 
the National Quality Forum (NQF) for the primary purpose of providing 
input to HHS on selecting performance measures for public reporting. 
The MAP published draft recommendations in their Pre-Rulemaking Report 
on January 11, 2012 (http://www.qualityforum.org/map/), which includes 
a list of, and rationales for, all the CQMs that the MAP did not 
support. The MAP did not review the CQMs for 2011 and 2012 that were 
previously adopted for the EHR Incentive Program in the Stage 1 final 
rule. We stated in the proposed rule that we included some of the CQMs 
not supported by the MAP in Tables 7 (EPs) and 8 (eligible hospitals 
and CAHs) to ensure alignment with other CMS quality reporting 
programs, address recommendations by other Federal advisory committees 
such as the HITPC, and support other quality goals such as the Million 
Hearts Campaign. We also stated that we included some CQMs to address 
specialty areas that may not have had applicable CQMs in the Stage 1 
final rule.
    We stated in the proposed rule that we anticipated that only a 
subset of these CQMs would be finalized. We stated that in considering 
which measures to finalize, we would take into account public comment 
on the CQMs themselves and the priorities listed previously. We also 
stated that we intended to prioritize CQMs in order to align with and 
support to the extent possible the measurement needs of CMS program 
activities related to quality of care, delivery system reform, and 
payment reform, especially the following:
     Encouraging the use of outcome measures, which provide 
foundational data needed to assess the impact of these programs on 
population health.
     Measuring progress in preventing and treating priority 
conditions, including those affecting a large number of CMS 
beneficiaries or contributing to a large proportion of program costs.
     Improving patient safety and reducing medical harm.
     Capturing the full range of populations served by CMS 
programs.
    Comment: Several commenters support the inclusion of CQMs 
recommended by the MAP. A commenter supported CQMs which are both MAP 
evaluated and NQF endorsed. Another commenter raised concern that CMS 
did not have enough time to consider the MAP recommendations as the 
CQMs published in the proposed rule differ from those recommended by 
the MAP. Some commenters were concerned that limiting the CQMs to MAP-
supported and/or NQF-endorsed CQMs would discourage CQM innovation and 
the creation of novel CQMs and those that cover more specialties.
    Response: We carefully considered the MAP recommendations and took 
NQF endorsement status into consideration when making our CQM 
selections for reporting beginning with 2014. In order to align with 
other quality reporting programs and address recommendations by other 
Federal advisory committees, such as the HITPC, as well as consider 
CQMs endorsed by other multistakeholder groups, we considered CQMs that 
were not supported by the MAP. After consideration of the public 
comments received, we are finalizing the policies on criteria for 
selecting CQMs as proposed.
4. CQM Specification
    We stated in the proposed rule that we do not intend to use notice 
and comment rulemaking as a means to update or modify CQM 
specifications. In general, it is the role of the measure steward to 
make changes to a CQM in terms of the initial patient population, 
numerator, denominator, and potential exclusions. We recognized that it 
may be necessary to update CQM specifications after they have been 
published to ensure their continued relevance, accuracy, and validity. 
Measure specifications updates may include administrative changes, such 
as adding the NQF endorsement number to a CQM, correcting faulty logic, 
adding or deleting codes as well as providing additional implementation 
guidance for a CQM.
    These changes would be described in full through supplemental 
updates to the electronic specifications for EHR submission provided by 
CMS. We stated that measures would be tracked on a version basis as 
updates to those CQMs are made, and we would require EPs, eligible 
hospitals, and CAHs to submit the versions of the CQMs as identified on 
our Web site.
    We stated in the proposed rule that the complete CQM specifications 
would be posted on our Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp) at or around the time of the final 
rule. In order to assist the public in considering the proposed CQMs, 
we published tables titled ``Proposed CQMs for 2014 CMS EHR Incentive 
Programs for Eligible Professionals'' and ``Proposed CQMs for 2014 CMS 
EHR Incentive Programs for Eligible Hospitals and CAHs'' on this Web 
site. These tables contain additional information for the EP, eligible 
hospital, and CAH CQMs, respectively, which may not be found on the NQF 
Web site. We noted that some of the CQMs were still being developed and 
that the additional descriptions provided in the tables may still 
change before the final rule is published. We noted that the titles and 
descriptions for the CQMs included in these tables were updated by the 
measure stewards and therefore may not match the information provided 
on the NQF Web site.
    We proposed that, under certain circumstances, it may be necessary 
to remove a CQM from the EHR Incentive Programs between rulemaking 
cycles. We stated in the proposed rule that when there is reason to 
believe the continued collection of a CQM as it is currently specified 
raises potential patient safety concerns and/or is no longer 
scientifically valid, we would take immediate action to remove the CQM 
from the EHR Incentive Programs and not wait for the next rulemaking 
cycle. Likewise, we stated if a CQM undergoes a substantive change by 
the measure steward between rulemaking cycles such that the measure's 
intent has changed, we would remove the measure immediately from the 
EHR Incentive Programs until the next rulemaking cycle when we could 
propose the revised CQM for public comment. Under this proposed policy, 
we would promptly remove such CQMs from the set of CQMs available for 
EPs or eligible hospitals and CAHs to report under the EHR Incentive 
Programs, confirm the removal or propose the revised CQM, in the next 
EHR Incentive Programs rulemaking cycle, and notify providers (EPs, 
eligible hospitals, and CAHs) and the public of our decision to remove 
the CQM(s) through the usual communication channels (memos, email 
notification, web site postings).
    Comment: Numerous commenters indicated the importance of having CQM 
specifications and implementation guides as soon as possible. Several 
commenters pointed out that CQMs without electronic specifications 
should be re-tooled as eMeasures prior to inclusion in meaningful use.

[[Page 54056]]

    Response: We will provide complete CQM specifications at or around 
the time of the publication of this final rule on our Web site (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/ElectronicSpecifications.html). All of the 
CQMs that we are finalizing will be fully specified.
    Comment: Many commenters noted that more than 6 months is needed to 
deploy and adequately test upgrades that may affect clinician workflows 
and patient safety. Other commenters stated that software developers 
need at least 18 to 24 months to alter their systems and allow for 
installation of software to complete process updates, development, 
testing, error checks, training, and roll-out before the reporting 
periods begin. Multiple commenters requested notification and a 
scheduled approach to making changes to CQM specifications. Commenters 
suggested that CMS post the CQMs and updates in one place for easy 
reference.
    Response: We understand health care providers and software 
developers need sufficient time to accommodate CQM specification 
updates. However, we must balance this with our policy priority for 
CQMs to remain consistent with clinical practice guidelines and any new 
scientific data related to efficacy. To address the timing concerns 
mentioned by commenters, we expect to make the updated specifications, 
which will be tracked on a version basis, publicly available through 
our Web site (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/ElectronicSpecifications.html) 
approximately 6 months in advance of the beginning of the CY and FY for 
EPs and hospitals, respectively. We will make every effort to have 
updated specifications made available earlier and ensure that measure 
updates are limited in scope. In the event that we remove CQMs between 
rulemakings, we will post this information on the same Web site and 
notify the public through listserv and any additional communication 
channels that may be appropriate.
    Comment: Many commenters stated that CQM specifications should not 
have to be updated in CEHRT during the period for which the EHR product 
is certified. Some commenters pointed out the burden and complexity of 
supporting multiple versions of the CQMs concurrently (that is, the 
specifications authorized for use within the current reporting period, 
and the updated specifications intended for implementation in the 
following reporting period).
    Response: CQM specifications are updated to maintain alignment with 
current clinical guidelines and ensure that the CQM remains relevant 
and actionable within the clinical care setting. We believe the 
benefits of having the ability to update specifications more frequently 
than the rulemaking cycle for the EHR Incentive Programs outweighs the 
burden and complexity identified by commenters.
    As a result of aligning with other quality reporting programs (for 
example, PQRS), the CQMs and specifications are being used in multiple 
programs. If we do not have the ability to update specifications 
annually, then our respective programs may no longer align. 
Furthermore, without having the ability to update the specifications at 
least annually, the CQMs could become obsolete and would not adequately 
reflect current best practices. The majority of the administrative 
changes expected in the annual specification updates would reflect 
updates that vendors would routinely push to their clients' EHR 
technologies (for example, drug code updates).
    We did not receive any comments on our proposed policy to remove 
CQMs between rulemaking cycles under certain circumstances.
    After consideration of the public comments received, we are 
finalizing the following policies on CQM specifications. Updates to CQM 
specifications may be provided annually approximately 6 months in 
advance of the FY/CY for hospitals and EPs, respectively. Providers 
will not be required to use the updated specifications for purposes of 
submitting the CQMs for the EHR Incentive Program unless specified in 
future rulemaking. We note that EPs choosing to submit CQMs through 
another quality reporting program (for example, PQRS) would need to use 
the updated specifications if required by the other program. We are 
finalizing the policy on removing CQMs between rulemaking cycles under 
certain circumstances as proposed. In the event that one or more CQMs 
are removed between rulemakings, the number of CQMs that an EP, 
eligible hospital, or CAH must report would be reduced by the number of 
CQMs removed. For example, if one EP CQM was removed from the set of 
CQMs finalized for EPs in Table 7, EPs would only be required to submit 
8 CQMs instead of 9. Likewise, if a hospital CQM is removed from the 
set of CQMs finalized in Table 8, eligible hospitals and CAHs would 
only be required to submit 15 CQMs instead of 16. The requirement that 
the CQMs submitted cover at least 3 domains will remain the same unless 
all CQMs for a particular domain have been eliminated. EPs that are not 
affected by such a removal of a CQM between rulemakings and could 
report on other CQMs are expected to continue reporting on 9 CQMs. 
Likewise, eligible hospitals and CAHs that are not affected and could 
report on other CQMs are expected to continue reporting on 16 CQMs.
5. CQMs for EPs
(a) Statutory and Other Considerations
    Sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C) of the Act provide 
for the reporting of CQMs by EPs as part of demonstrating meaningful 
use of CEHRT. For further explanation of the statutory requirements, we 
refer readers to the discussion in our proposed and final rules for 
Stage 1 (75 FR 1870 through 1902 and 75 FR 44380 through 44435, 
respectively).
    Under sections 1848(o)(1)(D)(iii) and 1903(t)(8) of the Act, the 
Secretary must seek, to the maximum extent practicable, to avoid 
duplicative requirements from federal and state governments for EPs to 
demonstrate meaningful use of CEHRT under Medicare and Medicaid. 
Therefore, to meet this requirement, we continued our practice from 
Stage 1 of proposing CQMs that would apply for both the Medicare and 
Medicaid EHR Incentive Programs, as listed in sections II.B.5.b. and 
II.B.5.c. of this final rule.
    Section 1848(o)(2)(B)(iii) of the Act requires that in selecting 
CQMs for EPs, and in establishing the form and manner of reporting, the 
Secretary shall seek to avoid redundant or duplicative reporting 
otherwise required, including reporting under subsection (k)(2)(C) 
(that is, reporting under the PQRS). Consistent with that requirement, 
we proposed to select CQMs for EPs for the EHR Incentive Programs that 
align with other quality reporting programs mentioned in the proposed 
rule (77 FR 13745). We stated in the proposed rule that when a CQM is 
included in more than one CMS quality reporting program and is reported 
using CEHRT, we would seek to avoid requiring EPs to report the same 
CQM to separate programs through multiple transactions or mechanisms.
    Section 1848(o)(2)(B)(i)(I) of the Act requires the Secretary to 
give preference to CQMs endorsed by the entity with a contract with the 
Secretary under section 1890(a) (namely, the NQF). We proposed CQMs for 
EPs for 2013, 2014, and 2015 (and potentially subsequent years) that 
reflect this preference,

[[Page 54057]]

although we note that the Act does not require the selection of NQF 
endorsed CQMs for the EHR Incentive Programs. CQMs listed in this final 
rule that do not have an NQF identifying number are not NQF endorsed, 
but are included in this final rule with the intent of eventually 
obtaining NQF endorsement of those CQMs determined to be critical to 
our program.
    We stated our intent to increase the total number of CQMs for EPs 
to include areas such as behavioral health, dental care, long-term 
care, special needs populations, and care coordination. We proposed new 
pediatric CQMs, an obstetric CQM, behavioral/mental health CQMs, CQMs 
related to HIV medical visits and antiretroviral therapy, two oral 
health CQMs, as well as other CQMs that address NQS goals. Although we 
did not propose additional CQMs in the areas of long-term and post-
acute care due to the lack of electronic specifications, we stated that 
we would continue to develop or identify CQMs for these areas for 
future years. We received public comments related to statutory and 
other considerations. We have responded to those comments in later 
sections of this final rule, including comments related to form and 
manner and the clinical areas covered by specific CQMs (see sections 
II.B.6.c. or II.B.6.d. of this final rule).
(b) CQMs for EPs for CY 2013
    We proposed that for the EHR reporting periods in CY 2013, EPs must 
submit data for the CQMs that were finalized in the Stage 1 final rule 
for CYs 2011 and 2012 (75 FR 44398 through 44411, Tables 6 and 7). We 
stated that we expected to post updates to the CQMs' electronic 
specifications on the EHR Incentive Program Web site at least 6 months 
prior to the start of CY 2013. As required by the Stage 1 final rule, 
EPs must report on 3 core or alternate core CQMs, plus 3 additional 
CQMs. We referred readers to the discussion in the Stage 1 final rule 
for further explanation of the requirements for reporting those CQMs 
(75 FR 44398 through 44411).
    We received no public comments and are finalizing these proposals 
for EPs for CY 2013. We have posted updates to the CQM specifications 
on the EHR Incentive Program Web site (https://www.cms.gov/apps/ama/license.asp?file=/QualityMeasures/Downloads/QMEPSupplemental.zip) and 
note that they will be optional with respect to CY 2013 reporting.
(c) CQMs and Reporting Options for EPs Beginning with CY 2014
(i) Reporting Options
    We proposed two reporting options that would begin in CY 2014 for 
Medicare and Medicaid EPs, as described as follows: Options 1 and 2. We 
proposed the CQMs listed in Table 8 of the proposed rule (77 FR 13749 
through 13757) for all EPs (Medicare and Medicaid) for the EHR 
reporting periods in CYs 2014, 2015, and potentially subsequent years, 
regardless of whether an EP is in Stage 1 or Stage 2 of meaningful use. 
We stated that the policies and CQMs proposed for CYs 2014 and 2015 
would continue to apply in CY 2016 and subsequent years until a new 
rule is published. Therefore, we referred to CQMs that apply 
''beginning with'' or ''beginning in'' CY 2014. We stated that for 
Medicaid EPs, although the reporting method for CQMs may vary by state, 
the set of CQMs from which to select would be the same as for Medicare 
EPs. We stated that Medicare EPs who are in their first year of Stage 1 
may report CQMs by attestation.
    For Option 1, we proposed two alternatives (Options 1a and 1b), but 
stated that we intended to finalize only a single method. We proposed 
that Medicare EPs who participate in both the PQRS EHR reporting option 
and the EHR Incentive Program may choose Option 2 instead of Option 1.
     Option 1a: We proposed that EPs would select and report 12 
CQMs from those listed in Table 8 of the proposed rule (77 FR 13749 to 
13757), including at least 1 CQM from each of the 6 domains, which are 
described in section II.B.3. of this final rule. EPs would select the 
CQMs that best apply to their scope of practice and/or unique patient 
population. If an EP's CEHRT does not contain patient data for at least 
12 CQMs, then the EP must report the CQMs for which there is patient 
data and report the remaining required CQMs as ''zero denominators'' as 
displayed by the EPs CEHRT. If there are no CQMs applicable to the EP's 
scope of practice or unique patient populations, EPs must still report 
12 CQMs even if zero is the result in either the numerator and/or the 
denominator of the CQM. If all applicable CQMs have a value of zero 
from their CEHRT, then EPs must report any 12 of the CQMs. We noted one 
advantage of this approach is that EPs can choose CQMs that best fit 
their practice and patient populations. However, because of the large 
number of CQMs to choose from, this approach would result in fewer EPs 
reporting on any given CQM, and likely only a small sample of patient 
data represented in each CQM. We proposed that EPs would submit the CQM 
data in an XML-based format on an aggregate basis reflective of all 
patients without regard to payer.
     Option 1b: We proposed that EPs would report 11 ``core'' 
CQMs listed in Table 6 of the proposed rule (77 FR 13746 to 13747), 
plus 1 ``menu'' CQM from Table 8 of the proposed rule (77 FR 13749 to 
13757). We noted that the ''core'' CQM set reflected the national 
priorities outlined in section II.B.3. of the proposed rule. EPs would 
select 1 CQM to report from the ``menu'' set based on their respective 
scope of practice and/or unique patient population. We explained one 
advantage of this approach is that quality data would be collected on a 
smaller set of CQMs, so the resulting data for each CQM would represent 
a larger number of patients and therefore could be more accurate. 
However, this approach could mean that more CQMs are reported with zero 
denominators (if they are not applicable to certain practices or 
populations), making the data less comprehensive. We stated that the 
policy on reporting ''zeros'' in the numerator and/or denominator of a 
CQM, as discussed previously under Option 1a, would also apply for 
Option 1b.
     Option 2: Submit and satisfactorily report CQMs under the 
PQRS's EHR Reporting Option.
    We proposed that Medicare EPs who participate in both the PQRS EHR 
reporting option and the EHR Incentive Program may choose Option 2 
instead of Option 1. In order to streamline quality reporting options 
for EPs participating in both programs, we proposed that Medicare EPs 
who submit and satisfactorily report PQRS CQMs under the PQRS's EHR 
reporting option using CEHRT would satisfy the CQM reporting 
requirement under the Medicare EHR Incentive Program. We referred 
readers to 42 CFR 414.90 and the CY 2012 Medicare PFS final rule with 
comment period (76 FR 73314) for more information about the existing 
requirements of the PQRS and stated that EPs who choose this Option 2 
would be required to comply with any changes to the requirements of the 
PQRS that may apply in future years.
    Comment: Many commenters preferred Option 1a instead of 1b since it 
offers more flexibility and a larger selection of CQMs, especially for 
specialties including surgery, otolaryngology, urology, and psychiatry. 
However, they also indicated that it would be difficult to report 1 CQM 
from each of the 6 domains that apply to their scope of practice and/or 
unique patient population.

[[Page 54058]]

    Other commenters supported Option 1b over 1a as long as it limits 
the number of CQMs to those that vendors would be required to support. 
A few commenters suggested removing the ``one menu CQM'' requirement 
entirely.
    Many commenters suggested a modification of Options 1a and 1b to 
require reporting a specific number of core CQMs (fewer than the 11 
proposed) and a specific number of menu CQMs (more than 1 as proposed) 
along with some changes to the domain requirement. Many commenters 
suggested a reporting option requiring EPs to report 6 clinically 
relevant CQMs covering at least 2 domains, and if no CQMs are 
clinically relevant for an EP, they must demonstrate zeros in the 
denominator for 6 CQMs covering at least 2 domains. A few commenters 
suggested requiring up to 9 CQMs covering a range of 2 to 4 domains. 
One commenter also advocated for the retention of all three reporting 
options (1a, 1b, and 2) so that EPs could select the one most 
appropriate to their practice.
    Response: We agree that a modified approach for Option 1 would 
provide a more optimal reporting schema for most EPs. In our modified 
approach, we included the positive and minimized the negative 
components of each of the two proposed options where possible. The 
Option 1 that we are finalizing (as explained in detail later) 
decreases the number of CQMs that EPs must select to report, decreases 
the total number of domains required to be covered among the selected 
CQMs, recommends but does not require reporting from a ``core'' set of 
CQMs, and offers specialist EPs the flexibility to select CQMs that are 
applicable to their scope of practice.
    We note the following CQMs in the finalized recommended core sets 
for adults and children were included in the proposed core set: NQF 
0018, 0022, 0024, 0028, 0418, and TBD--Closing the referral loop: 
receipt of specialist report.
    Comment: We also received many comments on Option 2. Numerous 
commenters supported Option 2, including the submission of CQM data via 
the PQRS program and receiving credit for both PQRS and meaningful use. 
However, some of these commenters indicated that not all EPs qualify to 
participate in PQRS. Another concern was that the patient population 
reported differs between the two programs in that PQRS requires 
reporting on Medicare patients only, whereas meaningful use reflects 
all patients without regard to payer.
    Response: For the reporting of CQMs, we are finalizing Option 2 as 
proposed in order to reduce reporting burden on EPs who participate in 
both programs and attain the goal of alignment with the PQRS EHR 
reporting option. EPs who do not participate in PQRS may submit CQMs 
for the EHR Incentive Program using Option 1. Regardless of whether an 
EP chooses Option 1 or Option 2 for CQM reporting, we note that all EPs 
must also report the meaningful use objectives and measures through 
attestation, as well as meet all other meaningful use requirements.
    We acknowledge that under the PQRS, only Medicare patient 
information is submitted. In general, our preference is to measure 
quality at the all patient level, based on samples of all patient data 
(that is, patients that meet the denominator criteria of each reported 
CQM). We believe this provides a better assessment of overall care 
quality rendered by EPs. However, although meaningful use reflects all 
patients without regard to payer, we believe Option 2 is appropriate 
because it is a step in the direction of the longer-term goal of a 
single, aligned mechanism for multiple CMS programs.
    After consideration of the public comments received, and for the 
reasons discussed earlier, we are finalizing two reporting options 
beginning with CY 2014 for EPs in all stages of meaningful use. These 
options will continue to apply in the event that we have not engaged in 
another round of rulemaking by CY 2016.
    Option 1: Report 9 CQMs covering at least 3 domains.
    Medicare and Medicaid EPs selecting this reporting option will be 
required to submit a total of 9 CQMs covering at least 3 domains from 
Table 7. We expect EPs would select the CQMs that best apply to their 
scope of practice and/or unique patient population. For this reporting 
option, CQMs will be submitted on an aggregate basis reflective of all 
patients without regard to payer. We are not requiring the submission 
of a core set of CQMs, but we identify two recommended core sets, one 
for adults and one for children, that we encourage EPs to report to the 
extent those CQMs are applicable to an EP's scope of practice and 
patient population. If an EP's CEHRT does not contain patient data for 
at least 9 CQMs covering at least 3 domains, then the EP must report 
the CQMs for which there is patient data and report the remaining 
required CQMs as ``zero denominators'' as displayed by the EP's CEHRT. 
If there are no CQMs applicable to the EP's scope of practice and 
patient population, EPs must still report 9 CQMs even if zero is the 
result in either the numerator or the denominator of the measure. If 
all applicable CQMs have a value of zero from their CEHRT, then EPs 
must report any 9 CQMs from Table 7.
    Option 2: Submit and satisfactorily report CQMs under the PQRS's 
EHR Reporting Option.
    Under this option, Medicare EPs who participate in both the PQRS 
and the Medicare EHR Incentive Program will satisfy the CQM reporting 
component of meaningful use if they submit and satisfactorily report 
PQRS CQMs under the PQRS's EHR reporting option using CEHRT. EPs 
choosing to report under this option for purposes of the Medicare EHR 
Incentive Program will be subject to the reporting periods established 
for the PQRS EHR reporting option, which may be different from their 
EHR reporting period for the meaningful use objectives and measures. 
For example, in CY 2014, an EP who is beyond his or her first year of 
meaningful use will have a 3-month quarter EHR reporting period for the 
meaningful use objectives and measures, but the reporting periods for 
the PQRS EHR reporting option that fall within CY 2014 would apply for 
purposes of reporting CQMs. We emphasize that EPs who are in their 
first year of demonstrating meaningful use in the year immediately 
preceding a payment adjustment year cannot choose this Option 2 for 
reporting CQMs for the EHR Incentive Program. For purposes of avoiding 
a payment adjustment, they must submit their CQM data by attestation no 
later than October 1 of such preceding year. For more information on 
the requirements of the PQRS, we refer readers to 42 CFR 414.90 and the 
CY 2013 Medicare PFS proposed rule (77 FR 44805 through 44988). EPs who 
choose this option to satisfy the CQM reporting component of meaningful 
use under the Medicare EHR Incentive Program will be required to comply 
with any changes to the PQRS that may apply in future years.
(ii) CQMs
    We proposed to remove three CQMs beginning with CY 2014 for EPs at 
all stages of meaningful use for the following reasons:
     NQF  0013--The measure steward did not submit 
this CQM to the NQF for continued endorsement. We included other CQMs 
that address high blood pressure and hypertension in Table 8 in the 
proposed rule.
     NQF 0027--We determined this CQM is very similar 
to NQF 0028 a and b; therefore, to avoid duplication, we 
proposed to only retain NQF  0028 a and b.
     NQF 0084--The measure steward did not submit this 
CQM to the NQF for continued endorsement. Additionally,

[[Page 54059]]

CMS has decided to remove this CQM because there are other FDA-approved 
anticoagulant therapies available in addition to Warfarin. We proposed 
to replace this measure, pending availability of electronic 
specifications, with NQF 1525--Atrial Fibrillation and Atrial 
Flutter: Chronic Anticoagulation Therapy.
    We did not receive public comments and are finalizing the 
elimination of measures NQF 0013, NQF 0027, and NQF 
0084 beginning with CY 2014 for EPs at all stages of 
meaningful use. We proposed to replace NQF 0084 with NQF 
1525, which was determined to contain data elements that were 
difficult to capture in EHRs after additional feasibility testing. 
Therefore, we are implementing an Adverse Drug Events CQM to replace 
NQF 0084:
    Title: ADE Prevention and Monitoring: Warfarin Time in Therapeutic 
Range.
    Description: Average percentage of time in which individuals with 
atrial fibrillation who are on chronic anticoagulation have 
International Normalized Ratio (INR) test results within the 
therapeutic range during the measurement period.
    For a list of all the CQMs proposed for EPs to report for the EHR 
Incentive Programs beginning with CY 2014, please refer to Table 8 in 
the Stage 2 proposed rule (77 FR 13749 to 13757). We stated that we 
expected to finalize only a subset of the CQMs listed in Table 8 based 
on public comments and the priorities discussed in section II.B.3. of 
the proposed rule.
    We noted that some of these CQMs had not yet been submitted for 
consensus endorsement consideration or were under review for 
endorsement consideration by the NQF. We stated that we expect that any 
measure proposed in Table 8 for inclusion beginning with CY 2014 would 
be submitted for endorsement consideration by the measure steward. 
Because measure specifications may need to be updated more frequently 
than our expected rulemaking cycle will allow for, we stated that we 
would provide updates to the specifications at least 6 months prior to 
the beginning of the calendar year for which the measures would be 
required, and we expected to update specifications annually.
    Comment: Many commenters indicated support for CMS's efforts to 
include CQMs that are broadly applicable across primary care and 
specialist EPs. However, many commenters also stated that most of the 
proposed CQMs apply to primary care practices and preventive medicine 
and requested more CQMs that apply to specialist practices or to adjust 
the reporting requirements to match the number of clinically available 
CQMs for nonprimary care EPs. Another commenter requested pediatricians 
be excluded from having to report on CQMs for patients older than 18 
years old rather than having to demonstrate zero denominators on a 
population that does not apply to them.
    Many commenters stated that there were too many CQMs, citing issues 
with implementation of such a large set of measures as well as diluting 
the impact of quality measurement. Some of these commenters believed 
that CMS should focus on a smaller set of CQMs to refine for accuracy 
in implementation. They also did not believe that they should have to 
build CQMs into their CEHRT if those CQMs did not apply to their scope 
of practice because those CQMs would only yield zero denominators. Some 
suggested alternatives to building out all CQMs included allowing EPs 
to attest to having a low denominator, such as 25 or fewer patients, or 
for CMS to assign the primary care or specialty fields that each CQM 
applies to, whereby EPs whose field is not listed for a particular CQM 
would be exempt from reporting that CQM.
    Many of the proposed EP CQMs received support from the public. Some 
commenters gave feedback on specific proposed CQMs, including questions 
on the feasibility of reporting the CQM, issues with specific 
requirements of the CQM, and preferences for preventative CQMs. A few 
commenters did not support finalizing CQMs that were not NQF endorsed. 
We also received suggestions for additional CQMs that were not included 
in the list of 125 proposed EP CQMs. A few commenters expressed concern 
about the lack of transparency in the development of the CQMs.
    Response: We stated in the Stage 2 proposed rule that we would be 
finalizing a subset of the proposed CQMs. We convened a Quality 
Measures Task Force (QMTF), which is made up of stakeholders from 
across the Department and includes representation from different 
quality reporting programs. Through the QMTF and with senior 
leadership, we considered public comments, feasibility of the 
electronic specifications to be captured in EHRs, and the goals stated 
in section II.B.3. of this final rule when selecting the finalized list 
of EP CQMs. By including such a large representation of stakeholders, 
we believe that we have prioritized CQMs that align with other 
programs, which includes CQMs that are not used in other programs 
currently but could be implemented in other programs as they include 
more electronically specified CQMs in their respective CQM lists. This 
will move us closer to our longer-term goal of having a single, aligned 
mechanism for CQM reporting.
    Since the measure stewards are responsible for any information that 
affects the requirements of the CQM, we have shared the feedback on 
specific CQMs with the respective measure stewards. Consideration of 
both evidence and expert consensus are integral parts of the NQF's 
measure endorsement process. More information on this Consensus 
Development Process is available on the NQF Web site: http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx. Although we give preference to CQMs that have been 
endorsed by NQF, section 1848(o)(2)(B)(i)(I) of the Act does not 
require the selection of NQF-endorsed CQMs for the EHR Incentive 
Program. Please refer to section II.B.3. of this final rule for the 
discussion on criteria for inclusion of a CQM.
    We appreciate the commenters' suggestions for additional CQMs that 
apply to specialties that may not have been as represented in the 
measure set as primary care or preventative medicine. Although we 
cannot in this final rule select CQMs that were not proposed in the 
proposed rule, we will consider the suggested CQMs for future 
inclusion. As for the commenters' request to adjust the reporting 
requirements or exclude certain specialties from reporting certain 
CQMs, we believe that our policy on allowing ``zero denominators'' to 
be reported allows specialists to meet the CQM reporting requirements 
of meaningful use and is a continuation of our policy from the Stage 1 
final rule.
    Comment/Response: Table 7 summarizes the public comments received 
on specific proposed EP CQMs and the CMS rationale (that is, our 
response to the CQM-specific comment(s)) for finalizing or not 
finalizing the CQM for reporting beginning with CY 2014.

[[Page 54060]]

         Table 7--Summary of EP CQM-Specific Comments and Rationale To Finalize or Not Finalize the CQM
----------------------------------------------------------------------------------------------------------------
                                                        Commenters do not
             CQM No.               Commenters support        support            Finalized          Rationale
                                      finalization         finalization
----------------------------------------------------------------------------------------------------------------
NQF 0002........................  No comments........  No comments........  Yes.............  Addresses
                                                                                               efficient use of
                                                                                               resources;
                                                                                               alignment with
                                                                                               other programs.
NQF 0004........................  Supports measure...  Privacy concerns;    Yes.............  Addresses high
                                                        concerned that it                      priority agency
                                                        could be difficult                     goals and aligns
                                                        to implement.                          with other
                                                                                               quality reporting
                                                                                               programs. We
                                                                                               retained NQF 0004
                                                                                               in order to
                                                                                               represent the
                                                                                               important issue
                                                                                               of alcohol or
                                                                                               other drug
                                                                                               dependence
                                                                                               treatment in our
                                                                                               measure set. We
                                                                                               also believe that
                                                                                               through our
                                                                                               collaboration
                                                                                               with ONC, we have
                                                                                               addressed the
                                                                                               issues associated
                                                                                               with data
                                                                                               collection.
NQF 0018........................  Public comment       No comments........  Yes.............  Supports high
                                   supports measure.                                           priority goals
                                                                                               (controlling high
                                                                                               blood pressure).
NQF 0022........................  No comments........  Measure is not       Yes.............  Addresses patient
                                                        supported by                           safety. NQF
                                                        evidence.                              requires clinical
                                                                                               evidence
                                                                                               supporting a
                                                                                               measure in order
                                                                                               to achieve NQF
                                                                                               endorsement.
NQF 0024........................  Support for measure  Contains data        Yes.............  Supports high
                                   but evidence only    elements that are                      priority goals
                                   for overweight,      difficult to                           (weight
                                   obese, or            capture as                             assessment,
                                   underweight          structured data.                       nutrition,
                                   children and not                                            physical activity
                                   ideal weight.                                               for children);
                                                                                               received strong
                                                                                               public support.
                                                                                               Based on industry
                                                                                               standards, CMS is
                                                                                               collaborating
                                                                                               with other
                                                                                               federal agencies
                                                                                               and private
                                                                                               organizations to
                                                                                               standardize data
                                                                                               elements.
NQF 0028........................  Support for measure  Concerns about       Yes.............  Supports high
                                                        capturing discrete                     priority goals
                                                        data.                                  (tobacco use
                                                                                               cessation);
                                                                                               alignment with
                                                                                               other programs.
NQF 0031........................  No comments........  Does not align with  Yes.............  This CQM is
                                                        current clinical                       currently NQF
                                                        guidelines for                         endorsed.# This
                                                        frequency of                           is a high
                                                        screening.                             priority
                                                                                               prevention
                                                                                               measure for
                                                                                               breast cancer.
NQF 0032........................  No comments........  Does not align with  Yes.............  This CQM is
                                                        current clinical                       currently NQF
                                                        guidelines for                         endorsed# and
                                                        frequency of                           will be updated
                                                        screening.                             for consistency
                                                                                               with clinical
                                                                                               guidelines as
                                                                                               discussed earlier
                                                                                               in this section.
                                                                                               This is a high
                                                                                               priority
                                                                                               prevention
                                                                                               measure for
                                                                                               cervical cancer.
NQF 0033........................  No comments........  Does not align with  Yes.............  This CQM is
                                                        current clinical                       currently NQF
                                                        guidelines for                         endorsed# and
                                                        frequency of                           will be updated
                                                        screening.                             for consistency
                                                                                               with clinical
                                                                                               guidelines as
                                                                                               discussed earlier
                                                                                               in this section.
                                                                                               This is a high
                                                                                               priority
                                                                                               prevention
                                                                                               measure.
NQF 0034........................  No comments........  Does not align with  Yes.............  This CQM is
                                                        current clinical                       currently NQF
                                                        guidelines.                            endorsed# and
                                                                                               will be updated
                                                                                               for consistency
                                                                                               with clinical
                                                                                               guidelines as
                                                                                               discussed earlier
                                                                                               in this section.
                                                                                               This is a high
                                                                                               priority
                                                                                               prevention
                                                                                               measure.

[[Page 54061]]

 
NQF 0036........................  No comments........  Duplicative of       Yes.............  Addresses high
                                                        other measures                         priority agency
                                                        (duplicate measure                     goals and aligns
                                                        not included).                         with other
                                                                                               quality reporting
                                                                                               programs. Some
                                                                                               aspects of this
                                                                                               measure may be
                                                                                               considered
                                                                                               duplicative of
                                                                                               other CQMs,
                                                                                               however we
                                                                                               believe that
                                                                                               there are unique
                                                                                               aspects of this
                                                                                               CQM that are
                                                                                               important to
                                                                                               measure.
NQF 0038........................  Supports measures    No comments........  Yes.............  Supports public
                                   to reduce rate of                                           health goals.
                                   Hepatitis B.
NQF 0041........................  Support for measure  No evidence to       Yes.............  This CQM is
                                                        support influenza                      currently NQF
                                                        vaccinations for                       endorsed.# This
                                                        all patients;                          is a high
                                                        Concerns about                         priority
                                                        capturing discrete                     prevention
                                                        data and                               measure. Delivery
                                                        accounting for                         of the vaccine
                                                        alternative                            should be
                                                        delivery locations.                    captured in the
                                                                                               EHR even if it
                                                                                               was delivered in
                                                                                               an alternate
                                                                                               location.
NQF 0043........................  Support for measure  Concerns about       Yes.............  Alignment with
                                                        capturing discrete                     PQRS/ACOs/NCQA-
                                                        data and                               PCMH
                                                        accounting for                         Accreditation.
                                                        alternative                            This is a high
                                                        delivery locations.                    priority
                                                                                               prevention
                                                                                               measure. Delivery
                                                                                               of the vaccine
                                                                                               should be
                                                                                               captured in the
                                                                                               EHR even if it
                                                                                               was delivered in
                                                                                               an alternate
                                                                                               location. Passed
                                                                                               feasibility
                                                                                               testing for the
                                                                                               data elements
                                                                                               needed.
NQF 0052........................  Support with         No comments........  Yes.............  Addresses
                                   suggestions for                                             efficient use of
                                   improvements.                                               resources.
NQF 0055........................  No comments........  Inconsistent with    Yes.............  This CQM is
                                                        evidence.                              currently NQF
                                                                                               endorsed.# This
                                                                                               is a high
                                                                                               priority
                                                                                               prevention
                                                                                               measure.
NQF 0056........................  Support for measure  Concerns about       Yes.............  Supports high
                                                        ability to collect                     priority goals
                                                        discrete data.                         (diabetes);
                                                                                               alignment with
                                                                                               other programs.
                                                                                               Passed
                                                                                               feasibility
                                                                                               testing for the
                                                                                               data elements
                                                                                               needed.
NQF 0059........................  Support for measure  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (diabetes);
                                                                                               alignment with
                                                                                               other programs.
NQF 0060........................  Support for measure  Concern that this    Yes.............  Supports high
                                                        measure is                             priority goals
                                                        untested in a                          (diabetes,
                                                        pediatric                              pediatric
                                                        population.                            population).
NQF 0062........................  Supports measure...  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (diabetes);
                                                                                               alignment with
                                                                                               other programs.
NQF 0064........................  Supports measure as  No comments........  Yes.............  Supports high
                                   a way to monitor                                            priority goals
                                   overuse and                                                 (diabetes);
                                   non[dash]evidence                                           alignment with
                                   based therapies.                                            other programs.
NQF 0068........................  Support for measure  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (heart disease);
                                                                                               alignment with
                                                                                               other programs.
NQF 0069........................  No comments........  No comments........  Yes.............  Addresses
                                                                                               efficient use of
                                                                                               resources;
                                                                                               alignment with
                                                                                               other programs.
NQF 0070........................  Support for measure  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (heart disease);
                                                                                               alignment with
                                                                                               other programs.
NQF 0075........................  Support for measure  Denominator is       Yes.............  Supports high
                                                        complex and                            priority goals
                                                        ability to capture                     (heart disease);
                                                        prior year data is                     alignment with
                                                        questioned.                            other programs.
                                                                                               We are also
                                                                                               collaborating
                                                                                               very closely with
                                                                                               the ONC to ensure
                                                                                               that these data
                                                                                               are captured
                                                                                               within CEHRT.

[[Page 54062]]

 
NQF 0081........................  Support for measure  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (heart disease);
                                                                                               alignment with
                                                                                               other programs.
NQF 0083........................  Support for measure  No comments........  Yes.............  Supports high
                                                                                               priority goals
                                                                                               (heart disease);
                                                                                               alignment with
                                                                                               other programs.
NQF 0086........................  Support for measure  Does not advance     Yes.............  This CQM is
                                                        quality of care.                       currently NQF
                                                                                               endorsed.#
NQF 0088........................  Supports measure...  Concerned about      Yes.............  Supports high
                                                        ability to                             priority goals
                                                        transmit data                          (diabetes);
                                                        between providers.                     alignment with
                                                                                               other programs.
                                                                                               Data is not
                                                                                               required to be
                                                                                               electronically
                                                                                               transmitted
                                                                                               between
                                                                                               providers.
NQF 0089........................  Supports measure...  Does not advance     Yes.............  This CQM is
                                                        quality of care;                       currently NQF
                                                        Concerned about                        endorsed.#
                                                        ability to                             Communication
                                                        transmit data                          between eye
                                                        between providers.                     specialist and
                                                                                               the physician who
                                                                                               manages diabetes
                                                                                               care is
                                                                                               important. Data
                                                                                               is not required
                                                                                               to be
                                                                                               electronically
                                                                                               transmitted
                                                                                               between
                                                                                               providers.
NQF 0101........................  Support for measure  Concerns about       Yes.............  Addresses patient
                                                        ability to collect                     safety. Passed
                                                        discrete data.                         feasibility
                                                                                               testing for the
                                                                                               data elements
                                                                                               required.
NQF 0104........................  Support for measure  Duplicative of       Yes.............  Supports public
                                                        other measures;                        health goals;
                                                        Concerns about                         alignment with
                                                        ability to collect                     other programs.
                                                        discrete data.                         Duplicative
                                                                                               measures have not
                                                                                               been finalized.
                                                                                               Takes initial
                                                                                               steps toward
                                                                                               collecting
                                                                                               discrete data.
NQF 0105........................  Support for measure  Concerns about       Yes.............  This CQM is
                                                        suggesting                             currently NQF
                                                        pharmacotherapy                        endorsed.#
                                                        over other
                                                        treatment options.
NQF 0108........................  No comments........  No comments........  Yes.............  Addresses
                                                                                               pediatric
                                                                                               population.
NQF 0110........................  Support for measure  Concerns about       Yes.............  We are
                                                        complexity and                         collaborating
                                                        confidentiality;                       very closely with
                                                        Concerns about                         the ONC to ensure
                                                        ability to collect                     that these data
                                                        discrete data.                         are captured
                                                                                               within CEHRT.
NQF 0384........................  Support for measure  Concerns about       Yes.............  Addresses patient
                                                        ability to collect                     engagement;
                                                        discrete data.                         alignment with
                                                                                               other programs.
NQF 0385........................  Supports measure...  Concerns about       Yes.............  Addresses high
                                                        ability to collect                     priority agency
                                                        discrete data.                         goals and aligns
                                                                                               with other
                                                                                               quality reporting
                                                                                               programs.
NQF 0387........................  Support for measure  Concerns about       Yes.............  Addresses high
                                                        ability to collect                     priority agency
                                                        discrete data.                         goals and aligns
                                                                                               with other
                                                                                               quality reporting
                                                                                               programs.
NQF 0389........................  Support for measure  Concerns about       Yes.............  We are
                                                        complexity;                            collaborating
                                                        Concerns about                         very closely with
                                                        ability to collect                     the ONC to ensure
                                                        discrete data.                         that these data
                                                                                               are captured
                                                                                               within CEHRT.
NQF 0403........................  Support for measure  Concerns about       Yes.............  Addresses high
                                                        ability to                             priority agency
                                                        document AIDS                          goals and aligns
                                                        status.                                with other
                                                                                               quality reporting
                                                                                               programs.
NQF 0405........................  Support for measure  Concerns about       Yes.............  This CQM is
                                                        agreement with                         currently NQF
                                                        current clinical                       endorsed# and
                                                        guidelines.                            will be updated
                                                                                               for consistency
                                                                                               with clinical
                                                                                               guidelines as
                                                                                               discussed earlier
                                                                                               in this section.
TBD (proposed as NQF 0407--HIV/   Support for measure  Concerns about       Yes.............  Alignment with
 AIDS RNA Control).                                     ability to collect                     other programs.
                                                        discrete data.                         This CQM will be
                                                                                               updated for
                                                                                               consistency with
                                                                                               the clinical
                                                                                               guidelines as
                                                                                               discussed earlier
                                                                                               in this section.

[[Page 54063]]

 
NQF 0418........................  Support for          Concern that         Yes.............  Supports public
                                   assessment of        patient refusal of                     health goals;
                                   depression.          screening could                        alignment with
                                                        count against EP;                      other programs.
                                                        Concerns about                        We also recognize
                                                        ability to collect                     that patients may
                                                        discrete data.                         refuse the
                                                                                               treatments
                                                                                               measured within
                                                                                               this CQM, but
                                                                                               there are no
                                                                                               performance
                                                                                               thresholds
                                                                                               established for
                                                                                               the EHR Incentive
                                                                                               Program.
NQF 0419........................  Support for measure  Too check[dash]boxy  Yes.............  This CQM is
                                   with concerns        and does not                           currently NQF
                                   about ability to     advance quality of                     endorsed.#
                                   capture discrete     care.
                                   data.
NQF 0421........................  Support for measure  Too check[dash]boxy  Yes.............  Supports public
                                                        and does not                           health goals.
                                                        advance quality of                     Alignment with
                                                        care; Concerns                         PQRS/ACOs/UDS.
                                                        about ability to                       This CQM is
                                                        collect discrete                       currently NQF
                                                        data.                                  endorsed.# Passed
                                                                                               feasibility
                                                                                               testing for the
                                                                                               data elements
                                                                                               needed.
NQF 0564........................  Supports measure     No comments........  Yes.............  Addresses patient
                                   that targets high                                           safety; alignment
                                   priority condition                                          with other
                                   to Medicare                                                 programs.
                                   population and
                                   will add
                                   substantial value
                                   to the clinical
                                   quality measure
                                   set.
NQF 0565........................  Supports measure     No comments........  Yes.............  Alignment with
                                   that targets high                                           other programs.
                                   priority condition
                                   to Medicare
                                   population and
                                   will add
                                   substantial value
                                   to the clinical
                                   quality measure
                                   set.
NQF 0608........................  No comments........  No comments........  Yes.............  Addresses high
                                                                                               priority agency
                                                                                               goals.
NQF 0710........................  Supports measure     Privacy concerns...  Yes.............  Addresses high
                                   concept but                                                 priority agency
                                   concerned metric                                            goals.
                                   is too high.                                               To protect patient
                                                                                               confidentiality
                                                                                               and adhere to
                                                                                               HIPAA
                                                                                               requirements, CMS
                                                                                               and all
                                                                                               contractors for
                                                                                               CMS are held to
                                                                                               maintaining and
                                                                                               abiding by the IT
                                                                                               Security Policy
                                                                                               in the
                                                                                               transmission of
                                                                                               electronic data.
NQF 0712........................  Supports measure...  Privacy concerns;    Yes.............  Addresses high
                                                        Concerns about                         priority agency
                                                        ability to collect                     goals and takes
                                                        discrete data.                         initial steps
                                                                                               towards
                                                                                               collecting
                                                                                               accurate discrete
                                                                                               data. To protect
                                                                                               patient
                                                                                               confidentiality
                                                                                               and adhere to
                                                                                               HIPAA
                                                                                               requirements, CMS
                                                                                               and all
                                                                                               contractors for
                                                                                               CMS are held to
                                                                                               maintaining and
                                                                                               abiding by the IT
                                                                                               Security Policy
                                                                                               in the
                                                                                               transmission of
                                                                                               electronic data.
TBD (proposed as 1335 Children    Supports measure...  Concerns about       Yes.............  Addresses child
 dental).                                               collecting data                        health and dental
                                                        via EHR and                            measures not
                                                        required changes                       previously
                                                        to workflow;                           included in
                                                        Concerns about                         program.
                                                        ability to collect                    We are
                                                        discrete data.                         collaborating
                                                                                               very closely with
                                                                                               the ONC to ensure
                                                                                               that these data
                                                                                               are captured
                                                                                               within CEHRT.
NQF 1365........................  Support for measure  Concerns about       Yes.............  Supports public
                                                        ability to collect                     health goals;
                                                        discrete data.                         alignment with
                                                                                               other programs.
                                                                                               Duplicative
                                                                                               measures have not
                                                                                               been finalized.
                                                                                               Takes initial
                                                                                               steps toward
                                                                                               collecting
                                                                                               discrete data.

[[Page 54064]]

 
NQF 1401........................  No comments........  Concerns about       Yes.............  Addresses public
                                                        linking measure to                     health goals. We
                                                        age of child when                      are collaborating
                                                        measure relates to                     very closely with
                                                        maternal                               the ONC to ensure
                                                        depression and                         that these data
                                                        ability to capture                     are captured
                                                        discrete data.                         within CEHRT.
TBD (proposed as 1419 Primary     Support if revised   Concerns about       Yes.............  Addresses child
 caries prevention).               to clarify           whether measure                        health and dental
                                   numerator and        reflects standard                      measures not
                                   denominator.         of care for                            previously
                                                        medical providers.                     included in
                                                                                               program. Received
                                                                                               strong public
                                                                                               support. The CQM
                                                                                               is currently NQF
                                                                                               endorsed for
                                                                                               medical
                                                                                               providers.#
TBD (LDL).......................  Supports measure...  Not NQF endorsed;    Yes.............  Addresses high
                                                        Concerns about                         priority goal
                                                        ability to collect                     (high
                                                        discrete data.                         cholesterol);
                                                                                               Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (Fasting LDL)...............  Supports measure...  Not NQF endorsed;    Yes.............  Addresses high
                                                        Concerns about                         priority goal
                                                        ability to collect                     (high
                                                        discrete data.                         cholesterol);
                                                                                               Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (Dementia)..................  Supports measure...  Not NQF endorsed;    Yes.............  Addresses high
                                                        Concerns about                         priority agency
                                                        ability to collect                     goals and takes
                                                        discrete data.                         initial steps
                                                                                               towards
                                                                                               collecting
                                                                                               accurate discrete
                                                                                               data; Though we
                                                                                               gave preference
                                                                                               to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (Hypertension)..............  No comments........  No comments........  Yes.............  Addresses high
                                                                                               priority goal
                                                                                               (hypertension).
TBD (Closing referral loop).....  Supports as an       Concerns about       Yes.............  Addresses care
                                   example of a core    ability to capture                     coordination;
                                   measure.             data exchange; not                     Though we gave
                                                        NQF endorsed.                          preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (FSA knee)..................  Supports measure...  Not NQF endorsed;    Yes.............  Addresses
                                                        Concerns about                         functional status
                                                        ability to collect                     assessment and
                                                        discrete data.                         patient
                                                                                               engagement;
                                                                                               Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (FSA hip)...................  Supports measure...  Not NQF endorsed;    Yes.............  Addresses
                                                        Concerns about                         functional status
                                                        ability to collect                     assessment and
                                                        discrete data.                         patient
                                                                                               engagement;
                                                                                               Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.

[[Page 54065]]

 
TBD (FSA complex)...............  Supports measure...  Not NQF endorsed;    Yes.............  Addresses
                                                        Concerns about                         functional status
                                                        ability to collect                     assessment and
                                                        discrete data.                         patient
                                                                                               engagement;
                                                                                               Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (ADE).......................  Supports...........  Not NQF endorsed;    Yes.............  Addresses patient
                                                        Concerns about                         safety; Though we
                                                        ability to collect                     gave preference
                                                        discrete data.                         to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
TBD (HBP followup)..............  No comments........  Measure focuses on   Yes.............  Addresses high
                                                        limited                                priority goals
                                                        population; not                        (hypertension);
                                                        NQF endorsed.                          Though we gave
                                                                                               preference to NQF
                                                                                               endorsement, some
                                                                                               measures selected
                                                                                               that were not NQF
                                                                                               endorsed based on
                                                                                               their measurement
                                                                                               of high priority
                                                                                               conditions.
NQF 0001........................  Supports measure...  Does not advance     No..............  Concur with public
                                                        quality of care;                       comment and
                                                        Concerns about                         complexity
                                                        ability to collect                     associated with
                                                        discrete data.                         collecting
                                                                                               discrete data.
NQF 0012........................  Measure could be     No comments........  No..............  Measure no longer
                                   adapted to use                                              supported by
                                   EHRs to create                                              measure steward.
                                   more accurate
                                   quality measures.
NQF 0014........................  No comments........  Does not advance     No..............  Measure no longer
                                                        quality of care.                       supported by
                                                                                               measure steward.
NQF 0045........................  No comments........  Measure is untested  No..............  Difficulty
                                                        in part of                             ensuring accurate
                                                        population age                         and standard data
                                                        range; focus on                        collected.
                                                        communications
                                                        instead of
                                                        outcomes.
NQF 0046........................  Supports measure...  Concerns about       No..............  Difficulty
                                                        ability to collect                     ensuring accurate
                                                        discrete data.                         and standard data
                                                                                               collected.
NQF 0047........................  Supports measure...  Measure is           No..............  Difficulty
                                                        complicated;                           ensuring accurate
                                                        concern about lack                     and standard data
                                                        of look back                           collected.
                                                        period.
NQF 0048........................  Supports measure     No comments........  No..............  Difficulty
                                   with suggested                                              ensuring accurate
                                   changes.                                                    and standard data
                                                                                               collected.
NQF 0050........................  Supports measure...  Does not advance     No..............  Concur with public
                                                        quality of care;                       comment and
                                                        Concerns about                         complexity
                                                        ability to collect                     associated with
                                                        discrete data.                         collecting
                                                                                               discrete data.
NQF 0051........................  Supports measure...  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0058........................  No comments........  Definition of        No..............  Concur with public
                                                        condition too                          comment that
                                                        restrictive.                           acute bronchitis
                                                                                               is too
                                                                                               restrictive for
                                                                                               an antibiotic
                                                                                               overuse CQM. Seek
                                                                                               to limit measure
                                                                                               set to reduce
                                                                                               burden.
NQF 0061........................  Support for measure  No comments........  No..............  Redundant with
                                                                                               other measures
                                                                                               assessing
                                                                                               condition (e.g.,
                                                                                               NQF 0018).
NQF 0066........................  Support for measure  Measure contains     No..............  Concur with public
                                                        two diagnoses and                      comment and
                                                        should separated                       complexity
                                                        into two measures;                     associated with
                                                        Concerns about                         collecting
                                                        ability to collect                     discrete data.
                                                        discrete data.
NQF 0067........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0073........................  Support for measure  No comments........  No..............  Redundant with
                                   and suggestion to                                           other measures
                                   adapt to further                                            assessing
                                   exploit EHRs.                                               condition (e.g.,
                                                                                               NQF 0018).

[[Page 54066]]

 
NQF 0074........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0097........................  Support for measure  Measure does not     No..............  Concur with public
                                                        advance quality of                     comment and
                                                        care, too ``check                      complexity
                                                        boxy,''                                associated with
                                                        reconciling across                     collecting
                                                        care settings;                         discrete data.
                                                        Concerns about
                                                        ability to collect
                                                        discrete data.
NQF 0098........................  Support for measure  Measure is vague;    No..............  Concur with public
                                                        ability to capture                     comment and
                                                        discrete data;                         complexity
                                                        need standardized                      associated with
                                                        tool for                               collecting
                                                        assessment; no                         discrete data.
                                                        evidence
                                                        interventions
                                                        support outcomes.
NQF 0100........................  Support for measure  No evidence          No..............  Concur with public
                                                        interventions                          comment and
                                                        support outcomes;                      complexity
                                                        Concerns about                         associated with
                                                        ability to collect                     collecting
                                                        discrete data.                         discrete data.
NQF 0102........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data and                      complexity
                                                        calculate measure.                     associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0103........................  Support for          Does not advance     No..............  Concur with
                                   measure; harmonize   quality of care;                       concerns in
                                   with other           privacy issues;                        public comments.
                                   measures.            Concerns about
                                                        ability to collect
                                                        discrete data.
NQF 0106........................  Support for measure  Measure is too       No..............  Concur with
                                                        complex; concerns                      concerns in
                                                        about ability to                       public comments
                                                        collect discrete                       that the measure
                                                        data.                                  is too complex;
                                                                                               and agree with
                                                                                               the concerns
                                                                                               about ability to
                                                                                               collect discrete
                                                                                               data.
NQF 0107........................  No comments........  Duplicative of       No..............  Concur with
                                                        other measures.                        concerns in
                                                                                               public comments
                                                                                               that it is
                                                                                               duplicative of
                                                                                               other measures.
NQF 0112........................  Support for measure  Measure is too       No..............  Concur with public
                                                        complex; privacy                       comment and
                                                        issues; vague;                         complexity
                                                        concerns about                         associated with
                                                        ability to collect                     collecting
                                                        discrete data.                         discrete data.
NQF 0239........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
Former NQF 0246.................  Support for measure  Does not advance     No..............  Concur with public
                                                        quality of care;                       comment and
                                                        not NQF endorsed;                      complexity
                                                        Concerns about                         associated with
                                                        ability to collect                     collecting
                                                        discrete data.                         discrete data.
NQF 0271........................  Support for measure  Questions if         No..............  Concur with public
                                                        appropriate for                        comment and
                                                        ambulatory                             complexity
                                                        setting; Concerns                      associated with
                                                        about ability to                       collecting
                                                        collect discrete                       discrete data.
                                                        data.
NQF 0312........................  Support for measure  Measure is vague...  No..............  Difficulty
                                                                                               ensuring accurate
                                                                                               and standard data
                                                                                               collected.
NQF 0321........................  Support for measure  No comments........  No..............  Complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0322........................  Support for measure  Measure is vague;    No..............  Concur with public
                                                        concerns about                         comment and
                                                        ability to capture                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0323........................  Support for measure  Interoperability     No..............  Concur with public
                                                        concerns.                              comment and
                                                                                               complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0382........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to capture                     comment and
                                                        numerator data.                        complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0383........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0388........................  Support for measure  Concerns about       No..............  Measure retired by
                                                        ability to collect                     steward.
                                                        discrete data.

[[Page 54067]]

 
NQF 0399........................  Support for measure  No comments........  No..............  Seek to limit
                                                                                               measure set to
                                                                                               reduce burden.
NQF 0400........................  Support for measure  No comments........  No..............  Seek to limit
                                                                                               measure set to
                                                                                               reduce burden.
NQF 0401........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0406........................  Support for measure  Concerns about       No..............  Concur with
                                                        keeping                                concerns from
                                                        up[dash]to[dash]da                     public comments
                                                        te with changing                       with concerns
                                                        guidelines.                            about keeping
                                                                                               up[dash]to[dash]d
                                                                                               ate with changing
                                                                                               guidelines.
NQF 0507........................  Support for measure  Does not advance     No..............  Concur with public
                                                        quality of care.                       comment and
                                                                                               complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0508........................  Support for measure  Inability to         No..............  Concur with public
                                                        capture screening                      comment and
                                                        results as                             complexity
                                                        discrete data.                         associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0510........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0513........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting
                                                                                               discrete data.
NQF 0519........................  Support for measure  Does not advance     No..............  Concur with public
                                                        quality of care;                       comment and
                                                        Concerns about                         complexity
                                                        ability to collect                     associated with
                                                        discrete data.                         collecting
                                                                                               discrete data.
NQF 0561........................  Support for          Does not advance     No..............  Concur with public
                                   measure; supports    quality of care;                       comment and
                                   care coordination    Concerns about                         complexity
                                   and alignment with   ability to collect                     associated with
                                   PQRS.                discrete data.                         collecting
                                                                                               discrete data.
NQF 0562........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data;                         complexity
                                                        important measure                      associated with
                                                        of overuse.                            collecting
                                                                                               discrete data.
NQF 0575........................  Support for measure  No comments........  No..............  Concur with
                                   with reasonable                                             concerns in
                                   target regarding                                            public comments
                                   potential adverse                                           regarding
                                   effects of tight                                            potential adverse
                                   diabetes control.                                           effects of tight
                                                                                               diabetes control.
NQF 0711........................  Supports measure     Potentially          No..............  Concur with
                                   concept but          duplicative;                           concerns in
                                   concerned metric     privacy issues.                        public comments
                                   is too high.                                                about potentially
                                                                                               duplicative
                                                                                               measure; and
                                                                                               privacy issues.
NQF 1525........................  Support for measure  Concerns about       No..............  Concur with public
                                                        ability to collect                     comment and
                                                        discrete data.                         complexity
                                                                                               associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Risk Assessment for Falls).  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Plan of Care for Falls)....  Support for measure  Not NQF endorsed;    No..............  Concur with public
                                                        questions evidence                     comment and
                                                        base for plan of                       complexity
                                                        care for falls.                        associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (ADK: BP Mgmt)..............  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (ADK: ESA)..................  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Wound Wet to Dry)..........  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Dementia Staging)..........  Support for measure  Not NQF endorsed;    No..............  Concur with public
                                                        does not advance                       comment and
                                                        quality of care.                       complexity
                                                        Concerns about                         associated with
                                                        ability to collect                     collecting these
                                                        discrete data.                         discrete data.

[[Page 54068]]

 
TBD (Dementia FSA)..............  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Dementia Safety)...........  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Dementia Driving)..........  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Dementia Caregiver)........  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Wound Compression).........  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (RA: FSA)...................  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Glaucoma)..................  No comments........  Not NQF endorsed...  No..............  Concur with public
                                                                                               comment and
                                                                                               complexity
                                                                                               associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Wound Diabetic)............  Support for measure  Not NQF endorsed.    No..............  Concur with public
                                                        Concerns about                         comment and
                                                        ability to collect                     complexity
                                                        discrete data.                         associated with
                                                                                               collecting these
                                                                                               discrete data.
TBD (Hypertension: BPM).........  No comments........  Not NQF endorsed;    No..............  Prefer CQMs on the
                                                        questions                              topic of
                                                        appropriateness                        hypertension with
                                                        due to narrow                          NQF endorsement.
                                                        population.
----------------------------------------------------------------------------------------------------------------
# NQF endorsement includes a consensus development process that takes into account clinical guidelines and
  scientific evidence. NQF describes its consensus development process at http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx.

    After consideration of the public comments received and the CQM 
selection criteria discussed, we are finalizing the list of 64 CQMs for 
EPs included in Table 7. We note that the CQMs that do not have a CQM 
number in Table 7 are those that are not NQF endorsed. EPs will 
identify these CQMs by the eMeasure ID and version number that will be 
included in the CQM specifications that will be made available on our 
Web site.
    We also note that three of the CQMs listed with a CQM number of TBD 
in Table 7 were proposed with NQF numbers but are changed to ``TBD'' in 
this final rule as follows:

 NQF 0407 is now HIV/AIDS: RNA control for Patients with HIV
 NQF 1335 is now Children who have dental decay or cavities
 NQF 1419 is now Primary Caries Prevention Intervention as Part 
of Well/Ill Child Care as Offered by Primary Care Medical Providers

    NQF 0407 referenced antiretroviral therapy as the means for RNA 
control. This CQM is scheduled for NQF review and, due to changing 
clinical guidelines regarding therapies, significant change in this 
measure is expected. Due to the nature of HIV/AIDS, the virus mutates 
frequently, necessitating frequent changes in clinical guidelines with 
respect to treatments. By respecifying the CQM to remove antiretroviral 
therapy as the specific treatment and only focus on the outcome of RNA 
control, the intent of this CQM remains the same. The respecified CQM 
will be submitted to NQF for endorsement. NQF 1335 was endorsed as 
population-based CQMs rather than individual provider-level CQMs and 
will be respecified to include individual provider reporting, and NQF 
1419 was endorsed at the individual provider level but only for primary 
care physicians and will be respecified to include dental providers. 
Both will undergo additional testing, and the results for each CQM will 
be submitted to NQF to determine whether the respecification warrants a 
new NQF number. However, the intent of each of these CQMs will remain 
the same as proposed.
    The CQMs finalized in the recommended core sets are included in 
Table 7 and are denoted with a ``*'' for adult populations (9 CQMs) and 
``**'' for pediatric populations (9 CQMs). We believe this approach 
supports the NQS and provides flexibility for specialists whose scope 
of practice may not be adequately represented in the proposed core CQM 
set. Controlling blood pressure has been and continues to be a high 
priority goal in many national health initiatives, including the 
Million Hearts campaign. Therefore, we emphasize the importance of 
reporting NQF 0018 as a primary recommended core CQM. We will 
monitor reporting on NQF 0018 and consider ways to increase 
its reporting. This may include, through future rulemaking, requiring 
EPs in relevant specialties such as primary care and cardiovascular 
care to report this CQM. We note that the designation of being 
recommended for

[[Page 54069]]

the adult population or pediatric population does not limit an EP from 
reporting the CQM only for those populations as long as the patients 
still fit the criteria to be included in the measure (for example, the 
CQM numbered ``TBD--Closing the referral loop: receipt of specialist 
report'' is designated as a recommended core CQM for adult populations, 
but it can apply to pediatric populations as well).

                                      Table 8--CQMs Finalized for Medicare and Medicaid EPs Beginning with CY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Other quality measure
           CQM No.                CQM title and description     Measure steward and   programs that use the         New CQM                Domain
                                                                contact information        same CQM***
--------------------------------------------------------------------------------------------------------------------------------------------------------
NQF 0002**...................  Title: Appropriate Testing for  National Committee     EHR PQRS, CHIPRA.....  .....................  Efficient Use of
                                Children with Pharyngitis.      for Quality                                                          Healthcare
                               Description: Percentage of       Assurance (NCQA)                                                     Resources.
                                children 2-18 years of age      Contact information:
                                who were diagnosed with         www.ncqa.org.
                                pharyngitis, ordered an
                                antibiotic and received a
                                group A streptococcus (strep)
                                test for the episode..
NQF 0004.....................  Title: Initiation and           NCQA Contact           EHR PQRS, HEDIS,       .....................  Clinical Process/
                                Engagement of Alcohol and       Information:           state use, ACA 2701,                          Effectiveness.
                                Other Drug Dependence           www.ncqa.org.          NCQA-PCMH
                                Treatment.                                             Recognition.
                               Description: Percentage of
                                patients 13 years of age and
                                older with a new episode of
                                alcohol and other drug (AOD)
                                dependence who received the
                                following. Two rates are
                                reported..
                               a. Percentage of patients who
                                initiated treatment within 14
                                days of the diagnosis.
                               b. Percentage of patients who
                                initiated treatment and who
                                had two or more additional
                                services with an AOD
                                diagnosis within 30 days of
                                the initiation visit.
NQF 0018*....................  Title: Controlling High Blood   NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                                Pressure.                       Information:           Reporting PQRS, UDS.                          Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 18-85 years of age
                                who had a diagnosis of
                                hypertension and whose blood
                                pressure was adequately
                                controlled (90mmHg)
                                during the measurement
                                =period..
NQF 0022*....................  Title: Use of High-Risk         NCQA Contact           PQRS.................  New..................  Patient Safety
                                Medications in the Elderly.     Information:
                               Description: Percentage of       www.ncqa.org.
                                patients 66 years of age and
                                older who were ordered high-
                                risk medications. Two rates
                                are reported..
                               a. Percentage of patients who
                                were ordered at least one
                                high-risk medication.
                               b. Percentage of patients who
                                were ordered at least two
                                different high-risk
                                medications.
NQF 0024**...................  Title: Weight Assessment and    NCQA Contact           EHR PQRS, UDS........  .....................  Population/Public
                                Counseling for Nutrition and    information:                                                         Health.
                                Physical Activity for           www.ncqa.org.
                                Children and Adolescents.
                                  Description: Percentage of
                                   patients 3-17 years of age
                                   who had an outpatient
                                   visit with a Primary Care
                                   Physician (PCP) or
                                   Obstetrician/Gynecologist
                                   (OB/GYN) and who had
                                   evidence of the following
                                   during the measurement
                                   period. Three rates are
                                   reported.
                                   Percentage of
                                   patients with height,
                                   weight, and body mass
                                   index (BMI) percentile
                                   documentation.
                                   Percentage of
                                   patients with counseling
                                   for nutrition.
                                   Percentage of
                                   patients with counseling
                                   for physical activity.
NQF 0028*....................  Title: Preventive Care and      AMA-PCPI Contact       EHR PQRS, ACO, Group   .....................  Population/Public
                                Screening: Tobacco.             Information: cpe@ama-  Reporting PQRS, UDS.                          Health.
                               Use: Screening and Cessation     assn.org.
                                Intervention..
                               Description: Percentage of
                                patients aged 18 years and
                                older who were screened for
                                tobacco use one or more times
                                within 24 months AND who
                                received cessation counseling
                                intervention if identified as
                                a tobacco user..
NQF 0031.....................  Title: Breast Cancer Screening  NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                               Description: Percentage of       Information:           Reporting PQRS, ACA                           Effectiveness.
                                women 40-69 years of age who    www.ncqa.org.          2701, HEDIS, state
                                had a mammogram to screen for                          use, NCQA-PCMH
                                breast cancer..                                        Recognition.
NQF 0032.....................  Title: Cervical Cancer          NCQA Contact           EHR PQRS, ACA 2701,    .....................  Clinical Process/
                                Screening.                      Information:           HEDIS, state use,                             Effectiveness.
                               Description: Percentage of       www.ncqa.org.          NCQA-PCMH
                                women 21-64 years of age, who                          Recognition, UDS.
                                received one or more Pap
                                tests to screen for cervical
                                cancer..
NQF 0033**...................  Title: Chlamydia Screening for  NCQA Contact           EHR PQRS, CHIPRA, ACA  .....................  Population/Public
                                Women.                          Information:           2701, HEDIS, state                            Health.
                               Description: Percentage of       www.ncqa.org.          use, NCQA-PCMH
                                women 16-24 years of age who                           Recognition.
                                were identified as sexually
                                active and who had at least
                                one test for chlamydia during
                                the measurement period..

[[Page 54070]]

 
NQF 0034.....................  Title: Colorectal Cancer        NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                                Screening.                      Information:           Reporting PQRS, NCQA-                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.          PCMH Recognition.
                                adults 50-75 years of age who
                                had appropriate screening for
                                colorectal cancer..
NQF 0036**...................  Title: Use of Appropriate       NCQA Contact           EHR PQRS.............  .....................  Clinical Process/
                                Medications for Asthma.         Information:                                                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 5-64 years of age
                                who were identified as having
                                persistent asthma and were
                                appropriately prescribed
                                medication during the
                                measurement period..
NQF 0038**...................  Title: Childhood Immunization   NCQA Contact           EHR PQRS, UDS........  .....................  Population/Public
                                Status.                         Information:                                                         Health.
                               Description: Percentage of       www.ncqa.org.
                                children 2 years of age who
                                had four diphtheria, tetanus
                                and acellular pertussis
                                (DTaP); three polio (IPV),
                                one measles, mumps and
                                rubella (MMR); three H
                                influenza type B (HiB); three
                                hepatitis B (Hep B); one
                                chicken pox (VZV); four
                                pneumococcal conjugate (PCV);
                                one hepatitis A (Hep A); two
                                or three rotavirus (RV); and
                                two influenza (flu) vaccines
                                by their second birthday..
NQF 0041.....................  Title: Preventative Care and    AMA-PCPI Contact       EHR PQRS, ACO, Group   .....................  Population/Public
                                Screening: Influenza            Information: cpe@ama-  Reporting PQRS.                               Health.
                                Immunization.                   assn.org.
                               Description: Percentage of
                                patients aged 6 months and
                                older seen for a visit
                                between October 1 and March
                                31 who received an influenza
                                immunization OR who reported
                                previous receipt of an
                                influenza immunization..
NQF 0043.....................  Title: Pneumonia Vaccination    NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                                Status for Older Adults.        Information:           Reporting PQRS, NCQA-                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.          PCMH Recognition.
                                patients 65 years of age and
                                older who have ever received
                                a pneumococcal vaccine..
NQF 0052*....................  Title: Use of Imaging Studies   NCQA Contact           EHR PQRS.............  .....................  Efficient Use of
                                for Low Back Pain.              Information:                                                         Healthcare
                               Description: Percentage of       www.ncqa.org.                                                        Resources.
                                patients 18-50 years of age
                                with a diagnosis of low back
                                pain who did not have an
                                imaging study (plain X-ray,
                                MRI, CT scan) within 28 days
                                of the diagnosis..
NQF 0055.....................  Title: Diabetes: Eye Exam.....  NCQA Contact           EHR PQRS, Group        .....................  Clinical Process/
                               Description: Percentage of       Information:           Reporting PQRS.                               Effectiveness.
                                patients 18-75 years of age     www.ncqa.org.
                                with diabetes who had a
                                retinal or dilated eye exam
                                by an eye care professional
                                during the measurement period
                                or a negative retinal exam
                                (no evidence of retinopathy)
                                in the 12 months prior to the
                                measurement period..
NQF 0056.....................  Title: Diabetes: Foot Exam....  NCQA Contact           EHR PQRS, Group        .....................  Clinical Process/
                               Description: Percentage of       Information:           Reporting PQRS.                               Effectiveness.
                                patients aged 18-75 years of    www.ncqa.org.
                                age with diabetes who had a
                                foot exam during the
                                measurement period..
NQF 0059.....................  Title: Diabetes: Hemoglobin     NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                                A1c Poor Control.               Information:           Reporting PQRS, UDS.                          Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 18-75 years of age
                                with diabetes who had
                                hemoglobin A1c >9.0% during
                                the measurement period..
NQF 0060.....................  Title: Hemoglobin A1c Test for  NCQA Contact           .....................  New..................  Clinical Process/
                                Pediatric Patients.             Information:                                                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 5-17 years of age
                                with diabetes with an HbA1c
                                test during the measurement
                                period..
NQF 0062.....................  Title: Diabetes: Urine Protein  NCQA Contact           EHR PQRS, Group        .....................  Clinical Process/
                                Screening.                      Information:           Reporting PQRS.                               Effectiveness.
                               Description: The percentage of   www.ncqa.org.
                                patients 18-75 years of age
                                with diabetes who had a
                                nephropathy screening test or
                                evidence of nephropathy
                                during the measurement
                                period..
NQF 0064.....................  Title: Diabetes: Low Density    NCQA Contact           PQRS, Group Reporting  .....................  Clinical Process/
                                Lipoprotein (LDL) Management.   Information:           PQRS.                                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 18-75 years of age
                                with diabetes whose LDL-C was
                                adequately controlled (dL) during the measurement
                                period..
NQF 0068.....................  Title: Ischemic Vascular        NCQA Contact           EHR PQRS, ACO, Group   .....................  Clinical Process/
                                Disease (IVD): Use of Aspirin   Information:           Reporting PQRS.                               Effectiveness.
                                or Another Antithrombotic.      www.ncqa.org.
                               Description: Percentage of
                                patients 18 years of age and
                                older who were discharged
                                alive for acute myocardial
                                infarction (AMI), coronary
                                artery bypass graft (CABG) or
                                percutaneous coronary
                                interventions (PCI) in the 12
                                months prior to the
                                measurement period, or who
                                had an active diagnosis of
                                ischemic vascular disease
                                (IVD) during the measurement
                                period, and who had
                                documentation of use of
                                aspirin or another
                                antithrombotic during the
                                measurement period..

[[Page 54071]]

 
NQF 0069 **..................  Title: Appropriate Treatment    NCQA Contact           PQRS, NCQA-PCMH        New..................  Efficient Use of
                                for Children with Upper         Information:           Recognition.                                  Healthcare
                                Respiratory Infection (URI).    www.ncqa.org.                                                        Resources.
                               Description: Percentage of
                                children 3 months-18 years of
                                age who were diagnosed with
                                upper respiratory infection
                                (URI) and were not dispensed
                                an antibiotic prescription on
                                or three days after the
                                episode..
NQF 0070.....................  Title: Coronary Artery Disease  AMA-PCPI Contact       EHR PQRS, NCQA-PCMH    .....................  Clinical Process/
                                (CAD): Beta-Blocker Therapy--   Information: cpe@ama-  Recognition.                                  Effectiveness.
                                Prior Myocardial Infarction     assn.org.
                                (MI) or Left Ventricular
                                Systolic Dysfunction (LVEF
                                
                                Disease (IVD): Complete Lipid   Information:           Reporting PQRS.                               Effectiveness.
                                Panel and LDL Control.          www.ncqa.org.
                               Description: Percentage of
                                patients 18 years of age and
                                older who were discharged
                                alive for acute myocardial
                                infarction (AMI), coronary
                                artery bypass graft (CABG) or
                                percutaneous coronary
                                interventions (PCI) in the 12
                                months prior to the
                                measurement period, or who
                                had an active diagnosis of
                                ischemic vascular disease
                                (IVD) during the measurement
                                period, and who had a
                                complete lipid profile
                                performed during the
                                measurement period and whose
                                LDL-C was adequately
                                controlled (dL)..
NQF 0081.....................  Title: Heart Failure (HF):      AMA-PCPI Contact       EHR PQRS, Group        .....................  Clinical Process/
                                Angiotensin-Converting Enzyme   Information: cpe@ama-  Reporting PQRS, NCQA-                         Effectiveness
                                (ACE) Inhibitor or              assn.org.              PCMH Recognition.
                                Angiotensin Receptor Blocker
                                (ARB) Therapy for Left
                                Ventricular Systolic
                                Dysfunction (LVSD).
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                heart failure (HF) with a
                                current or prior left
                                ventricular ejection fraction
                                (LVEF) 
                                Beta-Blocker Therapy for Left   Information: cpe@ama-  Reporting PQRS.                               Effectiveness.
                                Ventricular Systolic            assn.org.
                                Dysfunction (LVSD).
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                heart failure (HF) with a
                                current or prior left
                                ventricular ejection fraction
                                (LVEF) 
                                Glaucoma (POAG): Optic Nerve    Information: cpe@ama-                                                Effectiveness.
                                Evaluation.                     assn.org.
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                POAG who have an optic nerve
                                head evaluation during one or
                                more office visits within 12
                                months..
NQF 0088.....................  Title: Diabetic Retinopathy:    AMA-PCPI Contact       EHR PQRS.............  .....................  Clinical Process/
                                Documentation of Presence or    Information: cpe@ama-                                                Effectiveness.
                                Absence of Macular Edema and    assn.org.
                                Level of Severity of
                                Retinopathy.
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                diabetic retinopathy who had
                                a dilated macular or fundus
                                exam performed which included
                                documentation of the level of
                                severity of retinopathy and
                                the presence or absence of
                                macular edema during one or
                                more office visits within 12
                                months..
NQF 0089.....................  Title: Diabetic Retinopathy:    AMA-PCPI Contact       EHR PQRS.............  .....................  Clinical Process/
                                Communication with the          Information: cpe@ama-                                                Effectiveness.
                                Physician Managing Ongoing      assn.org.
                                Diabetes Care.
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                diabetic retinopathy who had
                                a dilated macular or fundus
                                exam performed with
                                documented communication to
                                the physician who manages the
                                ongoing care of the patient
                                with diabetes mellitus
                                regarding the findings of the
                                macular or fundus exam at
                                least once within 12 months..

[[Page 54072]]

 
NQF 0101.....................  Title: Falls: Screening for     AMA-PCPI Contact       PQRS, ACO, Group       New..................  Patient Safety.
                                Future Fall Risk.               Information: cpe@ama-  Reporting PQRS.
                               Description: Percentage of       assn.org; NCQA
                                patients 65 years of age and    Contact Information:
                                older who were screened for     www.ncqa.org.
                                future fall risk during the
                                measurement period..
NQF 0104.....................  Title: Major Depressive         AMA-PCPI Contact       PQRS.................  New..................  Clinical Process/
                                Disorder (MDD): Suicide Risk    Information: cpe@ama-                                                Effectiveness.
                                Assessment.                     assn.org.
                               Description: Percentage of
                                patients aged 18 years and
                                older with a new diagnosis or
                                recurrent episode of MDD who
                                had a suicide risk assessment
                                completed at each visit
                                during the measurement
                                period..
NQF 0105.....................  Title: Anti-depressant          NCQA Contact           EHR PQRS, HEDIS,       .....................  Clinical Process/
                                Medication Management.          Information:           state use, ACA 2701.                          Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients 18 years of age and
                                older who were diagnosed with
                                major depression and treated
                                with antidepressant
                                medication, and who remained
                                on antidepressant medication
                                treatment. Two rates are
                                reported..
                               a. Percentage of patients who
                                remained on an antidepressant
                                medication for at least 84
                                days (12 weeks).
                               b. Percentage of patients who
                                remained on an antidepressant
                                medication for at least 180
                                days (6 months).
NQF 0108**...................  Title: ADHD: Follow-Up Care     NCQA Contact           .....................  New..................  Clinical Process/
                                for Children Prescribed         Information:                                                         Effectiveness.
                                Attention-Deficit/              www.ncqa.org.
                                Hyperactivity Disorder (ADHD)
                                Medication.
                               Description: Percentage of
                                children 6-12 years of age
                                and newly dispensed a
                                medication for attention-
                                deficit/hyperactivity
                                disorder (ADHD) who had
                                appropriate follow-up care.
                                Two rates are reported..
                               a. Percentage of children who
                                had one follow-up visit with
                                a practitioner with
                                prescribing authority during
                                the 30-Day Initiation Phase.
                               b. Percentage of children who
                                remained on ADHD medication
                                for at least 210 days and
                                who, in addition to the visit
                                in the Initiation Phase, had
                                at least two additional
                                follow-up visits with a
                                practitioner within 270 days
                                (9 months) after the
                                Initiation Phase ended.
NQF 0110.....................  Title: Bipolar Disorder and     Center for Quality     NCQA-PCMH Recognition  New..................  Clinical Process/
                                Major Depression: Appraisal     Assessment and                                                       Effectiveness.
                                for alcohol or chemical         Improvement in
                                substance use.                  Mental Health
                               Description: Percentage of       (CQAIMH) Contact
                                patients with depression or     Information:
                                bipolar disorder with           www.cqaimh.org;
                                evidence of an initial          cqaimh@cqaimh.org.
                                assessment that includes an
                                appraisal for alcohol or
                                chemical substance use..
NQF 0384.....................  Title: Oncology: Medical and    AMA-PCPI Contact       PQRS.................  New..................  Patient and Family
                                Radiation--Pain Intensity       Information: cpe@ama-                                                Engagement.
                                Quantified.                     assn.org.
                               Description: Percentage of
                                patient visits, regardless of
                                patient age, with a diagnosis
                                of cancer currently receiving
                                chemotherapy or radiation
                                therapy in which pain
                                intensity is quantified..
NQF 0385.....................  Title: Colon Cancer:            AMA-PCPI Contact       EHR PQRS.............  .....................  Clinical Process/
                                Chemotherapy for AJCC Stage     Information: cpe@ama-                                                Effectiveness.
                                III Colon Cancer Patients.      assn.org;American
                               Description: Percentage of       Society of Clinical
                                patients aged 18 through 80     Oncology (ASCO):
                                years with Stage III colon      www.asco.org;
                                cancer who are referred for     National
                                adjuvant chemotherapy,          Comprehensive Cancer
                                prescribed adjuvant             Network (NCCN):
                                chemotherapy, or have           www.nccn.org.
                                previously received adjuvant
                                chemotherapy within the 12-
                                month reporting period..
NQF 0387.....................  Title: Breast Cancer: Hormonal  AMA-PCPI Contact       EHR PQRS.............  .....................  Clinical Process/
                                Therapy for Stage IC-IIIC       Information: cpe@ama-                                                Effectiveness.
                                Estrogen Receptor/              assn.org; ASCO:
                                Progesterone Receptor (ER/PR)   www.asco.org; NCCN:
                                Positive Breast Cancer.         www.nccn.org.
                               Description: Percentage of
                                female patients aged 18 years
                                and older with Stage IC
                                through IIIC, ER or PR
                                positive breast cancer who
                                were prescribed tamoxifen or
                                aromatase inhibitor (AI)
                                during the 12-month reporting
                                period..

[[Page 54073]]

 
NQF 0389.....................  Title: Prostate Cancer:         AMA-PCPI Contact       EHR PQRS.............  .....................  Efficient Use of
                                Avoidance of Overuse of Bone    Information: cpe@ama-                                                Healthcare
                                Scan for Staging Low Risk       assn.org.                                                            Resources.
                                Prostate Cancer Patients.
                               Description: Percentage of
                                patients, regardless of age,
                                with a diagnosis of prostate
                                cancer at low risk of
                                recurrence receiving
                                interstitial prostate
                                brachytherapy, OR external
                                beam radiotherapy to the
                                prostate, OR radical
                                prostatectomy, OR cryotherapy
                                who did not have a bone scan
                                performed at any time since
                                diagnosis of prostate cancer..
NQF 0403.....................  Title: HIV/AIDS: Medical Visit  AMA-PCPI Contact       .....................  New..................  Clinical Process/
                               Description: Percentage of       Information: cpe@ama-                                                Effectiveness.
                                patients, regardless of age,    assn.org; NCQA
                                with a diagnosis of HIV/AIDS    Contact Information:
                                with at least two medical       www.ncqa.org.
                                visits during the measurement
                                year with a minimum of 60
                                days between each visit..
NQF 0405.....................  Title: HIV/AIDS: Pneumocystis   AMA-PCPI Contact       PQRS, NCQA-PCMH        New..................  Clinical Process/
                                jiroveci pneumonia (PCP)        Information: cpe@ama-  Recognition.                                  Effectiveness.
                                Prophylaxis.                    assn.org; NCQA
                               Description: Percentage of       Contact Information:
                                patients aged 6 weeks and       www.ncqa.org.
                                older with a diagnosis of HIV/
                                AIDS who were prescribed
                                Pneumocystis jiroveci
                                pneumonia (PCP) prophylaxis..
TBD (proposed as NQF 0407)...  Title: HIV/AIDS: RNA control    NCQA Contact           PQRS.................  New..................  Clinical Process/
                                for Patients with HIV.          Information:                                                         Effectiveness.
                               Description: Percentage of       www.ncqa.org.
                                patients aged 13 years and
                                older with a diagnosis of HIV/
                                AIDS, with at least two
                                visits during the measurement
                                year, with at least 60 days
                                between each visit, whose
                                most recent HIV RNA level is
                                mL..
NQF 0418***..................  Title: Preventive Care and      Centers for Medicare   EHR PQRS, ACO, Group   New..................  Population/Public
                                Screening: Screening for        and Medicaid           Reporting PQRS.                               Health.
                                Clinical Depression and         Services (CMS) 1-888-
                                Follow-Up Plan.                 ;734-6433 or http://
                               Description: Percentage of       questions.cms.hhs.go
                                patients aged 12 years and      v/app/ask/p/
                                older screened for clinical     21,26,1139; Quality
                                depression on the date of the   Insights of
                                encounter using an age          Pennsylvania (QIP)
                                appropriate standardized        Contact Information:
                                depression screening tool AND   www.usqualitymeasure
                                if positive, a follow-up plan   s.org.
                                is documented on the date of
                                the positive screen..
NQF 0419*....................  Title: Documentation of         Centers for Medicare   PQRS, EHR PQRS.......  New..................  Patient Safety.
                                Current Medications in the      and Medicaid
                                Medical Record.                 Services (CMS) 1-888-
                               Description: Percentage of       734-6433 or http://
                                specified visits for patients   questions.cms.hhs.go
                                aged 18 years and older for     v/app/ask/p/
                                which the eligible              21,26,1139; QIP
                                professional attests to         Contact Information:
                                documenting a list of current   www.usqualitymeasure
                                medications to the best of      s.org.
                                his/her knowledge and
                                ability. This list must
                                include ALL prescriptions,
                                over-the-counters, herbals,
                                and vitamin/mineral/dietary
                                (nutritional) supplements AND
                                must contain the medications'
                                name, dosage, frequency and
                                route of administration..
NQF 0421*....................  Title: Preventive Care and      Centers for Medicare   EHR PQRS, ACO, Group   .....................  Population/Public
                                Screening: Body Mass Index      and Medicaid           Reporting PQRS, UDS.                          Health.
                                (BMI) Screening and Follow-Up.  Services (CMS) 1-888-
                               Description: Percentage of       734-6433 or http://
                                patients aged 18 years and      questions.cms.hhs.go
                                older with a calculated BMI     v/app/ask/p/
                                in the past six months or       21,26,1139; QIP
                                during the current reporting    Contact Information:
                                period documented in the        www.usqualitymeasure
                                medical record AND if the       s.org.
                                most recent BMI is outside of
                                normal parameters, a follow-
                                up plan is documented within
                                the past six months or during
                                the current reporting period..
                               Normal Parameters: Age 65
                                years and older BMI >=23 and
                                =18.5 and
                                assn.org; NCQA
                                Requiring Additional Surgical   Contact Information:
                                Procedures.                     www.ncqa.org.
                               Description: Percentage of
                                patients aged 18 years and
                                older with a diagnosis of
                                uncomplicated cataract who
                                had cataract surgery and had
                                any of a specified list of
                                surgical procedures in the 30
                                days following cataract
                                surgery which would indicate
                                the occurrence of any of the
                                following major
                                complications: retained
                                nuclear fragments,
                                endophthalmitis, dislocated
                                or wrong power IOL, retinal
                                detachment, or wound
                                dehiscence..

[[Page 54074]]

 
NQF 0565.....................  Title: Cataracts: 20/40 or      AMA-PCPI Contact       PQRS.................  New..................  Clinical Process/
                                Better Visual Acuity within     Information: cpe@ama-                                                Effectiveness.
                                90 Days Following Cataract      assn.org; NCQA
                                Surgery.                        Contact Information:
                               Description: Percentage of       www.ncqa.org.
                                patients aged 18 years and
                                older with a diagnosis of
                                uncomplicated cataract who
                                had cataract surgery and no
                                significant ocular conditions
                                impacting the visual outcome
                                of surgery and had best-
                                corrected visual acuity of 20/
                                40 or better (distance or
                                near) achieved within 90 days
                                following the cataract
                                surgery..
NQF 0608.....................  Title: Pregnant women that had  Ingenix Contact        .....................  New..................  Clinical Process/
                                HBsAg testing.                  Information:                                                         Effectiveness.
                               Description: This measure        www.ingenix.com.
                                identifies pregnant women who
                                had a HBsAg (hepatitis B)
                                test during their pregnancy..
NQF 0710.....................  Title: Depression Remission at  Minnesota Community    .....................  New..................  Clinical Process/
                                Twelve Months.                  Measurement (MNCM)                                                   Effectiveness.
                               Description: Adult patients      Contact Information:
                                age 18 and older with major     www.mncm.org;
                                depression or dysthymia and     info@mncm.org.
                                an initial PHQ-9 score >9 who
                                demonstrate remission at
                                twelve months defined as PHQ-
                                9 score less than 5. This
                                measure applies to both
                                patients with newly diagnosed
                                and existing depression whose
                                current PHQ-9 score indicates
                                a need for treatment..
NQF 0712.....................  Title: Depression Utilization   MNCM Contact           .....................  New..................  Clinical Process/
                                of the PHQ-9 Tool.              Information:                                                         Effectiveness.
                               Description: Adult patients      www.mncm.org;
                                age 18 and older with the       info@mncm.org.
                                diagnosis of major depression
                                or dysthymia who have a PHQ-9
                                tool administered at least
                                once during a 4 month period
                                in which there was a
                                qualifying visit..
TBD **.......................  Title: Children who have        Maternal and Child     .....................  New..................  Clinical Process/
                                dental decay or cavities.       Health Bureau,                                                       Effectiveness.
                               Description: Percentage of       Health Resources and
                                children ages 0-20, who have    Services
                                had tooth decay or cavities     Administration http:/
                                during the measurement          /mchb.hrsa.gov/.
                                period..
NQF 1365.....................  Title: Child and Adolescent     AMA-PCPI Contact       .....................  New..................  Patient Safety.
                                Major Depressive Disorder:      Information: cpe@ama-
                                Suicide Risk Assessment.        assn.org.
                               Description: Percentage of
                                patient visits for those
                                patients aged 6 through 17
                                years with a diagnosis of
                                major depressive disorder
                                with an assessment for
                                suicide risk..
NQF 1401.....................  Title: Maternal depression      NCQA Contact           .....................  New..................  Population/Public
                                screening.                      Information:                                                         Health.
                               Description: The percentage of   www.ncqa.org.
                                children who turned 6 months
                                of age during the measurement
                                year, who had a face-to-face
                                visit between the clinician
                                and the child during child's
                                first 6 months, and who had a
                                maternal depression screening
                                for the mother at least once
                                between 0 and 6 months of
                                life..
TBD..........................  Title: Primary Caries           University of          .....................  New..................  Clinical Process/
                                Prevention Intervention as      Minnesota Contact                                                    Effectiveness.
                                Offered by Primary Care         Information:
                                Providers, including Dentists.  www.umn.edu.
                               Description: Percentage of
                                children, age 0-20 years, who
                                received a fluoride varnish
                                application during the
                                measurement period..
TBD..........................  Title: Preventive Care and      CMS 1-888-734-6433 or  EHR PQRS.............  New..................  Clinical Process/
                                Screening: Cholesterol--        http://                                                              Effectiveness.
                                Fasting Low Density             questions.cms.hhs.go
                                Lipoprotein (LDL-C) Test        v/app/ask/p/
                                Performed.                      21,26,1139; QIP
                               Description: Percentage of       Contact Information:
                                patients aged 20 through 79     www.usqualitymeasure
                                years whose risk factors have   s.org.
                                been assessed and a fasting
                                LDL-C test has been
                                performed..
TBD..........................  Title: Preventive Care and      CMS 1-888-734-6433 or  EHR PQRS.............  New..................  Clinical Process/
                                Screening: Risk-Stratified      http://                                                              Effectiveness.
                                Cholesterol--Fasting Low        questions.cms.hhs.go
                                Density Lipoprotein (LDL-C).    v/app/ask/p/
                               Description: Percentage of       21,26,1139; QIP
                                patients aged 20 through 79     Contact Information:
                                years who had a fasting LDL-C   www.usqualitymeasure
                                test performed and whose risk-  s.org.
                                stratified fasting LDL-C is
                                at or below the recommended
                                LDL-C goal..
TBD..........................  Title: Dementia: Cognitive      AMA-PCPI Contact       PQRS.................  New..................  Clinical Process/
                                Assessment.                     Information: cpe@ama-                                                Effectiveness.
                               Description: Percentage of       assn.org.
                                patients, regardless of age,
                                with a diagnosis of dementia
                                for whom an assessment of
                                cognition is performed and
                                the results reviewed at least
                                once within a 12 month
                                period..

[[Page 54075]]

 
TBD..........................  Title: Hypertension:            CMS 1-888-734-6433 or  .....................  New..................  Clinical Process/
                                Improvement in blood pressure.  http://                                                              Effectiveness.
                               Description: Percentage of       questions.cms.hhs.go
                                patients aged 18-85 years of    v/app/ask/p/
                                age with a diagnosis of         21,26,1139.
                                hypertension whose blood
                                pressure improved during the
                                measurement period..
TBD*.........................  Title: Closing the referral     CMS 1-888-734-6433 or  .....................  New..................  Care Coordination.
                                loop: receipt of specialist     http://
                                report.                         questions.cms.hhs.go
                               Description: Percentage of       v/app/ask/p/
                                patients with referrals,        21,26,1139.
                                regardless of age, for which
                                the referring provider
                                receives a report from the
                                provider to whom the patient
                                was referred..
TBD..........................  Title: Functional status        CMS 1-888-734-6433 or  .....................  New..................  Patient and Family
                                assessment for knee             http://                                                              Engagement.
                                replacement.                    questions.cms.hhs.go
                               Description: Percentage of       v/app/ask/p/
                                patients aged 18 years and      21,26,1139.
                                older with primary total knee
                                arthroplasty (TKA) who
                                completed baseline and follow-
                                up (patient-reported)
                                functional status
                                assessments..
TBD..........................  Title: Functional status        CMS 1-888-734-6433 or  .....................  New..................  Patient and Family
                                assessment for hip              http://                                                              Engagement.
                                replacement.                    questions.cms.hhs.go
                               Description: Percentage of       v/app/ask/p/
                                patients aged 18 years and      21,26,1139.
                                older with primary total hip
                                arthroplasty (THA) who
                                completed baseline and follow-
                                up (patient-reported)
                                functional status
                                assessments..
TBD*.........................  Title: Functional status        CMS 1-888-734-6433 or  .....................  New..................  Patient and Family
                                assessment for complex          http://                                                              Engagement.
                                chronic conditions.             questions.cms.hhs.go
                               Description: Percentage of       v/app/ask/p/
                                patients aged 65 years and      21,26,1139.
                                older with heart failure who
                                completed initial and follow-
                                up patient-reported
                                functional status
                                assessments..
TBD..........................  Title: ADE Prevention and       CMS 1-888-734-6433 or  .....................  New..................  Patient Safety.
                                Monitoring: Warfarin Time in    http://
                                Therapeutic Range.              questions.cms.hhs.go
                               Description: Average             v/app/ask/p/
                                percentage of time in which     21,26,1139.
                                individuals with atrial
                                fibrillation who are on
                                chronic anticoagulation have
                                International Normalized
                                Ratio (INR) test results
                                within the therapeutic range
                                during the measurement
                                period..
TBD..........................  Title: Preventive Care and      CMS 1-888-734-6433 or  PQRS, EHR PQRS, Group  New..................  Population/Public
                                Screening: Screening for High   http://                Reporting PQRS, ACO.                          Health.
                                Blood Pressure and Follow-Up    questions.cms.hhs.go
                                Documented.                     v/app/ask/p/
                               Description: Percentage of       21,26,1139; QIP
                                patients aged 18 years and      Contact Information:
                                older seen during the           www.usqualitymeasure
                                reporting period who were       s.org.
                                screened for high blood
                                pressure AND a recommended
                                follow-up plan is documented
                                based on the current blood
                                pressure (BP) reading as
                                indicated..
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Recommended Adult Core CQMs for EPs.
** Recommended Pediatric Core CQMs for EPs.
*** PQRS = Physician Quality Reporting System.
EHR PQRS = Physician Quality Reporting System's Electronic Health Record Reporting Option.
CHIPRA = Children's Health Insurance Program Reauthorization Act.
HEDIS = Healthcare Effectiveness Data and Information Set.
ACA 2701 = Affordable Care Act section 2701.
NCQA-PCMH = National Committee for Quality Assurance--Patient Centered Medical Home.
Group Reporting PQRS = Physician Quality Reporting System's Group Reporting Option.
UDS = Uniform Data System (Health Resources Services Administration).
ACO = Accountable Care Organization (Medicare Shared Savings Program).

6. Reporting Methods for CQMs for EPs
(a) Reporting Methods for Medicaid EPs
    For Medicaid EPs, we stated in the proposed rule that states are, 
and will continue in Stage 2 to be, responsible for determining whether 
and how electronic reporting would occur, or whether they wish to 
continue to allow reporting through attestation. If a state does 
require such electronic reporting, the state is responsible for sharing 
the details of the process with its provider community. We stated that 
we anticipate that whatever means states have deployed for capturing 
Stage 1 CQMs electronically would be similar for reporting in CY 2013. 
However, we note that subject to our prior approval, this is within the 
states' purview. Beginning in CY 2014, we proposed that the states 
would establish the method and requirements, subject to CMS prior 
approval, for the electronic capture and reporting of CQMs from CEHRT.
    Comment: Commenters suggested unified Medicaid CQM reporting to 
reduce the burden on EPs operating in multiple states.
    Response: For the purposes of the Medicaid EHR Incentive Program, 
EPs report CQMs to the state making the EHR incentive payment. However, 
data from all practice locations that are equipped with CEHRT will be 
used for reporting CQMs, even if the practice locations are in 
different states.
    After consideration of the public comments received, we are 
finalizing the policies for electronic reporting of CQMs for Medicaid 
EPs as proposed. As part of certification for EHR technology, ONC is 
including testing for data capture, CQM calculation, and electronic 
submission. For CQMs, this includes certification criteria for the QRDA 
Category I (QRDA-I) and QRDA Category III (QRDA-III) transmission 
formats. We expect the states that have electronic reporting options 
for CQMs might choose to adopt QRDA-I for patient-level data and/or 
QRDA-III for aggregate data as the form in which EPs would report CQM 
data. By adopting the same QRDA-I and/or QRDA-III that

[[Page 54076]]

CMS is requiring for CQM reporting, the states would be able to 
leverage the development of the specifications by CMS and the industry 
as well as the testing done by ONC for certification of EHR technology. 
This would reduce the burden on EHR vendors to implement and test 
different specifications.
(b) Reporting Methods for Medicare EPs in CY 2013
    In the Stage 2 proposed rule, we did not propose any reporting 
methods for Medicare EPs in 2013. However, in the CY 2013 Medicare PFS 
proposed rule (77 FR 44988), we proposed that EPs may continue to 
report by attestation CQM results as calculated by CEHRT, as they did 
for 2011 and 2012. For further explanation of reporting CQMs by 
attestation, please see the Stage 1 final rule (75 FR 44430 through 
44434). We also proposed in the CY 2013 Medicare PFS proposed rule (77 
FR 44988) to continue the voluntary electronic reporting pilot for CQMs 
(the PQRS--Medicare EHR Incentive Pilot) for 2013, which we had 
previously established for 2012. We expect to finalize in the CY 2013 
Medicare PFS final rule the reporting methods that would apply in 2013 
for EPs participating in the Medicare EHR Incentive Program.
(c) Reporting Methods for Medicare EPs Beginning With CY 2014
    Under section 1848(o)(2)(A)(iii) of the Act, EPs must submit 
information on the CQMs selected by the Secretary ``in a form and 
manner specified by the Secretary'' as part of demonstrating meaningful 
use of CEHRT. We proposed that Medicare EPs who are in their first year 
of Stage 1 may report CQMs through attestation for a continuous 90-day 
EHR reporting period. We proposed that Medicare EPs who choose Option 1 
for reporting CQMs would submit through an aggregate reporting method, 
which would require the EP to log into a CMS-designated portal and 
submit through an upload process data produced as output from their 
CEHRT in an XML-based format specified by CMS. We proposed that 
Medicare EPs who choose to report CQMs as described in Option 2 would 
submit in accordance with the requirements of the PQRS program.
    Comment: We received several comments on the proposal to use an 
XML-based format for transmitting aggregate results. Those commenters 
were generally in favor of using an aggregate XML and that the 
technical structure aligns with the PQRS registry reporting option. One 
commenter noted that the aggregate-level standard QRDA-III is not 
currently mature. Some commenters indicated a preference that the 
aggregate reporting method should only require submission of one data 
file instead of multiple files, citing that submitting multiple files 
is onerous and may not be manageable due to the number of files EPs 
would need to upload.
    Response: We acknowledge that there is currently no consensus 
standard for the electronic transmission of aggregate results of CQMs. 
However, the 2014 Edition certification criteria adopt the QRDA-III 
specification. As a result, we expect to be able to receive data 
submitted using the QRDA-III specification.
    We proposed to consider an ``interim submission'' option for 
Medicare EPs who are in their first year of Stage 1 and who participate 
in PQRS. Under this option, EPs would submit the PQRS CQM data for a 
continuous 90-day EHR reporting period, and the data must be received 
no later than October 1 to meet the requirements of the EHR Incentive 
Program. We proposed that the EP would report the remainder of his/her 
CQM data by the deadline specified for PQRS in order to meet the 
requirements of the PQRS program. We solicited public comment on this 
potential option.
    Comment: Many commenters indicated the proposed interim submission 
option for Medicare EPs in their first year of Stage 1 is unclear and 
would involve a prohibitive amount of effort. The commenters also 
suggested removing this option. Other commenters supported the interim 
submission option.
    Response: This option was intended to accommodate Medicare EPs who 
are demonstrating meaningful use for the first time in 2014 and want to 
choose Option 2 (the PQRS EHR reporting option) for reporting CQMs. As 
proposed, however, it would require two submissions. We agree with the 
commenters that the ``interim submission option'' is complex and 
potentially burdensome. We are not finalizing the interim submission 
option.
    After consideration of the public comments received, we are 
finalizing the following reporting methods for Medicare EPs beginning 
in CY 2014:
     Option 1: Aggregate reporting through a CMS-designated 
electronic transmission method using CEHRT.
    The format required for aggregate reporting will be the QRDA-III, 
which is an XML-based format. The electronic transmission method for 
aggregate reporting differs from reporting via attestation in that the 
QRDA-III report would be generated by the EPs CEHRT and transmitted 
electronically rather than the aggregate results manually input into 
the Registration and Attestation system. EPs who are in their first 
year of Stage 1 must report CQMs under Option 1 through attestation 
(please refer to the Stage 1 final rule for an explanation of reporting 
CQMs through attestation (75 FR 44430 through 44434)). Consistent with 
section 1848(o)(2)(B)(ii) of the Act, in the unlikely event that the 
Secretary does not have the capacity to receive CQM data 
electronically, EPs who are beyond the first year of Stage 1 may 
continue to report aggregate CQM results through attestation.
     Option 2: Patient-level reporting via PQRS through the 
transmission methods established for the PQRS EHR-based reporting 
mechanisms and using CEHRT.
    Please refer to 42 CFR 414.90 and the CY 2013 Medicare PFS proposed 
rule (77 FR 44988) for more information on the PQRS.
(d) Group Reporting Option for Medicare and Medicaid EPs Beginning With 
CY 2014
    For Stage 1, EPs were required to report the CQMs on an individual 
basis and did not have an option to report the CQMs as part of a group 
practice. Under section 1848(o)(2)(A) of the Act, the Secretary may 
provide for the use of alternative means for EPs furnishing covered 
professional services in a group practice (as defined by the Secretary) 
to meet the requirements of meaningful use. Beginning with CY 2014, we 
proposed three group reporting options to allow EPs within a single 
group practice to report CQM data on a group level. We proposed that 
all three methods would be available for Medicare EPs, while only the 
first one would be possible for Medicaid EPs, at states' discretion.
    We proposed each of these options as an alternative to reporting 
CQM data as an individual EP under the proposed options and reporting 
methods discussed earlier in this rule. These group reporting options 
would only be available for reporting CQMs for purposes of the EHR 
Incentive Program and only if all EPs in the group are beyond the first 
year of Stage 1. EPs would not be able to use these group reporting 
options for any of the other meaningful use objectives and associated 
measures in the EHR Incentive Programs.
    The three group reporting options that we proposed for EPs are as 
follows:
     Two or more EPs, each identified with a unique NPI 
associated with a group practice identified under one tax

[[Page 54077]]

identification number (TIN) may be considered an EHR Incentive Group 
for the purposes of reporting CQMs for the Medicare EHR Incentive 
Program. This group reporting option would only be available for 
electronic reporting of CQMs and would not be available for those EPs 
in their first year of Stage 1. The CQMs reported under this option 
would represent all EPs within the group. EPs who choose this group 
reporting option for CQMs would have to individually satisfy the 
objectives and associated measures for their respective stage of 
meaningful use. We proposed that states may also choose this option to 
accept group reporting for CQMs, based upon a predetermined definition 
of a ``group practice,'' such as sharing one TIN.
     Medicare EPs participating in the Medicare SSP and the 
testing of the Pioneer ACO model who use CEHRT to submit ACO measures 
in accordance with the requirements of the Medicare SSP would be 
considered to have satisfied their CQM reporting requirement as a group 
for the Medicare EHR Incentive Program. The Medicare SSP does not 
require the use of CEHRT. However, all CQM data would have to be 
extracted from CEHRT in order for the EP to qualify for the Medicare 
EHR Incentive Program if an EP intends to use this group reporting 
option. EPs would have to individually satisfy the objectives and 
associated measures for their respective stage of meaningful use, in 
addition to submitting CQMs as part of an ACO. EPs who are part of an 
ACO but do not enter the data used for reporting the CQMs (which 
excludes the survey tool or claims-based measures that are collected to 
calculate the quality performance score in the Medicare SSP) into CEHRT 
would not be able to meet meaningful use requirements. For more 
information about the requirements of the Medicare SSP, see 42 CFR 425 
and the November 2, 2011 final rule (76 FR 67802). EPs who use this 
group reporting option for the Medicare EHR Incentive Program would be 
required to comply with any changes to the Medicare SSP that may apply 
in the future. EPs would be required to be part of a group practice 
(that is, two or more EPs, each identified with a unique NPI associated 
with a group practice identified under one TIN) to be able to use this 
group reporting option.
     Medicare EPs who satisfactorily report PQRS CQMs using 
CEHRT under the PQRS Group Practice Reporting Option (GPRO), would be 
considered to have satisfied their CQM reporting requirement as a group 
for the Medicare EHR Incentive Program. For more information about the 
PQRS GPRO, see 42 CFR 414.90 and the CY 2012 Medicare PFS final rule 
(76 FR 73314) and CY 2013 Medicare PFS proposed rule (77 FR 44805 
through 44807). EPs who use this group reporting option for the 
Medicare EHR Incentive Program would be required to comply with any 
changes to the PQRS GPRO that may apply in the future and would have to 
individually satisfy the objectives and associated measures for their 
respective stage of meaningful use.
    Comment: We received numerous comments on the proposed group 
reporting options. Generally, most commenters supported including group 
reporting. Many commenters indicated group reporting options are 
consistent with the intent of many of the measures and would promote a 
more patient focused healthcare experience. A commenter requested 
clarification regarding whether group reporting was confined to CQMs or 
other objectives in meaningful use as well. Other commenters requested 
more detail on how new EPs or EPs leaving group practices might affect 
reporting and validation. Commenters indicated the requirement that 
only EPs beyond Stage 1 be able to use this option be eliminated 
because new providers join practices frequently. A commenter requested 
that new members of a practice be able to report at the same level that 
the group is currently reporting. Many commenters requested greater 
specificity in the final rule and clarification whether all EPs under 
the same TIN need to submit as a group, or if some can submit as a 
group and others individually. A commenter recommended that not all EPs 
under the same TIN should have to have access to CEHRT at all group 
practice locations. Other commenters stated that the proposed option 
for group reporting is complex and suggested the files submitted 
contain only data related to providers within the group or practice 
that have met the measures. A commenter indicated that the addition of 
multiple reporting options has made it exceedingly difficult for 
providers already presented with multiple reporting options across 
state and federal programs.
    Response: We agree with commenters as to the benefits of reporting 
and measurement at the group level. We believe it can lessen the 
complexity and burden of reporting and also promote a greater patient 
focus. Group level reporting can avoid the need for multiple 
professionals in the same practice to report the same information on 
single patient that they may each treat. It can promote team work and 
the recognition that quality care often depends on interplay of 
multiple professionals rather that solely on a particular individual 
professional. Therefore, we agree that we should include the option of 
group reporting of CQMs for the EHR Incentive Program.
    With respect to applicability to measures other than CQMs, as 
proposed the group reporting options in section II.B.6.d. of the 
proposed rule (77 FR 13758) would apply only to CQM reporting and not 
to other meaningful use objectives and associated measures. EPs 
reporting CQMs under a group reporting option must still attest to the 
meaningful use objectives and associated measures individually or 
through the batch reporting process we are finalizing in section 
II.C.1.c of this final rule to successfully demonstrate meaningful use.
    As for the three options for group reporting we proposed, we agree 
with the potential for complexity of group reporting under which 
different individuals within a group would be treated differently, such 
as the proposed requirement that all EPs in the group must be beyond 
their first year of meaningful use. We believe that this would be 
complex and difficult to operationalize, so we are not finalizing this 
requirement. We note that for the group reporting option under PQRS and 
for professionals participating in the Medicare SSP and the testing of 
the Pioneer ACO model, all individuals within a group are treated as 
being part of the group for the purposes of quality reporting.
    As a result, for the Medicare EHR Incentive Program, we are 
finalizing the following two group reporting options for the purposes 
of CQM reporting:
     Medicare EPs participating in the Medicare SSP and the 
testing of the Pioneer ACO model who use CEHRT to submit ACO CQMs in 
accordance with the requirements of the Medicare SSP would be 
considered to have satisfied their CQM reporting requirement as a group 
for the Medicare EHR Incentive Program.
     Medicare EPs who satisfactorily report PQRS CQMs using 
CEHRT under the PQRS GPRO would be considered to have satisfied their 
CQM reporting requirement as a group for the Medicare EHR Incentive 
Program. Under the CY 2013 Medicare PFS proposed rule, additional group 
reporting options are proposed. We note that the proposed claims and 
registry options for GPRO, which do not involve the use of CEHRT, would 
not satisfy the CQM reporting requirement for the EHR Incentive 
Program. However, the options for GPRO involving the use of CEHRT, 
which include submissions from

[[Page 54078]]

CEHRT directly to CMS or through a data intermediary to CMS, could 
satisfy the CQM reporting requirement for the EHR Incentive Program. 
Under the PQRS GPRO, CQM submission is at the group level, not at the 
level of any individual EP that is part of the group. Each individual 
EP who is a member of the group would meet the CQM reporting 
requirement for the EHR Incentive Program if the group meets the 
requirements for PQRS, with the exception of the EPs in the group who 
are in their first year of demonstrating meaningful use as noted later 
in this section.
    We do not finalize any additional requirements beyond those of the 
programs themselves for group reporting, with the exception that the 
group must use CEHRT in connection with submitting CQMs. Although a 
group may include EPs that are demonstrating meaningful use for the 
first time, we emphasize that these EPs cannot use either of these 
group reporting options for reporting CQMs for the EHR Incentive 
Program. CQM data collected by EPs that are part of a group and are in 
their first year of demonstrating meaningful use could still be part of 
the group's collective data submission. However, for purposes of 
avoiding a payment adjustment, EPs who are in their first year of 
demonstrating meaningful use in the year immediately preceding a 
payment adjustment year must individually submit their CQM data by 
attestation no later than October 1 of such preceding year. We 
encourage EPs who would like to use the group reporting options 
beginning in 2014 to become meaningful EHR users in 2013. Please see 
section II.D.2. of this final rule for more details on payment 
adjustments.
    For the Medicaid EHR Incentive Program, the states will have the 
option to allow group reporting of CQMs through an update to their 
State Medicaid HIT plan, which must describe how they would address the 
issue of EPs who switch group practices during an EHR reporting period.
7. CQMs for Eligible Hospitals and Critical Access Hospitals
(a) Statutory and Other Considerations
    Sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act provide 
for the reporting of CQMs by eligible hospitals and CAHs as part of 
demonstrating meaningful use of CEHRT. For further explanation of the 
statutory requirements, we refer readers to the discussion in our Stage 
1 proposed and final rules (75 FR 1870 through 1902 and 75 FR 44380 
through 44435, respectively).
    Section 1886(n)(3)(B)(i)(I) of the Act requires the Secretary to 
give preference to CQMs that have been selected for the purpose of 
applying section 1886(b)(3)(B)(viii) of the Act (that is, measures that 
have been selected for the Hospital Inpatient Quality Reporting (IQR) 
Program) or that have been endorsed by the entity with a contract with 
the Secretary under section 1890(a) of the Act (namely, the NQF). We 
proposed CQMs for eligible hospitals and CAHs for 2013, 2014, and 2015 
(and potentially subsequent years) that reflect this preference, 
although we note that the Act does not require the selection of such 
CQMs for the EHR Incentive Programs. CQMs listed in this final rule 
that do not have an NQF identifying number are not NQF endorsed.
    Under section 1903(t)(8) of the Act, the Secretary must seek, to 
the maximum extent practicable, to avoid duplicative requirements from 
federal and state governments for eligible hospitals and CAHs to 
demonstrate meaningful use of CEHRT under Medicare and Medicaid. 
Therefore, to meet this requirement, we proposed to continue our 
practice from Stage 1 of proposed CQMs that would apply for both the 
Medicare and Medicaid EHR Incentive Programs.
    In accordance with CMS and HHS quality goals as well as the HHS 
National Quality Strategy recommendations, the hospital CQMs that we 
proposed beginning with FY 2014 can be categorized into the following 
six domains, which are described in section II.B.3. of this final rule:
     Patient & Family Engagement.
     Patient Safety.
     Care Coordination.
     Population & Public Health.
     Efficient Use of Healthcare Resources.
     Clinical Process/Effectiveness.
    The selection of CQMs we proposed for eligible hospitals and CAHs 
was based on statutory requirements, the HITPC's recommendations, 
alignment with other CMS and national hospital quality measurement 
programs such as the Joint Commission, the Medicare Hospital Inpatient 
Quality Reporting (IQR) Program and Hospital Value-Based Purchasing 
(HVBP) Program, the National Quality Strategy (NQS), and other 
considerations discussed in sections II.B.7.b. and II.B.7.c. of the 
proposed rule.
    Section 1886(n)(3)(B)(iii) of the Act requires that in selecting 
measures for eligible hospitals and CAHs, and in establishing the form 
and manner of reporting, the Secretary shall seek to avoid redundant or 
duplicative reporting with reporting otherwise required. In 
consideration of the importance of alignment with other measure sets 
that apply to eligible hospitals and CAHs, we analyzed the Hospital IQR 
Program, hospital CQMs used by state Medicaid agencies, and the Joint 
Commission's hospital CQMs when selecting the proposed CQMs to be 
reported under the EHR Incentive Program. Furthermore, as we noted in 
the proposed rule, we placed emphasis on those CQMs that are in line 
with the NQS and the HITPC's recommendations.
    Comment: Many commenters supported alignment of measure sets and 
reporting methods with other quality reporting programs and agency 
goals, such as Hospital IQR Program, HVBP, and NQS. These commenters 
commended CMS's intentions to reduce duplicative requirements between 
programs, prevent hospitals from calculating both electronic and paper-
based reports for the same CQMs, avoid confusion and move towards a 
single, aligned quality reporting mechanism. However, several 
commenters requested that we provide a timeline for these alignment 
efforts as well as additional clarification regarding how we intend to 
pursue and achieve alignment across quality report programs and what 
this means operationally for eligible hospitals and CAHs. One commenter 
requested that we also align with the Center for Disease Control and 
Prevention's (CDC's) National Healthcare Safety Network (NHSN) to make 
hospital acquired infections (HAI) a national healthcare priority. 
Other commenters requested that we seek alignment and accuracy in other 
areas of quality measurement, including electronic specifications, data 
reporting methodologies, and vendor certification requirements. One 
commenter also urged that we continuously align electronic 
specifications for all CQMs across quality reporting programs as 
measure stewards update and maintain their CQMs.
    Response: We appreciate the supportive comments regarding 
alignment. Our principal goals in alignment of the Hospital IQR, and 
the Medicare and Medicaid EHR Incentive Programs are to: (1) Provide a 
single set of CQMs for hospital reporting; (2) to the extent possible, 
avoid duplicate reporting by hospitals by using a single submission for 
multiple purposes as appropriate; and (3) transition from manual chart 
abstraction to automated extraction and electronic reporting based on 
the use of EHR technology.

[[Page 54079]]

    In the FY 2012 Inpatient Prospective Payment Systems/Long-Term Care 
Hospital Prospective Payment System (IPPS/LTCH PPS) proposed rule (76 
FR 25893), we stated our intention to explore mechanisms for Hospital 
IQR Program data collection using EHRs, and gave FY 2015 as an example 
of when hospitals might be able to switch to EHR-based reporting of 
manually chart-abstracted Hospital IQR measures. The CQMs we are 
finalizing beginning in 2014 for reporting under the EHR Incentive 
Program are electronically specified versions of current IQR chart 
abstracted CQMs. The 2015 target date would allow for at least 1 year 
of electronic submission of CQMs through the EHR Incentive Program 
prior to our targeted date to begin EHR-based reporting for IQR. We 
must assess any data collection mode differences between EHR-based 
reporting and chart abstracted measures using a diverse and robust 
sample of hospitals before proposing in rulemaking to use EHR data 
collection in the Hospital IQR program. Among other factors, our 
ability to transition to EHR-based reporting for IQR will depend on 
whether EHR-based reporting is accurate and reliable. Our goal would be 
to phase out manual chart abstraction for hospital reporting.
    We did not propose the IQR CQMs on HAI for the EHR Incentive 
Program. Hospitals may electronically submit HAI information to the 
CDC, although this is not required. Information of electronic 
submission through the NHSN can be found at http://www.cdc.gov/nhsn/CDA_eSurveillance.html. NHSN data is based on surveillance data rather 
than chart abstraction. We will consider the NHSN measures for the EHR 
Incentive Program in future years.
(b) CQMs for Eligible Hospitals and CAHs for FY 2013
    For the EHR reporting periods in FY 2013, we proposed to require 
that eligible hospitals and CAHs submit information on each of the 15 
CQMs that were finalized for FYs 2011 and 2012 in the Stage 1 final 
rule (75 FR 44418 through 44420). We refer readers to the discussion in 
the Stage 1 final rule for further explanation of the requirements for 
reporting those CQMs (75 FR 44411 through 44422).
    We did not receive any public comments on our proposals, and we are 
finalizing the CQMs for FY 2013 as proposed.
(c) CQMs for Eligible Hospitals and CAHs Beginning With FY 2014
(i) Reporting Options
    We proposed to require eligible hospitals and CAHs to report 24 
CQMs from a menu of 49 CQMs beginning with FY 2014, including at least 
1 CQM from each of the following 6 domains, which are discussed in 
section II.B.3. of this final rule:
     Patient and Family Engagement.
     Patient Safety.
     Care Coordination.
     Population and Public Health.
     Efficient Use of Healthcare Resources.
     Clinical Process/Effectiveness.

For the remaining CQMs, we proposed that eligible hospitals and CAHs 
would select and report CQMs that best apply to their patient mix. We 
solicited comments on the number of CQMs and the appropriateness of the 
CQMs and domains for eligible hospitals and CAHs.
    Comment: A few commenters stated that the requirement to report 24 
CQMs was too difficult and adds to the administrative burden placed on 
eligible hospitals and CAHs, especially rural hospitals. Many 
commenters suggested that CQM reporting requirement beginning with 2014 
remain at 15 CQMs due to the number of issues experienced by hospitals 
when implementing the Stage 1 CQMs, although other commenters stated 
that requiring up to 18 CQMs would be reasonable. A few commenters 
noted that CQMs were not evenly distributed among the 6 domains, making 
the requirement to report at least one CQM from each domain difficult 
for some hospitals. One commenter recommended that if a domain did not 
have at least 4 CQMs eligible hospitals and CAHs should not be required 
to report that domain. Multiple commenters stated that eligible 
hospitals and CAHs in Stage 1 in FY 2014 may have difficulty meeting 
the CQM requirement beginning in 2014 and recommend that the Stage 1 
CQMs meet the requirements for those hospitals. Alternatively, the 
commenters recommended that if the CQMs beginning in 2014 are required, 
that the number of CQMs being reported be reduced for the eligible 
hospitals and CAHs in Stage 1 beginning in FY 2014. One commenter 
stated that CQM requirements failed to align with other meaningful use 
objectives.
    Response: We acknowledge that increasing the number of CQMs 
required to be reported from 15 in 2011, 2012, and 2013 to 24 beginning 
in 2014 increases implementation burden on hospitals. We have stated 
our intention to implement EHR-based reporting of CQMs in other quality 
reporting programs, such as the Hospital IQR Program. One purpose of 
our proposal to increase the number of CQMs reported electronically for 
the EHR Incentive Program is to create an electronic reporting 
infrastructure that we can also use for other quality reporting 
programs. We also acknowledge that the requirement of reporting 24 CQMs 
for hospitals in their first year of Stage 1 in 2014 is a significant 
increase from the reporting requirement for hospitals that entered 
Stage 1 before 2014. We also acknowledge the difficulty in meeting the 
requirement to report at least 1 CQM in each of the 6 domains. For 
these reasons, we have finalized a policy that decreases the number of 
CQMs required from the proposal and decreases the total number of 
domains required to be covered among the selected CQMs.
    After consideration of the public comments received and for the 
reasons discussed previously, we are finalizing the following policy on 
reporting requirements for CQMs for eligible hospitals and CAHs 
beginning in 2014:
    Eligible hospitals and CAHs must report a total of 16 CQMs covering 
at least 3 domains from Table 8. We expect eligible hospitals and CAHs 
will select measures that best apply to their patient mix. As we 
proposed, if an eligible hospital's or CAH's CEHRT does not contain 
patient data for at least 16 CQMs covering at least 3 domains, then the 
eligible hospital or CAH must report the CQMs for which there is 
patient data and report the remaining required CQMs as ``zero 
denominators'' as displayed by their certified EHR technology. In the 
unlikely event that there are no CQMs applicable to the eligible 
hospital's or CAH's patient mix, eligible hospitals or CAHs must still 
report 16 CQMs even if zero is the result in either the numerator or 
the denominator of the measure. If all CQMs have a value of zero from 
their CEHRT, then eligible hospitals or CAHs must select any 16 CQMs 
from Table 8 to report. We stated in the proposed rule that our 
experience from Stage 1 in implementing the current set of 15 CQMs in 
specialty and low volume eligible hospitals illuminated several 
challenges. For example, children's hospitals rarely see patients 18 
years or older. One of the exceptions to this generality is individuals 
with sickle cell disease. National Institutes of Health Guidelines (NIH 
Publication 02-2117) list the conditions under which thrombolytic 
therapy cannot be recommended for adults or children with sickle cell 
disease. This, plus the

[[Page 54080]]

fact that children's hospitals have on average two or fewer cases of 
stroke per year, have created workflow, cost, and clinical barriers to 
demonstrating meaningful use as it relates to the CQMs for stroke and 
VTE.
    We proposed to consider whether a case number threshold would be 
appropriate, given the apparent burden on hospitals that very seldom 
have the types of cases addressed by certain CQMs such that hospitals 
that do not have enough cases to exceed the threshold would be exempt 
from reporting those CQMs. We solicited comments on what the numerical 
range of threshold should be, how hospitals would demonstrate to CMS or 
state Medicaid agencies that they have not exceeded this threshold, 
whether it should apply to only certain hospital CQMs (and if so, which 
ones), and the extent of the burden on hospitals if a case number 
threshold is not adopted given that they are allowed to report 
``zeroes'' for the measures. We solicited comments on limiting the case 
threshold exemption to only children's, cancer hospitals, and a subset 
of hospitals in the Indian Health System as they have a much narrower 
patient base than acute care and critical access hospitals. We 
requested comments on whether such thresholds should be established for 
2013, noting that the issue could be mitigated beginning in 2014 by our 
proposal to establish a larger menu set of CQMs from which hospitals 
would select.
    Comment: Many commenters noted that the implementation of a case 
number threshold for CQM reporting would help reduce the burden placed 
on hospitals that very seldom have cases in the denominator of certain 
CQMs. However, commenters suggested differing mechanisms by which to 
implement a case number threshold. Many commenters suggested that we 
use Medicare claims data from the year prior to a hospital's CQM 
submission or another historical data source to determine whether a 
hospital should be exempt from reporting certain CQMs. Another 
commenter suggested that the simplest option would be to continue to 
allow hospitals to report zeroes in the denominators for CQMs. A few 
commenters requested that we implement a case number threshold for all 
hospital types, not just specialty hospitals or CAHs, since some acute 
care hospitals do not provide a full range of services. Another 
commenter suggested that we work with children's hospitals and CAHs and 
other types of hospitals with unique patient populations to ensure that 
meaningful use requirements are feasible for them. Some commenters 
stated that low volume eligible hospitals and CAHs would not know at 
the beginning of a reporting period which CQMs would not meet a case 
number threshold and therefore should not have to select the CQMs in 
advance based on this criterion. This commenter suggested that the 
hospitals select the CQMs to report that are most appropriate for their 
patient populations. One commenter requested that a case number 
threshold be implemented for all CQM reporting for FY 2013.
    In terms of a specific case number threshold, one commenter 
suggested five or fewer cases per month as an appropriate threshold 
number to exempt any type of hospital from reporting a CQM. This same 
commenter also suggested that if a hospital does not have a least one 
CQM in a domain with a denominator greater than five, then that 
hospital should be exempt from reporting on that entire domain. Another 
commenter suggested exempting eligible hospitals and CAHs from 
reporting a CQM if the relevant patient population comprised less than 
10 percent of their discharges. Other commenters suggested that 
children's hospitals be excluded from all CQMs that are only applicable 
to patients 18 years of age or older. Another commenter recommended 
that we set a case number threshold of 30 cases and require hospitals 
to validate this exemption through attestation. Other commenters did 
not suggest a specific case number threshold, but requested that we 
empirically derive this value and that it be aligned with values across 
quality reporting programs.
    Response: We recognize the potential cost and work flow challenges 
when hospitals have a low volume of cases per year that apply to a 
particular CQM. We note that under the Hospital IQR Program, we do not 
require a hospital that has 5 or fewer inpatient discharges (Medicare 
and non-Medicare combined) in a topic area during a quarter in which 
data must be submitted to submit patient-level data for that topic area 
for the quarter (76 FR 51641). For the Hospital IQR Program, the 
hospital is still required to submit its aggregate population and 
sample size counts for Medicare and non-Medicare discharges for the 
topic areas each quarter, and hospitals that qualify for this exception 
for a particular topic can still elect to voluntarily submit their 
patient-level data. In order to align with the Hospital IQR Program, we 
will adopt a similar policy for all eligible hospitals and CAHs 
participating in the EHR Incentive Program, whereby hospitals with 5 or 
fewer inpatient discharges per quarter or 20 or fewer inpatient 
discharges per year (Medicare and non-Medicare combined) as defined by 
a CQM's denominator population would be exempted from reporting on that 
CQM.
    After consideration of the public comments received and for the 
reasons discussed earlier, we are finalizing the following policy on 
case threshold exemptions for eligible hospitals and CAHs in all stages 
of meaningful use beginning in FY 2014. However, eligible hospitals and 
CAHs that are demonstrating meaningful use for the first time must 
submit their CQMs through attestation and will not be able to qualify 
for this exemption. The burden of submitting the aggregate population 
and sample size counts in order to qualify for the exemption would be 
at least equal to the effort required to obtain and attest to the 
calculated CQM data.
    Eligible hospitals and CAHs that have 5 or fewer discharges per 
quarter in the same quarter as their reporting period in FY 2014, or 20 
or fewer discharges per full FY reporting period beginning in FY 2015, 
for which data is being electronically submitted (Medicare and non-
Medicare combined) as defined by the CQM's denominator population are 
exempted from reporting the CQM. For example, if the CQM's denominator 
population is ischemic stroke patients greater than or equal to 18 
years of age, then the threshold would be 5 or fewer ischemic stroke 
patients aged 18 years or older discharged from the hospital in the 
quarter for which data is being submitted (the hospital's FY 2014 3-
month quarter reporting period). To be eligible for the exemption, 
hospitals must submit their aggregate population and sample size counts 
for Medicare and non-Medicare discharges for the CQM for the reporting 
period no later than the 2-month submission period of October 1 through 
November 30 immediately following the reporting period (please see 
section II.B.1. of this final rule for a description of reporting and 
submission periods). Hospitals will report this information in the same 
manner as for the Hospital IQR Program (76 FR 51639 through 51641). 
Please refer to the QualityNet Web site (www.qualitynet.org) and the 
CMS/Joint Commission Specifications Manual for National Hospital 
Inpatient Quality Measures, located on the QualityNet Web site, for 
technical information about data submission requirements. Hospitals 
that do not seek an exemption under the EHR Incentive Program do not 
have to submit aggregate population and sample size counts for any CQMs 
for the purposes of the EHR Incentive Program.

[[Page 54081]]

(ii) Clinical Quality Measures
    We proposed CQMs in Table 9 of the Stage 2 proposed rule (77 FR 
13760 to 13763) that would apply for all eligible hospitals and CAHs 
beginning with FY 2014, regardless of whether an eligible hospital or 
CAH is in Stage 1 or Stage 2 of meaningful use. The set of 49 CQMs that 
we proposed included the current set of 15 CQMs that were finalized for 
FYs 2011 and 2012 in the Stage 1 final rule.
    The CQM titles and descriptions in Table 8 reflect the most current 
updates, as provided by the measure stewards who are responsible for 
maintaining and updating the measure specifications, and therefore may 
not reflect the title and/or description as presented on the NQF Web 
site.
    Comment: Many commenters requested that we finalize fewer than 49 
CQMs. The most common reasons given for reducing the complete list of 
CQMs included limitations of the vendors to program and deploy systems 
and for hospitals to effectively implement those systems, especially 
among resource-limited organizations.
    Several commenters recommended that CQMs that are suspended from 
the Hospital IQR program, not NQF endorsed, only apply to certain 
regions of the country or not electronically specified should not be 
considered for CQM reporting beginning in 2014. Additionally, some 
commenters suggested that no new CQMs be added until CEHRT can produce 
accurate calculations of the existing CQMs. A few commenters stated 
that increasing the number of CQMs in such a narrow timeframe would be 
challenging for organizations in terms of designing, creating, and 
implementing new workflows, building, testing and modifying 
configurations to ensure proper discrete data capture, and training 
staff. One of these commenters requested a phased-in approach for 
calculating CQMs through EHRs and requested that we do not add any new 
manually abstracted CQMs in other CMS quality reporting programs.
    One commenter stated that it was unclear if mid-cycle modifications 
of measures would require hospitals to resubmit data and recommended 
that if a measure were modified or deleted mid-cycle that hospitals not 
have to modify measures selected.
    Response: Some of the CQMs that were proposed but not finalized 
were not submitted by the measure stewards for continued NQF 
endorsement (NQF 0136 Heart Failure (HF)-1 Detailed Discharge 
Instructions, NQF 0481 First Temperature Measured within One Hour of 
Admission to the NICU, and NQF 0482 First NICU Temperature Response: Table 9 summarizes the public comments received 
on specific proposed eligible hospital and CAH CQMs and the CMS 
rationale (that is, our response to the CQM-specific comment(s)) for 
finalizing or not finalizing the CQM for reporting beginning with FY 
2014.

  Table 9--Summary of Eligible Hospital and CAH CQM-Specific Comments and Rationale To Finalize or Not Finalize
                                                     the CQM
----------------------------------------------------------------------------------------------------------------
                                                        Commenters do not
             CQM No.               Commenters support        support            Finalized        CMS rationale
                                      finalization         finalization
----------------------------------------------------------------------------------------------------------------
ED Throughput: NQF 0495, 0497,    Many supported       Few stated factors   Yes.............  Continues with
 0496.                             continuing with      affecting results                      Stage 1 CQM
                                   Stage 1 CQMs,        are outside                            reporting for
                                   instead of           control of ED,                         ED[dash]1&2,
                                   requiring            difficult to                           aligns with IQR/
                                   additional CQMs      implement without                      OQR/HVBP,
                                   for Stage 2          workflow changes                       retooled measures
                                   (ED[dash]1&2). ED    and CPOE                               passed
                                   throughput           implemented                            reliability,
                                   measures are         hospital[dash]wide                     validity, &
                                   required by the      , & may reflect                        feasibility
                                   Joint Commission.    negatively on                          testing.
                                                        hospitals
                                                        routinely
                                                        receiving complex
                                                        patients. One
                                                        commenter noted
                                                        may not correlate
                                                        with improved
                                                        outcomes.
Stroke[dash]2,3,4,5,6,8: NQF      Many supported       Few stated that it   Yes.............  Continues with
 0435, 0436, 0437, 0438, 0439,     continuing with      is difficult to                        Stage 1 CQM
 0440.                             Stage 1 CQMs,        capture certain                        reporting, aligns
                                   instead of           data elements                          with IQR/HVBP,
                                   requiring            within current                         retooled measures
                                   additional CQMs      clinical                               passed
                                   for Stage 2.         workflows, and                         reliability,
                                                        recommends delay                       validity, &
                                                        to Stage 3 after                       feasibility
                                                        further                                testing.
                                                        e[dash]specificati
                                                        on testing is
                                                        completed.

[[Page 54082]]

 
Stroke[dash]10: NQF 0441........  Many supported       A commenter stated   Yes.............  Continues with
                                   continuing with      that this is a                         Stage 1 CQM
                                   Stage 1 CQMs,        poor care                              reporting, aligns
                                   instead of           coordination                           with IQR/HVBP,
                                   requiring            measure but                            retooled measures
                                   additional CQMs      provided no                            passed
                                   for Stage 2.         reasons.                               reliability,
                                                                                               validity, &
                                                                                               feasibility
                                                                                               testing.
VTE[dash]1,2,3,4,5,6: NQF 371,    Many supported       Few stated that it   Yes.............  Continues with
 0372, 0373, 0374, 0375, 0376.     continuing with      is difficult to                        Stage 1 CQM
                                   Stage 1 CQMs,        capture certain                        reporting, aligns
                                   instead of           data elements                          with IQR/HVBP,
                                   requiring            within current                         retooled measures
                                   additional CQMs      clinical                               passed
                                   for Stage 2.         workflows, one                         reliability,
                                                        recommended delay                      validity, &
                                                        to Stage 3 after                       feasibility
                                                        further                                testing.
                                                        e[dash]specificati
                                                        on testing is
                                                        completed.
AMI[dash]1, 3, 5: NQF 0132,       One commenter        Many stated these    No..............  Suspended from
 0137, 0160.                       supported            measures should                        IQR, thus not
                                   AMI[dash]3, but      not be finalized                       supportive of
                                   for Stage 3 once     since they have                        program
                                   CPOE is more         been suspended                         alignment.
                                   widely implemented   from IQR, are not
                                   &                    recommended by the
                                   e[dash]specificati   MAP, are difficult
                                   ons can be           to implement
                                   published in a       without CPOE
                                   timely manner to     implemented
                                   allow for            hospital[dash]wide
                                   inclusion of new     & one commenter
                                   guidelines.          stated it is
                                   Inclusion will       difficult to
                                   help tracking        capture unless an
                                   compliance.          eMAR is
                                                        implemented.
                                                        AMI[dash]1 & 5 are
                                                        not included in
                                                        CMS programs.
AMI[dash]2, 7a: NQF 0142, 0164..  A few commenters     One commenter        Yes.............  Aligns with IQR/
                                   support including    requested delay to                     HVBP, which both
                                   these measures for   Stage 3 until CPOE                     consider it an
                                   Stage 3 to allow     is more widely                         important CQM on
                                   for additional       implemented. One                       post-discharge
                                   time for testing &   commenter noted                        AMI prevention
                                   implementation.      AMI[dash]2 is                          for hospitals to
                                   AMI[dash]2 is        topped out.                            report. Retooled
                                   required by the                                             measure passed
                                   Joint Commission.                                           reliability,
                                   Inclusion will                                              validity, &
                                   help tracking                                               feasibility
                                   compliance.                                                 testing.
AMI[dash]8a,10: NQF 0163, 0639..  N/A................  One commenter        Yes.............  Aligns with IQR/
                                                        stated it is                           HVBP, retooled
                                                        difficult to                           measure passed
                                                        capture certain                        reliability,
                                                        data elements                          validity, &
                                                        within current                         feasibility
                                                        clinical                               testing.
                                                        workflows; one
                                                        commenter stated
                                                        it is difficult to
                                                        capture if CPOE is
                                                        not widely
                                                        implemented.
PN[dash]3b: NQF 0148............  One commenter        Delay to Stage 3     No..............  Retired from NQF
                                   supports including   after further                          endorsement.
                                   this measure for     e[dash]specificati
                                   Stage 3 to allow     on testing is
                                   additional time      completed.
                                   for testing &
                                   implementation. A
                                   few commenters
                                   support this
                                   measure if
                                   e[dash]specificati
                                   ons are available
                                   in a timely
                                   manner. This is
                                   required by the
                                   Joint Commission.
PN[dash]6: NQF 0147               N/A................  One commenter        Yes.............  Aligns with IQR/
                                                        states data                            HVBP, retooled
                                                        collection is                          measure passed
                                                        difficult due to                       reliability,
                                                        absent decision                        validity, &
                                                        support algorithm.                     feasibility
                                                                                               testing.
Elective Delivery Prior to 39     A commenter          Not required in      Yes.............  Aligns with IQR,
 Weeks: NQF 0469.                  supports the         IQR, a commenter                       Medicaid Adult
                                   inclusion of this    was concerned that                     Core, & Strong
                                   safety[dash]relate   labor and delivery                     Start programs,
                                   d CQM.               applications are                       retooled measure
                                                        not part of                            passed
                                                        certification.                         reliability,
                                                                                               validity, &
                                                                                               feasibility
                                                                                               testing.
Exclusive Breast Feeding at       Many commenters      Not required in      Yes.............  Aligns with
 Discharge: NQF 0480.              support this,        IQR, highly                            Medicaid
                                   noting that it       subjective                             reporting
                                   will help improve    measure, specific                      initiatives.
                                   maternity care       to California only                     Measure passed
                                   practices and        and not well                           reliability,
                                   create an            vetted, and                            validity, &
                                   awareness of         contains data                          feasibility
                                   quality of care      elements difficult                     testing.
                                   issues. A            to capture.
                                   commenter
                                   supported this
                                   measure, but for
                                   Stage 3 once labor
                                   and delivery
                                   applications are
                                   part of
                                   certification.

[[Page 54083]]

 
Home Management Plan of Care,     A commenter          Not required in      Yes.............  Aligns with
 CAC[dash]3: NQF 0338.             supports this        IQR, not supported                     Medicaid
                                   measure, but not     by the MAP, and                        reporting
                                   until                overly burdensome.                     initiatives.
                                   documentation for                                           Measure passed
                                   peri[dash]operativ                                          reliability,
                                   e,                                                          validity, &
                                   intra[dash]operati                                          feasibility
                                   ve and anesthesia                                           testing.
                                   are parts of
                                   certification.
Healthy Term Newborn: NQF 0716..  A commenter          Not required in IQR  Yes.............  Aligns with
                                   supports this                                               Medicaid
                                   measure. A                                                  reporting
                                   commenter supports                                          initiatives.
                                   this measure, but                                           Measure passed
                                   for Stage 3 once                                            reliability,
                                   labor and delivery                                          validity, &
                                   applications are                                            feasibility
                                   part of                                                     testing.
                                   certification.
Hearing Screening: NQF 1354.....  One commenter        Not required in IQR  Yes.............  Aligns with
                                   supports this                                               Medicaid
                                   measure if                                                  reporting
                                   e[dash]specificati                                          initiatives.
                                   ons are available                                           Measure passed
                                   in a timely manner.                                         reliability,
                                                                                               validity, &
                                                                                               feasibility
                                                                                               testing.
SCIP INF[dash]1,2,9: NQF 0527,    A commenter          N/A................  Yes.............  Aligns with IQR/
 0528, 0453.                       supports these                                              HVBP, retooled
                                   measures, but not                                           measure passed
                                   until                                                       reliability,
                                   documentation for                                           validity, &
                                   peri[dash]operativ                                          feasibility
                                   e,                                                          testing.
                                   intra[dash]operati
                                   ve and anesthesia
                                   are parts of
                                   certification.
                                   Inclusion will
                                   help tracking
                                   compliance.
SCIP INF[dash]3,4,6: NQF 0529,    A commenter          Not required in IQR  No..............  SCIP[dash]INF[dash
 0300, 0301.                       supports this        and not                                ]3 reflects a
                                   measure, but not     recommended by the                     limited patient
                                   until                MAP. One commenter                     population, keeps
                                   documentation for    noted SCIP                             the total number
                                   peri[dash]operativ   INF[dash]6 may not                     of Stage 2
                                   e,                   correlate with                         measure options
                                   intra[dash]operati   improved outcomes.                     reasonable.
                                   ve and anesthesia                                           SCIP[dash]INF[das
                                   are parts of                                                h]4 is being
                                   certification.                                              reworked by the
                                   SCIP[dash]INF[dash                                          steward.
                                   ]3 is required by                                           SCIP[dash]INF[das
                                   the Joint                                                   h]6 is suspended
                                   Commission..                                                from reporting in
                                                                                               IQR.
HF[dash]1: NQF 0136.............  One commenter        One commenter did    No..............  Retired from NQF
                                   supported.           not support since                      endorsement.
                                                        being retired from
                                                        NQF endorsement.
First Temperature within 1 hour   One commenter        A few commenters     No..............  Retired from NQF
 in NICU > 36[deg] and A................  A few commenters     No..............  Required in IQR
 Influenza; NQF 1653, 1659.                             stated these are                       but not for HVBP,
                                                        not consistent                         and keeps the
                                                        with current                           total number of
                                                        guidelines.                            Stage 2 measure
                                                                                               options
                                                                                               reasonable.
Proportion of Infants 22[dash]29  N/A................  Contains data        No..............  Retired from NQF
 weeks old treated with                                 elements difficult                     endorsement.
 Surfactant: NQF 0484.                                  to capture.
----------------------------------------------------------------------------------------------------------------
# All hospital CQMs finalized in this rule are NQF-endorsed. NQF endorsement includes a consensus development
  process that takes into account clinical guidelines and scientific evidence. NQF describes its consensus
  development process at http://www.qualityforum.org/Measuring_Performance/Consensus_Development_Process.aspx.

    After consideration of the public comments received and the measure 
selection criteria discussed, we are finalizing the list of 29 CQMs for 
eligible hospitals and CAHs included in Table 10.

                 Table 10--CQMs Finalized for Eligible Hospitals and CAHs Beginning With FY 2014
----------------------------------------------------------------------------------------------------------------
                                       Measure steward    Other quality measure
   NQF No.             Title             and contact     programs that  use the     New CQM          Domain
                                         information          same CQM ***
----------------------------------------------------------------------------------------------------------------
0495........  Title: Emergency        CMS/Oklahoma       IQR...................  ............  Patient and
               Department (ED)-1       Foundation for                                           Family
               Emergency Department    Medical Quality                                          Engagement.
               Throughput--Median      (OFMQ)
               time from ED arrival    Qualitynet.org
               to ED departure for     and click on
               admitted ED patients.   ``Questions &
              Description: Median      Answers''.
               time from emergency
               department arrival to
               time of departure
               from the emergency
               room for patients
               admitted to the
               facility from the
               emergency department..

[[Page 54084]]

 
0497........  Title: ED-2 Emergency   CMS/OFMQ           IQR...................  ............  Patient and
               Department              Qualitynet.org                                           Family
               Throughput--admitted    and click on                                             Engagement.
               patients--Admit         ``Questions &
               decision time to ED     Answers''.
               departure time for
               admitted patients.
              Description: Median
               time (in minutes)
               from admit decision
               time to time of
               departure from the
               emergency department
               for emergency
               department patients
               admitted to inpatient
               status..
0435........  Title: Stroke-2         The Joint          IQR...................  ............  Clinical Process/
               Ischemic stroke--       Commission                                               Effectiveness.
               Discharged on anti-     www.jointcommiss
               thrombotic therapy.     ion.org and
              Description: Ischemic    click on
               stroke patients         ``Contact Us''.
               prescribed
               antithrombotic
               therapy at hospital
               discharge..
0436........  Title: Stroke-3         The Joint          IQR...................  ............  Clinical Process/
               Ischemic stroke--       Commission                                               Effectiveness.
               Anticoagulation         www.jointcommiss
               Therapy for Atrial      ion.org and
               Fibrillation/Flutter.   click on
              Description: Ischemic    ``Contact Us''.
               stroke patients with
               atrial fibrillation/
               flutter who are
               prescribed
               anticoagulation
               therapy at hospital
               discharge..
0437........  Title: Stroke-4         The Joint          IQR...................  ............  Clinical Process/
               Ischemic stroke--       Commission                                               Effectiveness.
               Thrombolytic Therapy.   www.jointcommiss
              Description: Acute       ion.org and
               ischemic stroke         click on
               patients who arrive     ``Contact Us''.
               at this hospital
               within 2 hours (120
               minutes) of time last
               known well and for
               whom IV t-PA was
               initiated at this
               hospital within 3
               hours (180 minutes)
               of time last known
               well..
0438........  Title: Stroke-5         The Joint          IQR...................  ............  Clinical Process/
               Ischemic stroke--       Commission                                               Effectiveness.
               Antithrombotic          www.jointcommiss
               therapy by end of       ion.org and
               hospital day two.       click on
              Description: Ischemic    ``Contact Us''.
               stroke patients
               administered
               antithrombotic
               therapy by the end of
               hospital day two..
0439........  Title: Stroke-6         The Joint          IQR...................  ............  Clinical Process/
               Ischemic stroke--       Commission                                               Effectiveness.
               Discharged on Statin    www.jointcommiss
               Medication.             ion.org and
              Description: Ischemic    click on
               stroke patients with    ``Contact Us''.
               LDL greater than or
               equal to 100 mg/dL,
               or LDL not measured,
               or, who were on a
               lipid-lowering
               medication prior to
               hospital arrival are
               prescribed statin
               medication at
               hospital discharge..
0440........  Title: Stroke-8         The Joint          IQR...................  ............  Patient & Family
               Ischemic or             Commission                                               Engagement.
               hemorrhagic stroke--    www.jointcommiss
               Stroke education.       ion.org and
              Description: Ischemic    click on
               or hemorrhagic stroke   ``Contact Us''.
               patients or their
               caregivers who were
               given educational
               materials during the
               hospital stay
               addressing all of the
               following: activation
               of emergency medical
               system, need for
               follow-up after
               discharge,
               medications
               prescribed at
               discharge, risk
               factors for stroke,
               and warning signs and
               symptoms of stroke..
0441........  Title: Stroke-10        The Joint          IQR...................  ............  Care
               Ischemic or             Commission                                               Coordination.
               hemorrhagic stroke--    www.jointcommiss
               Assessed for            ion.org and
               Rehabilitation.         click on
              Description: Ischemic    ``Contact Us''.
               or hemorrhagic stroke
               patients who were
               assessed for
               rehabilitation
               services..
0371........  Title: Venous           The Joint          IQR...................  ............  Patient Safety.
               Thromboembolism (VTE)-  Commission
               1 VTE prophylaxis.      www.jointcommiss
              Description: This        ion.org and
               measure assesses the    click on
               number of patients      ``Contact Us''.
               who received VTE
               prophylaxis or have
               documentation why no
               VTE prophylaxis was
               given the day of or
               the day after
               hospital admission or
               surgery end date for
               surgeries that start
               the day of or the day
               after hospital
               admission..

[[Page 54085]]

 
0372........  Title: VTE-2 Intensive  The Joint          IQR...................  ............  Patient Safety.
               Care Unit (ICU) VTE     Commission
               prophylaxis.            www.jointcommiss
              Description: This        ion.org and
               measure assesses the    click on
               number of patients      ``Contact Us''.
               who received VTE
               prophylaxis or have
               documentation why no
               VTE prophylaxis was
               given the day of or
               the day after the
               initial admission (or
               transfer) to the
               Intensive Care Unit
               (ICU) or surgery end
               date for surgeries
               that start the day of
               or the day after ICU
               admission (or
               transfer)..
0373........  Title: VTE-3 VTE        The Joint          IQR...................  New.........  Clinical Process/
               Patients with           Commission                                               Effectiveness.
               Anticoagulation         www.jointcommiss
               OverlapTherapy.         ion.org and
              Description: This        click on
               measure assesses the    ``Contact Us''.
               number of patients
               diagnosed with
               confirmed VTE who
               received an overlap
               of parenteral
               (intravenous [IV] or
               subcutaneous [subcu])
               anticoagulation and
               warfarin therapy. For
               patients who received
               less than five days
               of overlap therapy,
               they must be
               discharged on both
               medications or have a
               reason for
               discontinuation of
               overlap therapy.
               Overlap therapy must
               be administered for
               at least five days
               with an international
               normalized ratio
               (INR) greater than or
               equal to 2 prior to
               discontinuation of
               the parenteral
               anticoagulation
               therapy, discharged
               on both medications
               or have a reason for
               discontinuation of
               overlap therapy..
0374........  Title: VTE-4 VTE        The Joint          IQR...................  New.........  Clinical Process/
               Patients Receiving      Commission                                               Effectiveness.
               Unfractionated          www.jointcommiss
               Heparin (UFH) with      ion.org and
               Dosages/Platelet        click on
               Count Monitoring by     ``Contact Us''.
               Protocol (or
               Nomogram).
              Description: This
               measure assesses the
               number of patients
               diagnosed with
               confirmed VTE who
               received intravenous
               (IV) UFH therapy
               dosages AND had their
               platelet counts
               monitored using
               defined parameters
               such as a nomogram or
               protocol..
0375........  Title: VTE-5 VTE        The Joint          IQR...................  New.........  Patient and
               discharge               Commission                                               Family
               instructions.           www.jointcommiss                                         Engagement.
              Description: This        ion.org and
               measure assesses the    click on
               number of patients      ``Contact Us''.
               diagnosed with
               confirmed VTE that
               are discharged to
               home, home care,
               court/law
               enforcement, or home
               on hospice care on
               warfarin with written
               discharge
               instructions that
               address all four
               criteria: compliance
               issues, dietary
               advice, follow-up
               monitoring, and
               information about the
               potential for adverse
               drug reactions/
               interactions..
0376........  Title: VTE-6 Incidence  The Joint          IQR...................  New.........  Patient Safety.
               of potentially          Commission
               preventable VTE.        www.jointcommiss
              Description: This        ion.org and
               measure assesses the    click on
               number of patients      ``Contact Us''.
               diagnosed with
               confirmed VTE during
               hospitalization (not
               present at admission)
               who did not receive
               VTE prophylaxis
               between hospital
               admission and the day
               before the VTE
               diagnostic testing
               order date..
0142........  Title: AMI-2-Aspirin    CMS/OFMQ           IQR...................  New.........  Clinical Process/
               Prescribed at           www.qualitynet.o                                         Effectiveness.
               Discharge for AMI.      rg and click on
              Description: Acute       ``Questions &
               myocardial infarction   Answers''.
               (AMI) patients who
               are prescribed
               aspirin at hospital
               discharge..
0469........  Title: PC-01 Elective   The Joint          TJC...................  ............  Clinical Process/
               Delivery Prior to 39    Commission (TJC)                                         Effectiveness.
               Completed Weeks         www.jointcommiss
               Gestation.              ion.org and
              Description: Patients    click on
               with elective vaginal   ``Contact Us''.
               deliveries or
               elective cesarean
               sections at >= 37 and
               OFMQ           IQR, HVBP.............  New.........  Clinical Process/
               Fibrinolytic Therapy    www.qualitynet.o                                         Effectiveness.
               Received Within 30      rg and click on
               minutes of Hospital     ``Questions &
               Arrival.                Answers''.
              Description: Acute
               myocardial infarction
               (AMI) patients with
               ST-segment elevation
               or LBBB on the ECG
               closest to arrival
               time receiving
               fibrinolytic therapy
               during the hospital
               stay and having a
               time from hospital
               arrival to
               fibrinolysis of 30
               minutes or less..
0163........  Title: AMI-8a--Primary  CMS/OFMQ           IQR, HVBP.............  New.........  Clinical Process/
               PCI Received Within     www.qualitynet.o                                         Effectiveness.
               90 Minutes of           rg and click on
               Hospital Arrival.       ``Questions &
              Description: Acute       Answers''.
               myocardial infarction
               (AMI) patients with
               ST-segment elevation
               or LBBB on the ECG
               closest to arrival
               time receiving
               primary PCI during
               the hospital stay
               with a time from
               hospital arrival to
               PCI of 90 minutes or
               less..
0639........  Title: AMI-10 Statin    CMS/OFMQ           IQR...................  New.........  Clinical Process/
               Prescribed at           www.qualitynet.o                                         Effectiveness.
               Discharge.              rg and click on
              Description: Acute       ``Questions &
               Myocardial Infarction   Answers''.
               (AMI) patients who
               are prescribed a
               statin at hospital
               discharge..
0147........  Title: PN-6--Initial    CMS/OFMQ           IQR, HVBP.............  New.........  Efficient Use of
               Antibiotic Selection    www.qualitynet.o                                         Healthcare
               for Community-          rg and click on                                          Resources.
               Acquired Pneumonia      ``Questions &
               (CAP) in                Answers''.
               Immunocompetent
               Patients.
              Description:
               Immunocompetent
               patients with
               Community-Acquired
               Pneumonia who receive
               an initial antibiotic
               regimen during the
               first 24 hours that
               is consistent with
               current guidelines..
0527........  Title: SCIP-INF-1       CMS/OFMQ           IQR, HVBP.............  New.........  Patient Safety.
               Prophylactic            www.qualitynet.o
               Antibiotic Received     rg and click on
               within 1 Hour Prior     ``Questions &
               to Surgical Incision.   Answers''.
              Description: Surgical
               patients with
               prophylactic
               antibiotics initiated
               within one hour prior
               to surgical incision.
               Patients who received
               Vancomycin or a
               Fluoroquinolone for
               prophylactic
               antibiotics should
               have the antibiotics
               initiated within 2
               hours prior to
               surgical incision.
               Due to the longer
               infusion time
               required for
               Vancomycin or a
               Fluoroquinolone, it
               is acceptable to
               start these
               antibiotics within 2
               hours prior to
               incision time..
0528........  Title: SCIP-INF-2-      CMS/OFMQ           IQR, HVBP.............  New.........  Efficient Use of
               Prophylactic            www.qualitynet.o                                         Healthcare
               Antibiotic Selection    rg and click on                                          Resources.
               for Surgical Patients.  ``Questions &
              Description: Surgical    Answers''.
               patients who received
               prophylactic
               antibiotics
               consistent with
               current guidelines
               (specific to each
               type of surgical
               procedure)..
0453........  Title: SCIP-INF-9--     CMS/OFMQ           IQR, TJC..............  New.........  Patient Safety.
               Urinary catheter        www.qualitynet.o
               removed on              rg and click on
               Postoperative Day 1     ``Questions &
               (POD1) or               Answers''.
               Postoperative Day 2
               (POD2) with day of
               surgery being day
               zero.
              Description: Surgical
               patients with urinary
               catheter removed on
               Postoperative Day 1
               or Postoperative Day
               2 with day of surgery
               being day zero..
0496........  Title: ED-3--Median     CMS/OFMQ           OQR...................  New.........  Care
               time from ED arrival    www.qualitynet.o                                         Coordination.
               to ED departure for     rg and click on
               discharged ED           ``Questions &
               patients.               Answers''.
              Description: Median
               time from emergency
               department arrival to
               time of departure
               from the emergency
               room for patients
               discharged from the
               emergency department..
0338........  Title: Home Management  The Joint          state use.............  New.........  Patient & Family
               Plan of Care (HMPC)     Commission (TJC)                                         Engagement.
               Document Given to       www.jointcommiss
               Patient/Caregiver.      ion.org and
              Description: An          click on
               assessment that there   ``Contact Us''.
               is documentation in
               the medical record
               that a Home
               Management Plan of
               Care (HMPC) document
               was given to the
               pediatric asthma
               patient/caregiver..

[[Page 54087]]

 
0480........  Title: Exclusive        The Joint          state use.............  New.........  Clinical Process/
               Breast Milk Feeding.    Commission (TJC)                                         Effectiveness.
              Description: Exclusive   www.jointcommiss
               breast milk feeding     ion.org and
               during the newborn's    click on
               entire                  ``Contact Us''.
               hospitalization..
0716........  Title: Healthy Term     California         state use.............  New.........  Patient Safety.
               Newborn.                Maternal Quality
              Description: Percent     Care
               of term singleton       Collaborative
               live births             www.cmqcc.org
               (excluding those with   and click on
               diagnoses originating   ``Contact Us''.
               in the fetal period)
               who DO NOT have
               significant
               complications during
               birth or the nursery
               care..
1354........  Title: EHDI-1a--        CDC www.cdc.gov    state use.............  New.........  Clinical Process/
               Hearing screening       and click on                                             Effectiveness.
               prior to hospital       ``Contact CDC''.
               discharge.
              Description: This
               measure assesses the
               proportion of births
               that have been
               screened for hearing
               loss before hospital
               discharge..
----------------------------------------------------------------------------------------------------------------
*** IQR = Inpatient Quality Reporting.
TJC = The Joint Commission.
HVBP = Hospital Value-Based Purchasing.
OQR = Outpatient Quality Reporting.

8. Reporting Methods for Eligible Hospitals and Critical Access 
Hospitals
(a) Reporting Methods in FY 2013
    In the Stage 2 proposed rule, we did not propose any reporting 
methods for Medicare eligible hospitals and CAHs in 2013. However, in 
the CY 2013 OPPS proposed rule (77 FR 45188), we stated that eligible 
hospitals and CAHs may continue to report by attestation CQM results as 
calculated by CEHRT, as they did for 2011 and 2012. For further 
explanation of reporting CQMs by attestation, please see the Stage 1 
final rule (75 FR 44430 through 44434). We also proposed in the CY 2013 
OPPS proposed rule (77 FR 45188) to continue for 2013 the voluntary 
electronic reporting pilot for CQMs (the Medicare EHR Incentive Program 
Electronic Reporting Pilot for Eligible Hospitals and CAHs), which we 
had previously established for 2012. We expect to finalize in the CY 
2013 Hospital OPPS final rule the reporting methods that would apply in 
2013 for eligible hospitals and CAHs participating in the Medicare EHR 
Incentive Program.
(b) Reporting Methods Beginning With FY 2014
    Under section 1886(n)(3)(A)(iii) of the Act, eligible hospitals and 
CAHs must submit information on the CQMs selected by the Secretary ``in 
a form and manner specified by the Secretary'' as part of demonstrating 
meaningful use of CEHRT. We proposed that Medicare eligible hospitals 
and CAHs would select one of the following two options for submitting 
CQMs electronically.
     Option 1: Submit the selected 24 CQMs through a CMS-
designated portal.
    We proposed that CQM data would be submitted in an XML-based format 
on an aggregate basis reflective of all patients without regard to 
payer. This method would require eligible hospitals and CAHs to log 
into a CMS-designated portal and submit through an upload process data 
that is based on specified structures produced as output from their 
CEHRT.
     Option 2: Submit the selected 24 CQMs in a manner similar 
to the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot 
for Eligible Hospitals and CAHs using CEHRT.
    We proposed that, as an alternative to the aggregate-level 
reporting schema described previously under Option 1, Medicare eligible 
hospitals and CAHs that successfully report CQMs through an electronic 
reporting method similar to the 2012 Medicare EHR Incentive Program 
Electronic Reporting Pilot for Eligible Hospitals and CAHs using CEHRT 
would satisfy their CQMs reporting requirement under the Medicare EHR 
Incentive Program. Please refer to the CY 2012 OPPS final rule (76 FR 
74489 through 74492) for details on the pilot.
    We noted that the Hospital IQR program does not currently have an 
electronic reporting mechanism. We solicited comments on whether an 
electronic reporting option is appropriate for the Hospital IQR Program 
and whether it would provide further alignment with the EHR Incentive 
Program.
    Comment: One commenter preferred Option 1 because it seems less 
burdensome. This commenter believed that a third party data warehouse 
to store patient-level data and aggregate the results would be 
necessary prior to implementing Option 1. The commenter also believed 
that the hospital should be able to calculate its own results.
    Response: Hospitals have access to patient-level data. A hospital 
could use a CEHRT that can calculate CQM results and also directly 
report patient-level data to CMS, so these functions are not mutually 
exclusive. No data warehouse is necessary.
    Comment: One commenter supported both the aggregate XML-based 
reporting option and the option similar to the 2012 Medicare EHR 
Incentive Program Electronic Reporting Pilot as well as the longer-term 
goal of attaining full automatic electronic reporting. Another 
commenter urged us to make the strategy for automating the reporting of 
CQM data clear, so that hospitals can avoid reporting the same quality 
data through multiple reporting mechanisms. One commenter urged us to 
make the necessary investment to establish the infrastructure for the 
flow of EHR data, with careful consideration given to how we will 
ensure reliable, valid, and complete CQM data.
    Response: We are working to align the EHR Incentive Program with 
various other quality reporting programs in order to reduce duplicative 
reporting to the extent feasible and practical, beginning with the 
Hospital IQR Program. Under the Hospital IQR Program, hospitals report 
some

[[Page 54088]]

measures by submitting chart-abstracted patient-level data, reflective 
of all patients without regard to payer. More information on the 
Hospital IQR Program, including the chart-abstracted measure data 
submission process, can be found in the ``Guide to CMS Hospital IQR 
Program'' on the QualityNet Web site (http://www.qualitynet.org/, 
select ``Hospital Inpatient Quality Reporting Program'' from the 
``Hospitals--Inpatient'' dropdown menu and click on the link to the 
guide from the ``Handbooks'' menu on the right side of the page). We 
expect to establish a similar mechanism for electronic submission of 
CQM data for the EHR Incentive Program.
    The Hospital IQR Program does not currently have an EHR reporting 
option or requirement, but eligible hospitals and CAHs have been able 
to meet the CQM requirement for the EHR Incentive Program via the 
electronic reporting pilot. However, we expect that the Hospital IQR 
Program will transition to EHR-based reporting in a manner similar to 
the electronic reporting pilot, using an electronic transmission format 
such as the QRDA-I (for patient-level data). If the Hospital IQR 
Program establishes an EHR reporting option or requirement, we would 
consider whether we should allow hospitals to report CQMs through that 
mechanism using CEHRT for purposes of satisfying the CQM reporting 
component of the EHR Incentive Program.
    We proposed to consider an ``interim submission'' option for 
Medicare eligible hospitals and CAHs that are in their first year of 
Stage 1 beginning in FY 2014 through an electronic reporting method 
similar to the 2012 Medicare EHR Incentive Program Electronic Reporting 
Pilot for Eligible Hospitals and CAHs. Under this option, eligible 
hospitals and CAHs would electronically submit CQM data for a 
continuous 90-day EHR reporting period, and the data would have to be 
received no later than July 1 to meet the requirements of the EHR 
Incentive Program for purposes of avoiding a payment adjustment in the 
following year. We solicited public comment on this potential option.
    Comment: One commenter supported an ``interim submission'' option 
for those in their first year, which the commenter stated could also 
serve as a transitional step for those catching up.
    Response: Since we are allowing eligible hospitals and CAHs to 
submit their CQM data through attestation if they are in their first 
year of Stage 1, we are not finalizing the proposed interim submission 
option.
    After consideration of the public comments received, we are 
finalizing the following policy for CQM reporting methods for eligible 
hospitals and CAHs beginning in FY 2014.
    Eligible hospitals and CAHs that are in their first year of Stage 1 
must report the selected 16 CQMs through attestation (please refer to 
the Stage 1 final rule for an explanation of reporting CQMs through 
attestation (75 FR 44430 through 44434)). For purposes of avoiding a 
payment adjustment, eligible hospitals that are in their first year of 
demonstrating meaningful use in the year immediately preceding a 
payment adjustment year must submit their CQM data no later than July 1 
of such preceding year. We note that this deadline does not apply to 
CAHs. For more details on submission deadlines specific to CAHs, please 
refer to section II.D.4. of this final rule.
    Eligible hospitals and CAHs that are beyond their first year of 
meaningful use will be required to electronically submit the selected 
16 CQMs using CEHRT using one of the options listed in this section of 
this final rule. Consistent with section 1886(n)(3)(B)(ii) of the Act, 
in the unlikely event that the Secretary does not have the capacity to 
receive CQM data electronically, eligible hospitals and CAHs may 
continue to report aggregate CQM results through attestation.
     Option 1: Submit the selected 16 CQMs on an aggregate 
basis through a CMS-designated transmission method using CEHRT.
    The CQM data will be submitted in the QRDA-III format reflective of 
all patients without regard to payer. This method will require 
transmitting the data via a CMS-designated transmission method.
     Option 2: Submit the selected 16 CQMs on a patient-level 
basis in a manner similar to the 2012 Medicare EHR Incentive Program 
Electronic Reporting Pilot for Eligible Hospitals and CAHs using CEHRT. 
As long as the CQM data originates from CEHRT, it may be submitted 
directly from the hospital's CEHRT to CMS or through a data 
intermediary to CMS.
    The electronically reported patient-level CQM data must use the 
QRDA category I (release 2) based on the Quality Data Model (QDM), 
which will include only patients that meet the denominator criteria of 
each reported CQM without regard to payer. For example, if a hospital 
selects NQF 0438 to report, the denominator criteria include 
ischemic stroke patients, so the QRDA-I for this CQM would include only 
ischemic stroke patients. This method will require submitting the data 
via a transmission method similar to the 2012 Medicare EHR Incentive 
Program Electronic Reporting Pilot for Eligible Hospitals and CAHs (76 
FR 74122). The requirement that eligible hospitals and CAHs submit 
patient-level data under the EHR Incentive Program is consistent with 
the requirement that hospitals submit patient-level data under other 
quality reporting programs such as the Hospital IQR Program.
    We proposed to consider the following 4 options of patient 
population--payer data submission characteristics:
     All patients--Medicare only.
     All patients--all payer.
     Sampling--Medicare only, or
     Sampling--all payer.

Currently, the Hospital IQR program uses the ``sampling--all payer'' 
data submission characteristic. We solicited public comment on each of 
these 4 sets of characteristics and the impact they may have to vendors 
and hospitals, including but not limited to potential issues with the 
respective size of data files for each characteristic. We proposed to 
select 1 of the 4 sets as the data submission characteristic for the 
electronic reporting method for eligible hospitals and CAHs beginning 
in FY 2014.
    Comment: Many commenters favored the all patient-all payer 
submission option. Nearly all of these commenters supported this option 
because of challenges identifying whether a patient is covered by 
Medicare or not. One commenter also noted that sampling Medicare 
patients alone would severely decrease the population of patients 
reported in the denominator for many CQMs, and that it is difficult to 
validate that the sampling is being done correctly. The commenter also 
argued that since data is captured at the time of care, there should be 
no difficulty submitting the data and therefore no need for sampling. 
Another commenter advised against permitting sampling for CQM reporting 
beginning in 2014 as it adds an additional level of complexity. One 
commenter stated that the ideal solution would be having both--all 
patient-all payer, and all patient-Medicare only, which would allow for 
Medicare vs. non-Medicare comparisons.
    Some commenters who favored the all patient-all payer data 
submission option suggested that sampling-all payer be made available 
as an alternative option, with one noting that a no-sampling method may 
be burdensome for hospital staff who must manually enter clinical data 
that is not captured electronically.

[[Page 54089]]

If sampling is adopted, the commenter asks that it align with existing 
Hospital IQR Program sampling methodologies. One commenter preferred 
the sampling-all payer submission option, noting that it aligns with 
the reporting method for the Hospital IQR Program.
    Response: We acknowledge hospitals' concerns about accurately 
distinguishing Medicare patients from other patients in their 
populations, and recognize that reporting data on Medicare patients 
only would reduce the population of patients for whom data are reported 
in most cases. Since payer will be collected as a supplemental data 
element for all CQMs beginning in 2014, we will be able to stratify 
measure results by payer. In the 2014 Edition certification criteria, 
ONC has increased the focus on CEHRT's capability to capture the 
structured data elements required for reporting the CQMs finalized in 
this rule. Therefore, the burden on hospital staff to manually enter 
data from a source other than the CEHRT should be greatly reduced. We 
also expect to propose electronic sampling algorithms in future 
rulemaking.
    After consideration of the public comments received, we are 
finalizing the ``sampling-all payer'' option for patient-level data. 
This submission characteristic will only include patients that meet the 
denominator criteria of the CQMs that the eligible hospital or CAH 
selects to report to CMS and only the data elements listed in the CQM 
and transmission specifications for those patients would be sent to 
CMS.
(c) Electronic Reporting of Clinical Quality Measures for Medicaid 
Eligible Hospitals
    States that have launched their Medicaid EHR Incentive Programs 
plan to collect CQMs electronically from CEHRT used by eligible 
hospitals. Each state is responsible for sharing the details on the 
process for electronic reporting with its provider community. We 
anticipate that whatever means states have deployed for capturing CQMs 
included in the Stage 1 final rule electronically will be similar for 
CQMs beginning in 2014. However, we note that subject to our prior 
approval, the process, requirements, and the timeline is within the 
states' purview.
    Comment: Commenters suggested unified Medicaid CQM reporting to 
reduce the burden on eligible hospitals operating in multiple states.
    Response: For the purposes of the Medicaid EHR Incentive Program, 
eligible hospitals only have to report CQMs to the state making the EHR 
incentive payment. However, data from all practice locations that are 
equipped with CEHRT will be used for reporting CQMs, even if the 
practice locations are in different states.
    After consideration of the public comments received, we are 
finalizing the policies for electronic reporting of CQMs for Medicaid 
eligible hospitals as proposed. We are clarifying that dually-eligible 
hospitals may submit their CQMs via the methods outlined in section 
II.B.8.b. of this final rule. As part of certification for EHR 
technology, ONC is including testing for data capture, CQM calculation, 
and electronic submission. For CQMs, this includes certification 
criteria for the QRDA-I and QRDA-III transmission format. We expect the 
states that have electronic reporting options for CQMs might choose to 
adopt QRDA-I for patient-level data and/or QRDA-III for aggregate data 
as the form in which eligible hospitals would report CQM data. By 
adopting the same QRDA-I and/or QRDA-III formats that CMS is requiring 
for CQM reporting, the states would be able to leverage the development 
of the specifications by CMS and the industry as well as the testing 
done by ONC for certification of EHR technology. This would reduce the 
burden on EHR vendors to implement and test different specifications.

C. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
    We proposed to continue our common method for demonstrating 
meaningful use in both the Medicare and Medicaid EHR Incentive 
Programs. The demonstration methods we adopt for Medicare will 
automatically be available to the states for use in their Medicaid 
programs. The Medicare methods are segmented into CQMs and meaningful 
use objectives, both of which meaningful users must meet. (We note that 
the discussion in this part of the preamble discuss the methods for 
meaningful use objectives. For the discussion on CQM reporting, please 
refer to II.B. of this final rule). We did not receive any comments on 
this general policy and for this final rule will continue the policy 
that was proposed (that is, common methods of demonstration with some 
flexibility for states as described in II.A.3.c of this final rule).
b. Methods for Demonstration of the Stage 2 Criteria of Meaningful Use
    Except for the batch reporting option discussed in section 
II.C.1.c. of this final rule, we proposed no other changes to the 
attestation process for Stage 2 meaningful use objectives. We proposed 
several changes to reporting for CQMs beginning 2014, regardless of 
Stage, as discussed in section II.B. of this final rule. An EP, 
eligible hospital or CAH must successfully attest to the Stage 2 
meaningful use objectives and successfully submit clinical quality 
measures to be a meaningful EHR user. We have revised Sec.  495.8 to 
accommodate the Stage 2 objectives and measures, as well as changes to 
Stage 1.
    As discussed in our proposed rule (77 FR 13764), as HIT matures we 
expect to base demonstration more on automated reporting by CEHRT, such 
as the direct electronic reporting of measures, both clinical and 
nonclinical, and documented participation in HIE. As this occurs, fewer 
objectives will be demonstrated through attestation. As explained in 
the proposed rule, however, we do not believe that the current advances 
in HIT and the certification of EHR technologies allow an alternative 
to attestation for the Stage 2 final rule. We will continue to evaluate 
possible alternatives to attestation and the accompanying changes to 
certification and meaningful use.
    In addition, in lieu of EP-by-EP attestation, we proposed a batch 
file process for attestation. This batch file process would continue to 
require that meaningful use measures be assessed at the individual EP, 
eligible hospital or CAH level. It would be available no later than 
January 1, 2014. Batch reporting would allow large group practices to 
submit a large number of attestations at once, while still maintaining 
individual assessments of meaningful use. We proposed that a batch file 
process as discussed later would occur through the CMS attestation Web 
site. Each EP would still meet the required meaningful use thresholds 
independently; our proposal did not allow the use of group averages or 
any other method of group demonstration.
    We explained that CMS and the states could continue to test 
options, such as registries or the direct electronic reporting of some 
measures; however, any such testing would be voluntary.
c. Group Reporting Option of Meaningful Use Core and Menu Objectives 
and Associated Measures for Medicare and Medicaid EPs Beginning With CY 
2014
    As explained previously, we proposed a batch reporting process that 
would allow groups of EPs to report each individual EP's core and menu 
objective data through a batch process, but would

[[Page 54090]]

maintain individual assessments of meaningful use. (We note that the 
discussion in this part of the preamble does not discuss CQM reporting, 
which is discussed in II.B. of this final rule).
    Specifically, we proposed to establish a file format in which 
groups could submit core and menu objective information for individual 
Medicare EPs (including the stage of meaningful use the individual EP 
is in, numerator, denominator, exclusion, and yes/no information for 
each core and menu objective) as well as a process for uploading such 
batch files.
    We proposed that states would have the option, but not be required 
to, offer batch reporting of meaningful use data for Medicaid EP, and 
that states would outline their approaches in their state Medicaid HIT 
Plans (under current regulatory requirements in Sec.  495.332(c)(2) and 
(c)(3)).
    We proposed the following policies would apply to batch reporting:
     Define a Medicare EHR Incentive Group as 2 or more EPs, 
each identified with a unique NPI associated with a group practice 
identified under one tax identification number (TIN) through the 
Provider Enrollment, Chain, and Ownership System (PECOS).
     States choosing to exercise this option will have to 
clearly define a Medicaid EHR Incentive Group via their state Medicaid 
HIT Plan.
     None of the EPs in either a Medicare or Medicaid EHR 
Incentive Group could be hospital-based according to the definition for 
these programs (see 42 CFR 495.4).
     Any EP that successfully attests as part of one Medicare 
EHR Incentive Group will not be permitted to also attest individually 
or attest as part of a batch report for another Medicare EHR Incentive 
Group.
     Because EPs can only participate in either the Medicare or 
Medicaid incentive programs in the same payment year, an EP that is 
part of a Medicare EHR Incentive Group will not be able to receive a 
Medicaid EHR incentive payment or be included as part of a batch report 
for a Medicaid EHR Incentive Group or vice versa.
     The group reporting option discussed in this section is 
limited to data for the core and menu objectives and does not include 
the reporting of clinical quality measures, which is also required to 
demonstrate meaningful use and receive an EHR incentive payment. 
Clinical quality measures must be reported separately through other 
electronic submission options. (These options are described in section 
II.B. of this final rule.).
     Because we proposed multiple group reporting methods for 
clinical quality measures, EPs will not have to report core and menu 
objective data in the same EHR Incentive Group as they report clinical 
quality measures. An EP will be able to submit the core and menu 
objectives as part of a group and the clinical quality measures as an 
individual or submit the core and menu objectives as an individual and 
the clinical quality measures as part of a group.
     Batch reporting would not be required by CMS and t EPs 
will be permitted to attest individually through the CMS attestation 
Web site (as long as they did not also report as part of a group).
     As in Stage 1, EPs will be required to individually meet 
all of the thresholds of the core and menu objectives and could not use 
group averages or any other method of group demonstration.
     Batch reporting would not change the policy that payment 
adjustments will be applied to individual EPs and not to Medicare EHR 
Incentive Groups. This policy is described in section II.D. of this 
final rule.
     Batch reporting would not change incentive payment 
assignment. That is, as with Stage 1, an EP's incentive payment will 
not be automatically assigned to the Medicare EHR Incentive Group with 
which they batch report under this option. The EP will still have to 
select the payee TIN during the registration process.
     An EP who chooses the group reporting option will be 
required to include in such reporting core and menu objective 
information on all outpatient encounters (that is, all encounters 
except those in the inpatient and emergency departments) where CEHRT is 
available, even if some encounters occurred at locations not associated 
with the EP's Medicare EHR Incentive Group. We explained that this 
policy is required because EPs who practice in multiple practices or 
locations are responsible for submitting complete information for all 
actions taken at practices/locations equipped with CEHRT. Under Sec.  
495.4, to be considered a meaningful EHR user, an EP must have 50 
percent or more of their outpatient encounters in practice(s) or 
location(s) where CEHRT is available. In the July 28, 2010 final rule 
(75 FR 44329), we also made clear that an EP must include outpatient 
encounters for all locations equipped with CEHRT.
     There would not be a minimum participation threshold for 
reporting as part of an EHR Incentive Group; in other words, an EP who 
is able to meet the 50 percent threshold of patient encounters in 
locations equipped with CEHRT could report all of their core and menu 
objective data as part of an EHR Incentive Group in which they had only 
5 percent of their patient encounters with that group, provided they 
report all of the data from the other locations through the same batch 
reporting process with the EHR Incentive Group.
    Many commenters supported our proposal to institute a batch 
reporting process.
    Some commenters offered comments or requested clarification. The 
summary of the comments and our responses follow:
    Comment: A few commenters questioned the statement that a group for 
purposes of batch reporting is two or more EPs, each identified with a 
unique NPI associated with a group practice identified under one tax 
identification number (TIN) through the Provider Enrollment, Chain, and 
Ownership System (PECOS). These commenters suggested that the 
difference between this definition of a group and the one under the 
Physician Quality Reporting System (PQRS) is confusing and should be 
harmonized or aligned.
    Response: Generally we agree with the principle of aligning 
definitions when possible. However, this rulemaking does not address 
PQRS definitions. Alignment with the current PQRS definition would 
entail changing our policy from 2 or more EPs to 25 or more EPs. We do 
not believe the benefits of alignment are greater than the 
administrative relief to group practices made up of 2 to 24 EPs. 
However, we note that in the Medicare Program; Revisions to Payment 
Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, 
Elimination of the Requirement for Termination of Non-Random Prepayment 
Complex Medical Review and Other Revisions to Part B for CY 2013 
proposed rule (77 FR 44722) we proposed to revise the PQRS definitions 
to 2 or more EPs. If finalized, the PQRS definition would align with 
our policy. Therefore, we are finalizing our policy that would allow 
batch reporting for groups with 2 (or more) EPs that meet the rules for 
such reporting. After consideration of the comments, we will establish 
a file format in which groups could submit core and menu objective 
information for individual Medicare EPs (including the stage of 
meaningful use the individual EP is in, numerator, denominator, 
exclusion, and yes/no information for each core and menu objective) and 
also establish a process through which groups would submit this batch 
file for

[[Page 54091]]

upload as proposed. As noted previously, this batch file reporting 
process does not apply to CQM reporting, which is discussed in section 
II.B of this final rule.
    After consideration of the public comments received, we are 
finalizing this option as proposed. There is no accompanying regulation 
text for this policy, as it governs the procedures for attestation, but 
not the meaningful use requirements.
    We also sought public comment on a group reporting option that 
measures performance at a group, rather than at an individual, level 
(referred to as the ``group performance'' option.) Rather than 
proposing a set of rules for such group performance, we requested 
comment on a host of topics. Many commenters supported a group 
performance option; however, we received very few detailed comments on 
many of the specific issues we put forth for discussion. Therefore, we 
continue to believe that additional policy development is necessary to 
address specifically how group performance would operate. We are not 
finalizing the group performance policy at this time, as we wish to 
consider it further. EPs will continue to be required to individually 
meet all of the thresholds of the core and menu objectives. The 
following comments were received on issues relating to group 
performance.
    We requested comments on the definition of ``group,'' noting that 
the PQRS Group Reporting Option requires a physician group practice to 
have a single tax payer identification number (TIN), with 25 or more 
individual eligible professionals who have reassigned their billing 
rights to the TIN. Commenters responded that 25 is too large a number, 
with some suggesting 4 to 6, or even 2 or more, as an appropriate 
range. Commenters recommended that each EP within the TIN, be given the 
choice of participation in the group or individually. Some commenters 
also questioned whether a consistent TIN indicates a coherent group 
practice with care coordination.
    We requested comments on whether there should be a self-nomination 
process for groups, as in PQRS, or an alternative process for 
identifying groups. Commenters generally supported self-nomination, if 
it is a simple process.
    We also asked whether groups should be required to use the same 
CEHRT. Some commenters believed such a requirement would be onerous, 
explaining that in some cases imaging providers, such as radiologists 
have their own CEHRT. Other commenters supported using the same CEHRT 
to ensure consistent reporting.
    We questioned whether a group could be eligible for group reporting 
if CEHRT (same or different) were not available to all associated EPs 
at all locations. Some commenters responded yes, that in large systems 
clinics may be added or upgraded at different points in time and there 
may be transition times during which some clinics may not have CEHRT. 
Commenters stated that a threshold could be used to ensure that the EHR 
is available for most of the services provided by the group. Others 
stated that, no, groups should be held to the same standard; if the 
group as a whole is not eligible, individuals could still demonstrate 
meaningful use on an individual basis.
    We requested comment on the appropriate policy when a group uses 
multiple certified EHR technologies that cannot share data easily. Some 
commenters stated that because the group as a whole should still have 
to meet the meaningful use objectives, interoperability should not be a 
barrier to group performance. These commenters stated that while 
interoperability is the ultimate goal of EHR technology, it should not 
become a requirement prematurely and providers and vendors are best 
positioned to remedy interoperability problems. Commenters also urged 
us to ensure that clearinghouses and software vendors are within the 
scope of the covered entities that must comply with the rule, although 
no authority was cited for requiring such compliance.
    We questioned how meaningful use activities should be calculated, 
particularly when an EP practices individually and with a group, or in 
multiple group practices. Some commenters stated that meaningful use 
would always be at the group level. Others stated that if there are EPs 
practicing across two or more groups, then neither group should use the 
group reporting option, as this could result in different menu measure 
selections and other complications. Other commenters recommended that 
the EP's covered services be calculated as a whole to generate the 
incentive payment amount and separate payments be made to each TIN 
based on the percentage of the EP's covered services that were assigned 
to each TIN.
    We noted that the HITECH Act provides EPs who are meaningful users 
an incentive payment equal to 75 percent of Medicare allowable charges 
for covered professional services furnished by the EP in a payment 
year. Thus, we questioned how covered professional services performed 
by EPs in some other practice could be assigned to another group's TIN. 
Commenters suggested that groups could submit lists of EPs covered 
under its group submission and that have reassigned payment to the TIN. 
The covered services should include all covered services for the EP, 
regardless of TIN under which the services were billed. Commenters 
asserted that this process is not different from the current method in 
which individual EPs that work for multiple TINs can still reassign 
their incentive payments to a single TIN. Others recommended that for 
purposes of determining the 75 percent, CMS should simply limit its 
analysis to those services furnished at that practice.
    We solicited public comment on how meaningful use activities 
performed at other groups should be included. Some commenters stated 
that groups should attest only for the services within the group 
practice, not services outside of the group. These commenters expressed 
concern about not being able to validate outside data.
    If meaningful use activities outside the group were not included in 
group performance, we asked what the CMS policy should be for these 
activities performed outside the group. Commenters recommended that 
only the group activities should be considered, and that those 
activities performed outside the group should essentially be ignored.
    We solicited input on what our policy should be if an EP reports as 
part of a group, but he or she actually fails to meet a measure 
individually. Commenters generally stated that individual performance 
should be subsumed in the group performance. They assert that groups 
will have their own internal incentives to ensure that EPs are properly 
using the EHR system.
    Along the same lines, we requested information on what should 
happen if an EP rejects a particular objective completely. Should such 
an EP be considered a meaningful EHR user as long as the EP's non-
participation still allows group compliance with a percentage 
threshold? Again, commenters recommended measurement solely at the 
group level. Again, they stated that the group practice would have its 
own incentives to ensure EPs within the group properly use CEHRT.
    We questioned how yes/no objectives should be handled in group 
reporting. Commenters again recommended measurement at the group level: 
A yes would mean that the group has ``enabled'' and is using that 
functionality of its CEHRT.

[[Page 54092]]

    We questioned how group performance would operate in cases when 
some EPs in the group participate in Medicaid while others participate 
in Medicare. Commenters stated that groups could provide lists of EPs 
and indicate which EPs are covered under Medicare versus Medicaid. 
However, in any case we, could also encourage states to accept the 
group's submission as applying to Medicaid, as well as Medicare. While 
another commenter suggested that Medicare should be the default choice 
for a group, unless they all participate in Medicaid.
    As to our question of whether any incentive payment would be 
reassigned to the group automatically, or whether the EP would assign 
it to the group at registration, commenters gave conflicting 
recommendations. Some stated that individual EPs could reassign 
incentive payments to a TIN, and that the group could, at the end of 
the period, present a list of EPs who are within the TIN and reassigned 
payment to such TIN. Others favored automatic reassignment to the group 
demonstrating group performance, particularly when an EP is employed or 
contracts with only one group, or when a state does not permit 
assignment to an entity promoting the adoption of EHR technology. A 
commenter requested clarification on how an EP joining midyear would be 
handled.
    We requested comments on the policies that would apply if an EP 
participates in one group's performance and the incentive payment were 
reassigned to the group automatically, but the EP also has covered 
services billed to other TINs. Commenters stated that if an EP leaves a 
group, there should be a mechanism for reporting this and allowing the 
EP to report individually or become part of another group; regardless, 
the automatic reassignment should stand.
    We solicited information on how to address situations when an EP 
leaves a group during an active EHR reporting period. Commenters 
recommended that incentives could be pro-rated on this basis, perhaps 
with ``beginning and ending dates'' included in the group performance 
file to streamline the proration.
    We requested information regarding payment adjustments, and whether 
they should also be applied at the group level. Some stated that group 
performance should be consistent at the incentive and payment 
adjustment phases of the EHR Incentive Program. Thus, if groups can 
receive incentives based on group performance, then group performance 
should also dictate payment adjustments at a group level. Others 
favored maintaining payment adjustments at the individual EP level.
    Finally, we solicited alternative options for reporting meaningful 
use, while capturing necessary data. One commenter recommended a ``sub-
TIN'' group reporting option where a specific department, specialty or 
clinic could report performance on a group basis.
2. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    In addition to the data already being collected under our 
regulations at Sec.  495.10, we proposed to collect the business email 
address of EPs, eligible hospitals and CAHs to facilitate communication 
with providers. We proposed to begin collecting the information as soon 
as the registration system can be updated following the publication of 
this final rule for both the Medicare and Medicaid EHR Incentive 
Programs. We did not propose to post this information online. In our 
preamble, we proposed to amend Sec.  495.10 accordingly. However, no 
regulation text appeared. We did not receive any comments on our 
proposal. We are finalizing regulation text at Sec.  495.10(a)(3) to 
collect business email address.
    We note that we did not propose any changes to the registration for 
the Medicare and Medicaid EHR Incentive Programs, to the rules on EPs 
switching between programs, or to the record retention requirements in 
Sec.  495.10.
    We did not propose any changes to the registration for the Medicare 
and Medicaid EHR Incentive Programs, to the rules on EPs switching 
between programs, or to the record retention requirements in Sec.  
495.10.
    We did not receive any comments and we are finalizing these 
provisions as proposed.
3. Hospital-Based Eligible Professionals
    Our only proposed changes to the definition of hospital-based 
eligible professional were to allow the determination of hospital-based 
to continue once the payment adjustments go into effect, and to propose 
that the hospital-based analysis at the payment adjustment phase would, 
for Medicare, be based on federal FY 2 years prior to the payment 
adjustment year. (See proposed Sec.  495.4 and section II.D.2. of this 
final rule.)
    We also requested comments on whether the definition of hospital-
based should be refined to exclude from the definition those EPs who 
are not furnishing professional services ``through the use of the 
facilities and equipment, including qualified electronic health 
records, of the hospital'' (section 1903(t)(3)(D) and 1848(o)(1)(C)(ii) 
of the Act). We noted that during implementation of Stage 1, we were 
asked about situations where clinicians may work in specialized 
hospital units, the clinicians have independently procured and utilize 
EHR technology that is completely distinct from that of the hospital, 
and the clinicians are capable, without the facilities and equipment of 
the hospital, of meeting the eligible professional (for example 
ambulatory, not inpatient) definition of meaningful use. We stated our 
belief that such situations would be uncommon and might not be 
generalized under the uniform definition used by place of service 
codes.
    We specifically requested comments on the following subjects: (1) 
How to determine whether specialized hospital units are using stand-
alone certified EHR technology separate from that of the hospital; and 
(2) how to determine whether EPs using stand-alone certified EHR 
technology separate from that of the hospital are truly not accessing 
the facilities and equipment of the hospital. We proposed that hospital 
facilities and equipment would include the physical environment needed 
to support the necessary hardware; internet connections and firewalls; 
the hardware itself, including servers; and system interfaces necessary 
for demonstrating meaningful use, for example, to health information 
exchanges, laboratory information systems, or pharmacies. We proposed 
possibly using attestation for such elements, and noted our belief that 
any such attestations would be subject to audit and the False Claims 
Act.
    We also requested comments on whether the criteria for ambulatory 
EHRs and the meaningful use criteria that apply to EPs could be met in 
cases where EPs are primarily providing inpatient or Emergency 
Department services. By definition, the EPs affected by this issue are 
those who provide 90 percent or more of their services in the inpatient 
or emergency department, and who provide less than 10 percent of their 
services, and possibly none, in outpatient settings. However, since the 
beginning of the program, we have been clear that for EPs, meaningful 
use measures will not include patient encounters that occur within the 
inpatient or emergency departments (POS 21 or 23). See for example, FAQ 
10068, 10466, and FAQ 10462 at http://questions.cms.gov or in section 
II.A.3.d.(2). of this final rule.
    Some of our meaningful use criteria for EPs are measured based on 
office visits (clinical summaries) and others

[[Page 54093]]

assume an outpatient type of setting (patient reminders). The 
certification rules at 45 CFR part 170 differentiate between ambulatory 
and inpatient EHRs, and we requested comments on whether the EPs in 
this case would have inpatient or ambulatory technology.
    Comment: We received detailed comments addressing the majority of 
the questions we asked about how EPs would demonstrate they are not 
hospital-based were we to revise our definition of hospital-based to 
exclude EPs using stand-alone CEHRT separate from that of the hospital. 
These comments explained in a comprehensive manner how EPs use stand-
alone CEHRT separate from that of the hospital, and also provide the 
facilities and equipment that make the use of CEHRT possible, including 
internet connections and firewalls. Commenters supported using the 
ambulatory certification criteria and the EP meaningful use objectives 
and measures with the inclusion of inpatient and emergency department 
encounters in meeting such measures.
    Response: Given such comprehensive comments, we believe that it is 
possible for EPs to provide CEHRT in the hospital environment, that is, 
sufficiently independent of the facilities and equipment, including 
qualified electronic health records, of the hospital. In the Stage 1 
final rule, we explained why we were not interpreting the statute to 
provide for individualized determinations of whether EPs were hospital-
based. We focused on language in the statute stating that ``The 
determination of whether an eligible professional is a hospital-based 
eligible professional shall be made on the basis of the site of 
service.'' (See 75 FR 44440 through 44441). We continue to believe that 
this interpretation was reasonable based on the Congressional directive 
regarding site of service. However, we are now persuaded that the 
statute is also capable of the interpretation advanced by the 
commenters. Thus, while we continue to believe our prior interpretation 
was proper, we are convinced that other permissible interpretations may 
also be put forward through rulemaking. Therefore, we have added a new 
Sec.  495.5 to allow us to exclude EPs who can demonstrate to us that 
the EP funds the acquisition, implementation, and maintenance of 
Certified EHR Technology, including supporting hardware and any 
interfaces necessary to meet meaningful use without reimbursement from 
an eligible hospital or CAH; and uses such Certified EHR Technology in 
the inpatient or emergency department of a hospital (instead of the 
hospital's CEHRT).
    Once an EP registers for a given year they will know whether they 
are hospital based or not. An EP who is designated as hospital based, 
but wishes to be determined non hospital-based due to their funding of 
the acquisition, implementation and maintenance of CEHRT, including 
supporting hardware; and use of such CEHRT at a hospital, in lieu of 
using the CEHRT of such hospital will utilize an administrative process 
throughout the incentive payment year (and extending 2 months after the 
end of the incentive payment year) to provide documentation and seek a 
non-hospital based determination. Following a successful non-hospital 
based determination, the EP must attest each subsequent year that they 
continue to be in the same situation of funding of the acquisition, 
implementation and maintenance of CEHRT, including supporting hardware; 
and use of such CEHRT at a hospital without reimbursement from an 
eligible hospital or CAH, in lieu of using the Certified EHR Technology 
of such hospital, but would not have to provide the supporting 
documentation again. If and when a nonhospital-based determination has 
been made, the EP would then have to meet the same requirements of the 
EHR incentive program as any other EP including being subject to 
payment adjustments if applicable with a sole exception: The EP would 
include in their attestation to meaningful use all encounters at all 
locations, including those in the inpatient and emergency departments 
of the hospital, rather than just outpatient locations (other than the 
emergency department) as is the case for all other EPs.
4. Interaction With Other Programs
    There were no proposed changes to the ability of providers to 
participate in the Medicare and Medicaid EHR Incentive Programs and 
other CMS programs, and we are not finalizing any new policies in this 
area. We continue to work on aligning the data collection and reporting 
of the various CMS programs, especially in the area of clinical quality 
measurement. See section II.B. of this final rule for the proposed 
alignment initiatives for clinical quality measures.
    Comment: Several commenters suggested changes to other CMS 
programs.
    Response: Our proposed rule included policies for the EHR incentive 
program, and not other programs. Therefore, we are not addressing 
comments on rules other than the EHR incentive program, as these 
programs are outside the scope of this rulemaking.

D. Medicare Fee-for-Service

1. General Background and Statutory Basis
    As we discussed in the Stage 1 final rule, sections 4101(b) and 
4102(b) of the HITECH Act provide for reductions in payments to EPs, 
hospitals, and CAHs that are not meaningful users of CEHRT; beginning 
in CY 2015 for EPs, FY 2015 for hospitals, and in cost reporting 
periods beginning in FY 2015 for CAHs. We discuss the specific 
statutory requirements for each of these payment reductions in the 
following three sections. In these sections, we also present our 
specific policies for implementing these mandatory payment reductions.
2. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs 
Who Are Not Meaningful Users of CEHRT for an Applicable Reporting 
Period
    Section 1848(a)(7) of the Act, as amended by section 4101(b) of the 
HITECH Act, provides for payment adjustments effective for CY 2015 and 
subsequent years for EPs, as defined in Sec.  495.100 of the 
regulations, who are not meaningful EHR users during the relevant EHR 
reporting period for the year. In general, beginning in 2015, if an EP 
is not a meaningful EHR user for the EHR reporting period for the year, 
then the Medicare physician fee schedule (PFS) amount for covered 
professional services furnished by the EP during the year (including 
the fee schedule amount for purposes of determining a payment based on 
the fee schedule amount) is adjusted to equal the ``applicable 
percent'' (defined later) of the fee schedule amount that will 
otherwise apply. As we also discuss later, the HITECH Act includes an 
exception, which, if applicable, could exempt certain EPs from this 
payment adjustment. The payment adjustments do not apply to hospital-
based EPs.
    The term ``applicable percent'' is defined in the statute to mean: 
``(I) for 2015, 99 percent (or, in the case of an eligible professional 
who was subject to the application of the payment adjustment [if the EP 
is not a successful electronic prescriber] under section 1848(a)(5) of 
the Act for 2014, 98 percent); (II) for 2016, 98 percent; and (III) for 
2017 and each subsequent year, 97 percent.''
    In addition, section 1848(a)(7)(iii) of the Act provides that if, 
for CY 2018 and subsequent years, the Secretary finds that the 
proportion of EPs who are meaningful EHR users is less than 75

[[Page 54094]]

percent, the applicable percent shall be decreased by 1 percentage 
point for EPs who are not meaningful EHR users from the applicable 
percent in the preceding year, but that in no case shall the applicable 
percent be less than 95 percent.
    Section 1848(a)(7)(B) of the Act provides that the Secretary may, 
on a case-by-case basis, exempt an EP who is not a meaningful EHR user 
for the reporting period for the year from the application of the 
payment adjustment if the Secretary determines that compliance with the 
requirements for being a meaningful EHR user would result in a 
significant hardship, such as in the case of an EP who practices in a 
rural area without sufficient Internet access. The exception is subject 
to annual renewal, but in no case may an EP be granted an exception for 
more than 5 years.
a. Applicable Payment Adjustments in CY 2015 and Subsequent Calendar 
Years for EPs Who Are Not Meaningful Users of CEHRT
    Consistent with these provisions, in the Stage 1 final rule (75 FR 
44572), we provided in Sec.  495.102(d)(1) and (2) that, beginning in 
CY 2015, if an EP is not a meaningful EHR user for an EHR reporting 
period for the year, then the Medicare PFS amount that will otherwise 
apply for covered professional services furnished by the EP during the 
year will be adjusted by the following percentages: for 2015, 99 
percent (or, in the case of an EP who was subject to the application of 
the payment adjustment for e-prescribing under section 1848(a)(5) of 
the Act for 2014, 98 percent); (2) for 2016, 98 percent; and (3) for 
2017 and each subsequent year, 97 percent.
    However, while we discussed the application of the additional 
adjustment for CY 2018 and subsequent years if the Secretary finds that 
the proportion of EPs who are meaningful EHR users is less than 75 
percent in the preamble to the final rule (75 FR 44447), we did not 
include a specific provision for this adjustment in the regulations 
text. Therefore, we proposed to revise the current regulations, to 
provide specifically that, beginning with CY 2018 and subsequent years, 
if the Secretary has found that the proportion of EPs who are 
meaningful EHR users under Sec.  495.8 is less than 75 percent, the 
applicable percent is decreased by 1 percentage point for EPs who are 
not meaningful EHR users from the applicable percent in the preceding 
year, but that in no case is the applicable percent less than 95 
percent. In the proposed rule, we stated our expectation that we would 
base the determination of the proportion of EPs each year on the most 
recent CY for which we have sufficient data (that is, most likely, the 
data available as of October 1, 2017, as this is the last date for EPs 
to register and attest to meaningful use to avoid a payment adjustment 
in CY 2018). We proposed that the computation will be based on the 
ratio of EPs who have qualified as meaningful users in the numerator, 
to Medicare-enrolled EPs in the denominator. In the proposed rule we 
also explained that because hospital-based EPs and EPs are granted an 
exception meet the definition of ``EP,'' we would not include such EPs 
in the denominator, because such EPs would not be subject to a 
determination of meaningful use status ``under subsection (o)(2).'' We 
also stated that we would provide more specific detail on this 
computation in future guidance after the final regulation is published.
    In general terms, the two aforementioned provisions for payment 
adjustments to EPs who are not meaningful users of EHR technology have 
the following effects for CY 2015 and subsequent years. The adjustment 
to the Medicare PFS amount that will otherwise apply for covered 
professional services furnished by the EP will be 99 percent in CY 
2015. However, for CY 2015 the adjustment for an EP who, in CY 2014, 
was subject to the application of the payment adjustment for e-
prescribing under section 1848(a)(5) of the Act will be 98 percent of 
the Medicare PFS amount. In CY 2016, the adjustment to the Medicare PFS 
amount that will otherwise apply will be 98 percent. Similarly, the 
adjustment to the Medicare PFS amount that will otherwise apply will be 
97 percent in CY 2017. Depending on whether the proportion of EPs who 
are meaningful EHR users is less than 75 percent, the adjustment to the 
Medicare PFS amount can be as low as 96 percent in CY 2018, and 95 
percent in CY 2019 and subsequent years.
    We did not receive any comments on our proposed methodology for 
making the determination of the applicable payment adjustment for 
Medicare EPs, including our proposed methodology for making the ``75 
percent determination'' beginning for CY2018. Therefore, we are 
finalizing these provisions as proposed.
    We noted in our proposed rule that some eligible professionals may 
be eligible for both the Medicare and Medicaid EHR incentives, and have 
opted for the Medicaid EHR incentive. Under that program, in the first 
year of their participation, EPs may be eligible for an incentive 
payment for having adopted, implemented, or upgraded (AIU) to CEHRT. 
However, AIU does not constitute meaningful use of CEHRT. Therefore, 
those EPs who receive an incentive payment for AIU will not be 
considered meaningful EHR users for purposes of determining whether EPs 
are subject to the Medicare payment adjustment. Medicaid EPs who meet 
the first year requirements through AIU in either 2013 or 2014 will 
still be subject to the Medicare payment adjustment in 2015 if they are 
not meaningful EHR users for the applicable reporting period. However, 
Medicaid EPs can, avoid this consequence by making sure that they meet 
meaningful use in 2013 (or 2014 if this is the first year of 
demonstrating meaningful use). Since the Medicaid EHR Incentive Program 
allows EPs to initiate as late as 2016, AIU can still be an important 
initial step for providers who missed the window to avoid the Medicare 
penalties, assuming they then demonstrate meaningful use in the 
subsequent year.
    Comment: Commenters stated universal support for our proposal that 
EPs who are meaningful EHR users under the Medicaid EHR Incentive 
Program for an applicable reporting period will also be considered 
meaningful EHR users for that period for purposes of avoiding the 
Medicare payment adjustments.
    Response: We agree with commenters and are finalizing this 
provision as proposed for the reasons outlined in the proposed rule.
    Comment: A few commenters suggested that we allow Medicaid AIU to 
be used to avoid the payment adjustment.
    Response: The statute (section 1848(a)(7) of the Act) specifically 
requires that the Medicare payment adjustment be applied to an EP ``who 
is not a meaningful EHR user * * * for an EHR reporting period for the 
payment year.'' As we have discussed previously, AIU does not involve 
the demonstration of meaningful use. Therefore, we cannot accept the 
commenters' recommendation that demonstration of AIU be accepted to 
allow an EP to avoid the Medicare payment adjustment.
    After consideration of the public comments received, we are 
finalizing these provisions as proposed.

[[Page 54095]]

 Table 11--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That, for CY 2018 and Subsequent Years,
                  the Secretary Finds That Less Than 75 Percent of EPs are Meaningful EHR Users
----------------------------------------------------------------------------------------------------------------
 EPs who are non-meaningful users       2015         2016         2017         2018         2019        2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment            99%          98%          97%          96%          95%          95%
 adjustment for e-prescribing in
 2014.............................
EP is subject to the payment                 98           98           97           96           95           95
 adjustment for e-prescribing in
 2014.............................
----------------------------------------------------------------------------------------------------------------

  Table 12--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That the Secretary Always Finds That,
              for CY 2018 and Subsequent Years, at Least 75 Percent of EPs are Meaningful EHR Users
----------------------------------------------------------------------------------------------------------------
 EPs who are non-meaningful users       2015         2016         2017         2018         2019        2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment            99%          98%          97%          97%          97%          97%
 adjustment for e-prescribing in
 2014.............................
EP is subject to the payment                 98           98           97           97           97           97
 adjustment for e-prescribing in
 2014.............................
----------------------------------------------------------------------------------------------------------------

    Comment: A commenter noted use of the word, ``during,'' in section 
1848(a)(7) of the Act, which states: ``* * * if the eligible 
professional is not a meaningful EHR user (as determined under 
subsection (o)(2) for an EHR reporting period for the year, the fee 
schedule amount for such services furnished by such professional during 
the year (including the fee schedule amount for purposes of determining 
a payment based on such amount) shall be equal to the applicable 
percent of the fee schedule amount that would otherwise apply to such 
services under this subsection (determined after application of 
paragraph (3) but without regard to this paragraph).'' The commenter 
asserted that the phrase ``during the year'' allows the Secretary to 
apply the payment adjustment for any amount of time during the year and 
does not require that the payment adjustment be applied for the entire 
year.
    Response: We disagree with this interpretation. Other parts of the 
statute clearly show the payment adjustment applies for a year at a 
time, and the Congress' intent was to have the physician fee schedule 
adjusted for an entire calendar year (that is, 99 percent (or 98 
percent) in 2015, 98 percent in 2016, 97 percent in 2017, and so on.) 
The interpretation presented by the commenters would lead to absurd 
results, because it would allow the payment adjustment to be minimized 
to the point where it has no impact on the EP.
    Therefore, we are finalizing the payment adjustment percentages and 
time periods as proposed.
b. EHR Reporting Period for Determining Whether an EP Is Subject to the 
Payment Adjustment for CY 2015 and Subsequent Calendar Years
    In the Stage 1 final rule, we did not specifically discuss the EHR 
reporting periods that will apply for purposes of determining whether 
an EP is subject to the payment adjustments for CY 2015 and subsequent 
years. Section 1848(a)(7)(E)(ii) of the Act provides broad authority 
for the Secretary to choose the EHR reporting period for this purpose. 
Specifically, this section provides that ``term 'EHR reporting period' 
means, with respect to a year, a period (or periods) specified by the 
Secretary.'' Thus, the statute neither requires that such reporting 
period fall within the year of the payment adjustment, nor precludes 
the reporting period from falling within the year of the payment 
adjustment.
    In developing our proposals in the case of EPs, we sought to 
establish appropriate reporting periods for purposes of the payment 
adjustments in CY 2015 and subsequent years to avoid creating a 
situation in which it might be necessary either to recoup overpayments 
or make additional payments after a determination is made about whether 
the payment adjustment should apply. We noted that this consideration 
is especially important in the case of EPs because, unlike the case 
with eligible hospitals and CAHs, there is not an existing mechanism 
for reconciliation or settlement of final payments subsequent to a 
payment year, based on the final data for the payment year. (Although, 
as we discussed in relation to our proposals on the payment adjustments 
for eligible hospitals in CY 2015 and subsequent years, this 
consideration also carries significant weight even where such a 
reconciliation or settlement mechanism is available.) Similarly, we did 
not want to create any scenarios under which providers would be 
required either to refund money, or to seek additional payment from 
beneficiaries, due to the need to recalculate beneficiary coinsurance 
after a determination of whether the payment adjustment should apply. 
If we were to establish EHR reporting periods that run concurrently 
with the payment adjustment year, we would not be able to safeguard 
against such retroactive adjustments (potentially including adjustments 
to beneficiary copayments, which are determined as a percentage of the 
Medicare PFS amount).
    Therefore, we proposed that EHR reporting periods for payment 
adjustments will begin and end prior to the year of the payment 
adjustment. Furthermore, we proposed that the EHR reporting periods for 
purposes of such determinations will be far enough in advance of the 
payment adjustment year to give us sufficient time to implement the 
system edits necessary to apply any required adjustments correctly, and 
that EPs will know in advance of the payment adjustment year whether or 
not they are subject to the adjustments that we have discussed. 
Specifically, we proposed that the following rules would apply for 
establishing the appropriate reporting periods for purposes of 
determining whether EPs are subject to the payment adjustments in CY 
2015 and subsequent years:
     Except as provided in the following bulleted paragraph for 
EPs who become meaningful users for the first time in 2014, we proposed 
that the EHR reporting period for the 2015 payment adjustment would be 
the same EHR reporting period that applies in order to receive the 
incentive for payment year

[[Page 54096]]

2013. We stated that this proposal would align reporting periods for 
multiple physician reporting programs. For EPs we proposed that the 
period would generally be a full calendar year of 2013 (unless 2013 is 
the first year of demonstrating meaningful use, in which case a 90-day 
EHR reporting period would apply). Under our proposed policy, an EP who 
receives an incentive for payment year 2013 would be exempt from the 
payment adjustment in 2015. An EP who received an incentive for payment 
years in 2011 or 2012 (or both), but who failed to demonstrate 
meaningful use in 2013 would be subject to a payment adjustment in 
2015. (As all of these years will be for Stage 1 of meaningful use, we 
stated our belief that it is unnecessary to create a special process to 
accommodate providers that miss the 2013 year for meaningful use). For 
each year subsequent to CY 2015, we proposed an EHR reporting period 
for the payment adjustment that is the calendar year 2 years prior to 
the payment adjustment period, subject again to the special exception 
for new meaningful users of the CEHRT as follows:
     We proposed an exception for those EPs who never 
successfully attested to meaningful use prior to CY 2014. For these 
EPs, as it would be their first year of demonstrating meaningful use, 
for the 2015 payment adjustment, we proposed to allow a continuous 90-
day reporting period that begins in 2014 and that ends at least 3 
months before the end of CY 2014. In addition, the EP would have to 
successfully register for and attest to meaningful use no later than 
the date that occurs 3 months before the end of CY 2014. For EPs, we 
stated that under our proposal, the latest day the EP must successfully 
register for the incentive program and attest to meaningful use, and 
thereby avoid application of the adjustment in CY 2015, would be 
October 1, 2014. Thus, the EP's EHR reporting period would need to 
begin no later than July 3, 2014 (allowing the EP a 90-day EHR 
reporting period, followed by 1 extra day to successfully submit the 
attestation and any other information necessary to earn an incentive 
payment). We proposed that this policy would continue to apply in 
subsequent years for EPs who are in their first year of demonstrating 
meaningful use in the year immediately preceding the payment adjustment 
year.
    Comment: Many commenters disagreed with our interpretation of the 
statute. These commenters asserted that both the Congressional intent 
and the language of the statute required an EHR reporting period 
aligned with the payment adjustment year. Thus, these commenters 
maintained that an EP should be subject to a payment adjustment during 
a payment year only if he or she fails to demonstrate meaningful use 
during that payment year. These commenters proposed several alternative 
methods for employing an EHR reporting period that is concurrent to the 
payment adjustment year for EPs. These recommended methods involved 
either making a determination of meaningful use early in a payment 
year, and then applying the payment adjustment (where applicable) for 
only a later part of the year, or developing a reconciliation process 
at the end of the year in which the payment adjustment is either 
collected from or refunded to the EP as appropriate.
    Response: We disagree with the commenters' interpretation of the 
statutory language. As the commenters note, section 1848(a)(7) of the 
SSA specifically requires that the Medicare payment adjustment be 
applied to an EP ``who is not a meaningful EHR user * * * for an EHR 
reporting period for the payment year.'' However, as we discussed in 
the proposed rule, section 1848(a)(7)(E)(ii) of the Act specifically 
provides that ``term `EHR reporting period' means, with respect to a 
year, a period (or periods) specified by the Secretary.'' Thus, the 
statute neither requires that such reporting period fall within the 
year of the payment adjustment, nor precludes the reporting period from 
falling within the year of the payment adjustment. Rather, the statute 
allows the Secretary the discretion to set the EHR reporting period and 
link to a year of payment adjustments. Indeed, given that Congress 
directed that the payment reduction that is applied to the physician 
fee schedule also apply for purposes of determining coinsurance, we 
believe there was an underlying intent to ensure that the physician fee 
schedule amount (and whether a percentage reduction applies) would be 
known at the time coinsurance is calculated. This would explain why 
Congress provided flexibility to the Secretary in determining which 
reporting period dictates whether the EP is subject to a payment 
adjustment. Finally, we note that other payment adjustment programs, 
such as the e-prescribing program, and the physician quality reporting 
system, also use a prior reporting period. Thus, it is consistent for 
us to adopt a prior reporting period for the EHR program as well.
    Comment: Commenters also raised two more practical objections to 
our proposal to use a prior EHR reporting period. One objection is that 
there is insufficient vendor capacity for all providers to purchase 
CEHRT and achieve meaningful use prior to 2015, in order to avoid the 
payment adjustment in 2015. Some of these commenters asserted that the 
practical deadline for beginning the process of adopting and 
implementing CEHRT has already passed for some popular vendors; thus, 
vendor choice is limited by the proposed timeline. Commenters also 
assert that this issue is compounded because EHR vendors must upgrade 
current clients to 2014 CEHRT at roughly the same time.
    Response: We understand the commenters' concerns. However, EPs have 
known for several years that they would face a payment adjustment 
beginning in 2015, and we believe that they have thus had adequate time 
to make appropriate preparations. During the last 2 years there has 
been a significant adoption of CEHRT with over 100,000 EPs receiving an 
incentive for adoption/implementation/upgrade or meaningful use. We 
also acknowledge the concerns expressed by many commenters about vendor 
capacity, and especially about whether every vendor will be available 
to every EP seeking to establish meaningful use. We note that to avoid 
the payment adjustment in 2015, all providers will be required to 
establish only Stage 1 of meaningful use in the applicable reporting 
period. For the payment adjustment in 2016, only those who first 
demonstrated meaningful use in 2011 or 2012 will have to demonstrate 
Stage 2 in the applicable reporting period and we are finalizing a 
shorter EHR reporting period for these EPs to account for the time 
limitations. We also believe other factors outweigh the concerns noted 
by commenters. As discussed previously, we do not believe the statute 
should be read to allow payment adjustments for only part of the year. 
Each of the other alternative suggestions presented by commenters would 
require reprocessing of claims for EPs, as well as addressing the 
difficult issue of how to adjust co-insurance in the context of this 
reprocessing (that is, to refund some coinsurance or to collect 
additional coinsurance, depending upon the results of the reprocessing 
on each claim). The administrative and financial cost of the 
reprocessing that would be required would be quite significant for both 
CMS and the affected EPs. Especially for smaller dollar claims, it is 
possible that in 2015 the cost of reprocessing for CMS and EPs could 
exceed that payment adjustment. For example, a claim of $100 will be

[[Page 54097]]

reduced $1 or $2 in CY 2015. If that claim was reprocessed, CMS 
Medicare Administrative Contractors (MACs) would have to reprocess the 
claim, utilize the banking system to send the payment; the EP's 
accounting process would have to accept the new payment and update the 
old claim and possibly incur the costs of collecting or refunding 
coinsurance. As the payment adjustments increase, the balance between 
the cost of the payment adjustments weighed against the cost of claim 
reprocessing may shift. In addition, as time passes we also anticipate 
that the supply of CEHRT and supporting services will increase to 
better match demand, lessening the concerns presented by the 
commenters. Therefore, we are finalizing the EHR reporting period for 
determining whether an EP is subject to the payment adjustment for CY 
2015 and subsequent calendar years as proposed. The issue requiring all 
providers regardless of stage of meaningful use to upgrade to 2014 
CEHRT is addressed by ONC in their final rule published elsewhere in 
this issue of the Federal Register. We note that all providers, 
regardless of stage, will use a 3-month EHR reporting period in 2014.
c. Exception to the Application of the Payment Adjustment to EPs in CY 
2015 and Subsequent Calendar Years
    As previously discussed, section 1848(a)(7)(B) of the Act provides 
that the Secretary may, on a case-by-case basis, exempt an EP from the 
application of the payment adjustments in CY 2015 and subsequent CYs if 
the Secretary determines that compliance with the requirements for 
being a meaningful EHR user will result in a significant hardship, such 
as in the case of an EP who practices in a rural area without 
sufficient Internet access. As provided in the statute, the exception 
is subject to annual renewal, but in no case may an EP be granted an 
exception for more than 5 years. We note that the HITECH Act does not 
obligate the Secretary to grant exceptions. Nonetheless, in the 
proposed rule, we expressed our belief that there are hardships for 
which an exception should be granted. We therefore proposed three types 
of exceptions in the proposed rule and discussed a potential fourth. 
The three proposed exceptions were, by definition, time limited and we 
stated that the circumstances justifying such exceptions should not be 
present for more than 5 years. The fourth exception related to certain 
EPs and did not, by definition, involve time limited circumstances. 
Nevertheless, we noted that the 5\-\ year limitation is statutory and 
cannot be altered by regulations, and that barriers to achieving 
meaningful use should be minimized over time.
    Comment: Some commenters suggested that the exception be granted 
for an all 5 years rather than an annual determination to reduce the 
burden on EPs seeking the exception and the burden on CMS to process 
the exceptions.
    Response: Section 1848(a)(7)(B) of the Act makes the hardship 
exception subject to annual renewal. Therefore, we would not grant an 
exception for more than 1 year unless we are certain that the 
circumstances that qualify an EP for an exception will not change for 5 
years. The only such definitive case is for new EPs, and we grant a 2-
year exception for such new EPs, because the date when an individual 
becomes an EP is a fixed point in time and not subject to change. 
However, all other exceptions discussed in the proposed rule depend on 
variable circumstances and could change from year to year. For example, 
although the exception we are finalizing for certain EPs (see Sec.  
495.102(d)(4)(iv)) could depend on scope of practice, which may be 
relatively fixed, it also depends on the ability to control the 
availability of CEHRT, which could easily change from year to year. 
Therefore, for these cases, we are not adopting this recommendation, 
and are finalizing a requirement for annual renewal.
    As mentioned previously, we proposed three specific exceptions and 
a potential fourth in the proposed rule. First, we proposed that the 
Secretary may grant an exception to EPs who practice in areas without 
sufficient Internet access. We noted that section 1848(a)(7)(B) of the 
Act specifically allows the Secretary to establish a significant 
hardship ``in the case of an eligible professional who practices in a 
rural area without sufficient Internet access.'' However, our proposal 
recognized that a nonrural area may also lack sufficient Internet 
access to make complying with the requirements for being a meaningful 
EHR user a significant hardship for an EP.
    We noted that exceptions on the basis of insufficient Internet 
connectivity must intrinsically be considered on a case-by-case basis. 
Therefore, we proposed to require that EPs must demonstrate 
insufficient Internet connectivity to qualify for the exception through 
an application process. As we discussed in the proposed rule, the 
rationale for this exception is that lack of sufficient Internet 
connectivity renders compliance with the meaningful EHR use 
requirements a hardship, particularly for meeting those meaningful use 
objectives requiring Internet connectivity, such as, summary of care 
documents, electronic prescribing, making health information available 
online, and submission of public health information. Therefore, we 
proposed that the application must demonstrate insufficient Internet 
connectivity to comply with the meaningful use objectives and that 
there are insurmountable barriers to obtaining such infrastructure, 
such as a high cost of extending the Internet infrastructure to their 
facility. We also proposed that an EP must establish the existence of 
the hardship was for the year that is 2 years prior to the payment 
adjustment year. Therefore, we proposed to require that applications be 
submitted no later than July 1 of the calendar year before the payment 
adjustment year in order to provide sufficient time for a determination 
to be made and for the EP to be notified about whether an exception has 
been granted prior to the payment adjustment year. This proposed 
timeline for submission and consideration of hardship applications was 
intended to allow sufficient time to adjust our payment systems so that 
payment adjustments are not applied to EPs who have received an 
exception for a specific payment adjustment year.
    In our proposed rule, we also encouraged EPs to apply for the 
exception as soon as possible, which is after the first 90 days (the 
earliest EHR reporting period) of CY 2013. If applications are 
submitted close to or on the latest date possible (that is, July 1, 
2014 for the 2015 payment adjustment year), then the applications could 
not be processed in sufficient time to conduct an EHR reporting period 
in CY 2014 in the event that the application is denied.
    Comment: Commenters stated universal support for this exception. 
However, commenters expressed the concern about the situation of an EP 
who might have sufficient internet access in the 2 years prior, but 
lose it in 2014.
    Response: We are finalizing our proposed significant hardship 
exception for insufficient Internet connectivity with one modification. 
We believe that it is extremely unlikely that an EP would lose 
sufficient internet access at one location. However, an EP may relocate 
to a location without sufficient Internet access. Therefore, we are 
finalizing our proposal with the modification to allow for the 
demonstration of insufficient internet access for any 90-day continuous 
period between the start of the year 2 years prior to the payment 
adjustment year and through the application submission

[[Page 54098]]

date of July 1 of the year prior to the payment adjustment year. The 
90-day period should be within this timeframe (for example, for payment 
adjustment year 2015, the hardship would need to be shown for any 
continuous 90-day period that begins on or after January 1, 2013 and 
ends on or before July 1, 2014.
    Second, we proposed to provide an exception for new EPs for a 
limited period of time after the EP has begun practicing. Newly 
practicing EPs will not be able to demonstrate that they are meaningful 
EHR users for a reporting period that occurs prior to the payment 
adjustment year. Therefore, we proposed that for 2 years after they 
begin practicing, EPs could receive an exception from the payment 
adjustments that will otherwise apply in CY 2015 and thereafter. We 
also proposed that, for purposes of this exception, an EP who switches 
specialties and begins practicing under a new specialty will not be 
considered newly practicing. For example, an EP who begins practicing 
in CY 2015 will receive an exception from the payment adjustments in 
CYs 2015 and 2016. However, as discussed previously, the new EP will 
still be required to demonstrate meaningful use in CY 2016 in order to 
avoid being subject to the payment adjustment in CY 2017. In the 
absence of demonstrating meaningful use in CY 2016, an EP who had begun 
practicing in CY 2015 will be subject to the payment adjustment in CY 
2017. We proposed to employ an application process for granting this 
exception, and will provide additional information on the timeline and 
form of the application in guidance subsequent to the publication of 
the final rule.
    Comment: Commenters stated universal support for this exception in 
public comments, and we are finalizing this exception as proposed for 
the reasons outlined in the proposed rule.
    Third, we proposed an additional exception in this final rule for 
extreme circumstances that make it impossible for an EP to demonstrate 
meaningful use requirements through no fault of her own during the 
reporting period. Such circumstances might include: a practice being 
closed down; a hospital closed; a natural disaster in which an EHR 
system is destroyed; EHR vendor going out of business; and similar 
circumstances. Because exceptions on extreme, uncontrollable 
circumstances must be evaluated on a case-by-case basis, we proposed to 
require EPs to qualify for the exception through an application 
process.
    Comment: Many commenters supported this exception. However a number 
of the supporters requested that various circumstances be added to the 
list of example circumstances that we provided. These examples dealt 
primarily with concerns related to vendors of CEHRT. Specifically, 
commenters were concerned about vendors of CEHRT not maintaining their 
certification status, ability to meet implementation schedules, and 
ability to find a vendor of CEHRT willing to work with them. In 
addition, commenters suggested that the provider facing severe 
financial distress, such as bankruptcy or restructuring of debt should 
be included as an example.
    Response: In evaluating these circumstances, we considered whether 
first and foremost they met the criteria of making it impossible for 
the EP to demonstrate meaningful use requirements through no fault of 
his or her own during the EHR reporting period. Second, we considered 
whether they establish a definitive circumstance that would always rise 
to the level of the exception or whether they would be dependent on the 
individual scenario. We are including two examples submitted by 
commenters in the preamble of the final rule that match the former 
criteria. First, we would consider the case an EP whose CEHRT loses its 
certification either through revocation or because the vendor did not 
upgrade their CEHRT to the latest requirements as an extreme 
circumstance that might qualify for this exception. Second, we would 
consider the case of an EP suffering severe financial distress 
resulting in a bankruptcy or restructuring of debt as an extreme 
circumstance that might qualify for this exception.
    We require applications to be submitted no later than July 1 of the 
calendar year before the payment adjustment year in order to provide 
sufficient time for a determination to be made and for the EP to be 
notified about whether an exception has been granted prior to the 
payment adjustment year. This timeline for submission and consideration 
of hardship applications also allows for sufficient time to adjust our 
payment systems so that payment adjustments are not applied to EPs who 
have received an exception for a specific payment adjustment year.
    The purpose of this exception is to accommodate EPs who would have 
otherwise been able to become a meaningful EHR user and avoid the 
payment adjustment for a given year in the absence of the extreme 
circumstances they face. Therefore, it is necessary to establish 
whether the relevant circumstances exist during the EHR reporting 
period for a given payment adjustment year rather than the payment 
adjustment year itself. In the proposed rule, we explained the 
inherently case-by-case nature of this exception request. While we 
discussed circumstances that arise in ``either of the 2 calendar years 
before the payment adjustment year,'' our intent was to ensure that the 
regulations recognized the two different EHR reporting periods for new 
meaningful users (that is, those demonstrating meaningful use for the 
first time in the year immediately prior to the payment adjustment 
year), versus current meaningful users (that is, those demonstrating 
meaningful use in the calendar year that is two years before the 
payment adjustment year). Obviously, a ``current'' meaningful user, who 
is required under our regulations to demonstrate meaningful use in the 
calendar year two years before the payment adjustment year, may not 
receive an exception for circumstances that occur after that reporting 
period. While a new meaningful user might be able to demonstrate that 
extreme circumstances that occurred prior to the reporting period 
continue to warrant an exception, we believe the case-by-case nature of 
the exception requests would allow such ``new'' meaningful users this 
opportunity to demonstrate that a significant hardship continues to 
exist during the reporting period. Therefore, in this final rule, we 
are clarifying our regulation to distinguish between new and current 
meaningful users, to be clear that the extreme circumstances must exist 
during the period in which the provider would otherwise be required to 
demonstrate meaningful use. EPs should apply for this exception on the 
basis of circumstances arising in the CY 2 years prior to the payment 
adjustment year, or, in the case of EPs who have never attested to 
meaningful use, the year immediately prior to the payment adjustment 
year.
    Finally, we solicited comment on the appropriateness of granting a 
fourth exception for EPs meeting certain specific general criteria that 
might render demonstration of meaningful use very difficult. The 
criteria that we discussed were--
     Lack of face-to-face or telemedicine interaction with 
patients, thereby making compliance with meaningful use criteria more 
difficult. Meaningful use requires that a provider collect a 
considerable amount of information about the patient and is able 
transport information online (to a PHR, to another provider, or to a 
patient) and is significantly easier if the provider has direct contact 
with the patient and a need for follow up care or contact. Certain 
physicians often do not have a consultative interaction with the

[[Page 54099]]

patient. For example, pathologist and radiologists seldom have direct 
consultations with patients. Rather, they typically submit reports to 
other physicians who review the results with their patients;
     Lack of follow up with patients. Again, the meaningful use 
requirements for collecting information about the patient and 
transporting information online are significantly easier to meet if a 
provider has direct contact with a patient and a need to follow-up with 
the patient; and
     Lack of control over the availability of CEHRT at their 
practice locations.
    In our proposed rule, we stated that we did not believe any one of 
these barriers taken independently would constitute an insurmountable 
hardship; however, our experience with Stage 1 of meaningful use 
suggests that, taken together, they may pose a substantial obstacle to 
achieving meaningful use. Therefore, we discussed several options in 
the proposed rule. One option was to provide a time-limited, 2-year 
payment adjustment exception for all EPs who meet the previous 
criteria. This approach would allow us to reconsider this issue in 
future rulemaking. Another option was to provide such an exception with 
no specific time limit. However, we noted that even under this less 
restrictive option, by statute no individual EP can receive an 
exception for more than 5 years. As discussed earlier, we believe the 
proliferation of both CEHRT and health information exchange will reduce 
the barriers faced by specialties with less CEHRT adoption over time as 
other providers may be providing the necessary data for these 
specialties to meet meaningful use. We particularly requested comment 
on how soon EPs who meet the previous criteria will reasonably be able 
to achieve meaningful use.
    In the proposed rule, we encouraged comment on whether these 
criteria, or additional criteria not accounted for in the meaningful 
use exclusions, constitute a significant hardship to meeting meaningful 
use. We indicated that we that we would consider whether to adopt an 
exception based on these or similar criteria in the final rule, and, if 
so, whether such an exception should apply to individual EPs or across-
the-board based on specialty or other groupings that generally meet the 
appropriate criteria.
    Comment: Numerous commenters expressed support for including this 
exception. Some commenters agreed with CMS' assertion that all three 
barriers must be in place for this to be considered a significant 
hardship, while others maintained that any one of these barriers 
constitutes a significant hardship. Commenters from specific groups 
also presented arguments that they face one or more (up to all three) 
of the barriers presented in a sufficiently uniform way to have the 
exception apply across the board to their group.
    Response: After reviewing the comments on this issue, we believe 
that the hardships presented are significant. Some EPs in the 
specialties that face all three barriers have already successfully 
attested to meaningful use. Thus, even when all three barriers are 
present, meaningful use may be difficult, but not impossible to 
achieve. In establishing the criteria for meaningful use itself, we 
have adopted exclusions and constructed the measures to lower the first 
two barriers as much as possible. For example, EPs with no office 
visits (that is, without direct patient contact) do not have to provide 
visit summaries, nor do they have to provider patient reminders. Due to 
both the allowances built into the meaningful use criteria and the fact 
at least a few EPs in nearly all specialties have attested to 
meaningful use, we do not believe that each barrier stands alone as a 
significant hardship. However, in considering the hardships and how 
they would be overcome there are significant differences between the 
first two and the latter (lack of control of CEHRT). Lack of face-to-
face and need for follow up are both overcome through robust health 
information exchange. However, we do not believe that the existing 
availability health information exchange is sufficient to overcome 
these hardships. Therefore, we are finalizing an exception for those 
EPs who lack both face-to-face interactions with patients and those who 
lack the need to follow up with patients. An EP may apply for this 
exception only on the grounds that they meet both of these criteria 
(lack of face-to-face interactions and lack the to follow up with 
patients). We consider lack of face-to-face and need for follow-up care 
to be situations where the EP has no or nearly no face-to-face patient 
interactions or need for follow-up care. The EP would need to 
demonstrate either a complete lack of face-to-face interactions and 
follow-up or that cases of face-to-face interaction and follow-up are 
extremely rare and not part of normal scope of practice for that EP.
    In reviewing the arguments presented for a group determination as 
well as considering common knowledge about the scope of practice of 
various specialties, we agree with commenters that the specialties of 
anesthesiology, radiology, and pathology lack face-to-face interactions 
and need to follow up with patients with sufficient frequency to 
warrant granting an exception to each EP with one of these primary 
specialties. We note that anesthesiologists do interact with patients, 
but not in a manner that is conducive to collecting the information 
needed for many aspects of meaningful use. As discussed previously, 
this exemption is subject to annual renewal. In future rulemaking we 
will consider whether the proliferation of health information exchange 
or any other developments are sufficient to remove lack of face-to-face 
interaction as a barrier, and whether the proliferation of CEHRT is 
sufficient to remove lack of control over the availability of CEHRT as 
a barrier. We will consider these issues in relation both to the 
exception itself and its application to the specialties of 
anesthesiology, radiology, and pathology. As such, physicians in these 
three specialties should not expect that this exception will continue 
indefinitely, nor should they expect that we will grant the exception 
for the full 5-year period permitted by statute. We will consider the 
extent to which these specialties continue to face these barriers in 
the Stage 3 rule and in other future rulemaking. We will also work to 
develop strategies to assist physicians who lack face-to-face 
interactions and the need to follow up with patients in demonstrating 
meaningful use. We may develop such strategies in the context of future 
rulemaking (for example, the Stage 3 rule) or in the form of additional 
guidance to physicians in these specialties. We also encourage all 
anesthesiologists, radiologists, and pathologists to continue to build 
out their ability to participate in health information exchange, adopt 
CEHRT and apply for the Medicare or Medicaid EHR incentives. Those 
seeking the Medicare EHR incentives can start through 2014, while those 
seeking the Medicaid EHR incentives can start through 2016.
    As hospital-based anesthesiologists, radiologists, and pathologists 
are not eligible for the incentive and are thus exempted from the 
payment adjustment, the exception discussed in this section relates to 
these specialists in nonhospital settings.
    With regard to the third barrier (lack of control over the 
availability of CEHRT at practice locations), we believe that in cases 
where an EP practices at multiple locations just this one barrier could 
be sufficient to constitute a significant hardship. In such cases, the 
EP would have to truly have no control over the availability of CEHRT. 
Control does not imply final decision-making authority. For example, we 
would

[[Page 54100]]

generally view EPs practicing in a large, corporate, group as having 
control over the availability of CEHRT, because they can influence the 
group's purchase of CEHRT, they may reassign their claims to the group, 
they may have a partnership/ownership stake in the group, or any 
payment adjustment would affect the group's earnings, and the entire 
impact would not be borne by the individual EP. These EPs can influence 
the availability of CEHRT and the group's earnings are directly 
affected by the payment adjustment. Thus, such EPs would not, as a 
general rule, be viewed as lacking control over the availability of 
CEHRT and would not be eligible for the hardship exception based solely 
on their membership in a group practice that has not adopted CEHRT.
    On the other hand, there are EPs who practice at multiple locations 
who truly have little to no control over whether CEHRT is available at 
their locations. These might include, surgeons using ambulatory surgery 
centers or physicians treating patients in a nursing home. In these 
cases, the surgeon or physician likely would bear the entire impact of 
any payment adjustment--and such adjustment would not affect the 
earnings of the ambulatory surgery center or nursing home. In addition, 
because the surgeon or physician merely sees patients at the center or 
home, and does not have any other interest in the facility, we believe 
they would exert little to no influence over whether the nursing home, 
center, or other similar outpatient site adopts and implements CEHRT.
    We note that we already have in place an eligibility requirement 
that allows for an EP to still qualify as a meaningful EHR user even if 
up to 49.9 percent of the EP's outpatient encounters are in locations 
that lack CEHRT. Thus, our exception would apply only in the case of 
EPs practicing in multiple locations where the lack of control (as 
discussed previously) exists for a majority (50 percent or more) of 
their outpatient encounters at such locations, causing such EPs to not 
be eligible to become meaningful EHR users. (In addition, we wish to 
make clear that we will not grant the exception to EPs that lack 
control in their practice locations but where those locations have 
adopted CEHRT would mean that the EP could become a meaningful EHR 
user.)
    For the reasons discussed earlier, we have adopted a final 
regulation that allows an EP practicing at multiple locations to 
demonstrate that the EP was truly unable to control the availability of 
CEHRT at either one or a combination of locations that constitute more 
than 50 percent of their outpatient encounters. Inpatient hospital and 
emergency department encounters would not be included in either the 
numerator or the denominator for purposes determining whether the 50 
percent threshold is met. This approach is consistent with the 
categories of encounters that are considered to be outpatient for 
purposes of determining hospital based status. (As noted previously, 
the locations cited by the EP for purposes of qualifying for this 
exception could not have CEHRT available--otherwise, we would view the 
EP as being potentially able to demonstrate meaningful use.)
    After considering the public comments, we are finalizing an 
exception by adding a new Sec.  495.102(d)(4)(iv) to the regulations. 
EPs whose primary specialty is listed in PECOS as anesthesiology, 
radiology or pathology 6 months prior to the first day of the year in 
which payment adjustments that would otherwise apply will be deemed to 
qualify for this exception, subject to the 5-year limit that applies to 
all exceptions under this paragraph.
    Comment: Many commenters requested that these and other commenter 
proposed exceptions apply to other programs besides the Medicare EHR 
incentive program.
    Response: This final rulemaking focuses on the EHR Incentive 
program, and we did not propose to make changes to other programs. We 
encourage interested parties to submit comments on proposed rules (if 
any) for those other programs.
    Comment: Commenters suggested the following additional exceptions:
     All EPs over 60 or eligible for Social Security and for 
all practices with 5 or fewer physicians.
     EPs who make a good faith effort, but fail to reach the 
thresholds thereby making a distinction between those who make an 
effort and those who do not attempt to become meaningful EHR user.
     EP is not practicing for a significant period of time 
during the reporting period.
     EP working in a practice without CEHRT changes to a new 
practice that has CEHRT during the reporting period.
    Response: We address each of these in turn. We agree that there is 
evidence that older EPs and those in smaller practices have been slower 
to adopt CEHRT.6 7 The HITECH Act even acknowledged the 
problems for smaller practices by creating assistance programs for EPs 
in individual or small practices in Title XIII, section 3012(c)(4) of 
the Act. However, based on attestation information submitted to us, EPs 
in both groups are successfully meeting meaningful use in significant 
numbers. Therefore, we do not believe that either an EP's age or 
practice size constitutes a significant hardship. In addition, we 
believe it would be problematic to exempt a category of EPs based on 
age or size of practice given that the intent of the payment 
adjustments and incentives is to ensure widespread modernization to 
electronic health records. We do not believe that these elements, in 
themselves, demonstrate that the EP experiences a ``significant 
hardship'' in becoming a meaningful EHR user.
---------------------------------------------------------------------------

    \6\ Chun-Ju Hsiao, Sandra L. Decker, Esther Hing and Jane E. 
Sisk. Most Physicians Were Eligible For Federal Incentives In 2011, 
But Few Had EHR Systems That Met Meaningful Use Criteria, Health 
Affairs, 31, No. 5 (2012).
    \7\ Sandra L. Decker, Eric W. Jamoom and Jane E. Sisk. 
Physicians In Nonprimary Care And Small Practices And Those Age 55 
And Older Lag In Adopting Electronic Health Records Systems, Health 
Affairs, 31, No. 5 (2012).
---------------------------------------------------------------------------

    The next exception suggested by commenters is for EPs who attempt 
to become a meaningful EHR user, but fail to do so. Because we have 
already adopted an exception for EPs who face circumstances beyond 
their control, the application of this suggested exception would 
necessarily be limited to EPs who face normal difficulties, rather than 
significant hardship, in becoming meaningful EHR users. Again, the 
statute requires demonstration of a significant hardship as the basis 
for an exception, and we do not believe that a good faith attempt, in 
and of itself, demonstrates the existence of a significant hardship 
exists sufficient to prevent the EP from becoming a meaningful EHR 
user. Furthermore, Congress set the benchmark for receiving full 
payment, without being subject to payment adjustment, on the 
achievement of meaningful use rather than on the attempt to achieve 
meaningful use. Therefore, we do not believe that EPs who attempt, but 
fail, to meet meaningful use and do not qualify for one of our other 
exceptions should be granted a significant hardship exception.
    We also do not believe that it is appropriate to establish an 
exception for EPs not practicing for significant time periods during 
the EHR reporting period. First, we already proposed (and are 
finalizing) an exception for newly practicing EPs. Second, EPs who are 
not newly practicing, but only practice for part of the EHR reporting 
period should be able to report in the numerator and denominators 
simply the numbers that pertain to the time during which they

[[Page 54101]]

are practicing. For example, a measure based on number of patients seen 
or actions taken would include only those patients/actions during the 
time the EP is practicing during the applicable reporting period. We 
recognize that some meaningful use measures, such as drug-drug and 
drug-allergy interaction checks, require a functionality to be enabled 
for the entire EHR reporting period. In this case, the EP would have 
the functionality enabled for the period s/he is practicing.
    The final exception suggested by commenters is for an EP working in 
a practice without CEHRT who changes to a new practice with CEHRT. 
Again, the commenters did not explain why such a circumstance, by 
itself, supports a significant hardship that prevents the EP from 
becoming a meaningful EHR user. Moreover, if the EP has never 
demonstrated meaningful use he or she should have an initial 90-day 
reporting period that allows the EP to demonstrate meaningful use in a 
shorter period. In addition, under current guidance, if the EP has more 
than 50 percent of their outpatient encounters at the new practice 
equipped with CEHRT then they would be able to exclude the old practice 
from their meaningful use measures.
    After considering the public comments, we are not finalizing these 
exceptions recommended by the commenters. The following table 
summarizes the timeline for EPs to avoid the applicable payment 
adjustment by demonstrating meaningful use or qualifying for an 
exception from the application of the payment adjustment:

      Table 13--Timeline for Eligible Professionals (Other Than Hospital-Based) To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                             For an EP
                                                           demonstrating
                                                        meaningful use for
                                                         the first time in
                           Demonstrate MU                the year prior to
                             during EHR                     the payment
 EP payment  adjustment  reporting period 2              adjustment year,             Apply or otherwise qualify
  year (calendar year)     years prior to        or        EHR reporting       or     for an  exception no later
                           year of payment                  period is a                          than
                             adjustment                     continuous
                                                            90[dash]day
                                                         reporting period
                                                        beginning no later
                                                               than
----------------------------------------------------------------------------------------------------------------
2015...................  CY 2013 (with       .........  July 3, 2014 (with  ........  July 1, 2014.
                          submission no                  submission no
                          later than                     later than
                          February 28,                   October 1, 2014).
                          2014).
2016...................  CY 2014 (with       .........  July 3, 2015 (with  ........  July 1, 2015.
                          submission no                  submission no
                          later than                     later than
                          February 28,                   October 1, 2015).
                          2015).
2017...................  CY 2015 (with       .........  July 3, 2016 (with  ........  July 1, 2016.
                          submission no                  submission no
                          later than                     later than
                          February 29,                   October 1, 2016).
                          2016).
2018...................  CY 2016 (with       .........  July 3, 2017 (with  ........  July 1, 2017.
                          submission no                  submission no
                          later than                     later than
                          February 28,                   October 1, 2017).
                          2017).
2019...................  CY 2017 with        .........  July 3, 2018 (with  ........  July 1, 2018.
                          submission no                  submission no
                          later than                     later than
                          February 28,                   October 1, 2018).
                          2018).
----------------------------------------------------------------------------------------------------------------
Notes: (CY refers to the calendar year, January 1 through December 31 each year.)
The timelines for CY 2020 and subsequent calendar years will follow the same pattern.

      Table 14--Period Hardship Must Be Shown With Application Date
------------------------------------------------------------------------
                                                         Application for
                                       Period of             CY 2015
           Exception               consideration for      submitted no
                                       exception           later than
------------------------------------------------------------------------
Insufficient internet access..  Demonstrate             July 1, 2014.
                                 insufficient internet
                                 access for any
                                 continuous 90-day
                                 period from the start
                                 of the CY 2 years
                                 prior to the payment
                                 adjustment year to
                                 July 1 of the year
                                 prior to the payment
                                 adjustment year (For
                                 CY 2015--January 1,
                                 2013-July 1, 2014).
New EP........................  New EP granted an       Guidance to be
                                 exception for the       issued
                                 year they become an     following
                                 EP and the following    publication of
                                 year (For CY 2015,      the final rule.
                                 the EP would have to
                                 be new in either CY
                                 2014 or CY 2015).
Extreme Circumstances outside   For an EP who has       July 1, 2014.
 of the EP's Control.            previously
                                 demonstrated
                                 meaningful use, the
                                 EP must demonstrate
                                 extreme circumstances
                                 that affect either of
                                 the CYs in the 2
                                 years prior to the
                                 payment adjustment
                                 year. (For CY 2015-CY
                                 2013).
                                For EPs who have never
                                 demonstrated
                                 meaningful use, the
                                 EP must demonstrate
                                 extreme circumstances
                                 that affect the CY
                                 prior to the payment
                                 adjustment year. (For
                                 CY 2015-CY 2014).
Lack of Face-Face/Telemedicine  The CY 2 years prior    For applications
 Patient Interactions and Lack   to the payment          only: July 1,
 of Need for Follow Up Care,.    adjustment year (For    2014.
Lack of Control Over             CY 2015-CY 2013)
 Availability of CEHRT for EPs   through the
 practicing in multiple          application deadline..
 locations..                    For all EPs, if they
                                 are registered in
                                 PECOS with a primary
                                 specialty of
                                 anesthesiology,
                                 pathology or
                                 radiology 6 months
                                 prior to first day of
                                 the payment
                                 adjustment year they
                                 meet the exception.
                                 (For CY 2015--July 1,
                                 2014).
------------------------------------------------------------------------

d. HPSA Bonus Technical Change
    In this final rule we are also making a technical change to our 
regulations to correctly reflect our policy on EPs who predominantly 
furnish services in a geographic HPSA. This change is necessary to 
reflect the current policy that the 50 percent determination is based 
on the covered professional services provided during the payment year, 
in accordance with the preamble discussion in the Stage 1 final rule 
(75 FR 44444 through 44445). The current regulation erroneously uses 
the phrase ``the year prior to the payment year,'' which conflicts with 
our preamble discussion in both the proposed (75 FR 1908 through 1909) 
and final Stage 1 rules. We note that we are not changing the policy 
(already adopted) that the HPSA must be so designated by December 31 of 
the year prior to the payment year.

[[Page 54102]]

e. Payment Adjustment Not Applicable to Hospital-Based EPs
    Section 1848(a)(7)(D) of the Act provides that no EHR payment 
adjustments otherwise applicable for CY 2015 and subsequent years ``may 
be made * * * in the case of a hospital-based eligible professional (as 
defined in subsection (o)(1)(C)(ii)) of the Act.'' We proposed that the 
same definition of hospital-based should apply during the incentive and 
payment adjustment phases of the Medicare EHR incentive program (that 
is, those eligible to receive incentives will also be subject to 
adjustments). Therefore, we proposed that our regulations at Sec.  
495.100 and Sec.  495.102(d) would retain, during the payment 
adjustment phase of the EHR Incentive Program, the definition of 
hospital-based eligible professional at Sec.  495.4. For purposes of 
the Medicare EHR incentive payment program, the determination of 
whether an EP is hospital-based is made on the basis of data from ``the 
Federal FY prior to the payment year.'' In the preamble to the Stage 1 
final rule (75 FR 44442), we also stated that ``in order to provide 
information regarding the hospital-based status of each EP at the 
beginning of each payment year, we will need to use claims data from an 
earlier period. Therefore, we will use claims data from the prior 
fiscal year (October through September). Under this approach, the 
hospital-based status of each EP will be reassessed each year, using 
claims data from the fiscal year preceding the payment year. The 
hospital-based status will be available for viewing beginning in 
January of each payment year.''
    We proposed to retain the concept established in the Stage 1 final 
rule (75 FR 44442) of making hospital-based determinations based upon a 
prior fiscal year of data. However, in the proposed rule we expressed 
concern about ensuring that EPs are aware of their hospital-based 
status in time to purchase EHR technology and meaningfully use it 
during the EHR reporting period that applies to a payment adjustment 
year. EPs who believe that they are not hospital based will have 
already either worked towards becoming meaningful EHR users or planned 
for the payment adjustment. EPs who believe that they will be 
determined hospital based may not have done so. EPs in these 
circumstances will need to know they are not hospital based in time to 
become a meaningful EHR user for a 90-day EHR reporting period in the 
year prior to the payment adjustment year. To use the example of the CY 
2015 payment adjustment year, a determination based on FY 2013 data 
will allow an EP to know whether he or she is hospital-based by January 
1, 2014. This timeline would give the EP approximately 6 months to 
begin the EHR reporting period, which could last from July through 
September of 2014. We stated in the proposed rule that we did not 
believe this to be sufficient time for the EP to implement CEHRT. 
Therefore, we proposed to base the hospital based determination for a 
payment adjustment year on determinations made 2 years prior. Again 
using CY 2015 payment adjustment year as an example, the determination 
would be available on January 1, 2013 based on FY 2012 data. This 
proposed determination date will give the EP up to 18 months to 
implement CEHRT and begin the EHR reporting period to avoid the CY 2015 
payment adjustment. In the proposed rule, we asserted that this a 
reasonable time frame to accommodate a difficult situation for some 
EPs. However, we also are aware that there may be EPs who are 
determined nonhospital-based under this ``2-years prior'' policy when 
they will be determined hospital-based if we made the determination 
just 1-year prior. Again, using the example of the CY 2015 payment 
adjustment year, an EP determined nonhospital-based as of January 1, 
2013 (using FY 2012 data) may be found to be hospital-based as of 
January 1, 2014 (using FY 2013 data). In this situation, we stated in 
the proposed rule that we did not believe the EP should be penalized 
for having been nonhospital-based as of January 1, 2013, especially if 
the EP has never demonstrated meaningful use, and the EP's first EHR 
reporting period will have fallen within CY 2014. Therefore, in the 
proposed rule we requested comments on expanding the hospital-based 
determination to encompass determinations made either 1 or 2 years 
prior. Under this alternative, if the EP were determined hospital based 
as of either one of those dates, then the EP would be exempt from the 
payment adjustments in the corresponding payment adjustment year. This 
would mean that for the CY 2015 payment adjustment year, an EP 
determined hospital based as of either January 1, 2013 (using FY 2012 
data) or January 1, 2014 (using FY 2013 data) would not be subject to 
the payment adjustment. In all cases, we would need to know that the EP 
is considered hospital based in sufficient time for the payment 
adjustment year.
    Comment: Commenters provided only general supportive comments on 
this proposal.
    Response: We thank the commenters for the support. For the reasons 
stated in the proposed rule, we are finalizing a rule that will 
determine hospital based using either of the following fiscal year's 
data: (1) The fiscal year before the year that is 1 year prior to the 
payment adjustment year (for example, FY 2013 data for payment 
adjustment year 2015); or (2) the fiscal year before the year that is 2 
years prior to the payment adjustment year (for example, FY 2012 data 
for payment adjustment year 2015). If the data from either year result 
in a hospital-based determination, then the EP would not be subject to 
the payment adjustments for the relevant year.
    We discuss one aspect of determining hospital-based status, 
specifically the circumstances of EPs who fund the acquisition, 
implementation, and maintenance of their own CEHRT in a hospital-based 
setting, in section II.C.3. of the preamble to this final rule.
3. Incentive Market Basket Adjustment Effective in FY 2015 and 
Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR 
Users for an Applicable Reporting Period
    Section 1886(b)(3)(B)(ix)(I) of the Act, as amended by section 
4102(b)(1) of the HITECH Act, provides for an adjustment to the 
applicable percentage increase to the IPPS payment rate for those 
eligible hospitals that are not meaningful EHR users for the associated 
EHR reporting period for a payment year, beginning in FY 2015. 
Specifically, section 1886(b)(3)(B)(ix)(I) of the Act provides that, 
``for FY 2015 and each subsequent FY,'' an eligible hospital that is 
not ``a meaningful EHR user * * * for an EHR reporting period'' will 
receive a reduced update to the IPPS standardized amount. This 
reduction will apply to ``three-quarters of the percentage increase 
otherwise applicable.'' The reduction to three-quarters of the 
applicable update for an eligible hospital that is not a meaningful EHR 
user will be ``33\1/3\ percent for FY 2015, 66\2/3\ percent for FY 
2016, and 100 percent for FY 2017 and each subsequent FY.'' In other 
words, for eligible hospitals that are not meaningful EHR users, the 
Secretary is required to reduce the percentage increases otherwise 
applicable by 25 percent (33\1/3\ percent of 75 percent) in 2015, 50 
percent (66\2/3\ percent of 75 percent) in FY 2016, and 75 percent (100 
percent of 75 percent) in FY 2017 and subsequent years. Section 
4102(b)(1)(B) of the HITECH Act also provides that such ``reduction 
shall apply only with respect to the FY involved and the Secretary 
shall not take into account such reduction in computing the applicable 
percentage increase * * * for a subsequent FY.''

[[Page 54103]]

Table 15--Percentage Decrease in Applicable Hospital Percentage Increase
             for Hospitals That Are Not Meaningful EHR Users
------------------------------------------------------------------------
                                    2015          2016          2017+
------------------------------------------------------------------------
Hospital payment update is              25%           50%           75%
 subject to EHR payment
 reduction....................
------------------------------------------------------------------------

    Section 1886(b)(3)(B)(ix)(II) of the Act, as amended by section 
4102(b)(1) of the HITECH Act, provides that the Secretary may, on a 
case-by-case basis exempt a hospital from the application of the 
percentage increase adjustment for a fiscal year if the Secretary 
determines that requiring such hospital to be a meaningful EHR user 
will result in a significant hardship, such as in the case of a 
hospital in a rural area without sufficient Internet access. This 
section also provides that such determinations are subject to annual 
renewal, and that in no case may a hospital be granted such an 
exemption for more than 5 years.
    Finally section 1886(b)(3)(B)(ix)(III) of the Act, as amended by 
section 4102(b)(1) of the HITECH Act, provides that, for FY 2015 and 
each subsequent FY, a state in which hospitals are paid for services 
under section 1814(b)(3) of the Act shall adjust the payments to each 
eligible hospital in the state that is not a meaningful EHR user in a 
manner that is designed to result in an aggregate reduction in payments 
to hospitals in the state that is equivalent to the aggregate reduction 
that will have occurred if payments had been reduced to each eligible 
hospital in the state in a manner comparable to the reduction in 
section 1886(b)(3)(B)(ix)(I) of the Act. This section also requires 
that the state shall report to the Secretary the method it will use to 
make the required payment adjustment. (At present, section 1814(b)(3) 
of the Act applies to the State of Maryland.) As we discussed in the 
Stage 1 final rule establishing the EHR incentive program (75 FR 
44448), for purposes of determining whether hospitals are eligible for 
receiving EHR incentive payments, we employ the CMS Certification 
Number (CCN). We also proposed to use CCNs to identify hospitals for 
purposes of determining whether the reduction to the percentage 
increase otherwise applicable for FY 2015 and subsequent years applies. 
(In other words, whether a hospital was a meaningful EHR user for the 
applicable EHR reporting period will be dependent on the CCN for the 
hospital.) We noted the results of this policy for certain cases in 
which hospitals change ownership, merge, or otherwise reorganize and 
the applicable CCN changes. In cases where a single hospital changes 
ownership, we determine whether to retain the previous CCN or to assign 
a new CCN depending upon whether the new owner accepts assignment of 
the provider's prior participation agreement. Where a change of 
ownership has occurred, and a new CCN is assigned due to the new 
owner's decision not to accept assignment of the prior provider 
agreement, we proposed not to recognize a meaningful use determination 
that was established under the prior CCN for purposes of determining 
whether the payment adjustment applies. Where the new owner accepts the 
prior provider agreement and is assigned the same CCN, we proposed to 
continue to recognize the demonstration of meaningful use under that 
CCN. The same policy was proposed for merging hospitals that use a 
single CCN. For example, if hospital A is not a meaningful EHR user 
(for the applicable reporting period), and it absorbs hospital B, which 
was a meaningful EHR user, then the entire hospital will be subject to 
a payment adjustment if hospital A's CCN is the surviving identifier. 
The converse is true as well--if it were hospital B's CCN that 
survived, the entire merged hospital will not be subject to a payment 
adjustment. (The guidelines for determining CCN assignment in the case 
of merged hospitals are described in the State Operations Manual, 
sections 2779Aff. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.html) We advised 
hospitals that are changing ownership, merging, or otherwise 
reorganizing to take this policy into account.
    Comments received on the treatment of CCNs and new hospitals are 
addressed in the context of discussing our exception for new hospitals 
later in this section.
a. Applicable Market Basket Adjustment for Eligible Hospitals Who Are 
Not Meaningful EHR Users for FY 2015 and Subsequent FYs
    In the stage 1 final rule on the Medicare and Medicaid Electronic 
Health Record Incentive Payment Programs, we revised Sec.  412.64 of 
the regulations to provide for an adjustment to the applicable 
percentage increase update to the IPPS payment rate for those eligible 
hospitals that are not meaningful EHR users for the EHR reporting 
period for a payment year, beginning in FY 2015. Specifically, Sec.  
412.64(d)(3) now provides that--
     Beginning in fiscal year 2015, in the case of a 
``subsection (d) hospital,'' as defined under section 1886(d)(1)(B) of 
the Act, that is not a meaningful electronic health record (EHR) user 
as defined in part 495, three-fourths of the applicable percentage 
change specified in paragraph (d)(1) is reduced--
    ++ For fiscal year 2015, by 33\1/3\ percent;
    ++ For fiscal year 2016, by 66\2/3\ percent; and
    ++ For fiscal year 2017 and subsequent fiscal years, by 100 
percent.
    In order to conform with this new update reduction, as required in 
section 4102(b)(1)(A) of the HITECH Act, we also revised Sec.  
412.64(d)(2)(C) of our regulations to provide that, beginning with FY 
2015, the reduction to the IPPS applicable percentage increase for 
failure to submit data on quality measures to the Secretary shall be 
one-quarter of the applicable percentage increase, rather than the 2 
percentage point reduction that applies for FYs 2007 through 2014 in 
Sec.  412.64(d)(2)(B). The effect of this revision is that the combined 
reductions to the applicable percentage increase for meaningful EHR use 
and quality data reporting will not produce an update of less than zero 
for a hospital in a given FY as long as the hospital applicable 
percentage increase remains a positive number.
    We did not propose any changes to the establishment of the payment 
adjustment amounts. We did propose the applicable EHR reporting period, 
for purposes of determining whether a hospital is subject to the 
applicable percentage increase adjustment for FY 2015 and subsequent 
FYs, as a prior EHR reporting period (as defined in Sec.  495.4 of the 
regulations). We also proposed an amendment to Sec.  412.64(d) to 
provide for the hardship and other exceptions we discuss later, as well 
as the application of the applicable percentage increase adjustment in 
FY 2015 and subsequent FYs to a state operating under a payment waiver 
provided by section 1814(b)(3) of the Act. We discuss these proposals 
and the

[[Page 54104]]

comments relating to them in the following sections of this preamble.
b. EHR Reporting Period for Determining Whether a Hospital Is Subject 
to the Market Basket Adjustment for FY 2015 and Subsequent FYs
    Section 1886(b)(3)(B)(ix)(IV) of the Act makes clear that the 
Secretary has discretion to ``specify'' as the EHR reporting period 
``any period (or periods)'' that will apply ``with respect to a fiscal 
year.'' Thus, as in the case of designating the EHR reporting period 
for purposes of the EP payment adjustment, the statute governing the 
applicable percentage increase adjustment for hospitals that are not 
meaningful users of EHR technology neither requires that such reporting 
period fall within the year of the payment adjustment, nor precludes 
the reporting period from falling within the year of the payment 
adjustment.
    As in the case of EPs, we sought to avoid creating a situation in 
which it might be necessary to make large payment adjustments, either 
to lower or to increase payments to a hospital, after a determination 
is made about whether the applicable percentage increase adjustment 
should apply. We stated in the proposed rule that we believe that this 
consideration remains compelling in the case of hospitals, despite the 
fact that the IPPS for acute care hospitals provides, unlike the case 
of EPs, a mechanism to make appropriate changes to hospital payments 
for a payment year through the cost reporting process. Despite the 
availability of the cost reporting process as a mechanism for 
correcting over- and underpayments made during a payment year, we seek 
to avoid wherever possible circumstances under which it may be 
necessary to make large adjustments to the rate-based payments that 
hospitals receive under the IPPS. Since the EHR payment adjustment in 
FYs 2015 and subsequent years is an adjustment to the applicable 
percentage increase used in determining prospective payments, we 
believe that it is far preferable to determine whether the adjustment 
applies on the basis of an EHR reporting period before the payment 
period, rather than to make the adjustment (where necessary) in a 
settlement process after the payment period on the basis of a 
determination concerning whether the hospital was a meaningful user 
during the payment period.
    Therefore, we proposed, for purposes of determining whether the 
relevant applicable percentage increase adjustment applies to hospitals 
who are not meaningful users of EHR technology in FY 2015 and 
subsequent years, that we would establish EHR reporting periods that 
begin and end prior to the year of the payment adjustment. Furthermore, 
we proposed that the EHR reporting periods for purposes of such 
determinations would be far enough in advance of the payment year that 
we have sufficient time to implement the system edits necessary to 
apply any required applicable percentage increase adjustment correctly, 
and that hospitals will know in advance of the payment year whether or 
not they are subject to the applicable percentage increase adjustment. 
Specifically, we proposed the following rules establishing the 
appropriate reporting periods for purposes of determining whether 
hospitals are subject to the applicable percentage increase adjustment 
in FY 2015 and subsequent years (parallel to the rules that we proposed 
previously for determining whether EPs are subject to the payment 
adjustments in CY 2015 and subsequent years):
     Except as provided in second bulleted paragraph for 
eligible hospitals that become meaningful users for the first time in 
2014, we proposed that the EHR reporting period for the FY 2015 
applicable percentage increase adjustment will be the same EHR 
reporting period that applies in order to receive the incentive for FY 
2013. For hospitals this will generally be the full fiscal year of 2013 
(unless FY 2013 is the first year of demonstrating meaningful use, in 
which case a 90-day EHR reporting period will apply). Under our 
proposed policy, a hospital that receives an incentive for FY 2013 
would be exempt from the payment adjustment in FY 2015. A hospital that 
received an incentive for FYs 2011 or 2012 (or both), but that failed 
to demonstrate meaningful use for FY 2013 will be subject to a payment 
adjustment in FY 2015. (As all of these years will be for Stage 1 of 
meaningful use, we do not believe that it is necessary to create a 
special process to accommodate providers that miss the 2013 year for 
meaningful use). For each year subsequent to FY 2015, the EHR reporting 
period payment adjustment will continue to be the FY 2 years before the 
payment adjustment period, subject again to the special provision for 
new meaningful users of CEHRT.
     We proposed an exception for those hospitals that have 
never successfully attested to meaningful use prior to FY 2014. For 
these hospitals, as it is their first year of demonstrating meaningful 
use, we proposed to allow a continuous 90-day reporting period that 
begins in 2014 and that ends at least 3 months prior to the end of FY 
2014. In addition, the hospital would have to actually successfully 
register for and attest to meaningful use no later than the date that 
occurs 3 months before the end of the year. For hospitals, this means 
specifically that the latest day the hospital must successfully 
register for the incentive program and attest to meaningful use, and 
thereby avoid application of the adjustment in FY 2015, is July 1, 
2014. Thus, the hospital's EHR reporting period must begin no later 
than April 2, 2014 (allowing the hospital a 90-day EHR reporting 
period, followed by 1 extra day to successfully submit the attestation 
and any other information necessary to earn an incentive payment). In 
the proposed rule we used the date April 3, 2014 which would only allow 
an 89-day period through June 30, 2014. The correct date is April 2, 
2014 to allow September 30, 2014 to be the last day of the 90-day EHR 
reporting period with the extra day (Oct 1, 2014) to attest. This 
policy would continue to apply in subsequent years. If a hospital is 
demonstrating meaningful use for the first time for the fiscal year 
immediately before the applicable percentage increase adjustment year, 
then the reporting period will be a continuous 90-day period that 
begins in such prior fiscal year and ends at least 3 months before the 
end of such year. In addition, all attestation, registration, and any 
other details necessary to determine whether the hospital is subject to 
a applicable percentage increase adjustment for the upcoming year will 
need to be completed by July 1. (As we discuss later, exception 
requests will be due by the April 1 before the beginning of the payment 
adjustment fiscal year.)
    In conjunction with adopting these rules for establishing the EHR 
Reporting Period for determining whether a hospital is subject to the 
applicable percentage increase adjustment for FY 2015 and subsequent 
FYs, we proposed to revise Sec.  412.64(d)(3) of our regulations to 
insert the phrase ``for the applicable EHR reporting period,'' so that 
it is clear that the EHR reporting period will not fall within the year 
of the market basket adjustment.
    We stated our belief that these proposed EHR reporting periods 
provide adequate time both for the systems changes that will be 
required for CMS to apply any applicable percentage increase 
adjustments in FY 2015 and subsequent years, and for hospitals to be 
informed in advance of the payment year whether any adjustment(s) will 
apply. They also provide appropriate flexibility by allowing more 
recent adopters of EHR technology a

[[Page 54105]]

reasonable opportunity to establish their meaningful use of the 
technology and to avoid application of the payment adjustments.
    Comment: As with the comments on the EHR reporting period for EPs, 
many commenters made the same assertion that an EHR reporting period 
aligned with the payment adjustment year would be more consistent with 
the Congressional intent and the language of the statute. Some 
commenters contended that the statutory language requires the reporting 
period and payment adjustment year to coincide.
    Response: We believe our response to this comment in the context of 
the EP payment adjustments applies equally to his eligible hospital 
comment. The language in section 1886(b)(3)(B)(ix)(I) of the Act is 
substantially similar to the language in section 1848(a)(7) of the Act. 
As in the case of EPs, Congress provided the Secretary with flexibility 
to determine the EHR reporting period applicable to the payment 
adjustment year. Section 1886(b)(3)(B)(ix)(IV) of the Act specifically 
provides that ``term `EHR reporting period' means, with respect to a 
fiscal year, any period (or periods) specified by the Secretary.'' In 
addition, because the payment adjustment will be used to reduce the 
applicable percent increase that is used in the prospective ratesetting 
for hospitals, it is reasonable to conclude that this Secretarial 
flexibility was granted precisely because Congress understood that the 
Department needed to have final determinations on meaningful use prior 
to the fiscal year that is the payment adjustment year. As we have 
previously noted, other payment adjustment programs, such as the e-
prescribing program, and the physician quality reporting system, also 
use a prior reporting period. Thus, it is consistent for us to adopt a 
prior reporting period for the EHR program as well.
    Comment: Commenters made the same comments as they did for EPs 
(relating to insufficient vendor capacity; the practical deadline 
having passed for adopting and implementing CEHRT, especially for 
popular vendors; and the issues surrounding upgrading current clients 
to 2014 CEHRT). As with EPs, the options presented by commenters all 
involved a reconciliation process, in this case, using the cost 
reporting process.
    Response: The issue of upgrading to 2014 CEHRT is addressed by ONC 
in their final rule published elsewhere in this issue of the Federal 
Register. We appreciate the concerns of vendor capacity raised by the 
commenters. We discuss this situation and the reasons we are not 
revising our timetables in our previous discussion of the parallel 
policy for EPs. In the hospital context, the commenters correctly point 
out the existence of a payment reconciliation method, the hospital cost 
report, that it unavailable within the payment systems for EPs. We have 
carefully considered whether it is feasible to adopt a later reporting 
period (perhaps even the payment year itself) as the basis for 
determining whether eligible hospitals are subject to the EHR payment 
adjustment, and then to employ the cost reporting process to correct 
over and under payments in regards to the payment adjustments, as a 
number of commenters recommended. As a matter of course in the rate 
setting system, the basic rates and applicable percentage increase 
updates are fixed in advance and are not matters that are taken into 
account in the settlement of final payment amounts under the cost 
report reconciliation process. As the payment adjustment directly 
affects this rate we believe that it would not be possible to employ a 
cost report settlement process, but that claims would have to be 
reprocessed.
    It is true, as several commenters pointed out, that several 
components of the IPPS, including DSH and IME payments, are settled in 
the cost reporting process on the basis of final data (for example, bed 
days, resident FTEs) from the payment year. However, changes in other 
aspects of the payment system, such as outlier payments, cannot 
reconciled within the cost reporting process, but require reprocessing 
of claims. Application of the EHR payment adjustment changes the 
standardized amount upon which IPPS payments are based. Any change in 
the standardized amount applicable to a hospital changes the number of 
outlier payments the hospital would receive, and the amount of those 
payments. If we were to base final determination of whether the EHR 
payment adjustment should apply on meaningful use status during the 
payment year, it would be necessary to increase the standardized amount 
for some hospitals, that is, those that were assumed not to meet 
meaningful use requirements for purposes of making interim payments, 
but that subsequently established meaningful use during the payment 
year. Conversely, it would be necessary to decrease the standardized 
amount for those hospitals that had been assumed to meet meaningful use 
requirements for purposes of making interim payments, but that 
subsequently failed to meet those requirements during the payment year. 
In both cases, mass reprocessing of payments would be necessary in 
order to adjust outlier payments. Generally, hospitals whose 
standardized amounts are decreased at the time of final payment 
determination (due to application of a payment adjustment that was not 
applied to interim payments) would generally receive greater outlier 
payments. Conversely, hospitals whose standardized amounts are 
increased at the time of final payment determination (due to 
application of the full update that was not applied to interim 
payments) would generally receive lower outlier payments. (Reprocessing 
would also be necessary for new technology add-on payments, although 
the claims volume and dollar amounts involved in such reprocessing 
would be significantly lower.) Such reprocessing imposes significant 
costs on both the eligible hospital and CMS. As in the case of EPs, 
then, we continue to believe that the timeline we proposed is the most 
realistic approach to making payment adjustment determinations in an 
effective manner.
    Therefore, we are finalizing the proposed EHR reporting period for 
determining whether an eligible hospital is subject to the payment 
adjustment for CY 2015 and subsequent calendar years as proposed.
c. Exception to the Application of the Market Basket Adjustment to 
Hospitals in FY 2015 and Subsequent FYs
    As mentioned previously, section 1886(b)(3)(B)(ix)(II) of the Act, 
as amended by section 4102(b)(1) of the HITECH Act, provides that the 
Secretary may, on a case-by-case basis exempt a hospital from the 
application of the applicable percentage increase adjustment for a 
fiscal year if the Secretary determines that requiring such hospital to 
be a meaningful EHR user will result in a significant hardship, such as 
in the case of a hospital in a rural area without sufficient Internet 
access. This section also provides that such determinations are subject 
to annual renewal, and that in no case may a hospital be granted such 
an exception for more than 5 years.
    We proposed to add a new Sec.  412.64(d)(4), specifying the 
circumstances under which we will exempt a hospital from the 
application of the applicable percentage increase adjustment for a 
fiscal year. To be considered for an exception, a hospital must submit 
an application demonstrating that it meets one more of the exception 
criteria.
    As noted previously, the statute does not mandate the circumstances 
under which an exception must be granted,

[[Page 54106]]

but (as in the case of a similar exception provided under the statute 
for EPs) it does state that the exception may be granted when 
``requiring such hospital to be a meaningful EHR user during such 
fiscal year will result in a significant hardship, such as in the case 
of a hospital in a rural area without sufficient Internet access.'' 
Therefore, we proposed to provide in new Sec.  412.64(d)(4) that the 
Secretary may grant an exception to a hospital that is located in an 
area without sufficient Internet access. Furthermore, while the statute 
specifically states that such an exception may be granted to hospitals 
in ``a rural area without sufficient Internet access,'' it does not 
require that such an exception be restricted only to rural areas 
without such access. While we believe that a lack of sufficient 
Internet access will rarely be an issue in an urban or suburban area, 
we do not believe that it is necessary to preclude the possibility 
that, in very rare and exceptional cases, a nonrural area may also lack 
sufficient Internet access to make complying with meaningful use 
requirements a significant hardship for a hospital. Therefore, we 
proposed that the Secretary may grant such an exception to a hospital 
in any area without sufficient Internet access.
    Because exceptions on the basis of insufficient Internet 
connectivity must intrinsically be considered on a case-by-case basis, 
we proposed to require hospitals to demonstrate insufficient Internet 
connectivity to qualify for the exception through an application 
process. The rationale for this exception is that lack of sufficient 
Internet connectivity renders compliance with the meaningful EHR use 
requirements a hardship particularly those objectives requiring 
Internet connectivity, summary of care documents, electronic 
prescribing, making health information available online, and submission 
of public health information. Therefore, we proposed that such an 
application must demonstrate insufficient Internet connectivity to 
comply with the meaningful use objectives listed previously and 
insurmountable barriers to obtaining such Internet connectivity such as 
high cost to build out Internet to their facility. As with EPs, the 
hardship would be demonstrated for period that is 2-years prior to the 
payment adjustment year (for example, FY 2013 for the payment 
adjustment in FY 2015). As with EPs, we will require applications to be 
submitted 6 months before the beginning of the payment adjustment year 
(that is, by April 1 before the FY to which the adjustment will apply) 
in order to provide sufficient time for a determination to be made and 
for the hospital to be notified about whether an exception has been 
granted. This timeline for submission and consideration of hardship 
applications also allows for sufficient time to adjust our payment 
systems so that payment adjustments are not applied to hospitals who 
have received an exception for a specific FY. (Please also see our 
previous discussion of the parallel exception for EPs, with respect to 
encouraging providers to file these applications as early as possible, 
and the likelihood that there will not be an opportunity to 
subsequently demonstrate meaningful use if hospitals file close to or 
at the application deadline of April 1.)
    Comment: Commenters provided universal support for this proposed 
exception. However, some commenters raised concern about the situation 
of hospitals that might have Internet access in the 2-years prior, but 
lose it in the next year.
    Response: We are finalizing this exception as proposed with one 
modification. We appreciate the commenters' concern about hospitals 
that might have sufficient Internet access in the 2 years prior to the 
adjustment period, but lose it in next year. We believe this is even 
less likely for hospitals than EPs, but as there is no downside to 
extending the time, we are finalizing a modification of our proposal to 
allow for the demonstration of insufficient Internet access for any 90-
day period between the start of the year 2 years prior to the payment 
adjustment year through the application submission date of April 1 of 
the year prior to the payment adjustment year.
    For the same reasons we proposed an exception for new EPs, we 
proposed an exception for a new hospital for a limited period of time 
after it has begun services. We proposed to allow new hospitals an 
exception for at least 1 full year cost reporting period after they 
accept their first patient. For example, a hospital that accepted its 
first patient in March of 2015, but with a cost reporting period from 
July 1 through June 30, would receive an exception from payment 
adjustment for FY 2015, as well as for FY 2016. However, the new 
hospital would be required to demonstrate meaningful use within the 9 
months of FY 2016 (register and attest by July 1, 2016) to avoid being 
subject to the payment adjustment in FY 2017.
    In proposing such an exception for new hospitals, however, we 
wanted to ensure that the exception would not be available to hospitals 
that have already been in operation in one form or another, perhaps 
under a different owner or merely in a different location, and thus 
have in fact had an opportunity to demonstrate meaningful use of EHR 
technology. Therefore, for purposes of qualifying for this exception, 
we proposed that the following hospitals would not be considered new 
hospitals under the exception:
     A hospital that builds new or replacement facilities at 
the same or another location even if coincidental with a change of 
ownership, a change in management, or a lease arrangement.
     A hospital that closes and subsequently reopens.
     A hospital that has been in operation for more than 2 
years but has participated in the Medicare program for less than 2 
years.
     A hospital that changes its status from a CAH to a 
hospital that is subject to the Medicare hospital in patient 
prospective payment systems.
    It is important to note that we proposed to consider a hospital 
that changes its status from a hospital (other than a CAH) that is 
excluded from the Medicare hospital inpatient prospective payment 
system (IPPS) to a hospital that is subject to the IPPS to be a new 
hospital for purposes of qualifying for the proposed exception. These 
IPPS-exempt hospitals, such as long-term care hospitals, inpatient 
psychiatric facilities, inpatient rehabilitation facilities, children's 
hospitals, and cancer hospitals, are excluded from the definition of 
``eligible hospital'' for purposes of the Medicare EHR Incentive 
Program and have not necessarily had an opportunity to demonstrate 
meaningful use. On the other hand, CAHs are eligible for incentive 
payments and subject to payment adjustments. Under the guidelines for 
assigning CCNs to Medicare providers, a CAH that changes status to an 
IPPS hospital will necessarily receive a new CCN. This is because 
several digits of the CCN encode the provider's status (for example, 
IPPS, CAH) under the Medicare program, However, we proposed to allow 
the CAH to register its meaningful use designation obtained under its 
previous CCN in order to avoid being subject to the hospital payment 
adjustment. It is worth noting that we adapted the proposed definition 
of ``new hospital'' for these purposes from similar rules that have 
been employed in the capital prospective payment system in Sec.  
412.300(b) of our regulations. We invited comment concerning the 
appropriateness of adapting these rules to the exception under the EHR 
program, and about whether modifications or other

[[Page 54107]]

revisions to these rules will be appropriate in the EHR context.
    Comment: Several commenters recommended that the new hospitals 
exception for at least 1 full year cost reporting period be triggered 
not when the hospital accepts its first patient, but rather when it 
accepts its first Medicare covered patient. These commenters point out 
that there can be significant lapse between the time when a hospital 
accepts its first patient and the time when it accepts its first 
Medicare covered patient. Because the EHR payment adjustment applies to 
the Medicare payments, the commenters argued it is more appropriate to 
base the beginning of the new hospital exception on the admission of 
its first Medicare covered patient.
    Response: We agree with the commenters and are revising the new 
hospital exception in this final rule to run for at least one full year 
cost reporting period after the hospital accepts its first Medicare-
covered patient. This change renders our third criterion (a hospital 
that has been in operation for more than 2 years but has participated 
in the Medicare program for less than 2 years) for not considering a 
hospital new moot as the exception is now based on the admission of the 
first Medicare-covered patient, which we believe is sufficiently 
analogous to starting participation in the Medicare program to allow us 
to remove this criterion.
    Comment: Some commenters argued that a hospital that undergoes a 
change of ownership and has a new CCN assigned due to the new owner's 
decision not to accept the assignment of the prior provider agreement 
should be allowed to register its meaningful use designation for the 
old CCN in the same manner a CAH that becomes an inpatient PPS hospital 
would.
    Response: When a hospital has a new CCN assigned due to the new 
owner's decision not to accept the assignment of the prior provider 
agreement it is not considered a change of ownership. Rather the 
hospital is terminated from the Medicare program and then reapplies for 
a new CCN. We disagree with the commenters that the history of the old 
CCN should carry forward in this case. In cases where a new owner 
decides not to accept the previous provider agreement and a new CCN is 
assigned by CMS, the new owner is in effect, making a conscious 
decision to create a rupture with significant, and relevant, aspects of 
the hospital's history. Specifically, when a new owner acquires a 
Medicare participating hospital, CMS automatically assigns the provider 
agreement to the new owner. The new owner must then decide whether to 
accept or reject assignment of the existing agreement. If the new owner 
accepts assignment, the provider agreement remains intact and the owner 
retains all the benefits and liabilities of that agreement (as provided 
under 42 CFR 489.18 of the regulations). If the new owner rejects 
assignment, the owner has voluntarily terminated the previous provider 
agreement, the CCN of the hospital is terminated, and the owner is not 
responsible for Medicare liabilities (known or unknown), as well as 
eligibility for Medicare payment. Under these circumstances, where the 
new owner has made a conscious decision to terminate the previous 
provider agreement, we believe it is appropriate not to recognize the 
meaningful use designation obtained under that provider agreement and 
CCN. We have consistently reminded new owners of hospitals that they 
cannot obtain the benefits of a decision not to accept assignment of 
the provider agreement without accepting the burdens of the decision as 
well. Unlike the case of a CAH that becomes an inpatient PPS hospital, 
the assignment of a new CCN follows from a voluntary decision of the 
new owner not to retain the previous provider agreement and CCN.
    We believe a similar result should apply in other cases where 
acquisitions and/or combinations of hospitals lead to the 
discontinuation of a CCN under which meaningful use had been 
demonstrated. For example, in some cases there is a combination of two 
or more certified hospitals under one agreement and one CCN. If the 
combined hospital has multiple locations, one location becomes the 
``main location,'' and all other locations become remote and/or 
provider based. The hospital is considered ``one hospital'' by Medicare 
and must be truly integrated at all levels, including its system for 
maintaining medical records. Where the new owner rejects the assignment 
of the provider agreement for one or more of the facilities that are 
being combined into the integrated hospital, known and unknown Medicare 
liabilities of those facilities do not transfer to the new owner. Under 
these circumstances, for the same reasons discussed in the previous 
case, it is appropriate not to recognize the meaningful use designation 
that was obtained under the provider agreement(s) and CCN(s) that have 
not been retained under the integrated hospital.
    Even where the new owners retain the acquired hospital's Medicare 
provider agreement, the acquired hospital's agreement is subsumed 
(although not terminated) into the single provider agreement of the 
combined hospital, and the acquired hospital's CCN is retired (again, 
not terminated). The new owners are responsible for all known and 
unknown Medicare liabilities of previous owners of the hospital, and 
there is no break in Medicare payments, as is the case where assignment 
of the prior provider agreement is rejected. However, as noted 
previously, in these cases, if the combined hospital has multiple 
locations, one location becomes the ``main location,'' and all other 
locations become remote and/or provider based. The hospital is 
considered ``one hospital'' by Medicare and must be truly integrated at 
all levels. In these cases it is most appropriate to recognize the 
prior meaningful use status of the surviving CCN of the main location 
for purposes of determining whether the payment penalty applies to the 
newly integrated hospital. In that way, the meaningful use 
determination will be based on the prior status of the major portion of 
the newly integrated hospital. Otherwise, the meaningful use 
designation of a relatively minor remote and/or provider-based hospital 
may become the basis for the designation of a much larger combined and 
integrated hospital. Therefore, we are finalizing our proposed policy, 
in cases of various ownership changes, acquisitions, and combinations 
of hospitals, to employ the meaningful use status of the surviving CCN 
to determine whether the payment adjustment applies.
    Finally, we proposed an additional exception in this final rule for 
extreme circumstances that make it impossible for a hospital to 
demonstrate meaningful use requirements through no fault of its own 
during the reporting period. Such circumstances might include: A 
hospital closed; a natural disaster in which an EHR system is 
destroyed; EHR vendor going out of business; and similar circumstances. 
Because exceptions on extreme, uncontrollable circumstances must be 
evaluated on a case-by-case basis, we believe that it is appropriate to 
require hospitals to qualify for the exception through an application 
process.
    Comment: Commenters stated universal support for this exception. 
However many commenters requested various circumstances be added to the 
list of example circumstances. This list is very similar, but not 
entirely identical to that for EPs. These examples dealt primarily with 
concerns related to vendors of CEHRT. Specifically, commenters were 
concerned about vendors of CEHRT not maintaining their

[[Page 54108]]

certification status, ability to meet implementation schedules, and 
ability to find a vendor of CEHRT willing to work with them. In 
addition, commenters suggested that the provider facing severe 
financial distress, such as bankruptcy or restructuring of debt should 
be included as an example.
    Response: We used the same evaluation criteria we used for EPs and 
came to the same conclusion to add two examples to the list that was 
proposed: (1) A hospital whose CEHRT (complete or modular) loses its 
certification either through revocation or because the vendor did not 
upgrade their CEHRT to the latest requirements; and (2) a hospital 
suffering severe financial distress resulting in a bankruptcy or 
restructuring of debt.
    We will require applications to be submitted no later than April 1 
of the year before the payment adjustment year in order to provide 
sufficient time for a determination to be made and for the hospital to 
be notified about whether an exception has been granted prior to the 
payment adjustment year. This timeline for submission and consideration 
of hardship applications also allows for sufficient time to adjust our 
payment systems so that payment adjustments are not applied to 
hospitals who have received an exception for a specific payment 
adjustment year. As discussed earlier, in relation to EPs, in order for 
a hospital to apply for this exception, extreme circumstances would 
need to exist for the period in which the hospital would otherwise 
demonstrate meaningful use (that is, the EHR reporting period). We have 
modified our regulation to be clear that the circumstances must exist 
during the EHR reporting period (that is, 2 years prior to the payment 
adjustment year or, for hospitals that have never attested to 
meaningful use before, in the year immediately prior to the payment 
adjustment year).
    Comment: Commenters suggested the following additional exceptions:
     Hospitals who make a good faith effort to purchase CEHRT, 
but could not find a vendor willing to work with them.
     Hospitals that determine they must switch EHR vendors to 
achieve meaningful use.
     Hospitals unable to meet meaningful use requirements 
because of failures on the part of EHR vendors.
    Response: For the first suggested exception, we do not believe that 
hospitals that attempt to purchase CEHRT but cannot find a vendor would 
warrant an exception. The mere failure of an attempt to purchase CEHRT 
does not demonstrate that the hospital faces hardship significant 
enough to prevent it from becoming a meaningful EHR user. We also 
believe it would be problematic to define the parameters for 
determining that no vendor was willing to work with a hospital. 
Moreover, we already have provided for an exception for hospitals that 
face extreme circumstances beyond their control. Under this exception, 
eligible hospitals could attempt to show that their situation is 
extreme and out of the ordinary and that failure to obtain CEHRT was 
truly beyond their control. We are skeptical that such showings could 
be made when all the hospital has done is to make an attempt to 
purchase CEHRT. However, this exception provides hospitals with the 
opportunity to demonstrate that their failure of attempts to obtain 
CEHRT was due to circumstances beyond their control.
    The next two exceptions may fall under the exception for extreme 
circumstances beyond the hospital's control, but the hospital would 
need to demonstrate that it meets this extreme exception. Any 
determination would be highly dependent on individual circumstances and 
evaluation of whether it is truly necessary to switch vendors, whether 
the switching vendors would prevent the hospital from reaching 
meaningful use, and whether the ``failures'' of the EHR vendor are both 
outside the norm of EHR implementation and beyond the control of the 
hospital.
    Table 16 summarizes the timeline for hospitals to avoid the 
applicable payment adjustment by demonstrating meaningful use or 
qualifying for an exception from the application of the adjustment.

                      Table 16--Timeline for Eligible Hospitals To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                          For an eligible
                                                             hospital
                                                           demonstrating
                                                        meaningful use for
                           Demonstrate MU                the first time in
   Hospital  payment         during EHR                  the year prior to
    adjustment year      reporting period 2      Or         the payment        Or     Apply for an  exception no
     (fiscal year)         years prior to                 adjustment year                     later than:
                           year of payment               use a continuous
                             adjustment                     90[dash]day
                                                         reporting period
                                                        beginning no later
                                                               than:
----------------------------------------------------------------------------------------------------------------
2015...................  FY 2013 (with       .........  April 2, 2014       ........  April 1, 2014.
                          submission no                  (with submission
                          later than                     no later than
                          November 30, 2013              July 1, 2014).
                          ).
2016...................  FY 2014 (with       .........  April 2, 2015       ........  April 1, 2015.
                          submission no                  (with submission
                          later than                     no later than
                          November 30,                   July 1, 2015).
                          2014).
2017...................  FY 2015 (with       .........  April 2, 2016       ........  April 1, 2016.
                          submission no                  (with submission
                          later than                     no later than
                          November 30,                   July 1, 2016).
                          2015).
2018...................  FY 2016 (with       .........  April 2, 2017       ........  April 1, 2017.
                          submission no                  (with submission
                          later than                     no later than
                          November 30,                   July 1, 2017).
                          2016).
2019...................  FY 2017 (with       .........  April 2, 2018       ........  April 1, 2018.
                          submission no                  (with submission
                          later than                     no later than
                          November 30,                   July 1, 2014).
                          2017).
----------------------------------------------------------------------------------------------------------------
Notes: (FY refers to the Federal fiscal year: October 1 to September 30. For example, FY 2015 is October 1, 2014
  through September 30, 2015.)
The timelines for FY 2020 and subsequent fiscal years follow the same pattern.

      Table 17--Period Hardship Must Be Shown With Application Date
------------------------------------------------------------------------
                                                             Submit
                                       Period of         application for
           Exception               consideration for    FY 2015 no later
                                       exception              than
------------------------------------------------------------------------
Insufficient Internet access..  Demonstrate             April 1, 2014.
                                 insufficient Internet
                                 access for any 90
                                 days from the start
                                 of the FY 2 years
                                 prior to the payment
                                 adjustment year to
                                 April 1 of the year
                                 prior to the payment
                                 adjustment year (For
                                 FY 2015-October 1,
                                 2012-April 1, 2014).

[[Page 54109]]

 
New hospital..................  New hospital granted    Guidance to be
                                 an exception for one    issued
                                 full cost reporting     following
                                 period after they       publication of
                                 admit their first       the final rule.
                                 Medicare patient.
Extreme Circumstances outside   For a hospital that     April 1, 2014.
 of the hospital's Control.      has previously
                                 demonstrated
                                 meaningful use, the
                                 hospital must
                                 demonstrate extreme
                                 circumstances that
                                 affect the FY 2 years
                                 prior to the payment
                                 adjustment year. (For
                                 FY 2015-FY 2013).
                                For a hospital that
                                 has never
                                 demonstrated
                                 meaningful use, the
                                 hospital must
                                 demonstrate extreme
                                 circumstances that
                                 affect the FY prior
                                 to the payment
                                 adjustment year. (For
                                 FY 2015-FY 2014).
------------------------------------------------------------------------

d. Application of Market Basket Adjustment in FY 2015 and Subsequent 
FYs to a State Operating Under a Payment Waiver Provided by Section 
1814(b)(3) of the Act
    As discussed previously, the statute requires payment adjustments 
for eligible hospitals in states where hospitals are paid under section 
1814(b)(3) of the Act. The statute also requires such adjustments to be 
designed to result in an aggregate reduction in payments equivalent to 
the aggregate reduction that would have occurred if payments had been 
reduced under section 1886(b)(3)(B)(ix)(I) of the Act. We proposed that 
an aggregate reduction in payments would mean the same dollar amount in 
reduced Medicare payments that that would have occurred if payments had 
been reduced to each eligible hospital in the state in a manner 
comparable to the reduction under Sec.  412.64(d)(3).
    To implement this provision, we proposed a new Sec.  412.64(d)(5) 
that includes this statutory requirement and that required states 
operating under a payment waiver under section 1814(b)(3) of the Act to 
provide to the Secretary, no later than January 1, 2013, a report on 
the method that it proposes to employ in order to make the requisite 
payment adjustment.
    We did not receive any comments on this proposal; and therefore, we 
are finalizing these provisions as proposed.
4. Reduction of Reasonable Cost Reimbursement in FY 2015 and Subsequent 
Years for CAHs That Are Not Meaningful EHR Users
    Section 4102(b)(2) of the HITECH Act amends section 1814(l) of the 
Act to include an adjustment to a CAH's Medicare reimbursement for 
inpatient services if the CAH has not met the meaningful EHR user 
definition for an EHR reporting period. The adjustment will be made for 
a cost reporting period that begins in FY 2015, FY 2016, FY 2017, and 
each subsequent FY thereafter. Specifically, sections 1814(l)(4)(A) and 
(B) of the Act now provide that, if a CAH has not demonstrated 
meaningful use of CEHRT for an applicable reporting period, then for a 
cost reporting period that begins in FY 2015, its reimbursement will be 
reduced from 101 percent of its reasonable costs to 100.66 percent. For 
a cost reporting period beginning in FY 2016, its reimbursement will be 
reduced to 100.33 percent of its reasonable costs. For a cost reporting 
period beginning in FY 2017 and each subsequent FY, its reimbursement 
will be reduced to 100 percent of reasonable costs.
    However, as provided for eligible hospitals, a CAH may, on a case-
by-case basis, be granted an exception from this adjustment if CMS or 
its Medicare contractor determines, on an annual basis, that a 
significant hardship exists, such as in the case of a CAH in a rural 
area without sufficient Internet access. However, in no case may a CAH 
be granted an exception under this provision for more than 5 years.
a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015 
and Subsequent Years for CAHs That Are Not Meaningful EHR Users
    In the Stage 1 final rule (75 FR 44564), we finalized the 
regulations regarding the CAH adjustment at Sec.  495.106(e) and Sec.  
413.70(a)(6).
b. EHR Reporting Period for Determining Whether a CAH Is Subject to the 
Applicable Reduction of Reasonable Cost Payment in FY 2015 and 
Subsequent Years
    For CAHs we proposed an EHR reporting period that is aligned with 
the payment adjustment year. For example, if a CAH is not a meaningful 
EHR user in FY 2015, then its Medicare reimbursement will be reduced to 
100.66 percent for its cost reporting period that begins in FY 2015. 
This differs from what was proposed for eligible hospitals: an EHR 
reporting period prior to the payment adjustment year. We stated in the 
proposed rule that we believed the Medicare cost report process would 
allow us to make the CAH reduction for the cost reporting period that 
begins in the payment adjustment year, with minimal disruptions to the 
CAH's cash flow and minimal administrative burden on the Medicare 
contractors as discussed later.
    CAHs are required to file an annual Medicare cost report that is 
typically for a consecutive 12-month period. The cost report reflects 
the inpatient statistical and financial data that forms the basis of 
the CAH's Medicare reimbursement. Interim Medicare payments may be made 
to the CAH during the cost reporting period based on the previous 
year's data. Cost reports are filed with the CAH's Medicare contractor 
after the close of the cost reporting period and the data on the cost 
report are subject to reconciliation and a settlement process prior to 
a final Medicare payment being made.
    We proposed to amend the definition of the EHR reporting period 
that will apply for purposes of payment adjustments under Sec.  495.4. 
For CAHs this will be the full Federal fiscal year that is the same as 
the payment adjustment year (unless a CAH is in its first year of 
demonstrating meaningful use, in which case a continuous 90-day 
reporting period within the payment adjustment year will apply). The 
adjustment would then apply based upon the cost reporting period that 
begins in the payment adjustment year (that is, FY 2015 and 
thereafter). Thus, if a CAH is not a meaningful user for FY 2015, and 
thereafter, then the adjustment would be applied to the CAH's 
reasonable costs incurred in a cost reporting period that begins in 
that affected FY as described in Sec.  413.70(a)(6)(i).
    We proposed to require CAHs to submit their attestations on 
meaningful use by November 30th of the following FY. For example, if a 
CAH is attesting that it was a meaningful EHR user for FY 2015, the 
attestation must be submitted no later than November 30, 2015. Such an 
attestation (or lack

[[Page 54110]]

thereof) will then affect interim payments to the CAH made after 
December 1st of the applicable FY. If the cost reporting period ends 
prior to December 1st of the applicable FY then any applicable payment 
adjustment will be made through the cost report settlement process.
    All comments received on this provision were in support. We thank 
commenters for their support and finalize as proposed for the reasons 
outlined in the proposed rule.
c. Exception to the Application of Reasonable Cost Payment Reductions 
to CAHs in FY 2015 and Subsequent FYs
    As discussed previously, CAHs may receive exceptions from the 
payment adjustments for significant hardship. While our current 
regulations, in Sec.  413.70(a)(6)(ii) and (iii) contain this hardship 
provision we proposed revising these regulations to align them with the 
exceptions being proposed for EPs and subsection (d) hospitals. As with 
EPs and subsection (d) hospitals we proposed that CAHs could apply for 
an exception on the basis of lack of sufficient Internet connectivity. 
Applications will be required to demonstrate insufficient Internet 
connectivity to comply with the meaningful use objectives requiring 
internet connectivity (that is, summary of care documents, electronic 
prescribing, making health information available online, and submission 
of public health information) and insurmountable barriers to obtaining 
such internet connectivity. As CAHs will have an EHR reporting period 
aligned with the payment adjustment year, we proposed that the 
insufficient Internet connectivity will need to be demonstrated for 
each applicable payment adjustment year. For example, as proposed, to 
avoid a payment adjustment for cost reporting periods that begin during 
FY 2015, the hardship would need to be demonstrated for FY 2015. For 
each year subsequent to FY 2015, the basis for an exception would 
continue to be for the hardship in the FY in which the affected cost 
reporting period begins. As stated in Sec.  413.70(a)(6)(iii), any 
exception granted may not exceed 5 years. After 5 years, the exception 
will expire and the appropriate adjustment will apply if the CAH has 
not become a meaningful EHR user for the appropriate EHR reporting 
period.
    Comment: Commenters have suggested that it is inappropriate to base 
the Internet connectivity exception on the same year that a CAH is 
expected to demonstrate meaningful use. They assert that it is 
impractical for a CAH to achieve sufficient internet connectivity and 
meet meaningful use all in 1 year. A few commenters recommended a 2-
year prospective exception for Internet connectivity as used for the 
EPs and inpatient PPS hospitals.
    Response: We agree with commenters that established sufficient 
Internet connectivity and meaningful use in the same year is not 
feasible. However, since the payment adjustment year is aligned with 
the CAH's EHR period, we believe that using a 2-year lookback period 
similar to EPs and eligible hospitals is inappropriate for CAHs. 
Therefore, we will base the insufficient internet access exception on 
the cost reporting period that begins prior to or during the payment 
adjustment year. For FY 2015, the CAH must submit the application by 
November 30, 2015, but eligibility for this exception would be based on 
the information for any 90-day period within the cost reporting period 
that begins prior to or during the payment adjustment year.
    After consideration of the comments, we are revising this exception 
to base it on any 90-day period within the cost reporting period that 
begins prior to or during the payment adjustment year.
    As with new EPs and new eligible hospitals, we proposed an 
exception for a new CAH for a limited period of time after it has begun 
services. We proposed to allow an exception for 1 year after they 
accept their first patient. For example, a CAH that is established in 
FY 2015 would be exempt from the penalty through its cost reporting 
period ending at least 1 year after the CAH accepts its first patient. 
If the CAH is established March 15, 2015 and its first cost reporting 
period is less than 12 months (for example, from March 15 through June 
30, 2015), the exception would exist for both the short cost reporting 
period and the following 12-month cost reporting period lasting from 
July 1, 2015 through June 30, 2016. However, the new CAH would be 
required to submit its attestation that it was a meaningful EHR user 
for FY 2016 no later than November 30, 2016, in order to avoid being 
subject to the payment adjustment for the cost reporting period that 
begins in FY 2016 (in the previous example from July 1, 2016 through 
June 30, 2017).
    We stated in the proposed rule that in proposing such an exception 
for newly established CAHs, it is important to ensure that the 
exception is not available to CAHs that have already been in operation 
in one form or another, perhaps under a different ownership or merely 
in a different location, and thus have in fact had an opportunity to 
demonstrate meaningful use of EHR technology. Therefore, we proposed 
that for the purposes of qualifying for this exception, a new CAH means 
a CAH that has operated (under previous or present ownership) for less 
than 1 year.
    We stated in the proposed rule that in some cases an eligible 
hospital may convert to a CAH. An eligible hospital is a subsection (d) 
hospital that is a meaningful user and is paid under the inpatient 
hospital prospective payment systems as described in subpart A of Part 
412 of the regulations. In these cases, eligible hospitals were able to 
qualify for purposes of the EHR hospital incentive payments by 
establishing meaningful use, and (as discussed previously) are also 
subject to a payment adjustment provision in FY 2015 and subsequent 
years if they fail to demonstrate meaningful use of EHR technology 
during an applicable reporting period. Therefore, we proposed not to 
treat a CAH that has converted from an eligible hospital as a newly 
established CAH for the purposes of this exception.
    On the other hand, we stated in the proposed rule that other types 
of hospitals such as long-term care hospitals, psychiatric hospitals, 
and inpatient rehabilitation facilities are not subsection (d) 
hospitals. These other types of hospitals do not meet the definition of 
an ``eligible hospital'' for purposes of the Medicare EHR hospital 
incentive payments and the application of the proposed hospital market 
basket adjustment in FY 2015 and subsequent years under section 
1886(n)(6)(B) of the Act. In some instances, a CAH may be converted 
from one of these types of hospitals. In that case, the CAH would not 
have had an opportunity to demonstrate meaningful use, and it is 
therefore appropriate to treat them as newly established CAHs if they 
convert from one of these other types of hospitals to a CAH for 
purposes of determining whether they should qualify for an exception 
from the application of the adjustment in FY 2015 and subsequent years. 
Thus, we proposed to consider a CAH that converts from one of these 
other types of hospitals to be a newly established CAH for the purposes 
of qualifying for this proposed exception from the application of the 
adjustment in FY 2015 and subsequent years.
    In summary, we proposed for purposes of qualifying for the 
exception to revise Sec.  413.70(a)(6)(ii) to state that a newly 
established CAH means a CAH that has operated (under previous or 
present ownership) for less than 1 year. We also proposed to revise 
Sec.  413.70(a)(6)(ii) to state that the

[[Page 54111]]

following CAHs are not newly established CAHs for purposes of this 
exception:
     A CAH that builds new or replacement facilities at the 
same or another location even if coincidental with a change of 
ownership, a change in management, or a lease arrangement.
     A CAH that closes and subsequently reopens.
     A CAH that has been in operation for more than 1 year but 
has participated in the Medicare program for less than 1 year.
     A CAH that has been converted from an eligible subsection 
(d) hospital.
    Comment: Identical to the concerns raised for subsection (d) 
hospitals, several comments stated that the new CAH exception for at 
least 1 full year cost reporting period be triggered not by when the 
hospital accepts its first patient, but rather when it accepts its 
first Medicare-covered patient.
    Response: We agree with the commenters and revise the exception for 
new CAHs to be for at least 1 full year cost reporting period after 
they accept their first Medicare-covered patient. This change renders 
our third criteria (a CAH that has been in operation for more than 2 
years but has participated in the Medicare program for less than 2 
years) for not considering a CAH new moot as the exception is now based 
on the admission of the first Medicare-covered patient, which we 
believe is sufficiently analogous to starting participation in the 
Medicare program to allow us to remove this criteria.
    After consideration of comments, we are revising this exception to 
base it on the point when the CAH accepts their first Medicare patient.
    Finally, we proposed an additional exception in this final rule for 
extreme circumstances that make it impossible for a CAH to demonstrate 
meaningful use requirements through no fault of its own during the 
reporting period. Such circumstances might include: A CAH is closed; a 
natural disaster in which an EHR system is destroyed; EHR vendor going 
out of business; and similar circumstances. Because exceptions on 
extreme, uncontrollable circumstances must be evaluated on a case-by-
case basis, we believe that it is appropriate to require CAHs to 
qualify for the exception through an application process.
    Comment: Commenters supported this exception in principle. However, 
many commenters requested various circumstances be added to the list of 
example circumstances. This list is nearly entirely identical to that 
for EPs and subsection (d) hospitals as described earlier.
    Response: We used the same evaluation criteria we used for EPs and 
came to the same conclusion to add two examples. First, a CAH whose 
CEHRT (complete or modular) loses its certification either through 
revocation or because the vendor did not upgrade their CEHRT to the 
latest requirements; and second, a CAH suffering severe financial 
distress resulting in a bankruptcy or restructuring of debt
    As described previously, we are finalizing the policy to align a 
CAH's payment adjustment year with the applicable EHR reporting period. 
A CAH must submit their meaningful use attestation for a specific EHR 
reporting period no later than 60 days after the close of the EHR 
reporting period (no later than November 30th of the year) otherwise 
the payment penalty could be applied to the CAH's cost reporting period 
that begins in that payment adjustment year. We proposed to require a 
CAH to submit an application for an exception, as described previously, 
to its Medicare contractor by the same November 30th date that the 
meaningful use attestation is due. Therefore, we proposed that a CAH 
will be subject to the payment adjustment if it has not submitted its 
meaningful use attestation (or its attestation has been denied) and has 
not submitted an application for an exception by November 30th of the 
subsequent EHR reporting period. If a CAH's request for an exception is 
not granted by the Medicare contractor then we proposed that the 
payment adjustment will be applied. We stated in the proposed rule that 
if a CAH anticipates submitting an exception application we recommend 
that the CAH communicate with its Medicare contractor to determine the 
necessary supporting documentation to submit by the November 30th due 
date.
    After consideration of public comments, we are finalizing these 
application deadlines exception as proposed.
    Table 18, summarizes the timeline for CAHs to avoid the applicable 
payment adjustment by demonstrating meaningful use or qualifying for an 
exception from the application of the adjustment.
    Comment: Commenters provided the same suggestions for additional 
exceptions for CAHs that they did for eligible hospitals.
    Response: As we stated in our response to similar comments 
submitted for eligible hospitals these additional exceptions could have 
been suggested as examples for the exception for extreme circumstances. 
We encourage hospitals in these situations to utilize the extreme 
circumstances exception. We believe these exceptions are too subjective 
to be finalized as new exceptions as suggested by commenters.

                             Table 18--Timeline for CAHs To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                           For a CAH
                                                        demonstrating MU
CAH with cost reporting                                  for the first
period beginning during  Demonstrate MU for                 time, a                   Apply for an exception no
  payment  adjustment      EHR  reporting       Or     continuous 90-day     Or              later than
          year                 period                  reporting  period
                                                        ending no later
                                                              than
----------------------------------------------------------------------------------------------------------------
FY 2015................  FY 2015 (with       ........  September 30,      ........  November 30, 2015.
                          submission no                 2015 (with
                          later than                    submission no
                          November 30,                  later than
                          2015).                        November 30,
                                                        2015).
FY 2016................  FY 2016 (with       ........  September 30,      ........  November 30, 2016.
                          submission no                 2016 (with
                          later than                    submission no
                          November 30,                  later than
                          2016).                        November 30,
                                                        2016).
FY 2017................  FY 2017 (with       ........  September 30,      ........  November 30, 2017.
                          submission no                 2017 (with
                          later than                    submission no
                          November 30,                  later than
                          2017).                        November 30,
                                                        2017).
FY 2018................  FY 2018 (with       ........  September 30,      ........  November 30, 2018.
                          submission no                 2018 (with
                          later than                    submission no
                          November 30,                  later than
                          2018).                        November 30,
                                                        2018).
FY 2019................  FY 2019 (with       ........  September 30,      ........  November 30, 2019.
                          submission no                 2019 (with
                          later than                    submission no
                          November 30,                  later than
                          2019).                        November 30,
                                                        2019).
----------------------------------------------------------------------------------------------------------------
Notes: (FY refers to the Federal fiscal year October 1 to September 30. For example, FY 2015 is October 1, 2014
  to September 30, 2015.)
The timelines for FY 2020 and subsequent fiscal years follow the same pattern.

[[Page 54112]]

 Table 19--Period Hardship Must Be Shown With Application Date for CAHs
------------------------------------------------------------------------
                                                             Submit
                                       Period of         application for
           Exception               consideration for    FY 2015 no later
                                       exception              than
------------------------------------------------------------------------
Insufficient Internet access--  Demonstrate             Nov 30, 2015.
 CAHs.                           insufficient internet
                                 access for any 90 day
                                 period within the
                                 cost reporting period
                                 that begins prior to
                                 or during the payment
                                 adjustment year.
New CAHl......................  New CAH granted an      Guidance to be
                                 exception for one       issued
                                 full cost reporting     following
                                 period after they       publication of
                                 admit their first       the final rule.
                                 Medicare patient.
Extreme Circumstances outside   Oct 1 through Sept 30   Nov 30, 2015.
 of the CAH's Control.           of the payment
                                 adjustment year.
------------------------------------------------------------------------

5. Administrative Review Process of Certain Electronic Health Record 
Incentive Program Determinations
    In the Stage 2 proposed rule we proposed an administrative appeals 
process would apply to both Stage 1 and Stage 2 of meaningful use. We 
also posted guidance on the CMS Web site, http://www.cms.gov/qualitymeasures/05_ehrincentiveprogramappeals.asp, in the interim 
between the publication of this proposed rule and the publication of 
the final rule. We sought public comments both on the guidance and the 
proposed rule.
    We proposed to limit permissible appeals to the following three 
types of appeals:

 Eligibility Appeals
 Meaningful Use Appeals
 Incentive Payment Appeals

We also proposed certain filing and other deadlines for such 
administrative appeals. We refer readers to our proposed rule at (77 FR 
13779 through 13780) for a full explanation of these proposals.
    We received several comments on our appeals proposals, which are 
discussed in this section of the preamble. However, after review of the 
public comments and the appeals filed as of the writing of this final 
rule, we believe the administrative review process is primarily 
procedural and does not need to be specified in regulation. The appeals 
process we proposed essentially constituted an agency reconsideration 
of certain types of determinations regarding eligibility for the 
program, meaningful use, or incentive payment amounts. We believe such 
an informal reconsideration process may be included in procedural 
guidance, rather than in our regulations. Therefore, our administrative 
appeals process will be included on our Web site at www.cms.gov/EHRIncentivePrograms.
    We recognize that there is a procedural appeals process currently 
in effect, and in all cases, we will require that requests for appeals, 
all filings, and all supporting documentation and data be submitted 
through a mechanism and in a manner specified by us. We expect all 
providers to exhaust this administrative review process prior to 
seeking review in Federal Court.
    As we stated in the proposed rule, we also note that the HITECH Act 
prohibits both administrative and judicial review of the standards and 
method used to determine eligibility and payment (including those 
governing meaningful use) (see 42 CFR 413.70(a)(7), 495.106(f), 
495.110, 495.212). Our limited appeal process would not provide 
administrative review of these areas; but rather would involve cases of 
individual applicability; that is, where a provider is challenging not 
the standards and methods themselves, but whether the provider met the 
regulatory standards and methods promulgated by CMS in its rules.
    While we are not finalizing regulations on appeals, we respond to 
comments we received on our proposals.
    Comment: Several commenters requested CMS make more explicit 
information available to providers on the documentation that should be 
available in the event of an audit.
    Response: In the event of an audit, at a minimum, providers should 
have available electronic or paper documentation that supports 
providers' completion of the Attestation Module responses, including 
the specific information that supports each measure. In addition, 
providers should have documentation to support the submission of CQMs, 
including the specific information that supports each measure. 
Providers should also maintain documentation to support their incentive 
payment calculations, for example data to support amounts included on 
their cost report, which are used in the calculation. As indicated in 
the Stage 1 final rule, providers should keep documentation for at 
least 6 years following the date of attestation.
    Comment: A commenter noted that states may need to change their 
audit procedures or State Medicaid Health Information Technology (HIT) 
Plans (SMHPs) regarding audit and appeals by CMS for demonstrating 
meaningful use.
    Response: We proposed that states would have an option to have CMS 
audit and conduct appeals of eligible hospitals' meaningful use. We 
finalize that proposal in our Medicaid regulations at Sec.  495.332. We 
agree that SMHPs regarding audit and appeals may need revising. We are 
working closely with states to align principles regarding both audit 
and appeals process for both the Medicare and Medicaid EHR Incentive 
Programs. We intend to give states both technical support and program 
information to ensure consistency in the application of those audit and 
appeals principles.
    Comment: A number of commenters asked for the addition of appeal 
categories beyond those we proposed. Several commenters requested CMS 
implement an appeals process for penalties and hardship exemptions. One 
commenter requested more comprehensive language to better define the 
requirements and circumstances under which appeals may be heard and 
acted upon. Another commenter requested CMS institute an appeals 
process relating to MACs' decisions regarding reasonable costs and 
determining incentive payments for CAHs.
    Response: We appreciate the number of commenters that requested 
additional appeal categories. Since the writing and publication of the 
Stage 1 final rule, we have had the opportunity to review a number of 
appeals, and we note that many of these appeals do not necessarily fit 
easily into the categories we proposed. Based on the comments we 
received and the information we have regarding appeals that have 
already been filed, we are concerned that finalizing the categories we 
proposed for appeals could negatively impact providers and potentially 
add unnecessary burden and complexity. We are also concerned that 
specifying these categories could limit the flexibility we might 
otherwise have in addressing new or unanticipated appeal categories in 
the future, or in adding greater detail regarding the scope and 
requirements of particular types of

[[Page 54113]]

appeals. For example, a number of the appeals we have received are 
related neither to eligibility, meaningful use, or incentive payments 
directly, but instead address registration or attestation system 
changes that we are currently in the process of implementing for 
providers' benefit. Because of these concerns, we decline to finalize 
the categories of appeals as proposed and intend to issue guidance 
regarding types or categories of appeals and accompanying requirements 
on our Web site at www.cms.gov/EHRIncentivePrograms.
    As stated earlier, the HITECH Act prohibits both administrative and 
judicial review of the standards and methods used to determine 
eligibility and payment (including those governing meaningful use) (see 
42 CFR 413.70(a)(7), 495.106(f), 495.110, 495.212). Any procedures 
would not allow administrative appeals of these issues. As for 
reasonable costs reported by CAHs, we already stated in the Stage 1 
final rule that a CAH ``may appeal the statistical and financial 
amounts from the Medicare cost report used to determine the CAH 
incentive payment,'' but that the CAH ``would utilize the current 
provider appeal process pursuant to section 1878 of the Act.'' (75 FR 
44464)
    Finally, we note that there will not be appeal reconsiderations of 
hardship exception or payment adjustment determinations. As specified 
in section II.D.2.c. of this final rule, the granting of a hardship 
exception will be through an application process, and we expect 
providers to make a full declaration of all relevant information at the 
time of filing of that application. We are concerned that there would 
not be adequate time to process hardship exception applications, render 
determinations, and also process appeals of those redeterminations. 
Therefore, we decline to allow appeal reconsiderations of hardship 
exception determinations. We note that the HITECH Act prohibits both 
administrative and judicial review of the standards and methods used to 
determine payment adjustments, including hardship exceptions to those 
payment adjustments.
    Comment: A number of commenters noted concerns regarding the 
timelines proposed for filing appeals and forwarding documentation.
    Response: We appreciate the many comments regarding the proposed 
timelines for appeals. However, we are not finalizing our appeal 
regulations in this final rule. We intend to issue guidance regarding 
timelines for types or categories of appeals on our Web site at 
www.cms.gov/EHRIncentivePrograms.

E. Medicare Advantage Organization Incentive Payments

1. Definitions (Sec.  495.200)
    We proposed to add definitions of the terms ``Adverse eligibility 
determination,'' ``Adverse payment determination'' and ``MA payment 
adjustment year.'' We also proposed to add a definition for the term 
``Potentially qualifying MA-EPs and potentially qualifying MA-
affiliated eligible hospitals,'' to cross reference the existing 
definition at Sec.  495.202(a)(4).
    We proposed to clarify the application of ``hospital-based EP'' as 
that term is used in paragraph 5 of the definition of ``qualifying MA-
EP'' in Sec.  495.200, to make clear that the calculation is not based 
on FFS-covered professional services, but rather on MA plan enrollees. 
Otherwise, qualifying MA-EPs who provide at least 80 percent of their 
covered professional services to MA plan enrollees of a qualifying MA 
organization might be considered ``hospital based'' solely on the basis 
of 90 percent of their FFS-covered professional services being provided 
in a hospital setting. We provided an example of a qualifying MA-EP 
that might bill FFS 10 times over a year for emergency room services 
provided to various Medicare patients. Although the vast majority of 
the MA-EP's covered services were reimbursed under his or her 
arrangement with a qualifying MA organization, 100 percent (or 10) of 
the MA-EP's FFS-covered services would have been for hospital-based 
services, which would prohibit the MA organization from receiving 
reimbursement under the MA EHR incentive program for the MA-EP. We do 
not believe that we should exclude MA-EPs from the MA EHR Incentive 
Program due to only a few FFS claims. Therefore, we are clarifying the 
definition of ``qualifying MA-EP'' to state that for purposes of the MA 
EHR Incentive Program, a hospital-based MA-EP provides 90 percent or 
more of his or her covered professional services in a hospital setting 
to MA plan enrollees of the qualifying MA organization.
    We did not receive any comments on these provisions and we are 
finalizing them as proposed with the exception of the definitions of 
the terms ``Adverse eligibility determination,'' and ``Adverse payment 
determination.'' As we explain later in this preamble discussion, we do 
not believe formal regulations for an informal reconsideration 
procedural rule are necessary and therefore, we are not finalizing 
these two definitions in our regulations.
2. Identification of Qualifying MA Organizations, MA-EPs, and MA-
Affiliated Eligible Hospitals (Sec.  495.202)
    We proposed a technical change to Sec.  495.202(b)(1) to require 
that the qualifying MA organization identify those MA-EPs and MA-
affiliated eligible hospitals that the qualifying MA organization 
believes would be meaningful users of CEHRT during the reporting 
period, when a qualifying MA organization intends to claim an incentive 
payment for a given qualifying MA-EP or MA-affiliated eligible 
hospital.
    We also proposed an amendment to Sec.  495.202(b)(2) to reflect 
current policy that qualifying MA organizations must report the CMS 
Certification Number (CCN) for qualifying MA-affiliated eligible 
hospitals. We explained that as the program matures, it is necessary to 
report this detail to effectively administer the program. We are 
adopting this change in this final rule (Sec.  495.202(b)(2)).
    We proposed a new Sec.  495.202(b)(3) to establish a reporting 
requirement to identify qualifying MA-EPs who have furnished more than 
50 percent of their covered Medicare professional services to MA 
enrollees of the qualifying MA organization in a designated geographic 
Health Professional Shortage Area (HPSA) during the reporting period. 
We also proposed to redesignate the current Sec.  495.202(b)(3) as 
(b)(4), and revised the introductory language in (b)(2) to reflect this 
redesignation.
    We also proposed to require MA organizations to identify qualifying 
MA-EPs or MA-affiliated eligible hospitals within 2 months of the close 
of the payment year (rather than within 60 days) (previously Sec.  
495.202(b)(3), now newly redesignated Sec.  495.202(b)(4)). We 
explained that this change would be consistent with the Medicare FFS 
EHR Incentive Program, but in nonleap years this would reduce the time 
for reporting revenue amounts to CMS for qualifying MA-EPs from 60 days 
to 59 days. We proposed conforming amendments to Sec.  495.204(b)(2) 
and Sec.  495.210(b) and (c).
    We also explained that because the redesignated Sec.  495.202(b)(4) 
relates to both the payment phase and the payment adjustment phase of 
the program, we are adding the word ``qualifying'' to the text of the 
regulation. Therefore, we explained, this regulation applies to both 
qualifying MA-EPs and MA-affiliated eligible hospitals (both payment 
and payment adjustment phases of the program) and

[[Page 54114]]

potentially qualifying MA-EPs and MA-affiliated eligible hospitals 
(only the payment adjustment phase of the program).
    We proposed to redesignate the current Sec.  495.202(b)(4) as Sec.  
495.202(b)(5), and to require a qualifying MA organization to identify 
the MA-EPs and MA-affiliated eligible hospitals that it believes would 
be both ``qualifying'' and ``potentially qualifying.'' To calculate the 
payment adjustment, we explained that we will need to know how many 
qualifying MA-EPs and MA-affiliated eligible hospitals are, and are 
not, meaningful users. We also proposed to correct a cross-reference.
    We did not receive any comments on these provisions and we are 
finalizing them as proposed.
3. Incentive Payments to Qualifying MA Organizations for Qualifying MA-
EPs and Qualifying MA-Affiliated Eligible Hospitals (Sec.  495.204)
a. Amount Payable to a Qualifying MA Organization for Its Qualifying 
MA-EPs
    In Sec.  495.204(b), we proposed to clarify that methods relating 
to overhead costs may be submitted for MA-EPs regardless of whether the 
MA-EPs are salaried or paid in another fashion, such as on a capitated 
basis.
    As stated previously, we also proposed to require MA organizations, 
to submit revenue amounts relating to their qualifying MA-EPs within 2 
months of the close of the payment year, (rather than within 60 days).
b. Increase in Incentive Payment for MA-EPs Who Predominantly Furnish 
Services in a Geographic Health Professional Shortage Area (HPSA)
    In a new Sec.  495.204(e) (we proposed to redesignate the current 
paragraph (e) as paragraph (f)), we proposed to add a provision 
clarifying the currently existing policy governing whether a qualifying 
MA organization is entitled to a HPSA increase for a given qualifying 
MA-EP. We explained that section 1848(o)(1)(B)(iv) of the Act, which is 
currently in effect, and as applied to the MA program, provides a 10-
percent increase in the maximum incentive payment available for MA-EPs 
that predominantly furnish covered professional services during the MA 
EHR payment year in a geographic HPSA. We explained that consistent 
with the Medicare FFS EHR Incentive Program, we interpreted the term 
``predominantly'' to mean more than 50 percent. For the MA EHR 
Incentive Program, we proposed to determine eligibility for the 
geographic HPSA increase on whether the qualifying MA-EP predominantly 
provided services to MA plan enrollees of the qualifying MA 
organization in a HPSA during the applicable MA EHR payment year.
    Further, we explained that it is worth noting that an MA 
organization does not automatically receive a HPSA bonus merely because 
its qualifying MA-EPs predominantly served a geographic HPSA. We stated 
that in order for the MA organization to receive the 10 percent 
increase, the MA-EP needs to provide at least 10 percent or more of 
Medicare Part B covered professional services to MA plan enrollees of 
the qualifying MA organization. In other words, to qualify for the HPSA 
bonus an MA-EP needs to provide more than $24,000 of Medicare Part B 
covered professional services to MA plan enrollees of the qualifying MA 
organization. The MA-EP needs to provide up to $26,400 in covered 
services to earn the maximum HPSA-enhanced bonus of $19,800 if the 
first payment year is 2011 or 2012. Thus, for MA-EPs who predominantly 
furnish services in a geographic HPSA, the ``incentive payment limit'' 
in Sec.  495.102(b) would be $19,800, instead of $18,000, if the first 
MA EHR payment year for the MA organization with respect to the MA-EP 
is 2011 or 2012. If an MA organization could show that an MA-EP 
predominantly served beneficiaries in a HPSA during the payment year 
and that that MA-EP provided, for example, for the 2011 payment year, 
at least $26,400 in Part B professional services to MA plan enrollees 
of the MA organization during the payment year, we stated that the MA 
organization could receive the entire $19,800 incentive payment for 
that MA-EP. If the MA-EP provided less than $26,400 in Part B 
professional services, the potential incentive payment for that MA-EP 
for that MA organization would be less than $19,800 for the payment 
year. We proposed a conforming amendment in Sec.  495.202(b)(2)(ii) to 
require MA organizations to notify CMS whether the qualifying MA-EP 
predominantly provided covered services to MA plan enrollees in a HPSA.
    We added a new paragraph (5) to redesignated paragraph (f). This 
new paragraph (5) clarifies that we would recoup the EHR incentive 
payment if one of the following entities fails to comply with an audit 
request to produce documents or data needed to audit the validity of an 
EHR incentive payment:--(1) A qualifying MA-EP, (2) an entity that 
employs a qualifying MA-EP (or in which a qualifying MA-EP had a 
partnership interest), (3) an MA-affiliated eligible hospital, or (4) 
any other party contracting with the qualifying MA organization. We 
explained that we already have the authority to do this under the 
current Sec.  495.204(e)(4), (to be redesignated as (f)(4)); however, 
we proposed to amend the regulations to specifically address what would 
happen in the case of a failure to produce documents or data related to 
an audit request.
    We added a new paragraph (g) to Sec.  495.204 to clarify the 
current policy that in the unlikely event we paid a qualifying MA 
organization for a qualifying MA-EP, and it was later determined that 
the MA-EP--(1) was entitled to a full incentive payment under the 
Medicare FFS EHR Incentive Program; or (2) had received payment under 
the Medicaid EHR Incentive Program, we would recover the funds paid to 
the qualifying MA organization for such an MA-EP from the MA 
organization. (We stated that the former case would be in the unlikely 
event an MA-EP appeared to have earned an EHR incentive of less than 
the full amount under FFS, and then later was determined to have earned 
the full amount under FFS. In accordance with duplicate payment 
avoidance provisions in section 1853(l)(3)(B) of the Act and 
implementing regulations at Sec.  495.208, we would recover the MA EHR 
incentive payment since a full FFS EHR payment was due.) If the 
organization still had an MA contract, we would recoup the amount from 
the MA organization's monthly payment under section 1853(a)(1)(A) of 
the Act. If the organization no longer had an MA contract, we would 
recoup any amounts through other means, such as formal collection. We 
stated that since duplicate and overpayments are prohibited by statute 
(sections 1853(l)(3)(B), 1853(m)(3)(B), and 1903(t)(2) of the Act), we 
believe that this policy must apply to all years of the program, 
beginning with payment year 2011. Thus, we would recover overpaid MA 
EHR incentive payments for all MA EHR payment years, including payment 
year 2011.
    We also clarified that, in accordance with statutory requirements, 
if it is determined that an MA organization received an incentive 
payment for an MA-affiliated eligible hospital that also received a 
payment under the Medicare FFS EHR Incentive program or that otherwise 
should not have received such payment, we would similarly recover the 
funds paid to the qualifying MA organization for such MA-affiliated 
eligible hospital from either the MA organization's monthly payment 
under section 1853(a)(1)(A) of the Act, from

[[Page 54115]]

the MA-affiliated eligible hospital's CMS payment through the typical 
process for recouping Medicare funds from a ``subsection (d)'' 
hospital, or through other means such as a collection process, as 
necessary. As with EPs, as the statute prohibits us from making 
duplicate and overpayments, we explained that this policy does not 
constitute a new rule and must apply to all years of the program, 
beginning with payment year 2011.
    We did not receive any comments on these provisions and are 
finalizing them as proposed.
4. Avoiding Duplicate Payments
    We stated that qualifying MA-EPs are eligible for the Medicare FFS 
EHR incentive payment if they meet certain requirements under that 
program. However, we also stated that an EHR incentive payment is only 
allowed from one program. We believe that the requirement that MA 
organizations notify MA-EPs that the MA organization intended to claim 
them for the MA EHR Incentive Program would minimize misunderstandings 
among MA-EPs (particularly if they expected to receive an incentive 
payment under the Medicare FFS Incentive Program). We stated that it 
was important for MA-EPs to understand certain aspects of the program 
such as when a qualifying MA organization claimed an MA-EP under the MA 
EHR Incentive Program and the MA-EP was not entitled to a full FFS EHR 
Incentive payment, the MA organization claim would prevent a partial 
payment under the Medicare FFS EHR Incentive Program from being paid 
directly to the MA-EP.
    We proposed to require each qualifying MA organization to attest 
that it notified the MA-EPs it intends to claim. We proposed to require 
that this attestation be submitted along with the MA organization's 
meaningful use attestation for the MA EHR payment year for which the MA 
organization is seeking payment.
    Therefore, we proposed to revise Sec.  495.208 by adding--(1) a new 
paragraph (a) that requires a qualifying MA organization to notify MA-
EPs when the MA organization intends to claim them for the MA EHR 
Incentive Program prior to making its attestation of meaningful use to 
CMS; (2) a new paragraph (b) that requires a qualifying MA organization 
to notify MA-EPs when it is claiming them, that the MA-EPs may still 
receive an incentive payment under the Medicare FFS or Medicaid EHR 
Incentive Program, if certain requirements are met; and (3) a new 
paragraph (c) that requires a qualifying MA organization to attest to 
CMS that these notification requirements have been satisfied by the MA 
organization. We also proposed to redesignate the current paragraphs 
(a) through (c) of Sec.  495.208 as (d) through (f), respectively.
    As discussed previously, in Sec.  495.210, we proposed to change 
the requirement that MA organizations attest to meaningful use within 
60 days after the close of the MA EHR payment year for both MA-EPs and 
MA-affiliated eligible hospitals, to a requirement to do so within 2 
months in order to provide consistency between the Medicare FFS and MA 
EHR Incentive Programs.
    Comment: A commenter requested that CMS confirm that MA 
organization reporting to CMS under HEDIS, HOS, and CAHPS will continue 
to apply for purposes of the MA EHR Incentive Payment Program during 
Stage 2. The commenter questioned if MA organizations, for both 
qualifying MA-EPs and MA-affiliated eligible hospitals, will be 
permitted to continue to submit HEDIS, HOS, and CAHPS data in lieu of 
CQMs during Stage 2.
    Response: We are confirming that during Stage 2 and subsequent 
stages of MA EHR Program implementation, we will continue to require 
qualifying MA organizations to successfully report HEDIS, HOS, and 
CAHPS measures in lieu of CQMs for purposes of meaningful use reporting 
for qualifying MA-EPs and MA-affiliated eligible hospitals.
    After review of the public comments received, we are finalizing 
these provisions as proposed.
5. Payment Adjustments Effective for 2015 and Subsequent MA Payment 
Adjustment Years (Sec.  495.211)
    In the proposed rule we explained that beginning in 2015, the law 
provides for adjustments to monthly MA payments under sections 
1853(l)(4) and 1853(m)(4) of the Act if a qualifying MA organization's 
potentially qualifying MA-EPs or MA-affiliated eligible hospitals (or 
both) are not meaningful users of certified EHR technology. We proposed 
to add a definition of ``MA Payment Adjustment Year'' to the 
definitions in Sec.  495.200. The definition was needed in part because 
the payment adjustment phase of the MA EHR program continued 
indefinitely--beyond the last year for which MA EHR incentive payments 
could be made to qualifying MA organizations. Additionally, since we 
proposed to operationalize MA EHR payment adjustments in a different 
manner than under the FFS Medicare program, we believed a definition 
was warranted.
    We proposed that an MA organization would have to had at least 
initiated participation in the incentive payment phase of the program 
from 2011 through 2014 for MA-EPs or through 2015 for MA-affiliated 
eligible hospitals, to have its Part C payment under section 
1853(a)(1)(A) of the Act adjusted during the payment adjustment phase 
of the program, and would have to continue to qualify for participation 
in the program as a ``qualifying MA organization'' as defined for 
purposes of this program. The imposition of a payment adjustment is 
also conditioned on the qualifying MA organization having potentially 
qualifying MA-EPs and MA-affiliated eligible hospitals for the 
respective payment adjustment years. We took this approach because we 
believed that it would be impossible to verify that a given MA 
organization is, in fact, a qualifying MA organization with potentially 
qualifying MA-EPs and MA-affiliated eligible hospitals, unless the MA 
organization had first demonstrated that it met these requirements 
through receipt of MA EHR incentive payments for at least one of the MA 
EHR payment years as defined for purposes of this program. We noted 
that although MA EHR payment years for both MA-EPs and MA-affiliated 
eligible hospitals could theoretically continue through 2016, the last 
first MA EHR payment year for which an MA organization could receive an 
EHR incentive payment is 2014 for MA-EPs, and 2015 for MA-affiliated 
hospitals.
    Furthermore, we believe that payment adjustments under section 1853 
of the Act would have limited applicability in the MA EHR Incentive 
Program because the HITECH Act limited the type of organization that 
would qualify as a ``qualifying MA organization'' for purposes of the 
MA EHR Incentive Program in both phases of the program (the phase of 
the program during which we make incentive payments, and the phase of 
the program when we adjust payments under sections 1853(l)(4) and 
1853(m)(4) of the Act). We stated that section 1853(l)(5) of the Act 
limits which MA organizations may participate by defining the term 
``qualifying MA organization.'' We explained that a ``qualifying MA 
organization'' must be organized as a health maintenance organization 
(HMO), as defined in section 2791(b)(3) of the Public Health Service 
(PHS) Act (42 U.S.C. 1395w-23(l)(5)). The PHS Act further defines an 
HMO as a ``federally qualified HMO, an organization recognized under 
state law as an HMO, or a similar organization regulated under state 
law for solvency in the same

[[Page 54116]]

manner and to the same extent as such an HMO.'' (See 42 U.S.C. 300gg-
91). We explained that an MA organization participating in Medicare 
Part C might not be a federally qualified HMO, nor an organization 
recognized under state law as an HMO, nor a similar organization 
regulated under state law for solvency in the same manner and to the 
same extent as such an HMO. We noted that organizations that do not 
meet the PHS definition of ``HMO'' may not receive an incentive 
payment, nor would they be eligible to have their Part C payment 
adjusted for having potentially qualifying MA-EPs or MA-affiliated 
eligible hospitals that do not successfully demonstrate meaningful use 
of certified EHR technology.
    Secondly, section 1853(l)(2) of the Act requires that MA-EPs be as 
described in that paragraph. We stated that the vast majority of MA 
organizations do not employ their physicians; nor do they use 
physicians who work for, or who are partners of, an entity that 
contracts nearly exclusively with the MA organization (as set out in 
the definition of a ``Qualifying MA-EP'' in Sec.  495.200).
    Thirdly, section 1853(m)(2) of the Act requires that a qualifying 
MA organization have common corporate governance with a hospital in 
order for it to be considered an MA-affiliated eligible hospital, and 
we did not expect many qualifying MA organizations to meet this test.
    We explained that the current Sec.  495.202(b)(4) (which we 
proposed to redesignate as Sec.  495.202(b)(5)) requires all qualifying 
MA organizations that have potentially qualifying MA-EPs or MA-
affiliated eligible hospitals that are not meaningful users to 
initially report that fact to us beginning in June of MA plan year 
2015. We proposed that this reporting requirement would include only 
qualifying MA organizations that participated in and received MA EHR 
incentive payments.
    Further, we discussed that there may be MA organizations that 
participated in the incentive payment phase of the program, but then 
ceased being qualifying MA organizations, or that no longer have any 
qualifying MA-EPs or MA-affiliated eligible hospitals. We provided an 
example of a qualifying MA organization that contracts with a specific 
entity to deliver physicians' services during the payment phase of the 
EHR Incentive Program, but then the entity changes, or the MA 
organization loses its contract with the entity. We explained that such 
changes could cause the MA organization's MA EPs to no longer meet the 
80/80/20 rule due to loss of the contract, or the entity might begin 
contracting with additional MA organizations. (See Sec.  495.200, for 
the definition of ``Qualifying MA-EP.'') Therefore, we explained, the 
MA organization would not necessarily have its monthly payment adjusted 
because it might no longer meet the basic requirements under which MA 
EHR incentive payments were made to it.
    Therefore, we proposed to adjust payments, beginning for payment 
adjustment year 2015, only for qualifying MA organizations that 
received MA EHR payments and that had potentially qualifying MA-EPs or 
MA-affiliated eligible hospitals that were not meaningful EHR users. We 
proposed to rely on the existing self-reporting requirement in 
redesignated Sec.  495.202(b)(5) and subsequent audits to ensure 
compliance.
    Comment: A commenter recommended that CMS apply MA payment 
adjustments to qualifying MA organizations only for the category of MA 
provider (that is, MA-EP versus MA-affiliated hospital) for which it 
claimed and received MA EHR incentive payments. For example, if a 
qualifying MA organization claimed incentive payments during the 
payment phase of the program only for MA-EPs and not for any MA-
affiliated eligible hospitals, then the MA organization should only be 
required to report on qualifying and potentially qualifying MA-EPs 
during the adjustment phase of the program, and should not be subject 
to payment adjustments for MA-affiliated hospitals.
    Response: We agree with the commenter that we will apply payment 
adjustments only to qualifying MA organizations for the category (or 
categories) of MA provider (either MA-EP, MA-affiliated eligible 
hospital, or both) for which it claimed and received MA EHR incentive 
payments. To the same extent that qualifying MA organizations have 
identified themselves and their qualifying MA-EPs and/or MA-affiliated 
eligible hospitals during the payment phase of the MA EHR Incentive 
Program, we expect them to continue to identify themselves and their 
MA-EPs and MA-affiliated hospitals during the adjustment phase of the 
program. We are taking this approach because we believe it would be 
impossible to verify that a given qualifying MA organization has 
potentially qualifying MA-EPs or MA-affiliated eligible hospitals, 
unless it had first identified those providers to us. We have modified 
Sec.  495.211(c) to clarify that MA EHR payment adjustments with 
respect to MA-affiliated hospitals will only apply to qualifying MA 
organizations that previously received incentive payments under the MA 
EHR Incentive Program for MA-affiliated hospitals, and similarly, that 
MA EHR payment adjustments with respect to MA-EPs will only apply to 
qualifying MA organizations that previously received incentive payments 
under the MA EHR Incentive Program for MA-EPs.
    We proposed to collect payment adjustments made under sections 
1853(l)(4) and 1853(m)(4) of the Act after meaningful use attestations 
have been made. Final attestations of meaningful use occur after the 
end of an EHR reporting period, which for MA-EPs would run concurrent 
with the payment adjustment year. In the case of potentially qualifying 
MA-affiliated eligible hospitals, attestations of meaningful use would 
occur by the end of November after the EHR reporting period. As noted 
previously, we proposed to amend Sec.  495.202(b) to indicate that in 
addition to initial identification of potentially qualifying MA-EPs and 
MA-affiliated eligible hospitals that are not meaningful users (as 
required by redesignated Sec.  495.202(b)(5)), qualifying MA 
organizations would also need to finally identify such MA-EPs and MA-
affiliated eligible hospitals within 2 months of the close of the 
applicable EHR reporting period. Final identification by qualifying MA 
organizations of potentially qualifying MA-EPs and/or MA-affiliated 
eligible hospitals that are not meaningful users would then result in 
application of a payment adjustment by CMS. On the other hand, final 
identification of all qualifying MA-EPs and/or MA-affiliated eligible 
hospitals as meaningful users would obviate an adjustment. We stated 
that, through audit, we would verify the accuracy of an applicable MA 
organization's assertions or nonreporting.
    We proposed to adjust one or more of the qualifying MA 
organization's monthly MA payments made under section 1853(a)(1)(A) of 
the Act after the qualifying MA organization attested to the percent of 
hospitals and professionals that either were, or were not, meaningful 
users of certified EHR technology. We stated that, to the extent a 
formerly qualifying MA organization did not report under Sec.  
495.202(b)(4) or (5), we would verify, upon audit, the accuracy of the 
applicable MA organization's nondisclosure of such qualifying and 
potentially qualifying users.
    Under our proposed approach, the adjustment would be calculated 
based on Part C payment data made under section 1853(a)(1)(A) of the 
Act for the payment adjustment year. We stated

[[Page 54117]]

that since an MA-affiliated eligible hospital must attest to meaningful 
use by November 30th, we could use the Part C payment information in 
effect at the time of the attestation to calculate the payment 
adjustment for a specific potentially qualifying MA-affiliated eligible 
hospital with respect to a specific MA organization. Although we 
expected (and preferred) to make an adjustment to a single MA monthly 
payment totaling the adjustment for the year, we requested comment on 
whether more than one monthly payment should be adjusted. We stated 
that one possible approach would be to make this decision on a case-by-
case basis depending upon a given qualifying MA organization's 
situation (for example, payment adjustment amount versus MA 
organization monthly payment).
    For payment adjustments based on potentially qualifying MA-EPs that 
are not meaningful users of certified EHR technology, we also proposed 
to calculate the adjustment based on the Part C payment made under 
section 1853(a)(1)(A) of the Act for the payment adjustment year. 
Because attestations of meaningful use for qualifying MA-EPs occur in 
February of the calendar year following the EHR reporting year, we 
noted that we could calculate the payment adjustment based on the prior 
MA payment year's payment, and that we could apply that adjustment to 
one or more of the prospective Part C payments. While we preferred to 
make an adjustment to one MA prospective payment for the full amount of 
the payment adjustment when possible, we solicited comment on whether 
we should make adjustments over several months or in a single month 
(for the entire adjustment amount), when possible. We received no 
comments on this proposal and therefore we are adopting the policy of 
collecting payment adjustments as quickly as possible in a single 
month, when possible.
    Thus, adjustments for MA payment adjustment year 2015 would be 
based on MA payment data under section 1853(a)(1)(A) of the Act. 
However, while the payment adjustment for the 2015 payment adjustment 
year would be collected as soon as possible, we stated that this might 
not be until CY 2016 through an adjustment to the MA organization's MA 
capitation payment or payments under section 1853(a)(1)(A) of the Act.
    We stated that proposed Sec.  495.211(c) made clear that the 
potentially qualifying MA-EP and MA-affiliated eligible hospital 
payment adjustments would be calculated separately, and that each 
adjustment was applied to the qualifying MA organization's monthly 
payment under section 1853(a)(1)(A) of the Act. As discussed 
previously, we are modifying Sec.  495.211(c) to clarify that MA EHR 
payment adjustments for MA-affiliated hospitals only apply to 
qualifying MA organizations that previously received incentive payments 
under the MA EHR Incentive Program for MA-affiliated hospitals, and 
that payment adjustments for MA-EPs only apply to qualifying MA 
organizations that previously received incentive payments under the MA 
EHR Incentive Program for MA-EPs.
    Proposed paragraphs (a) through (c) would apply to adjustments 
based on both potentially qualifying and qualifying MA-EPs and MA-
affiliated eligible hospitals that were not meaningful EHR users. 
Proposed paragraph (d) would apply only to adjustments based on 
potentially qualifying and qualifying MA-EPs that were not meaningful 
users of certified EHR technology. We also stated that paragraph (d) 
makes it clear that if a potentially qualifying MA-EP was not a 
meaningful user of CEHRT in payment adjustment year 2015 (and 
subsequent payment adjustment years), the qualifying MA organization's 
monthly Part C payment would be adjusted accordingly.
    During the payment phase of the MA EHR Incentive Program qualifying 
MA organizations attest to meaningful use for each qualifying MA-EP and 
MA-affiliated eligible hospital they claimed. We also stated that 
during the payment adjustment phase of the program, we would need to 
know the percentage of both qualifying and potentially qualifying MA-
EPs and MA-affiliated eligible hospitals that were not meaningful users 
of certified EHR technology. This percentage could be derived by taking 
the total number of the qualifying MA organization's qualifying and 
potentially qualifying MA-EPs, or MA-affiliated eligible hospitals, and 
identifying the portion of those MA-EPs or MA-affiliated hospitals that 
were not meaningful EHR users. We would use this percentage to make the 
adjustment proportional to the percent that were not meaningful users 
for a given adjustment year and qualifying MA organization.
    Moreover, in determining the proportion of potentially qualifying 
MA-EPs and potentially qualifying MA-affiliated eligible hospitals 
(those that were not meaningful users), we would exclude EPs and 
hospitals that were neither qualifying nor potentially qualifying in 
accordance with the definition of ``qualifying'' and ``potentially 
qualifying MA-EPs'' and ``MA-affiliated eligible hospitals'' in Sec.  
495.200. Thus, an MA-EP that was a hospital-based EP would not be a 
qualifying or potentially qualifying MA-EP since such an EP did not 
meet item (5) of the definition of qualifying MA-EP in Sec.  495.200 
and thus would not be used in our computation of the proportion of MA-
EPs for purposes of applying the payment adjustment. We proposed the 
following formula to apply the payment adjustments proposed in Sec.  
495.211(d)(2) to MA-EPs:

[the total number of potentially qualifying MA-EPs]/[(the total number 
of potentially qualifying MA-EPs) + (the total number of qualifying MA-
EPs)].

    Similarly, the formula we proposed for purposes of applying payment 
adjustments in Sec.  495.211(e)(2)(iii) with respect to MA-affiliated 
hospitals was:

[the total number of potentially qualifying MA-affiliated eligible 
hospitals]/[(the total number of potentially qualifying MA-affiliated 
eligible hospitals) + (the total number of qualifying MA-affiliated 
eligible hospitals)].

    Keeping in mind that redesignated Sec.  495.202(b)(4) and (5) 
required qualifying MA organizations to identify potentially qualifying 
MA-EPs and potentially qualifying MA-affiliated eligible hospitals and 
to provide other information beginning for plan year 2015, we solicited 
comment on the question of whether, in the payment adjustment phase of 
this program, qualifying MA organizations with potentially qualifying 
MA-EPs and MA-affiliated eligible hospitals should--(1) still be 
required to attest to the meaningful use objectives and measures; or 
(2) instead be required only to report the percent of MA-EPs and MA-
affiliated eligible hospitals that are not meaningful users of 
certified EHR technology. We suggested that commenters take into 
account that MA-affiliated eligible hospitals would still be required 
to perform a reporting function on behalf of their MA-affiliated 
organization in the National Level Repository (NLR), and that they were 
generally bound to ``subsection (d)'' hospital reporting requirements 
of the NLR. Thus, we were primarily interested in comments related to 
MA-EPs.
    We explained that while we wished to minimize burden, we were also 
concerned with our ability to audit the information reported to ensure 
compliance with MA program requirements. Having received no comments on 
this provision, we therefore adopt a final requirement to

[[Page 54118]]

use only percentage-based reporting and, require MA organizations to 
retain and produce data and records necessary to substantiate their 
submissions, including evidence of meaningful use by those MA-EPs and 
MA-affiliated eligible hospitals so reported.
    We proposed that payment adjustments for MA-EPs would be calculated 
by multiplying: (1) The percent established under Sec.  495.211(d)(4) 
(which, in accordance with the statute, increases the adjustment amount 
up until 2017 and potentially beyond); with (2) the Medicare Physician 
Expenditure Proportion; and (3) by the percent of the qualifying MA 
organization's qualifying and potentially qualifying MA-EPs that were 
not meaningful users. We explained that section 1853(l)(4)(B)(i) of the 
Act requires MA payments to be reduced using the ``percentage points'' 
reduction of section 1848(a)(7)(A)(ii) of the Act. As section 
1848(a)(7)(A)(ii) of the Act is ``subject to clause (iii),'' and as 
clause (iii) of that same provision requires payment adjustments to 
increase when the proportion of EPs who are meaningful EHR users is 
less than 75 percent, we proposed to apply a similar policy for the MA 
program. Specifically, we proposed that if the proportion of MA-EPs of 
a qualifying MA organization did not meet the 75 percent threshold (as 
determined in proposed Sec.  495.211(d)(2)) in 2018 and subsequent 
years, the percentage reduction could increase to 4 percent in 2018, 
and 5 percent in 2019 and subsequent years. We did not propose a 
possible 2 percent reduction for 2015 (consistent with the Medicare FFS 
EHR Incentive Program when an EP is subject to an adjustment in 2014 
under the e-prescribing program), because MA organizations are not 
independently subject to e-prescribing payment adjustments.
    We proposed that the Medicare Physician Expenditure Proportion for 
a year would be the Secretary's estimate of expenditures under Parts A 
and B not attributable to Part C that are attributable to expenditures 
for physician services. While we proposed a uniform portion for all MA 
organizations, we also proposed to adjust the proportion on a more 
individual basis to account for the fact that qualifying MA 
organizations may contract with a large number of EPs that are neither 
qualifying nor potentially qualifying. We explained that this 
individualized policy was based on the statutory language in section 
1853(l)(1) of the Act, which states that the provisions of section 
1848(a)(7) of the Act (that is, the payment adjustments) apply ``with 
respect to'' the EPs ``described in paragraph (2)'' of section 1853(l) 
of the Act. As section 1853(l)(2) of the Act creates several additional 
requirements for MA-EPs (that is, that they be employed by the 
qualifying MA organization, that they meet the 80/80/20 requirements, 
and so on), we proposed adjusting the Physician Expenditure Proportion 
to recognize that many EPs may not qualify as MA-EPs, regardless of 
meaningful use. Thus, we proposed to adjust each MA organization's 
Physician Expenditure Proportion to recognize that not all of the EPs 
would meet the technical (nonmeaningful use) requirements to be 
potentially qualifying or qualifying MA-EPs. Without our proposed 
adjustment, a small sample size of MA-EPs could magnify the reduction 
amount during the payment adjustment phase of the program, because the 
actions of a limited set of qualifying and potentially qualifying MA-
EPs (and whether they meaningfully used certified EHR technology) would 
determine whether all of an MA organization's physician expenditure 
proportion was reduced.
    We provided an example of our proposed MA payment adjustment for 
adjustment year 2015 as follows:
    Assume the hypothetical Medicare Physician Expenditure Proportion, 
adjusted as described previously, is 10 percent for 2015;
    The qualifying MA organization's percent of qualifying and 
potentially qualifying MA-EPs that are not meaningful users is 15 
percent for 2015; and
    The monthly payment in 2015 for the given qualifying MA 
organization is $10,000,000.
    The proposed formula would read as follows:

0.01 (the payment adjustment for 2015) x 0.1 (the hypothetical Medicare 
Physician Expenditure Proportion) x 0.15 (the percentage of qualifying 
and potentially qualifying MA-EPs that are not meaningful EHR users) x 
$10,000,000 (monthly Part C payment) x 12 (number of months in the MA 
payment year) = $18,000 for the entire year, or $1,500 a month. We 
proposed that this adjustment would then be collected against one or 
more of the qualifying MA organization's payments under section 
1853(a)(1)(A) of the Act.

    In proposed Sec.  495.211(e), we set out a formula for payment 
adjustments based on potentially qualifying MA-affiliated eligible 
hospitals that are not meaningful users of certified EHR technology.
    We proposed an adjustment equal to the product of the following:
     Monthly Part C payment for the payment adjustment year;
     The percentage point reduction that applies to FFS 
hospitals as a result of section 1886(b)(3)(B)(ix)(I) of the Act;
     The Medicare hospital expenditure proportion, adjusted in 
the same manner as the Physician Expenditure Proportion to recognize 
that not all hospitals are necessarily qualifying or potentially 
qualifying MA-affiliated eligible hospitals; and
     The percentage of qualifying and potentially qualifying 
MA-affiliated eligible hospitals of a given qualifying MA organization 
that are not meaningful users of certified EHR technology.
    We proposed that the percentage point reduction of the first bullet 
(that is, the reduction that applies as a result of section 
1886(b)(3)(B)(ix)(I) of the Act) would be based on the point reduction 
that results when three-fourths of the otherwise applicable percentage 
increase for the fiscal year was reduced by 33\1/3\ percent for FY 
2015, 66\2/3\ percent for FY 2016, and 100 percent for FY 2017 and 
subsequent fiscal years. We stated this had the result of decreasing 
the otherwise applicable market basket update by one-fourth (for 2015), 
one-half (for 2016), and three-fourths (for 2017 and subsequent payment 
adjustment years).
    We stated that the Medicare Hospital Expenditure Proportion for a 
year was the Secretary's estimate of expenditures under Medicare Parts 
A and B that were not attributable to Part C, that were attributable to 
expenditures for inpatient hospital services. As mentioned previously, 
we proposed that this proportion reflects only the MA-affiliated 
eligible hospitals that were either qualifying or potentially 
qualifying MA-affiliated eligible hospitals.
    We also proposed to use the market basket percentage increase that 
would otherwise apply to ``subsection (d)'' hospitals for an MA payment 
adjustment year. We provided the following hypothetical example. The 
market basket percentage increase for FY 2015 was hypothetically 4 
percent. Three-quarters of one-third of 4 percent would be 1 percent. 
The hypothetical Medicare Hospital Expenditure proportion for the year 
was 15 percent, and one of two of the relevant MA-affiliated eligible 
hospitals was not a meaningful EHR user for the applicable period (FY 
2015). The monthly payment to the MA organization in 2015 was 
$10,000,000 a month.
    The calculation would be as follows:

[[Page 54119]]

0.01 (the market basket percentage point reduction) x 0.15 (the 
Medicare Hospital Expenditure Proportion) x 0.5 (percent of the 
qualifying MA organization's qualifying and potentially qualifying MA-
affiliated eligible hospitals that are not meaningful users) x 
$10,000,000 (monthly Part C payment) x 12 (number of months in the MA 
payment year) = $90,000 for the year, or $7,500 a month. The payment 
adjustment would be applied on either a monthly basis, or in one 
adjustment. As stated previously, we requested comment on this aspect 
of the final rule.

    Comment: A commenter stated that the formula for computing the 
Medicare Physician Expenditure Proportion percent in Sec.  
495.211(d)(3)(ii) was not clear on whether physicians who saw no 
Medicare patient at all would be excluded from the expenditure 
proportion calculation (for example, most pediatricians), and whether a 
distinction would be made between services provided by MA-EPs and 
potential MA-EPs of the organization, and other physicians and the 
services they provide. The commenter explained that under the model of 
reimbursement for physician services it uses, the ability to track Part 
A and Part B costs to individual physicians was limited. The commenter 
proposed an alternate method for computing the Medicare Physician 
Expenditure Proportion based on what it called a ``uniform distribution 
model as a proxy for the adjustment to the MPEP percent.''
    Response: We believe it is unnecessary to specifically exclude 
physicians, such as pediatricians, who see no Medicare patients from 
the Medicare Physician Expenditure Proportion calculation. Expenditures 
that are provided by EPs that are neither qualifying nor potentially 
qualifying MA-EPs are already adjusted out. This would be true in two 
ways for physicians, such as pediatricians, who see no Medicare 
patients. First, these physicians would not meet item (2) of the 
definition of a ``qualifying MA-EP'' in Sec.  495.200, since these 
physicians do not provide ``at least 80 percent'' of their Medicare-
covered professional services to enrollees of the qualifying MA 
organization. Since they provide no Medicare-covered professional 
services to enrollees of the qualifying MA organization, they do not 
meet the ``80 percent'' requirement. Second, the Physician Expenditure 
Proportion is based only on Medicare expenditures for physician 
services (that is, the proportion of expenditures under Parts A and B 
not attributable to Part C that are attributable to expenditures for 
physician's services). Physician expenditures for non-Medicare services 
(like most services of a pediatrician) do not count in the calculation. 
Finally, we do not believe an alternative method of computing the 
Medicare Physician Expenditure Proportion is necessary and therefore 
are not considering the alternate approach proposed by this commenter 
in this final rule. It should be noted that tracking Part B costs to 
individual MA-EPs (physicians) is a critical part of determining the 
incentive payment due a qualifying MA organization (see 42 CFR 
495.204(ff)). To the extent methodologies for estimating the portion of 
MA-EP compensation that is attributable to Part B professional services 
are used during the payment phase of the MA EHR Incentive Program, we 
believe these methodologies can also be successfully used during the 
adjustment phase of the Program.
    Comment: A commenter questioned if section 3401 of the Affordable 
Care Act market basket update adjustment due to changes in economy-wide 
productivity for FY 2012 and each subsequent fiscal year would be 
included, or if any other adjustment would be included in the market 
basket update rate used in the penalty adjustment formula.
    Response: Section 1853(m)(4)(B)(i) of the Act directs us to use the 
``number of the percentage point reduction effected under section 
1886(b)(3)(B)(ix)(I) for the period.'' That reduction is based off of a 
starting point of the applicable percentage increase otherwise 
applicable under clause (i), while mandating that this be ``determined 
without regard to clause (viii), (xi), or (xii)'' of section 
1886(b)(3)(B) of the Act. Thus, the starting point for determining the 
percentage points by which the update is reduced is the applicable 
percentage increase in clause (i) of section 1886(b)(3)(B) of Act, 
before it has been further reduced for productivity (under clause (xi) 
for other statutory reductions (in clause (xii)), or for failure to 
report on certain measures (under clause (viii)). Currently, the 
applicable percentage increase in clause (i), before the other 
reductions have been made, is the market basket percentage increase for 
hospitals in all areas. Thus, such a market basket increase will be our 
starting point, and the percentage points by which that increase is 
reduced solely due to the application of EHR Program adjustments will 
be the point reduction we use in the MA formula.
    Comment: A commenter proposed an alternate method for computing the 
Medicare Hospital Expenditure Proportion based on what they believe is 
``consistent with fee-for-service hospital penalties.''
    Response: We believe our proposed method is consistent with the 
method the Medicare fee-for-service program will use to implement EHR 
adjustments for ``subsection (d)'' hospitals.
    Comment: One commenter expressed concern that CMS had proposed that 
payment adjustments would be based on an earlier payment period.
    Response: We believe the commenter is confused, as we did not 
propose a prior EHR reporting period for the MA program.
    We received no other comments on this section of the proposed rule. 
After consideration of the public comments received, we are finalizing 
these provisions as proposed with the one modification noted to Sec.  
495.211(c).
6. Reconsideration Process for MA Organizations
    We proposed a reconsideration process in new section, Sec.  
495.213. We did not receive any comments on the proposed process. 
However, for the reasons stated in section II.D.5 of this final rule, 
we do not believe formal regulations for an informal reconsideration 
procedural rule are necessary and therefore we are not including this 
new section in this final rule.
    As noted in the proposed rule and as required by statute, our 
administrative reconsideration process would not permit administrative 
review of the standards and methods used to determine eligibility and 
payment (see sections 1853(l)(8) and (m)(6) of the Act, and Sec.  
495.212 of the regulations). However, it would allow a reconsideration 
of the application of such standards and methods, in certain 
circumstances.

F. Revisions and Clarifications to the Medicaid EHR Incentive Program

    Unless otherwise specified, the changes discussed in this section 
of the rule will take effect upon publication of this final rule.
1. Net Average Allowable Costs
    In this final rule, we are formalizing through rulemaking the 
guidance that was shared with state Medicaid Directors in a letter on 
April 8, 2011 (available at: http://www.cms.gov/smdl/downloads/SMD11002.pdf). These technical changes are required to implement 
section 205(e) of the Medicare and Medicaid Extenders Act of 2010 
(Extenders Act, Pub. L. 111-309). The Extenders Act, enacted on

[[Page 54120]]

December 15, 2010, amended sections 1903(t)(3)(E) and 1903(t)(6)(B) of 
the Act. The amended sections change the requirements for an EP to 
demonstrate the ``net average allowable costs,'' the contributions from 
other sources, and the 15 percent provider contribution requirements to 
participate in the Medicaid EHR Incentive Payment Program. The 
Extenders Act provided that an EP has met this responsibility, as long 
as the incentive payment is not in excess of 85 percent of the net 
average allowable cost ($21,250 for first year payments).
    Before the Extenders Act, Medicaid EPs who wanted to participate in 
the EHR Incentive Payment Program were required to provide 
documentation of certain costs related to acquiring and implementing 
certified EHR technology. The Extenders Act amended the relevant 
statute by allowing for providers to simply document and attest that 
they have adopted, implemented, upgraded, or meaningfully used 
certified EHR technology, while allowing us to set these average costs.
    As a result, rather than requiring each EP to calculate the 
payments received from outside sources, each will use the average costs 
and contribution amount we established. After conducting a meta-
analysis of existing data of an EP's costs to adopt, implement, or 
upgrade certified EHR technology, we determined that average 
contributions from outside sources should not exceed $29,000. The 
documentation originally required by an EP to demonstrate that he or 
she contributed 15 percent (for example, $3,750 for year 1) of the 
``net average allowable costs'' is also no longer needed. The Act now 
provides that an EP has met this responsibility as long as the 
incentive payment is not in excess of 85 percent of the net average 
allowable cost ($21,250). Given that this change is already in effect, 
we proposed to remove from the required content in the state Medicaid 
HIT Plan, the requirement that states describe the process in place to 
ensure that Medicaid EHR incentive payments are not paid at amounts 
higher than 85 percent of the net average allowable cost of certified 
EHR technology, as described in Sec.  495.332.
    We received no comments on our proposal to codify this already-
existing policy, and we are finalizing our proposals without 
modification.

                Table E1--Determination of Net Average Allowable Costs for the First Payment Year
----------------------------------------------------------------------------------------------------------------
                                                             Prior to Extenders Act
     First year variables \1\              Amounts                   changes                   Currently
----------------------------------------------------------------------------------------------------------------
Average Allowable Costs...........  $54,000..............  Determined through a CMS    No change.
                                                            meta[dash]analysis,
                                                            described in both the
                                                            proposed rule (75 FR
                                                            1844) and the final rule
                                                            (75 FR 44314).
Contributions from Other Sources..  Does not exceed        Subtracted from Average     No documentation is
                                     $29,000.               Allowable Costs to reach    needed. We have
                                                            ``Net'' Average Allowable   determined that average
                                                            Costs. An EP was required   contributions do not
                                                            to show documentation of    exceed $29,000.
                                                            all contributions from
                                                            certain other sources.
Capped Amount of ``Net'' Average    $25,000..............  Capped by statute and       No change.
 Allowable Costs.                                           designated in CMS final
                                                            rule.
Contribution from the EP..........  $3,750...............  An EP was required to       No documentation needed.
                                                            demonstrate that he or      Determined to have been
                                                            she had contributed at      met by virtue of EP
                                                            least 15 percent of the     receiving no more than
                                                            net average allowable       $21,250 in the first
                                                            costs towards a certified   payment year.
                                                            EHR.
Incentive payment \2\.............  $21,250..............  85 percent of the Net       All EPs will receive the
                                                            Average Allowable Costs;    maximum incentive
                                                            determined through          payment of $21,250, as
                                                            statute. An EP could        all EPs will be
                                                            receive less than this      determined to have
                                                            amount if he or she had     contributions from other
                                                            contributions from other    sources under $29,000.
                                                            sources exceeding $29,000.
----------------------------------------------------------------------------------------------------------------
\1\ These same concepts (but not figures) apply to the second through sixth years, integrating the figures from
  the Stage 1 final rule. Ultimately, the incentive paid in the second through sixth years is still the
  statutory maximum of $8,500.
\2\ This figure is further reduced to two-thirds for pediatricians qualifying with reduced Medicaid patient
  volumes. This is described at 42 CFR 495.310.

2. Definition of Adopt, Implement Upgrade
    We are adding clarifying language that maintains our policy that to 
qualify for an AIU payment, a provider must adopt, implement or upgrade 
to certified EHR technology that would allow that provider to qualify 
as a meaningful user. Our regulation has always defined certified EHR 
technology by reference to the ONC definition at 45 CFR 170.102, and 
ONC's definition of certified EHR technology has consistently required 
the technology to support meaningful use. While ONC is changing the 
definition of certified EHR technology, we do not believe this change 
would allow a provider to receive an incentive for technology that 
could not support meaningful use (that is for purchasing only ``Base 
EHR'' technology). Nevertheless, in order to be absolutely clear in our 
regulations, we are amending them to ensure that providers do not 
receive Medicaid incentives for adopting technology that would not 
allow them to demonstrate meaningful use.
3. Eligibility Requirements for Children's Hospitals
    We proposed to revise the definition of a children's hospital in 
Sec.  495.302 to also include any separately certified hospital, either 
freestanding or hospital within hospital that predominately treats 
individuals under 21 years of age; and does not have a CMS 
certification number (CCN) because they do not serve any Medicare 
beneficiaries but has been provided an alternative number by CMS for 
purposes of enrollment in the Medicaid EHR Incentive Program. We will 
provide future guidance on how to obtain these alternative numbers.
    The only comments we received on this proposal were favorable. We 
are finalizing these policies as proposed. Guidance to these hospitals 
and the states on enumeration and determining eligibility is also 
forthcoming.
4. Medicaid Professionals Program Eligibility
    Section 1903(t) of the Act authorizes Medicaid payments to 
encourage the adoption and use of certified EHR

[[Page 54121]]

technology, and places Medicaid patient volume requirements on EPs to 
qualify for such payments under the Medicaid program. Patient volume 
requirements ensure that Medicaid funding is used to encourage the 
adoption and use of technology specifically to benefit the care of 
Medicaid populations. Therefore, we proposed that at least one of the 
clinical locations used for the calculation of an EP's patient volume 
have CEHRT during the payment year for which the EP is attesting to 
adoption, implementation or upgrade or meaningful use. This will ensure 
that Medicaid funding goes to EPs using CEHRT to improve Medicaid 
patients' care.
    The only comments that we received on this proposal were in support 
of the proposal. For the reasons explained in the proposed rule, we are 
finalizing this policy as proposed. We have amended Sec.  495.304 and 
Sec.  495.332 accordingly.
a. Calculating Patient Volume Requirements
    We proposed to revise Sec.  495.306(c) to allow states the option 
for their providers to calculate total Medicaid encounters or total 
needy individual patient encounters in any representative, continuous 
90-day period in the 12 months preceding the EP or eligible hospital's 
attestation. This option will be in addition to the current regulatory 
language that bases patient volume on the prior calendar or fiscal 
year. We believe this adjustment will provide greater flexibility in 
eligible providers' patient volume calculations.
    Likewise, we proposed to revise Sec.  495.306(d)(1)(i)(A) to allow 
for the calculation of the total Medicaid patients assigned to the EP's 
panel in any representative, continuous 90-day period in either the 
preceding calendar year, as is currently permitted, or in the 12 months 
preceding the EPs' attestation, when at least one Medicaid encounter 
took place with the Medicaid patient in the 24 months prior to the 
beginning of the 90-day period. We also proposed to revise Sec.  
495.306(d)(1)(ii)(A) accordingly, so that the numerator and denominator 
are using equivalent periods. We proposed conforming changes to Sec.  
495.306(d)(2)(i) and (ii) for needy individual patient volume. We 
proposed changing the period during which the encounter must take place 
from 12 months to 24 months to account for new clinical guidelines from 
the U.S. Preventive Health Services Task Force that allow greater 
spacing between some wellness visits. Therefore, in order for a patient 
to be considered ``active'' on a provider's panel, we proposed 24 
months is more appropriate. This change is also in order to be 
consistent with the proposed Stage 2 meaningful use measure for patient 
reminders sent to ``active patients.''
    The only comments we received on this proposal were supportive. For 
the reasons explained in the proposed rule, we are finalizing this 
policy as proposed. We note that as explained in the proposed rule, 
this will be an option for states to implement at their discretion. 
States must seek prior approval from CMS via an amendment to their 
state Medicaid HIT Plan before implementing this change.
    We also proposed to expand the definition of ``encounter'' to 
include any service rendered on any one day to an individual enrolled 
in a Medicaid program. We explained that such a definition will ensure 
that patients enrolled in a Medicaid program are counted, even if the 
Medicaid program did not pay for the service (because, for example, a 
third party payer paid for the item or service, or the service is not 
covered under Medicaid). We also explained that the definition would 
include encounters for patients who are Title XIX eligible and who meet 
the definition of ``optional targeted low income children'' under 
section 1905(u)(2) of the Act. Thus, individuals in Title XXI-funded 
Medicaid expansions (but not separate CHIPs) could be counted in 
providers' patient volume calculations. We stated that this approach is 
consistent with existing policies that provide Title XIX protections to 
children enrolled in Title XXI-funded Medicaid expansions.
    In the proposed rule, we noted that as of 2010, 33 states have 
Title XXI Medicaid expansions via approved state plan amendments. 
Therefore, under our proposed policy, providers in those states would 
be able to include encounters with individuals in such expansions in 
their patient volume calculation for purposes of this program. In 2010, 
over 2.1 million children were covered in Medicaid expansion programs. 
We stated that our proposed change would likely increase the number of 
eligible providers who qualify for the Medicaid EHR Incentive Program, 
particularly those serving children because it allows states to create 
a larger base of Medicaid patients to be counted toward the patient 
volume requirements than existed under the Stage 1 rule.
    Comment: Some commenters were concerned about verifying patient 
volume requirements for patients seen for a service where Medicaid did 
not pay for all or part of the service. Commenters asked CMS to clarify 
the prepayment audit expectations of states with this broader 
definition.
    Response: This final rule does not change states' obligations to 
complete due diligence to verify all eligibility criteria, including 
patient volume. Existing subregulatory guidance is available to states 
to assist in developing audit processes. We encourage states to take 
advantage of those materials, guidance, and technical assistance 
resources that we have made available to support their auditing 
activities.
    Comment: Commenters, while supportive of these changes, inquired 
whether these changes would be retroactive and affect payments already 
disbursed. They asked, for example, whether EPs who attested to 
Medicare for CY 2011 would be able to refund Medicare incentive 
payments and qualify for the Medicaid payment; or whether pediatricians 
who received the incentive for a patient volume of 20 percent would be 
able to receive a replacement payment associated with the 30 percent 
patient volume.
    Response: These changes are not retroactive. Patient volume 
requirements for 2011 and 2012 are not affected by these changes. 
Eligibility for the program is determined at the time of attestation 
and prior to payment. States should implement this new definition of an 
encounter no later than 6 months after this rule is published and only 
for providers attesting for the 2013 program year and subsequent 
program years. In no event will this definition apply to attestations 
for the 2012 program year.
    Comment: Commenters also inquired whether these new eligibility 
changes meant that an EP or eligible hospital denied an incentive 
payment because of failure to satisfy patient volume requirements could 
reapply in the same program year.
    Response: As explained in our response to the previous comment, 
these changes would not be retroactive. Existing rules permit an EP or 
eligible hospital to reapply if they fail to meet the requirements for 
an incentive payment. If a provider fails to meet the requirements in 
2013 before their state has implemented this change, they may then 
reapply after the change is made to their state's systems. 
Additionally, an EP or eligible hospital denied eligibility in a 
previous year is always permitted to reapply for a subsequent year 
(subject to rules for EPs switching programs as explained in Sec.  
495.10).
    For the reasons explained in the proposed rule, and because this 
change will help more Medicaid providers qualify for the program, we 
are finalizing this policy as proposed. The expanded definition of 
encounter will

[[Page 54122]]

include individuals enrolled in Medicaid who had a billable service on 
any one day during the 90-day patient volume timeframe.
    In our proposed rule, we also clarified that we understand that 
multiple providers may submit an encounter for the same individual. For 
example, it may be common for a PA or NP to provide care to a patient, 
then a physician to also see, or invoice for services to that patient. 
We explained that it is acceptable in these and similar circumstances 
to count the same encounter for multiple providers for purposes of 
calculating each provider's patient volume when the encounters take 
place within the scope of practice. We did not receive any comments on 
this clarification and retain it for the final rule.
b. Practices Predominantly
    Similar to our proposed revisions for patient volume, we proposed 
to revise the definition of ``practices predominantly'' at Sec.  
495.302 in order to provide more flexibility for eligible professionals 
and states. A state could choose to allow EPs to use either: (1) The 
most recent calendar year; or (2) the most recent 12 months prior to 
attestation. Also, as with the previously noted patient volume changes, 
these ``practices predominantly'' changes are not retroactive. Patient 
volume requirements for 2011 and 2012 are not affected by these 
changes. States should implement this new definition of an encounter no 
later than 6 months after this rule is published and only for providers 
attesting to meeting program requirements for the 2013 program year and 
subsequent program years. In no event will this definition apply to 
attestations for the 2012 program year.
    Comment: Some commenters--commenting on the patient volume changes 
in Sec.  495.306, the ``practice predominantly'' changes in Sec.  
495.302, and the revised definition of encounter--expressed concerns 
about the system challenges associated with such changes. They 
requested that CMS consider the burden on state systems to implement 
these changes.
    Response: We recognize that system changes must be considered when 
enacting or revising policies. However, we note that much of what we 
have proposed would be optional for states, while some would be 
required. We believe our final rule strikes a balance between optional 
and required policies for states, and providing 6 months to make 
systems changes balances implementation timelines with the overall goal 
to promote EHR adoption through the Medicaid EHR Incentive Program. We 
note that states receive 90 percent Federal matching funds for 
administrative costs associated with the EHR Incentive Program.
    Comment: Although we did not make any proposals on the subject, 
some commenters requested a more prescriptive definition of 
pediatrician be provided to the states that includes pediatric 
ophthalmologists.
    Response: We did not make any proposals on the definition of 
pediatrician. This final rule does not change the previous flexibility 
that states had to define pediatrician. In some states, pediatric 
ophthalmologists are eligible for the program, but that is entirely 
dependent on how the state has chosen to define pediatrician. This 
suggestion is also outside the scope of this rulemaking.
    After consideration of the public comments received, we are 
finalizing the revised definition of ``practices predominantly'' at 
Sec.  495.302 as proposed; this revised definition is applicable to 
providers attesting to meeting program requirements for the 2013 
program year and subsequent program years.
5. Medicaid Hospital Incentive Payment Calculation
a. Discharge Related Amount
    In order to ensure that Medicaid regulations are consistent with 
Medicare, we proposed that the Medicaid calculation should be 
consistent with the Medicare calculation found in Sec.  495.104(c)(2). 
Our current regulations at Sec.  495.310(g)(1)(i)(B) require the use of 
the ``12-month period selected by the state, but ending in the Federal 
fiscal year before the hospital's fiscal year that serves as the first 
payment year.'' We also published a tip sheet with additional guidance 
on the Medicaid hospital incentive payment calculation, which can be 
found at: (https://www.cms.gov/MLNProducts/downloads/Medicaid_Hosp_Incentive_Payments_Tip_Sheets.pdf). However, some hospitals may not 
have a full 12 months of data ending with the Federal fiscal year 
immediately preceding the first payment year, or they may have a 
slightly older 12-month period that could be used. Therefore, we have 
revised our regulations at Sec.  495.310(g)(1)(i)(B) to allow states to 
use, for the purpose of calculating the discharge related amount, and 
other determinations (such as inpatient bed days), the most recent 
continuous 12-month period for which data are available prior to the 
payment year. If such 12-month period is a cost report, it should be 
one, single 12-month cost reporting period (and not a consolidation of 
two separate cost reporting periods). If it is an alternative source 
different from the cost report, we will rely on the state to ensure 
that the source is an appropriate source, and that the period is a 
continuous 12 months, and that the state is using the most recent data 
that are available. States should implement these changes only for 
hospitals that begin participation in the program starting in federal 
fiscal year 2013 or subsequent federal fiscal years. Hospitals that 
began participation before federal fiscal year 2013 must use discharge 
data from the hospital fiscal year that ends during the federal fiscal 
year prior to the hospital fiscal year that serves as the first payment 
year.
    Comment: Commenters were concerned that hospitals may not have a 
full 12 months of data available ending with the Federal fiscal year 
immediately preceding the first payment year, thus restricting 
hospitals participation in the program.
    Response: We appreciate the commenters concern; however, the change 
in regulatory language does not require hospitals to use data 
immediately preceding the first payment year, but rather the most 
recent 12 consecutive months of data available to the hospital prior to 
the payment year. The intent of this regulatory change was to encourage 
timely participation in the program. For the base year, the former 
policy required hospitals to initiate participation using a 12-month 
period ending in the Federal fiscal year before the hospital's fiscal 
year that serves as the first payment year. In recognition of this 
challenge, we are changing the regulation at Sec.  495.310(g)(1)(i)(B) 
to allow hospitals to use, for purposes of determining the base year 
for the Medicaid incentive payment calculation, the most recent 
continuous 12-month period for which data are available prior to the 
payment year. Only those hospitals that begin participation in program 
year 2013 and beyond will be affected by this change. Hospitals that 
began participation in the program before 2013 will not have to adjust 
previous calculations.
    Comment: A commenter suggested that ``the most recent data that are 
available'' is ambiguous. Hospital cost report data are subject to 
significant audit and adjustments subsequent to their submission to the 
state, so the definition of ``available'' has a large impact on the 
reliability of the data used to calculate the incentive payment amount. 
The commenter noted that the state and CMS have a strong interest in 
ensuring that the data used to calculate

[[Page 54123]]

the hospital incentive payment is accurate, defensible, and final, and 
the use of data that are not properly audited would create a 
significant potential for issuing incentive payments that would later 
need to be adjusted. The commenter suggested that CMS clarify ``the 
most recent data that are available'' means the most recent data that, 
in the judgment of the state, are properly audited and finalized.
    Response: We appreciate the commenters concern; however, we do not 
agree that the data needs to be audited and finalized in order to be 
used for the incentive payment calculation. It is our expectation that 
the hospital incentive payment is calculated using the most accurate 
data available at the time of calculation and it is the responsibility 
of the state to make the determination of which source is most 
accurate. We do not restrict data sources, as we believe the states are 
best positioned to balance the accuracy and timeliness of the data 
available. Medicare pays hospitals using preliminary, filed, cost 
report data and reconciles payment when the data is audited and 
finalized. Similarly, we allow states to adjust calculations and 
reconcile payments when audited and finalized data are available. State 
policy changes or proposals regarding reconciliation of hospital 
incentive payments must be reflected in the state' Medicaid Health 
Information Technology Plan (SMHP) and must be reviewed and approved by 
CMS.
b. Acute Care Inpatient Bed Days and Discharges for the Medicaid Share 
and Discharge-Related Amount
    In order to ensure that the regulations accurately reflect our 
current policy, we proposed to amend the hospital payment regulations 
at Sec.  495.310(g)(1)(i)(B) and (g)(2) to recognize that only acute-
care discharges and bed-days are included in our calculations. We 
currently require that only discharges from the acute care part of the 
hospital may be counted in both the discharge-related amount and the 
Medicaid share. For example, in response to a frequently asked question 
(https://questions.cms.gov, FAQ 2991), we explained that 
nursery days and nursery discharges (for newborns) could not be counted 
in both the Medicare and Medicaid EHR incentive programs. We stated: 
``[N]ursery days and discharges are not included in inpatient bed-day 
or discharge counts in calculating hospital incentives * * * because 
they are not considered acute inpatient services based on the level of 
care provided during a normal nursery stay.''
    Such regulatory amendments do not represent a change in policy but 
rather a clarification of existing policy. The Medicaid share will 
count only those days that will count as inpatient-bed days for 
Medicare purposes under section 1886(n)(2)(D) of the Act. (See 75 FR 
44498). In addition, in determining the overall EHR amount, section 
1903(t)(5)(B) of the Act requires the use of applicable amounts 
specified in section 1886(n)(2)(A) of the Act.
    Comment: A commenter expressed concern with the perceived removal 
of newborn nursery days from the hospital calculation. The commenter 
stated that this would create a disadvantage for some hospitals.
    Response: We wish to be clear our policy on nursery days is not a 
new policy or a proposed change. The change in regulatory language on 
the use of acute inpatient bed days is to ensure that our regulation 
text clearly reflects our existing policy. The requirement to exclude 
non-acute inpatient bed days from the incentive payment calculation is 
consistent with both the Medicare and Medicaid regulations under Stage 
1, as stated in our frequently asked questions (available at https://questions.cms.gov, FAQ 2991). In that FAQ, we explain that the 
Medicaid payment to hospitals is based largely on the method that 
applies to Medicare incentive payments. Because such nursery discharges 
and bed days would not be included in the Medicare calculation, and 
because the Medicaid statute incorporates Medicare concepts, they also 
would not be counted in the Medicaid formula. We are simply adding 
additional language to clarify that all bed days and discharges used in 
the calculation are strictly limited to the acute-inpatient portion of 
the hospital. All hospitals will continue to exclude nonacute bed days 
and discharges from the hospital incentive calculation.
    Comment: A commenter suggested that CMS clarify and inform states 
and providers that neonatal intensive care days are considered acute, 
and should be included in the Medicaid hospital incentive payment 
calculation.
    Response: We appreciate the commenter's suggestion and recognize 
that neonatal intensive care days are considered acute inpatient 
services that should be included in the hospital incentive calculation.
c. Hospitals Switching States
    There may be a situation where a hospital changes participation in 
one state Medicaid EHR incentive program to participation in another 
state. We are clarifying that in no case will a hospital receive more 
than the aggregate incentive amount calculated by the state from which 
the hospital initiated participation in the program. Section 495.310(e) 
requires a hospital to choose only one state per payment year from 
which to receive an incentive payment. Additionally, Sec.  
495.310(f)(2) states that in no case can total incentives received by a 
hospital exceed the aggregate EHR incentive amount, as calculated in 
Sec.  495.310(g).
    In this scenario, both states will be required to work together to 
determine the remaining payments due to the hospital based on the 
aggregate incentive amount and incentive amounts already paid. The 
hospital will then assume the second state's payment cycle, less the 
money paid from the first state. States should consult with CMS before 
addressing this specific scenario.
    We did not receive any comments and we are finalizing these 
provisions as proposed for the reasons provided in the proposed rule.
6. Hospital Demonstrations of Meaningful Use--Auditing and Appeals
    We proposed revisions to Sec.  495.312 under which states would 
have the option for CMS to conduct audits and handle any subsequent 
appeals of whether eligible hospitals are meaningful EHR users, on the 
state's behalf. (We note that the preamble text (at 77 FR 13788) did 
not reflect the proposed regulations.) We also proposed revisions to 
the SMHP requirements in Sec.  495.332 by adding a new paragraph (g) 
that would allow the state, at the state's option, to include a signed 
agreement if the state has opted for CMS to conduct such audits and 
appeals. Under these proposals, the state electing the option would be 
required to (1) designate CMS to conduct all audits and appeals of 
eligible hospitals' meaningful use attestations; (2) be bound by the 
audit and appeal findings; (3) perform any necessary recoupments 
arising from the audits; and (4) be liable for any FFP granted the 
state to pay eligible hospitals that, upon audit (and any subsequent 
appeal) are determined not to have been meaningful EHR users. Finally, 
we proposed to revise our regulations at Sec.  495.370 to make clear 
that results of any adverse CMS audits (for states that have made the 
election) would be subject to the CMS administrative appeals process 
and not the state appeals process.
    Most hospitals are eligible for both Medicare and Medicaid 
incentive payments, submit attestations on meaningful use to us under 
the Medicare attestation system, and, if

[[Page 54124]]

successful, under the authority of section 1903(t)(8) of the Act, are 
deemed to have met the meaningful use requirements for Medicaid. Thus, 
we believe the revisions that were included in our proposed regulation 
text would provide states with the option to alleviate their burden to 
develop an audit process for hospitals and then perform audits on 
hospitals' meaningful use attestations. Because the regulation text 
made the CMS audits and appeals a state option, no state would be 
required to delegate the responsibility to CMS.
    As discussed in the proposed rule preamble, many states indicated 
an interest in having CMS audit all hospitals' meaningful use 
attestations, and a majority of states have two or fewer Medicaid-only 
hospitals applying for incentive payments. Therefore, a state option 
for CMS to conduct audits and appeals will leverage the resources 
already devoted to auditing the vast majority of hospitals that are 
eligible for both incentive programs while retaining state flexibility 
to perform their own meaningful use audits and appeals for the 
Medicaid-only hospitals in states that choose to do so. (In cases where 
a state has made the election, meaningful use attestation data 
collected by states for the Medicaid-only eligible hospitals would be 
shared with our auditors to enable this process).
    As discussed in the proposed rule, we note that this policy does 
not extend to Medicaid eligible professionals, given the anticipated 
large number of Medicaid eligible professionals demonstrating 
meaningful use solely under the Medicaid program. In addition, states 
that opt for CMS to conduct audits and appeals will remain responsible 
for auditing all other aspects of eligibility for both EPs and eligible 
hospitals for incentive payments, including, but not limited to--(1) 
adopt, implement or upgrade; (2) patient volume; (3) average stay 
length; and (4) calculation of payment amounts. States will also remain 
responsible for auditing EPs for compliance with meaningful use of 
certified EHR technology.
    We did not receive any comments on either the preamble or the 
regulation text, and we are finalizing the proposed regulations for the 
reasons discussed previously.
7. State Flexibility for Stage 2 of Meaningful Use
    We proposed to offer states flexibility with the public health 
measures in Stage 2, similar to that of Stage 1, subject to the same 
conditions and standards as the Stage 1 flexibility policy. This 
applies to the public health measures as well as the measure to 
generate lists of specific conditions to use for quality improvement, 
reduction of disparities, research or outreach. In addition, we 
proposed that whether moved to the core or left in the menu, states 
could also specify the means of transmission of the data or otherwise 
change the public health measure, as long as it does not require EHR 
functionality above and beyond that which is included in the ONC EHR 
certification criteria as finalized for Stage 2 of meaningful use.
    We did not receive any comments on this policy. Although Sec.  
495.316(d)(2) already contains provisions for state flexibility, there 
are new public health measures for Stage 2 of meaningful use and some 
of the descriptions are changing slightly for Stage 2. Therefore, in 
this final rule, we have amended Sec.  495.316(d)(2) to ensure that the 
objectives for which states will have flexibility are adequately 
represented for both Stage 1 and Stage 2.
8. State Medicaid Health Information Technology Plan (SMHP) and 
Implementation Advance Planning Document (IAPD)
a. Frequency of Health Information Technology (HIT) Implementation 
Advanced Planning Document (IAPD) Updates
    We proposed to revise Sec.  495.342 regarding the frequency of HIT 
IAPD updates. Rather than requiring each state to submit an annual HIT 
IAPD within 60 days from the HIT IAPD approved anniversary date, we 
proposed to require that a state's annual IAPD (also known as an IAPD 
Update (IAPD-U)) be submitted a minimum of 12 months from the date of 
the last CMS approved HIT IAPD. For example, if the initial HIT IAPD or 
previous IAPD-U was approved by CMS effective July 25, 2011, the state 
must submit their next HIT IAPD-U on or before July 25, 2012. 
Therefore, annual IAPD updates are required only if the state has not 
submitted an IAPD-U in the past 12 months, rather than on a fixed 
annual basis as currently reflected in Sec.  495.342. We did not 
propose to change the requirements of the circumstances of ``as 
needed'' IAPD updates as defined by Sec.  495.340.
    Comment: Comments received on the change to the annual HIT IAPD 
submission deadline requirements were supportive of the change and the 
idea of reducing the administrative burden on states. A commenter 
requested that the phrase, ``minimum of 12 months'' be changed to 
``maximum of 12 months.''
    Response: We believe that a better solution would be to remove the 
word ``minimum'' from the text so it reads, ``Each state is required to 
submit the HIT IAPD Updates 12 months from the date of the last CMS 
approved HIT IAPD and must contain the following.'' This more 
accurately describes the intent to clarify the timeline in which the 
state must submit the annual HIT IAPD. Therefore, Sec.  495.342 is 
revised accordingly.
b. Requirements of States Transitioning From HIT Planning Advanced 
Planning Documents (P-APDs) to HIT IAPDs
    We proposed the following process for states that have an approved 
HIT P-APD and are ready to submit a HIT IAPD for review and approval. 
We do not allow states to have more than one HIT Advance Planning 
Document (APD) open at a time. If planning activities from the HIT P-
APD have been completed, in their HIT IAPD the state should explain in 
a narrative format that all planning activities have been completed and 
the planning advanced planning document can be closed out. If there are 
HIT planning activities that the state determines will continue during 
the implementation period, these planning activities must be included 
as line items within the HIT IAPD budget.
    We did not receive any comments on this discussion of the process 
states should use. We will use the previously-described process for 
states transitioning from a HIT P-APD to a HIT IAPD.

III. Waiver of Delayed Effective Date

    We ordinarily provide a 60-day delay in the effective date of the 
provisions of a major rule in accordance with the Administrative 
Procedure Act (APA) (5 U.S.C. 553(d), which requires a 30-day delayed 
effective date, and the Congressional Review Act (5 U.S.C. 801(a)(3), 
which requires a 60-day delayed effective date for major rules. 
However, we can waive the delay in effective date if the Secretary 
finds, for good cause, that such delay is impracticable, unnecessary, 
or contrary to the public interest, and incorporates a statement of the 
finding and the reasons in the rule issued under 5 U.S.C. 553(d)(3) and 
5 U.S.C. 808(2).
    The Secretary finds that good cause exists to make certain 
regulatory provisions effective upon publication in the Federal 
Register.
    Our revisions to Sec.  495.6(f) and (g) change certain criteria for 
meaningful use beginning with FY 2013. Some eligible hospitals and CAHs 
will begin their EHR reporting period using the criteria under Sec.  
495.6(f) and (g)

[[Page 54125]]

beginning October 1, 2012. All of these changes are optional and are 
meant to provide greater flexibility in meeting these criteria. Because 
these revisions relieve a restriction on eligible hospitals and CAHs, a 
waiver of the delayed effective date is in order. It is both 
unnecessary to delay the effective date, and in the public's best 
interest to waive the delay in effective date for these changes. 
Furthermore, ensuring that these provisions are effective beginning 
with FY 2013 would mitigate any disadvantage experienced by eligible 
hospitals and CAHs beginning their EHR reporting periods at the 
beginning of the fiscal year, because it would allow them to use these 
revised criteria at the beginning of such period. Our revisions to 
Sec.  495.6(f) include eliminating the reporting of clinical quality 
measures as a separate objective of meaningful use and instead 
including this reporting requirement as part of the definition of 
``meaningful EHR user'' under Sec.  495.4. Accordingly, the delayed 
effective date must also be waived with regard to the definition of 
``meaningful EHR user'' under Sec.  495.4 and the revisions to Sec.  
495.8. To allow these provisions to take effect with the beginning of 
FY 2013, it is impracticable to delay the effective date, which would 
occur after the beginning of the fiscal year.
    We have also made a technical correction to Sec.  495.102(c) so 
that it correctly reflects the policy we adopted in the Stage 1 final 
rule for EPs who predominantly furnish services in a geographic HPSA. 
This change is technical in nature and merely codifies our existing 
policy. Retaining current regulatory language would allow an error to 
persist. Therefore, it is unnecessary, impracticable, and contrary to 
the public interest to delay the effective date of this codification.
    We are also waiving the delay in effective date for all of the 
changes we are making to subpart D of part 495. Some of these changes 
either codify or more clearly specify already existing policy 
(deletions of Sec.  495.310(a)(1)(ii), Sec.  495.310(a)(2)(ii), and 
Sec.  495.332(d)(9) to reflect the existing policy on net average 
allowable cost under the Medicare and Medicaid Extenders Act of 2010; 
changes to Sec.  495.310(g) to clarify that the rules are for ``acute-
care inpatient discharges'' and ``acute care inpatient bed-days''; 
changes to Sec.  495.310 to clarify policy on hospitals switching 
states). Therefore, it is unnecessary, impracticable, and contrary to 
the public interest to delay the effective date of these provisions as 
they are already in effect as CMS policies.
    Others of these changes merely provide states or eligible providers 
with additional flexibility to adopt policies that will be of benefit 
to the states or providers, thus relieving a restriction (Sec.  495.302 
change in definition for children's hospital and practices 
predominantly; Sec.  495.304 regarding allowing EPs and eligible 
hospitals to include individuals enrolled in a Medicaid program in 
2013; changes to Sec.  495.306 regarding additional flexibility for 
determining patient volume in 2013; changes to Sec.  495.312 and Sec.  
495.332(c) and (g) and Sec.  495.370 regarding additional options for 
states in conducting audits and appeals of eligible hospitals' 
meaningful use; and changes to Sec.  495.342 adding flexibility on 
submission of the HIT IAPD). These changes will be in the public 
interest of states or eligible providers or both, because they provide 
additional flexibility allowing states to relieve their burdens, or 
allowing additional providers to qualify for Medicaid incentives under 
the program. It is important that these changes be in place as soon as 
possible, and especially as of October 1, 2012 for eligible hospitals 
beginning their fiscal years. Therefore, a waiver in the delay in the 
effective date is both impracticable and contrary to the public 
interest, and the Secretary finds good cause not to delay the effective 
date of these provisions.
    The final change to subpart D (in Sec.  495.304(f) and Sec.  
495.332(b)(6)) applies to EPs, who will not begin payment year 2013 
until the beginning of the calendar year in any case. However, in the 
interest of ensuring that states have a reasonable opportunity to amend 
their SMHPs and to ensure consistency in effective date for the entire 
subpart it is in the public interest to waive the delay in effective 
date for these changes as well. Again, the effect on EPs would not take 
place until January of 2013 in any case--well after a 60-day delay has 
occurred.
    For all these reasons, we believe that a 60-day delay in the 
effective date of the previously discussed provisions would be 
unnecessary, impracticable, and contrary to the public interest. 
Therefore, we find good cause for waiving the 60-day delay in the 
effective date for these provisions and making the provisions effective 
upon publication.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    The following is a discussion of the requirements we believe are 
subject to the PRA and collection of information requirements (ICRs) as 
a result of this final rule. This analysis finalizes our projections 
which were proposed in the March 7, 2012 Federal Register (77 FR 13790 
through 13800) in which we proposed a revision to the existing PRA 
package approved under OMB control number 0938-1158. The projected 
numbers of EPs, eligible hospitals, CAHs, MA organizations, MA EPs, and 
MA-affiliated hospitals are based on the numbers used in the impact 
analysis assumptions as well as estimated federal costs and savings in 
section V. of this final rule. The actual burden will remain constant 
for all of Stage 2 as EPs, eligible hospitals, and CAHs will only need 
to attest that they have successfully demonstrated meaningful use one 
time per year. The only variable from year to year in Stage 2 will be 
the number of respondents, as noted in the impact analysis assumptions. 
For the purposes of this analysis, we are focusing only on 2014, the 
first year in which a provider may participate in Stage 2 of the 
Medicare EHR Incentive Program. We do not believe the burden for EPs, 
eligible hospitals, and CAHs participating in Stage 1 prior to 2014 
will be different from the agency information collection activities (75 
FR 65354) based on this final rule. Beginning in 2012, Medicare EPs, 
eligible hospitals, and CAHs have the option to electronically report 
their clinical quality measures through the respective electronic 
reporting pilots. The burden for the EP pilot is discussed in the CY 
2012 Medicare PFS final rule with comment period (76 FR 73450 through 
73451). For eligible hospitals and CAHs, the burden is discussed in the 
CY 2012 OPPS final rule with comment period (76 FR 74489 through 
74492).

[[Page 54126]]

A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  495.6 
and Sec.  495.8)

    In Sec.  495.6 of the proposed rule, we proposed that to 
successfully demonstrate meaningful use of CEHRT for Stage 2, an EP, 
eligible hospital or CAH (collectively referred to as ``provider'' in 
this section) must attest, through a secure mechanism in a specified 
manner, to the following during the EHR reporting period: (1) The 
provider used CEHRT and specified the technology was used; and (2) the 
provider satisfied each of the applicable objectives and associated 
measures in Sec.  495.6. In Sec.  495.8, we proposed that a provider 
must also successfully report the clinical quality measures selected by 
CMS to CMS or the states, as applicable. We assumed that the CEHRT 
adopted by the provider would capture many of the objectives and 
associated measures and generate automated numerator and denominator 
information where required, or generate automated summary reports. We 
also expect that the provider would enable the functionality required 
to complete the objectives and associated measures that require the 
provider to attest that they have done so.
    We proposed that EPs would be required to report on a total of 17 
core objectives and associated measures, 3 of 5 menu set objectives and 
associated measures, and 12 ambulatory clinical quality measures. We 
estimated the total average annual cost burden for all 198,912 
nonhospital-based EPs who may attest in 2014 to be $186,098,885 
(198,912 EPs x 10 hours 24 minutes x $89.96 (mean hourly rate for 
physicians based on May 2010 Bureau of Labor Statistics (BLS) data)). 
We proposed that eligible hospitals and CAHs would be required to 
report on a total of 16 core objectives and associated measures, 2 of 
the 4 menu set objectives and associated measures, and 24 clinical 
quality measures. We estimated the total annual cost burden for all 
eligible hospitals and CAHs to attest to EHR technology, meaningful use 
core set and menu set criteria, and electronically submit the clinical 
quality measures would be $2,375,564 (4,993 eligible hospitals and CAHs 
x $62.23 (12 hours 14 minutes x $62.23 (mean hourly rate for lawyers 
based on May 2010 BLS) data)).
    Comment: A commenter suggested CMS account for Web site 
responsiveness when estimating the burden for providers as they enter 
attestation data. The commenter noted that the Web site would take 
several minutes after entering data until the next page would become 
available.
    Response: We cannot forecast technical difficulties with our Web 
sites, but strive to maintain a high level of responsiveness.
    Comment: Some commenters suggested CMS underestimated the amount of 
time it takes providers to attest that they have successfully 
demonstrated meaningful use. They noted that providers see attestation 
as more than just reporting their data at the end of the reporting 
period, rather, a process that is continuously monitored throughout 
that time. Others noted that the operational burden that providers 
encounter on a per-patient basis will increase significantly in Stage 
2.
    Response: We appreciate the public comments on this burden 
analysis. However, this analysis specifically reflects the amount of 
time we estimate providers will take to prepare and report their 
meaningful use data through the Medicare and Medicaid EHR Incentive 
Programs Registration and Attestation System. We cannot account for 
individual providers' workflows or training needs to participate in 
these programs.
    After consideration of the public comments received, we are 
finalizing these burden estimates as proposed but have updated them to 
reflect policy changes implemented through this final rule.
    In this final rule, there are 13 core objectives and up to 3 menu 
set objectives that will require an EP to enter numerators and 
denominators during attestation. Eligible hospitals and CAHs will have 
to attest they have met 10 core objectives and 3 menu set objectives 
that require numerators and denominators. For objectives and associated 
measures requiring a numerator and denominator, we limit our estimates 
to actions taken in the presence of CEHRT. We do not anticipate a 
provider will maintain two recordkeeping systems when CEHRT is present. 
Therefore, we assume that all patient records that will be counted in 
the denominator will be kept using certified EHR technology. We expect 
it will take an individual provider or their designee approximately 10 
minutes to attest to each meaningful use objective and associated 
measure that requires a numerator and denominator to be generated, as 
well as each CQM for providers attesting in their first year of the 
program.
    Additionally, providers will be required to report they have 
completed objectives and associated measures that require a ``yes'' or 
``no'' response during attestation. For EPs, there are 3 core 
objectives and up to 3 menu set objectives that will require a ``yes'' 
or ``no'' response during attestation. For eligible hospitals and CAHs, 
there are 5 core objectives and that will require a ``yes'' or ``no'' 
response during attestation and no such menu set objectives. We expect 
that it will take a provider or their designee 1 minute to attest to 
each objective that requires a ``yes'' or ``no'' response.
    Providers will also be required to attest that they are protecting 
electronic health information. We estimate completion of the analysis 
required to successfully meet the associated measure for this objective 
will take approximately 6 hours, which is identical to our estimate for 
the Stage 1 requirement. This burden estimate assumes that covered 
entities are already conducting and reviewing these risk analyses under 
current HIPAA regulations. Therefore, we have not accounted for the 
additional burden associated with the conduct or review of such 
analyses.
    Table 20 lists those objectives and associated measures for EPs, 
eligible hospitals and CAHs. We estimate the core set of objectives and 
associated measures will take an EP 8 hours and 13 minutes to complete, 
and will take an eligible hospital or CAH 7 hours and 45 minutes to 
complete. For EPs, we estimate the completion of 3 menu set objectives 
and associated measures will take between 3 minutes and 30 minutes to 
complete, depending on the combination of objectives they choose to 
attest to. We estimate the selection, preparation, and electronic 
submission of the 9 ambulatory clinical quality measures will take EPs 
1 hour and 30 minutes. We estimate it will take eligible hospitals and 
CAHs 30 minutes to attest to the 3 menu set objectives they choose. For 
eligible hospitals and CAHs, we estimate the selection, preparation, 
and electronic submission of 16 required clinical quality measures will 
take 2 hours and 40 minutes.

[[Page 54127]]

                                                               Table 20--Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Eligible hospitals and                            Burden estimate per respondent    Burden estimate per respondent
       Eligible professionals                 CAHs              Stage 2 measures                   (EPs)                           (hospitals)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        CORE SET
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use computerized provider order      Use computerized        More than 60% of        10 minutes.......................  10 minutes.
 entry (CPOE) for medication,         provider order entry    medication, 30% of
 laboratory and radiology orders      (CPOE) for              laboratory, and 30%
 directly entered by any licensed     medication,             of radiology orders
 healthcare professional who can      laboratory and          created by the EP or
 enter orders into the medical        radiology orders        authorized providers
 record per state, local and          directly entered by     of the eligible
 professional guidelines.             any licensed            hospital's or CAH's
                                      healthcare              inpatient or
                                      professional who can    emergency department
                                      enter orders into the   (POS 21 or 23) during
                                      medical record per      the EHR reporting
                                      state, local and        period are recorded
                                      professional            using CPOE.
                                      guidelines.
Generate and transmit permissible    ......................  More than 50% of all    10 minutes.......................
 prescriptions electronically (eRx).                          permissible
                                                              prescriptions, or all
                                                              prescriptions written
                                                              by the EP and queried
                                                              for a drug formulary
                                                              and transmitted
                                                              electronically using
                                                              CEHRT.
Record the following demographics..  Record the following    More than 80% of all    10 minutes.......................  10 minutes.
 Preferred language........   demographics.           unique patients seen
 Sex.......................   Preferred       by the EP or admitted
 Race......................   language.               to the eligible
 Ethnicity.................   Sex..........   hospital's or CAH's
 Date of birth.............   Race.........   inpatient or
                                      Ethnicity....   emergency department
                                      Date of birth   (POS 21 or 23) have
                                      Date and        demographics recorded
                                      preliminary cause of    as structured data.
                                      death in the event of
                                      mortality in the
                                      eligible hospital or
                                      CAH.
Record and chart changes in vital    Record and chart        More than 80% of all    10 minutes.......................  10 minutes.
 signs:.                              changes in vital        unique patients seen
 Height/length.............   signs:.                 by the EP or admitted
 Weight....................   Height/length   to the eligible
 Blood pressure (age 3 and    Weight.......   hospital's or CAH's
 over).                               Blood           inpatient or
 Calculate and display BMI.   pressure (age 3 and     emergency department
 Plot and display growth      over).                  (POS 21 or 23) during
 charts for patients 0-20 years,      Calculate and   the EHR reporting
 including BMI.                       display BMI.            period have blood
                                      Plot and        pressure (for
                                      display growth charts   patients age 3 and
                                      for patients 0-20       over only) and height/
                                      years, including BMI.   length and weight
                                                              (for all ages)
                                                              recorded as
                                                              structured data.
Record smoking status for patients   Record smoking status   More than 80% of all    10 minutes.......................  10 minutes.
 13 years old or older.               for patients 13 years   unique patients 13
                                      old or older.           years old or older
                                                              seen by the EP or
                                                              admitted to the
                                                              eligible hospital's
                                                              or CAH's inpatient or
                                                              emergency departments
                                                              (POS 21 or 23) have
                                                              smoking status
                                                              recorded as
                                                              structured data.
Use clinical decision support to     Use clinical decision   1. Implement five
 improve performance on high-         support to improve      clinical decision
 priority health conditions.          performance on high-    support interventions
                                      priority health         related to four or
                                      conditions.             more clinical quality
                                                              measures at a
                                                              relevant point in
                                                              care for the entire
                                                              EHR reporting period.
                                                              Absent four clinical
                                                              quality measures
                                                              related to an EP,
                                                              eligible hospital or
                                                              CAH's scope of
                                                              practice or patient
                                                              population, the
                                                              clinical decision
                                                              support interventions
                                                              must be related to
                                                              improving healthcare
                                                              efficiency.

[[Page 54128]]

 
                                     ......................  2. The EP, eligible     1 minute.........................  1 minute.
                                                              hospital or CAH has
                                                              enabled and
                                                              implemented the
                                                              functionality for
                                                              drug-drug and drug-
                                                              allergy interaction
                                                              checks for the entire
                                                              EHR reporting period.
Incorporate clinical lab-test        Incorporate clinical    More than 55% of all    10 minutes.......................  10 minutes.
 results as structured data.          lab-test results as     clinical lab tests
                                      structured data.        results ordered by
                                                              the EP or by
                                                              authorized providers
                                                              of the eligible
                                                              hospital or CAH for
                                                              patients admitted to
                                                              its inpatient or
                                                              emergency department
                                                              (POS 21 or 23) during
                                                              the EHR reporting
                                                              period whose results
                                                              are either in a
                                                              positive/negative
                                                              affirmation or
                                                              numerical format are
                                                              incorporated in CEHRT
                                                              as structured data.
Generate lists of patients by        Generate lists of       Generate at least one   1 minute.........................  1 minute.
 specific conditions to use for       patients by specific    report listing
 quality improvement, reduction of    conditions to use for   patients of the EP,
 disparities, research, or outreach.  quality improvement,    eligible hospital or
                                      reduction of            CAH with a specific
                                      disparities,            condition.
                                      research, or outreach.
Use clinically relevant information  ......................  More than 10% of all    10 minutes.......................
 to identify patients who should                              unique patients who
 receive reminders for preventive/                            have had two or more
 follow-up care and send these                                office visits with
 patients the reminder, per patient                           the EP within the 24
 preference.                                                  months before the
                                                              beginning of the EHR
                                                              reporting period were
                                                              sent a reminder, per
                                                              patient preference
                                                              when available.
                                     Automatically track     More than 10% of        .................................  10 minutes.
                                      medications from        medication orders
                                      order to                created by authorized
                                      administration using    providers of the
                                      assistive               eligible hospital's
                                      technologies in         or CAH's inpatient or
                                      conjunction with an     emergency department
                                      electronic medication   (POS 21 or 23) during
                                      administration record   the EHR reporting
                                      (eMAR).                 period for which all
                                                              doses are tracked
                                                              using eMAR.
Provide patients the ability to      ......................  1. More than 50% of     10 minutes.......................
 view online, download, and                                   all unique patients
 transmit their health information                            seen by the EP during
 within 4 business days of the                                the EHR reporting
 information being available to the                           period are provided
 EP.                                                          timely (within 4
                                                              business days after
                                                              the information is
                                                              available to the EP)
                                                              online access to
                                                              their health
                                                              information subject
                                                              to the EP's
                                                              discretion to
                                                              withhold certain
                                                              information.
                                                             2. More than 5% of all
                                                              unique patients seen
                                                              by the EP during the
                                                              EHR reporting period
                                                              (or their authorized
                                                              representatives)
                                                              view, download, or
                                                              transmit to a third
                                                              party their health
                                                              information..

[[Page 54129]]

 
                                     Provide patients the    1. More than 50% of     .................................  10 minutes.
                                      ability to view         all patients who are
                                      online, download, and   discharged from the
                                      transmit information    inpatient or
                                      about a hospital        emergency department
                                      admission.              (POS 21 or 23) of an
                                                              eligible hospital or
                                                              CAH have their
                                                              information available
                                                              online within 36
                                                              hours of discharge.
                                                             2. More than 5% of all
                                                              patients (or their
                                                              authorized
                                                              representatives) who
                                                              are discharged from
                                                              the inpatient or
                                                              emergency department
                                                              (POS 21 or 23) of an
                                                              eligible hospital or
                                                              CAH view, download or
                                                              transmit to a third
                                                              party their
                                                              information during
                                                              the reporting period..
Provide clinical summaries for       ......................  Clinical summaries      10 minutes.......................
 patients for each office visit.                              provided to patients
                                                              or patient-authorized
                                                              representatives
                                                              within 1 business day
                                                              for more than 50% of
                                                              office visits.
Use CEHRT to identify patient-       Use CEHRT to identify   Patient-specific        10 minutes.......................  10 minutes.
 specific education resources and     patient-specific        education resources
 provide those resources to the       education resources     identified by CEHRT
 patient.                             and provide those       are provided to
                                      resources to the        patients for more
                                      patient.                than 10% of all
                                                              unique patients with
                                                              office visits seen by
                                                              the EP during the EHR
                                                              reporting period.
                                                             More than 10% of all
                                                              unique patients
                                                              admitted to the
                                                              eligible hospital's
                                                              or CAH's inpatient or
                                                              emergency departments
                                                              (POS 21 or 23) are
                                                              provided patient-
                                                              specific education
                                                              resources identified
                                                              by CEHRT..
Use secure electronic messaging to   ......................  A secure message was    10 minutes.......................
 communicate with patients on                                 sent using the
 relevant health information.                                 electronic messaging
                                                              function of CEHRT by
                                                              more than 5% of
                                                              unique patients (or
                                                              their authorized
                                                              representatives) seen
                                                              by the EP during the
                                                              EHR reporting period.
The EP who receives a patient from   The eligible hospital   The EP, eligible        10 minutes.......................  10 minutes.
 another setting of care or           or CAH who receives a   hospital or CAH
 provider of care or believes an      patient from another    performs medication
 encounter is relevant should         setting of care or      reconciliation for
 perform medication reconciliation.   provider of care or     more than 50% of
                                      believes an encounter   transitions of care
                                      is relevant should      in which the patient
                                      perform medication      is transitioned into
                                      reconciliation.         the care of the EP or
                                                              admitted to the
                                                              eligible hospital's
                                                              or CAH's inpatient or
                                                              emergency department
                                                              (POS 21 or 23).

[[Page 54130]]

 
The EP who transitions their         The eligible hospital   1. The EP, eligible     10 minutes.......................  10 minutes.
 patient to another setting of care   or CAH who              hospital, or CAH that
 or provider of care or refers        transitions their       transitions or refers
 their patient to another provider    patient to another      their patient to
 of care provides a summary care      setting of care or      another setting of
 record for each transition of care   provider of care or     care or provider of
 or referral.                         refers their patient    care provides a
                                      to another provider     summary of care
                                      of care provides a      record for more than
                                      summary care record     50% of transitions of
                                      for each transition     care and referrals.
                                      of care or referral.   2. The EP, eligible
                                                              hospital or CAH that
                                                              transitions or refers
                                                              their patient to
                                                              another setting of
                                                              care or provider of
                                                              care provides a
                                                              summary of care
                                                              record for more than
                                                              10% of such
                                                              transitions and
                                                              referrals either (a)
                                                              electronically
                                                              transmitted using
                                                              CEHRT to a recipient
                                                              or (b) where the
                                                              recipient receives
                                                              the summary of care
                                                              record via exchange
                                                              facilitated by an
                                                              organization that is
                                                              a NwHIN Exchange
                                                              participant or in a
                                                              manner that is
                                                              consistent with the
                                                              governance mechanism
                                                              ONC establishes for
                                                              the nationwide health
                                                              information network..
                                                             3. An EP, eligible
                                                              hospital or CAH must
                                                              satisfy one of the
                                                              two following
                                                              criteria:.
                                                             (A) conducts one or
                                                              more successful
                                                              electronic exchanges
                                                              of a summary of care
                                                              document, as part of
                                                              which is counted in
                                                              ``measure 2'' (for
                                                              EPs the measure at
                                                              Sec.
                                                              495.6(j)(14)(ii)(B)
                                                              and for eligible
                                                              hospitals and CAHs
                                                              the measure at Sec.
                                                              495.6(l)(11)(ii)(B))
                                                              with a recipient who
                                                              has EHR technology
                                                              that was developed
                                                              designed by a
                                                              different EHR
                                                              technology developer
                                                              than the sender's EHR
                                                              technology certified
                                                              to 45 CFR
                                                              170.314(b)(2)..
Capability to submit electronic      Capability to submit    Successful ongoing      1 minute.........................  1 minute.
 data to immunization registries or   electronic data to      submission of
 immunization information systems     immunization            electronic
 except where prohibited, and in      registries or           immunization data
 accordance with applicable law and   immunization            from CEHRT to an
 practice.                            information systems     immunization registry
                                      except where            or immunization
                                      prohibited, and in      information system
                                      accordance with         for the entire EHR
                                      applicable law and      reporting period.
                                      practice.
                                     Capability to submit    Successful ongoing      .................................  1 minute.
                                      electronic reportable   submission of
                                      laboratory results to   electronic reportable
                                      public health           laboratory results
                                      agencies, except        from CEHRT to public
                                      where prohibited, and   health agencies for
                                      in accordance with      the entire EHR
                                      applicable law and      reporting period.
                                      practice.
                                     Capability to submit    Successful ongoing      .................................  1 minute.
                                      electronic syndromic    submission of
                                      surveillance data to    electronic syndromic
                                      public health           surveillance data
                                      agencies, except        from CEHRT to a
                                      where prohibited, and   public health agency
                                      in accordance with      for the entire EHR
                                      applicable law and      reporting period.
                                      practice.

[[Page 54131]]

 
Protect electronic health            Protect electronic      Conduct or review a     6 hours..........................  6 hours.
 information created or maintained    health information      security risk
 by the CEHRT through the             created or maintained   analysis in
 implementation of appropriate        by the CEHRT through    accordance with the
 technical capabilities.              the implementation of   requirements under 45
                                      appropriate technical   CFR 164.308(a)(1),
                                      capabilities.           including addressing
                                                              the encryption/
                                                              security of data
                                                              stored in CEHRT in
                                                              accordance with
                                                              requirements under 45
                                                              CFR 164.312
                                                              (a)(2)(iv) and 45 CFR
                                                              164.306(d)(3), and
                                                              implement security
                                                              updates as necessary
                                                              and correct
                                                              identified security
                                                              deficiencies as part
                                                              of the provider's
                                                              risk management
                                                              process.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Core Set Burden                                    8 hours 13 minutes...............  7 hours 45 minutes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        MENU SET
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Record whether a        More than 50% of all    .................................  10 minutes.
                                      patient 65 years old    unique patients 65
                                      or older has an         years old or older
                                      advance directive.      admitted to the
                                                              eligible hospital's
                                                              or CAH's inpatient
                                                              department (POS 21)
                                                              during the EHR
                                                              reporting period have
                                                              an indication of an
                                                              advance directive
                                                              status recorded as
                                                              structured data.
Imaging results consisting of the    Imaging results         More than 10% of all    10 minutes.......................  10 minutes.
 image itself and any explanation     consisting of the       tests whose result is
 or other accompanying information    image itself and any    one or moreimages
 are accessible through CEHRT.        explanation or other    ordered by the EP or
                                      accompanying            by an authorized
                                      information are         provider of the
                                      accessible through      eligible hospital or
                                      CEHRT.                  CAH for patients
                                                              admitted to its
                                                              inpatient or
                                                              emergency department
                                                              (POS 21 and 23)
                                                              during the EHR
                                                              reporting period are
                                                              accessible through
                                                              CEHRT.
Record patient family health         Record patient family   More than 20% of all    10 minutes.......................  10 minutes.
 history as structured data.          health history as       unique patients seen
                                      structured data.        by the EP or admitted
                                                              to the eligible
                                                              hospital or CAH's
                                                              inpatient or
                                                              emergency department
                                                              (POS 21 or 23) during
                                                              the EHR reporting
                                                              period have a
                                                              structured data entry
                                                              for one or more first-
                                                              degree relatives.
                                     Generate and transmit   More than 10% of        .................................  10 minutes
                                      permissible discharge   hospital discharge
                                      prescriptions           medication orders for
                                      electronically (eRx).   permissible
                                                              prescriptions (for
                                                              new, changed, and
                                                              refilled
                                                              prescriptions) are
                                                              queried for a drug
                                                              formulary and
                                                              transmitted
                                                              electronically using
                                                              CEHRT.

[[Page 54132]]

 
Record electronic notes in patient   Record electronic       Enter at least one      10 minutes.......................  10 minutes.
 records.                             notes in patient        electronic progress
                                      records.                note created, edited,
                                                              and signed by an
                                                              eligible professional
                                                              for more than 30
                                                              percent of unique
                                                              patients with at
                                                              least one office
                                                              visit during the EHR
                                                              reporting period.
                                                             Enter at least one
                                                              electronic progress
                                                              note created, edited
                                                              and signed by an
                                                              authorized provider
                                                              of the eligible
                                                              hospital's or CAH's
                                                              inpatient or
                                                              emergency department
                                                              (POS 21 or 23) for
                                                              more than 30 percent
                                                              of unique patients
                                                              admitted to the
                                                              eligible hospital or
                                                              CAH's inpatient or
                                                              emergency department
                                                              during the EHR
                                                              reporting period.
                                                              Electronic progress
                                                              notes must be text-
                                                              searchable.
                                                              Nonsearchable, notes
                                                              do not qualify, but
                                                              this does not mean
                                                              that all of the
                                                              content has to be
                                                              character text.
                                                              Drawings and other
                                                              content can be
                                                              included with
                                                              searchable notes
                                                              under this measure..
                                     Provide structured      Hospital labs send      .................................  10 minutes
                                      electronic lab          structured electronic
                                      results to ambulatory   clinical lab results
                                      providers.              to the ordering
                                                              provider for more
                                                              than 20% of
                                                              electronic lab orders
                                                              received.
Capability to submit electronic      ......................  Successful ongoing      1 minute.........................
 syndromic surveillance data to                               submission of
 public health agencies, except                               electronic syndromic
 where prohibited, and in                                     surveillance data
 accordance with applicable law and                           from CEHRT to a
 practice.                                                    public health agency
                                                              for the entire EHR
                                                              reporting period.
Capability to identify and report    ......................  Successful ongoing      1 minute.........................
 cancer cases to a public health                              submission of cancer
 central cancer registry, except                              case information from
 where prohibited, and in                                     CEHRT to a public
 accordance with applicable law and                           health central cancer
 practice.                                                    registry for the
                                                              entire EHR reporting
                                                              period.
Capability to identify and report    ......................  Successful ongoing      1 minute.........................
 specific cases to a specialized                              submission of
 registry (other than a cancer                                specific case
 registry), except where                                      information from
 prohibited, and in accordance with                           CEHRT to a
 applicable law and practice.                                 specialized registry
                                                              for the entire EHR
                                                              reporting period.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Menu Set Least Burdensome Criteria                          3 minutes........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Menu Set Most Burdensome Criteria                           30 minutes.......................  30 minutes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Time to Attest and Report Clinical Quality Measures                  1 hour 30 minutes................  2 hours 40 minutes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
       Total--Core Set (including CQMs) + Least Burdensome Menu Set Criteria         9 hours 46 minutes...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Total--Core Set (including CQMs) + Most Burdensome Menu Set Criteria         10 hours 13 minutes.               10 hours 55 minutes.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     First, we will discuss the burden associated with the EP 
attestation to meeting the core meaningful use objectives and 
associated measures. We estimate that it will take no longer than 8 
hours and 13 minutes to attest that

[[Page 54133]]

during the EHR reporting period, they used the CEHRT, specify the EHR 
technology used, and satisfy each of the applicable core objectives and 
associated measures. We estimate it will take an EP 30 minutes if they 
choose to submit the most burdensome objectives and associated measures 
from the menu set. If an EP chooses to attest to the least burdensome 
menu set objectives and associated measures, we estimate this will take 
approximately 3 minutes. We also estimate that it will take an EP an 
additional 1 hour and 30 minutes to select, prepare, and electronically 
submit the ambulatory clinical quality measures. The total burden hours 
for an EP to attest to the most burdensome criteria previously 
specified is 10 hours and 13 minutes. The total burden hours for an EP 
to attest to the least burdensome criteria previously specified is 9 
hours and 46 minutes. We estimate that there could be approximately 
537,600 nonhospital-based Medicare and Medicaid EPs in 2014. We 
anticipate approximately 37 percent (198,912) of these EPs may attest 
to the information previously specified (after registration and 
completion of Stage 1) in CY 2014 to receive an incentive payment. We 
estimate the burden for the approximately 13,000 MA EPs in the MAO 
burden section. We estimate the total burden associated with these 
requirements for an EP is 10 hours and 13 minutes (8 hours 13 minutes + 
30 minutes + 1 hour 30 minutes). The total estimated annual cost burden 
for all EPs to attest to EHR technology, meaningful use core set and 
most burdensome menu set criteria, and electronically submit the 
ambulatory clinical quality measures is $182,877,942 (198,912 EPs x 10 
hours 13 minutes x $89.96 (mean hourly rate for physicians based on May 
2010 Bureau of Labor Statistics (BLS) data)). We estimate the total 
burden associated with these requirements for an EP is 9 hours and 46 
minutes (8 hours 13 minutes + 3 minutes + 1 hour 30 minutes). The total 
estimated cost burden for all EPs to attest to EHR technology, 
meaningful use core set and least burdensome menu set criteria, and 
electronically submit the ambulatory clinical quality measures is 
$174,825,587 (198,912 EPs x 9 hours 46 minutes x $89.96 (mean hourly 
rate for physicians based on May 2010 BLS data)).
    Similarly, eligible hospitals and CAHs will attest that they have 
met the core meaningful use objectives and associated measures, and 
will electronically submit the clinical quality measures. We estimate 
that it will take no longer than 7 hours and 45 minutes to attest that 
during the EHR reporting period, they used the CEHRT, specify the EHR 
technology used, and satisfied each of the applicable core objectives 
and associated measures. We estimate it will take an eligible hospital 
or CAH 30 minutes to choose and submit the objectives and associated 
measures from the menu set. We also estimate that it will take an 
eligible hospital or CAH an additional 2 hours and 40 minutes to 
select, prepare, and electronically submit the clinical quality 
measures. Therefore, the total burden hours for an eligible hospital or 
CAH to attest to the aforementioned criteria is 10 hours, 55 minutes. 
We estimate that there are about 4,993 eligible hospitals and CAHs 
(3,573 acute care hospitals, 1,325 CAHs, 84 children's hospitals, and 
11 cancer hospitals) that may attest to the aforementioned criteria 
(after registration and completion of Stage 1) in FY 2014 to receive an 
incentive payment. We estimate the burden for the 30 MA-affiliated 
hospitals in section III.B. of this final rule. We estimate the total 
burden associated with these requirements for an eligible hospital or 
CAH is 10 hours and 55 minutes (7 hours 45 minutes + 30 minutes + 2 
hours 40 minutes). The total estimated annual cost burden for all 
eligible hospitals and CAHs to attest to EHR technology, meaningful use 
core set and menu set criteria, and electronically submit the clinical 
quality measures is $2,069,061 (4,993 eligible hospitals and CAHs x 
$62.23 (11 hours 4 minutes x $62.23 (mean hourly rate for lawyers based 
on May 2010 BLS) data)).

B. ICRs Regarding Qualifying MA Organizations (Sec.  495.210)

    We estimate that the burden will be significantly less for 
qualifying MA organizations attesting to the meaningful use of their MA 
EPs in Stage 2, because--(1) qualifying MA organizations do not have to 
report the ambulatory clinical quality measures for their qualifying MA 
EPs; and (2) qualifying MA EPs use the EHR technology in place at a 
given location or system, so if CEHRT is in place and the qualifying MA 
organization requires its qualifying MA EPs to use the technology, 
qualifying MA organizations will be able to determine at a faster rate 
than individual FFS EPs, that its qualifying MA EPs meaningfully used 
CEHRT. In other words, qualifying MA organizations can make the 
determination en masse if the CEHRT is required to be used at its 
facilities, whereas under FFS, each EP likely must make the 
determination on an individual basis. We estimate that, on average, it 
will take an individual 45 minutes to collect information necessary to 
determine if a given qualifying MA EP has met the meaningful use 
objectives and measures, and 15 minutes for an individual to make the 
attestation for each MA EP. Furthermore, the individuals performing the 
assessment and attesting will not likely be eligible professionals, but 
non-clinical staff. We believe that the individual gathering the 
information could be equivalent to a GS 9, step 1, with an hourly rate 
of approximately $25.00/hour, and the person attesting (and who may 
bind the qualifying MA organization based on the attestation) could be 
equivalent to a GS 15, step 1, or approximately $59.00/hour. Therefore, 
for the approximately 13,000 potentially qualifying MA EPs, we believe 
it will cost the participating qualifying MA organizations 
approximately $435,500 annually to make the attestations ([9,750 hours 
x $25.00] + [3,250 hours x $59.00]).
    Furthermore, MA-affiliated eligible hospitals will be able to 
complete the attestations slightly faster than eligible hospitals 
because MA-affiliated eligible hospitals do not have to report the 
hospital clinical quality measures. While it is estimated that it will 
take an eligible hospital or CAH approximately between 16 hours, 24 
minutes and 16 hours, 33 minutes to attest to the applicable meaningful 
use objectives and associated measures, 8 of those hours are attributed 
to reporting clinical quality measures, which MA organizations do not 
have to report. Therefore, we estimate that it will take between 8 
hours, 24 minutes and 8 hours, 33 minutes (which on average is 8 hours 
29 minutes) for an MA organization's MA-affiliated eligible hospitals 
to make the attestations. We believe that the individual gathering the 
information could be equivalent to a GS 9, step 1, with an hourly rate 
of approximately $25.00/hour, and the person attesting (and who may 
bind the qualifying MA organization based on the attestation) could be 
equivalent to a GS 15, step 1, or approximately $59.00/hour. We believe 
that the person gathering the information could dedicate 7 of the 
estimated hours to gathering the information, and the individual 
certifying could take 1 hour and 29 minutes of the estimated time. 
Therefore, for the approximately 30 potentially qualifying MA-
affiliated eligible hospitals, we believe it will cost the 
participating qualifying MA organizations in the aggregate 
approximately $7,870 annually to

[[Page 54134]]

successfully attest ([210 hrs x $25.00] + [44 hrs x $59.00]).
    We did not receive any comments and we are finalizing these 
estimates as proposed.

C. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital 
Activities (Sec.  495.332 Through Sec.  495.344)

    The burden associated with this section is the time and effort 
associated with completing the single provider election repository and 
each state's process for the administration of the Medicaid incentive 
payments, including tracking of attestations and oversight; the 
submission of the state Medicaid HIT Plan and the additional planning 
and implementation documents; enrollment or reenrollment of providers, 
and collection and submission of the data for providers to demonstrate 
that they have adopted, implemented, or upgraded CEHRT or that they are 
meaningful users of such technology. We believe the burden associated 
with these requirements has already been accounted for in our 
discussion of the burden for Sec.  495.316 in the Stage 1 final rule. 
However, we proposed to revise 42 CFR 495 regarding the frequency of 
HIT IAPD updates. Rather than requiring each state to submit an annual 
HIT IAPD within 60 days from the HIT IAPD approved anniversary date, we 
proposed to require that a state's annual IAPD or IAPD Update (IAPD-U) 
be submitted at a minimum of 12 months from the date of the last CMS 
approval. We are finalizing our proposed revision to 42 CFR 495; 
therefore, annual IAPD updates are only required if a state has not 
submitted an IAPD-U in the past 12 months, which will create less of a 
burden on the states. We expect that it will take a state 70 hours to 
update an annual IAPD. We believe that the requirement for states to 
agree to have CMS conduct audits and appeals for hospitals for 
meaningful use will reduce state burden, as they will not conduct their 
own audits. Also, the alternatives for calculating patient volume will 
alleviate state burden as patient volume will be more easily 
calculated.
    We did not receive any comments and we are finalizing these 
estimates as proposed.

                                           Table 21--Estimated Annual Reporting and Recordkeeping Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Burden per     Total annual    Hourly labor
             Reg section                 OMB Control      Number of       Number of       response         burden          cost of      Total cost  ($)
                                             No.         respondents      responses        (hours)         (hours)     reporting  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   495.6--EHR Technology Used,            ???-New         198,912         198,912            8.22       1,635,057           89.96     147,089,695.33
 Core Set Objectives/Measures (EPs)..
Sec.   495.6--Menu Set Objectives/            ???-New         198,912         198,912            0.50          99,456           89.96       8,947,061.76
 Measures (EPs) HIGH.................
Sec.   495.6--Menu Set Objectives/            ???-New         198,912         198,912            0.05           9,946           89.96         894,706.18
 Measures (EPs) LOW..................
Sec.   495.6--Menu Set Objectives/            ???-New         198,912         198,912            0.28          54,701           89.96       4,920,883.97
 Measures (EPs) AVERAGE..............
Sec.   495.8--CQMs for EPs...........         ???-New         198,912         198,912            1.50         298,368           89.96      26,841,185.28
Sec.   495.6--EHR Technology Used,            ???-New           2,696           2,696            7.75          20,894           62.23       1,300,233.62
 Core Set Objectives/Measures
 (hospitals/CAHs)....................
Sec.   495.6--Menu Set Objectives/            ???-New           2,696           2,696            0.50           1,348           89.96         121,266.08
 Measures (hospitals/CAHs)...........
Sec.   495.8--CQMs for hospitals/CAHs         ???-New           2,696           2,696            2.67           7,198           89.96         647,560.87
Sec.   495.210--Gather information            ???-New          13,000          13,000            0.75           9,750           25.00         243,750.00
 for attestation (MA EPs)............
Sec.   495.210--Attesting on behalf           ???-New          13,000          13,000            0.25           3,250           59.00         191,750.00
 of MA EPs...........................
Sec.   495.210--Total cost of                 ???-New          13,000          13,000            1.00          13,000             n/a         435,500.00
 attestation for Stage 2 (MA EPs)....
Sec.   495.210--Gather information            ???-New              30              30            7.00             210           25.00           5,250.00
 for attestation (MA-affiliated
 hospitals)..........................

[[Page 54135]]

 
Sec.   495.210--Attesting on behalf           ???-New              30              30            1.48              44           59.00           2,619.60
 of MA-affiliated hospitals..........
Sec.   495.210--Total cost of                 ???-New              30              30            8.48             254             n/a           7,869.60
 attestation for Stage 2 (MA-
 affiliated hospitals)...............
Sec.   495.342-1. Frequency of Health         ???-New              56              56           70.00           3,920           56.24         220,460.80
 Information Technology (HIT)
 Implementation Advanced Planning
 Document (IAPD) Updates.............
    Burden Total for 2014............  ..............  ..............  ..............  ..............    2,034,740.16  ..............        181,584,656
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: All nonwhole numbers in this table are rounded to 2 decimal places.

    If you would like to comment on these information collection and 
recordkeeping requirements, submit your comments to the Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Attention: CMS Desk Officer, [CMS-0044-F], Fax: (202) 395-6974; or 
Email: OIRA_submission@omb.eop.gov.

V. Regulatory Impact Analysis

A. Statement of Need

    This final rule will implement the provisions of the ARRA that 
provide incentive payments to EPs, eligible hospitals, and CAHs 
participating in Medicare and Medicaid programs that adopt and 
meaningfully use CEHRT. The final rule specifies applicable criteria 
for earning incentives and avoiding payment adjustments.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This final rule is anticipated to have an annual effect on the economy 
of $100 million or more, making it an economically significant rule 
under the Executive Order and a major rule under the Congressional 
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis 
that to the best of our ability presents the costs and benefits of the 
final rule.
    As noted in section I. of this final rule, this final rule is one 
of two coordinated rules related to the adoption and meaningful use of 
CEHRT. The other is ONC's final rule, titled ``Health Information 
Technology: Standards, Implementation Specifications, and Certification 
Criteria for Electronic Health Record Technology, 2014 Edition; 
Revisions to the Permanent Certification Program for Health Information 
Technology'' published elsewhere in this Federal Register. This 
analysis focuses on the impact associated with Stage 1 meaningful use 
participation in 2014, Stage 2 requirements for meaningful use, the 
changes in quality measures that will take effect beginning in 2014, 
and other changes in the Medicare and Medicaid EHR Incentive Programs.
    A number of factors will affect the adoption of EHR systems and 
demonstration of meaningful use. Many of these factors are addressed in 
this analysis and in the provisions of the final rule titled ``Health 
Information Technology: Standards, Implementation Specifications, and 
Certification Criteria for Electronic Health Record Technology, 2014 
Edition; Revisions to the Permanent Certification Program for Health 
Information Technology'' published elsewhere in this Federal Register. 
Readers should understand that these forecasts are also subject to 
substantial uncertainty since demonstration of meaningful use will 
depend not only on the standards and requirements for FYs 2014 and 2015 
for eligible hospitals and CYs 2014 and 2015 for EPs, but on future 
rulemakings issued by the HHS.
    The Act provides Medicare and Medicaid incentive payments for the 
meaningful use of CEHRT. Additionally, the Medicaid program also 
provides incentives for the adoption, implementation, and upgrade of 
CEHRT. Payment adjustments are incorporated into the Medicare program 
for providers unable to demonstrate meaningful use. The absolute and 
relative strength of these is unclear. For example, a provider with 
relatively small Medicare billings will be less disadvantaged by 
payment adjustments than one with relatively large Medicare billings. 
Another uncertainty arises because there are likely to be ``bandwagon'' 
effects as the number of providers using EHRs rises, thereby inducing 
more participation in the

[[Page 54136]]

incentives program, as well as greater adoption by entities (for 
example, clinical laboratories) that are not eligible for incentives or 
subject to payment adjustments, but do business with EHR adopters. It 
is impossible to predict exactly if and when such effects may take 
hold.
    One legislative uncertainty arises because under current law, 
physicians are scheduled for payment reductions under the sustainable 
growth rate (SGR) formula for determining Medicare payments. The 
current override of SGR payment reductions prevents any further 
reductions of Medicare physician payments throughout the rest of 2012. 
Any payment reductions implemented in CY 2013 and subsequent calendar 
years could cause major changes in physician behavior, enrollee care, 
and other Medicare provider payments, but the specific nature of these 
changes is exceptionally uncertain. Under a current law scenario, the 
EHR incentives or payment adjustments will exert only a minor influence 
on physician behavior relative to any large payment reductions. 
However, the Congress has legislatively avoided physician payment 
reductions for each year since 2002.
    All of these factors taken together make it difficult to predict 
with precision the timing or rates of adoption and ultimately 
meaningful use. Further, new data regarding rates of adoption or costs 
of implementation is just starting to emerge. Because of this continued 
uncertainty, these estimates for adoption rates should be used with 
caution. Our estimate of meaningful use demonstration assumes that by 
2019 nearly 100 percent of hospitals and nearly 70 percent of EPs will 
be meaningful users. This estimate is based on the substantial economic 
incentives created by the combined direct and indirect factors 
affecting providers.
    Data from the EHR Incentive Program to date has shown that about 12 
percent of EPs and 8 percent of hospitals received incentive payments 
in 2011, the first year. This may be because providers have taken a 
``wait and see approach'' in the first year of implementation or that 
they have had problems receiving certified systems. Two thousand eleven 
was the first year of the program and saw initially slow, but rapidly 
accelerating, growth in qualification for and payment of meaningful use 
incentives. Given that this is very early data, and given the 
differences between Stage 1 and Stage 2 requirements, this data only 
indicates preliminary penetration rates.
    Overall, we expect spending under the EHR incentive program for 
transfer payments to Medicare and Medicaid providers between 2014 and 
2019 to be $15.4 billion (these estimates include payment adjustments 
for Medicare providers who do not achieve meaningful use in 2015 and 
subsequent years in the amount of $2.1 billion). We have also estimated 
``per entity'' costs for EPs, eligible hospitals, and CAHs for 
implementation/maintenance and reporting requirement costs, not all 
costs. We believe also that adopting entities will achieve dollar 
savings at least equal to their total costs, and that there will be 
additional benefits to society. We believe that implementation costs 
are significant for each participating entity because providers must 
purchase CEHRT to qualify as meaningful users of EHRs. However, we 
believe that providers who have already purchased CEHRT and 
participated in Stage 1 of meaningful use will experience significantly 
lower costs for participation in the program. We continue to believe 
that the short-term costs to demonstrate meaningful use of CEHRT are 
outweighed by the long-term benefits, including practice efficiencies 
and improvements in medical outcomes. Although both cost and benefit 
estimates are highly uncertain, the RIA that we have prepared to the 
best of our ability presents the costs and benefits of this final rule.
    Previously, the Stage 2 proposed rule and the Stage 1 final rule 
impact analyses showed two plausible scenarios for program costs. In 
this RIA, we are showing a scenario based on the FY 2013 Mid-Session 
Review of the President's budget. The estimates are based on the 
limited actual historical data that is now available for the EHR 
Incentive Programs. The new projections differ somewhat from the two 
scenarios presented previously. The major reasons for the differences 
are different assumed penetration rates based on more recent data and 
analysis, and revised assumptions as to the timing of payments in 
relation to when meaningful use is achieved based on the actual 
experience of the programs to date. When compared with the two 
illustrations from the Stage 2 proposed rule and Stage 1 final rule, 
the penetration rates for the current estimates are generally closer to 
those in the high cost scenario. In general, the actual program 
experience, which is included in the new estimates, showed somewhat 
lower payments early in the first year, and somewhat higher payments 
towards the end of the first year than assumed in the two previously-
used scenarios. The accounting statement numbers under the 7-percent 
discount for the two scenarios from the previous estimates were $706 
million and $2,346 million. The current accounting statement number 
under the 7-percent discount is $2,558 million. The current 
projections, while based on more up-to-date information, are still very 
uncertain and actual future outcomes are likely to differ somewhat from 
these projections.
    Comment: A commenter suggested that the impact analysis should only 
address Stage 2 of the EHR Incentive Programs.
    Response: Although we considered the idea of only addressing Stage 
2 in this impact analysis, we do not believe that such an analysis 
would provide a comprehensive impact of this final rule. This final 
rule establishes not only Stage 2 criteria but also changes to Stage 1 
criteria and both payment adjustments and hardship exceptions that 
could affect providers at all stages of meaningful use. In addition, 
providers in all payment years will be at differing stages of 
meaningful use, and any impact analysis that focused on a single stage 
would not accurately capture the costs and benefits that accrue from 
all providers who are participating in the EHR Incentive Programs 
during a given payment year. Therefore, we include all providers in 
this impact analysis.

C. Anticipated Effects

    The objective of the remainder of this RIA is to summarize the 
costs and benefits of the HITECH Act incentive program for the Medicare 
FFS, Medicaid, and MA programs. We also provide assumptions and a 
narrative addressing the potential costs to the industry for 
implementation of this technology.
1. Overall Effects
a. Regulatory Flexibility Analysis and Small Entities
    The Regulatory Flexibility Act (RFA) requires agencies to prepare a 
Final Regulatory Flexibility Analysis to describe and analyze the 
impact of the final rule on small entities unless the Secretary can 
certify that the regulation will not have a significant impact on a 
substantial number of small entities. In the healthcare sector, Small 
Business Administration (SBA) size standards define a small entity as 
one with between $7 million and $34 million in annual revenues. For the 
purposes of the RFA, essentially all non-profit organizations are 
considered small entities, regardless of size. Individuals and states 
are not included in the definition of a small entity. Since the vast 
majority of Medicare providers

[[Page 54137]]

(well over 90 percent) are small entities within the RFA's definitions, 
it is the normal practice of HHS simply to assume that all affected 
providers are ``small'' under the RFA. In this case, most EPs, eligible 
hospitals, and CAHs are either nonprofit or meet the SBA's size 
standard for small business. We also believe that the effects of the 
incentives program on many and probably most of these affected entities 
will be economically significant. Accordingly, this RIA section, in 
conjunction with the remainder of the preamble, constitutes the 
required Regulatory Flexibility Analysis. We believe that the adoption 
and meaningful use of EHRs will have an impact on virtually every EP 
and eligible hospital, as well as CAHs and some EPs and hospitals 
affiliated with MA organizations. While the program is voluntary, in 
the first 5 years it carries substantial positive incentives that will 
make it attractive to virtually all eligible entities. Furthermore, 
entities that do not demonstrate meaningful use of EHR technology for 
an applicable reporting period will be subject to significant Medicare 
payment reductions beginning with 2015. The anticipation of these 
Medicare payment adjustments are expected to motivate EPs, eligible 
hospitals, and CAHs to adopt and meaningfully use certified EHR 
technology.
    For some EPs, CAHs and eligible hospitals the EHR technology they 
currently have could be upgraded to meet the criteria for certified EHR 
technology as defined for this program. These costs may be minimal, 
involving no more than a software upgrade. ``Home-grown'' EHR systems 
that might exist may also require an upgrade to meet the certification 
requirements. We believe many currently noncertified EHR systems will 
require significant changes to achieve certification and that EPs, 
CAHs, and eligible hospitals will have to make process changes to 
achieve meaningful use.
    The most recent data available suggests that more providers have 
adopted EHR technology since the publication of the Stage 1 final rule. 
A 2011 survey conducted by the ONC and the AHA found that the 
percentage of U.S. hospitals which had adopted EHRs doubled from 16 to 
35 percent between 2009 and 2011. In November 2011, a CDC survey found 
the percentage of physicians who adopted basic EHRs in their practice 
had doubled from 17 to 34 percent between 2008 and 2011, with the 
percent of primary care doctors using this technology nearly doubling 
from 20 to 39 percent. While these numbers are encouraging, they are 
still low relative to the overall population of providers. The majority 
of EPs still need to purchase certified EHR technology, implement this 
new technology, and train their staff on its use. The costs for 
implementation and complying with the criteria of meaningful use could 
lead to higher operational expenses. However, we believe that the 
combination of payment incentives and long-term overall gains in 
efficiency will compensate for the initial expenditures.
(1) Number of Small Entities
    In total, we estimate that there are approximately 624,000 
healthcare organizations (EPs, practices, eligible hospitals or CAHs) 
that will be affected by the incentive program. These include hospitals 
and physician practices as well as doctors of medicine or osteopathy, 
dental surgery or dental medicine, podiatric medicine, optometry or a 
chiropractor. Additionally, as many as 47,000 nonphysician 
practitioners (such as certified nurse-midwives, etc) will be eligible 
to receive the Medicaid incentive payments.
    Of the 624,000 healthcare organizations we estimate will be 
affected by the incentive program, we estimate that 94.71 percent will 
be EPs, 0.8 percent will be hospitals, and 4.47 percent will be MA 
organization physicians or hospitals. We further estimate that EPs will 
spend approximately $54,000 to purchase and implement a certified EHR 
and $10,000 annually for ongoing maintenance according to the 
Congressional Budget Office (CBO). In the paper, Evidence on the Costs 
and Benefits of Health Information Technology, May 2008, in attempting 
to estimate the total cost of implementing health IT systems in office-
based medical practices, recognized the complicating factors of EHR 
types, available features, and differences in characteristics of the 
practices that are adopting them. The CBO estimated a cost range of 
$25,000 to $45,000 per physician. For all eligible hospitals, the range 
is from $1 million to $100 million. Though reports vary widely, we 
anticipate that the average will be $5 million to achieve meaningful 
use. We estimate $1 million for maintenance, upgrades, and training 
each year.
(2) Conclusion
    As discussed later in this analysis, we believe that there are many 
positive effects of adopting EHR on health care providers, quite apart 
from the incentive payments to be provided under this rule. While 
economically significant, we do not believe that the net effect on 
individual providers will be negative over time except in very rare 
cases. Accordingly, we believe that the object of the RFA to minimize 
burden on small entities is met by this rule.
b. Small Rural Hospitals
    Section 1102(b) of the Act requires us to prepare a RIA if a rule 
will have a significant impact on the operations of a substantial 
number of small rural hospitals. This analysis must conform to the 
provisions of section 604 of the RFA. For purposes of section 1102(b) 
of the Act, we define a small rural hospital as a hospital that is 
located outside of a metropolitan statistical area and has fewer than 
100 beds. This final rule will affect the operations of a substantial 
number of small rural hospitals because they may be subject to adjusted 
Medicare payments in 2015 if they fail to adopt certified EHR 
technology by the applicable reporting period. As stated previously, we 
have determined that this final rule will create a significant impact 
on a substantial number of small entities, and have prepared a 
Regulatory Flexibility Analysis as required by the RFA and, for small 
rural hospitals, section 1102(b) of the Act. Furthermore, any impacts 
that will arise from the implementation of certified EHR technology in 
a rural eligible hospital will be positive, with respect to the 
streamlining of care and the ease of sharing information with other EPs 
to avoid delays, duplication, or errors. However, we have statutory 
authority to make case-by-case exceptions for significant hardship, and 
proposed certain case-by-case applications that may be made when there 
are barriers to internet connectivity that will impact health 
information exchange.
c. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates will require spending in any 1 year 
$100 million in 1995 dollars, updated annually for inflation. In 2012, 
that threshold is approximately $139 million. UMRA does not address the 
total cost of a rule. Rather, it focuses on certain categories of cost, 
mainly those ``Federal mandate'' costs resulting from--(1) imposing 
enforceable duties on State, local, or tribal governments, or on the 
private sector; or (2) increasing the stringency of conditions in, or 
decreasing the funding of, State, local, or tribal governments under 
entitlement programs.
    This final rule imposes no substantial mandates on States. This 
program is voluntary for States and States offer the

[[Page 54138]]

incentives at their option. The State role in the incentive program is 
essentially to administer the Medicaid incentive program. While this 
entails certain procedural responsibilities, these do not involve 
substantial State expense. In general, each State Medicaid Agency that 
participates in the incentive program will be required to invest in 
systems and technology to comply. States will have to identify and 
educate providers, evaluate their attestations and pay the incentive. 
However, the Federal government will fund 90 percent of the State's 
related administrative costs, providing controls on the total State 
outlay.
    The investments needed to meet the meaningful use standards and 
obtain incentive funding are voluntary, and hence not ``mandates'' 
within the meaning of the statute. However, the potential reductions in 
Medicare reimbursement beginning with FY 2015 will have a negative 
impact on providers that fail to meaningfully use certified EHR 
technology for the applicable reporting period. We note that we have no 
discretion as to the amount of those potential payment reductions. 
Private sector EPs that voluntarily choose not to participate in the 
program may anticipate potential costs in the aggregate that may exceed 
$139 million; however, because EPs may choose for various reasons not 
to participate in the program, we do not have firm data for the 
percentage of participation within the private sector. This RIA, taken 
together with the remainder of the preamble, constitutes the analysis 
required by UMRA.
d. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has Federalism implications. This 
final rule will not have a substantial direct effect on State or local 
governments, preempt State law, or otherwise have a Federalism 
implication. Importantly, State Medicaid agencies are receiving 100 
percent match from the Federal government for incentives paid and a 90 
percent match for expenses associated with administering the program. 
As previously stated, we believe that State administrative costs are 
minimal. We note that this final rule does add a new business 
requirement for States, because of the existing systems that will need 
to be modified to track and report on the new meaningful use 
requirements for provider attestations. We are providing 90 percent FFP 
to States for modifying their existing EHR Incentive Program systems. 
We believe the Federal share of the 90 percent match will protect the 
States from burdensome financial outlays and, as noted previously, 
States offer the Medicaid EHR incentive program at their option.
2. Effects on Eligible Professionals, Eligible Hospitals, and CAHs
a. Background and Assumptions
    The principal costs of this final rule are the additional 
expenditures that will be undertaken by eligible entities in order to 
obtain the Medicare and Medicaid incentive payments to adopt, implement 
or upgrade and/or demonstrate meaningful use of certified EHR 
technology, and to avoid the Medicare payment adjustments that will 
ensue if they fail to do so. The estimates for the provisions affecting 
Medicare and Medicaid EPs, eligible hospitals, and CAHs are somewhat 
uncertain for several reasons: (1) The program is voluntary although 
payment adjustments will be imposed on Medicare providers beginning in 
2015 if they are unable to demonstrate meaningful use for the 
applicable reporting period; (2) the Stage 1 and Stage 2 criteria for 
the demonstration of meaningful use of CEHRT has been finalized, but 
will change in Stage 3 and over time; and (3) the impact of the 
financial incentives and payment adjustments on the rate of adoption of 
certified EHR technology by EPs, eligible hospitals, and CAHs is 
difficult to predict based on the information we have currently 
collected. The net costs and savings shown for this program represent a 
possible scenario and actual impacts could differ substantially.
    Based on input from a number of internal and external sources, 
including the Government Accountability Office (GAO) and CBO, we 
estimated the numbers of EPs and eligible hospitals, including CAHs 
under Medicare, Medicaid, and MA and used them throughout the analysis.
     About 568,900 Medicare FFS EPs in 2014 (some of whom will 
also be Medicaid EPs).
     About 14 percent of the total EPs are hospital-based 
Medicare EPs, and are not eligible for the program. This leaves 
approximately 491,000 nonhospital-based Medicare EPs in 2014.
     About 20 percent of the nonhospital-based Medicare EPs 
(approximately 98,200 Medicare EPs in 2014) are also eligible for 
Medicaid (meet the 30 percent Medicaid patient volume criteria), but 
can only be paid under one program. We assume that any EP in this 
situation will choose to receive the Medicaid incentive payment, 
because it is larger.
     About 46,600 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible nonphysicians such as certified nurse-
midwives, nurse practitioners and physicians assistants) will be 
eligible to receive the Medicaid incentive payments.
     4,993 eligible hospitals comprised of the following:
    ++ 3,573 acute care hospitals.
    ++ 1,325 CAHs.
    ++ 84 children's hospitals (Medicaid only).
    ++ 11 cancer hospitals (Medicaid only).
     All eligible hospitals, except for children's and cancer 
hospitals, may qualify and apply for both Medicare and Medicaid 
incentive payments.
     12 MA organizations (about 28,000 EPs, and 29 hospitals) 
will be eligible for incentive payments.
b. Industry Costs and Adoption Rates
    In the Stage 1 final rule (75 FR 44545 through 44547), we estimated 
the impact on healthcare providers using information from the same four 
studies cited previously in this final rule. Based on these studies and 
current average costs for available certified EHR technology products, 
we continue to estimate for EPs that the average adopt/implement/
upgrade cost is $54,000 per physician FTE, while annual maintenance 
costs average $10,000 per physician FTE.
    For all eligible hospitals, the range is from $1 million to $100 
million. Although reports vary widely, we anticipate that the average 
will be $5 million to achieve meaningful use, because providers who 
will like to qualify as meaningful users of EHRs will need to purchase 
certified EHRs. We further acknowledge ``certified EHRs'' may differ in 
many important respects from the EHRs currently in use and may differ 
in the functionalities they contain. We estimate $1 million for 
maintenance, upgrades, and training each year. Both of these estimates 
are based on average figures provided in the 2008 CBO report. Industry 
costs are important, in part, because EHR adoption rates will be a 
function of these industry costs and the extent to which the costs of 
``certified EHRs'' are higher than the total value of EHR incentive 
payments available to EPs and eligible hospitals (as well as 
adjustments, in the case of the Medicare EHR incentive program) and any 
perceived benefits including societal benefits. Because of the 
uncertainties surrounding industry cost

[[Page 54139]]

estimates, we have made various assumptions about adoption rates in the 
following analysis in order to estimate the budgetary impact on the 
Medicare and Medicaid programs.
c. Costs of EHR Adoption for EPs
    Since the publication of the Stage 1 final rule, there has been 
little data published regarding the cost of EHR adoption and 
implementation. A 2011 study (http://content.healthaffairs.org/content/30/3/481.abstract) estimated costs of implementation for a five-
physician practice to be $162,000, with $85,500 in maintenance expenses 
in the first year. These estimates are similar to estimates made in the 
Stage 1 final rule. In the absence of additional data regarding the 
cost of adoption and implementation costs for certified EHR technology, 
we proposed to continue to estimate for EPs that the average adopt/
implement/upgrade cost is $54,000 per physician FTE, while annual 
maintenance costs average $10,000 per physician FTE, based on the cost 
estimate of the Stage 1 final rule.
    Comment: Some commenters suggested that specific costs and 
financial gains for each provider be recorded as part of attestation to 
inform the overall impact analysis. Another commenter suggested that 
the analysis should include costs associated with unintended 
consequences of the regulation, such as the loss of revenue to 
providers through the elimination of unnecessary or duplicative tests 
and the resistance of the market to improving patient care under such 
circumstances. The commenter also suggested that the impact analysis 
should be stratified according to primary care and specialty providers.
    Response: Although we agree that a system that records the specific 
costs and benefits for each provider would yield a more accurate 
financial analysis, we believe that such a requirement would place a 
significant burden on providers and potentially limit participation in 
the EHR Incentive Programs. We also do not believe that there is an 
accurate method to calculate the loss of revenue due to the elimination 
of unnecessary or duplicative tests or market resistance to improving 
patient care. The reduction of costs while improving patient care is 
one of the goals of the EHR Incentive Programs, and we do not believe 
that these reductions should be classified as negative impacts for the 
healthcare system as they would also lead to lower overall health care 
costs. Nor do we believe it is possible for us to proactively estimate 
such savings at this time. Because both primary-care and specialty 
providers receive the same incentive payment amounts under this 
program, we do not believe there is a benefit to stratifying the impact 
analysis in this way.
d. Costs of EHR Adoption for Eligible Hospitals
    AHA conducts annual surveys that among other measures, track 
hospital spending. This data reflects the latest figures from the 2008 
AHA Survey. Costs at these levels of adoption were significantly higher 
in 2008 than in previous years. This may better reflect the costs of 
implementing additional functionalities. The range in yearly 
information technology spending among hospitals is large, from $36,000 
to over $32 million based on the AHA data. EHR system costs 
specifically were reported by experts to run as high as $20 million to 
$100 million. HHS discussions with experts led to cost ranges for 
adoption that varied by hospital size and level of EHR system 
sophistication. Research to date has shown that adoption of 
comprehensive EHR systems is limited. In the aforementioned AHA study, 
1.5 percent of these organizations had comprehensive systems, which 
were defined as hospital-wide clinical documentation of cases, test 
results, prescription and test ordering, plus support for decision-
making that included treatment guidelines. Some 10.9 percent have a 
basic system that does not include physician and nursing notes, and can 
only be used in one area of the hospital. Applying a similar standard 
to the 2008 AHA data, results in roughly 3 to 4 percent of hospitals 
having comprehensive systems and 12 to 13 percent having basic systems. 
According to hospital CEOs, the main barrier to adoption is the cost of 
the systems, and the lack of capital. Hospitals have been concerned 
that they will not be able to recoup their investment, and they are 
already operating on limited margins. Because uptake of advanced 
systems is low, it is difficult to get a solid average estimate for 
implementation and maintenance costs that can be applied across the 
industry. In addition, we recognize that there are additional industry 
costs associated with adoption and implementation of EHR technology 
that are not captured in our estimates that eligible entities will 
incur. Because the impact of those activities, such as reduced staff 
productivity related to learning how to use the EHR technology, the 
need to add additional staff to work with HIT issues, and 
administrative costs related to reporting are unknown at this time and 
difficult to quantify.
    Comment: Some commenters suggested that overall IT operating costs 
should be included as part of the analysis. These commenters also 
suggested that estimates for costs related to staff training were too 
low and should include time and resources devoted to understanding the 
EHR Incentive Programs regulations. Other commenters suggested that 
costs associated with the time and resources related to registration 
and attestation should be included as part of the analysis. Finally, 
some commenters suggested that costs associated with EHR products, 
consultants, and trained IT professionals have increased since the 
start of the EHR Incentive Programs and should be reflected in the 
analysis.
    Response: As noted in this impact analysis, we based cost estimates 
for IT on peer-reviewed studies of EHR and health IT costs. These cost 
estimates included maintenance and operating costs specific to EHRs and 
staff training. There are many aspects of IT operating costs that are 
not directly related to the maintenance or operation of CEHRT, and we 
do not believe it would be appropriate to include those costs as part 
of the impact analysis of this regulation. We are not aware of any new 
data that suggests an overall increase in the costs of CEHRT or related 
implementation and maintenance costs since the start of the EHR 
Incentive Programs, and in many cases we believe that the product and 
maintenance costs of CEHRT can be significantly lower than our 
estimates. Therefore, we are continuing to use the estimates we 
proposed for this impact analysis. We also do not believe it is 
appropriate to include additional costs related to registration and 
attestation, as the cost for dedicating resources to these activities 
is addressed earlier in this final rule in our discussion of 
information collection requirements.
3. Medicare Incentive Program Costs
a. Medicare Eligible Professionals (EPs)
    We continue the method of cost estimation we used to determine the 
estimated costs of the Medicare incentives for EPs in our Stage 1 final 
rule (75 FR 44549). In order to determine estimated costs, we first 
needed to determine the EPs with Medicare claims. Then, we calculated 
that about 14 percent of those EPs are hospital based according to the 
definition in Sec.  495.4 (finalized in our Stage 1 final rule), and 
therefore, do not qualify for incentive payments. This percent of EPs 
was subtracted from the

[[Page 54140]]

total number of EPs who have claims with Medicare. These numbers were 
tabulated from Medicare claims data.
    In the Stage 1 final rule, we also estimated that about 20 percent 
of EPs that were not hospital based will qualify for Medicaid incentive 
payments and will choose that program because the payments are higher. 
Current program data does not provide additional evidence regarding 
this, so we continued to use the 20 percent estimation in the current 
projections. Of the remaining EPs, we estimated the percentage which 
will be meaningful users each calendar year. As discussed previously, 
our estimates for the number of EPs that will successfully demonstrate 
meaningful use of CEHRT are uncertain. The percentage of Medicare EPs 
who will satisfy the criteria for demonstrating meaningful use of CEHRT 
and will qualify for incentive payments is a key, but a highly 
uncertain factor. Accordingly, the estimated number of nonhospital 
based Medicare EPs who will demonstrate meaningful use of CEHRT over 
the period CYs 2014 through 2019 is as shown in Table 22.

                 Table 22--Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
                                                                 Calendar year
                             -----------------------------------------------------------------------------------
                                  2014          2015          2016          2017          2018          2019
----------------------------------------------------------------------------------------------------------------
EPs who have claims with             568.9         574.8         580.8         586.8         592.7         598.6
 Medicare (thousands).......
Nonhospital Based EPs                491.0         496.1         501.3         506.4         511.5         516.7
 (thousands)................
EPs that are both Medicare            98.2          99.2         100.3         101.3         102.3         103.3
 and Medicaid EPs
 (thousands)................
Percent of EPs who are                37            46            52            57            62            67
 Meaningful Users...........
Meaningful Users (thousands)         147.1         184.2         206.5         229.3         252.5         276.1
----------------------------------------------------------------------------------------------------------------

    Our estimates of the incentive payments and payment adjustment 
savings are presented in Table 23. These payments reflect the Medicare 
and Medicaid incentive payments and payment adjustments included in 42 
CFR Part 495 of our regulations. They reflect our assumptions about the 
proportion of EPs who will demonstrate meaningful use of CEHRT. These 
assumptions were developed based on a review of the studies presented 
in the Stage 1 impact analysis.
    Specifically, our assumptions are based on literature estimating 
current rates of physician EHR adoption and rates of diffusion of EHRs 
and similar technologies. There are a number of studies that have 
attempted to measure the rate of adoption of electronic medical records 
(EMR) among physicians prior to the enactment of the HITECH Act (see, 
for example, Funky and Taylor (2005) The State and Pattern of Health 
Information Technology Adoption. RAND Monograph MG-409. Santa Monica: 
The RAND Corporation; Ford, E.W., Menachemi, N., Peterson, L.T., 
Huerta, T.R. (2009) ``Resistance is Futile: But it is Slowing the Pace 
of EHR Adoption Nonetheless'' Journal of the American Informatics 
Association 16(3): 274-281). More recently, there is also some data 
available to suggest that more providers have adopted EHR technology 
since the start of the EHR Incentive Programs. The 2011 ONC-AHA survey 
cited earlier found that the percentage of U.S. hospitals which had 
adopted EHRs increased from 16 to 35 percent between 2009 and 2011. In 
November 2011, the CDC survey cited earlier found the percentage of 
physicians who adopted basic (EHRs in their practice had doubled from 
17 to 34 percent between 2008 and 2011. These survey results are in 
line with the estimated rate of EHR adoption presented in the Stage 1 
impact analysis, but they constitute a relatively small sample on which 
to base new estimates. Therefore we maintain the estimates that were 
based on the study with the most rigorous definition, though we note 
again that neither the Stage 1 nor the Stage 2 meaningful use criteria 
are equivalent to a fully functional system as defined in this study. 
(DesRoches, CM, Campbell, EG, Rao, SR et al (2008) ``Electronic Health 
Records in Ambulatory Care-A National Survey of Physicians'' New 
England Journal of Medicine 359(1): 50-60. In addition, we note that 
the final penetration rates used in the initial estimates were 
developed in consensus with industry experts relying on the studies. 
Actual adoption trends could be different from these assumptions, given 
the elements of uncertainty we describe throughout this analysis.
    Estimated net costs of the Medicare EP portion of the HITECH Act 
are shown in Table 23.

  Table 23--Estimated Costs (+) and Savings (-) for Medicare EPs Demonstrating Meaningful Use of Certified EHR
                                                   technology
                                                  [In billions]
----------------------------------------------------------------------------------------------------------------
                                                               Incentive     Payment
                         Fiscal year                            payments    adjustment    Benefit     Net total
                                                                  ($)        receipts     payments       ($)
----------------------------------------------------------------------------------------------------------------
2014........................................................          1.9  ...........  ...........          1.9
2015........................................................          2.0         -0.1  ...........          1.9
2016........................................................          0.8         -0.1  ...........          0.6
2017........................................................          0.3         -0.2  ...........          0.1
2018........................................................  ...........         -0.2  ...........         -0.2
2019........................................................  ...........         -0.2  ...........         -0.2
----------------------------------------------------------------------------------------------------------------

[[Page 54141]]

b. Medicare Eligible Hospitals and CAHs
    In brief, the estimates of hospital adoption were developed by 
calculating projected incentive payments (which are driven by 
discharges), comparing them to projected costs of attaining meaningful 
use, and then making assumptions about how rapidly hospitals will adopt 
given the fraction of their costs that were covered.
    Specifically, the first step in preparing estimates of Medicare 
program costs for eligible hospitals was to determine the amount of 
Medicare incentive payments that each hospital in the country could 
potentially receive under the statutory formula, based on its discharge 
numbers (total patients and Medicare patients). The total incentive 
payments potentially payable over a 4-year period vary significantly by 
hospitals' inpatient caseloads, ranging from a low of about $11,000 to 
a high of $12.9 million, with the median being $3.8 million. The 
potential Medicare incentive payments for each eligible hospital were 
compared with the hospital's expected cost of purchasing and operating 
certified EHR technology. Costs of adoption for each hospital were 
estimated using data from the 2009 AHA survey and IT supplement. 
Estimated costs varied by size of hospital and by the likely status of 
EHR adoption in that class of hospitals. Hospitals were grouped first 
by size (CAHs, non-CAH hospitals under 400 beds, and hospitals with 400 
or more beds) because EHR adoption costs do vary by size: namely, 
larger hospitals with more diverse service offerings and large 
physician staffs generally implement more customized systems than 
smaller hospitals that might purchase off-the-shelf products. We then 
calculated the proportion of hospitals within each class that were at 
one of three levels of EHR adoption: (1) Hospitals which had already 
implemented relatively advanced systems that included CPOE systems for 
medications; (2) hospitals which had implemented more basic systems 
through which lab results could be shared, but not CPOE for 
medications; and (3) hospitals starting from a base level with neither 
CPOE or lab reporting. The CPOE for medication standard was chosen for 
this estimate because expert input indicated that the CPOE standard in 
the final meaningful use definition will be the hardest one for 
hospitals to meet. Table 24 provides these proportions.

                                                   Table 24--Hospital IT Capabilities by Hospital Size
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Levels of adoption
                                                 -------------------------------------------------------------------------------------------------------
                                                        Any CPOE meds              Lab results                 Neither                    Total
                  Hospital size                  -------------------------------------------------------------------------------------------------------
                                                   Number of                 Number of                 Number of                 Number of
                                                   hospitals    Percentage   hospitals    Percentage   hospitals    Percentage   hospitals    Percentage
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAHs............................................          169           22          390           51          210           27          769           23
Small/Medium....................................          834           37        1,051           47          348           16        2,233           67
Large (400+ beds)...............................          200           56          145           41           10            3          355           10
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................        1,203           36        1,586           47          568           17        3,357          100
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We then calculated the costs of moving from these stages to 
meaningful use for each class of hospital, assuming that even for 
hospitals with CPOE systems they will incur additional costs of at 
least 10 percent of their IT budgets. These costs were based on cross-
sectional data from the AHA survey and thus do not likely represent the 
true costs of implementing systems. This data reflects the latest 
figures from the 2009 AHA Survey. Costs at these levels of adoption 
were significantly higher than in previous years. This may better 
reflect the costs of implementing additional functionalities. We have 
also updated the number of discharges using the most recent cost report 
data available. The payment incentives available to hospitals under the 
Medicare and Medicaid programs are included in our regulations at 42 
CFR part 495. We estimate that there are 12 MAOs that might be eligible 
to participate in the incentive program. Those plans have 29 eligible 
hospitals. The costs for the MA program have been included in the 
overall Medicare estimates.
    Our estimated net costs for section 4102 of the HITECH Act are 
shown in Table 25: Estimated costs (+) and savings (-) for eligible 
hospitals adopting certified EHRs. This provision is estimated to 
increase Medicare hospital expenditures by a net total of $5.3 billion 
during FYs 2014 through 2019.

  Table 25--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
                                            Certified EHR Technology
                                                  [In billions]
----------------------------------------------------------------------------------------------------------------
                                                                             Payment
                         Fiscal year                           Incentive    adjustment    Benefit     Net total
                                                                payments     receipts     payments
----------------------------------------------------------------------------------------------------------------
2014........................................................         $2.1  ...........        (\1\)         $2.1
2015........................................................          2.2         -0.4        (\1\)          1.8
2016........................................................          1.7         -0.5        (\1\)          1.2
2017........................................................          0.5         -0.3        (\1\)          0.2
2018........................................................  ...........         -0.1        (\1\)         -0.1
2019........................................................  ...........  ...........        (\1\)        (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

[[Page 54142]]

    Based on the comparison of Medicare incentive payments and 
implementation/operating costs for each eligible hospital (described 
previously), we made the assumptions shown in Table 25, related to the 
prevalence of CEHRT for FYs 2014 through 2018. These assumptions are 
consistent with the actual program data for 2011. As indicated, 
eligible hospitals that could cover the full cost of an EHR system 
through Medicare incentive payments were assumed to implement them 
relatively rapidly, and vice versa. In other words, eligible hospitals 
will have an incentive to purchase and implement an EHR system if they 
perceive that a large portion of the costs will be covered by the 
incentive payments. Table 26 shows the assumptions that were used.

 Table 26--Assumed Proportion of Eligible Hospitals With Certified EHR Technology, by Percentage of System Cost
                                     Covered by Medicare Incentive Payments
----------------------------------------------------------------------------------------------------------------
                                                   Incentive payments as percentage of EHR technology cost
                Fiscal year                 --------------------------------------------------------------------
                                                100+%        75-100%       50-75%        25-50%         0-25%
----------------------------------------------------------------------------------------------------------------
2014.......................................          1.0          0.95          0.85          0.5           0.3
2015.......................................          1.0          1.0           0.95          0.75          0.5
2016.......................................          1.0          1.0           1.0           0.9           0.75
2017.......................................          1.0          1.0           1.0           1.0           0.9
2018.......................................          1.0          1.0           1.0           1.0           1.0
----------------------------------------------------------------------------------------------------------------

    For instance, 95 percent of eligible hospitals whose incentive 
payments will cover between 75 percent and 100 percent of the cost of a 
certified EHR system were assumed to have a certified system in FY 
2014. All such hospitals were assumed to have a certified EHR system in 
FY 2015 and thereafter.
    High rates of EHR adoption are anticipated in the years leading up 
to FY 2015 due to the payment adjustments that will be imposed on 
eligible hospitals. However, we know from industry experts that issues 
surrounding the capacity of vendors and expert consultants to support 
implementation, issues of access to capital, and competing priorities 
in responding to payer demand will limit the number of hospitals that 
can adopt advanced systems in the short term. Therefore, we cannot be 
certain of the adoption rate for hospitals due to these factors and 
others previously outlined in this preamble.
    For large, organized facilities such as hospitals, we believe that 
the revenue losses caused by these payment adjustments will be a 
substantial incentive to adopt certified EHR technology, even in 
instances where the Medicare incentive payments will cover only a 
portion of the costs of purchasing, installing, populating, and 
operating the EHR system. Based on the assumptions about incentive 
payments as percentages of EHR technology costs in Table 26, we 
estimated that the great majority of eligible hospitals will qualify 
for at least a portion of the Medicare incentive payments that they 
could potentially receive, and only a modest number will incur payment 
adjustments. Nearly all eligible hospitals are projected to have 
implemented CEHRT by FY 2019. Table 27 shows our estimated percentages 
of the total potential incentive payments associated with eligible 
hospitals that could demonstrate meaningful use of EHR systems. Also 
shown are the estimated percentages of potential incentives that will 
actually be paid each year.

  Table 27--Estimated Percentage of Medicare Incentives Which Could Be
   Paid for Meaningful Use of Certified EHR Technology Associated With
       Eligible Hospitals and Estimated Percentage Payable in Year
------------------------------------------------------------------------
                                                  Percent
                                                 associated    Percent
                  Fiscal year                       with      payable in
                                                  eligible       year
                                                 hospitals
------------------------------------------------------------------------
2014..........................................         66.1         66.1
2015..........................................         80.2         72.2
2016..........................................         91.3         48.8
2017..........................................         97.7  ...........
2018..........................................        100.0  ...........
------------------------------------------------------------------------

    For instance in FY 2014, 66.1 percent of the total amount of 
incentive payments which could be payable in that year will be for 
eligible hospitals who have demonstrated meaningful use of CEHRT and 
therefore will be paid. In FY 2015, 80.2 percent of the total amount of 
incentive payments which could be payable will be for hospitals who 
have certified EHR systems, but some of those eligible hospitals will 
have already received 4 years of incentive payments, and therefore 72.2 
percent of all possible incentive payments actually paid in that year.
    The estimated payments to eligible hospitals were calculated based 
on the hospitals' qualifying status and individual incentive amounts 
under the statutory formula. Similarly, the estimated payment 
adjustments for nonqualifying hospitals were based on the market basket 
reductions and Medicare revenues. The estimated savings in Medicare 
eligible hospital benefit expenditures resulting from the use of 
hospital certified EHR systems are discussed under ``general 
considerations'' at the end of this section. We assumed no future 
growth in the total number of hospitals in the U.S. because growth in 
acute care hospitals has been minimal in recent years.
c. Critical Access Hospitals (CAHs)
    We estimate that there are 1,325 CAHs eligible to receive EHR 
incentive payments. In the Stage 1 impact analysis, we estimated that 
the 22 percent of CAHs with relatively advanced EHR systems will 
achieve meaningful use before 2016 given on the financial assistance 
available under HITECH for Regional Extension Centers, whose priorities 
include assisting CAHs in EHR adoption. We also estimated that most of 
the remaining CAHs that had already adopted some kind of EHR system at 
that time (51 percent of CAHs) will also achieve meaningful use by 
2016. Current program payment data, as well as current data from the 
Regional Extension Centers, provides some more information for us to 
alter these estimates. Our new estimates regarding the incentives that 
will be paid to CAHs are incorporated into the overall Medicare and 
Medicaid program costs.
4. Medicaid Incentive Program Costs
    Under section 4201 of the HITECH Act, states can voluntarily 
participate in the Medicaid incentive payment program. However, as of 
the writing of this final rule 48 states are already participating in 
the Medicaid incentive payment program and the remaining

[[Page 54143]]

states have indicated they will begin participation in 2012. Therefore 
we anticipate that all states will be participating by 2014, as we 
estimated in the Stage 1 impact analysis. The payment incentives 
available to EPs and hospitals under the Medicaid programs are included 
in our regulations at 42 CFR part 495. The Federal costs for Medicaid 
incentive payments to providers who can demonstrate meaningful use of 
EHR technology were estimated similarly to the estimates for Medicare 
eligible hospital and EP. Table 28 shows our estimates for the net 
Medicaid costs for eligible hospitals and EPs.

                      Table 28--Estimated Federal Costs (+) and Savings (-) Under Medicaid
                                                  [In billions]
----------------------------------------------------------------------------------------------------------------
                                               Incentive payments
                                     --------------------------------------
             Fiscal year                                      Eligible       Benefit payments      Net total
                                          Hospitals        professionals
----------------------------------------------------------------------------------------------------------------
2014................................                0.6                0.5              (\1\)                1.1
2015................................                0.4                0.8              (\1\)                1.2
2016................................                0.5                0.8              (\1\)                1.2
2017................................                0.5                0.7              (\1\)                1.2
2018................................                0.1                0.7              (\1\)                0.8
2019................................                0.0                0.5              (\1\)                0.5
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

a. Medicaid EPs
    To determine the Medicaid EP incentive payments, we first 
determined the number of qualifying EPs. As indicated previously, we 
assumed that 20 percent of the nonhospital-based Medicare EPs will meet 
the requirements for Medicaid incentive payments (30 percent of patient 
volume from Medicaid). All of these EPs were assumed to choose the 
Medicaid incentive payments, as they are larger. In addition, the total 
number of Medicaid EPs was adjusted to include EPs who qualify for the 
Medicaid incentive payments but not for the Medicare incentive 
payments, such as most pediatricians, dentists, certified nurse-
midwives, nurse practitioners, and physicians assistants. As noted 
previously, there is much uncertainty about the rates of demonstration 
of meaningful use that will be achieved. Our estimates are listed in 
Table 29.

    Table 29--Assumed Number of Nonhospital-Based Medicaid EPS Who Will Be Meaningful Users of Certified EHR
                                                   Technology
                                    [All population figures are in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                    Calendar year
                                   -----------------------------------------------------------------------------
                                        2014         2015         2016         2017         2018         2019
----------------------------------------------------------------------------------------------------------------
            EPs who have claims           568.9        574.8        580.8        586.8        592.7        598.6
             with Medicare.
            Nonhospital-based EPs.        491.0        496.1        501.3        506.4        511.5        516.7
A           EPs who meet the               98.2         99.2        100.3        101.3        102.3        103.3
             Medicaid patient
             volume threshold.
B           Medicaid \1\ only EPs.         46.6         47.4         48.1         48.9         49.7         50.4
            Total Medicaid EPs (A         144.8        146.6        148.4        150.2        152.0        153.8
             + B).
            Percent of EPs                49.2%        58.8%        64.0%        52.9%        29.5%        22.6%
             receiving incentive
             payment during year.
            Number of EPs                  71.2         86.3         95.0         79.4         44.8         34.8
             receiving incentive
             payment during year.
            Percent of EPs who            49.2%        58.8%        64.0%        68.9%        73.5%        77.9%
             have ever received
             incentive payment.
            Number of EPs who have         71.2         86.3         95.0        103.4        111.7        119.8
             ever received
             incentive payment.
----------------------------------------------------------------------------------------------------------------

    It should be noted that since the Medicaid EHR incentive payment 
program provides that a Medicaid EP can receive an incentive payment in 
their first year because he or she has demonstrated a meaningful use or 
because he or she has adopted, implemented, or upgraded certified EHR 
technology, these participation rates include not only meaningful users 
but eligible providers implementing CEHRT as well.
b. Medicaid Hospitals
    Medicaid incentive payments to most acute-care hospitals were 
estimated using the same adoption assumptions and method as described 
previously for Medicare eligible hospitals and shown in Table 30. 
Because hospitals' Medicare and Medicaid patient loads differ, we 
separately calculated the range of percentage of total potential 
incentives that could be associated with qualifying hospitals, year by 
year, and the corresponding actual percentages payable each year. Acute 
care hospitals may qualify to receive both the Medicare and Medicaid 
incentive payments.
    As stated previously, the estimated eligible hospital incentive 
payments were calculated based on the hospitals' qualifying status and 
individual incentive amounts payable under the statutory formula. The 
estimated savings in Medicaid benefit expenditures resulting from the 
use of CEHRT are discussed under ``general considerations.'' Since we 
were using

[[Page 54144]]

Medicare cost report data and little data existed for children's 
hospitals, we estimated the Medicaid incentives payable to children's 
hospitals as an add-on to the base estimate, using data on the number 
of children's hospitals compared to nonchildren's hospitals.

     Table 30--Estimated Percentage of Potential Medicaid Incentives
Associated With Eligible Hospitals and Estimated Percentage Payable Each
                                  Year
------------------------------------------------------------------------
                                                  Percent
                                                 associated    Percent
                  Fiscal year                       with      payable in
                                                  eligible       year
                                                 hospitals
------------------------------------------------------------------------
2014..........................................         67.5         59.3
2015..........................................         81.1         37.9
2016..........................................         91.8         33.7
2017..........................................         97.7         24.3
2018..........................................        100.0         10.7
2019..........................................        100.0          0.0
------------------------------------------------------------------------

5. Benefits for All EPs and All Eligible Hospitals
    In this final rule we have not quantified the overall benefits to 
the industry, nor to eligible hospitals or EPs in the Medicare, 
Medicaid, or MA programs. Although information on the costs and 
benefits of adopting systems that specifically meet the requirements 
for the EHR Incentive Programs (for example, certified EHR technology) 
has not yet been collected, and although some studies question the 
benefits of health information technology, a 2011 study completed by 
ONC (Buntin et al. 2011 ``The Benefits of Health Information 
Technology: A Review of the Recent Literature Shows Predominantly 
Positive Results'' Health Affairs.) found that 92 percent of 154 
articles published from July 2007 up to February 2010 reached 
conclusions that showed the overall positive effects of health 
information technology on key aspects of care, including quality and 
efficiency of health care. Among the positive results highlighted in 
these articles were decreases in patient mortality, reductions in 
staffing needs, correlation of clinical decision support to reduced 
transfusion and costs, reduction in complications for patients in 
hospitals with more advanced health IT, and a reduction in costs for 
hospitals with less advanced health IT. Another study, at one hospital 
emergency room in Delaware, showed the ability to download and create a 
file with a patient's medical history saved the ER $545 per use, mostly 
in reduced waiting times. A pilot study of ambulatory practices found a 
positive ROI within 16 months and annual savings thereafter (Greiger, 
et al. 2007, A Pilot Study to Document the Return on Investment for 
Implementing an Ambulatory Electronic Health Record at an Academic 
Medical Center http://www.journalacs.org/article/S1072-7515%2807%2900390-0/abstract-article-footnote-1s.) A study that 
compared the productivity of 75 providers within a large urban primary 
care practice over a 4-year period showed increases in productivity of 
1.7 percent per month per provider after EHR adoption (DeLeon et al. 
2010, ``The business end of health information technology. Can a fully 
integrated electronic health record increase provider productivity in a 
large community practice?'' J Med Pract Manage). Some vendors have 
estimated that EHRs could result in cost savings of between $100 and 
$200 per patient per year. At the time of the writing of this final 
rule, there was only limited information on participation in the EHR 
Incentive Programs and on adoption of Certified EHR Technology. As 
participation and adoption increases, there will be more opportunities 
to capture and report on cost savings and benefits. A number of 
relevant studies are required in the HITECH Act for this specific 
purpose, and the results will be made public, as they are available.
6. Benefits to Society
    According to the recent CBO study ``Evidence on the Costs and 
Benefits of Health Information Technology'' (http://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf) when used effectively, EHRs 
can enable providers to deliver health care more efficiently. For 
example, the study states that EHRs can reduce the duplication of 
diagnostic tests, prompt providers to prescribe cost-effective generic 
medications, remind patients about preventive care reduce unnecessary 
office visits and assist in managing complex care. This is consistent 
with the findings in the ONC study cited previously. Further, the CBO 
report claims that there is a potential to gain both internal and 
external savings from widespread adoption of health IT, noting that 
internal savings will likely be in the reductions in the cost of 
providing care, and that external savings could accrue to the health 
insurance plan or even the patient, such as the ability to exchange 
information more efficiently. However, it is important to note that the 
CBO identifies the highest gains accruing to large provider systems and 
groups and claims that office-based physicians may not realize similar 
benefits from purchasing health IT products. At this time, there is 
limited data regarding the efficacy of health IT for smaller practices 
and groups, and the CBO report notes that this is a potential area of 
research and analysis that remains unexamined. The benefits resulting 
specifically from this final rule are even harder to quantify because 
they represent, in many cases, adding functionality to existing systems 
and reaping the network externalities created by larger numbers of 
providers participating in information exchange.
    Since the CBO study, there has been additional research that has 
emerged documenting the association of EHRs with improved outcomes 
among diabetics (Hunt, JS et al. (2009) ``The impact of a physician-
directed health information technology system on diabetes outcomes in 
primary care: A pre- and post-implementation study'' Informatics in 
Primary Care 17(3):165-74; Pollard, C et al. (2009) ``Electronic 
patient registries improve diabetes care and clinical outcomes in rural 
community health centers'' Journal of Rural Health 25(1):77-84) and 
trauma patients (Deckelbaum, D. et al. (2009) ``Electronic medical 
records and mortality in trauma patients'' The Journal of Trauma: 
Injury, Infection, and Critical Care 67(3): 634-636), enhanced 
efficiencies in ambulatory care settings (Chen, C et al. (2009) ``The 
Kaiser Permanente Electronic Health Record: Transforming and 
Streamlining Modalities of Care.''Health Affairs 28(2):323-333), and 
improved outcomes and lower costs in hospitals (Amarasingham, R. et al. 
(2009) ``Clinical information technologies and inpatient outcomes: A 
multiple hospital study'' Archives of Internal Medicine 169(2):108-14). 
However, data relating specifically to the EHR Incentive Programs is 
limited at this time.
7. General Considerations
    The estimates for the HITECH Act provisions were based on the 
economic assumptions underlying the President's 2013 Budget. Under the 
statute, Medicare incentive payments for CEHRT are excluded from the 
determination of MA capitation benchmarks. As noted previously, there 
is considerable uncertainty about the rate at which eligible hospitals, 
CAHs and EPs are adopting EHRs and other HIT. Nonetheless, we believe 
that the Medicare incentive payments and the prospect of significant 
payment adjustments for not demonstrating meaningful use will result in 
the great majority of hospitals implementing CEHRT in the early years 
of the Medicare EHR incentive program. We expect that a steadily 
growing proportion of practices will implement CEHRT over the next 10 
years, even in the absence of the Medicare incentives.

[[Page 54145]]

Actual future Medicare and Medicaid costs for eligible hospital and EP 
incentives will depend in part on the standards developed and applied 
for assessing meaningful use of certified EHR technology. We are 
administering the requirements in such a way as to encourage adoption 
of CEHRT and facilitate qualification for incentive payments, and 
expect to adopt progressively demanding standards at each stage year. 
Certified EHR technology has the potential to help reduce medical costs 
through efficiency improvements, such as prompter treatments, avoidance 
of duplicate or otherwise unnecessary services, and reduced 
administrative costs (once systems are in place), with most of these 
savings being realized by the providers rather than by Medicare or 
Medicaid. To the extent that this technology will have a net positive 
effect on efficiency, then more rapid adoption of such EHR systems will 
achieve these efficiencies sooner than will otherwise occur, without 
the EHR incentives. As noted, the possible efficiency savings from the 
adoption of EHR is expected to be realized by the providers rather than 
the payers. We expect a negligible impact on benefit payments to 
hospitals and EPs from Medicare and Medicaid as a result of the 
implementation of EHR technology.
    In the process of preparing the estimates for this rule, we 
consulted with and/or relied on internal CMS sources, as well as the 
following sources:
     Congressional Budget Office (staff and publications).
     American Medical Association (staff and unpublished data).
     American Hospital Association.
     Actuarial Research Corporation.
     CMS Statistics 2011.
     RAND Health studies on:
    ++ ``The State and Pattern of Health Information Technology 
Adoption'' (Fonkych & Taylor, 2005);
    ++ ``Extrapolating Evidence of Health Information Technology 
Savings and Costs'' (Girosi, Meili, & Scoville, 2005); and
    ++ ``The Diffusion and Value of Healthcare Information Technology'' 
(Bower, 2005).
     Kaiser Permanente (staff and publications).
     Miscellaneous other sources (Health Affairs, American 
Enterprise Institute, ONC survey, Journal of Medical Practice 
Management, news articles and perspectives).
    As noted at the beginning of this analysis, it is difficult to 
predict the actual impacts of the HITECH Act with much certainty. We 
believe the assumptions and methods described herein are reasonable for 
estimating the financial impact of the provisions on the Medicare and 
Medicaid programs, but acknowledge the wide range of possible outcomes.
8. Summary
    The total cost to the Medicare and Medicaid programs between 2014 
and 2019 is estimated to be $15.4 billion in transfers. We do not 
estimate total costs to the provider industry, but rather provide a 
possible per EP and per eligible hospital outlay for implementation and 
maintenance.

        Table 31--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the Hitech EHR Incentive Program
                                                              [Fiscal year]--[In billions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Medicare eligible                     Medicaid eligible
                       Fiscal year                        ----------------------------------------------------------------------------       Total
                                                               Hospitals        Professionals        Hospitals        Professionals
--------------------------------------------------------------------------------------------------------------------------------------------------------
2014.....................................................               $2.1               $1.9               $0.6               $0.5               $5.1
2015.....................................................                1.8                1.9                0.4                0.8                4.9
2016.....................................................                1.2                0.6                0.5                0.8                3.1
2017.....................................................                0.2                0.1                0.5                0.7                1.5
2018.....................................................               -0.1               -0.2                0.1                0.7                0.5
2019.....................................................  .................               -0.2                0.0                0.5                0.3
--------------------------------------------------------------------------------------------------------------------------------------------------------

9. Explanation of Benefits and Savings Calculations
    In our analysis, we assume that benefits to the program will accrue 
in the form of savings to Medicare, through the Medicare payment 
adjustments. Expected qualitative benefits, such as improved quality of 
care, better health outcomes, and the like, are unable to be quantified 
at this time.

D. Accounting Statement

    Whenever a rule is considered a significant rule under Executive 
Order 12866, we are required to develop an accounting statement 
indicating the classification of the expenditures associated with the 
provisions of this final rule. Monetary annualized benefits and 
nonbudgetary costs are presented as discounted flows using 3 percent 
and 7 percent factors. Additional expenditures that will be undertaken 
by eligible entities in order to obtain the Medicare and Medicaid 
incentive payments to adopt and demonstrate meaningful use of certified 
EHR technology, and to avoid the Medicare payment adjustments that will 
ensue if they fail to do so are noted by a placeholder in the 
accounting statement. We are not able to explicitly define the universe 
of those additional costs, nor specify what the high or low range might 
be to implement EHR technology in this final rule.
    Expected qualitative benefits include improved quality of care, 
better health outcomes, reduced errors and the like. Private industry 
costs will include the impact of EHR activities such as temporary 
reduced staff productivity related to learning how to use the EHR, the 
need for additional staff to work with HIT issues, and administrative 
costs related to reporting.

[[Page 54146]]

         Table 32--Accounting Statement: Classification of Estimated Expenditures CYs 2014 Through 2019
                                                  [In millions]
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                    Category
----------------------------------------------------------------------------------------------------------------
                                                                      Benefits
----------------------------------------------------------------------------------------------------------------
Qualitative......................  Expected qualitative benefits include improved quality of care, better health
                                                       outcomes, reduced errors and the like.
----------------------------------------------------------------------------------------------------------------
                                                                       Costs
----------------------------------------------------------------------------------------------------------------
 
                                   Year dollar   Estimates       Unit        Period
                                                    (in        discount     covered
                                                 millions)       rate
----------------------------------------------------------------------------------------------------------------
                                                    Low          High
                                                  estimate     Estimate
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Costs to             2014       $178.0       $186.1           7%  CY 2014
 Private Industry Associated with
 Reporting Requirements.
                                               ---------------------------------------
                                                     $178.0       $186.1           3%
----------------------------------------------------------------------------------------------------------------
Qualitative--Other private         These costs will include the impact of EHR activities such as reduced staff
 industry costs associated with    productivity related to learning how to use the EHR technology, the need for
 the adoption of EHR technology.   additional staff to work with HIT issues, and administrative costs related to
                                   reporting.
----------------------------------------------------------------------------------------------------------------

                                                                     Transfers
----------------------------------------------------------------------------------------------------------------
                                         0Year   0Estimates (in millions)        0Unit  0Period covered
                                        dollar                                discount
                                                                                  rate
----------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized.....         2014                     $2,558           7%  CYs 2014-2019
                                               ----------------------------------------
                                                                   $2,441           3%
----------------------------------------------------------------------------------------------------------------
From Whom To Whom?...............  Federal Government to Medicare[dash] and Medicaid[dash]eligible professionals
                                   and hospitals.
----------------------------------------------------------------------------------------------------------------

E. Conclusion

    The previous analysis, together with the remainder of this 
preamble, provides an RIA. We believe there are many positive effects 
of adopting EHR on health care providers, quite apart from the 
incentive payments to be provided under this rule. We believe there are 
benefits that can be obtained by eligible hospitals and EPs, including: 
reductions in medical recordkeeping costs, reductions in repeat tests, 
decreases in length of stay, and reduced errors. When used effectively, 
EHRs can enable providers to deliver health care more efficiently. For 
example, EHRs can reduce the duplication of diagnostic tests, prompt 
providers to prescribe cost-effective generic medications, remind 
patients about preventive care, reduce unnecessary office visits, and 
assist in managing complex care. We also believe that internal savings 
will likely come through the reductions in the cost of providing care. 
While economically significant, we do not believe that the net effect 
on individual providers will be negative over time except in very rare 
cases. Accordingly, we believe that the RFA objective to minimize 
burden on small entities is met by this final rule.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 413

    Health facilities, Kidney diseases, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Electronic health records, 
Health facilities, Health professions, Health maintenance organizations 
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
1. The authority citation for part 412 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart D--Basic Method for Determining Prospective Payment Federal 
Rates for Inpatient Operating Costs

0
2. Section 412.64 is amended as follows:
0
A. Revising paragraph (d)(3) introductory text.
0
B. Adding paragraphs (d)(4) and (5).

[[Page 54147]]

    The revision and addition read as follows:

Sec.  412.64  Federal rates for inpatient operating costs for Federal 
fiscal year 2005 and subsequent fiscal years.

* * * * *
    (d) * * *
    (3) Beginning fiscal year 2015, in the case of a ``subsection (d) 
hospital,'' as defined under section 1886(d)(1)(B) of the Act, that is 
not a meaningful electronic health record (EHR) user as defined in part 
495 of this chapter for the applicable EHR reporting period and does 
not receive an exception, three-fourths of the applicable percentage 
change specified in paragraph (d)(1) of this section is reduced--
* * * * *
    (4) Exception-(i) General rules. The Secretary may, on a case-by-
case basis, exempt an eligible hospital that is not a qualifying 
eligible hospital from the application of the reduction under paragraph 
(d)(3) of this section if the Secretary determines that compliance with 
the requirement for being a meaningful EHR user would result in a 
significant hardship for the eligible hospital.
    (ii) To be considered for an exception, a hospital must submit an 
application, in the manner specified by CMS, demonstrating that it 
meets one or more than one of the criteria specified in this paragraph 
(d)(4) of this section. These types of exceptions are subject to annual 
renewal, but in no case may a hospital be granted this type of 
exception for more than 5 years. (See Sec.  495.4 for definitions of 
payment adjustment year, EHR reporting period, and meaningful EHR 
user.)
    (A) During any 90-day period from the beginning of the fiscal year 
that is 2 years before the payment adjustment year to April 1 of the 
year before the payment adjustment year, the hospital was located in an 
area without sufficient Internet access to comply with the meaningful 
use objectives requiring internet connectivity, and faced 
insurmountable barriers to obtaining such internet connectivity. 
Applications requesting this exception must be submitted by April 1 of 
the year before the applicable payment adjustment year.
    (B)(1) During the fiscal year that is 2 fiscal years before the 
payment adjustment year, the hospital that has previously demonstrated 
meaningful use faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user. Applications requesting 
this exception must be submitted by April 1 of the year before the 
applicable payment adjustment year.
    (2) During the fiscal year preceding the payment adjustment year, 
the hospital that has not previously demonstrated meaningful use faces 
extreme and uncontrollable circumstances that prevent it from becoming 
a meaningful EHR user. Applications requesting this exception must be 
submitted by April 1 of the year before the applicable payment 
adjustment year.
    (C) The hospital is new in the payment adjustment year, and has not 
previously operated (under previous or present ownership). This 
exception expires beginning with the first Federal fiscal year that 
begins on or after the hospital has had at least one 12-month (or 
longer) cost reporting period after they accept their first Medicare 
covered patient. For purposes of this exception, the following 
hospitals are not considered new hospitals:
    (1) A hospital that builds new or replacement facilities at the 
same or another location even if coincidental with a change of 
ownership, a change in management, or a lease arrangement.
    (2) A hospital that closes and subsequently reopens.
    (3) A hospital that changes its status from a CAH to a hospital 
that is subject to the Medicare hospital inpatient prospective payment 
systems.
    (5) A State in which hospitals are paid for services under section 
1814(b)(3) of the Act must--
    (i) Adjust the payments to each eligible hospital in the State that 
is not a meaningful EHR user in a manner that is designed to result in 
an aggregate reduction in payments to hospitals in the State that is 
equivalent to the aggregate reduction that would have occurred if 
payments had been reduced to each eligible hospital in the State in a 
manner comparable to the reduction under paragraph (d)(3) of this 
section; and
    (ii) Provide to the Secretary, by January 1, 2013, a report on the 
method that it proposes to employ in order to make the requisite 
payment adjustment described in paragraph (d)(5)(i) of this section.
* * * * *

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
END-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED 
PAYMENT RATES FOR SKILLED NURSING FACILITIES

0
3. The authority citation for part 413 continues to read as follows:

    Authority:  Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), 
and (n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security 
Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and 
(n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww); and sec. 124 of 
Public Law 106-133 (113 Stat. 1501A-332).

0
4. Section 413.70 is amended by revising paragraphs (a)(6)(i) 
introductory text, (a)(6)(ii), and (a)(6)(iii) to read as follows:

Sec.  413.70  Payment for services of a CAH.

    (a) * * *
    (6)(i) For cost reporting periods beginning in or after FY 2015, if 
a CAH is not a qualifying CAH for the applicable EHR reporting period, 
as defined in Sec.  495.4 and Sec.  495.106(a) of this chapter, then 
notwithstanding the percentage applicable in paragraph (a)(1) of this 
section, the reasonable costs of the CAH in providing CAH services to 
its inpatients are adjusted by the following applicable percentage:
* * * * *
    (ii) The Secretary may on a case-by-case basis, exempt a CAH that 
is not a qualifying CAH from the application of the payment adjustment 
under paragraph (a)(6)(i) of this section if the Secretary determines 
that compliance with the requirement for being a meaningful user would 
result in a significant hardship for the CAH. In order to be considered 
for an exception, a CAH must submit an application demonstrating that 
it meets one or more of the criteria specified in this paragraph (a)(6) 
for the applicable payment adjustment year no later than November 30 
after the close of the applicable EHR reporting period. The Secretary 
may grant an exception for one or more of the following:
    (A) During any 90-day period from the beginning of the cost 
reporting period that begins in the fiscal year before the payment 
adjustment year to November 30 after the end of the payment adjustment 
year, the hospital was located in an area without sufficient Internet 
access to comply with the meaningful use objectives requiring Internet 
connectivity, and faced insurmountable barriers to obtaining such 
Internet connectivity.
    (B) A CAH that faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user during the payment 
adjustment year.
    (C) The CAH is new in the payment adjustment year and has not 
previously operated (under previous or present ownership). This 
exception expires beginning with the first Federal fiscal year that 
begins on or after the hospital

[[Page 54148]]

has had at least one 12-month (or longer) cost reporting period after 
they accept their first Medicare-covered patient. For the purposes of 
this exception, the following CAHs are not considered new CAHs:
    (1) A CAH that builds new or replacement facilities at the same or 
another location even if coincidental with a change of ownership, a 
change in management, or a lease arrangement.
    (2) A CAH that closes and subsequently reopens.
    (3) A CAH that has been converted from an eligible hospital as 
defined at Sec.  495.4 of this chapter.
    (iii) Exceptions granted under paragraph (a)(6)(ii) of this section 
are subject to annual renewal, but in no case may a CAH be granted such 
an exception for more than 5 years.
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
5. The authority citation for part 495 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart A--General Provisions

0
6. Section 495.4 is amended as follows:
0
A. Revising the definition of ``EHR reporting period''.
0
B. Adding the definition of ``EHR reporting period for a payment 
adjustment year'' in alphabetical order.
0
C. Revising the definition of ``Hospital-based EP''.
0
D. Revising paragraphs (1) and (3) of the definition of ``Meaningful 
EHR user''.
0
E. Adding the definition of ``Payment adjustment year'' in alphabetical 
order.
    The revisions and additions read as follows:

Sec.  495.4  Definitions.

* * * * *
    EHR reporting period. Except with respect to payment adjustment 
years, EHR reporting period means either of the following:
    (1) For an eligible EP--
    (i) For the payment year in which the EP is first demonstrating he 
or she is a meaningful EHR user, any continuous 90-day period within 
the calendar year;
    (ii) Except as specified in paragraphs (1)(iii) and (1)(iv) of this 
definition, for the subsequent payment years following the payment year 
in which the EP first successfully demonstrates he or she is a 
meaningful EHR user, the calendar year.
    (iii) For an EP seeking to demonstrate he or she is a meaningful 
EHR user for the Medicare EHR incentive program for CY 2014, any of the 
following 3-month periods:
    (A) January 1, 2014 through March 31, 2014.
    (B) April 1, 2014 through June 30, 2014.
    (C) July 1, 2014 through September 30, 2014.
    (D) October 1, 2014 through December 31, 2014.
    (iv) For an EP seeking to demonstrate he or she is a meaningful EHR 
user for the Medicaid EHR incentive program for CY 2014 any continuous 
90-day period within CY 2014.
    (2) For an eligible hospital or CAH--
    (i) For the payment year in which the eligible hospital or CAH is 
first demonstrating it is a meaningful EHR user, any continuous 90-day 
period within the Federal fiscal year;
    (ii) Except as specified in paragraph (2)(iii) of this definition, 
for the subsequent payment years following the payment year in which 
the eligible hospital or CAH first successfully demonstrates it is a 
meaningful EHR user, the Federal fiscal year.
    (iii) For an eligible hospital or CAH seeking to demonstrate it is 
a meaningful EHR user for FY 2014, any of the following 3-month 
periods:
    (A) October 1, 2013 through December 31, 2013.
    (B) January 1, 2014 through March 31, 2014.
    (C) April 1, 2014 through June 30, 2014.
    (D) July 1, 2014 through September 30, 2014.
    EHR reporting period for a payment adjustment year. For a payment 
adjustment year, the EHR reporting period means the following:
    (1) For an EP--
    (i)(A) Except as provided in paragraphs (1)(i)(B), (ii), and (iii) 
of this definition, the calendar year that is 2 years before the 
payment adjustment year.
    (B) The special EHR reporting period for CY 2014 (specified in 
paragraph (1)(iii) or (1)(iv) of this definition, as applicable) of the 
definition of ``EHR Reporting Period'' that occurs within the calendar 
year that is 2 years before the payment adjustment year and is only for 
EHR reporting periods in CY 2014.
    (ii) If an EP is demonstrating he or she is a meaningful EHR user 
for the first time in the calendar year, that is 2 years before the 
payment adjustment year, then any continuous 90-day period within such 
(2 years prior) calendar year.
    (iii)(A) If in the calendar year that is 2 years before the payment 
adjustment year and in all prior calendar years, the EP has not 
successfully demonstrated he or she is a meaningful EHR user, then any 
continuous 90-day period that both begins in the calendar year 1 year 
before the payment adjustment year and ends at least 3 months before 
the end of such prior year.
    (B) Under this exception, the provider must successfully register 
for and attest to meaningful use no later than the date October 1 of 
the year before the payment adjustment year.
    (2) For an eligible hospital--
    (i)(A) Except as provided in paragraphs (2)(i)(B), (ii), and (iii) 
of this definition, the Federal fiscal year that is 2 years before the 
payment adjustment year.
    (B) The special EHR reporting period for FY 2014 (defined in 
paragraph (2)(iii) of the definition ``EHR Reporting Period'') that 
occurs within the fiscal year that is 2 years before the payment 
adjustment year and is only for EHR reporting periods in fiscal year 
2014.
    (ii) If an eligible hospital is demonstrating it is a meaningful 
EHR user for the first time in the Federal fiscal year that is 2 years 
before the payment adjustment year, then any continuous 90-day period 
within such (2 years prior) Federal fiscal year.
    (iii)(A) If in the Federal fiscal year that is 2 years before the 
payment adjustment year and for all prior Federal fiscal years the 
eligible hospital has not successfully demonstrated it is a meaningful 
EHR user, then any continuous 90-day period that both begins in the 
Federal fiscal year that is 1 year before the payment adjustment year 
and ends at least 3 months before the end of such prior Federal fiscal 
year.
    (B) Under this exception, the eligible hospital must successfully 
register for and attest to meaningful use no later than July 1 of the 
year before the payment adjustment year.
    (3) For a CAH--
    (i) Except as provided in paragraph (3)(ii) of this definition, the 
Federal fiscal year that is the payment adjustment year.
    (ii) If the CAH is demonstrating it is a meaningful EHR user for 
the first time in the payment adjustment year, any continuous 90-day 
period within the Federal fiscal year that is the payment adjustment 
year.
* * * * *
    Hospital-based EP. Unless it meets the requirements of Sec.  495.5 
of this part, a hospital-based EP means an EP who furnishes 90 percent 
or more of his or her covered professional services in

[[Page 54149]]

sites of service identified by the codes used in the HIPAA standard 
transaction as an inpatient hospital or emergency room setting in the 
year preceding the payment year, or in the case of a payment adjustment 
year, in either of the 2 years before such payment adjustment year.
    (1) For Medicare, this is calculated based on--
    (i) The FFY preceding the payment year; and
    (ii) For the payment adjustments, on the--
    (A) FFY preceding the payment adjustment year; or
    (B) FFY 2 years before the payment adjustment year.
    (2) For Medicaid, it is at the State's discretion if the data is 
gathered on the Federal fiscal year or calendar year preceding the 
payment year.
* * * * *
    Meaningful EHR user * * *
    (1) Subject to paragraph (3) of this definition, an EP, eligible 
hospital or CAH that, for an EHR reporting period for a payment year or 
payment adjustment year, demonstrates in accordance with Sec.  495.8 
meaningful use of Certified EHR Technology by meeting the applicable 
objectives and associated measures under Sec.  495.6 and successfully 
reporting the clinical quality measures selected by CMS to CMS or the 
States, as applicable, in the form and manner specified by CMS or the 
States, as applicable; and
* * * * *
    (3) To be considered a meaningful EHR user, at least 50 percent of 
an EP's patient encounters during an EHR reporting period for a payment 
year (or, in the case of a payment adjustment year, during an 
applicable EHR reporting period for such payment adjustment year) must 
occur at a practice/location or practices/locations equipped with 
Certified EHR Technology.
* * * * *
    Payment adjustment year means either of the following:
    (1) For an EP, a calendar year beginning with CY 2015.
    (2) For a CAH or an eligible hospital, a Federal fiscal year 
beginning with FY 2015.
* * * * *

0
7. Section 495.5 is added to read as follows:

Sec.  495.5  Requirements for EPs seeking to reverse a hospital-based 
determination under Sec.  495.4.

    (a) Exception for certain EPs. Beginning with payment year 2013, an 
EP who meets the definition of hospital-based EP specified in Sec.  
495.4 but who can demonstrate to CMS that the EP funds the acquisition, 
implementation, and maintenance of Certified EHR Technology, including 
supporting hardware and interfaces needed for meaningful use without 
reimbursement from an eligible hospital or CAH, and uses such Certified 
EHR Technology in the inpatient or emergency department of a hospital 
(instead of the hospital's Certified EHR Technology), may be determined 
by CMS to be a nonhospital-based EP.
    (b) Process for determining a nonhospital-based EP. When an EP 
registers for a given payment year they should receive a determination 
of whether they have been determined ``hospital-based.''
    (1) An EP determined ``hospital-based,'' but who wishes to be 
determined nonhospital-based as specified in paragraph (a) of section, 
may use an administrative process to provide documentation and seek a 
nonhospital-based determination. Such administrative process will be 
available throughout the incentive payment year and including the 2 
months following the incentive payment year in which the EP may attest 
to being a meaningful EHR user.
    (2) If an EP is determined nonhospital-based under paragraph (a) of 
this section, to be considered nonhospital-based for subsequent payment 
years, the EP must attest in such payment year (or by the time the EP 
must attest it is a meaningful EHR user for such year) that the EP 
continues to meet the criteria of paragraph (a) of this section.
    (c) Requirements for nonhospital-based EPs. An EP determined 
nonhospital-based must--
    (1) Continue to meet all applicable requirements to receive an 
incentive payment, including meeting all requirements for meaningful 
use; and
    (2) Demonstrate meaningful use using all encounters at all 
locations equipped with Certified EHR Technology, including those in 
the inpatient and emergency departments of the hospital.

0
8. Section 495.6 is amended as follows:
0
A. Redesignating paragraph (a)(2)(ii) as paragraph (a)(2)(ii)(A).
0
B. Adding paragraph (a)(2)(ii)(B).
0
C. Redesignating paragraph (b)(2)(ii) as paragraph (b)(2)(ii)(A).
0
D. Adding paragraph (b)(2)(ii)(B).
0
E. In paragraphs (c) introductory text and (c)(1), the references 
``paragraphs (d) through (g)'' are removed and the references 
``paragraphs (d) through (m)'' is added in their place.
0
F. Redesignating paragraph (d)(1)(ii) as paragraph (d)(1)(ii)(A).
0
G. Adding paragraph (d)(1)(ii)(B).
0
H. Redesignating paragraph (d)(4)(iii) as paragraph (d)(4)(iii)(A).
0
I. Adding a paragraph (d)(4)(iii)(B).
0
J. Redesignating paragraph (d)(8)(i)(E) as paragraph (d)(8)(i)(E)(1).
0
K. Adding paragraphs (d)(8)(i)(E)(2) and (3).
0
L. Redesignating paragraph (d)(8)(ii) as paragraph (d)(8)(ii)(A).
0
M. Adding paragraphs (d)(8)(ii)(B) and (C).
0
N. Redesignating paragraph (d)(8)(iii) as paragraph (d)(8)(iii)(A).
0
O. Adding paragraphs (d)(8)(iii)(B) and (C).
0
P. Redesignating paragraph (d)(10)(i) as paragraph (d)(10)(i)(A).
0
Q. Adding paragraph (d)(10)(i)(B).
0
R. Redesignating paragraph (d)(10)(ii) as paragraph (d)(10)(ii)(A).
0
S. Adding a paragraph (d)(10)(ii)(B).
0
T. Redesignating paragraph (d)(12)(i) as paragraph (d)(12)(i)(A).
0
U. Adding a paragraph (d)(12)(i)(B).
0
V. Redesignating paragraph (d)(12)(ii) as paragraph (d)(12)(ii)(A).
0
W. Adding a paragraph (d)(12)(ii)(B).
0
X. Redesignating paragraph (d)(12)(iii) as paragraph (d)(12)(iii)(A).
0
Y. Adding a paragraph (d)(12)(iii)(B).
0
Z. Redesignating paragraph (d)(14)(i) as paragraph (d)(14)(i)(A).
0
AA. Adding a paragraph (d)(14)(i)(B).
0
BB. Redesignating paragraph (d)(14)(ii) as paragraph (d)(14)(ii)(A).
0
CC. Adding a paragraph (d)(14)(ii)(B).
0
DD. In paragraph (e) introductory text--
0
i. Removing the colon and adding a period in its place.
0
ii. Adding a sentence at the end of the paragraph.
0
EE. Redesignating paragraph (e)(5)(i) as paragraph (e)(5)(i)(A).
0
FF. Adding a paragraph (e)(5)(i)(B).
0
GG. Redesignating paragraph (e)(5)(ii) as paragraph (e)(5)(ii)(A).
0
HH. Adding paragraph (e)(5)(ii)(B).
0
II. Redesignating paragraph (e)(9)(i) as (e)(9)(i)(A).
0
JJ. Adding paragraph (e)(9)(i)(B).
0
KK. Redesignating paragraph (e)(10)(i) as (e)(10)(i)(A).
0
LL. Adding paragraph (e)(10)(i)(B).
0
MM. Redesignating paragraph (f)(1)(ii) as paragraph (f)(1)(ii)(A).
0
NN. Adding paragraphs (f)(1)(ii)(B) and (C).
0
OO. Redesignating paragraph (f)(7)(i)(E) as paragraph (f)(7)(i)(E)(1).
0
PP. Adding a paragraphs (f)(7)(i)(E)(2) and (3).
0
QQ. Redesignating paragraph (f)(7)(ii) as (f)(7)(ii)(A).
0
RR. Adding paragraphs (f)(7)(ii)(B) and (C).

[[Page 54150]]

0
SS. Redesignating paragraph (f)(9)(i) as paragraph (f)(9)(i)(A).
0
TT. Adding a paragraph (f)(9)(i)(B).
0
UU. Redesignating paragraph (f)(9)(ii) as paragraph (f)(9)(ii)(A).
0
VV. Adding a paragraph (f)(9)(ii)(B).
0
WW. Redesignating paragraphs (f)(11)(i) and (ii) as paragraphs 
(f)(11)(i)(A) and (ii)(A), respectively.
0
XX. Adding paragraphs (f)(11)(i)(B) and (ii)(B).
0
YY. Redesignating paragraph (f)(12)(i) as paragraph (f)(12)(i)(A).
0
ZZ. Adding a paragraph (f)(12)(i)(B).
0
AAA. Redesignating paragraph (f)(12)(ii) as paragraph (f)(12)(ii)(A).
0
BBB. Adding a paragraph (f)(12)(ii)(B).
0
CCC. Redesignating paragraph (f)(12)(iii) as paragraph (f)(12)(iii)(A).
0
DDD. Adding a paragraph (f)(12)(iii)(B).
0
EEE. Redesignating paragraph (f)(13)(i) as paragraph (f)(13)(i)(A).
0
FFF. Adding a paragraph (f)(13)(i)(B).
0
GGG. Redesignating paragraph (f)(13)(ii) as paragraph (f)(13)(ii)(A).
0
HHH. Adding a paragraph (f)(13)(ii)(B).
0
III. In paragraph (g) introductory text--
0
i. Removing the colon and adding a period in its place.
0
ii. Adding a sentence at the end of the paragraph.
0
JJJ. Redesignating paragraph (g)(8)(i) as paragraph (g)(8)(i)(A).
0
KKK. Adding a paragraph (g)(8)(i)(B).
0
LLL. Redesignating paragraph (g)(9)(i) as paragraph (g)(9)(i)(A).
0
MMM. Adding a paragraph (g)(9)(i)(B).
0
NNN. Redesignating paragraph (g)(10)(i) as paragraph (g)(10)(i)(A).
0
OOO. Adding a paragraph (g)(10)(i)(B).
0
PPP. Revising paragraphs (h) and (i).
0
QQQ. Adding new paragraphs (j) through (m).
    The additions and revisions read as follows:

Sec.  495.6  Meaningful use objectives and measures for EPs, eligible 
hospitals, and CAHs.

* * * * *
    (a) * * *
    (2) * * *
    (ii) * * *
    (B) Beginning 2014, an exclusion does not reduce (by the number of 
exclusions applicable) the number of objectives that would otherwise 
apply in paragraph (e) of this section unless five or more objectives 
can be excluded. An EP must meet five of the objectives and associated 
measures specified in paragraph (e) of this section, one of which must 
be either paragraph (e)(9) or (10) of this section, unless the EP has 
an exclusion from five or more objectives specified in paragraph (e) of 
this section, in which case the EP must meet all remaining objectives 
and associated measures in paragraph (e) of this section.
* * * * *
    (b) * * *
    (2) * * *
    (ii) * * *
    (B) Beginning 2014, an exclusion does not reduce (by the number of 
exclusions applicable) the number of objectives that would otherwise 
apply in paragraph (g) of this section. Eligible hospitals or CAHs must 
meet five of the objectives and associated measures specified in 
paragraph (g) of this section, one which must be specified in paragraph 
(g)(8), (9), or (10) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (B) Subject to paragraph (c) of this section, more than 30 percent 
of medication orders created by the EP during the EHR reporting period 
are recorded using computerized provider order entry, or the measure 
specified in paragraph (d)(1)(ii)(A) of this section.
* * * * *
    (4) * * *
    (iii) * * *
    (B) Beginning 2013, any EP who does not have a pharmacy within 
their organization and there are no pharmacies that accept electronic 
prescriptions within 10 miles of the EP's practice location at the 
start of his/her EHR reporting period, or the exclusion specified in 
(d)(4)(iii)(A) of this section.
* * * * *
    (8)(i) * * *
    (E) * * *
    (2) For 2013, plot and display growth charts for patients 0-20 
years, including body mass index, or paragraph (d)(8)(i)(E)(1) of this 
section.
    (3) Beginning 2014, plot and display growth charts for patients 0-
20 years, including body mass index.
    (ii) * * *
    (B) For 2013--(1) Subject to paragraph (c) of this section, more 
than 50 percent of all unique patients seen by the EP during the EHR 
reporting period have blood pressure (for patients age 3 and over only) 
and height/length and weight (for all ages) recorded as structured 
data; or
    (2) The measure specified in paragraph (d)(8)(ii)(A) of this 
section.
    (C) Beginning 2014, only the measure specified in paragraph 
(d)(8)(ii)(B)(1) of this section.
    (iii) * * *
    (B) For 2013, either of the following:
    (1) The exclusion specified in paragraph (d)(8)(iii)(A) of this 
section.
    (2) The exclusion for an EP who--
    (i) Sees no patients 3 years or older is excluded from recording 
blood pressure;
    (ii) Believes that all three vital signs of height/length, weight, 
and blood pressure have no relevance to their scope of practice is 
excluded from recording them;
    (iii) Believes that height/length and weight are relevant to their 
scope of practice, but blood pressure is not, is excluded from 
recording blood pressure; or
    (iv) Believes that blood pressure is relevant to their scope of 
practice, but height/length and weight are not, is excluded from 
recording height/length and weight.
    (C) Beginning 2014, only the exclusion specified in paragraph 
(d)(8)(iii)(B)(2) of this section.
* * * * *
    (10)(i) * * *
    (B) Beginning 2013, this objective is reflected in the definition 
of a meaningful EHR user in Sec.  495.4 and is no longer listed as an 
objective in this paragraph (d).
    (ii) * * *
    (B) Beginning 2013, this measure is reflected in the definition of 
a meaningful EHR user in Sec.  495.4 and no longer listed as a measure 
in this paragraph (d).
* * * * *
    (12)(i) * * *
    (B) Beginning 2014, provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    (ii) * * *
    (B) Beginning 2014, subject to paragraph (c) of this section, more 
than 50 percent of all unique patients seen by the EP during the EHR 
reporting period are provided timely (available to the patient within 4 
business days after the information is available to the EP) online 
access to their health information subject to the EP's discretion to 
withhold certain information.
    (iii) * * *
    (B) Beginning 2014, any EP who neither orders nor creates any of 
the information listed for inclusion as part of this measure.
* * * * *
    (14)(i) * * *
    (B) Beginning 2013, this objective is no longer required as part of 
the core set.
    (ii) * * *
    (B) Beginning 2013, this measure is no longer required as part of 
the core set.
* * * * *

[[Page 54151]]

    (e) * * * Beginning 2014, an EP must meet five of the following 
objectives and associated measures, one of which must be either 
paragraph (e)(9) or (10) of this section unless the EP has an exclusion 
from five or more objectives in this paragraph (e), in which case the 
EP must meet all remaining objectives and associated measures in 
paragraph (e) of this section.
* * * * *
    (5)(i) * * *
    (B) Beginning 2014, this objective is no longer included in the 
menu set.
    (ii) * * *
    (B) Beginning 2014, this measure is no longer included in the menu 
set.
* * * * *
    (9)(i) * * *
    (B) Beginning 2013, capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission except where prohibited and according to applicable law and 
practice.
* * * * *
    (10)(i) * * *
    (B) Beginning 2013, capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission 
except where prohibited and according to applicable law and practice.
* * * * *
    (f) * * *
    (1) * * *
    (ii) * * *
    (B) Subject to paragraph (c) of this section, more than 30 percent 
of medication orders created by the authorized providers of the 
eligible hospital or CAH for patients admitted to their inpatient or 
emergency departments (POS 21 or 23) during the EHR reporting period 
are recorded using computerized provider order entry, or the measure 
specified in paragraph (f)(1)(ii)(A) of this section.
* * * * *
    (7) * * *
    (i) * * *
    (E) * * *
    (2) For 2013, plot and display growth charts for patients 0-20 
years, including body mass index, or paragraph (f)(7)(i)(E)(1) of this 
section.
    (3) Beginning 2014, plot and display growth charts for patients 0-
20 years, including body mass index.
    (ii) * * *
    (B) For 2013--(1) Subject to paragraph (c) of this section, more 
than 50 percent of all unique patients admitted to the eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period have blood pressure (for patients age 3 
and over only) and height/length and weight (for all ages) recorded as 
structured data; or
    (2) The measure specified in paragraph (f)(7)(ii)(A) of this 
section.
    (C) Beginning 2014, only the measure specified in paragraph 
(f)(7)(ii)(B)(1) of this section.
* * * * *
    (9) * * *
    (i) * * *
    (B) Beginning 2013, this objective is reflected in the definition 
of a meaningful EHR user in Sec.  495.4 and no longer listed as an 
objective in this paragraph (f).
    (ii) * * *
    (B) Beginning 2013, this measure is reflected in the definition of 
a meaningful EHR user in Sec.  495.4 and no longer listed as a measure 
in this paragraph (f).
* * * * *
    (11) * * *
    (i) * * *
    (B) Beginning 2014, this objective is no longer required as part of 
the core set.
    (ii) * * *
    (B) Beginning 2014, this measure is no longer required as part of 
the core set.
    (12) * * *
    (i) * * *
    (B) Beginning 2014, provide patients the ability to view online, 
download, and transmit information about a hospital admission.
    (ii) * * *
    (B) Beginning 2014, subject to paragraph (c) of this section, more 
than 50 percent of all patients who are discharged from the inpatient 
or emergency department (POS 21 or 23) of an eligible hospital or CAH 
have their information available online within 36 hours of discharge.
    (iii) * * *
    (B) Beginning 2014, this exclusion is no longer available.
* * * * *
    (13) * * *
    (i) * * *
    (B) Beginning 2013, this objective is no longer required as part of 
the core set.
    (ii) * * *
    (B) Beginning 2013, this measure is no longer required as part of 
the core set.
* * * * *
    (g) * * * Beginning 2014, eligible hospitals or CAHs must meet five 
of the following objectives and associated measures, one which must be 
specified in paragraph (g)(8), (9), or (10) of this section:
* * * * *
    (8)(i) * * *
    (B) Beginning 2013, Capability to submit electronic data to 
immunization registries or immunization information systems and actual 
submission except where prohibited and according to applicable law and 
practice.
    (9)(i) * * *
    (B) Beginning 2013, capability to submit electronic data on 
reportable (as required by State or local law) lab results to public 
health agencies and actual submission except where prohibited according 
to applicable law and practice.
    (10)(i) * * *
    (B) Beginning 2013, capability to submit electronic syndromic 
surveillance data to public health agencies and actual submission 
except where prohibited and according to applicable law and practice.
* * * * *
    (h) Stage 2 criteria for EPs-(1) General rule regarding Stage 2 
criteria for meaningful use for EPs. Except as specified in paragraph 
(h)(2) of this section, EPs must meet all objectives and associated 
measures of the Stage 2 criteria specified in paragraph (j) of this 
section and 3 objectives of the EP's choice from paragraph (k) of this 
section to meet the definition of a meaningful EHR user.
    (2) Exclusion for nonapplicable objectives. (i) An EP may exclude a 
particular objective contained in paragraph (j) or (k) of this section, 
if the EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (j) or (k) of this 
section includes an option for the EP to attest that the objective is 
not applicable.
    (B) Meets the criteria in the applicable objective that would 
permit the attestation.
    (C) Attests.
    (ii)(A) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (j) of this section. For example, an EP that has an exclusion 
from one of the objectives in paragraph (j) of this section must meet 
16 objectives from such paragraph to meet the definition of a 
meaningful EHR user.
    (B) An exclusion does not reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (k) of this section unless four or more exclusions apply. For 
example, an EP that has an exclusion for one of the objectives in 
paragraph (k) of this section must meet three of the five nonexcluded 
objectives from such paragraph to meet the definition of a meaningful 
EHR user. If an EP has an exclusion for four of the objectives in 
paragraph (k) of this

[[Page 54152]]

section, then he or she must meet the remaining two nonexcluded 
objectives from such paragraph to meet the definition of a meaningful 
EHR user.
    (i) Stage 2 criteria for eligible hospitals and CAHs-(1) General 
rule regarding Stage 2 criteria for meaningful use for eligible 
hospitals or CAHs. Except as specified in paragraph (i)(2) of this 
section, eligible hospitals and CAHs must meet all objectives and 
associated measures of the Stage 2 criteria specified in paragraph (l) 
of this section and three objectives of the eligible hospital's or 
CAH's choice from paragraph (m) of this section to meet the definition 
of a meaningful EHR user.
    (2) Exclusions for nonapplicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective that includes an 
option for exclusion contained in paragraphs (l) or (m) of this 
section, if the hospital meets all of the following requirements:
    (A) The hospital meets the criteria in the applicable objective 
that would permit an exclusion.
    (B) The hospital so attests.
    (ii)(A) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (l) of this section. For example, an eligible hospital that 
has an exclusion from 1 of the objectives in paragraph (l) of this 
section must meet 15 objectives from such paragraph to meet the 
definition of a meaningful EHR user.
    (B) An exclusion does not reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (m) of this section. For example, an eligible hospital that 
has an exclusion for one of the objectives in paragraph (m) of this 
section must meet three of the five nonexcluded objectives from such 
paragraph to meet the definition of a meaningful EHR user.
    (j) Stage 2 core criteria for EPs. An EP must satisfy the following 
objectives and associated measures, except those objectives and 
associated measures for which an EP qualifies for an exclusion under 
paragraph (h)(2) of this section specified in this paragraph (j).
    (1)(i) Objective. Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per State, local, and professional guidelines.
    (ii) Measures. Subject to paragraph (c) of this section--
    (A) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry;
    (B) More than 30 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry; and
    (C) More than 30 percent of radiology orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (iii) Exclusions in accordance with paragraph (h)(2) of this 
section. (A) For the measure specified in paragraph (j)(1)(ii)(A) of 
this section, any EP who writes fewer than 100 medication orders during 
the EHR reporting period.
    (B) For the measure specified in paragraph (j)(1)(ii)(B) of this 
section, any EP who writes fewer than 100 laboratory orders during the 
EHR reporting period.
    (C) For the measure specified in paragraph (j)(1)(ii)(C), any EP 
who writes fewer than 100 radiology orders during the EHR reporting 
period.
    (2)(i) Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (ii) Measure. Subject to paragraph (c) of this section, more than 
50 percent of all permissible prescriptions, or all prescriptions, 
written by the EP are queried for a drug formulary and transmitted 
electronically using Certified EHR Technology.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who--
    (A) Writes fewer than 100 permissible prescriptions during the EHR 
reporting period; or (B) Does not have a pharmacy within their 
organization and there are no pharmacies that accept electronic 
prescriptions within 10 miles of the EP's practice location at the 
start of his or her EHR reporting period.
    (3)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Sex.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.
    (ii) Measure. More than 80 percent of all unique patients seen by 
the EP during the EHR reporting period have demographics recorded as 
structured data.
    (4)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height/Length.
    (B) Weight.
    (C) Blood pressure (ages 3 and over).
    (D) Calculate and display body mass index (BMI).
    (E) Plot and display growth charts for patients 0-20 years, 
including body mass index.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
80 percent of all unique patients seen by the EP during the EHR 
reporting period have blood pressure (for patients age 3 and over only) 
and height/length and weight (for all ages) recorded as structured 
data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who--
    (A) Sees no patients 3 years or older is excluded from recording 
blood pressure;
    (B) Believes that all three vital signs of height/length, weight, 
and blood pressure have no relevance to their scope of practice is 
excluded from recording them;
    (C) Believes that height/length and weight are relevant to their 
scope of practice, but blood pressure is not, is excluded from 
recording blood pressure; or
    (D) Believes that blood pressure is relevant to their scope of 
practice, but height/length and weight are not, is excluded from 
recording height/length and weight.
    (5)(i) Objective. Record smoking status for patients 13 years old 
or older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
80 percent of all unique patients 13 years old or older seen by the EP 
during the EHR reporting period have smoking status recorded as 
structured data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who sees no patients 13 years old or older.
    (6)(i) Objective. Use clinical decision support to improve 
performance on high priority health conditions.
    (ii) Measures. (A) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an EP's scope of 
practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions; and
    (B) The EP has enabled and implemented the functionality for drug-
drug and drug-allergy interaction checks for the entire EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this section 
for paragraph (j)(6)(ii)(B) of this section. An EP who writes fewer 
than 100 medication orders during the EHR reporting period.
    (7)(i) Objective. Incorporate clinical lab test results into 
Certified EHR Technology as structured data.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
55 percent of all clinical lab tests results ordered by the EP during 
the EHR reporting period whose results are either in a positive/

[[Page 54153]]

negative affirmation or numerical format are incorporated in Certified 
EHR Technology as structured data.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who orders no lab tests whose results are either in a 
positive/negative affirmation or numerical format during the EHR 
reporting period.
    (8)(i) Objective. Generate lists of patients by specific conditions 
to use for quality improvement, reduction of disparities, research, or 
outreach.
    (ii) Measure. Generate at least one report listing patients of the 
EP with a specific condition.
    (9)(i) Objective. Use clinically relevant information to identify 
patients who should receive reminders for preventive/follow-up care and 
send these patients the reminder, per patient preference.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
10 percent of all unique patients who have had two or more office 
visits with the EP within the 24 months before the beginning of the EHR 
reporting period were sent a reminder, per patient preference when 
available.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who has had no office visits in the 24 months before 
the beginning of the EHR reporting period.
    (10)(i) Objective. Provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    (ii) Measures. (A) More than 50 percent of all unique patients seen 
by the EP during the EHR reporting period are provided timely 
(available to the patient within 4 business days after the information 
is available to the EP) online access to their health information 
subject to the EP's discretion to withhold certain information; and
    (B) More than 5 percent of all unique patients seen by the EP 
during the EHR reporting period (or their authorized representatives) 
view, download or transmit to a third party their health information.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who--
    (A) Neither orders nor creates any of the information listed for 
inclusion as part of the measures in paragraphs (j)(10)(ii)(A) and (B) 
of this section, except for ``Patient name'' and ``Provider's name and 
office contact information,'' is excluded from both paragraphs 
(j)(10)(ii)(A) and (B) of this section; or
    (B) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units 
with 3Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period is 
excluded from paragraph (j)(10)(ii)(B) of this section.
    (11)(i) Objective. Provide clinical summaries for patients for each 
office visit.
    (ii) Measure. Subject to paragraph (c) of this section, clinical 
summaries provided to patients or patient-authorized representatives 
within 1 business day for more than 50 percent of office visits.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who has no office visits during the EHR reporting 
period.
    (12)(i) Objective. Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) Measure. Patient-specific education resources identified by 
Certified EHR Technology are provided to patients for more than 10 
percent of all unique patients with office visits seen by the EP during 
the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who has no office visits during the EHR reporting 
period.
    (13)(i) Objective. The EP who receives a patient from another 
setting of care or provider of care or believes an encounter is 
relevant should perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the EP 
performs medication reconciliation for more than 50 percent of 
transitions of care in which the patient is transitioned into the care 
of the EP.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who was not the recipient of any transitions of care 
during the EHR reporting period.
    (14)(i) Objective. The EP who transitions their patient to another 
setting of care or provider of care or refers their patient to another 
provider of care provides a summary care record for each transition of 
care or referral.
    (ii) Measures. (A) Subject to paragraph (c) of this section, the EP 
that transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 50 
percent of transitions of care and referrals;
    (B) Subject to paragraph (c) of this section, the EP that 
transitions or refers their patient to another setting of care or 
provider of care provides a summary of care record for more than 10 
percent of such transitions and referrals either--
    (1) Electronically transmitted using Certified EHR Technology to a 
recipient; or
    (2) Where the recipient receives the summary of care record via 
exchange facilitated by an organization that is a NwHIN Exchange 
participant or in a manner that is consistent with the governance 
mechanism ONC establishes for the nationwide health information 
network, and
    (C) Subject to paragraph (c) of this section an EP must satisfy one 
of the following:
    (1) Conducts one or more successful electronic exchanges of a 
summary of care record meeting the measure specified in paragraph 
(j)(14)(ii)(B) of this section with a recipient using technology to 
receive the summary of care record that was designed by a different EHR 
developer than the sender's EHR technology certified at 45 CFR 
107.314(b)(2); or
    (2) Conducts one or more successful tests with the CMS designated 
test EHR during the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who transfers a patient to another setting or refers a 
patient to another provider less than 100 times during the EHR 
reporting period.
    (15)(i) Objective. Capability to submit electronic data to 
immunization registries or immunization information systems except 
where prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic 
immunization data from Certified EHR Technology to an immunization 
registry or immunization information system for the entire EHR 
reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP that meets one or more of the following criteria:
    (A) Does not administer any of the immunizations to any of the 
populations for which data is collected by their jurisdiction's 
immunization registry or immunization information system during the EHR 
reporting period.
    (B) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required for Certified EHR Technology at the start of his or 
her EHR reporting period.
    (C) Operates in a jurisdiction where no immunization registry or 
immunization information system provides information timely on 
capability to receive immunization data.

[[Page 54154]]

    (D) Operates in a jurisdiction for which no immunization registry 
or immunization information system that is capable of accepting the 
specific standards required by Certified EHR Technology at the start of 
his or her EHR reporting period can enroll additional EPs.
    (16)(i) Objective. Protect electronic health information created or 
maintained by the Certified EHR Technology through the implementation 
of appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data stored in Certified EHR 
Technology in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the EP's risk management process.
    (17)(i) Objective. Use secure electronic messaging to communicate 
with patients on relevant health information.
    (ii) Measure. A secure message was sent using the electronic 
messaging function of Certified EHR Technology by more than 5 percent 
of unique patients (or their authorized representatives) seen by the EP 
during the EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who meets one or more of the following criteria:
    (A) Has no office visits during the EHR reporting period.
    (B) Who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 3Mbps broadband availability according to the latest 
information available from the FCC on the first day of their EHR 
reporting period.
    (k) Stage 2 menu set criteria for EPs. An EP must meet 3 of the 
following objectives and associated measures, unless the EP has an 
exclusion from 4 or more objectives in this paragraph (k) of this 
section, in which case the EP must meet all remaining objectives and 
associated measures.
    (1)(i) Objective. Imaging results consisting of the image itself 
and any explanation or other accompanying information are accessible 
through Certified EHR Technology.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
10 percent of all tests whose result is one or more images ordered by 
the EP during the EHR reporting period are accessible through Certified 
EHR Technology.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who meets one or more of the following criteria.
    (A) Orders less than 100 tests whose result is an image during the 
EHR reporting period.
    (B) Has no access to electronic imaging results at the start of the 
EHR reporting period.
    (2)(i) Objective. Record patient family health history as 
structured data.
    (ii) Measure. More than 20 percent of all unique patients seen by 
the EP during the EHR reporting period have a structured data entry for 
one or more first-degree relatives.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who has no office visits during the EHR reporting 
period.
    (3)(i) Objective. Capability to submit electronic syndromic 
surveillance data to public health agencies, except where prohibited, 
and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic syndromic 
surveillance data from Certified EHR Technology to a public health 
agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP that meets one or more of the following criteria:
    (A) Is not in a category of providers who collect ambulatory 
syndromic surveillance information on their patients during the EHR 
reporting period.
    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required for Certified EHR Technology at the start 
of their EHR reporting period.
    (C) Operates in a jurisdiction where no public health agency 
provides information timely on capability to receive syndromic 
surveillance data.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional EPs.
    (4)(i) Objective. Capability to identify and report cancer cases to 
a public health central cancer registry, except where prohibited, and 
in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of cancer case 
information from Certified EHR Technology to a public health central 
cancer registry for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who meets one or more of the following--
    (A) Does not diagnose or directly treat cancer.
    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic cancer case information in the specific 
standards required for Certified EHR Technology at the start of their 
EHR reporting period.
    (C) Operates in a jurisdiction where no public health agency 
provides information timely on capability to receive electronic cancer 
case information.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of receiving electronic cancer case information in the 
specific standards required for Certified EHR Technology at the 
beginning of their EHR reporting period can enroll additional EPs.
    (5)(i) Objective. Capability to identify and report specific cases 
to a specialized registry (other than a cancer registry), except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of specific case 
information from Certified EHR Technology to a specialized registry for 
the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who meets one or more of the following criteria:
    (A) Does not diagnose or directly treat any disease associated with 
a specialized registry sponsored by a national specialty society for 
which the EP is eligible, or the public health agencies in their 
jurisdiction;
    (B) Operates in a jurisdiction for which no specialized registry 
sponsored by a public health agency or by a national specialty society 
for which the EP is eligible is capable of receiving electronic 
specific case information in the specific standards required by 
Certified EHR Technology at the beginning of their EHR reporting 
period;
    (C) Operates in a jurisdiction where no public health agency or 
national specialty society for which the EP is eligible provides 
information timely on capability to receive information into their 
specialized registries; or
    (D) Operates in a jurisdiction for which no specialized registry 
sponsored by a public health agency or by a national specialty society 
for which the EP is eligible that is capable of receiving electronic 
specific case information in the specific standards required by

[[Page 54155]]

Certified EHR Technology at the beginning of his or her EHR reporting 
period can enroll additional EPs.
    (6)(i) Objective. Record electronic notes in patient records.
    (ii) Measure. Enter at least one electronic progress note created, 
edited, and signed by an EP for more than 30 percent of unique patients 
with at least one office visit during the EHR reporting period. The 
text of the electronic note must be text-searchable and may contain 
drawings and other content.
    (l) Stage 2 core criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the following objectives and 
associated measures except those objectives and associated measures for 
which an eligible hospital or CAH qualifies for an exclusion under 
paragraph (i)(2) of this section.
    (1)(i) Objective. Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per State, local, and professional guidelines.
    (ii) Measures. Subject to paragraph (c) of this section, more 
than--
    (A) Sixty percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry,
    (B) Thirty percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry, and
    (C) Thirty percent of radiology orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (2)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Sex.
    (C) Race.
    (D) Ethnicity.
    (E) Date of birth.
    (F) Date and preliminary cause of death in the event of mortality 
in the eligible hospital or CAH.
    (ii) Measure. More than 80 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) during the EHR reporting period have demographics 
recorded as structured data.
    (3)(i) Objective. Record and chart changes in the following vital 
signs:
    (A) Height/Length.
    (B) Weight.
    (C) Blood pressure (ages 3 and over).
    (D) Calculate and display body mass index (BMI).
    (E) Plot and display growth charts for patients 0-20 years, 
including body mass index.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
80 percent of all unique patients admitted to the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period have blood pressure (for patients age 3 and over 
only) and height/length and weight (for all ages) recorded as 
structured data.
    (4)(i) Objective. Record smoking status for patients 13 years old 
or older.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
80 percent of all unique patients 13 years old or older admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period have smoking status recorded as 
structured data.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that admits no patients 13 years 
old or older to their inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period.
    (5)(i) Objective. Use clinical decision support to improve 
performance on high priority health conditions.
    (ii) Measures. (A) Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an eligible hospital 
or CAH's patient population, the clinical decision support 
interventions must be related to high-priority health conditions; and
    (B) The eligible hospital or CAH has enabled and implemented the 
functionality for drug-drug and drug-allergy interaction checks for the 
entire EHR reporting period.
    (6)(i) Objective. Incorporate clinical lab test results into 
Certified EHR Technology as structured data.
    (ii) Measure. More than 55 percent of all clinical lab tests 
results ordered by authorized providers of the eligible hospital or CAH 
for patients admitted to its inpatient or emergency department (POS 21 
or 23) during the EHR reporting period whose results are either in a 
positive/negative affirmation or numerical format are incorporated in 
Certified EHR Technology as structured data.
    (7)(i) Objective. Generate lists of patients by specific conditions 
to use for quality improvement, reduction of disparities, research or 
outreach.
    (ii) Measure. Generate at least one report listing patients of the 
eligible hospital or CAH with a specific condition.
    (8)(i) Objective. Provide patients the ability to view online, 
download, and transmit information about a hospital admission.
    (ii) Measures. (A) More than 50 percent of all patients who are 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH have their information available online 
within 36 hours of discharge; and
    (B) More than 5 percent of all patients who are discharged from the 
inpatient or emergency department (POS 21 or 23) of an eligible 
hospital or CAH (or their authorized representative) view, download or 
transmit to a third party their information during the EHR reporting 
period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that is located in a county that 
does not have 50 percent or more of its housing units with 3Mbps 
broadband availability according to the latest information available 
from the FCC on the first day of the EHR reporting period is excluded 
from paragraph (l)(8)(ii)(B) of this section.
    (9)(i) Objective. Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) Measure. More than 10 percent of all unique patients admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23) are provided patient-specific education resources 
identified by Certified EHR Technology.
    (10)(i) Objective. The eligible hospital or CAH that receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant should perform medication reconciliation.
    (ii) Measure. Subject to paragraph (c) of this section, the 
eligible hospital or CAH performs medication reconciliation for more 
than 50 percent of transitions of care in which the patient is admitted 
to the eligible hospital's or CAH's inpatient or emergency department 
(POS 21 or 23).
    (11)(i) Objective. The eligible hospital or CAH that transitions 
their patient to another setting of care or provider of care or refers 
their patient to another provider of care provides a summary care 
record for each transition of care or referral.

[[Page 54156]]

    (ii) Measures. (A) Subject to paragraph (c) in this section, the 
eligible hospital or CAH that transitions or refers their patient to 
another setting of care or provider of care provides a summary of care 
record for more than 50 percent of transitions of care and referrals,
    (B) Subject to paragraph (c) in this section, the eligible hospital 
or CAH that transitions their patient to another setting of care or 
provider of care provides a summary of care record for more than 10 
percent of such transitions and referrals either--
    (1) Electronically transmitted using Certified EHR Technology to a 
recipient; or
    (2) Where the recipient receives the summary of care record via 
exchange facilitated by an organization that is a NwHIN Exchange 
participant or in a manner that is consistent with the governance 
mechanism ONC establishes for the nationwide health information 
network; and
    (C) Subject to paragraph (c) of this section an eligible hospital 
or CAH must satisfy one of the following:
    (1) Conducts one or more successful electronic exchanges of a 
summary of care record meeting the measure specified in paragraph 
(l)(11)(ii)(B) of this section with a recipient using technology to 
receive the summary of care record that was designed by a different EHR 
developer than the sender's EHR technology certified at 45 CFR 
107.314(b)(2); or
    (2) Conducts one or more successful tests with the CMS designated 
test EHR during the EHR reporting period.
    (12)(i) Objective. Capability to submit electronic data to 
immunization registries or immunization information systems except 
where prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic 
immunization data from Certified EHR Technology to an immunization 
registry or immunization information system for the entire EHR 
reporting period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that meets one or more of the 
following criteria:
    (A) The eligible hospital or CAH does not administer any of the 
immunizations to any of the populations for which data is collected by 
their jurisdiction's immunization registry or immunization information 
system during the EHR reporting period.
    (B) The eligible hospital or CAH operates in a jurisdiction for 
which no immunization registry or immunization information system is 
capable of accepting the specific standards required for Certified EHR 
Technology at the start of their EHR reporting period.
    (C) The eligible hospital or CAH operates in a jurisdiction where 
no immunization registry or immunization information system provides 
information timely on capability to receive immunization data.
    (D) Operates in a jurisdiction for which no immunization registry 
or immunization information system that is capable of accepting the 
specific standards required by Certified EHR Technology at the start of 
their EHR reporting period can enroll additional eligible hospitals or 
CAHs.
    (13)(i) Objective. Capability to submit electronic reportable 
laboratory results to public health agencies, where except where 
prohibited, and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic 
reportable laboratory results from Certified EHR Technology to a public 
health agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that meets one or more of the 
following criteria:
    (A) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic reportable laboratory results in the 
specific standards required for Certified EHR Technology at the start 
of their EHR reporting period.
    (B) Operates in a jurisdiction for which no public health agency 
provides information timely on capability to receive electronic 
reportable laboratory results.
    (C) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional eligible hospitals or CAHs.
    (14)(i) Objective. Capability to submit electronic syndromic 
surveillance data to public health agencies, except where prohibited, 
and in accordance with applicable law and practice.
    (ii) Measure. Successful ongoing submission of electronic syndromic 
surveillance data from Certified EHR Technology to a public health 
agency for the entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that meets one or more of the 
following criteria:
    (A) Does not have an emergency or urgent care department.
    (B) Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required for Certified EHR Technology at the start 
of their EHR reporting period or can enroll additional eligible 
hospitals or CAHs.
    (C) Operates in a jurisdiction for which no public health agency 
provides information timely on capability to receive syndromic 
surveillance data.
    (D) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific standards required by 
Certified EHR Technology at the start of their EHR reporting period can 
enroll additional eligible hospitals or CAHs.
    (15)(i) Objective. Protect electronic health information created or 
maintained by the Certified EHR Technology through the implementation 
of appropriate technical capabilities.
    (ii) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the encryption/security of data stored in Certified EHR 
Technology in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the eligible hospital's or CAH's risk management process.
    (16)(i) Objective. Automatically track medications from order to 
administration using assistive technologies in conjunction with an 
electronic medication administration record (eMAR).
    (ii) Measure. Subject to paragraph (c) of this section, more than 
10 percent of medication orders created by authorized providers of the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period for which all doses are tracked 
using eMAR.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH with an average daily inpatient 
census of fewer than 10 patients.
    (m) Stage 2 menu set criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the measure criteria for three of 
the following objectives and associated measures.
    (1)(i) Objective. Record whether a patient 65 years old or older 
has an advance directive.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
50 percent of all unique patients 65 years old or older admitted to the 
eligible hospital's or CAH's inpatient department (POS 21) during the 
EHR reporting period have an indication of an advance directive status 
recorded as structured data.

[[Page 54157]]

    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that admits no patients age 65 
years old or older during the EHR reporting period.
    (2)(i) Objective. Imaging results consisting of the image itself 
and any explanation or other accompanying information are accessible 
through Certified EHR Technology.
    (ii) Measure. Subject to paragraph (c) of this section, more than 
10 percent of all tests whose result is an image ordered by an 
authorized provider of the eligible hospital or CAH for patients 
admitted to its inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period are accessible through Certified EHR 
Technology.
    (3)(i) Objective. Record patient family health history as 
structured data.
    (ii) Measure. More than 20 percent of all unique patients admitted 
to the eligible hospital or CAH's inpatient or emergency department 
(POS 21 or 23) during the EHR reporting period have a structured data 
entry for one or more first-degree relatives.
    (4)(i) Objective. Generate and transmit permissible discharge 
prescriptions electronically (eRx).
    (ii) Measure. More than 10 percent of hospital discharge medication 
orders for permissible prescriptions (for new, changed and refilled 
prescriptions) are queried for a drug formulary and transmitted 
electronically using Certified EHR Technology.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that does not have an internal 
pharmacy that can accept electronic prescriptions and there are no 
pharmacies that accept electronic prescriptions within 10 miles at the 
start of its EHR reporting period.
    (5)(i) Objective. Record electronic notes in patient records.
    (ii) Measure: Enter at least one electronic progress note created, 
edited and signed by an authorized provider of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) for more than 
30 percent of unique patients admitted to the eligible hospital or 
CAH's inpatient or emergency department during the EHR reporting 
period. The text of the electronic note must be text-searchable and may 
contain drawings and other content.
    (6)(i) Objective. Provide structured electronic lab results to 
ambulatory providers.
    (ii) Measure. Hospital labs send structured electronic clinical lab 
results to the ordering provider for more than 20 percent of electronic 
lab orders received.

0
9. Section 495.8 is amended as follows:
0
A. Revising paragraph (a)(2)(i)(B) and (a)(2)(ii).
0
B. Revising paragraphs (b)(2)(i)(B) and (b)(2)(ii).

Sec.  495.8  Demonstration of meaningful use criteria.

    (a) * * *
    (2) * * *
    (i) * * *
    (B) Satisfied the required objectives and associated measures under 
Sec.  495.6 for the EP's stage of meaningful use.
* * * * *
    (ii) Reporting clinical quality information. Successfully report 
the clinical quality measures selected by CMS to CMS or the States, as 
applicable, in the form and manner specified by CMS or the States, as 
applicable.
* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (B) Satisfied the required objectives and associated measures under 
Sec.  495.6 for the eligible hospital or CAH's stage of meaningful use.
* * * * *
    (ii) Reporting clinical quality information. Successfully report 
the clinical quality measures selected by CMS to CMS or the States, as 
applicable, in the form and manner specified by CMS or the States, as 
applicable.
* * * * *

Sec.  495.10  [Amended]

0
10. In Sec.  495.10, paragraph (a)(3) is amended by removing the phrase 
``Business address and'' and adding in its place the phrase ``Business 
address, business email address, and''.

0
11. Section 495.100 is amended by revising the definitions of 
``Qualifying CAH,'' ``Qualifying eligible professional (qualifying 
EP),'' and ``Qualifying hospital'' to read as follows:

Sec.  495.100  Definitions.

* * * * *
    Qualifying CAH means a CAH that is a meaningful EHR user for the 
EHR reporting period applicable to a payment year or payment adjustment 
year in which a cost reporting period begins.
    Qualifying eligible professional (qualifying EP) means an EP who is 
a meaningful EHR user for the EHR reporting period applicable to a 
payment or payment adjustment year and who is not a hospital-based EP, 
as determined for that payment or payment adjustment year.
    Qualifying hospital means an eligible hospital that is a meaningful 
EHR user for the EHR reporting period applicable to a payment or 
payment adjustment year.

0
10. Section 495.102 is amended as follows:
0
A. Revising paragraphs (c), (d)(1), and (d)(2)(iii).
0
B. Adding paragraph (d)(2)(iv).
0
C. Revising paragraph (d)(3).
0
D. Adding paragraphs (d)(4) and (5).
    The revisions and additions read as follows:

Sec.  495.102  Incentive payments to EPs.

* * * * *
    (c) Increase in incentive payment limit for EPs who predominantly 
furnish services in a geographic HPSA. In the case of a qualifying EP 
who furnishes more than 50 percent of his or her covered professional 
services during the payment year in a geographic HPSA that is 
designated as of December 31 of the prior year, the incentive payment 
limit determined under paragraph (b) of this section is to be increased 
by 10 percent.
    (d) Payment adjustment effective in CY 2015 and subsequent years 
for nonqualifying EPs. (1)(i) Subject to paragraphs (d)(3) and (4) of 
this section, beginning 2015, for covered professional services 
furnished by an EP who is not hospital-based, and who is not a 
qualifying EP by virtue of not being a meaningful EHR user (for the EHR 
reporting period applicable to the payment adjustment year), the 
payment amount for such services is equal to the product of the 
applicable percent specified in paragraph (d)(2) of this section and 
the Medicare physician fee schedule amount for such services.
    (2) * * *
    (iii) For 2017, 97 percent.
    (iv) For 2018 and subsequent years, 97 percent, except as provided 
in paragraph (d)(3) of this section.
    (3) Decrease in applicable percent in certain circumstances. If, 
beginning CY 2018 and for each subsequent year, the Secretary finds 
that the proportion of EPs who are meaningful EHR users is less than 75 
percent, the applicable percent must be decreased by 1 percentage point 
for EPs from the applicable percent in the preceding year, but in no 
case will the applicable percent be less than 95 percent.
    (4) Exceptions. The Secretary may, on a case-by-case basis, exempt 
an EP from the application of the payment adjustment under paragraph 
(d)(1) of this section if the Secretary determines that compliance with 
the requirement for being a meaningful EHR user would result in a 
significant hardship for the EP. To be considered for an exception, an 
EP must submit, in the manner specified by CMS, an application

[[Page 54158]]

demonstrating that it meets one or more of the criteria in this 
paragraph (d)(4) unless otherwise specified in the criteria. The 
Secretary's determination to grant an EP an exemption may be renewed on 
an annual basis, provided that in no case may an EP be granted an 
exemption for more than 5 years.
    (i) During any 90-day period from the beginning of the year that is 
2 years before the payment adjustment year to July 1 of the year 
preceding the payment adjustment year, the EP was located in an area 
without sufficient Internet access to comply with the meaningful use 
objectives requiring internet connectivity, and faced insurmountable 
barriers to obtaining such internet connectivity. Applications 
requesting this exception must be submitted no later than July 1 of the 
year before the applicable payment adjustment year.
    (ii) The EP has been practicing for less than 2 years.
    (iii)(A) During the calendar year that is 2 calendar years before 
the payment adjustment year, the EP that has previously demonstrated 
meaningful use faces extreme and uncontrollable circumstances that 
prevent it from becoming a meaningful EHR user. Applications requesting 
this exception must be submitted no later than July 1 of the year 
before the applicable payment adjustment year.
    (B) During the calendar year preceding the payment adjustment year, 
the EP that has not previously demonstrated meaningful use faces 
extreme and uncontrollable circumstances that prevent it from becoming 
a meaningful EHR user. Applications requesting this exception must be 
submitted by July 1 of the year before the applicable payment 
adjustment year.
    (iv) An EP may request an exception through an application 
submitted by July 1 of the year before the applicable payment 
adjustment year due to difficulty in meeting meaningful use based on 
any one of the following during the period that begins 2 calendar years 
before the payment adjustment year through the application deadline:
    (A) The EP practices at multiple locations and can demonstrate 
inability to control the availability of Certified EHR Technology at 
one such practice location or a combination of practice locations, and 
where the location or locations constitute more than 50 percent of 
their patient encounters.
    (B) The EP can demonstrate difficulty in meeting meaningful use on 
the basis of lack of face-to-face or telemedicine interaction with 
patients and lack of need for follow up with patients.
    (C) The EP has a primary specialty listed in PECOS as 
anesthesiology, radiology or pathology 6 months prior to the first day 
of the payment adjustments that would otherwise apply. Such an EP may 
be deemed to qualify for this exception, subject to the 5-year limit 
that applies to all exceptions under this paragraph.
    (5) Payment adjustments not applicable to hospital-based EPs. No 
payment adjustment under paragraphs (d)(1) through (3) of this section 
may be made in the case of a hospital-based eligible professional, as 
defined in Sec.  495.4.

Sec.  495.106  [Amended]

0
12. In Sec.  495.106, paragraph (e) is amended by removing the phrase 
``for a payment year'' and adding the phrase ``for a payment adjustment 
year'' in its place.

0
13. Section 495.200 is amended by--
0
A. Adding definitions for ``MA payment adjustment year,'' and 
``Potentially qualifying MA EPs and potentially qualifying MA-
affiliated eligible hospitals'' in alphabetical order.
0
B. Revising paragraph (5) of the definition of ``Qualifying MA EP''.
    The additions and revision read as follows:

Sec.  495.200  Definitions.

* * * * *
    MA payment adjustment year means--(1) For qualifying MA 
organizations that receive an MA EHR incentive payment for at least 1 
payment year, calendar years beginning with CY 2015.
    (2) For MA-affiliated eligible hospitals, the applicable EHR 
reporting period for purposes of determining whether the MA 
organization is subject to a payment adjustment is the federal fiscal 
year ending in the MA payment adjustment year.
    (3) For MA EPs, the applicable EHR reporting period for purposes of 
determining whether the MA organization is subject to a payment 
adjustment is the calendar year concurrent with the payment adjustment 
year.
* * * * *
    Potentially qualifying MA EPs and potentially qualifying MA-
affiliated eligible hospitals are defined for purposes of this subpart 
in Sec.  495.202(a)(4).
* * * * *
    Qualifying MA EP * * *
    (5) Is not a ``hospital-based EP'' (as defined in Sec.  495.4 of 
this part) and in determining whether 90 percent or more of his or her 
covered professional services were furnished in a hospital setting, 
only covered professional services furnished to MA plan enrollees of 
the qualifying MA organization, in lieu of FFS patients, will be 
considered.
* * * * *

0
14. Section 495.202 is amended as follows:
0
A. Revising paragraph (b)(1).
0
B. In paragraph (b)(2) introductory text, removing the cross-reference 
``(b)(3)'' and adding the cross-reference ``(4)'' in its place.
0
C. Revising paragraph (b)(2)(iii).
0
D. Redesignating paragraphs (b)(3) and (4) as paragraphs (b)(4) and 
(5).
0
E. Adding a new paragraph (b)(3).
0
F. Revising newly redesignated paragraph (b)(4).
0
G. Revising newly redesignated paragraphs (b)(5)(i) and (ii).
    The addition and revisions read as follows:

Sec.  495.202  Identification of qualifying MA organizations, MA-EPs 
and MA-affiliated eligible hospitals.

* * * * *
    (b) * * *
    (1) A qualifying MA organization, as part of its initial bid 
starting with plan year 2012, must make a preliminary identification of 
MA EPs and MA-affiliated eligible hospitals that the MA organization 
believes will be qualifying MA EPs and MA-affiliated eligible hospitals 
for which the organization is seeking incentive payments for the 
current plan year.
    (2) * * *
    (iii) NPI or CCN.
* * * * *
    (3) When reporting under either paragraph (b)(1) or (4) of this 
section for purposes of receiving an incentive payment, a qualifying MA 
organization must also indicate whether more than 50 percent of the 
covered Medicare professional services being furnished by a qualifying 
MA EP to MA plan enrollees of the MA organization are being furnished 
in a designated geographic HPSA (as defined in Sec.  495.100 of this 
part).
    (4) Final identification of qualifying and potentially qualifying, 
as applicable, MA EPs and MA-affiliated eligible hospitals must be made 
within 2 months of the close of the payment year or the EHR reporting 
period that applies to the payment adjustment year as defined in Sec.  
495.200.
    (5) * * *
    (i) Identify all MA EPs and MA-affiliated eligible hospitals of the 
MA organization that the MA organization believes will be either 
qualifying or potentially qualifying;

[[Page 54159]]

    (ii) Include information specified in paragraph (b)(2)(i) through 
(iii) of this section for each professional or hospital; and
* * * * *

0
15. Section 495.204 is amended as follows:
0
A. Revising the section heading.
0
B. Revising paragraphs (b)(2) and (b)(4) introductory text, and 
(b)(4)(i) and (ii).
0
C. Redesignating paragraph (e) as paragraph (f).
0
D. Adding new paragraphs (e), (f)(5), and (g).
    The revisions and additions read as follows:

Sec.  495.204  Incentive payments to qualifying MA organizations for 
qualifying MA-EPs and qualifying MA-affiliated eligible hospitals.

* * * * *
    (b) * * *
    (2) The qualifying MA organization must report to CMS within 2 
months of the close of the calendar year, the aggregate annual amount 
of revenue attributable to providing services that would otherwise be 
covered as professional services under Part B received by each 
qualifying MA EP for enrollees in MA plans of the MA organization in 
the payment year.
* * * * *
    (4) CMS requires the qualifying MA organization to develop a 
methodological proposal for estimating the portion of each qualifying 
MA EP's salary or revenue attributable to providing services that would 
otherwise be covered as professional services under Part B to MA plan 
enrollees of the MA organization in the payment year. The 
methodological proposal--
    (i) Must be approved by CMS; and
    (ii) May include an additional amount related to overhead, where 
appropriate, estimated to account for the MA-enrollee related Part B 
practice costs of the qualifying MA EP.
* * * * *
    (e) Potential increase in incentive payment for furnishing services 
in a geographic HPSA. In the case of a qualifying MA EP who furnishes 
more than 50 percent of his or her covered professional services to MA 
plan enrollees of the qualifying MA organization during a payment year 
in a geographic HPSA, the maximum amounts referred to in paragraph 
(b)(3) of this section are increased by 10 percent.
    (f) * * *
    (5) If an MA EP, or entity that employs an MA EP, or in which an MA 
EP has a partnership interest, MA-affiliated eligible hospital, or 
other party contracting with the MA organization, fails to comply with 
an audit request to produce applicable documents or data, CMS recoups 
all or a portion of the incentive payment, based on the lack of 
applicable documents or data.
    (g) Coordination of payment with FFS or Medicaid EHR incentive 
programs. (1) If, after payment is made to an MA organization for an MA 
EP, it is determined that the MA EP is eligible for the full incentive 
payment under the Medicare FFS EHR Incentive Program or has received a 
payment under the Medicaid EHR Incentive Program, CMS recoups amounts 
applicable to the given MA EP from the MA organization's monthly MA 
payment, or otherwise recoups the applicable amounts.
    (2) If, after payment is made to an MA organization for an MA-
affiliated eligible hospital, it is determined that the hospital is 
ineligible for the incentive payment under the MA EHR Incentive 
Program, or has received a payment under the Medicare FFS EHR Incentive 
Program, or if it is determined that all or part of the payment should 
not have been made on behalf of the MA-affiliated eligible hospital, 
CMS recoups amounts applicable to the given MA-affiliated eligible 
hospital from the MA organization's monthly MA payment, or otherwise 
recoups the applicable amounts.

0
16. Section 495.208 is amended as follows:
0
A. Redesignating paragraphs (a) through (c) as paragraphs (d) through 
(f).
0
B. Adding new paragraphs (a) through (c).
    The additions read as follows:

Sec.  495.208  Avoiding duplicate payment.

    (a) CMS requires a qualifying MA organization that registers MA EPs 
for the purpose of participating in the MA EHR Incentive Program to 
notify each of the MA EPs for which it is claiming an incentive payment 
that the MA organization intends to claim, or has claimed, the MA EP 
for the current plan year under the MA EHR Incentive Program.
    (b) The notice must make clear that the MA EP may still directly 
receive an EHR incentive payment if the MA EP is entitled to a full 
incentive payment under the FFS portion of the EHR Incentive Program, 
or if the MA EP registered to participate under the Medicaid portion of 
the EHR Incentive Program and is entitled to payment under that 
program--in both of which cases no payment would be made for the EP 
under the MA EHR incentive program.
    (c) An attestation by the qualifying MA organization that the 
qualifying MA organization provided notice to its MA EPs in accordance 
with this section must be required at the time that meaningful use 
attestations are due with respect to MA EPs for the payment year.
* * * * *

0
17. Section 495.210 is amended by revising paragraphs (b) and (c) to 
read as follows:

Sec.  495.210  Meaningful EHR user attestation

* * * * *
    (b) Qualifying MA organizations are required to attest within 2 
months after the close of a calendar year whether each qualifying MA EP 
is a meaningful EHR user.
    (c) Qualifying MA organizations are required to attest within 2 
months after close of the FY whether each qualifying MA-affiliated 
eligible hospital is a meaningful EHR user.

0
18. Add Sec.  495.211 to subpart C to read as follows:

Sec.  495.211  Payment adjustments effective for 2015 and subsequent MA 
payment years with respect to MA EPs and MA-affiliated eligible 
hospitals.

    (a) In general. Beginning for MA payment adjustment year 2015, 
payment adjustments set forth in this section are made to prospective 
payments (issued under section 1853(a)(1)(A) of the Act) of qualifying 
MA organizations that previously received incentive payments under the 
MA EHR Incentive Program, if all or a portion of the MA-EPs and MA-
affiliated eligible hospitals that would meet the definition of 
qualifying MA-EPs or qualifying MA-affiliated eligible hospitals (but 
for their demonstration of meaningful use) are not meaningful EHR 
users.
    (b) Adjustment based on payment adjustment year. The payment 
adjustment is calculated based on the payment adjustment year.
    (c) Separate application of adjustments for MA EPs and MA-
affiliated eligible hospitals. The payment adjustments identified in 
paragraphs (d) and (e) of this section are applied separately. 
Paragraph (d) of this section applies only to qualifying MA 
organizations that received payment for any MA payment year for 
qualifying MA EPs under Sec.  495.204. Paragraph (e) of this section 
applies only to qualifying MA organizations that received payment for 
any MA payment year for qualifying MA-affiliated eligible hospitals 
under Sec.  495.204.
    (d) Payment adjustments effective for 2015 and subsequent years 
with respect to MA EPs. (1) For payment adjustment year 2015, and 
subsequent payment

[[Page 54160]]

adjustment years, if a qualifying MA EP is not a meaningful EHR user 
during the payment adjustment year, CMS--
    (i) Determines a payment adjustment based on data from the payment 
adjustment year; and
    (ii) Collects the payment adjustment owed by adjusting a subsequent 
year's prospective payment or payments (issued under section 
1853(a)(1)(A) of the Act), or by otherwise collecting the payment 
adjustment, if, in the year of collection, the MA organization does not 
have an MA contract with CMS.
    (2) Beginning for payment adjustment year 2015, a qualifying MA 
organization that previously received incentive payments must, for each 
payment adjustment year, report to CMS the following:

[the total number of potentially qualifying MA EPs]/[(the total number 
of potentially qualifying MA EPs) + (the total number of qualifying MA 
EPs)].

    (3) The monthly prospective payment amount paid under section 
1853(a)(1)(A) of the Act for the payment adjustment year is adjusted by 
the product of--
    (i) The percent calculated in accordance with paragraph (d)(2) of 
this section;
    (ii) The Medicare Physician Expenditure Proportion percent, which 
is CMS's estimate of proportion of expenditures under Parts A and B 
that are not attributable to Part C that are attributable to 
expenditures for physicians' services, adjusted for the proportion of 
expenditures that are provided by EPs that are neither qualifying nor 
potentially qualifying MA EPs with respect to a qualifying MA 
organization; and
    (iii) The applicable percent identified in paragraph (d)(4) of this 
section.
    (4) Applicable percent. The applicable percent is as follows:
    (i) For 2015, 1 percent;
    (ii) For 2016, 2 percent;
    (iii) For 2017, 3 percent.
    (iv) For 2018, 3 percent, except, in the case described in 
paragraph (d)(4)(vi) of this section, 4 percent.
    (v) For 2019 and each subsequent year, 3 percent, except, in the 
case described in paragraph (d)(4)(vi) of this section, the percent 
from the prior year plus 1 percent. In no case will the applicable 
percent be higher than 5 percent.
    (vi) Beginning with payment adjustment year 2018, if the percentage 
in paragraph (d)(2) of this section is more than 25 percent, the 
applicable percent is increased in accordance with paragraphs 
(d)(4)(iv) and (v) of this section.
    (e) Payment adjustments effective for 2015 and subsequent years 
with respect to MA-affiliated eligible hospitals. (1)(i) The payment 
adjustment set forth in this paragraph (e) applies if a qualifying MA 
organization that previously received an incentive payment (or a 
potentially qualifying MA-affiliated eligible hospital on behalf of its 
qualifying MA organization) attests that a qualifying MA-affiliated 
eligible hospital is not a meaningful EHR user for a payment adjustment 
year.
    (ii) The payment adjustment is calculated by multiplying the 
qualifying MA organization's monthly prospective payment for the 
payment adjustment year under section 1853(a)(1)(A) of the Act by the 
percent set forth in paragraph (e)(2) of this section.
    (2) The percent set forth in this paragraph (e) is the product of--
    (i) The percentage point reduction to the applicable percentage 
increase in the market basket index for the relevant Federal fiscal 
year as a result of Sec.  412.64(d)(3) of this chapter;
    (ii) The Medicare Hospital Expenditure Proportion percent specified 
in paragraph (e)(3) of this section; and
    (iii) The percent of qualifying and potentially qualifying MA-
affiliated eligible hospitals that are not meaningful EHR users. 
Qualifying MA organizations are required to report to CMS

[the number of potentially qualifying MA-affiliated eligible 
hospitals]/[(the total number of potentially qualifying MA-affiliated 
eligible hospitals) + (the total number of qualifying MA-affiliated 
eligible hospitals)].

    (3) The Medicare Hospital Expenditure Proportion for a year is the 
Secretary's estimate of expenditures under Parts A and B that are not 
attributable to Part C, that are attributable to expenditures for 
inpatient hospital services, adjusted for the proportion of 
expenditures that are provided by hospitals that are neither qualifying 
nor potentially qualifying MA-affiliated eligible hospitals with 
respect to a qualifying MA organization.

0
19. Section 495.302 is amended as follows:
0
A. In the definition of ``Adopt, implement or upgrade,'' by revising 
paragraph (1).
0
B. In the definition of ``Children's hospital,'' by revising paragraph 
(1), redesignating paragraph (2) as paragraph (3), and adding a new 
paragraph (2).
0
C. In the definition of ``Practices predominantly,'' by removing the 
phrase ``in the most recent calendar year'' and adding the phrase 
``(within the most recent calendar year or, as an optional State 
alternative beginning for payment year 2013, within the 12-month period 
preceding attestation)''.
    The revisions and addition read as follows:

Sec.  495.302  Definitions.

* * * * *
    Adopt, implement or upgrade * * *
    (1) Acquire, purchase, or secure access to certified EHR technology 
capable of meeting meaningful use requirements;
* * * * *
    Children's hospital * * *
    (1) Has a CMS certification number (CCN), (previously known as the 
Medicare provider number), that has the last 4 digits in the series 
3300-3399; or
    (2) Does not have a CCN but has been provided an alternative number 
by CMS for purposes of enrollment in the Medicaid EHR Incentive Program 
as a children's hospital and;
* * * * *

0
20. Section 495.304 is amended as follows:
0
A. In paragraphs (c)(1) and (2), by removing the phrase ``individuals 
receiving Medicaid'' and adding the phrase '' individuals enrolled in a 
Medicaid program'' in its place.
0
B. Adding paragraph (f).
    The addition reads as follows:

Sec.  495.304  Medicaid provider scope and eligibility.

* * * * *
    (f) Further patient volume requirements for the Medicaid EP. For 
payment year 2013 and all subsequent payment years, at least one 
clinical location used in the calculation of patient volume must have 
Certified EHR Technology--
    (1) During the payment year for which the EP attests to having 
adopted, implemented or upgraded Certified EHR Technology (for the 
first payment year); or
    (2) During the payment year for which the EP attests it is a 
meaningful EHR user.

0
21. Section 495.306 is amended as follows;
0
A. Revising paragraphs (b), (c)(1)(i), (c)(2)(i), (c)(3)(i), 
(d)(1)(i)(A), (d)(1)(ii)(A), (d)(2)(i)(A), (d)(2)(ii)(A), and (e)(1) 
introductory text.
0
B. In paragraph (e)(1)(i), by removing ``; or'' and adding a period in 
its place.
0
C. Adding paragraph (e)(1)(iii).
0
D. Revising paragraph (e)(2)(i) introductory text.
0
E. In paragraph (e)(2)(i)(A), by removing ``; or'' and adding a period 
in its place.

[[Page 54161]]

0
F. Adding paragraph (e)(2)(i)(C).
0
G. Revising paragraph (e)(2)(ii) introductory text.
0
H. In paragraph (e)(2)(ii)(A), by removing ``; or'' and adding a period 
in its place.
0
I. Adding paragraph (e)(2)(ii)(C).
0
J. Revising paragraph (e)(3) introductory text.
0
K. In paragraphs (e)(3)(i) and (ii), by removing the semicolon and 
adding a period in its place.
0
L. In paragraph (e)(3)(iii), by removing ``; or'' and adding a period 
in its place.
0
M. Redesignating paragraphs (e)(3)(iii) and (e)(3)(iv) as paragraphs 
(e)(3)(iv) and (e)(3)(v).
0
N. Adding a new paragraph (e)(3)(iii).
    The revisions and additions read as follows:

Sec.  495.306  Establishing patient volume.

* * * * *
    (b) State option(s) through SMHP. (1) A State must submit through 
the SMHP the option or options it has selected for measuring patient 
volume.
    (2)(i) A State must select the method described in either paragraph 
(c) or paragraph (d) of this section (or both methods).
    (ii) Under paragraphs (c)(1)(i), (c)(2)(i), (c)(3)(i), (d)(1)(i), 
and (d)(2)(i) of this section, States may choose whether to allow 
eligible providers to calculate total Medicaid or total needy 
individual patient encounters in any representative continuous 90-day 
period in the 12 months preceding the EP or eligible hospital's 
attestation or based upon a representative, continuous 90-day period in 
the calendar year preceding the payment year for which the EP or 
eligible hospital is attesting.
    (3) In addition, or as an alternative to the method selected in 
paragraph (b)(2) of this section, a State may select the method 
described in paragraph (g) of this section.
    (c) * * *
    (1) * * *
    (i) The total Medicaid patient encounters in any representative, 
continuous 90-day period in the calendar year preceding the EP's 
payment year, or in the 12 months before the EP's attestation; by
* * * * *
    (2) * * *
    (i) The total Medicaid encounters in any representative, continuous 
90-day period in the fiscal year preceding the hospitals' payment year 
or in the 12 months before the hospital's attestation; by
* * * * *
    (3) * * *
    (i) The total needy individual patient encounters in any 
representative, continuous 90-day period in the calendar year preceding 
the EP's payment year, or in the 12 months before the EP's attestation; 
by
* * * * *
    (d) * * *
    (1) * * *
    (i)(A) The total Medicaid patients assigned to the EP's panel in 
any representative, continuous 90-day period in either the calendar 
year preceding the EP's payment year, or the 12 months before the EP's 
attestation when at least one Medicaid encounter took place with the 
individual in the 24 months before the beginning of the 90-day period; 
plus
* * * * *
    (ii)(A) The total patients assigned to the provider in that same 
90-day period with at least one encounter taking place with the patient 
during the 24 months before the beginning of the 90-day period; plus
* * * * *
    (2) * * *
    (i)(A) The total Needy Individual patients assigned to the EP's 
panel in any representative, continuous 90-day period in the either the 
calendar year preceding the EP's payment year, or the 12 months before 
the EP's attestation when at least one Needy Individual encounter took 
place with the individual in the 24 months before the beginning of the 
same 90-day period; plus
* * * * *
    (ii)(A) The total patients assigned to the provider in that same 
90-day period with at least one encounter taking place with the patient 
during the 24 months before the beginning of the 90-day period, plus
* * * * *
    (e) * * *
    (1) A Medicaid encounter means services rendered to an individual 
on any one day where:
* * * * *
    (iii) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
    (2) * * *
    (i) A Medicaid encounter means services rendered to an individual 
per inpatient discharge when any of the following occur:
    (C) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
    (ii) A Medicaid encounter means services rendered in an emergency 
department on any 1 day if any of the following occur:
* * * * *
    (C) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
    (3) For purposes of calculating needy individual patient volume, a 
needy patient encounter means services rendered to an individual on any 
1 day if any of the following occur:
* * * * *
    (iii) The individual was enrolled in a Medicaid program (or a 
Medicaid demonstration project approved under section 1115 of the Act) 
at the time the billable service was provided.
* * * * *

0
22. Section 495.310 is amended as follows:
0
A. Removing and reserving paragraphs (a)(1)(ii) and (a)(2)(ii).
0
B. Adding paragraph (f)(8).
0
C. Revising paragraph (g)(1)(i)(B) introductory text.
0
D. In paragraphs (g)(1)(i)(B)(1) through (g)(1)(i)(B)(3), by removing 
the term ``discharge'' wherever it appears and adding the term ``acute-
care inpatient discharge'' in its place.
0
E. In paragraph (g)(1)(i)(C), by removing the term ``discharges'' and 
adding the term ``acute-care inpatient discharges'' in its place.
0
F. In paragraphs (g)(2)(i)(A) and (B), (g)(2)(ii)(A), and (g)(2)(iii), 
by removing the phrase ``inpatient-bed-days'' wherever it appears and 
adding the phrase ``acute care inpatient-bed-days'' in its place.
    The addition and revision read as follows:

Sec.  495.310  Medicaid provider incentive payments.

* * * * *
    (f) * * *
    (8) The aggregate EHR hospital incentive amount calculated under 
paragraph (g) of this section is determined by the State from which the 
eligible hospital receives its first payment year incentive. If a 
hospital receives incentive payments from other States in subsequent 
years, total incentive payments received over all payment years of the 
program can be no greater than the aggregate EHR incentive amount 
calculated by the initial State.
    (g) * * *
    (1) * * *
    (i) * * *
    (B) The discharge-related amount for the most recent continuous 12-
month period selected by the State, but ending before the federal 
fiscal year that serves

[[Page 54162]]

as the first payment year. The discharge-related amount is the sum of 
the following, with acute-care inpatient discharges over the 12-month 
period and based upon the total acute-care inpatient discharges for the 
eligible hospital (regardless of any source of payment):
* * * * *

0
23. Section 495.312 is amended by revising paragraph (c) to read as 
follows:

Sec.  495.312  Process for payments.

* * * * *
    (c) State's role. (1) Except as specified in paragraph (c)(2) of 
this section, the State determines the provider's eligibility for the 
EHR incentive payment under subparts A and D of this part and approves, 
processes, and makes timely payments using a process approved by CMS.
    (2) At the State's option, CMS conducts the audits and handles any 
subsequent appeals, of whether eligible hospitals are meaningful EHR 
users on the States' behalf.
* * * * *

0
24. Section 495.316 is amended by revising paragraph (d)(2) to read as 
follows:

Sec.  495.316  State monitoring and reporting regarding activities 
required to receive an incentive payment.

* * * * *
    (d) * * *
    (2)(i) Subject to Sec.  495.332, the State may propose a revised 
definition for Stage 1 of meaningful use of certified EHR technology, 
subject to CMS prior approval, but only with respect to the following 
objectives:
    (A) Generate lists of patients by specific conditions to use for 
quality improvement, reduction of disparities, research or outreach.
    (B) Capability to submit electronic data to immunization registries 
or immunization information systems and actual submission except where 
prohibited, and according to applicable law and practice.
    (C) Capability to submit electronic data on reportable (as required 
by State or local law) lab results to public health agencies and actual 
submission except where prohibited according to applicable law and 
practice.
    (D) Capability to submit electronic syndromic surveillance data to 
public health agencies and actual submission except where prohibited 
and according to applicable law and practice.
    (ii) Subject to Sec.  495.332, the State may propose a revised 
definition for Stage 2 of meaningful use of certified EHR technology, 
subject to CMS prior approval, but only with respect to the following 
objectives:
    (A) Generate lists of patients by specific conditions to use for 
quality improvement, reduction of disparities, research, or outreach.
    (B) Capability to submit electronic data to immunization registries 
or immunization information systems, except where prohibited, and in 
accordance with applicable law and practice.
    (C) Capability to submit electronic reportable laboratory results 
to public health agencies, except where prohibited, and in accordance 
with applicable law and practice.
    (D) Capability to provide electronic syndromic surveillance data to 
public health agencies, except where prohibited, and in accordance with 
applicable law and practice.
    (E) Capability to identify and report cancer cases to a public 
health central cancer registry, except where prohibited, and in 
accordance with applicable law and practice.
    (F) Capability to identify and report specific cases to a 
specialized registry (other than a cancer registry), except where 
prohibited, and in accordance with applicable law and practice.
* * * * *

0
23. Section 495.332 is amended by:
0
A. Adding paragraph (b)(6).
0
B. Revising paragraph (c) introductory text.
0
C. Removing paragraph (d)(9).
0
D. Adding paragraph (g).
    The additions and revisions read as follows:

Sec.  495.332  State Medicaid health information technology (HIT) plan 
requirements.

* * * * *
    (b) * * *
    (6) For ensuring that at least one clinical location used for the 
calculation of the EP's patient volume has Certified EHR Technology 
during the payment year for which the EP is attesting.
    (c) Monitoring and validation. Subject to paragraph (g) of this 
section, for monitoring and validation of information States must 
include the following:
* * * * *
    (g) Optional--signed agreement. At the State's option, the State 
may include a signed agreement indicating that the State does all of 
the following:
    (1) Designates CMS to conduct all audits and appeals of eligible 
hospitals' meaningful use attestations.
    (2) Is bound by the audit and appeal findings described in 
paragraph (g)(1) of this section.
    (3) Performs any necessary recoupments if audits (and any 
subsequent appeals) described in paragraph (g)(1) of this section 
determine that an eligible hospital was not a meaningful EHR user.
    (4) Is liable for any FFP granted to the State to pay eligible 
hospitals that, upon audit (and any subsequent appeal) are determined 
not to have been meaningful EHR users.

0
26. Section 495.342 is amended by revising the introductory text to 
read as follows:

Sec.  495.342  Annual HIT IAPD requirements.

    Each State is required to submit the HIT IAPD Updates 12 months 
from the date of the last CMS approved HIT IAPD and must contain the 
following:
* * * * *

0
27. Section 495.370 is amended by adding paragraph (d) to read as 
follows:

Sec.  495.370  Appeals process for a Medicaid provider receiving 
electronic health record incentive payments.

* * * * *
    (d) This section does not apply in the case that CMS conducts the 
audits and handles any subsequent appeals under Sec.  495.312(c)(2) of 
this part.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: August 21, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.

    Approved: August 21, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-21050 Filed 8-23-12; 2:30 pm]
BILLING CODE 4120-01-P
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