[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Proposed Rules]
[Pages 13698-13829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4443]



[[Page 13697]]

Vol. 77

Wednesday,

No. 45

March 7, 2012

Part II





Department of Health and Human Services





-----------------------------------------------------------------------





Centers for Medicare & Medicaid Services





-----------------------------------------------------------------------





42 CFR Parts 412, 413, and 495





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

Federal Register / Vol. 77 , No. 45 / Wednesday, March 7, 2012 / 
Proposed Rules

[[Page 13698]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412, 413, and 495

[CMS-0044-P]
RIN 0938-AQ84


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

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

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would specify 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 would specify 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 and other program participation requirements. 
This proposed rule would also revise certain Stage 1 criteria, as well 
as criteria that apply regardless of Stage, as finalized in the final 
rule titled Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program published on July 28, 2010 in the Federal Register. 
The provisions included in the Medicaid section of this proposed rule 
(which relate to calculations of patient volume and hospital 
eligibility) would take effect shortly after finalization of this rule, 
not subject to the proposed 1 year delay for Stage 2 of meaningful use 
of certified EHR technology. Changes to Stage 1 of meaningful use would 
take effect for 2013, but most would be optional until 2014.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on May 7, 2012.

ADDRESSES: In commenting, please refer to file code CMS-0044-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-0044-P, P.O. Box 8013, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-0044-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-1066 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Elizabeth Holland, (410) 786-1309, or 
Robert Anthony, (410) 786-6183, EHR Incentive Program issues. Jessica 
Kahn, (410) 786-9361, for Medicaid Incentive Program issues. James 
Slade, (410) 786-1073, or Matthew Guerand, (410) 786-1450, for Medicare 
Advantage issues. Travis Broome, (214) 767-4450, Medicare payment 
adjustment issues. Douglas Brown, (410) 786-0028, or Maria Durham, 
(410) 786-6978, for Clinical quality measures issues. Lawrence Clark, 
(410) 786-5081, for Administrative appeals process issues.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

Acronyms

ARRA--American Recovery and Reinvestment Act of 2009
AAC--Average Allowable Cost (of certified EHR technology)
AIU--Adopt, Implement, Upgrade (certified EHR technology)
CAH--Critical Access Hospital
CAHPS--Consumer Assessment of Healthcare Providers and Systems
CCN--CMS Certification Number
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 Physician Order Entry
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

[[Page 13699]]

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
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 certified EHR technology)
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
PFFS--Private Fee-For-Service
PHO--Physician Hospital Organization
PHS--Public Health Service
PHSA--Public Health Service Act
PIHP--Prepaid Inpatient Health Plan
POS--Place of Service
PPO--Preferred Provider Organization
PQRI--Physician Quality Reporting Initiative
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. 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
    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)
    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
    3. Criteria for Selecting Clinical Quality Measures
    4. Proposed Clinical Quality Measures for Eligible Professionals
    a. Statutory and Other Considerations
    b. Clinical Quality Measures Proposed for Eligible Professionals 
for CY 2013
    c. Clinical Quality Measures Proposed for Eligible Professionals 
Beginning With CY 2014
    5. Proposed 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. Proposed Clinical Quality Measures for Eligible Hospitals and 
Critical Access Hospitals
    a. Statutory and Other Considerations
    b. Clinical Quality Measures Proposed for Eligible Hospitals and 
CAHs for FY 2013
    7. Proposed 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 Certified EHR Technology
    a. Applicable Payment Adjustments for EPs Who Are Not Meaningful 
Users of Certified EHR Technology in CY 2015 and Subsequent Calendar 
Years
    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. Payment Adjustment Not Applicable to Hospital-Based EPs
    3. Incentive Market Basket Adjustment Effective In FY 2015 and 
Subsequent Years for Eligible Hospitals Who Are Not Meaningful EHR 
Users
    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 to 
CAHs in FY 2015 and Subsequent FYs
    5. Proposed Administrative Review Process of Certain Electronic 
Health Records Incentive Program Determinations
    a. Permissible Appeals
    b. Filing Requirements
    c. Preclusion of Administrative and Judicial Review
    d. Inchoate Review
    e. Informal Review Process Standards
    (1) Request for Supporting Documentation
    b. Informal Review Decision
    3. Final Reconsideration
    4. Exhaustion of Administrative Review
    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)

[[Page 13700]]

    4. Avoiding Duplicate Payments
    5. Payment Adjustments Effective in 2015 and Subsequent MA 
Payment Adjustment Years for Potentially Qualifying MA EPs and 
Potentially Qualifying MA-Affiliated Eligible Hospitals (Sec.  
495.211)
    6. Appeals Process for MA Organizations
    F. Proposed 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 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. Collection of Information Requirements
    A. ICR Regarding Demonstration of Meaningful Use Criteria (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)
IV. Response to Comments
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Accounting Statement

I. Executive Summary and Overview

A. Executive Summary

1. Purpose of Regulatory Action
a. Need for the Regulatory Action
    In this proposed rule the Secretary of the Department of Health and 
Human Services (the Secretary) would specify Stage 2 criteria EPs, 
eligible hospitals, and CAHs must meet in order to qualify for an 
incentive payment, as well as introduce changes to the program timeline 
and detail payment adjustments. These proposed criteria were 
substantially adopted from the recommendations of the Health IT Policy 
Committee (HITPC), a Federal Advisory Committee that coordinates 
industry and provider input regarding the Medicare and Medicaid EHR 
Incentive Programs, as well as in consideration of current program data 
for the Medicare and Medicaid EHR Incentive Programs.
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 eligible professionals (EPs), 
eligible hospitals, and critical access hospitals (CAHs), and Medicare 
Advantage (MA) organizations to promote the adoption and meaningful use 
of certified electronic health record (EHR) technology.
    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 certified EHR technology), 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 certified EHR technology 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 
statutory basis, 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 criteria, we 
finalized a separate set of core objectives and menu objectives for 
both EPs and eligible hospitals and CAHs. EPs and hospitals must meet 
or qualify for an exclusion to all of the core objectives and 5 out of 
the 10 menu measures in order to qualify for an EHR incentive payment. 
In this proposed rule, we propose to maintain the same core-menu 
structure for the program for Stage 2. We propose that EPs must meet or 
qualify for an exclusion to 17 core objectives and 3 of 5 menu 
objectives. We propose that eligible hospitals and CAHs must meet or 
qualify for an exclusion to 16 core objectives and 2 of 4 menu 
objectives. Nearly all of the Stage 1 core and menu objectives would be 
retained for Stage 2. The ``exchange of key clinical information'' core 
objective from Stage 1 would be 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 would be removed because it would be replaced by an 
``electronic/online access'' core objective. There are also multiple 
Stage 1 objectives that would be 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. For 
EPs, we propose a set of clinical quality measures beginning in 2014 
that align with existing quality programs such as measures used for the 
Physician Quality Reporting System (PQRS), CMS Shared Savings Program, 
and National Council for Quality Assurance (NCQA) for medical home 
accreditation, as well as those proposed under Children's Health 
Insurance Program Reauthorization Act (CHIPRA) and under ACA Section 
2701. For eligible hospitals and CAHs, the set of CQMs we propose 
beginning in 2014 would align with the Hospital Inpatient Quality 
Reporting (HIQR) and the Joint Commission's hospital quality measures.
    This proposed rule also outlines a process by which EPs, eligible 
hospitals, and CAHs would submit CQM data electronically, reducing the 
associated burden of reporting on quality measures for providers. We 
are soliciting public feedback on several mechanisms for electronic CQM 
reporting, including aggregate-level electronic reporting group 
reporting options; and through existing quality reporting systems. 
Within these mechanisms of reporting, we outline different approaches 
to CQM reporting that would require EPs to report 12 CQMs and eligible 
hospitals and CAHs to report 24 CQMs in total.
c. Payment Adjustments and Exceptions
    Medicare payment adjustments are required by statute to take effect 
in 2015. We propose a process by which payment adjustment would be 
determined by a prior reporting period. Therefore, we propose that any 
successful meaningful user in 2013

[[Page 13701]]

would avoid payment adjustment in 2015. Also, any Medicare provider 
that first meets meaningful use in 2014 would avoid the penalty if they 
are able to demonstrate meaningful use at least 3 months prior to the 
end of the calendar or fiscal year (respectively) and meet the 
registration and attestation requirement by July 1, 2014 (eligible 
hospitals) or October 1, 2014 (EPs).
    We also propose exceptions to these payment adjustments. This 
proposed rule outlines three categories of exceptions based on the lack 
of availability of Internet access or barriers to obtaining IT 
infrastructure, a time-limited exception for newly practicing EPs or 
new hospitals who would not otherwise be able to avoid payment 
adjustments, and unforeseen circumstances such as natural disasters 
that would be handled on a case-by-case basis. We also solicit comment 
on a fourth category of exception due to a combination of clinical 
features limiting a provider's interaction with patients and lack of 
control over the availability of Certified EHR technology at their 
practice locations.
d. Modifications to Medicaid EHR Incentive Program
    We propose to expand the definition of what constitutes a Medicaid 
patient encounter, which is a required eligibility threshold for the 
Medicaid EHR Incentive Programs. We propose to include encounters for 
individuals enrolled in a Medicaid program, including Title XXI-funded 
Medicaid expansion encounters (but not separate CHIP programs. We also 
propose flexibility in the look-back period for patient volume to be 
over the 12 months preceding attestation, not tied to the prior 
calendar year.
    We also propose to make 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.
e. Stage 2 Timeline Delay
    Finally, we propose a minor delay of 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 for Medicare 
in 2011 would begin using Stage 2 criteria in 2013. This proposed rule 
delays the onset of those Stage 2 criteria until 2014, which we believe 
provides the needed time for vendors to develop Certified EHR 
Technology.
3. Summary of Costs and Benefits
    This proposed 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 
proposed rule. The total Federal cost of the Medicare and Medicaid EHR 
Incentive Programs is estimated to be $14.6 billion in transfers 
between 2014 and 2019. In this proposed rule we have not quantified the 
overall benefits to the industry, nor to eligible hospitals, or EPs 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.

----------------------------------------------------------------------------------------------------------------
                                         Medicare eligible               Medicaid eligible
           Fiscal year           ----------------------------------------------------------------      Total
                                     Hospitals     Professionals     Hospitals     Professionals
----------------------------------------------------------------------------------------------------------------
2014............................            $1.3            $1.2            $0.4            $0.8            $3.7
2015............................             1.2             1.1             0.5             0.9             3.7
2016............................             0.6             0.8             0.9             1.0             3.3
2017............................             0.0             0.2             1.0             1.0             2.2
2018............................            -0.2            -0.2             0.6             0.9             1.1
2019............................            -0.0            -0.2             0.1             0.7             0.6
----------------------------------------------------------------------------------------------------------------
Amounts are in 2012 billions.

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 eligible professionals (EPs), 
eligible hospitals, and critical access hospitals (CAHs), and Medicare 
Advantage (MA) Organizations to promote the adoption and meaningful use 
of certified electronic health record (EHR) technology. On July 28, 
2010 we published in the Federal Register (75 FR 44313 through 44588) a 
final rule titled ``Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program,'' that specified the Stage 1 criteria 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 final rule (75 FR 44316).) In that final rule, we also 
detailed that the Medicare and Medicaid EHR Incentive Programs would 
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 Certified EHR Technology and the 
standards and certification criteria for Certified EHR Technology were 
coordinated. Current ONC regulations may be found at 45 CFR part 170. 
For Stage 2, CMS and ONC will again work together to align our 
regulations.
    We urge those interested in this proposed rule to also review the 
ONC proposed rule on standards and implementation specifications for 
Certified EHR Technology. Readers may also visit http://healthit.hhs.gov and http://www.cms.hhs.gov/EHRincentiveprograms for 
more information on the efforts at the Department of Health and Human 
Services (HHS) to advance HIT initiatives.

[[Page 13702]]

II. Provisions of the Proposed Regulations

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

1. Uniform Definitions
    In the Stage 1 final rule, we finalized many uniform definitions 
for the Medicare FFS, MA, and Medicaid EHR incentive programs. These 
definitions are set forth in part 495 subpart A of the regulations, and 
we are proposing to maintain most of these definitions, including, for 
example, ``Certified EHR Technology,'' ``Qualified EHR,'' ``Payment 
Year,'' and ``First, Second, Third, Fourth, Fifth, and Sixth Payment 
Year.'' We note that our definitions of ``Certified EHR Technology'' 
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 proposed rule that is 
published elsewhere in this issue of the Federal Register. We are 
revising the descriptions of the EHR reporting period to clarify that 
for providers who are demonstrating meaningful for the first time their 
EHR reporting period is 90 days regardless of payment year. We propose 
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, as discussed in section II.D. of this 
proposed rule.
2. Meaningful EHR User
    We propose to include clinical quality measure reporting as part of 
the definition of ``meaningful EHR user'' instead of as a separate 
meaningful use objective under 42 CFR 495.6. This change is explained 
in section II.A.3.d. in the context of the proposed Stage 2 criteria 
for meaningful use.
    The third paragraph of the definition of meaningful EHR user at 42 
CFR 495.4 currently read as follows: ``(3) To be considered a 
meaningful EHR user, at least 50 percent of an EP's patient encounters 
during the EHR reporting period during the payment year must occur at a 
practice/location or practices/locations equipped with certified EHR 
technology.'' We propose to revise the third paragraph of the 
definition of meaningful EHR user at 42 CFR 495.4 to 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 Certified EHR Technology.'' This change is to 
include the payment adjustment in this definition. Currently, it only 
refers to the incentives.
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, 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 Certified EHR Technology if they are to receive 
incentives under Title XIX. Certified EHR Technology 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, 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.
    Based on public and stakeholder input received during our Stage 1 
rulemaking, 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 Certified EHR Technology 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 July 28, 2010, and this rule outlines our 
proposed Stage 2 approach. We currently anticipate at least one 
additional update, and anticipate updating the Stage 3 criteria with 
another proposed rule by early 2014. The stages represent an initial 
graduated approach to arriving at the ultimate goal.
    <bullet> Stage 1: 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 Certified EHR Technology that will allow for 
continuous quality improvement and ease of information exchange. By 
having these functionalities in certified EHR technology 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 Certified EHR Technology. 
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 proposing certain 
changes to the Stage 1 criteria in section II.B.3.b. of this proposed 
rule.
    <bullet> Stage 2: Our Stage 2 goals, consistent with other 
provisions of Medicare and Medicaid law, 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 encourage the use of 
health IT for continuous quality improvement at

[[Page 13703]]

the point of care and the exchange of information in the most 
structured format possible. Stage 2 meaningful use requirements include 
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 to support transitions 
in care across unaffiliated providers, settings and EHR systems. 
Increasingly robust expectations for health information exchange in 
Stage 2 and Stage 3 will support the goal that information follows the 
patient. In addition, as we forecasted in the Stage 1 final rule, we 
now consider nearly every objective that was optional for Stage 1 to be 
required in Stage 2, and we reevaluated the thresholds and exclusions 
of all the measures.
    <bullet> 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, 
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 (as described later in this 
section) 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 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 with our expected timeline for the stages of meaningful use.

                                     Table 1--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 are proposing changes to this timeline as well as its extension 
beyond 2014. Under the timeline used in the Stage 1 final rule (75 FR 
44323), 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 or October 1, 2012, respectively. 
We anticipate publishing a final rule by summer 2012. The HIT Policy 
Committee recommended we delay by 1 year the start of Stage 2 for 
providers who became meaningful EHR users in 2011. Stage 2 of 
meaningful use requires changes to both technology and workflow that 
cannot reasonably be expected to be completed in the time between the 
publication of the final rule and the start of the EHR reporting 
periods. We have heard similar concerns from other stakeholders and 
agree that, based on our proposed definition of meaningful use for 
Stage 2, providers could have difficulty implementing these changes in 
time. Therefore, we are proposing a 1-year extension of Stage 1 of 
meaningful use for providers who successfully demonstrated meaningful 
use for 2011. Our proposed timeline through 2021 is displayed in Table 
2. We refer readers to II.D.2 of this proposed rule for a discussion of 
the applicable EHR reporting period that would be used to determine 
whether providers are subject to payment adjustments.

                                                                 Table 2--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.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Please note 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. 
Medicaid EPs and eligible hospitals can receive a Medicaid EHR 
incentive payment for ``adopting, implementing, and upgrading'' (AIU) 
to Certified EHR Technology for their first payment year, which is not 
reflected in Table 2. 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 there will be a Stage 4 of meaningful use, we expect to update 
this table in the rulemaking for Stage 3.

[[Page 13704]]

b. Changes to Stage 1 Criteria for Meaningful Use
    We propose the following changes to the objectives and associated 
measures for Stage 1. As explained later in this proposed rule, most of 
these changes would be optional for Stage 1 in 2013 and would be 
required for Stage 1 beginning in 2014 (CY for EPs, FY for eligible 
hospitals/CAHs). We do not believe that this creates an additional 
hardship as providers would have the option of completing Stage 1 in 
the same manner in 2013 as in 2011 and 2012, and in fact, the changes 
we propose create flexibility for EPs, eligible hospitals, and CAHs 
seeking to achieve Stage 1 meaningful use objectives.
    The current denominator for the CPOE objective measure for Stage 1 
is the number of unique patients with at least one medication in their 
medication list seen by an EP or admitted to an eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period. We created this denominator in response to comments 
that our original Stage 1 proposed denominator for this measure, the 
number of orders for medications, is difficult to measure. Following 
publication of the final rule, we have received nearly unanimous 
feedback from providers that the logical denominator for this measure 
is the number of orders for medications and that it is measurable. For 
more details please reference the discussion of the Stage 2 CPOE 
objective. Beginning in 2013 (CY for EPs, FY for eligible hospitals/
CAHs), we propose to allow providers in Stage 1 to 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 proposed CPOE 
objective in the Stage 2 criteria section). A provider seeking to meet 
Stage 1 in 2013 could use either the current or the proposed 
alternative denominator to calculate the percentage for the CPOE 
measure.
    Starting with the EHR reporting periods in FY/CY 2014, the proposed 
``alternative denominator'' would be required for all providers in 
Stage 1 and Stage 2.
    For the objective of record and chart changes in vital signs, our 
Stage 2 proposal 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). We 
propose an identical change to the Stage 1 exclusion as well, starting 
in CY 2013. We also propose 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 propose identical changes 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 would be an alternative in 2013 to the current Stage 1 
requirements and would be required for Stage 1 beginning in 2014. We 
have found the objective of ``capability to exchange key clinical 
information'' to be surprisingly difficult for providers to understand, 
which has made the objective considerably more difficult to achieve 
than we envisioned in the Stage 1 final rule. As the measure for this 
objective is simply a test with no associated requirement for follow-up 
submission, we are concerned the value of this objective is not 
sufficient to justify the burden of compliance. However, we also 
strongly believe that meaningful use of EHRs must ultimately involve 
real and ongoing electronic health information exchange to support care 
coordination, as the Stage 2 objectives on this subject (described 
below) make clear. We considered four options for this objective, and 
welcome comment on all four, that variously reduce or eliminate the 
burden of the objective or increase the value of the objective. The 
first option we considered is removal of this objective. This 
acknowledges our experience with Stage 1 and the limited benefit of 
just a test. The second option is to require that the test be 
successful. This would increase the value of the objective and 
eliminate a common question we receive on what happens if the test is 
unsuccessful. The third option is 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 from the menu set. This would eliminate the 
burden and complexity of the test, but preserve the domain of care 
coordination for Stage 1. The fourth option is 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. This would 
increase the benefit of the objective and reduce the complexity of the 
defining the parameters of the test, but potentially increases the real 
burden of compliance significantly beyond what is currently included in 
Stage 1. We are proposing 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). In Stage 2, we propose to move to actual use 
cases of electronic exchange of health information as discussed later 
in this proposed rule, which would require significant testing in the 
years of Stage 1. We encourage comments on all four options and will 
evaluate them again in light of the public comment received.
    We propose for Stage 2 a new method for making patient information 
available electronically, which would enable patients to view online 
and download their health information and hospital admission 
information. We discuss in the Stage 2 criteria section the proposed 
``view, download, and transmit'' objectives for EPs and hospitals. 
Starting in 2014, Certified EHR Technology will no longer be certified 
to the Stage 1 EP and hospital core objectives of providing patients 
with electronic copies of their health information and discharge 
instructions upon request, nor will it support the Stage 1 EP menu 
objective of providing patients with timely electronic access to their 
health information. Therefore starting in 2014, for Stage 1, we propose 
to replace these objectives with the new ``view online, download and 
transmit'' objectives. We discuss these objectives further in our 
proposed Stage 2 criteria.
    We are proposing a revised definition of a meaningful EHR user 
which would incorporate the requirement to submit clinical quality 
measures, as discussed in section II.A.2. of this proposed rule, and as 
such are removing the objective to submit clinical quality measures 
beginning in 2013 and the associated regulation text under 45 CFR 495.6 
for Stage 1 to conform with this change in the definition of a 
meaningful EHR user.
    For the Stage 1 public health objectives, beginning in 2013, we 
also propose to add ``except where prohibited'' to the regulation text, 
because we want 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).

[[Page 13705]]



                       Table 3--Changes to Stage 1
------------------------------------------------------------------------
                                                         Effective year
       Stage 1 objective           Proposed changes          (CY/FY)
------------------------------------------------------------------------
Use CPOE for medication orders  Change: Addition of an  2013-Only
 directly entered by any         alternative measure.    (Optional).
 licensed healthcare            More than 30 percent
 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.
Use CPOE for medication orders  Change: Replacing the   2014-Onward
 directly entered by any         measure.                (Required).
 licensed healthcare            More than 30 percent
 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.
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 Growth  (Required)
                                 Charts 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
                                 42 CFR 495.6.
EP Objective: Provide patients  Change: Replace these   2014-Onward
 with an electronic copy of      three objectives with  (Required).
 their health information        the Stage 2 objective
 (including diagnostics test     and one of the two
 results, problem list,          Stage 2 measures.
 medication lists, medication   EP Objective: Provide
 allergies) upon request.        patients the ability
                                 to view online,
                                 download and transmit
                                 their health
                                 information within 4
                                 business days of the
                                 information being
                                 available to the EP.
Hospital Objective: Provide     EP Measure: More than
 patients with an electronic     50 percent of all
 copy of their discharge         unique patients seen
 instructions and procedures     by the EP during the
 at time of discharge, upon      EHR reporting period
 request.                        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.
EP Objective: Provide patients  Hospital Objective:
 with timely electronic access   Provide patients the
 to their health information     ability to view
 (including lab results,         online, download and
 problem list, medication        transmit information
 lists, medication allergies)    about a hospital
 within 4 business days of the   admission.
 information being available    Hospital Measure: More
 to the EP.                      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.
Public Health Objectives:.....  Change: Addition of     2013-Onward
                                 ``except where         (Required).
                                 prohibited'' to the
                                 objective regulation
                                 text for the public
                                 health objectives
                                 under 42 CFR 495.6.
------------------------------------------------------------------------


[[Page 13706]]

c. State Flexibility for Stage 2 of Meaningful Use
    We propose 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, whether moved to the core or left 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 ONC EHR 
certification criteria as finalized for Stage 2 of meaningful use.
    We solicit comment on extending State flexibility as described for 
Stage 2 of meaningful use and whether this remains a useful tool for 
State Medicaid agencies.
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
    We are proposing 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 propose to 
follow that approach for our Stage 2 core set with two exceptions. We 
are proposing 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 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 are also proposing 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 are proposing new objectives for Stage 2, some of which would be 
part of the Stage 2 core set and others would make up the Stage 2 menu 
set, as discussed below with each objective. We are proposing to 
eliminate certain Stage 1 objectives for Stage 2, such as the objective 
for testing the capability to exchange key clinical information. We are 
also proposing 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 would 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 are proposing a total of 17 core objectives and 5 menu 
objectives for EPs. We propose 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 by the number of exclusions applicable to the 
EP the number of menu set objectives that the EP would otherwise need 
to meet. We received feedback on Stage 1 that we have received 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, so we are proposing 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 are proposing this change because we are 
concerned that under the current Stage 1 requirements 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 greater flexibility 
to do this in the selection of Stage 1 menu objectives through 2013, we 
believe 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 have provided 
exclusions for the Stage 2 menu objectives that we believe will 
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 
currently intend 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. 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. The same policy would also apply for the Stage 1 menu 
objectives for EPs beginning in 2014.
    We propose a total of 16 core objectives and 4 menu objectives for 
eligible hospitals and CAHs for Stage 2. We propose 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. 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.
(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs Can 
Meet All Stage 2 Meaningful Use Objectives Given Established Scopes of 
Practice
    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 discuss the barriers and include exclusions in our descriptions of 
the individual objectives later. We are proposing 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 recognize that at the time of publication, our data (derived 
internally from attestations) only reflects the meaningful use 
attestation from Medicare providers. Before the publication of the 
final rule, we plan on adjusting the data on the successful 
attestations to date to reflect the experience of successful Medicaid 
meaningful EHR users. This may result in changes to our current 
assumptions based upon the data available at the time of the proposed 
rule, especially given the different eligible professional types in the 
Medicaid EHR Incentive Program. It may be that different eligible 
professional types may have different levels of success in meeting the 
meaningful use measure thresholds, given their scope of practice.
(2) EPs Practicing in Multiple Practices/Locations
    We propose 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

[[Page 13707]]

during the EHR reporting period at a practice/location or practices/
locations equipped with Certified EHR Technology. 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 percent threshold through a 
combination of practices/locations equipped with Certified EHR 
Technology. For 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 Certified EHR Technology 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 Certified EHR Technology 
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 
Certified EHR Technology 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.
    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 have also received requests for 
clarification on what it means for a practice/location to be equipped 
with Certified EHR Technology. We define a practice/location as 
equipped with Certified EHR Technology if the record of the patient 
encounter that occurs at that practice/location is created and 
maintained in Certified EHR Technology. This can be accomplished in 
three ways: Certified EHR Technology could be permanently installed at 
the practice/location, the EP could bring Certified EHR Technology to 
the practice/location on a portable computing device, or the EP could 
access Certified EHR Technology 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 Certified EHR 
Technology at the practice/location and then later input that 
information into Certified EHR Technology that exists at a different 
practice/location, we do not believe this process takes advantage of 
the value Certified EHR Technology offers. We are proposing 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. There is no 
interaction. The determination of whether an EP is hospital-based or 
not occurs prior to the application of this policy, so only non-
hospital 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).
(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 Certified EHR Technology, but 
including all patients in the denominators of other measures, to be 
complicated for providers to implement. We are proposing 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 Certified 
EHR Technology, making this distinction no longer relevant.
    We also continue our policy that EPs practicing in multiple 
locations do not have to include patients seen at practices/locations 
that are not equipped with Certified EHR Technology in the calculations 
of the meaningful use measures as long as the EP has 50 percent of 
their patient encounters during the EHR reporting period at locations 
equipped with Certified EHR Technology.
    We are proposing new objectives that could increase reporting 
burden. To minimize the burden, we are proposing 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 
wherever possible and if appropriate. To provide a check on the burden 
of reporting of meaningful use, we propose for Stage 2 to use 1 of 4 
denominators for each of the measures associated with the meaningful 
use objectives. We focus on denominators because the action that moves 
something from the denominator to the numerator usually requires the 
use of Certified EHR Technology by the provider. These actions are 
easily tracked by the technology.
    The four proposed denominators for EPs:
    <bullet> Unique patients seen by the EP during the EHR reporting 
period (stratified by age or previous office visit).
    <bullet> Number of orders (medication, labs, radiology).
    <bullet> Office visits, and
    <bullet> Transitions of care/referrals.
    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 would 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 would 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 would not be able to satisfy meaningful use, 
as they would 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

[[Page 13708]]

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.
    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. Transitions of care are 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 proposed rule is only intended to 
apply to the EHR Incentive Programs and is not applicable to other 
Federal regulations.)
    The four proposed denominators for eligible hospitals and CAHs:
    <bullet> Unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department during the EHR reporting period 
(stratified by age).
    <bullet> Number of orders (medication, labs, radiology).
    <bullet> Inpatient bed days.
    <bullet> Transitions of care.
    The explanation of ``unique patients'' and ``transitions of care'' 
in the preceding paragraph for EPs also applies for eligible hospitals 
and CAHs. 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).
    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 would 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.
(4) Discussion of the Relationship of Meaningful Use to Certified EHR 
Technology
    We propose to continue our policy of linking each meaningful use 
objective to certification criteria for Certified EHR Technology. 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. 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 Certified 
EHR Technology. For example, in e-Rx and public health reporting, 
Certified EHR Technology 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 despite these standards and capabilities such as contacting both 
parties and troubleshooting issues that may arise through the normal 
course of business.
(5) Discussion of the Relationship Between a Stage 2 Meaningful Use 
Objective and its Associated Measure
    We propose 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, meeting the criteria of the measure 
means that the provider has met the objective for Stage 2.
(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.
    We propose to continue to define CPOE as entailing 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.
    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 would 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 this is a logical step 
in the progression of meaningful use.
    Our experience with Stage 1 of meaningful use demonstrated that our 
definition of CPOE in the Stage 1 final

[[Page 13709]]

rule does not indicate when in the ordering process the CPOE function 
must be utilized. We provided guidance at: https://questions.cms.hhs.gov/app/answers/detail/a_id/10134/ on the Stage 1 
criteria to say 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. Our experience shows that the 
limiting criterion is the first time the order becomes part of the 
patient's medical record rather than the limitation to licensed 
healthcare professionals entering the order. Our experience has also 
demonstrated that each provider must make the decision of whether the 
record of an order is part of the patient's medical record 
independently as the possible variations in process and record keeping 
are too numerous for a universal statement on when in the process an 
order becomes part of the patient's medical record. To further CPOE's 
ability to improve safety and efficiency and to provide greater clarity 
for Stage 2 of meaningful use, we are proposing to redefine the point 
in the ordering process when CPOE must be utilized. We propose that to 
be considered CPOE, the CPOE function must be utilized to create the 
first record of any type for the order. This removes the possibility 
that a record of the order could be created prior to CPOE, but not be 
part of the patient's medical record. In a practice, this means the 
originating provider (the provider whose judgment creates the order) 
must personally use the CPOE function, verbally communicate the order 
to someone else who will use the CPOE function, or give an electronic 
or written order that must not be retained in any way once the CPOE 
function has been utilized. This is a meaningful use requirement and 
does not affect any other legal or regulatory requirements as to what 
constitutes a patient's health record or order. With this new proposal, 
we invite 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 nonlicensed healthcare 
professionals such as scribes.
    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.
    Our experience with Stage 1 of meaningful use has shown that a 
denominator of all orders created by the EP or in the hospital would 
not be unduly burdensome for providers. Many providers have voluntarily 
provided information on the number of medication orders in their clinic 
or hospital. However, this does not guarantee such a denominator would 
be feasible for all providers. We believe the EHRs can calculate a 
denominator of all orders entered into the Certified EHR Technology, 
with the numerator limited to those entered into Certified EHR 
Technology using CPOE. Potentially, this would exclude those orders 
that are never entered into the Certified EHR Technology in any manner. 
The provider would be responsible for including those orders in their 
denominator. However, we believe that providers using Certified EHR 
Technology use it as the patient's medical record; therefore, an order 
not entered into Certified EHR Technology would be an order that is not 
entered into a patient's medical record. For this reason, we expect 
that orders given for patients that are never entered into the 
Certified EHR Technology to be few in number or non-existent. We 
encourage comments on whether a denominator other than number of 
medication, laboratory, and radiology orders created by the EP or in 
the hospital would be needed for EPs and/or hospitals. For example, the 
HIT Policy Committee recommended a denominator of ``patients with at 
least one type of order.'' We are proposing, however, a different 
denominator for this measure, which we believe would be possible to 
collect given our experience in Stage 1 of meaningful use and a much 
more accurate measure of actual CPOE usage. The denominator of 
``patients with at least one type of order'' is a proxy measure for the 
number of orders issued by the EP, eligible hospital or CAH. The 
accuracy of that proxy is dependent on the frequency in which an 
encounter results in an order. For example, an EP whose scope of 
practice is such that they order a medication on nearly every encounter 
would have every encounter as an opportunity to move the patient from 
the denominator to a numerator. The 2005 National Ambulatory Medical 
Care Survey (referenced in the Stage 1 final rule, 75 FR 44333) found 
that 66 percent of office-based visits had any type of medication 
order. EPs whose office visits are consistent with the survey findings 
would have a third fewer opportunities to move the patient from the 
denominator to the numerator. We believe a direct measure of the number 
of orders is feasible and more accurate as it is not dependent on the 
frequency of orders. We encourage comments on whether the barriers to 
collecting information for our proposed denominator would be greater in 
a hospital or ambulatory setting. As we noted previously, the 
denominator used in Stage 1 (as well as the denominator recommended by 
the HIT Policy Committee) is much more representative of CPOE use in a 
hospital setting than an ambulatory setting, so these settings could 
require different denominators or measures. We request comment on 
different denominators or measures and encourage 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.
    Based on our experience with attestation data from Stage 1, we 
continue to believe that the 60 percent threshold that we finalized 
previously for Stage 2 is appropriate. We also believe that this 
threshold translates to our new measure. The HIT Policy Committee 
recommended including laboratory and radiology orders in the measure, 
but as ``yes/no'' attestations of one order being entered using CPOE 
rather than at the 60 percent threshold. We believe this is unnecessary 
given the advance of CPOE. In our discussions with EPs, eligible 
hospitals and CAHs we find that they do not roll out CPOE with only one 
order type, but rather include medications, laboratory and radiology/
imaging orders as a package. We are also concerned 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. We welcome comment on whether laboratory and 
radiology orders are sufficiently different in the use of CPOE that 
they would require a different threshold and whether such a threshold 
should be a lower percentage or a yes/no attestation.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of medication, radiology, and 
laboratory orders created by the EP or authorized providers in the 
eligible hospital's or CAH's inpatient or emergency

[[Page 13710]]

department (POS 21 or 23) during the EHR reporting period.
    <bullet> Numerator: The number of orders in the denominator 
recorded using CPOE.
    <bullet> 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, laboratory 
and radiology orders during the EHR reporting period.
    To qualify for the exclusion, an EP's total number of medication, 
laboratory and radiology orders collectively must be less than 100. For 
example, an EP who writes 75 medication orders, 50 laboratory orders 
and no radiology orders during the EHR reporting period would not meet 
the exclusion.
    Consolidated Objective: Implement drug-drug and drug-allergy 
interaction checks.
    For Stage 2, we are proposing 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 continue to believe 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 believe 
it is appropriate to include this functionality as part of the 
objective for using clinical decision support.
    Proposed EP Objective: Generate and transmit permissible 
prescriptions electronically (eRx).
    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, Certified EHR 
Technology 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 Certified EHR 
Technology 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 propose to continue to define prescription as the authorization 
by an EP to dispense a drug that would not be dispensed without such 
authorization. This includes authorization for refills of previously 
authorized drugs. We propose 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. 
However, as Stage 2 of meaningful use would not go into effect until 
2014, it is possible that significant progress in the availability of 
products enabling the electronic prescribing of controlled substances 
may occur. We encourage comments addressing the current and expected 
availability of these products and whether the availability would be 
sufficient to include controlled substances in the Stage 2 measure for 
e-Rx or to warrant an additional measure for EPs to choose that would 
include controlled substance electronic prescriptions in the 
denominator.
    We do not believe that OTC medicines will be routinely 
electronically prescribed and propose to continue to exclude them from 
the definition of a prescription. However, we encourage public comment 
on this assumption.
    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 Certified EHR Technology 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 
propose 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, the EP needs to use Certified EHR Technology 
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 the standards included in certification of 
EHRs.
    We received many inquiries as to the alignment with this objective 
and the eRx payment adjustment authorized by the Medicare Improvements 
for Patients and Providers Act of 2008 (MIPPA). The HITECH Act phases 
out the adjustment starting in CY 2015 so alignment between the 
programs is no longer necessary. At the time of publication of this 
proposed rule, the determination for CY 2013 MIPPA eRx payment 
adjustment will have already occurred. For these reasons alignment with 
Stage 2 becomes a moot point.
    Proposed EP Measures: More than 65 percent of all permissible 
prescriptions written by the EP are compared to at least one drug 
formulary and transmitted electronically using Certified EHR 
Technology.
    In Stage 1 of meaningful use, we adopted a measure of more than 40 
percent of all permissible prescriptions written by the EP are 
transmitted electronically using Certified EHR Technology. In the Stage 
1 rule (75 FR 44338), we acknowledged that there were reasons why a 
patient may prefer a paper prescription. A patient could have this 
preference for any number of reasons such as the desire to shop for

[[Page 13711]]

the best price (especially for patients in the Part D ``donut hole''), 
the ability to obtain medications through the Department of Veterans 
Affairs, lack of finances, indecision about whether to have the 
prescription filled locally or by mail order, and desire to use a 
manufacturer coupon to obtain a discount. We correspondingly lowered 
the threshold to 40 percent from 75 percent as proposed for Stage 1 to 
account for patient preference for a paper prescription. While pharmacy 
acceptance of electronic prescriptions continues to accelerate, these 
patient preferences remain creating a ceiling for this threshold on 
which there is limited data with which to estimate.
    The HIT Policy Committee recommended an increase in the threshold 
of this measure from 40 percent to 50 percent. The average successful 
Medicare meaningful EHR user rate currently exceeds 50 percent 
demonstrating to us that 50 percent does not exceed the ceiling created 
by patient preferences. We also believe that providers participating in 
Stage 2 will already have significant experience with this objective 
and can meet an even higher threshold. Therefore we are proposing a 
threshold of 65 percent for this measure.
    The ease with which an EP can meet this measure depends heavily on 
the availability of pharmacies in their local area that accept 
electronic prescriptions. We propose 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. For EP's practicing 
at multiple locations, they are eligible for the exclusion if any of 
their practice locations that are equipped with Certified EHR 
Technology 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 have considered instances where an EP may prescribe 
medications in a facility (such as a nursing home or ambulatory surgery 
center) where they are compelled to use the facility's ordering system, 
which may not be Certified EHR Technology. While we are not proposing 
exclusionary criteria related to this circumstance, we encourage 
comments on whether one is necessary or if the proposed 50 percent 
threshold is low enough to account for this situation.
    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. We recognize 
that not all drug formularies are linked to all Certified EHR 
Technologies, so we are not requiring that the formulary be relevant 
for each patient. Therefore, the comparison could return a result of 
formulary unavailable for that patient and medication combination and 
still allow the EP to meet the measure of this objective. This 
modification of the measure replaces the Stage 1 menu objective of 
``Implement drug-formulary checks'' and is intended to provide better 
integration guidance for both EPs and their supporting vendors.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of prescriptions written for drugs 
requiring a prescription in order to be dispensed other than controlled 
substances during the EHR reporting period.
    <bullet> Numerator: The number of prescriptions in the denominator 
generated, compared to a drug formulary and transmitted electronically.
    <bullet> Threshold: The resulting percentage must be more than 65 
percent in order for an EP to meet this measure.
    Exclusions: Any EP who writes fewer than 100 prescriptions during 
the EHR reporting period or does not have a pharmacy within their 
organization and there are no pharmacies that accept electronic 
prescriptions within 25 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.
    Consolidated Objective: Maintain active medication list.
    Consolidated Objective: Maintain active medication allergy list.
    For Stage 2, we are proposing 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 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 Certified EHR Technology. However, the continued demonstration of 
their meaningful use in Stage 2 is 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 are proposing 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 summary care record for each transition 
of care or referral.'' EPs and hospitals would have to ensure the 
accuracy of these fields when providing the summary of care, which we 
believe will 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 proposed rule 
published elsewhere in this issue of the Federal Register.
    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.
    The recording of demographic data benefits healthcare and 
population health. Gender, race, ethnicity, and age are all established 
risk factors for a large number of diseases and conditions. Having this 
information available to healthcare providers improves their ability to 
care for individual patients. This same information combined with 
preferred language and date and cause of death can create revealing 
data on the health of populations as small as the population treated by 
a single healthcare provider to the national population. Health 
disparities can be identified and risk factors for disease and 
conditions can be identified and refined, among other uses for this 
data.
    In order to obtain these benefits, especially for public health, it 
is important that information from different sources be comparable. For 
this reason, we propose to continue the use of the Office of Management 
and Budget (OMB) standards for race and ethnicity (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). As outlined in the OMB 
policy, more detailed descriptions of race can be used, but ultimately 
would need to be mapped to 1 of the 5 races included in the OMB 
standards. Current OMB standards align race categories with

[[Page 13712]]

every geographic location in the globe so there are not barriers to 
completing such mapping. We recognize that race is a social construct 
that varies across cultures and time which is why we fully support the 
use of other descriptions that can then be mapped using geography 
constructs to the OMB standards. There must also be the option for the 
selection of multiple races for a patient and an option for cases when 
a patient declines to provide the information.
    The recording of the cause of death raised many questions from 
providers in Stage 1 of meaningful use. Some cases are referred to 
medical examiners to determine the official cause of death while others 
are not. Individual hospital policies and local/State laws and 
regulations vary. For purposes of meaningful use, we refer to the 
preliminary cause of death recorded by the hospital. This preliminary 
cause is not required to be amended due to additional information, but 
the hospital may amend the information if they want to maintain the 
most accurate information. The recording of the preliminary cause of 
death also does not have to occur within a specified timeframe from the 
death. We believe these clarifications will enable hospitals to meet 
this measure, but we encourage comments on our description of recording 
the cause of death.
    In addition, we encourage public comment on the burden and ability 
of including disability status for patients as part of the data 
collection for this objective. We believe that the recording of 
disability status for certain patients can improve care coordination, 
and so we are considering making the recording of disability status an 
option for providers. We seek comment on the burden incorporating such 
an option would impose on EHR vendors, as well as the burden that 
collection of this data might impose on EPs, eligible hospitals, and 
CAHs. In addition, we request public comment on--(1) how to define the 
concept ``disability status'' in this context; and (2) whether the 
option to collect disability status for patients should be captured 
under the objective to record demographics, or if another objective 
would be more appropriate.
    We also seek comment on whether, we should also include the 
recording of gender identity and/or sexual orientation. We encourage 
commenters to identify the benefits of inclusion and the applicability 
across providers.
    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.
    For Stage 1 of meaningful use, we adopted a measure of 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) have demographics recorded as structured data. We agree with the 
HIT Policy Committee recommendation to increase the threshold of this 
measure and are proposing a more than 80 percent threshold for Stage 2 
of meaningful use. Our experience with Stage 1 shows performance on 
this measure above 80 percent.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of unique patients 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.
    <bullet> 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.
    <bullet> 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 Certified EHR Technology 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 proposed 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.
    Having accurate information on height/length (depending on a 
patient's age), weight, and blood pressure both on the current 
condition of the patient and changes over time provide context to a 
large number and great variety of clinical decisions. By capturing 
height, weight, and blood pressure in a structured format, EHRs can 
analyze and display the information without the need for intervention 
by the provider. The calculation of body mass index and plotting of 
growth charts are just two examples. The provider need not do anything 
to calculate BMI or plot a growth chart if height and weight are 
recorded as structured data because this functionality is included 
within Certified EHR Technology. Similarly, information on blood 
pressure provides many opportunities for clinical decision support and 
the identification of patient education materials. Again, these 
automated processes can be enabled within Certified EHR Technology 
simply by recording blood pressure as structured data.
    We propose to continue our policy from Stage 1 that height/length, 
weight, and blood pressure do not each need to be updated by a provider 
at every patient encounter nor even once per patient seen during the 
EHR reporting period. For this objective, we are primarily concerned 
that some information is available to the EP, eligible hospital or CAH, 
who can then make the determination based on the patient's individual 
circumstances as to whether height/length, weight, and blood pressure 
need to be updated. The information can get into the patient's medical 
record as structured data in a number of ways. Some examples include 
entry by the EP, eligible hospital, or CAH, entry by someone on the EP, 
eligible hospital, or CAH's staff, transfer of the information 
electronically or otherwise from another provider, or 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 hospital to 
determine what level of accuracy is needed for them to provide care to 
the patient and how best to obtain this information. Any method of 
obtaining height, weight or blood pressure is acceptable for purposes 
of this objective as long as the information is recorded as structured 
data.
    We have received continuous feedback during Stage 1 of meaningful 
use on the appropriate age for collecting these vital signs. In 
particular, we have heard from numerous health care professionals and 
associations and the HIT Policy Committee recommended that height/
length and weight should not be age-limited and that the limit for 
blood pressure should be raised to 3 years of age and older in order to 
align with guidelines and recommendations from other health care 
associations. We agree with this alignment and propose to remove the 
height/length and weight age limits and raise the blood pressure limit 
to 3 years of age and older, but we encourage public comment on the age 
limitations of vital signs. Age is

[[Page 13713]]

determined based on the date when the patient is last seen by the EP or 
admitted to the inpatient or emergency department of the hospital 
during the EHR reporting period.
    Because we propose to remove the age restrictions on recording 
height/length and weight, we also propose to remove the age 
restrictions on calculating and displaying BMI and growth charts.
    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 included two exclusions for EPs for this measure in Stage 1 of 
meaningful use. The first is that EPs who do not see any patients 2 
years old or older (proposed to be raised to 3 years old or older 
optionally in 2013 and permanently in 2014) are excluded from recording 
blood pressure. The second is for EPs who believe that all 3 vital 
signs of height/length, weight, and blood pressure have no relevance to 
their scope of practice. We received considerable feedback on Stage 1 
that many EPs believe that while they may collect weight and blood 
pressure, they do not believe height/length is relevant to their scope 
of practice, or that blood pressure is relevant, but not height/length 
and weight, or some other combination.
    Weight without height/length is not useful from a record keeping 
perspective. A 225 pound man who is 5'5'' has different considerations 
than a 225 pound man who is 6'5'' . Therefore, we propose to keep the 
recording of height/length and weight as linked requirements. We 
believe there are situations where height/length and weight may be 
relevant, but blood pressure is not. We are less certain that there 
would be cases where blood pressure is relevant, but height/length and 
weight are not. We propose for Stage 2 to split the exclusion so that 
an EP can choose to record height/length and weight only and exclude 
blood pressure or record blood pressure only and exclude height/length 
and weight. We encourage comments on this split and whether it should 
or should not go both ways.
    For Stage 1 of meaningful use, we adopted a measure of 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) have vital signs recorded as structured data. We agree with the 
HIT Policy Committee recommendation to increase the threshold of this 
measure and are proposing a more than 80 percent threshold for Stage 2 
of meaningful use. Our preliminary Stage 1 data shows that the 
recording of vital signs far exceeded the measure threshold of more 
than 50 percent, so we are proposing a threshold of 80 percent for this 
measure for Stage 2 of meaningful use. We will continue to monitor this 
Stage 1 data as we solicit public comment so that we can determine if 
the more than 80 percent threshold is appropriate for this measure.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: Number of patients in the denominator who have 
at least one entry of their height/length and weight (all ages) and 
blood pressure (ages 3 and over) recorded as structured data.
    <bullet> 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.
    An 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. An 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.
    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 do not 
propose rules on who may record smoking status or how often the record 
should be updated.
    For Stage 2, we propose to limit this measure to those patients 13 
years old and older (as we did in Stage 1). We have not observed any 
significant consensus around when it is appropriate to collect smoking 
status, regardless of the presence or absence of other risk factors. If 
commenters disagree with our age limitation, we encourage them to 
include their reasons for disagreement and any evidence that may be 
available as to improved consensus among healthcare providers on what 
age limit is appropriate.
    In Stage 1 of meaningful use, we considered whether to expand the 
collection of information from smoking status to other forms of tobacco 
use. We continue to believe that there are insufficient electronic 
standards for collecting information on other types of tobacco use and 
that situations where a patient might use multiple types of tobacco 
would damage the standardized collection of smoking data, but we 
request comment on whether this is the case.
    Finally, in Stage 1 of meaningful use, we considered whether to 
include second hand smoke information as part of this objective. We 
continue to believe that the level of complexity in introducing this 
requirement is beyond a reasonable expectation of meaningful use at 
this time. We believe it would be difficult to define what constitutes 
a level of exposure to trigger recording second hand smoke information. 
We encourage commenters to submit information to us that demonstrates 
consensus and/or standards around the collection of second hand smoking 
data that would provide the basis on which to create an additional 
tobacco-related measure that is applicable to all EPs and hospitals.
    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 Stage 1 of meaningful use, we adopted a measure of more than 50 
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) have smoking status recorded as structured 
data. As we discussed in the Stage 1 final rule (75 FR 44344), there 
were many concerns by commenters over the appropriate age at which to 
inquire about smoking status. There were also considerable differences 
among commenters as to what the appropriate inquiry was and what it 
should have included. Because of these comments, we adopted 50 percent 
as the measure of this objective. The HIT Policy Committee recommended 
an increase in the

[[Page 13714]]

threshold of this measure from more than 50 percent to more than 80 
percent. Our preliminary Stage 1 data shows that the recording of 
smoking status far exceeded the measure threshold of more than 50 
percent, so we are proposing a threshold of 80 percent for this measure 
for Stage 2 of meaningful use. We will continue to monitor this Stage 1 
data as we solicit public comment so that we can determine if the more 
than 80 percent threshold is appropriate for this measure.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of patients in the denominator with 
smoking status recorded as structured data.
    <bullet> 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.
    Replaced EP Objective: Report ambulatory clinical quality measures 
to CMS or, in the case of Medicaid EPs, the States.
    Replaced Eligible Hospital/CAH Objective: Report hospital clinical 
quality measures to CMS or, in the case of Medicaid eligible hospitals, 
the States.
    In addition to the meaningful use core and menu objectives, EPs and 
hospitals are still required to report clinical quality measures to CMS 
or the States in order to demonstrate meaningful use of Certified EHR 
Technology. However, we propose to eliminate these objectives under 42 
CFR 495.6 and instead include the reporting of clinical quality 
measures (CQMs) as part of the definition of ``meaningful EHR user'' 
under 42 CFR 495.4. For more information about the requirements for 
reporting clinical quality measures, see section II.B.3. of this 
proposed rule. As explained in that section, we are proposing to move 
to electronic reporting of clinical quality measure information. 
Because the core and menu objectives under Sec.  495.6 are reported 
through attestation, we believe it makes more sense to separate the 
reporting of CQMs from the other meaningful use objectives and measures 
for Stage 2.
    Proposed Objective: Use clinical decision support to improve 
performance on high-priority health conditions.
    Clinical decision support at the point of care is an area of health 
IT in which significant evidence exists for its substantial positive 
impact on the quality, safety, and efficiency of care delivery. In 
Stage 1, we specified that the clinical decision support rule should be 
relevant to the provider's specialty or related to a high clinical 
priority. We purposely used a description that would allow a provider 
significant leeway in determining the clinical decision support 
interventions that are most relevant to their scope of practice and 
benefit their patients in the greatest way. Following the 
recommendations of the HIT Policy Committee, we are proposing to modify 
the objective for Stage 2 to using clinical decision support to improve 
performance on high-priority health conditions. We believe that it is 
best left to the provider's clinical discretion to determine which 
clinical decision support interventions would address high-priority 
conditions for their individual patient populations, but we are 
requiring as a measure of this objective that the clinical decision 
support intervention be related to 5 or more of the clinical quality 
measures on which EPs or hospitals would be expected to report. We 
define ``related'' to mean that the intervention's intent is to improve 
the performance of the EP, eligible hospital, or CAH on a given 
clinical quality measure. Because clinical quality measures focus on 
high-priority health conditions by definition, this alignment will 
ensure that clinical decision support is also focused on high-priority 
health conditions and improved performance in measurable quality areas.
    For Stage 2, we are also proposing to make the Stage 1 objective 
for ``Implement drug-drug and drug-allergy checks'' one of the measures 
of this clinical decision support objective. We continue to believe 
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 believe 
it is appropriate to include this functionality as part of this 
objective for using clinical decision support. Finally, we have 
replaced the term ``clinical decision support rule'' used in our Stage 
1 rule with the term ``clinical decision support intervention'' to 
better align with, and clearly allow for, the variety of decision 
support mechanisms available to help improve clinical performance and 
outcomes. This mirrors an identical change in the ONC Standards and 
Certification proposed rule.
    Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy 
both measures in order to meet the objective:
    1. Implement 5 clinical decision support interventions related to 5 
or more clinical quality measures at a relevant point in patient care 
for the entire EHR reporting period.
    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.
    The drug-drug and drug-allergy checks and the implementation of 5 
clinical decision support interventions are separate measures for this 
objective. Therefore the EP or hospital must implement clinical 
decision support interventions in addition to drug-drug and drug-
allergy interaction checks.
    For Stage 2 based on the HIT Policy Committee recommendations, each 
clinical decision support intervention must enable the provider to 
review all of the following attributes of the intervention: Developer 
of the intervention, bibliographic citation, funding source of the 
intervention, and release/revision date of the intervention. This will 
enable providers to review complete information including any potential 
conflict of interest for the decision support intervention(s), if they 
so choose. Certified EHR technology will display these attributes 
allowing providers to review them. Such information may be valuable so 
that providers can understand whether the clinical evidence that the 
intervention represents is current, and whether the development of that 
intervention was sponsored by an organization that may have conflicting 
business interests including, but not limited to, a pharmaceutical 
company, pharmacy benefits management company, or device manufacturer. 
We believe that there may be cases in which such organizations will 
have interest in sponsoring clinical decision support interventions, 
and such interventions may very well be in the patient's best interest. 
Nonetheless, such sponsorship should be made transparent to the 
provider using the system.
    In addition to the review of clinical decision support attributes, 
providers must implement the clinical decision support intervention at 
a relevant point in patient care when the intervention can influence 
clinical decision making before an action is taken on behalf of the 
patient. Although we leave it to the provider's clinical discretion to 
determine the relevant point in patient

[[Page 13715]]

care when such interventions will be most effective, the interventions 
must be presented through Certified EHR Technology to a licensed 
healthcare professional who can exercise clinical judgment about the 
decision support intervention before an action is taken on behalf of 
the patient.
    Finally, we propose that clinical decision support intervention 
must be related to 5 or more of the clinical quality measures that we 
will finalize for EPs and hospitals and on which they will be expected 
to report. By relating clinical decision support interventions to one 
or more clinical quality measures, providers are necessarily focusing 
on high-priority health conditions, as required by the objective and 
recommended by the HIT Policy Committee. Providers would implement 5 
clinical decision support interventions that they believe will result 
in improvement in performance for 5 or more of the clinical quality 
measures on which they report. For example, EPs reporting on the 
clinical quality measure of ``Preventive Care and Screening: Influenza 
Immunization for Patients 50 Years Old or Older'' (NQF 0041, PQRI 110) 
could choose to implement a clinical decision support intervention that 
triggers an alert in Certified EHR Technology prompting a licensed 
healthcare professional to ask about influenza immunizations whenever a 
patient 50 years old or older presents for an office visit or other 
action that increases the likelihood that the patient receives an 
influenza immunization.
    Please note that for Stage 2, we do not propose to require the 
provider to demonstrate actual improvement in performance on clinical 
quality measures. Rather, the provider must use the goal of improvement 
in performance for a clinical quality measure when the provider selects 
a clinical decision support intervention to implement. 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.
    We do not believe that any EP, eligible hospital, or CAH would be 
in a situation where they could not implement five clinical decision 
support intervention as previously described. Therefore, we do not 
propose any exclusions for this objective and its associated measure.
    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 are not proposing 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. The HIT Policy Committee recommended that these objectives be 
combined with objectives for online viewing and downloading. We agree 
with the HIT Policy Committee and are replacing these Stage 1 
objectives with proposed objectives and measures for Stage 2 that would 
enable patients to view online and download their health information 
and hospital admission information (discussed later in this rule). We 
believe 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.
    Proposed EP Objective: Provide 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.
    We also note 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.
    Proposed EP Measure: Clinical summaries provided to patients within 
24 hours for more than 50 percent of office visits.
    Following the recommendation of the HIT Policy Committee, we 
propose to continue the 50 percent threshold from Stage 1. Although 
many EPs provide paper summaries as the patient leaves the office, we 
believe that a timeframe is still needed for those EPs who provide 
electronic summaries either as the provider's preferred method of 
distribution or to accommodate patient requests for electronic 
summaries. Because the clinical summary is intended to be a summary of 
clinical information relevant to an office visit, we agree with the HIT 
Policy Committee that 24 hours is a sufficient timeframe in which to 
provide this summary. We note that the vast majority of information 
required in the clinical summary should be immediately available upon 
completion of the office visit. Although we provided 3 business days to 
send the clinical summary in Stage 1, we now believe that a faster 
exchange of information with patient is not only possible but also 
encourages better quality of care. However, we welcome comments on this 
timeframe. As in Stage 1, if a paper summary is mailed to the patient, 
the timeframe relates to when the summary is mailed and not when it is 
received by the patient.
    Summaries of an office visit 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 results. When such information 
becomes available, the HIT Policy Committee recommended that the EP 
have 4 business days to make the information known to the patient. We 
concur that EPs should make this information known to the patient, but 
do not believe that a new clinical summary must be issued in every 
instance. For example, current common practice is for laboratory 
results to be delivered by phone. We are proposing another objective of 
meaningful use that would provide for online access to the latest 
health information, whereas this clinical summary objective focuses on 
a singular visit. We also are concerned with the practicality of 
measuring this aspect and cannot determine how we would assign a 
denominator to it. The EHR would have to be capable of recognizing that 
additional information is available, link such information to a 
specific office visit, time the provision of information to the 
patient, and create a record that the patient was notified. We believe 
that this is too burdensome. The clinical summary would include 
information on pending tests, and therefore, will alert

[[Page 13716]]

patients that more information may soon be available if necessary. To 
calculate the percentage, CMS and ONC have worked together to define 
the following for this objective:
    <bullet> Denominator: Number of office visits conducted by the EP 
during the EHR reporting period.
    <bullet> Numerator: Number of office visits in the denominator 
where the patient is provided a clinical summary of their visit within 
24 hours.
    <bullet> 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.
    We propose to require the following information to be part of the 
clinical summary for Stage 2:
    <bullet> Patient Name.
    <bullet> Provider's name and office contact information.
    <bullet> Date and location of the visit.
    <bullet> Reason for the office visit.
    <bullet> Current problem list and any updates to it.
    <bullet> Current medication list and any updates to it.
    <bullet> Current medication allergy list and any updates to it.
    <bullet> Procedures performed during the visit.
    <bullet> Immunizations or medications administered during the 
visit.
    <bullet> Vital signs and any updates.
    <bullet> Laboratory test results.
    <bullet> List of diagnostic tests pending.
    <bullet> Clinical instructions.
    <bullet> Future appointments.
    <bullet> Referrals to other providers.
    <bullet> Future scheduled tests.
    <bullet> Demographics maintained by EP (gender, race, ethnicity, 
date of birth, preferred language). (New requirement for Stage 2.)
    <bullet> Smoking status (New requirement for Stage 2.)
    <bullet> Care plan field, including goals and instructions. (New 
requirement for Stage 2.)
    <bullet> Recommended patient decision aids (if applicable to the 
visit). (New requirement for Stage 2.)
    This is not intended to limit the information made available in the 
clinical summary by the EP. An EP can make available additional 
information and still meet the objective. The content of the care plan 
is dependent on the clinical context. We propose to describe a care 
plan as the structure used to define the management actions for the 
various conditions, problems, or issues. For purposes of meaningful use 
measurement, we propose that 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).
    We encourage EPs to develop the most robust care plan that is 
warranted by the situation. We also welcome comments on both our 
description of a care plan and whether a description is necessary for 
purpose of meaningful use. When an office visit lasts for several 
consecutive days and/or the patient is seen by multiple EPs during one 
office visit, a single consolidated summary at the end of the visit 
meets this objective. An example of a multiday office visit could be an 
evaluation one day, a diagnostic test the next and a follow-up 
treatment the next day based on the results of the test. Even in cases 
where multiple office visits occur under a global or bundled claim/fee, 
each visit results in an update to the status of the health of the 
patient and must be accompanied with a clinical summary.
    We would also maintain several other policies from Stage 1. For 
purposes of meaningful use, an EP may withhold information from the 
clinical summary if they believe substantial harm may arise from its 
disclosure through an after-visit clinical summary. 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 can 
select any modality (for example, online, CD, USB) as their electronic 
option and does not have to accommodate requests for different 
modalities. We do not believe it would be appropriate for an EP to 
charge the patient a fee for providing the summary.
    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.
    Removed Objective: Capability to exchange key clinical information.
    In Stage 2, we propose 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 believe that this actual use case is more 
beneficial and easier to understand. We also propose to remove this 
objective for Stage 1 as well, but consider other option. Please refer 
to the section titled ``Changes to Stage 1'' for details of the options 
considered. As we propose that the EHR reporting period for Stage 2 of 
meaningful use is the entire year, a prudent provider would 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 Certified EHR Technology through the 
implementation of appropriate technical capabilities.
    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.
    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.
    This measure is the same as in Stage 1 except that we specifically 
address the encryption/security of data that is stored in Certified EHR 
Technology (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 do not propose to change the HIPAA Security Rule requirements, or 
require any more than would be required under HIPAA. We only emphasize 
the importance of an EP or hospital including in its security risk 
analysis an assessment of the reasonableness and appropriateness of 
encrypting electronic protected health information as a means of 
securing it, and where it is not reasonable and

[[Page 13717]]

appropriate, the adoption of an equivalent alternative measure.
    We propose this measure because the implementation of Certified EHR 
Technology 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.
    We emphasize 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.
    (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 propose 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 
would remain in the menu set for Stage 2. As discussed later, we also 
propose to modify and combine some of these objectives and associated 
measures for Stage 2.
    Consolidated Objective: Implement drug formulary checks.
    For Stage 2, we are proposing 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.
    Proposed Objective: Incorporate clinical lab-test results into 
Certified EHR Technology as structured data.
    We believe that incorporating clinical lab-test results into 
Certified EHR Technology as structured data assists in the exchange of 
complete information between providers of care, facilitates the sharing 
of information with patients and their designated representatives, and 
contributes to the improvement of health care delivery to the patient. 
We encourage every EP, eligible hospital, and CAH to utilize electronic 
exchange of results with laboratories in accordance with the 
certification criteria in the ONC standards and certification proposed 
rule published elsewhere in this issue of the Federal Register. If 
results are not received through electronic exchange, then they are 
presumably received in another form (such as by fax, telephone call, 
mail) and would need to be incorporated into the patient's medical 
record in some way. We encourage the recording of results as structured 
data; however, there would be risk of recording the data twice (for 
example, scanning the faxed results and then entering the results as 
structured data). To reduce the risk of entry error, we highly 
encourage the electronic exchange of the results with the laboratory, 
instead of manual entry through typing, option selecting, scanning or 
other means.
    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 Certified EHR Technology as structured data.
    Although the HIT Policy Committee did not recommend an increase in 
the threshold for this measure, our initial data on Stage 1 of 
meaningful use shows high compliance with this measure for those 
providers individually selecting the objective from the menu set. 
Therefore we are proposing to increase the threshold of this objective 
to 55 percent for Stage 2.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: Number of lab test results whose results are 
expressed in a positive or negative affirmation or as a number which 
are incorporated in Certified EHR Technology as structured data.
    <bullet> 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 whose results are either 
in a positive/negative 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.
    Reducing the risk of entry error is one of the primary reasons we 
lowered the measure threshold to 40 percent for Stage 1, during which 
providers are changing their workflow processes to accurately 
incorporate information into EHRs through either electronic exchange or 
manual entry. However, for this measure, we do not limit the EP, 
eligible hospital or CAH to only counting structured data received via 
electronic exchange, but count in the numerator all structured data. By 
entering these results into the patient's medical record as structured 
data, the EP, eligible hospital or CAH is accomplishing a task that 
must be performed regardless of whether the provider is attempting to 
demonstrate meaningful use or not. We believe that entering the data as 
structured data encourages future exchange of information. We have 
received inquiries on Stage 1 on how to account for laboratory tests 
that are ordered in a group or panel. The inquiries have highlighted 
several problems this creates for measurement (for example, EHR only 
counting a panel as one, but the results individually creating more 
than 100 percent performance, panels that include tests that are 
included in the measure and other tests that are not included in the 
measure, EHRs that count the entire panel if one test meets the 
numerator criteria). The measure in Stage 1 and Stage 2 counts lab 
tests individually, not as panels or groups in both the numerator and 
the denominator for the very complications illustrated by the inquiries 
that occur when this is not done. However, we solicit comment on 
whether such individual accounting is infeasible. We note that this in 
no way precludes the use of grouping and panels when ordering labs. 
While we are not proposing to move beyond numeric and

[[Page 13718]]

yes/no tests, we request comments on whether standards and other 
capabilities would allow us to expand the measure to all quantitative 
results (all results that can be compared on as a ratio or on a 
difference scale).
    Proposed Objective: Generate lists of patients by specific 
conditions to use for quality improvement, reduction of disparities, 
research, or outreach.
    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 would use these reports in combination with one of 
the 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 proposed rule published elsewhere in this issue of 
the Federal Register; not all capabilities and variables must be used 
for every list.
    Proposed Measure: Generate at least one report listing patients of 
the EP, eligible hospital, or CAH with a specific condition.
    We propose 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 do 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 
are also seeking comment on whether a measure that either increases the 
number and/or frequency of the patient lists would further the intent 
of this objective.
    Proposed EP Objective: Use clinically relevant information to 
identify patients who should receive reminders for preventive/follow-up 
care.
    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.
    In Stage 1, this objective was stated as ``Send reminders to 
patients per patient preference for preventive/follow-up care.'' For 
Stage 2, the HIT Policy Committee recommended that clinically relevant 
information from Certified EHR Technology be used to identify patients 
to whom reminders of preventive/follow-up care would be most 
beneficial. We agree with this recommendation and are proposing to 
modify this objective for Stage 2 as ``Use clinically relevant 
information to identify patients who should receive reminders for 
preventive/follow-up care.'' An EP should use clinically relevant 
information stored within the Certified EHR Technology 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.
    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 propose 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 encourage 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 are proposing 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.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of unique patients who have had an 
office visit with the EP in the 24 months prior to the beginning of the 
EHR reporting period.
    <bullet> Numerator: Number of patients in the denominator who were 
sent a reminder per patient preference during the EHR reporting period.
    <bullet> 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.
    The goal of this objective is 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, this objective aligns with the 
Fair Information Practice Principles (FIPPs),\1\ in affording baseline 
privacy protections to individuals.\2\ In particular, the principles 
include Individual Access (patients should be provided with a

[[Page 13719]]

simple and timely means to access and obtain their individually 
identifiable information in a readable form and format). 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 agree 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, the patient must be able 
to access this information on demand, such as through a patient portal 
or personal health record (PHR). 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. 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.
---------------------------------------------------------------------------

    \1\ 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 
would 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 would 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.
    \2\ 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 
\2\ 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.
---------------------------------------------------------------------------

    In the Stage 1 final rule (75 FR 44356), we indicated that 
information should be available to the patient through online access 
within 4 business days of the information being available to the EP 
through either the receipt of final lab results or a patient encounter 
that updates the EP's knowledge of the patient's health. For Stage 2, 
we propose to maintain the requirement of information being made 
available to the patient through online access within 4 business days 
of the information being available to the EP. To that end, we propose 
to continue the definition of business days as Monday through Friday 
excluding Federal or State holidays on which the EP or their 
administrative staff are unavailable. The HIT Policy Committee 
recommended that EPs be required to make information resulting from a 
patient encounter available within 24 hours instead of 4 business days. 
They also recommended continuing the 4 business day timeframe for 
updates following the receipt of new information. We believe that 
splitting the timeframes in this manner adds unnecessary complexity to 
this objective and associated measure. We believe that 4 business days 
remains a reasonable timeframe and limits the needs for updating. To 
the extent that Certified EHR Technologies enable a quicker posting 
time we expect that this will be workflow benefit to the providers and 
they will utilize this quicker time regardless of the threshold 
timeline in meaningful use.
    Proposed EP Measures: We propose 2 measures for this objective, 
both of which must be satisfied in order to meet the objective:
    1. 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.
    2. 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.
    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 would be a download.
    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:
    <bullet> Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
    <bullet> 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 online.
    <bullet> Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
    To calculate the percentage of the second measure for patients or 
patient-authorized representatives to view, download or transmit health 
information, CMS and ONC have worked together to define the following 
for this objective:
    <bullet> Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
    <bullet> Numerator: The number of unique patients (or their 
authorized representatives) in the denominator who have viewed online 
or downloaded or transmitted to a third party the patient's health 
information.
    <bullet> Threshold: The resulting percentage must be more than 10 
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 this measure 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 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.
    The thresholds of both of these measures must be reached in order 
for the EP to meet the objective. If the EP reaches one of these 
thresholds but not the other, then the EP will fail to meet this 
objective, unless the EP meets an applicable exclusion. An EP that 
conducts the 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 the second measure. According to the FCC at the time of 
formulation of this proposed rule, 370 counties in the United States 
have broadband penetration of less than 50 percent (www.broadband.gov). 
Further discussion of this exclusion can be found under the eligible 
hospital and CAH objective of ``Provide patients the ability to view 
online, download, and transmit information about a hospital 
admission.'' We are also proposing that an EP who neither orders nor 
creates any of the information listed for inclusion as part of these 
measures may exclude both the first and second measures.
    Consistent with the recommendations of the HIT Policy Committee, we 
are proposing a threshold of more than 10 percent for patients (or 
their authorized representatives) to view, download or transmit to a 
third party health information. An EP has any number of ways to make 
this information available online. The EP can host a patient portal, 
contract with a vendor to host a patient portal, connect with an online 
PHR or other means. As long as the patient can view, download, and 
transmit the information using a standard web browser and internet 
connection, the

[[Page 13720]]

means is at the discretion of the EP. We note that this new measure 
does not focus solely on access and instead requires action by patients 
or their authorized representatives in order for the EP to meet it. A 
patient who views their information online, downloads it from the 
internet or uses the internet to transmit it to a third party would 
count for purposes of the numerator. While this is a departure from 
most meaningful use measures, which are dependent solely on actions 
taken by the EP, we believe that requiring a measurement of patient use 
ensures that the EP will promote the availability and active use of 
electronic health information by the patient or their authorized 
representatives. Furthermore, we believe that accountable care should 
extend to meaningful use objectives that encourage patient and family 
engagement. We invite comment on this new measure and whether the 10 
percent threshold is too high or too low given the patient's role in 
achieving it.
    We define patient-authorized representative as any individual to 
whom the patient has granted access to their health information. 
Examples would include family members, an advocate for the patient, or 
other individual identified by the patient. A patient would have to 
affirmatively grant access to these representatives with the exception 
of minors for whom existing local, State or Federal law grants their 
parents or guardians access without the need for the minor to consent 
and individuals who are unable to provide consent and where the State 
appoints a guardian.
    In order to make the information available to patients online 
consistent with the information provided during transitions of care, we 
are aligning the information required to meet this objective with the 
information provided in the summary of care record for each transition 
of care or referral. Therefore, 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:
    <bullet> Patient name.
    <bullet> Provider's name and office contact information.
    <bullet> Problem list.
    <bullet> Procedures.
    <bullet> Laboratory test results.
    <bullet> Medication list.
    <bullet> Medication allergy list.
    <bullet> Vital signs (height, weight, blood pressure, BMI, growth 
charts).
    <bullet> Smoking status.
    <bullet> Demographic information (preferred language, gender, race, 
ethnicity, date of birth).
    <bullet> Care plan field, including goals and instructions, and
    <bullet> Any additional known care team members beyond the 
referring or transitioning provider and the receiving provider.
    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.
    As stated in the Stage 1 final rule (75 FR 44356), we understand 
that there may be situations where a provider decides that online 
posting is not the best forum to communicate results. Within the 
confines of laws governing patient access to their medical records, we 
defer to an EP's judgment as to whether to hold information back in 
anticipation of an actual encounter or conversation between the EP or a 
member of their staff and the patient. Furthermore, for purposes of 
meeting this objective, an EP may withhold information from being 
accessible electronically if its disclosure would cause substantial 
harm to the patient or another individual. Therefore, if in the EP's 
judgment substantial harm may arise from the disclosure of particular 
information, an EP may choose to withhold that particular information. 
Any such withholding would not affect the EP's ability to meet this 
measure as that information would not be included in the percentage 
calculation. However, we note that such withholding of information 
would not have any effect on a provider's obligations under 45 CFR 
164.524 when an individual exercises his or her right of access to 
inspect and obtain a copy of protected health information about the 
individual in a designated record set. We do not believe there would be 
a circumstance where all information about an encounter would be 
withheld from the patient and therefore some information would be 
eligible for uploading for online access. If nothing else, information 
that the encounter occurred should be provided. This is a meaningful 
use provision, which does not override applicable federal, State or 
local laws regarding patient access to health information, including 
the requirements under the HIPAA Privacy Rule at 45 CFR 164.524.
    As discussed earlier in this proposed rule, beginning in 2014, 
Certified EHR Technology will no longer be certified for the Stage 1 
objectives of providing patients with an electronic copy of their 
health information upon request and providing patients with timely 
electronic access to their health information. This new ``view and 
download'' objective would replace those objectives, and we are 
proposing to include it in the core set for Stages 1 and 2 beginning in 
2014.'' However, for Stage 1, we are only proposing the first measure 
of ``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.'' Both measures would be 
required for Stage 2.
    Proposed Objective: Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    Providing clinically relevant education resources to patients is a 
priority for the meaningful use of Certified EHR Technology. Because of 
our experience with this objective in Stage 1, we are clarifying that 
while Certified EHR Technology 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 
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 Certified EHR Technology (that is, 
specific patient characteristics are linked to specific consumer health 
content). The EP or hospital should utilize Certified EHR Technology in 
a manner where the technology suggests patient-specific educational 
resources based on the information stored in the Certified EHR 
Technology. 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 Certified EHR Technology 
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).

[[Page 13721]]

    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 are proposing to remove 
the phrase ``if appropriate'' from the objective for Stage 2 because we 
do not believe that any EP or hospital would have difficulty 
identifying appropriate patient-specific education resources for the 
low percentage of patients required by the measure of this objective.
    We also recognize 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 
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. We are specifically inviting 
comments and seeking input on whether EPs and hospitals believe that 
patient-specific education resources at appropriate literacy levels and 
with appropriate cultural competencies could be successfully identified 
at this time through the use of Certified EHR Technology.
    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 Stage 1, the measure of 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 are proposing this as a core 
objective for Stage 2, we have modified the measure for EPs to 
``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.'' We recognize 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 are proposing to alter 
the measure to account for office visits rather than unique patients 
seen by the EP. We are also proposing an exclusion for EPs who have no 
office visits in order to accommodate such EPs. The resources would 
have to be those identified by CEHRT. If resources are not identified 
by CEHRT and provided to the patient then it would 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 set the threshold at only ten 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 would need to be provided prior to the calculation 
and subsequent attestation to meaningful use.
    To calculate the percentage for EPs, CMS and ONC have worked 
together to define the following for this objective:
    <bullet> Denominator: Number of office visits by the EP during the 
EHR reporting period.
    <bullet> Numerator: Number of patients who had office visits during 
the EHR reporting period who were subsequently provided patient-
specific education resources identified by Certified EHR Technology.
    <bullet> 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.
    To calculate the percentage for hospitals, CMS and ONC have worked 
together to define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: Number of patients in the denominator who are 
subsequently provided patient-specific education resources identified 
by Certified EHR Technology.
    <bullet> Threshold: The resulting percentage must be more than 10 
percent in order for an eligible hospital or CAH to meet this measure.
    Our explanation of ``patient-specific education resources 
identified by Certified EHR Technology'' for the EP measure also 
applies for the hospital 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.
    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.
    We note 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. 
It is for the receiving provider that up-to-date medication information 
will be most crucial in order to make informed clinical judgments for 
patient care. We reiterate 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. For the purposes 
of this objective, we propose to maintain the definition of a 
transition of care as the movement of a patient from one setting of 
care (for example, a hospital, ambulatory primary care practice, 
ambulatory specialty care practice, long-term care, home health, 
rehabilitation facility) to another.
    For Stage 2, we also propose to maintain the definition of 
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. There are additional resources available that further 
define medication reconciliation that while not incorporated into 
meaningful use may be helpful for EPs, eligible hospitals, and CAHs. 
While we believe that an electronic exchange of information following 
the transition of care of a patient is the most efficient method of 
performing medication reconciliation, we also realize it is unlikely 
that an automated process within the EHR will fully supplant the 
medication reconciliation conducted between the provider and the 
patient. Therefore, the electronic exchange of information is not a 
requirement for medication reconciliation.
    While the objective is to conduct medication reconciliation at all 
relevant encounters, determining which encounters are relevant beyond 
transitions of care is too subjective to be included in the measure.
    Proposed Measure: The EP, eligible hospital or CAH performs 
medication

[[Page 13722]]

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).
    The HIT Policy Committee recommended maintaining this threshold at 
50 percent. However, because this measure relates directly to the role 
of information exchange that we seek to promote through the meaningful 
use of Certified EHR Technology, we believe that a higher threshold for 
this measure is appropriate. Although the majority chose to defer this 
measure in Stage 1, the performance of both EPs and hospitals was well 
above the Stage 1 threshold. For these reasons we are proposing to 
raise the threshold of this measure to 65 percent for Stage 2.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of transitions of care in the 
denominator where medication reconciliation was performed.
    <bullet> Threshold: The resulting percentage must be more than 65 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
    <bullet> 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.
    By guaranteeing 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.
    The feedback we have received from providers who have met Stage 1 
meaningful use requirements has convinced us that the exchange of key 
clinical information is most efficiently accomplished within the 
context of providing a summary of care record during transitions of 
care. Therefore, we are proposing to eliminate the 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.
    In addition the HIT Policy Committee made two separate Stage 2 
recommendations for EPs, eligible hospitals, and CAHs to record 
additional information--
    <bullet> Record care plan fields, including goals and instructions, 
for at least 10 percent of transitions of care; and
    <bullet> Record team member, including primary care practitioner, 
for at least 10 percent of patients.
    We believe that this information is best incorporated as required 
data within the summary of care record itself. Rather than implement 
two separate objectives and measures for these recommendations, we are 
establishing these as required fields along with the summary of care 
information listed later. The ONC proposed rule on standards and 
certification includes these as standard fields required to populate 
the summary of care document so Certified EHR Technology would be able 
to include this information. We also recognize that a ``care plan'' may 
require further definition. The content of the care plan is dependent 
on the clinical context. We propose to describe a care plan as the 
structure used to define the management actions for the various 
conditions, problems, or issues. For purposes of meaningful use 
measurement we propose that 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).
    We encourage EPs to develop the most robust care plan that is 
warranted by the situation. We also welcome comments on both our 
description of a care plan and whether a description is necessary for 
purpose of meaningful use.
    All summary of care documents used to meet this objective must 
include the following:
    <bullet> Patient name.
    <bullet> Referring or transitioning provider's name and office 
contact information (EP only).
    <bullet> Procedures.
    <bullet> Relevant past diagnoses.
    <bullet> Laboratory test results.
    <bullet> Vital signs (height, weight, blood pressure, BMI, growth 
charts).
    <bullet> Smoking status.
    <bullet> Demographic information (preferred language, gender, race, 
ethnicity, date of birth).
    <bullet> Care plan field, including goals and instructions, and
    <bullet> Any additional known care team members beyond the 
referring or transitioning provider and the receiving provider.
    In addition, eligible hospitals and CAHs would be required to 
include discharge instructions.
    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:
    <bullet> An up-to-date problem list of current and active 
diagnoses.
    <bullet> An active medication list, and
    <bullet> An active medication allergy list.
    We encourage all summary of care documents to contain the most 
recent and up-to-date information on all elements. In order for the 
summary of care document to count in the numerator of this objective, 
the EP or hospital must verify these three fields for problem list, 
medication list, and 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. We define problem list as a 
list of current and active diagnoses. We solicit 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 define 
an up-to-date problem list as a list populated with the most recent 
diagnoses known by the EP or hospital. 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

[[Page 13723]]

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. 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.''
    We leave it to the provider's clinical judgment to identify any 
additional clinical information that would be relevant to include in 
the summary of care record.
    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 Certified EHR Technology to a 
recipient with no organizational affiliation and using a different 
Certified EHR Technology vendor than the sender for more than 10 
percent of transitions of care and referrals.
    <bullet> Exclusion: Any EP who neither transfers a patient to 
another setting nor refers a patient to another provider during the EHR 
reporting period is excluded from both measures.
    To calculate the percentage of the first measure, CMS and ONC have 
worked together to define the following for this objective:
    <bullet> 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.
    <bullet<ls-thn-eq> Numerator: The number of transitions of care and 
referrals in the denominator where a summary of care record was 
provided.
    <bullet<ls-thn-eq> Threshold: The percentage must be more than 65 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
    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 Certified EHR Technology would have access to 
the same information, so providing a clinical care summary for 
transfers within the hospital would not be necessary.
    To calculate the percentage of the second measure, CMS and ONC have 
worked together to define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of transitions of care and referrals 
in the denominator where a summary of care record was electronically 
transmitted using Certified EHR Technology to a recipient with no 
organizational affiliation and using a different Certified EHR 
Technology vendor than the sender.
    <bullet> Threshold: The percentage must be more than 10 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    For Stage 2, we are proposing 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 proposed 2014 
Edition EHR certification criteria. Please see the ONC proposed rule 
published elsewhere in this issue of the Federal Register for more 
details.
    These protocols will allow every provider with certified electronic 
health record technology 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 
propose 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 a provider must use 
Certified EHR Technology 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 Certified EHR Technology 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.
    We acknowledge 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. Thus, 
ONC requests comments on whether equivalent alternative transport 
standards exist to the ones ONC proposes to exclusively permit for 
certification. Comments on transports standards should be made to the 
ONC proposed rule published elsewhere in this issue of the Federal 
Register, while comments on the appropriateness of limiting this 
measure to only those standards finalized by ONC should be made to this 
rule. Note, 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. The required elements and 
standards of the summary of care document will be discussed in the ONC 
standards and certification proposed rule published elsewhere in this 
issue of the Federal Register. We are considering, in lieu of requiring 
solely the transmission capability and transport standard(s) included 
in a provider's Certified EHR Technology 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

[[Page 13724]]

through regulation. We request public comment on whether this 
additional flexibility should be added to our proposed numerator 
limitations.
    Another potential concern could be 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 has indicated in its proposed rule that it 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 solicit 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 propose 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 
Certified EHR Technology from the same EHR vendor.
    We propose 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 believe that it is 
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 
recognize 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 solicit comment on the following concerns 
stakeholders may have relative to the numerator limitations we proposed 
previously.
    We could see 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 that 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 recognize 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 recognize 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 seek 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 exclusions Certified EHR Technology 
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, and ONC will seek comment in their 
proposed certification rule as to the feasibility of this reporting 
requirement for certified EHR technologies.
    Despite the possible unintended consequences of the parameters we 
propose for the numerator, we believe that these limitations will help 
ensure that electronic health information exchange proceeds at the pace 
necessary to accomplish the goals of meaningful use. We encourage 
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.
    However, we note that electronic transmittal is not a requirement 
for the first measure to provide a summary of care record. For the 
first measure, where the electronic transmittal of the summary of care 
record is not a requirement but an option, a provider is permitted to 
generate an electronic or paper copy of the summary of care record 
using the Certified EHR Technology and to document that it was provided 
to the patient, receiving provider or both. In this case, the use of 
physical media such as a CD-ROM, a USB or hard drive, or other formats 
could satisfy the measure of this objective.
    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. We believe 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 encourage comment on whether 
there are significant barriers in addition to those discussed above to 
EPs meeting the 10 percent threshold for this measure.
    In addition, the HIT Policy Committee recommended maintaining the 
50 percent threshold from Stage 1. However, because this measure 
relates directly to the role of information exchange that we seek to 
promote through the meaningful use of Certified EHR Technology, we 
believe that a higher threshold for this measure is appropriate. 
Although the majority chose to defer this measure in Stage 1, the 
performance of both EPs and hospitals was well above the Stage 1 
threshold. For these reasons we are proposing to raise the threshold of 
this measure to 65 percent for Stage 2.
    The thresholds of both measures must be reached in order for the 
EP, eligible hospital, or CAH to meet the objective. If the EP, 
eligible hospital, or CAH reaches one of these thresholds but not the 
other, then the EP, eligible hospital, or CAH will fail to meet this 
objective.

[[Page 13725]]

(c) Public Health Objectives
    Due to similar considerations among the public health objectives, 
we are discussing them together. Some Stage 2 public health objectives 
are in the core set while others are in the menu set. Each objective is 
identified as either core or menu in the below discussion.
    <bullet> Capability to submit electronic data to immunization 
registries or immunization information systems except where prohibited, 
and in accordance with applicable law and practice.
    <bullet> Capability to submit electronic reportable laboratory 
results to public health agencies, except where prohibited, and in 
accordance with applicable law and practice.
    <bullet> Capability to submit electronic syndromic surveillance 
data to public health agencies, except where prohibited, and in 
accordance with applicable law and practice.
    <bullet> Capability to identify and report cancer cases to a State 
cancer registry where authorized, and in accordance with applicable law 
and practice.
    <bullet> 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 are proposing the following requirements, which would apply to 
all of the public health objectives and measures. We propose that 
actual patient data is required for the meaningful use measures that 
include ongoing submission of patient data.
    There are a growing number of public health agencies partnering 
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 at: https://questions.cms.hhs.gov/app/answers/detail/a_id/10764/kw/immunizations) we clarify that such 
arrangements with HIE organizations, if serving on the behalf of the 
public health agency 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 
Certified EHR Technology 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.
    <bullet> An eligible provider is required to utilize the transport 
method or methods supported by the public health agency in order to 
achieve meaningful use.
    <bullet> Unlike in Stage 1, a failed submission would not meet the 
objective. An eligible provider must either have successful ongoing 
submission or meet exclusion criteria.
    <bullet> We expect that CMS, CDC and public health agencies (PHA) 
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 request comments on challenges to implementing this 
strategy.
    We will accept a yes/no attestation and information indicating to 
which public health agency the public health data were submitted to 
support each of the public health meaningful use measures.
    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 would not preempt otherwise applicable 
State or local laws that govern reporting. In the latter case, EPs, 
eligible hospitals and CAHs would be excluded from 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.
    This objective is in the Stage 2 core set for EPs, eligible 
hospitals and CAHs. 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 Certified EHR 
Technology, 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 propose 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.
    The HIT Policy Committee recommended making this a core objective 
for Stage 2 for EPs and hospitals, and we are adopting their 
recommendation. We agree that the bar for Stage 2 should move from 
simply testing the electronic submission of immunization data to 
ongoing submission. We also agree that given the focus on upgrading and 
enhancing immunization registries' capacity, under CDC's guidance, this 
measure is sufficiently achievable to warrant its inclusion in the core 
set of Stage 2 meaningful use measures. However, we specifically invite 
comment on the challenges that moving this objective from the menu set 
to the core set would present for EPs and hospitals.
    We also propose to modify the Stage 1 objective to add ``except 
where prohibited'' because we want 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 is not required by either 
law or practice. There are a few instances where some EPs, eligible 
hospitals, and CAHs are not authorized or cannot submit 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).
    Proposed 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.
    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 
the 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 receiving electronic 
immunization data in the specific for Certified EHR Technology at the 
start of their EHR reporting period; or (3) the EP, eligible hospital 
or CAH operates in a

[[Page 13726]]

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. For the second and third scenarios, there is no 
exclusion if an entity designated by the immunization registry can 
receive electronic immunization data submissions. For example, if the 
immunization registry cannot accept the data directly or in the version 
of HL7 used by the provider's Certified EHR Technology, but has 
designated a Health Information Exchange to do so on their behalf, the 
provider could not claim the 2nd or 3rd exclusions previously noted.
    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.
    This objective is in the Stage 2 core set for eligible hospitals 
and CAHs. The same rationale for the 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.
    Proposed Eligible Hospital/CAH Measure: Successful ongoing 
submission of electronic reportable laboratory results from Certified 
EHR Technology to a public health agency for the entire EHR reporting 
period.
    Please refer to the general public health discussion regarding use 
of intermediaries.
    Exclusions: The eligible hospital or CAH operates in a jurisdiction 
for which no public health agency is capable of receiving electronic 
reportable laboratory results in the specific standards required by ONC 
for EHR certification at the start of the EHR reporting period.
    Proposed Objective: Capability to submit electronic syndromic 
surveillance data to public health agencies except where prohibited, 
and in accordance with applicable law and practice.
    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 acknowledged that our nation's public health IT infrastructure 
is not universally capable of receiving syndromic surveillance data 
from Certified EHR Technology, either due to technical or resource 
readiness. Given public health IT infrastructure improvements and new 
implementation guidance, for Stage 2, we are proposing 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 proposed 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 providers, and there is no corresponding 
implementation guide at the time of this proposed rule. CDC is working 
with the syndromic surveillance community to develop a new 
implementation guide for ambulatory reporting of syndromic surveillance 
information, which it expects will be available in the fall of 2012. 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 are not proposing to 
adopt their recommendation for EPs. We specifically invite 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.
    Proposed Measure: Successful ongoing submission of electronic 
syndromic surveillance data from Certified EHR Technology to a public 
health agency for the entire 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 (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 would not 
collect such information); (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 ONC for EHR certification for 
2014 at the start of their EHR reporting period; or (4) the EP, 
eligible hospital, or CAH operates in a jurisdiction for which no 
public health agency is capable of accepting the specific standards 
required for Certified EHR Technology at the start of their EHR 
reporting period. As was described under the immunization registry 
measure, the third and fourth exclusions do not apply if the public 
health agency has designated an HIE to collect this information on its 
behalf and that HIE can do so in the specific Stage 2 standards and/or 
the same standard as the provider's Certified EHR Technology. 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 would be open at all times.
(d) New Core and Menu Set Objectives and Measures for Stage 2
    We are proposing 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 are proposing 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 
these new menu set 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 Certified EHR Technology.
    Making the image that results from diagnostic scans and 
accompanying information accessible through Certified EHR Technology 
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

[[Page 13727]]

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.
    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 Certified EHR Technology, but 
in absence of such exchange it is acceptable to manually add the image 
and accompanying information to Certified EHR Technology.
    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 EHR 
reporting period are accessible through Certified EHR Technology.
    For Stage 2, we do 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 Certified 
EHR Technology may be counted in the numerator of this measure. We 
define accessible as either incorporation of the image and accompanying 
information into Certified EHR Technology or an indication in Certified 
EHR Technology 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 Certified 
EHR Technology. Meaningful use does not 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 Certified EHR Technology. This 
link must conform to the certification requirements associated with 
this objective in the ONC rule. We encourage comments on the necessary 
level of specification and what those specifications should be to 
define accessible and what constitutes a direct link.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of scans and tests whose result is one 
or more image 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.
    <bullet> Numerator: The number of results in the denominator that 
are accessible through Certified EHR Technology.
    <bullet> Threshold: The resulting percentage must be more than 40 
percent in order to meet this measure.
    Exclusion: Any EP who does not perform diagnostic interpretation of 
scans or tests whose result is an image during the EHR reporting 
period.
    We also solicit comments on a potential second measure for this 
objective that would encourage the exchange of imaging and results 
between providers. We are considering 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 Certified EHR 
Technology also be exchanged with another provider of care. However, we 
are concerned that this extra measure may be difficult for some EPs to 
meet and might discourage a significant number of EPs from selecting 
this objective as part of their menu set. We also solicit comment on 
whether an exclusion for this second measure should be included for 
providers who do not typically exchange imaging scans and test results 
as a normal part of their workflow, and we encourage commenters to 
provide details about how such an exclusion might be included.
    Proposed Objective: Record patient family health history as 
structured data.
    Family health history is a major risk indicator for a variety of 
chronic conditions for which effective screening and prevention tools 
are available. Certified EHR technology can use family health history, 
if captured as structured data, to inform clinical decision support, 
patient reminders, and patient education. Family health history would 
also benefit from greater interoperability made possible by EHRs. A 
family health history is unique to each patient and fairly static over 
time. Currently, every provider requests this information 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.
    The HIT Policy Committee recommended delaying the inclusion of this 
objective until Stage 3 due to absence of available standards. However, 
we believe that standards supporting family health history are 
currently available. We are proposing this as a menu objective for 
Stage 2.
    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.
    For Stage 2, we do not propose to include the capability to 
exchange family health history electronically as part of the measure. 
We do not believe there is sufficient structured data capture of family 
health history to support such exchange. After Stage 2 increases the 
capture of family health history in EHRs, we will seek to include 
exchange with other providers and the patient in Stage 3.
    We propose 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 note that this is a minimum and not a limitation on the 
health history that can be recorded. We invite comment on the utility 
of expanding this definition to capture risks associated with social 
and other environmental determinants.
    We do 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.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of patients in the denominator with 
a structured data entry for one or more first-degree relatives.
    <bullet> Threshold: The resulting percentage must be more than 20 
percent in order to meet this measure.
    We are concerned that certain EPs may not be able to meet this 
measure either due to scope of practice constraints or lack of patient 
interaction. Therefore, we are proposing an

[[Page 13728]]

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 
would not have the face-to-face contact with patients necessary to 
obtain family health history information. We also believe that EPs who 
do not have office visits may be unable to obtain family health history 
information from referring physicians, which could prevent them from 
being able to meet the measure of this objective. While the exclusion 
does not relate directly to the denominator, it represents the barriers 
justifying the exclusion. Furthermore, all office visits would not 
require updates to family health history.
    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.
    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. 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 have included this objective to provide more 
flexibility in the menu objectives that EPs can choose. We believe that 
cancer reporting could provide many EPs with a meaningful use public 
health reporting option that is more aligned with their scope of 
practice.
    We include ``except where prohibited and in accordance with 
applicable law'' 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.
    Proposed EP Measure: Successful ongoing submission of cancer case 
information from Certified EHR Technology to a cancer registry for the 
entire EHR reporting period.
    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; or (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 under Stage 2 at 
the beginning of their EHR reporting period.
    An EP must either successfully submit or meet 1 of the exclusion 
criteria.
    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.
    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.
    Proposed EP Measure: Successful ongoing submission of specific case 
information from Certified EHR Technology to a specialized registry for 
the entire EHR reporting period.
    Exclusions: Any EP that meets at least 1of 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; or 
(2) the EP operates in a jurisdiction for which no registry is capable 
of receiving electronic specific case information in the specific 
standards required under Stage 2 at the beginning of their EHR 
reporting period.
    Proposed EP Objective: Use secure electronic messaging to 
communicate with patients on relevant health information.
    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 are proposing this as a core objective for EPs for Stage 2. The 
additional time made available for Stage 2 implementation makes 
possible the inclusion of some new objectives in the core set. 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--
    <bullet> Ensuring that each person/family is engaged as partners in 
their care; and
    <bullet> 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 seek comment on whether

[[Page 13729]]

there may be special concerns with this objective in regards to 
behavioral health.
    Proposed EP Measure: A secure message was sent using the electronic 
messaging function of Certified EHR Technology by more than 10 percent 
of unique patients seen by the EP during the EHR reporting period.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
    <bullet> Numerator: The number of patients in the denominator who 
send a secure electronic message to the EP using the electronic 
messaging function of Certified EHR Technology during the EHR reporting 
period.
    <bullet> 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.
    We note that this new measure requires action by patients in order 
for the EP to meet it. While this is a departure from most meaningful 
use measures, which are dependent solely on actions taken by the EP, we 
believe that requiring a measurement of patient use ensures that the EP 
will promote the availability and active use of secure electronic 
messaging by the patient. Furthermore, we believe that accountable care 
should extend to accountability for meaningful use objectives that 
encourage patient and family engagement. We invite comment on this new 
measure and whether EPs believe that the 10 percent threshold is too 
high or too low given the patient's role in achieving it.
    We specify that 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, not because we believe that the messages sent by the patient 
to the healthcare provider do not need to contain relevant health 
information, but because we believe the provider is best equipped to 
determine whether such information is included. It would be too great a 
burden for the certified EHR technology, or the attestation process, to 
determine whether the information in the secure message has such 
information. We also note that 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 as a condition of meeting this measure.
    To address some circumstances regarding scope of practice, we 
propose an exclusion to this objective for EPs who have no office 
visits during the EHR reporting period. Not having any office visits 
for an entire EHR reporting period indicates that there may not be a 
need for follow-up communication through secure electronic messaging.
    Proposed Eligible Hospital/CAH Objective: Automatically track 
medications from order to administration using assistive technologies 
in conjunction with an electronic medication administration record 
(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 are proposing 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 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 propose to define eMAR as technology that automatically 
documents the administration of medication into Certified EHR 
Technology 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 proposed rule published elsewhere in this issue 
of the Federal Register.
    By its very definition, eMAR occurs at the point of care so we do 
not propose additional qualifications on when it must be used or who 
must use it.
    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.
    This recommendation by the HIT Policy Committee was that the 
measure of this objective be that eMAR is implemented and in use for 
the entire EHR reporting period in at least one ward/unit of the 
hospital. However, we recognize that it may be difficult to provide a 
definition of ward or unit that is applicable for all eligible 
hospitals and CAHs. Therefore we are proposing a percentage-based 
measure that would be applicable to all medication orders created by 
authorized providers of an inpatient or emergency department. We 
believe the low threshold of 10 percent allows eligible hospitals and 
CAHs maximum flexibility in how they choose to implement eMAR. We note 
that this approach does not prevent an eligible hospital or CAH from 
implementing eMAR in a single ward or unit, provided that they are able 
to meet the 10 percent threshold from orders tracked through eMAR in 
that unit. Eligible hospitals and CAHs might also elect to implement 
eMAR more widely in order to better complement their current workflow.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of orders in the denominator tracked 
using eMAR.
    <bullet> Threshold: The resulting percentage must be more than 10 
percent in order for an eligible hospital or CAH to meet this measure.
    Proposed Eligible Hospital/CAH Objective: Generate and transmit 
permissible discharge prescriptions electronically (eRx)
    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, Certified EHR 
Technology can recognize the information and can provide decision

[[Page 13730]]

support to promote safety and quality in the form of adverse 
interactions and other treatment possibilities. The Certified EHR 
Technology 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.
    The HIT Policy Committee recommended the inclusion of eRx for 
hospitals for discharge medications. We agree that eRx has unique 
advantages for discharge medications versus medications dispensed 
within the hospital. Primarily the efficiency of the transmission and 
the information it provides to the external pharmacy and/or third party 
to compare to other medication orders received for the patient.
    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 Certified EHR 
Technology.
    The HIT Policy Committee recommended that this measure be limited 
to new or changed prescriptions that were ordered during the course of 
treatment of the patient while in the hospital. The limitation is 
necessary because prescriptions that originate prior to the hospital 
stay, and that remain unchanged, would be within the purview of the 
original prescriber, and not hospital staff or attending physicians. We 
propose to include this limitation as we agree with the HIT Policy 
Committee that the hospital would not issue refills for medications 
they did not authorize or alter during their treatment of the patient. 
We ask that commenters consider whether a hospital issues refills to 
patients being discharged for medications the patient was taking when 
they arrived at the hospital and, if so, whether distinguishing those 
prescriptions from new or altered prescriptions is unnecessarily 
burdensome for the hospital.
    As this would be a new menu objective for hospitals for Stage 2 and 
we continue to have concerns about the effect of patient preferences, 
we are proposing a threshold of 10 percent as recommended by the HIT 
Policy Committee. We do not believe that an exclusion based on the 
number of medications is necessary, as we cannot envision a hospital 
with fewer than 100 prescriptions, but we do propose an exclusion if 
there are no pharmacies that accept electronic prescriptions within 25 
miles of the hospital. A hospital with an internal pharmacy that can 
dispense these electronic prescriptions to patients after discharge 
could not qualify for this exclusion.
    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. Not all drug 
formularies are linked to all Certified EHR Technologies, so we do not 
require that the formulary be one that is relevant for the particular 
patient. Therefore, the comparison could return a result of formulary 
unavailable for that patient and medication combination. This 
modification of the measure replaces the Stage 1 menu objective of 
``Implement drug-formulary checks'' and is intended to provide better 
integration guidance both for the hospital and their supporting 
vendors. To calculate the percentage, CMS and ONC have worked together 
to define the following for this objective:
    <bullet> Denominator: Number of new or changed prescriptions 
written for drugs requiring a prescription in order to be dispensed 
other than controlled substances for patients discharged during the EHR 
reporting period.
    <bullet> Numerator: The number of prescriptions in the denominator 
generated, compared to a drug formulary and transmitted electronically.
    <bullet> 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 there 
are no pharmacies that accept electronic prescriptions within 25 miles 
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.
    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, this objective 
aligns with the FIPPs,\3\ in affording baseline privacy protections to 
individuals. We believe that 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 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. 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\ Ibid.
---------------------------------------------------------------------------

    We propose this as a core objective for hospitals in Stage 2 with 
the following information that must be available as part of the 
objective:
    <bullet> Admit and discharge date and location.
    <bullet> Reason for hospitalization.
    <bullet> Providers of care during hospitalization.
    <bullet> Problem list maintained by the hospital on the patient.
    <bullet> Relevant past diagnoses known by the hospital.
    <bullet> Medication list maintained by the hospital on the patient 
(both current admission and historical).
    <bullet> Medication allergy list maintained by the hospital on the 
patient (both current admission and historical).
    <bullet> Vital signs at discharge.
    <bullet> Laboratory test results (available at time of discharge).
    <bullet> Care transition summary and plan for next provider of care 
(for transitions other than home).
    <bullet> Discharge instructions for patient, and
    <bullet> Demographics maintained by hospital (gender, race, 
ethnicity, date of birth, preferred language, smoking status).
    This is not intended to limit the information made available by the

[[Page 13731]]

hospital. A hospital can make available additional information and 
still align with the objective.
    A hospital has any number of ways to make this information 
available online. The hospital can host a patient portal, contract with 
a vendor to host a patient portal, connect with an online PHR, or other 
means. As long as the patient can view and download the information 
using a standard Web browser and internet connection, the means is at 
the discretion of the hospital.
    Proposed 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.
    This objective replaces two Stage 1 objectives for providing 
patients electronic copies of their health information upon request and 
providing electronic copies of discharge instructions. In Stage 1 of 
meaningful use, there was a measure of 50 percent of patients 
requesting electronic copies (within 3 business days) and discharge 
instructions (at time of discharge) were provided to them. The creation 
of this Stage 2 combined objective creates different time constraints. 
The HIT Policy Committee recommended 36 hours from discharge as an 
appropriate time period to meet this measure. We see no compelling 
reason to alter this recommendation; however, we encourage comment on 
whether this is an appropriate time frame for this new measure.
    The second measure represents a new concept for meaningful use 
criteria, because it measures the hospital based upon the actions of 
the patient. The HIT Policy Committee noted that providers would want 
flexibility with respect to the type of guidance provided to patients. 
In turn, the HIT Policy Committee recommended best practice guidance 
for providers, vendors, and software developments. We believe the 
hospital can sponsor education and awareness activities that result in 
patients viewing their information. Also, the low threshold of 10 
percent recognizes that this kind of measure is in its earlier stages. 
A patient who views their information online, downloads it from the 
internet or uses the internet to transmit it to a third party would 
count for purposes of the numerator. However, we recognize, that in 
areas of the country where a significant section of the patient 
population does not have access to broadband internet, this measure may 
be significantly harder or impossible to achieve. For example, for a 
hospital in an area with 100 percent broadband availability, only 10 
percent of the patient population must view the information. However, a 
hospital in an area with 30 percent broadband availability must 
essentially have a third of their patient population view the 
information. In addition, areas with high broadband penetration tend to 
correlate with more prolific users making it more likely that patients 
will view information online. There are 2 possible solutions to this 
disparity. The first is to exclude hospitals that operate in areas with 
below a certain threshold of broadband penetration. The second would be 
to change the measure to 10 percent of the broadband penetration. 
According to the FCC, 370 counties in the United States have broadband 
penetration of less than 50 percent (www.broadband.gov). Hospitals in 
areas of low broadband availability tend to service large areas that 
may extend beyond the county in which the hospital is located. Under 
the first option we considered, if the county in which the hospital is 
located has less than 50 percent 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, the hospital 
may exclude the second measure. Under the second option, the hospital 
would have to meet 10 percent of the broadband availability according 
to the FCC in the county in which they are located at the beginning of 
the EHR reporting period. For example, if the reported availability in 
a county on October 1, 2014, for a hospital was 23 percent, the 
hospital's threshold for the second measure would be 2.3 percent. There 
are counties currently with zero percent availability. If there is a 
hospital in a county with zero percent availability, those hospitals 
would not have to meet the second measure. We propose to adopt the 
first method as we believe the second method is too complex to be a 
practical requirement. However, we welcome comments on both options as 
well as the correct threshold for the first option.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    First Measure:
    <bullet> 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.
    <bullet> Numerator: The number of patients in the denominator whose 
information is available online within 36 hours of discharge.
    <bullet> Threshold: The resulting percentage must be more than 50 
percent in order for an eligible hospital or CAH to meet this measure.
    Second Measure:
    <bullet> 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.
    <bullet> Numerator: The number of patients in the denominator who 
view, download or transmit to a third party the information provided by 
the eligible hospital or CAH online during the EHR reporting period.
    <bullet> 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 will be excluded from the 
second measure if it is located in a county that does not have 50 
percent or more of their housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
at the start of the EHR reporting period is excluded from the second 
measure.
(e) Objective and Measure Carried Over Unmodified From Stage 1 Menu Set 
to Stage 2 Menu Set
    Proposed Eligible Hospital/CAH Objective: Record whether a patient 
65 years old or older has an advance directive.
    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 Certified EHR 
Technology or link to an electronic copy of the advance directive. 
However, we propose to maintain this objective as part of the Menu Set 
and we are not proposing a copy or link to the advance directive for 
eligible hospitals and CAHs in Stage 2. 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

[[Page 13732]]

workflows may change as EHR technology develops and becomes more widely 
adopted. Therefore, we do not propose to adopt the HIT Policy 
Committee's recommendations to require this objective as a core 
measure, to store an electronic copy of the advance directive in the 
Certified EHR Technology, or to link to an electronic copy of the 
advance directive.
    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 would not record this information 
under current standards of practice and would 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 would be excluded from the objective would be too 
cumbersome and still might not be comprehensive. Therefore, we are not 
proposing the recording of the existence of advance directives as an 
objective for EPs in Stage 2. However, we invite public comment on this 
decision and encourage 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.
    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 an indication of an advance directive status 
recorded as structured data.
    We propose that the measure of this objective would remain 
unmodified from Stage 1. To calculate the percentage, CMS and ONC have 
worked together to define the following for this objective:
    <bullet> 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.
    <bullet> Numerator: The number of patients in the denominator who 
have an indication of an advance directive status entered using 
structured data.
    <bullet> 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.
    Please note 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.
(f) Other HIT Policy Committee Recommended Objectives Not Proposed
    We are not proposing these objectives for Stage 2 as explained at 
each objective, but we encourage comments on whether these objectives 
should be incorporated into Stage 2.
    Hospital Objective: Provide structured electronic lab results to 
eligible professionals.
    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 would need to be 
done so using the capabilities Certified EHR Technology. 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 Certified EHR Technology. To 
facilitate the ease with which this electronic exchange may take place, 
ONC has proposed that for certification, ambulatory EHR technology 
would need to be able to incorporate lab test results formatted in the 
same standard and implementation specifications to which inpatient EHR 
technology would need to be certified as being able to create. However, 
we are not proposing this objective for a variety of reasons. While ONC 
is working to ease the barriers to this exchange through certification, 
this assumes that over 40 percent of the ordering providers would be 
utilizing Certified EHR Technology. Also, as discussed elsewhere, there 
is more to exchange than the established standards. Secondly, although 
hospital labs supply nearly half of all lab results to EPs, 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 are 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 focuses on the 
inpatient and emergency departments of a hospital. This objective is 
not related to these departments, in fact, it explicitly excludes 
services provided in these departments. We encourage comments on both 
the pros and cons of this objective and whether it should be considered 
for the final rule as recommended by the HIT Policy Committee. The HIT 
Policy Committee recommended this as a core objective for Stage 2 for 
eligible hospitals.
    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 believe that this requirement is better incorporated with other 
objectives that require patient communication and is not necessary as a 
standalone objective.
    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 believe that this requirement is better incorporated with other 
objectives that require summary of care documents and is not necessary 
as a standalone objective.
    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 believe that this requirement is better incorporated with other 
objectives that require summary of care documents and is not necessary 
as a standalone objective.
    Objective/Measure: Record electronic notes in patient records for 
more than 30 percent of office visits.
    While we believe that medical evaluation entries by providers are 
an important component of patient records that can provide information 
not otherwise captured within standardized fields, we believe there is 
evidence to suggest that electronic notes are already widely used by 
providers of Certified EHR Technology and therefore do not need to be 
included as a meaningful use objective. For example, a 2008 survey of 
healthcare professionals indicated that 75 percent of respondents were 
already using an EHR for physician charting/

[[Page 13733]]

documentation and 74 percent were already using the EHR for nursing 
charting/documentation (2008 HIMSS/HIMSS Analytics Ambulatory 
Healthcare IT Survey: http://www.himss.org/content/files/2008_HA_HIMSS_ambulatory_Survey.pdf). However, we note that ONC has included 
in its Stage 2 proposed rule certification capabilities that require 
Certified EHR Technology to allow the inclusion of electronic notes 
that are text-searchable.
    Table 4 provides a summary of stage 2 objectives and measures that 
we are proposing to adopt.
BILLING CODE 4120-01-P

[[Page 13734]]

[GRAPHIC] [TIFF OMITTED] TP07MR12.002


[[Page 13735]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.003


[[Page 13736]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.004


[[Page 13737]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.005


[[Page 13738]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.006


[[Page 13739]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.007


[[Page 13740]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.008


[[Page 13741]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.009

BILLING CODE 4120-01-C

[[Page 13742]]

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

1. Time Periods for Reporting Clinical Quality Measures
    This section clarifies the time periods as they relate to reporting 
clinical quality measures only. We are not proposing any changes to the 
time periods for reporting clinical quality measures. The EHR reporting 
period for clinical quality measures under the EHR Incentive Program is 
the period during which data collection or measurement for clinical 
quality measures occurs. The reporting period is consistent with our 
Stage 1 final rule (75 FR 44314) and will continue to track with the 
EHR reporting periods for the meaningful use criteria:
    <bullet> Eligible Professionals (EPs): January 1 through December 
31 (calendar year).
    <bullet> Eligible Hospitals and Critical Access Hospitals (CAHs): 
October 1 through September 30 (Federal fiscal year).
    <bullet> EPs, eligible hospitals, and CAHs in their first year of 
meaningful use for Stage 1, the EHR reporting period would be any 
continuous 90-day period within the calendar year (CY) or Federal 
fiscal year (FY), respectively. 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 the 90-day EHR 
reporting period ends at least three months before the end of the CY or 
FY, and that all submission is completed by October 1 or July 1, 
respectively. For an explanation of the applicable EHR reporting 
periods for determining the payment adjustments, please see section 
II.D. of this proposed rule.

    Table 5--Reporting on Clinical Quality Measures Using Certified EHR Technology by Eligible Professionals,
                                Eligible Hospitals and Critical Access Hospitals
----------------------------------------------------------------------------------------------------------------
                                                                           Reporting period    Submission period
                                   Reporting period    Submission period    for subsequent      for subsequent
                                   for first year of   for first year of       years of            years of
          Provider type             meaningful use      meaningful use      meaningful use      meaningful use
                                       (Stage 1)           (Stage 1)         (Stage 1 and        (Stage 1 and
                                                                          Subsequent Stages)  subsequent stages)
----------------------------------------------------------------------------------------------------------------
EP..............................  90 consecutive      Anytime             1 calendar year     2 months following
                                   days.               immediately         (January 1-         the end of the
                                                       following the end   December 31).       EHR reporting
                                                       of the 90-day                           period (January 1-
                                                       reporting period,                       February 28).
                                                       but no later than
                                                       February 28 of
                                                       the following
                                                       calendar year.
Eligible Hospital/CAH...........  90 consecutive      Anytime immediate   1 fiscal year       2 months following
                                   days.               following the end   (October1-Septemb   the end of the
                                                       of the 90-day       er 30).             EHR reporting
                                                       reporting period,                       period (October 1-
                                                       but no later than                       November 30).
                                                       November 30 of
                                                       the following
                                                       fiscal year.
----------------------------------------------------------------------------------------------------------------

    For example, for an EP, an EHR reporting period would be January 1, 
2014 through December 31, 2014 and is the same as CY 2014. If the EP is 
in his or her first year of Stage 1, the EHR reporting period could be 
at the earliest from January 1, 2014 through March 31, 2014 and at the 
latest from October 3, 2014 through December 31, 2014. If the EP is 
demonstrating meaningful use for the first time in CY 2014, for 
purposes of avoiding the payment adjustment in CY 2015, the EHR 
reporting period must end by September 30, 2014.
    For an eligible hospital or CAH, an EHR reporting period would be 
October 1, 2013 through September 30, 2014 and is the same as FY 2014. 
If the eligible hospital or CAH is in its first year of meaningful use 
for Stage 1, the EHR reporting period could be at the earliest from 
October 1, 2013 through December 29, 2013 and at the latest from July 
3, 2014 through September 30, 2014. If an eligible hospital is 
demonstrating meaningful use for the first time in FY 2014, for 
purposes of avoiding the payment adjustment in FY 2015, the EHR 
reporting period must end by June 30, 2014.
    For EPs, eligible hospitals, and CAHs, the submission period for 
clinical quality measure data to us generally would be 2 months 
immediately following the end of the EHR reporting period:
    <bullet> Eligible Professionals: January 1 through February 28.
    <bullet> Eligible Hospitals and CAHs: October 1 through November 
30.
    <bullet> EPs, eligible hospitals, and CAHs in their first year of 
Stage 1 could submit clinical quality measure data anytime after their 
respective 90-day EHR reporting period up to 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 clinical quality measure data no later than 
October 1 (for EPs) or July 1 (for eligible hospitals) of such 
preceding year.
    Using the same examples for the EHR reporting periods previously 
for an EP, the submission period for CY 2014 would be January 1, 2015 
through February 28, 2015. If the EP is in his or her first year of 
Stage 1, the submission period could begin at the earliest April 1, 
2014 and would end February 28, 2015. However, if the EP is 
demonstrating meaningful use for the first time in CY 2014, for 
purposes of avoiding the payment adjustment in CY 2015, the clinical 
quality measure data must be submitted by October 1, 2014.
    Using the same examples for the EHR reporting periods previously 
for an eligible hospital and CAH, the submission period for FY 2014 
would be October 1, 2014 through November 30, 2014. If the eligible 
hospital and CAH is in its first year of Stage 1, the submission period 
could begin at the earliest December 30, 2013 and would end November 
30, 2014. However, if an eligible hospital is demonstrating meaningful 
use for the first time in FY 2014, for purposes of avoiding the payment 
adjustment in FY 2015, the clinical quality measure data must be 
submitted by July 1, 2014.
2. Certification Requirements for Clinical Quality Measures
    The Office of the National Coordinator (ONC) sets the certification

[[Page 13743]]

criteria for EHR technology, which for clinical quality measures are 
described in 45 CFR 170.314(c) in ONC's proposed rule published 
elsewhere in this issue of the Federal Register. Certified EHR 
Technology will be required for the reporting methods finalized from 
this proposed rule. This may include attestation, reporting under the 
PQRS EHR reporting option, the group reporting options for EPs, the 
aggregate portal-based reporting methods, and the finalized reporting 
method for eligible hospitals and CAHs. Readers should refer to ONC's 
proposed rule for an explanation of the definition of Certified EHR 
Technology that would apply beginning with 2014.
    In addition, for attestation and the aggregate portal-based 
reporting methods for EPs, eligible hospitals and CAHs, Certified EHR 
Technology must be certified to ``incorporate and calculate'' in 
accordance with 45 CFR 170.314(c)(2) for each individual clinical 
quality measure that an EP, eligible hospital or CAH submits. EPs, 
eligible hospitals and CAHs must only submit clinical quality measures 
that their Certified EHR Technology is explicitly certified to 
calculate according to 45 CFR 170.314(c)(2) in ONC's proposed rule in 
order to meet the meaningful use requirement for reporting clinical 
quality measures. For example, if an EP's Certified EHR Technology is 
only certified to calculate clinical quality measures <greek-i>1 
through <greek-i>12, and the EP submits clinical quality measures 
<greek-i>1 through <greek-i>11 and <greek-i>37, the EP would not have 
met the meaningful use requirement for reporting clinical quality 
measures because his/her Certified EHR Technology was not certified to 
calculate clinical quality measure <greek-i>37.
    Likewise, for attestation and the aggregate portal-based reporting 
methods, Certified EHR Technology must be certified for ``reporting'' 
(please refer to the discussion of 45 CFR 170.314(c)(3) in ONC's 
proposed rule), which certifies the capability to create and transmit a 
standard aggregate XML-based file that can be electronically accepted 
by CMS.
3. Criteria for Selecting Clinical Quality Measures
    We are soliciting comment on a wide ranging list of 125 potential 
measures for EPs and 49 potential measures for eligible hospitals and 
CAHs. We expect to finalize only a subset of these proposed measures.
    We are committed to aligning quality measurement and reporting 
among our programs (for example, IQR, PQRS, CHIPRA, ACO programs). Our 
alignment efforts focus on several fronts including choosing the same 
measures for different program measure sets, standardizing measure 
development and specification processes across CMS programs, 
coordinating quality measurement stakeholder involvement efforts and 
opportunities for public input, and identifying ways to minimize 
multiple submission requirements and mechanisms. For example, we are 
working towards allowing CQM data submitted via certified EHRs by EPs 
and EHs/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 believe the 
alignment options for PQRS/EHR Incentive Program proposed in this rule 
are the first step towards such a vision. We are exploring how 
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 ACA measure sets, etc). 
This would lessen provider burden and harmonize with our data exchange 
priorities, while also supporting our goal of the programs transforming 
our system to provide higher quality care, better health outcomes, and 
lower cost through improvement.
    In addition to statutory requirements for EPs (section II.B.4.(a) 
of this proposed rule), eligible hospitals (section II.B.6.(a) of this 
proposed rule), and CAHs (section II.B.6.(a) of this proposed rule), we 
relied on the following criteria to select this initial list of 
proposed clinical quality measures for EPs, eligible hospitals, and 
CAHs:
    <bullet> 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.
    <bullet> Measures 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 Congress, ``National Strategy for Quality 
Improvement in Health Care'' (National Quality Strategy) (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). These include the following 6 
priorities:
    ++ Making care safer by reducing harm caused in the delivery of 
care.
    ++ Ensuring that each person and family are engaged as partners in 
their care.
    ++ Promoting effective communication and coordination of care.
    ++ Promoting the most effective prevention and treatment practices 
for the leading causes of mortality, starting with cardiovascular 
disease.
    ++ Working with communities to promote wide use of best practices 
to enable healthy living.
    ++ Making quality care more affordable for individuals, families, 
employers, and governments by developing and spreading new health care 
delivery models.
    <bullet> Measures 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.
    <bullet> Measures that address areas of care for different types of 
eligible professionals (for example, Medicare- and Medicaid-eligible 
physicians, and Medicaid-eligible nurse-practitioners, certified nurse-
midwives, dentists, physician assistants).
    In an effort to align the clinical quality measures used within the 
EHR Incentive Program with the goals of CMS and HHS, the National 
Quality Strategy, and the HITPC's recommendations, we have assessed all 
proposed measures against six domains based on the National Quality 
Strategy's six priorities, which were developed by the HITPC 
Workgroups, as follows:
    <bullet> Patient and Family Engagement. These are measures 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

[[Page 13744]]

families in decision making, self care, activation, and understanding 
of their health condition and its effective management.
    <bullet> Patient Safety. These are measures 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.
    <bullet> Care Coordination. These are measures 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.
    <bullet> Population and Public Health. These are measures 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.
    <bullet> Efficient Use of Healthcare Resources. These are measures 
that reflect efforts to significantly improve outcomes and reduce 
errors. These measures 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.
    <bullet> Clinical Processes/Effectiveness. These are measures that 
reflect clinical care processes closely linked to outcomes based on 
evidence and practice guidelines.
    We welcome comments on these domains, and whether they will 
adequately align with and support the breadth of CMS and HHS activities 
to improve quality of care and health outcomes.
    We also considered the recommendations of the Measure Applications 
Partnership (MAP) for inclusion of clinical quality measures. 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 clinical quality measures that the MAP did not 
support. The MAP did not review the clinical quality measures for 2011 
and 2012 that were previously adopted for the EHR Incentive Program in 
the Stage 1 final rule. We have included some of the clinical quality 
measures not supported by the MAP in Tables 8 (EPs) and 9 (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 included some measures to address 
specialty areas that may not have had applicable measures in the Stage 
1 final rule.
    We anticipate that only a subset of these measures will be 
finalized. When considering which measures to finalize, we will take 
into account public comment on the measures themselves and the 
priorities listed previously. We intend to prioritize measures that 
align with and support the measurement needs of CMS program activities 
related to quality of care, delivery system reform, and payment reform, 
especially:
    <bullet> Encouraging the use of outcome measures, which provide 
foundational data needed to assess the impact of these programs on 
population health.
    <bullet> 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.
    <bullet> Improving patient safety and reducing medical harm.
    <bullet> Capturing the full range of populations served by CMS 
programs.
4. Measure Specification
    We do not intend to use notice and comment rulemaking as a means to 
update or modify clinical quality measure specifications. A clinical 
quality measure that has completed the consensus process has a measure 
steward who has accepted responsibility for maintaining and updating 
the measure. In general, it is the role of the measure steward to make 
changes to a measure in terms of the initial patient population, 
numerator, denominator, and potential exclusions. We recognize that it 
may be necessary to update measure 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 measure, correcting faulty 
logic, adding or deleting codes as well as providing additional 
implementation guidance for a measure. These changes would be described 
in full through supplemental updates to the electronic specifications 
for EHR submission provided by CMS.
    The complete measure 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 
when considering the proposed clinical quality measures in this 
proposed rule, we would publish tables titled ``Proposed Clinical 
Quality Measures for 2014 CMS EHR Incentive Programs for Eligible 
Professionals'' and ``Proposed Clinical Quality Measures for 2014 CMS 
EHR Incentive Programs for Eligible Hospitals and CAHs'' on this Web 
site at or around the time of the publication of this proposed rule. 
These tables contain additional information for the EP, eligible 
hospital and CAH clinical quality measures, respectively, which may not 
be found on the NQF Web site. Some of these measures are still being 
developed, therefore the additional descriptions provided in these 
tables may still change before the final rule is published. Public 
comments regarding these measures should be submitted using the same 
method required for all other comments related to this proposed rule. 
Please note that the titles and descriptions for the clinical quality 
measures included in these tables were updated by the measure stewards 
and therefore may not match the information provided on the NQF Web 
site. Measures that do not have an NQF number are not currently 
endorsed.
    Measures would be tracked on a version basis as updates to those 
measures are made. We would require all EPs, eligible hospitals, and 
CAHs to submit the versions of the clinical quality measure as 
identified on our Web site, and they would need to include the version 
numbers when they report the measure. It is our intent to include the 
version numbers with our updates to the measure specifications.
    Under certain circumstances, we believe it may be necessary to 
remove a clinical quality measure from the EHR Incentive Program 
between rulemaking cycles. When there is reason to believe that the 
continued collection of a measure as it is currently specified raises 
potential patient safety concerns and/or is no longer scientifically 
valid, it would be appropriate for us to take immediate action to 
remove the measure from the EHR Incentive Program and not wait for the 
rulemaking cycle. Likewise, if a clinical quality measure undergoes a 
substantive change by the measure steward between rulemaking cycles 
such that the measure's intent has

[[Page 13745]]

changed, we would expect to remove the measure immediately from the EHR 
Incentive Program until the next rulemaking cycle when we could propose 
the revised measure for public comment. Under this policy, we would 
promptly remove such clinical quality measures from the set of measures 
available for providers to report under the EHR Incentive Program, 
confirm the removal (or propose the revised measure) in the next EHR 
Incentive Program rulemaking cycle, and notify providers (EPs, eligible 
hospitals, and CAHs) and the public of our decision to remove the 
measure(s) through the usual communication channels (memos, email 
notification, Web site postings).
5. Proposed Clinical Quality Measures for Eligible Professionals
(a) Statutory and Other Considerations
    Sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C) of the Act provide 
for the reporting of clinical quality measures by EPs as part of 
demonstrating meaningful use of Certified EHR Technology. 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 Certified EHR Technology under Medicare 
and Medicaid. Therefore, to meet this requirement, we continue our 
practice from Stage 1 of proposing clinical quality measures that would 
apply for both the Medicare and Medicaid EHR Incentive Programs, as 
listed in sections II.B.4.(b). and II.B.4.(c). of this proposed rule.
    Section 1848(o)(2)(B)(iii) of the Act requires that in selecting 
measures 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 Physician Quality Reporting System). 
Consistent with that requirement, we are proposing to select clinical 
quality measures for EPs for the EHR Incentive Programs that align with 
other existing quality programs such as the Physician Quality Reporting 
System (PQRS) (76 FR 73026), the Medicare Shared Savings Program (76 FR 
67802), measures used by the National Committee for Quality Assurance 
(NCQA) for medical home accreditation (http://ncqa.org), the Health 
Resources and Services Administration's (HRSA) Uniform Data System 
(UDS) (75 FR 73170), Children's Health Insurance Program 
Reauthorization Act (CHIPRA) (75 FR 44314), and the final Section 2701 
adult measures under the Affordable Care Act (ACA) published in the 
Federal Register on January 4, 2012 (77 FR 286). When a measure is 
included in more than one CMS quality reporting program and is reported 
using Certified EHR Technology, we would seek to avoid requiring EPs to 
report the same clinical quality measure 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 clinical quality measures endorsed by the entity 
with a contract with the Secretary under section 1890(a) (namely, the 
National Quality Forum (NQF)). We are proposing clinical quality 
measures for EPs 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 NQF endorsed measures for the EHR 
Incentive Programs. Measures listed in this proposed rule that do not 
have an NQF identifying number are not NQF endorsed, but are included 
in this proposed rule with the intent of eventually obtaining NQF 
endorsement of those measures determined to be critical to our program.
    Per the preamble discussion in the Stage 1 final rule regarding 
measures gaps and Medicaid providers (75 FR 44506), we are proposing to 
increase the total number of clinical quality measures for EPs in order 
to cover areas noted by commenters such as behavioral health, dental 
care, long-term care, special needs populations, and care coordination. 
The new measures we are proposing beginning with CY 2014 include new 
pediatric measures, an obstetric measure, behavioral/mental health 
measures, and measures related to HIV medical visits and antiretroviral 
therapy, as well as other measures that address National Quality 
Strategy goals.
    We recognize that we do not have additional measures to propose 
beginning with CY 2014 in the areas of long-term and post-acute care. 
Since the publication of the Stage 1 final rule, we have partnered with 
the National Governor's Association to participate in a panel with 
long-term care and health information exchange experts to gain insight 
and consensus on possible clinical quality measures. At this time, 
however, no clinical quality measures for long-term and post-acute care 
have been identified as being ready (electronically specified) 
beginning with CY 2014. We expect to continue to develop or identify 
clinical quality measures for these areas with our partners and 
stakeholders for future years.
    We are pleased to propose two oral health measures beginning with 
CY 2014. In the past year, we partnered with Agency for Healthcare 
Research and Quality (AHRQ) to solicit input from a technical expert 
panel to identify barriers to the adoption and use of health IT for 
oral health care providers. A final report titled ``Quality Oral Health 
Care in Medicaid Through Health IT'' is available at http://healthit.ahrq.gov/portal/server.pt/community/ahrq-fundedprojects/654/medicaid-schip/14760. CMS, the American Dental Association, and the 
Dental Quality Alliance have all strategized ways to encourage and 
support the use of EHRs for oral health providers. We expect to 
continue to develop or identify clinical quality measures for dental/
oral health care with our partners and stakeholders that could be ready 
for future years.
(b) Proposed Clinical Quality Measures for Eligible Professionals for 
CY 2013
    We propose that for the EHR reporting periods in CY 2013, EPs must 
submit data for the clinical quality measures that were finalized in 
the Stage 1 final rule for CYs 2011 and 2012 (75 FR 44398 through 
44411, Tables 6 and 7). Updates to these clinical quality measures' 
electronic specifications are expected to be posted on the EHR 
Incentive Program Web site at least 6 months prior to the start of CY 
2013 (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp). As required by the Stage 1 final rule, 
EPs must report on three core or alternate core measures, plus three 
additional measures. We refer readers to the discussion in the Stage 1 
final rule for further explanation of the requirements for reporting 
those clinical quality measures (75 FR 44398 through 44411). The 
proposed reporting methods for EPs for CY 2013 are discussed in 
sections II.B.5.(a). and II.B.5.(b). of this proposed rule.
(c) Proposed Clinical Quality Measures for Eligible Professionals 
Beginning With CY 2014
    We are proposing two reporting options that would begin in CY 2014 
for Medicare and Medicaid EPs, as described below: Options 1 and 2. For 
Options 1, we are proposing the following two alternatives, but intend 
to finalize only a single method:

[[Page 13746]]

    <bullet> Option 1a: EPs would report 12 clinical quality measures 
from those listed in Table 8, including at least 1 measure from each of 
the 6 domains.
    <bullet> Option 1b: EPs would report 11 ``core'' clinical quality 
measures listed in Table 6 plus 1 ``menu'' clinical quality measure 
from Table 8.
    We welcome comment regarding the advantages and disadvantages of 
Options 1a and 1b, including EP preference, the appropriateness of the 
domains, the number of clinical quality measures required, and the 
appropriate split between ``core'' and ``menu'' clinical quality 
measures. It is our intent to finalize the most operationally viable 
and appropriate option or combination of options in our final rule. As 
an alternative to Options 1a or 1b, Medicare EPs who participate in 
both the Physician Quality Reporting System and the EHR Incentive 
Program may choose Option 2, as described below (the Physician Quality 
Reporting System EHR Reporting Option).
    We are proposing clinical quality measures in Table 8 that would 
apply to all EPs for the EHR reporting periods in CYs 2014 and 2015 
(and potentially subsequent years), regardless of whether an EP is in 
Stage 1 or Stage 2 of meaningful use. For Medicaid EPs, the reporting 
method for clinical quality measures may vary by State. However, the 
set of clinical quality measures from which to select (Table 8) would 
be the same for both Medicaid EPs and Medicare EPs. Medicare EPs who 
are in their first year of Stage 1 of meaningful use may report 
clinical quality measures through attestation during the 2 months 
immediately following the end of the 90-day EHR reporting period as 
described in section II.B.1. of this proposed rule. Readers should 
refer to the discussion in the Stage 1 final rule for more information 
about reporting clinical quality measures through attestation (75 FR 
44430 through 44431). We expect that by CY 2016, we will have engaged 
in another round of rulemaking for the EHR Incentive Programs. However, 
in the unlikely event such rulemaking does not occur, the clinical 
quality measures proposed for CYs 2014 and 2015 would continue to apply 
for the EHR reporting periods in CY 2016 and subsequent years. 
Therefore, we refer to clinical quality measures that apply ``beginning 
with'' or ``beginning in'' CY 2014.
    <bullet> Option 1a: Select and submit 12 clinical quality measures 
from Table 8, including at least 1 measure from each of the 6 domains.
    We are proposing that EPs must report 12 clinical quality measures 
from those listed in Table 8, which must include at least one measure 
from each of the following 6 domains, which are described in section 
II.B.3. of this proposed rule:
    <bullet> Patient and Family Engagement.
    <bullet> Patient Safety.
    <bullet> Care Coordination.
    <bullet> Population and Public Health.
    <bullet> Efficient Use of Healthcare Resources.
    <bullet> Clinical Process/Effectiveness.
    EPs would select the clinical quality measures that best apply to 
their scope of practice and/or unique patient population. If an EP's 
Certified EHR Technology does not contain patient data for at least 12 
clinical quality measures, then the EP must report the clinical quality 
measures for which there is patient data and report the remaining 
required clinical quality measures as ``zero denominators'' as 
displayed by the EPs Certified EHR Technology. If there are no clinical 
quality measures applicable to the EP's scope of practice or unique 
patient populations, EPs must still report 12 clinical quality measures 
even if zero is the result in either the numerator and/or the 
denominator of the measure. If all applicable clinical quality measures 
have a value of zero from their Certified EHR Technology, then EPs must 
report any 12 of the clinical quality measures. For this option, the 
clinical quality measures data would be submitted in an XML-based 
format on an aggregate basis reflective of all patients without regard 
to payer. One advantage of this approach is that EPs can choose 
measures that best fit their practice and patient populations. However, 
because of the large number of measures to choose from, this approach 
would result in fewer EPs reporting on any given measure, and likely 
only a small sample of patient data represented in each measure.
    <bullet> Option 1b: Submit 12 clinical quality measures composed of 
all 11 of the core clinical quality measures in Table 6 plus 1 menu 
clinical quality measure from Table 8.
    We are considering a ``core'' clinical quality measure set that all 
EPs must report, which will reflect the national priorities outlined in 
section II.B.3. of this proposed rule. In addition to the core clinical 
quality measure set, we are considering a ``menu'' set from which EPs 
would select 1 clinical quality measure to report based on their 
respective scope of practice and/or unique patient population. One 
advantage of this approach is that quality data would be collected on a 
smaller set of measures, so the resulting data for each measure would 
represent a larger number of patients and therefore could be more 
accurate. However, this approach could mean that more measures are 
reported with zero denominators (if they are not applicable to certain 
practices or populations), making the data less comprehensive. The menu 
set would consist of the measures in Table 8 that are not part of the 
core clinical quality measure set. The core clinical quality measure 
set for EPs consists of the following measures in Table 6 (these 
clinical quality measures are also in Table 8):

  Table 6--Potential Core Clinical Quality Measure Set To Be Reported by Eligible Professionals Beginning in CY
                                                      2014
----------------------------------------------------------------------------------------------------------------
                                                                     Clinical quality
          Measure  Number              Clinical quality measure      measure steward &            Domain
                                         title & description        contact information
----------------------------------------------------------------------------------------------------------------
TBD................................  Title: Closing the referral  Centers for Medicare    Care Coordination.
                                      loop: receipt of             and Medicaid Services
                                      specialist report            (CMS).
                                      Description: Percentage of  1-888-734-6433 or
                                      patients regardless of age   http://
                                      with a referral from a       questions.cms.hhs.gov/
                                      primary care provider for    app/ask/p/21,26,1139;
                                      whom a report from the       Quality Insights of
                                      provider to whom the         Pennsylvania (QIP)
                                      patient was referred was     Contact Information:
                                      received by the referring    www.usqualitymeasures
                                      provider.                    .org.

[[Page 13747]]

 
TBD................................  Title: Functional status     CMS 1-888-734-6433 or   Patient and Family
                                      assessment for complex       http://                 Engagement.
                                      chronic conditions;          questions.cms.hhs.gov/
                                      Description: Percentage of   app/ask/p/21,26,1139.
                                      patients aged 65 years and
                                      older with heart failure
                                      and two or more high
                                      impact conditions who
                                      completed initial and
                                      follow-up (patient-
                                      reported) functional
                                      status assessments.
NQF 0018...........................  Title: Controlling High      NCQA Contact            Clinical Process/
                                      Blood Pressure;              Information:            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
                                      during the measurement
                                      year.
NQF 0097...........................  Title: Medication            AMA-PCPI Contact        Patient Safety.
                                      Reconciliation;              Information: cpe@ama-
                                      Description: Percentage of   assn.org; National
                                      patients aged 65 years and   Committee for Quality
                                      older discharged from any    Assurance (NCQA)
                                      inpatient facility (e.g.     Contact information:
                                      hospital, skilled nursing    www.ncqa.org.
                                      facility, or
                                      rehabilitation facility)
                                      and seen within 60 days
                                      following discharge in the
                                      office by the physician
                                      providing on-going care
                                      who had a reconciliation
                                      of the discharge
                                      medications with the
                                      current medication list in
                                      the medical record
                                      documented.
NQF 0418...........................  Title: Screening for         CMS 1-888-734-6433 or   Population/Public
                                      Clinical Depression;         http://                 Health.
                                      Description: Percentage of   questions.cms.hhs.gov/
                                      patients aged 12 years and   app/ask/p/21,26,1139.
                                      older screened for
                                      clinical depression using
                                      an age appropriate
                                      standardized tool and
                                      follow up plan documented.
NQF 0028...........................  Title: Preventive Care and   AMA-PCPI Contact        Population/Public
                                      Screening: Tobacco Use:      Information: cpe@ama-   Health.
                                      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.
TBD................................  Title: Preventive Care and   CMS 1-888-734-6433 or   Clinical Process/
                                      Screening: Cholesterol--     http://                 Effectiveness.
                                      Fasting Low Density          questions.cms.hhs.gov/
                                      Lipoprotein (LDL) Test       app/ask/p/21,26,1139;
                                      Performed AND Risk-          QIP Contact
                                      Stratified Fasting LDL;      Information:
                                      Description: Percentage of   www.usqualitymeasures
                                      patients aged 20 through     .org.
                                      79 years whose risk
                                      factors * have been
                                      assessed and a fasting LDL
                                      test has been performed.
                                      Percentage of patients
                                      aged 20 through 79 years
                                      who had a fasting LDL test
                                      performed and whose risk-
                                      stratified* fasting LDL is
                                      at or below the
                                      recommended LDL goal.
NQF 0068...........................  Title: Ischemic Vascular     NCQA Contact            Clinical Process/
                                      Disease (IVD): Use of        Information:            Effectiveness.
                                      Aspirin or Another           www.ncqa.org.
                                      Antithrombotic;
                                      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 transluminal
                                      coronary angioplasty
                                      (PTCA) from January 1-
                                      November 1 of the year
                                      prior to the measurement
                                      year, or who had a
                                      diagnosis of ischemic
                                      vascular disease (IVD)
                                      during the measurement
                                      year and the year prior to
                                      the measurement year and
                                      who had documentation of
                                      use of aspirin or another
                                      antithrombotic during the
                                      measurement year.
NQF 0024...........................  Title: Weight Assessment     NCQA Contact            Population/Public
                                      and Counseling for           information:            Health.
                                      Nutrition and Physical       www.ncqa.org.
                                      Activity for Children and
                                      Adolescents; Description:
                                      Percentage of patients 3-
                                      17 years of age who had an
                                      outpatient visit with a
                                      Primary Care Physician
                                      (PCP) or OB/GYN and who
                                      had evidence of body mass
                                      index (BMI) percentile
                                      documentation, counseling
                                      for nutrition and
                                      counseling for physical
                                      activity during the
                                      measurement year.
NQF 0022...........................  Title: Use of High-Risk      NCQA Contact            Patient Safety.
                                      Medications in the           Information:
                                      Elderly; Description:        www.ncqa.org.
                                      Percentage of patients
                                      ages 65 years and older
                                      who received at least one
                                      high-risk medication.
                                      Percentage of patients 65
                                      years of age and older who
                                      received at least two
                                      different high-risk
                                      medications.
TBD................................  Title: Adverse Drug Event    CMS 1-888-734-6433 or   Patient Safety.
                                      (ADE) Prevention:            http://
                                      Outpatient therapeutic       questions.cms.hhs.gov/
                                      drug monitoring;             app/ask/p/21,26,1139.
                                      Description: Percentage of
                                      patients 18 years of age
                                      and older receiving
                                      outpatient chronic
                                      medication therapy who had
                                      the appropriate
                                      therapeutic drug
                                      monitoring during the
                                      measurement year.
----------------------------------------------------------------------------------------------------------------

    We selected these measures for the proposed core set based upon 
analysis of several factors that include: conditions that contribute 
the most to Medicare and Medicaid beneficiaries' morbidity and 
mortality; conditions that represent national public/population health 
priorities; conditions that are common to health disparities; those 
conditions that disproportionately drive healthcare costs that could 
improve with better quality measurement; measures that would enable 
CMS, States, and the provider community to measure quality of care in 
new dimensions with a stronger focus on parsimonious measurement; and 
those measures that include patient and/or caregiver engagement.
    We request public comment on the core and menu set reporting schema

[[Page 13748]]

described as well as the number and appropriateness of the core set 
listed in Table 6. We are considering that all identified core clinical 
quality measures must be reported by all EPs in addition to a menu set 
clinical quality measure. The policy on reporting ``zeros'' discussed 
previously under Option 1a would also apply for this core and menu 
option. In this option, an EP who does not report all of the identified 
core clinical quality measures, plus a menu set clinical quality 
measure, would have not met the requirements for submitting the 
clinical quality measures.
    <bullet> Option 2: Submit and satisfactorily report clinical 
quality measures under the Physician Quality Reporting System's EHR 
Reporting Option.
    We propose an alternative option for Medicare EPs who participate 
in both the Physician Quality Reporting System and the EHR Incentive 
Program. As an alternative to reporting the 12 clinical quality 
measures as described under Options 1a and 1b, and in order to 
streamline quality reporting options for participating providers, 
Medicare EPs who submit and satisfactorily report Physician Quality 
Reporting System clinical quality measures under the Physician Quality 
Reporting System's EHR reporting option using Certified EHR Technology 
would satisfy their clinical quality measures reporting requirement 
under the Medicare EHR Incentive Program. For more information about 
the requirements of the Physician Quality Reporting System, we refer 
readers to 42 CFR 414.90 and the CY 2012 Medicare Physician Fee 
Schedule final rule with comment period (76 FR 73314). EPs who choose 
this option to satisfy their clinical quality measures reporting 
obligation under the Medicare EHR Incentive Program would be required 
to comply with any changes to the requirements of the Physician Quality 
Reporting System that may apply in future years.
    Table 7 lists the clinical quality measures that were finalized in 
the Stage 1 final rule (75 FR 44398 through 44408) that we are 
proposing to eliminate beginning with CY 2014.

  Table 7--Clinical Quality Measures Included in the Stage 1 Final Rule
         That Are Proposed To Be Eliminated Beginning in CY 2014
------------------------------------------------------------------------
                                                        Clinical quality
                                   Clinical quality          measure
          Measure No.               measure title &       developer * &
                                      description            contact
                                                           information
------------------------------------------------------------------------
NQF<greek-i> 0013.............  Title: Hypertension:    AMA-PCPI Contact
                                 Blood Pressure          Information:
                                 Management;             cpe@ama-
                                 Description:            assn.org.
                                 Percentage of patient
                                 visits aged 18 years
                                 and older with a
                                 diagnosis of
                                 hypertension who have
                                 been seen for at
                                 least 2 office
                                 visits, with blood
                                 pressure (BP)
                                 recorded.
NQF<greek-i> 0027.............  Title: Smoking and      NCQA Contact
                                 Tobacco Use             Information:
                                 Cessation, Medical      www.ncqa.org.
                                 Assistance: a.
                                 Advising Smokers and
                                 Tobacco Users to
                                 Quit, b. Discussing
                                 Smoking and Tobacco
                                 Use Cessation
                                 Strategies.
NQF<greek-i> 0084.............  Title: Heart Failure    AMA-PCPI Contact
                                 (HF): Warfarin          Information:
                                 Therapy Patients with   cpe@ama-
                                 Atrial Fibrillation;    assn.org.
                                 Description:
                                 Percentage of all
                                 patients aged 18
                                 years and older with
                                 a diagnosis of heart
                                 failure and
                                 paroxysmal or chronic
                                 atrial fibrillation
                                 who were prescribed
                                 warfarin therapy.
------------------------------------------------------------------------
*AMA-PCPI = American Medical Association-Physician Consortium for
  Performance Improvement.
NCQA = National Committee for Quality Assurance.

    Based in part on the feedback received throughout Stage 1, we 
propose to eliminate these three clinical quality measures beginning 
with CY 2014 for EPs at all Stages for the following reasons:
    <bullet> NQF <greek-i> 0013--The measure steward did not submit 
this measure to the National Quality Forum for continued endorsement. 
We have included other measures that address high blood pressure and 
hypertension in Table 8.
    <bullet> NQF <greek-i>0027--We determined this measure is very 
similar to NQF <greek-i>0028 a and b; therefore, to avoid duplication 
of measures, we propose to only retain NQF <greek-i> 0028 a and b.
    <bullet> NQF <greek-i>0084--The measure steward did not submit this 
measure to the National Quality Forum for continued endorsement. 
Additionally, CMS has decided to remove this measure because there are 
other FDA-approved anticoagulant therapies available in addition to 
Warfarin. We are proposing to replace this measure, pending 
availability of electronic specifications, with NQF <greek-i>1525--
Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation 
Therapy.
    Table 8 lists all of the clinical quality measures that we are 
considering for EPs to report for the EHR Incentive Programs beginning 
with CY 2014. However, we expect to finalize only a subset of these 
proposed measures based on public comment and the priorities listed in 
section II.B.3. of this proposed rule. The measures 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. Measures 
which are designated as ``New'' in the ``New Measures'' column were not 
finalized in the Stage 1 final rule. Please note that measures which 
are listed as also being part of the ``ACO'' program in the ``Other 
Quality Programs that Use the Same Measure'' column of Table 8 are 
Medicare Shared Savings Program measures. Some of the clinical quality 
measures in Table 8 will require the development of electronic 
specifications. Therefore, we propose to consider these measures for 
inclusion beginning with CY 2014 based on our expectation that their 
electronic specifications will be available at the time of or within a 
reasonable period after the publication of the final rule.
    Additionally, some of these measures have not yet been submitted 
for consensus endorsement consideration or are currently under review 
for endorsement consideration by the National Quality Forum. We expect 
that any measure proposed in Table 8 for inclusion beginning with CY 
2014 will be submitted for endorsement consideration by the measure 
steward. The finalized list of measures that would apply for EPs 
beginning with CY 2014 will be published in the final rule. Because 
measure specifications may need to be updated more frequently than our 
expected rulemaking cycle would allow for, 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 expect 
to update specifications annually. All clinical quality measure 
specification updates, including a schedule for updates to electronic 
specifications,

[[Page 13749]]

would be posted on the EHR Incentive Program Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp), and we 
would notify the public of the posting.

                   TABLE 8--Clinical Quality Measures Proposed for Medicare and Medicaid Eligible Professionals Beginning With Cy 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Clinical quality    Other quality measure
            Measure No.              Clinical quality measure     measure steward &    programs that use the       New measure             Domain
                                        title & description      contact information       same measure**
--------------------------------------------------------------------------------------------------------------------------------------------------------
NQF 0001..........................  Title: Asthma: Assessment   American Medical       EHR PQRS.............  ....................  Clinical Process/
                                     of Asthma Control.          Association-                                                        Effectiveness.
                                    Description: Percentage of   Physician Consortium
                                     patients aged 5 through     for Performance
                                     50 years with a diagnosis   Improvement (AMA-
                                     of asthma who were          PCPI).
                                     evaluated at least once    Contact Information:
                                     for asthma control          <a href="/cdn-cgi/l/email-protection#85e6f5e0c5e4e8e4a8b9e4a5edf7e0e3b8" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     (comprising asthma
                                     impairment and asthma
                                     risk).
NQF 0002..........................  Title: Appropriate Testing  National Committee     EHR PQRS, CHIPRA.....  ....................  Efficient Use of
                                     for Children with           for Quality                                                         Healthcare
                                     Pharyngitis.                Assurance (NCQA).                                                   Resources.
                                    Description: Percentage of  Contact Information:
                                     children 2-18 years of      www.ncqa.org..
                                     age who were diagnosed
                                     with pharyngitis,
                                     dispensed an antibiotic
                                     and received a group A
                                     streptococcus (strep)
                                     test for the episode.
NQF 0004..........................  Title: Initiation and       NCQA.................  EHR PQRS, HEDIS,       ....................  Clinical Process/
                                     Engagement of Alcohol and  Contact Information:    State use, ACA 2701,                         Effectiveness.
                                     Other Drug Dependence       www.ncqa.org..         NCQA-PCMH
                                     Treatment: (a)                                     Accreditation.
                                     Initiation, (b)
                                     Engagement.
                                    Description: The
                                     percentage of adolescent
                                     and adult patients with a
                                     new episode of alcohol
                                     and other drug (AOD)
                                     dependence who initiate
                                     treatment through an
                                     inpatient AOD admission,
                                     outpatient visit,
                                     intensive outpatient
                                     encounter or partial
                                     hospitalization within 14
                                     days of the diagnosis and
                                     who initiated treatment
                                     and who had two or more
                                     additional services with
                                     an AOD diagnosis within
                                     30 days of the initiation
                                     visit.
NQF 0012..........................  Title: Prenatal Care:       AMA-PCPI.............  EHR PQRS.............  ....................  Population/Public
                                     Screening for Human        Contact Information:                                                 Health.
                                     Immunodeficiency Virus      <a href="/cdn-cgi/l/email-protection#9ffceffadffef2feb2a3febff7edfaf9a2" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     (HIV).
                                    Description: Percentage of
                                     patients, regardless of
                                     age, who gave birth
                                     during a 12-month period
                                     who were screened for HIV
                                     infection during the
                                     first or second prenatal
                                     care visit.
NQF 0014..........................  Title: Prenatal Care: Anti- AMA-PCPI.............  EHR PQRS, NCQA-PCMH    ....................  Patient Safety.
                                     D Immune Globulin.         Contact Information:    Accreditation.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#ea899a8faa8b878bc7d68bca82988f8cd7" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     D (Rh) negative,
                                     unsensitized patients,
                                     regardless of age, who
                                     gave birth during a 12-
                                     month period who received
                                     anti-D immune globulin at
                                     26-30 weeks gestation.
NQF 0018..........................  Title: Controlling High     NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Blood Pressure.            Contact 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
                                     during the measurement
                                     year.
NQF 0022..........................  Title: Use of High-Risk     NCQA.................  PQRS.................  New.................  Patient Safety.
                                     Medications in the         Contact Information:
                                     Elderly.                    www.ncqa.org..
                                    Description: Percentage of
                                     patients ages 65 years
                                     and older who received at
                                     least one high-risk
                                     medication. Percentage of
                                     patients 65 years of age
                                     and older who received at
                                     least two different high-
                                     risk medications.
NQF 0024..........................  Title: Weight Assessment    NCQA.................  EHR PQRS, UDS........  ....................  Population/Public
                                     and Counseling for         Contact Information:                                                 Health.
                                     Nutrition and Physical      www.ncqa.org..
                                     Activity for Children and
                                     Adolescents.
                                    Description: Percentage of
                                     patients 3-17 years of
                                     age who had an outpatient
                                     visit with a Primary Care
                                     Physician (PCP) or OB/GYN
                                     and who had evidence of
                                     body mass index (BMI)
                                     percentile documentation,
                                     counseling for nutrition
                                     and counseling for
                                     physical activity during
                                     the measurement year.
NQF 0028..........................  Title: Preventive Care and  AMA-PCPI.............  EHR PQRS, ACO, Group   ....................  Population/Public
                                     Screening: Tobacco Use:    Contact Information:    Reporting PQRS, UDS.                         Health.
                                     Screening and Cessation     <a href="/cdn-cgi/l/email-protection#3655465376575b571b0a57165e4453500b" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     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        NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Screening.                 Contact Information:    Reporting PQRS, ACA                          Effectiveness.
                                    Description: Percentage of   www.ncqa.org..         2701, HEDIS, State
                                     women 40-69 years of age                           use, NCQA-PCMH
                                     who had a mammogram to                             Accreditation.
                                     screen for breast cancer.
NQF 0032..........................  Title: Cervical Cancer      NCQA.................  EHR PQRS, ACA 2701,    ....................  Clinical Process/
                                     Screening.                 Contact Information:    HEDIS, State use,                            Effectiveness.
                                    Description: Percentage of   www.ncqa.org..         NCQA-PCMH
                                     women 21-64 years of age,                          Accreditation, UDS.
                                     who received one or more
                                     Pap tests to screen for
                                     cervical cancer.
NQF 0033..........................  Title: Chlamydia Screening  NCQA.................  EHR PQRS, CHIPRA, ACA  ....................  Population/Public
                                     in Women.                  Contact Information:    2701, HEDIS, State                           Health.
                                    Description: Percentage of   www.ncqa.org..         use, NCQA-PCMH
                                     women 16-24 years of age                           Accreditation.
                                     who were identified as
                                     sexually active and who
                                     had at least one test for
                                     Chlamydia during the
                                     measurement year.
NQF 0034..........................  Title: Colorectal Cancer    NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Screening.                 Contact Information:    Reporting PQRS, NCQA-                        Effectiveness.
                                    Description: Percentage of   www.ncqa.org..         PCMH Accreditation.
                                     adults 50-75 years of age
                                     who had appropriate
                                     screening for colorectal
                                     cancer.
NQF 0036..........................  Title: Use of Appropriate   NCQA.................  EHR PQRS.............  ....................  Clinical Process/
                                     Medications for Asthma.    Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   www.ncqa.org..
                                     patients 5-50 years of
                                     age who were identified
                                     as having persistent
                                     asthma and were
                                     appropriately prescribed
                                     medication during the
                                     measurement year. Report
                                     three age stratifications
                                     (5-11 years, 12-50 years,
                                     and total).
NQF 0038..........................  Title: Childhood            NCQA.................  EHR PQRS, UDS........  ....................  Population/Public
                                     Immunization Status.       Contact 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);
                                     two H influenza type B
                                     (HiB); three hepatitis B
                                     (Hep B); one chicken pox
                                     (VZV); four pneumococcal
                                     conjugate (PCV); two
                                     hepatitis A (Hep A); two
                                     or three rotavirus (RV);
                                     and two influenza (flu)
                                     vaccines by their second
                                     birthday. The measure
                                     calculates a rate for
                                     each vaccine and nine
                                     separate combination
                                     rates.
NQF 0041..........................  Title: Preventative Care    AMA-PCPI.............  EHR PQRS, ACO, Group   ....................  Population/Public
                                     and Screening: Influenza   Contact Information:    Reporting PQRS.                              Health.
                                     Immunization.               <a href="/cdn-cgi/l/email-protection#0261726742636f632f3e63226a7067643f" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    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.

[[Page 13750]]

 
NQF 0043..........................  Title: Pneumonia            NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Vaccination Status for     Contact Information:    Reporting PQRS, NCQA-                        Effectiveness.
                                     Older Adults.               www.ncqa.org..         PCMH Accreditation.
                                    Description: Percentage of
                                     patients 65 years of age
                                     and older who have ever
                                     received a pneumococcal
                                     vaccine.
NQF 0045..........................  Title: Osteoporosis:        NCQA.................  PQRS, NCQA-PCMH        New.................  Care Coordination.
                                     Communication with the     Contact Information:    Accreditation.
                                     Physician Managing          www.ncqa.org..
                                     Ongoing Care Post-
                                     Fracture.
                                    Description: Percentage of
                                     patients aged 50 years
                                     and older treated for a
                                     hip, spine, or distal
                                     radial fracture with
                                     documentation of
                                     communication with the
                                     physician managing the
                                     patient's on-going care
                                     that a fracture occurred
                                     and that the patient was
                                     or should be tested or
                                     treated for osteoporosis.
NQF 0046..........................  Title: Osteoporosis:        NCQA.................  PQRS, NCQA-PCMH        New.................  Clinical Process/
                                     Screening or Therapy for   Contact Information:    Accreditation.                               Effectiveness.
                                     Osteoporosis for Women      www.ncqa.org..
                                     Aged 65 Years and Older.
                                    Description: Percentage of
                                     female patients aged 65
                                     years and older who have
                                     a central dual-energy X-
                                     ray absorptiometry
                                     measurement ordered or
                                     performed at least once
                                     since age 60 or
                                     pharmacologic therapy
                                     prescribed within 12
                                     months.
NQF 0047..........................  Title: Asthma               AMA-PCPI.............  EHR PQRS, UDS........  ....................  Clinical Process/
                                     Pharmacologic Therapy for  Contact Information:                                                 Effectiveness.
                                     Persistent Asthma.          <a href="/cdn-cgi/l/email-protection#5f3c2f3a1f3e323e72633e7f372d3a3962" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 5 through
                                     50 years with a diagnosis
                                     of persistent asthma and
                                     at least one medical
                                     encounter for asthma
                                     during the measurement
                                     year who were prescribed
                                     long-term control
                                     medication.
NQF 0048..........................  Title: Osteoporosis:        NCQA.................  PQRS.................  New.................  Clinical Process/
                                     Management Following       Contact Information:                                                 Effectiveness.
                                     Fracture of Hip, Spine or   www.ncqa.org..
                                     Distal radius for Men and
                                     Women Aged 50 Years and
                                     Older.
                                    Description: Percentage of
                                     patients aged 50 years or
                                     older with fracture of
                                     the hip, spine or distal
                                     radius that had a central
                                     dual-energy X-ray
                                     absorptiometry
                                     measurement ordered or
                                     performed or
                                     pharmacologic therapy
                                     prescribed.
NQF 0050..........................  Title: Osteoarthritis       AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     (OA): Function and Pain    Contact Information:                                                 Engagement.
                                     Assessment.                 <a href="/cdn-cgi/l/email-protection#3457445174555955190855145c46515209" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patient visits for
                                     patients aged 21 years
                                     and older with a
                                     diagnosis of OA with
                                     assessment for function
                                     and pain.
NQF 0051..........................  Title: Osteoarthritis       AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     (OA): assessment for use   Contact Information:                                                 Effectiveness.
                                     of anti-inflammatory or     <a href="/cdn-cgi/l/email-protection#7c1f0c193c1d111d51401d5c140e191a41" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     analgesic over-the-
                                     counter (OTC) medications.
                                    Description: Percentage of
                                     patient visits for
                                     patients aged 21 years
                                     and older with a
                                     diagnosis of OA with an
                                     assessment for use of
                                     anti-inflammatory or
                                     analgesic OTC medications.
NQF 0052..........................  Title: Use of Imaging       NCQA.................  EHR PQRS.............  ....................  Efficient Use of
                                     Studies for Low Back Pain. Contact Information:                                                 Healthcare
                                    Description: Percentage of   www.ncqa.org..                                                      Resources.
                                     patients with a primary
                                     diagnosis of low back
                                     pain who did not have an
                                     imaging study (plain x-
                                     ray, MRI, CT scan) within
                                     28 days of diagnosis.
NQF 0055..........................  Title: Diabetes: Eye Exam.  NCQA.................  EHR PQRS, Group        ....................  Clinical Process/
                                    Description: Percentage of  Contact Information:    Reporting PQRS.                              Effectiveness.
                                     patients 18-75 years of     www.ncqa.org..
                                     age with diabetes (type 1
                                     or type 2) who had a
                                     retinal or dilated eye
                                     exam or a negative
                                     retinal exam (no evidence
                                     of retinopathy) by an eye
                                     care professional.
NQF 0056..........................  Title: Diabetes: Foot Exam  NCQA.................  EHR PQRS, Group        ....................  Clinical Process/
                                    Description: The            Contact Information:    Reporting PQRS.                              Effectiveness.
                                     percentage of patients      www.ncqa.org..
                                     aged 18-75 years with
                                     diabetes (type 1 or type
                                     2) who had a foot exam
                                     (visual inspection,
                                     sensory exam with
                                     monofilament, or pulse
                                     exam).
NQF 0058..........................  Title: Avoidance of         NCQA.................  PQRS.................  New.................  Efficient Use of
                                     Antibiotic Treatment in    Contact Information:                                                 Healthcare
                                     Adults with Acute           www.ncqa.org..                                                      Resources.
                                     Bronchitis.
                                    Description: Percentage of
                                     adults ages 18 through 64
                                     years with a diagnosis of
                                     acute bronchitis who were
                                     not dispensed an
                                     antibiotic prescription
                                     on or within 3 days of
                                     the initial date of
                                     service.
NQF 0059..........................  Title: Diabetes:            NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Hemoglobin A1c Poor        Contact Information:    Reporting PQRS, UDS.                         Effectiveness.
                                     Control.                    www.ncqa.org..
                                    Description: Percentage of
                                     patients 18-75 years of
                                     age with diabetes (type 1
                                     or type 2) who had
                                     hemoglobin A1c >9.0%.
NQF 0060..........................  Title: Hemoglobin A1c Test  NCQA.................  .....................  New.................  Clinical Process/
                                     for Pediatric Patients.    Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   www.ncqa.org..
                                     pediatric patients with
                                     diabetes with an HbA1c
                                     test in a 12-month
                                     measurement period.
NQF 0061..........................  Title: Diabetes: Blood      NCQA.................  EHR PQRS, Group        ....................  Clinical Process/
                                     Pressure Management.       Contact Information:    Reporting PQRS.                              Effectiveness.
                                    Description: Percentage of   www.ncqa.org..
                                     patients 18-75 years of
                                     age with diabetes (type 1
                                     or type 2) who had blood
                                     pressure <140/90 mmHg.
NQF 0062..........................  Title: Diabetes: Urine      NCQA.................  EHR PQRS, Group        ....................  Clinical Process/
                                     Screening.                 Contact Information:    Reporting PQRS.                              Effectiveness.
                                    Description: Percentage of   www.ncqa.org..
                                     patients 18-75 years of
                                     age with diabetes (type 1
                                     or type 2) who had a
                                     nephropathy screening
                                     test or evidence of
                                     nephropathy.
NQF 0064..........................  Title: Diabetes: Low        NCQA.................  PQRS, Group Reporting  ....................  Clinical Process/
                                     Density Lipoprotein (LDL)  Contact Information:    PQRS.                                        Effectiveness.
                                     Management and Control.     www.ncqa.org..
                                    Description: Percentage of
                                     patients 18-75 years of
                                     age with diabetes (type 1
                                     or type 2) who had LDL-C
                                     <100 mg/dL.
NQF 0066..........................  Title: Coronary Artery      AMA-PCPI.............  ACO, Group Reporting   New.................  Clinical Process/
                                     Disease (CAD):             Contact Information:    PQRS.                                        Effectiveness.
                                     Angiotensin-converting      <a href="/cdn-cgi/l/email-protection#d3b0a3b693b2beb2feefb2f3bba1b6b5ee" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Enzyme (ACE) Inhibitor or
                                     Angiotensin Receptor
                                     Blocker (ARB) Therapy-
                                     Diabetes or Left
                                     Ventricular Systolic
                                     Dysfunction (LVEF <40%).
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of coronary
                                     artery disease seen
                                     within a 12 month period
                                     who also have diabetes OR
                                     a current or prior Left
                                     Ventricular Ejection
                                     Fraction (LVEF) <40% who
                                     were prescribed ACE
                                     inhibitor or ARB therapy.
NQF 0067..........................  Title: Coronary Artery      AMA-PCPI.............  EHR PQRS, Group        ....................  Clinical Process/
                                     Disease (CAD):             Contact Information:    Reporting PQRS.                              Effectiveness.
                                     Antiplatelet Therapy.       <a href="/cdn-cgi/l/email-protection#e98a998ca9888488c4d588c9819b8c8fd4" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of coronary
                                     artery disease seen
                                     within a 12 month period
                                     who were prescribed
                                     aspirin or clopidogrel.

[[Page 13751]]

 
NQF 0068..........................  Title: Ischemic Vascular    NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Disease (IVD): Use of      Contact Information:    Reporting PQRS.                              Effectiveness.
                                     Aspirin or Another          www.ncqa.org..
                                     Antithrombotic.
                                    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 transluminal
                                     coronary angioplasty
                                     (PTCA) from January 1-
                                     November 1 of the year
                                     prior to the measurement
                                     year, or who had a
                                     diagnosis of ischemic
                                     vascular disease (IVD)
                                     during the measurement
                                     year and the year prior
                                     to the measurement year
                                     and who had documentation
                                     of use of aspirin or
                                     another antithrombotic
                                     during the measurement
                                     year.
NQF 0069..........................  Title: Appropriate          NCQA.................  PQRS, NCQA-PCMH        New.................  Efficient Use of
                                     Treatment for Children     Contact Information:    Accreditation.                               Healthcare
                                     with Upper Respiratory      www.ncqa.org..                                                      Resources.
                                     Infection (URI).
                                    Description: Percentage of
                                     children who were given a
                                     diagnosis of URI and were
                                     not dispensed an
                                     antibiotic prescription
                                     on or three days after
                                     the episode date.
NQF 0070..........................  Title: Coronary Artery      AMA-PCPI.............  EHR PQRS, NCQA-PCMH    ....................  Clinical Process/
                                     Disease (CAD): Beta-       Contact Information:    Accreditation.                               Effectiveness.
                                     Blocker Therapy- Prior      <a href="/cdn-cgi/l/email-protection#7c1f0c193c1d111d51401d5c140e191a41" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Myocardial Infarction
                                     (MI) or Left Ventricular
                                     Systolic Dysfunction
                                     (LVEF <40%).
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of coronary
                                     artery disease seen
                                     within a 12 month period
                                     who also have a prior MI
                                     or a current or prior
                                     LVEF <40% who were
                                     prescribed beta-blocker
                                     therapy.
NQF 0073..........................  Title: Ischemic Vascular    NCQA.................  EHR PQRS.............  ....................  Clinical Process/
                                     Disease (IVD): Blood       Contact Information:                                                 Effectiveness.
                                     Pressure Management.        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 transluminal
                                     coronary angioplasty
                                     (PTCA) from January 1-
                                     November 1 of the year
                                     prior to the measurement
                                     year, or who had a
                                     diagnosis of ischemic
                                     vascular disease (IVD)
                                     during the measurement
                                     year and the year prior
                                     to the measurement year
                                     and whose recent blood
                                     pressure is in control
                                     (<140/90 mmHg).
NQF 0074..........................  Title: Coronary Artery      AMA-PCPI.............  PQRS, ACO, Group       ....................  Clinical Process/
                                     Disease (CAD): Lipid       Contact Information:    Reporting PQRS.                              Effectiveness.
                                     Control.                    <a href="/cdn-cgi/l/email-protection#bbd8cbdefbdad6da9687da9bd3c9dedd86" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of coronary
                                     artery disease seen
                                     within a 12 month period
                                     who have a LDL-C result
                                     <100mg/dL OR patients who
                                     have a LDL-C result
                                     >=100mg/dL and have a
                                     documented plan of care
                                     to achieve LDL-C <100mg/
                                     dL, including at a
                                     minimum the prescription
                                     of a statin.
NQF 0075..........................  Title: Ischemic Vascular    NCQA.................  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Disease (IVD): Complete    Contact Information:    Reporting PQRS.                              Effectiveness.
                                     Lipid Panel and LDL         www.ncqa.org..
                                     Control.
                                    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 transluminal
                                     angioplasty (PTCA) from
                                     January 1-November 1 of
                                     the year prior to the
                                     measurement year, or who
                                     had a diagnosis of
                                     ischemic vascular disease
                                     (IVD) during the
                                     measurement year and the
                                     year prior to the
                                     measurement year and who
                                     had a complete lipid
                                     profile performed during
                                     the measurement year and
                                     whose LDL-C<100 mg/dL.
NQF 0081..........................  Title: Heart Failure (HF):  AMA-PCPI.............  EHR PQRS, Group        ....................  Clinical Process/
                                     Angiotensin-Converting     Contact Information:    Reporting PQRS, NCQA-                        Effectiveness.
                                     Enzyme (ACE) Inhibitor or   <a href="/cdn-cgi/l/email-protection#5231223712333f337f6e33723a2037346f" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.      PCMH Accreditation.
                                     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) <40% who
                                     were prescribed ACE
                                     inhibitor or ARB therapy
                                     either within a 12 month
                                     period when seen in the
                                     outpatient setting OR at
                                     each hospital discharge.
NQF 0083..........................  Title: Heart Failure (HF):  AMA-PCPI.............  EHR PQRS, ACO, Group   ....................  Clinical Process/
                                     Beta-Blocker Therapy for   Contact Information:    Reporting PQRS.                              Effectiveness.
                                     Left Ventricular Systolic   <a href="/cdn-cgi/l/email-protection#3556455075545854180954155d47505308" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     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) <40% who
                                     were prescribed beta-
                                     blocker therapy either
                                     within a 12 month period
                                     when seen in the
                                     outpatient setting OR at
                                     each hospital discharge.
NQF 0086..........................  Title: Primary Open Angle   AMA-PCPI.............  EHR PQRS.............  ....................  Clinical Process/
                                     Glaucoma (POAG): Optic     Contact Information:                                                 Effectiveness.
                                     Nerve Evaluation.           <a href="/cdn-cgi/l/email-protection#2744574267464a460a1b46074f5542411a" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    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             AMA-PCPI.............  EHR PQRS.............  ....................  Clinical Process/
                                     Retinopathy:               Contact Information:                                                 Effectiveness.
                                     Documentation of Presence   <a href="/cdn-cgi/l/email-protection#b8dbc8ddf8d9d5d99584d998d0caddde85" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     or Absence of Macular
                                     Edema and 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             AMA-PCPI.............  EHR PQRS.............  ....................  Clinical Process/
                                     Retinopathy:               Contact Information:                                                 Effectiveness.
                                     Communication with the      <a href="/cdn-cgi/l/email-protection#a3c0d3c6e3c2cec28e9fc283cbd1c6c59e" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Physician Managing
                                     Ongoing 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 13752]]

 
NQF 0097..........................  Title: Medication           AMA-PCPI.............  ACO, Group Reporting   New.................  Patient Safety.
                                     Reconciliation.            Contact Information:    PQRS, NCQA-PCMH
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#d1b2a1b491b0bcb0fcedb0f1b9a3b4b7ec" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;      Accreditation.
                                     patients aged 65 years      NCQA Contact
                                     and older discharged from   Information:
                                     any inpatient facility      www.ncqa.org.
                                     (e.g. hospital, skilled
                                     nursing facility, or
                                     rehabilitation facility)
                                     and seen within 60 days
                                     following discharge in
                                     the office by the
                                     physician providing on-
                                     going care who had a
                                     reconciliation of the
                                     discharge medications
                                     with the current
                                     medication list in the
                                     medical record documented.
NQF 0098..........................  Title: Urinary              NCQA.................  PQRS.................  New.................  Clinical Process/
                                     Incontinence: Assessment   Contact Information:                                                 Effectiveness.
                                     of Presence or Absence of   www.ncqa.org..
                                     Urinary Incontinence in
                                     Women Age 65 Years and
                                     Older.
                                    Description: Percentage of
                                     female patients aged 65
                                     years and older who were
                                     assessed for the presence
                                     or absence of urinary
                                     incontinence within 12
                                     months.
NQF 0100..........................  Title: Urinary              AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Incontinence: Plan of      Contact Information:                                                 Engagement.
                                     Care for Urinary            <a href="/cdn-cgi/l/email-protection#3b584b5e7b5a565a16075a1b53495e5d06" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Incontinence in Women       NCQA Contact
                                     Aged 65 Years and Older.    Information:
                                    Description: Percentage of   www.ncqa.org.
                                     female patients aged 65
                                     years and older with a
                                     diagnosis of urinary
                                     incontinence with a
                                     documented plan of care
                                     for urinary incontinence
                                     at least once within 12
                                     months.
NQF 0101..........................  Title: Falls: Screening     AMA-PCPI.............  PQRS, ACO, Group       New.................  Patient Safety.
                                     for Falls Risk.            Contact Information:    Reporting PQRS.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#8eedfeebceefe3efa3b2efaee6fcebe8b3" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     patients aged 65 years      NCQA Contact
                                     and older who were          Information:
                                     screened for future fall    www.ncqa.org.
                                     risk (patients are
                                     considered at risk for
                                     future falls if they have
                                     had 2 or more falls in
                                     the past year or any fall
                                     with injury in the past
                                     year) at least once
                                     within 12 months.
NQF 0102..........................  Title: Chronic Obstructive  AMA-PCPI.............  PQRS, Group Reporting  New.................  Clinical Process/
                                     Pulmonary Disease (COPD):  Contact Information:    PQRS.                                        Effectiveness.
                                     Bronchodilator Therapy.     <a href="/cdn-cgi/l/email-protection#a0c3d0c5e0c1cdc18d9cc180c8d2c5c69d" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of COPD and who
                                     have FEV1/FVC less than
                                     70% and have symptoms who
                                     were prescribed an
                                     inhaled bronchodilator.
NQF 0103..........................  Title: Major Depressive     AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     Disorder (MDD):            Contact Information:                                                 Effectiveness.
                                     Diagnostic Evaluation.      <a href="/cdn-cgi/l/email-protection#aac9dacfeacbc7cb8796cb8ac2d8cfcc97" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a new
                                     diagnosis or recurrent
                                     episode of MDD who met
                                     the DSM-IV criteria
                                     during the visit in which
                                     the new diagnosis or
                                     recurrent episode was
                                     identified during the
                                     measurement period.
NQF 0104..........................  Title: Major Depressive     AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     Disorder (MDD): Suicide    Contact Information:                                                 Effectiveness.
                                     Risk Assessment.            <a href="/cdn-cgi/l/email-protection#c3a0b3a683a2aea2eeffa2e3abb1a6a5fe" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    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.................  EHR PQRS, HEDIS,       ....................  Clinical Process/
                                     Medication Management:     Contact Information:    State use, ACA 2701.                         Effectiveness.
                                     (a) Effective Acute Phase   www.ncqa.org..
                                     Treatment, (b) Effective
                                     Continuation Phase
                                     Treatment.
                                    Description: The
                                     percentage of patients 18
                                     years of age and older
                                     who were diagnosed with a
                                     new episode of major
                                     depression, treated with
                                     antidepressant
                                     medication, and who
                                     remained on an
                                     antidepressant medication
                                     treatment.
NQF 0106..........................  Title: Diagnosis of         Institute for          .....................  New.................  Care Coordination.
                                     attention deficit           Clinical Systems
                                     hyperactivity disorder      Improvement (ICSI).
                                     (ADHD) in primary care     Contact Information:
                                     for school age children     www.icsi.org.
                                     and adolescents.
                                    Description: Percentage of
                                     patients newly diagnosed
                                     with ADHD whose medical
                                     record contains
                                     documentation of DSM-IV-
                                     TR or DSM-PC criteria.
NQF 0107..........................  Title: Management of        ICSI.................  .....................  New.................  Clinical Process/
                                     attention deficit          Contact Information:                                                 Effectiveness.
                                     hyperactivity disorder      www.icsi.org.
                                     (ADHD) in primary care
                                     for school age children
                                     and adolescents.
                                    Description: Percentage of
                                     patients treated with
                                     psychostimulant
                                     medication for the
                                     diagnosis of ADHD whose
                                     medical record contains
                                     documentation of a follow-
                                     up visit at least twice a
                                     year.
NQF 0108..........................  Title: ADHD: Follow-Up      NCQA.................  .....................  New.................  Clinical Process/
                                     Care for Children          Contact Information:                                                 Effectiveness.
                                     Prescribed Attention-       www.ncqa.org..
                                     Deficit/Hyperactivity
                                     Disorder (ADHD)
                                     Medication.
                                    Description: (a)
                                     Initiation Phase:
                                     Percentage of children 6-
                                     12 years of age as of the
                                     Index Prescription
                                     Episode Start Date with
                                     an ambulatory
                                     prescription dispensed
                                     for ADHD medication and
                                     who had one follow-up
                                     visit with a practitioner
                                     with prescribing
                                     authority during the 30-
                                     Day Initiation Phase.
                                    (b) Continuation and
                                     Maintenance (C&M) Phase:
                                     Percentage of children 6-
                                     12 years of age as of the
                                     Index Prescription
                                     Episode Start Date with
                                     an ambulatory
                                     prescription dispensed
                                     for ADHD medication who
                                     remained on the
                                     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     Center for Quality     NCQA-PCMH              New.................  Clinical Process/
                                     and Major Depression:       Assessment and         Accreditation.                               Effectiveness.
                                     Appraisal for alcohol or    Improvement in
                                     chemical substance use.     Mental Health
                                    Description: Percentage of   (CQAIMH).
                                     patients with depression   Contact Information:
                                     or bipolar disorder with    www.cqaimh.org;
                                     evidence of an initial      <a href="/cdn-cgi/l/email-protection#1b786a7a7276735b786a7a7276733574697c"><span class="__cf_email__" data-cfemail="71120010181c1931120010181c195f1e0316">[email protected]</span></a>.
                                     assessment that includes
                                     an appraisal for alcohol
                                     or chemical substance use.
NQF 0112..........................  Title: Bipolar Disorder:    CQAIMH...............  .....................  New.................  Clinical Process/
                                     Monitoring change in       Contact Information:                                                 Effectiveness.
                                     level-of-functioning.       www.cqaimh.org;
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#573426363e3a3f173426363e3a3f79382530"><span class="__cf_email__" data-cfemail="ea899b8b838782aa899b8b838782c485988d">[email protected]</span></a>.
                                     patients aged 18 years
                                     and older with an initial
                                     diagnosis or new episode/
                                     presentation of bipolar
                                     disorder.
NQF 0239..........................  Title: Perioperative Care:  AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Venous Thromboembolism     Contact Information:
                                     (VTE) Prophylaxis (when     <a href="/cdn-cgi/l/email-protection#dab9aabf9abbb7bbf7e6bbfab2a8bfbce7" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     indicated in ALL
                                     patients).
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older undergoing
                                     procedures for which VTE
                                     prophylaxis is indicated
                                     in all patients, who had
                                     an order for Low
                                     Molecular Weight Heparin
                                     (LMWH), Low-Dose
                                     Unfractionated Heparin
                                     (LDUH), adjusted-dose
                                     warfarin, fondaparinux or
                                     mechanical prophylaxis to
                                     be given within 24 hours
                                     prior to incision time or
                                     within 24 hours after
                                     surgery end time.

[[Page 13753]]

 
Formerly NQF 0246,                  Title: Stroke and Stroke    AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
no longer endorsed................   Rehabilitation: Computed   Contact Information:                                                 Effectiveness.
                                     Tomography (CT) or          <a href="/cdn-cgi/l/email-protection#3a594a5f7a5b575b17065b1a52485f5c07" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Magnetic Resonance          NCQA Contact
                                     Imaging (MRI) Reports.      Information:
                                    Description: Percentage of   www.ncqa.org.
                                     final reports for CT or
                                     MRI studies of the brain
                                     performed either:.
                                    <bullet> In the hospital
                                     within 24 hours of
                                     arrival, OR.
                                    <bullet> In an outpatient
                                     imaging center to confirm
                                     initial diagnosis of
                                     stroke, transient
                                     ischemic attack (TIA) or
                                     intracranial hemorrhage..
                                    For patients aged 18 years
                                     and older with either a
                                     diagnosis of ischemic
                                     stroke, TIA or
                                     intracranial hemorrhage
                                     OR at least one
                                     documented symptom
                                     consistent with ischemic
                                     stroke, TIA or
                                     intracranial hemorrhage
                                     that includes
                                     documentation of the
                                     presence or absence of
                                     each of the following:
                                     hemorrhage, mass lesion
                                     and acute infarction.
NQF 0271..........................  Title: Perioperative Care:  AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Patient Safety.
                                     Discontinuation of         Contact Information:    Accreditation.
                                     Prophylactic Antibiotics    <a href="/cdn-cgi/l/email-protection#f99a899cb9989498d4c598d9918b9c9fc4" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     (Non-Cardiac Procedures).
                                    Description: Percentage of
                                     non-cardiac surgical
                                     patients aged 18 years
                                     and older undergoing
                                     procedures with the
                                     indications for
                                     prophylactic parenteral
                                     antibiotics AND who
                                     received a prophylactic
                                     parenteral antibiotic,
                                     who have an order for
                                     discontinuation of
                                     prophylactic parenteral
                                     antibiotics within 24
                                     hours of surgical end
                                     time.
NQF 0312..........................  Title: Lower Back Pain:     NCQA.................  .....................  New.................  Efficient Use of
                                     Repeat Imaging Studies.    Contact Information:                                                 Healthcare
                                    Description: Percentage of   www.ncqa.org..                                                      Resources.
                                     patients with back pain
                                     who received
                                     inappropriate imaging
                                     studies in the absence of
                                     red flags or progressive
                                     symptoms (overuse
                                     measure, lower
                                     performance is better).
NQF 0321..........................  Title: Adult Kidney         AMA-PCPI.............  PQRS.................  New.................  Care Coordination.
                                     Disease: Peritoneal        Contact Information:
                                     Dialysis Adequacy: Solute.  <a href="/cdn-cgi/l/email-protection#f1928194b1909c90dccd90d199839497cc" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of ESRD
                                     receiving peritoneal
                                     dialysis who have a Kt/
                                     V>= 1.7 per week measured
                                     once every 4 months.
NQF 0322..........................  Title: Back Pain: Initial   NCQA.................  PQRS.................  New.................  Efficient Use of
                                     Visit                      Contact Information:                                                 Healthcare
                                    Description: The             www.ncqa.org..                                                      Resources.
                                     percentage of patients
                                     with a diagnosis of back
                                     pain who have medical
                                     record documentation of
                                     all of the following on
                                     the date of the initial
                                     visit to the physician:.
                                    1. Pain assessment........
                                    2. Functional status......
                                    3. Patient history,
                                     including notation of
                                     presence or absence of
                                     ``red flags''.
                                    4. Assessment of prior
                                     treatment and response,
                                     and.
                                    5. Employment status......
NQF 0323..........................  Title: Adult Kidney         AMA-PCPI.............  PQRS.................  New.................  Care Coordination.
                                     Disease: Hemodialysis      Contact Information:
                                     Adequacy: Solute.           <a href="/cdn-cgi/l/email-protection#b6d5c6d3f6d7dbd79b8ad796dec4d3d08b" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     calendar months within a
                                     12-month period during
                                     which patients aged 18
                                     years and older with a
                                     diagnosis of end-stage
                                     renal disease (ESRD)
                                     receiving hemodialysis
                                     three times a week have a
                                     spKt/V>=1.2.
NQF 0382..........................  Title: Oncology: Radiation  AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Dose Limits to Normal      Contact Information:
                                     Tissues.                    <a href="/cdn-cgi/l/email-protection#2744574267464a460a1b46074f5542411a" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;.
                                    Description: Percentage of
                                     patients, regardless of
                                     age, with a diagnosis of
                                     pancreatic or lung cancer
                                     receiving 3D conformal
                                     radiation therapy with
                                     documentation in medical
                                     record that radiation
                                     dose limits to normal
                                     tissues were established
                                     prior to the initiation
                                     of a course of 3D
                                     conformal radiation for a
                                     minimum of two tissues.
NQF 0383..........................  Title: Oncology: Measure    AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Pair: Oncology: Medical    Contact Information:                                                 Engagement.
                                     and Radiation--Plan of      <a href="/cdn-cgi/l/email-protection#c2a1b2a782a3afa3effea3e2aab0a7a4ff" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Care for Pain.
                                    Description: Percentage of
                                     patient visits,
                                     regardless of patient
                                     age, with a diagnosis of
                                     cancer currently
                                     receiving chemotherapy or
                                     radiation therapy who
                                     report having pain with a
                                     documented plan of care
                                     to address pain.
NQF 0384..........................  Title: Oncology: Measure    AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Pair: Oncology: Medical    Contact Information:                                                 Engagement.
                                     and Radiation- Pain         <a href="/cdn-cgi/l/email-protection#bad9cadffadbd7db9786db9ad2c8dfdc87" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Intensity Quantified.
                                    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.............  EHR PQRS.............  ....................  Clinical Process/
                                     Chemotherapy for Stage     Contact Information:                                                 Effectiveness.
                                     III Colon Cancer Patients.  <a href="/cdn-cgi/l/email-protection#1a796a7f5a7b777b37267b3a72687f7c27" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                    Description: Percentage of   American Society of
                                     patients aged 18 years      Clinical Oncology
                                     and older with Stage IIIA   (ASCO):
                                     through IIIC colon cancer   www.asco.org;
                                     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:       AMA-PCPI.............  EHR PQRS.............  ....................  Clinical Process/
                                     Hormonal Therapy for       Contact Information:                                                 Effectiveness.
                                     Stage IC-IIIC Estrogen      <a href="/cdn-cgi/l/email-protection#c9aab9ac89a8a4a8e4f5a8e9a1bbacaff4" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Receptor/Progesterone       ASCO: www.asco.org;
                                     Receptor (ER/PR) Positive   NCCN: www.nccn.org.
                                     Breast Cancer.
                                    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.
NQF 0388..........................  Title: Prostate Cancer:     AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Three Dimensional (3D)     Contact Information:
                                     Radiotherapy.               <a href="/cdn-cgi/l/email-protection#0261726742636f632f3e63226a7067643f" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients, regardless of
                                     age, with a diagnosis of
                                     clinically localized
                                     prostate cancer receiving
                                     external beam
                                     radiotherapy as a primary
                                     therapy to the prostate
                                     with or without nodal
                                     irradiation (no
                                     metastases; no salvage
                                     therapy) who receive
                                     three-dimensional
                                     conformal radiotherapy
                                     (3D-CRT) or intensity
                                     modulated radiation
                                     therapy (IMRT).

[[Page 13754]]

 
NQF 0389..........................  Title: Prostate Cancer:     AMA-PCPI.............  EHR PQRS.............  ....................  Efficient Use of
                                     Avoidance of Overuse of    Contact Information:                                                 Healthcare
                                     Bone Scan for Staging Low   <a href="/cdn-cgi/l/email-protection#f0938095b0919d91ddcc91d098829596cd" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.                                                   Resources.
                                     Risk 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 0399..........................  Title: Hepatitis C:         AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Population/Public
                                     Hepatitis A Vaccination    Contact Information:    Accreditation.                               Health.
                                     in Patients with HCV.       <a href="/cdn-cgi/l/email-protection#3457445174555955190855145c46515209" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of hepatitis C
                                     who have received at
                                     least one injection of
                                     hepatitis A vaccine, or
                                     who have documented
                                     immunity to hepatitis A.
NQF 0400..........................  Title: Hepatitis C:         AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Population/Public
                                     Hepatitis B Vaccination    Contact Information:    Accreditation.                               Health.
                                     in Patients with HCV.       <a href="/cdn-cgi/l/email-protection#c6a5b6a386a7aba7ebfaa7e6aeb4a3a0fb" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of hepatitis C
                                     who have received at
                                     least one injection of
                                     hepatitis B vaccine, or
                                     who have documented
                                     immunity to hepatitis B.
NQF 0401..........................  Title: Hepatitis C:         AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Clinical Process/
                                     Counseling Regarding Risk  Contact Information:    Accreditation.                               Effectiveness.
                                     of Alcohol Consumption.     <a href="/cdn-cgi/l/email-protection#7714071237161a165a4b16571f0512114a" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of hepatitis C
                                     who were counseled about
                                     the risks of alcohol use
                                     at least once within 12
                                     months.
NQF 0403..........................  Title: Medical Visits.....  AMA-PCPI.............  .....................  New.................  Clinical Process/
                                    Description: Percentage of  Contact Information:                                                 Effectiveness.
                                     patients regardless of      <a href="/cdn-cgi/l/email-protection#ea899a8faa8b878bc7d68bca82988f8cd7" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     age, with a diagnosis of    NCQA Contact
                                     HIV/AIDS with at least      Information:
                                     one medical visit in each   www.ncqa.org.
                                     6 month period with a
                                     minimum of 60 days
                                     between each visit.
NQF 0405..........................  Title: Pneumocystitis       AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Clinical Process/
                                     jiroveci pneumonia (PCP)   Contact Information:    Accreditation.                               Effectiveness.
                                     Prophylaxis.                <a href="/cdn-cgi/l/email-protection#bbd8cbdefbdad6da9687da9bd3c9dedd86" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                    Description: Percentage of   NCQA Contact
                                     patients with HIV/AIDS      Information:
                                     who were prescribed         www.ncqa.org.
                                     Pneumocystis jiroveci
                                     pneumonia (PCP)
                                     prophylaxis.
NQF 0406..........................  Title: Patients with HIV/   AMA-PCPI.............  PQRS, NCQA-PCMH        New.................  Clinical Process/
                                     AIDS Who Are Prescribed    Contact Information:    Accreditation.                               Effectiveness.
                                     Potent Antiretroviral       <a href="/cdn-cgi/l/email-protection#e88b988da8898589c5d489c8809a8d8ed5" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Therapy.                    NCQA Contact
                                    Description: Percentage of   Information:
                                     patients who were           www.ncqa.org.
                                     prescribed potent
                                     antiretroviral therapy.
NQF 0407..........................  Title: HIV RNA control      NCQA.................  PQRS.................  New.................  Clinical Process/
                                     after six months of        Contact Information:                                                 Effectiveness.
                                     potent antiretroviral       www.ncqa.org..
                                     therapy.
                                    Description: Percentage of
                                     patients aged 13 years
                                     and older with a
                                     diagnosis of HIV/AIDS who
                                     had at least two medical
                                     visits during the
                                     measurement year, with at
                                     least 60 days between
                                     each visit, who are
                                     receiving potent
                                     antiretroviral therapy,
                                     who have a viral load
                                     below limits of
                                     quantification after at
                                     least 6 months of potent
                                     antiretroviral therapy OR
                                     whose viral load is not
                                     below limits of
                                     quantification after at
                                     least 6 months of potent
                                     antiretroviral therapy
                                     and has a documented plan
                                     of care.
NQF 0418..........................  Title: Screening for        Centers for Medicare   EHR PQRS, ACO........  New.................  Population/Public
                                     Clinical Depression.        and Medicaid                                                        Health.
                                    Description: Percentage of   Services (CMS).
                                     patients aged 12 years     1-888-734-6433 or
                                     and older screened for      http://
                                     clinical depression using   questions.cms.hhs.go
                                     an age appropriate          v/app/ask/p/
                                     standardized tool and       21,26,1139;.
                                     follow up plan documented. Quality Insights of
                                                                 Pennsylvania (QIP).
                                                                Contact Information:
                                                                 www.usqualitymeasures.org.
NQF 0419..........................  Title: Documentation of     Centers for Medicare   PQRS, EHR PQRS, Group  New.................  Patient Safety.
                                     Current Medications in      and Medicaid           Reporting PQRS.
                                     the Medical Record.         Services (CMS) 1-888-
                                    Description: Percentage of   734-6433 or http://
                                     specified visits as         questions.cms.hhs.go
                                     defined by the              v/app/ask/p/
                                     denominator criteria for    21,26,1139; QIP.
                                     which the eligible         Contact Information:
                                     professional attests to     www.usqualitymeasure
                                     documenting a list of       s.org.
                                     current medications to
                                     the best of his/her
                                     knowledge and ability.
                                     This list must include
                                     ALL prescriptions, over-
                                     the-counters, herbals,
                                     vitamin/mineral/dietary
                                     (nutritional) supplements
                                     AND must contain the
                                     medications' name,
                                     dosage, frequency and
                                     route.
NQF 0421..........................  Title: Adult Weight         Centers for Medicare   EHR PQRS, ACO, Group   ....................  Population/Public
                                     Screening and Follow-Up.    and Medicaid           Reporting PQRS, UDS.                         Health.
                                    Description: Percentage of   Services (CMS) 1-888-
                                     patients aged 18 years      734-6433 or http://
                                     and older with a            questions.cms.hhs.go
                                     calculated body mass        v/app/ask/p/
                                     index (BMI) in the past     21,26,1139;.
                                     six months or during the   QIP..................
                                     current visit documented   Contact Information:
                                     in the medical record AND   www.usqualitymeasure
                                     if the most recent BMI is   s.org.
                                     outside of normal
                                     parameters, a follow-up
                                     plan is documented.
                                    Normal Parameters: Age 65
                                     years and older BMI >=23
                                     and <30.
                                    Age 18-64 years BMI >=18/5
                                     and <25.
NQF 0507..........................  Title: Radiology: Stenosis  AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     Measurement in Carotid     Contact Information:                                                 Effectiveness.
                                     Imaging Studies.            <a href="/cdn-cgi/l/email-protection#2b485b4e6b4a464a06174a0b43594e4d16" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     final reports for all
                                     patients, regardless of
                                     age, for carotid imaging
                                     studies (neck magnetic
                                     resonance angiography
                                     [MRA], neck computer
                                     tomography angiography
                                     [CTA], neck duplex
                                     ultrasound, carotid
                                     angiogram) performed that
                                     include direct or
                                     indirect reference to
                                     measurements of distal
                                     internal carotid diameter
                                     as the denominator for
                                     stenosis measurement.
NQF 0508..........................  Title: Radiology:           AMA-PCPI.............  PQRS.................  New.................  Efficient Use of
                                     Inappropriate Use of       Contact Information:                                                 Healthcare
                                     ``Probably Benign''         <a href="/cdn-cgi/l/email-protection#593a293c1938343874653879312b3c3f64" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.                                                   Resources.
                                     Assessment Category in
                                     Mammography Screening.
                                    Description: Percentage of
                                     final reports for
                                     screening mammograms that
                                     are classified as
                                     ``probably benign.''.
NQF 0510..........................  Title: Radiology: Exposure  AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Time Reported for          Contact Information:
                                     Procedures Using            <a href="/cdn-cgi/l/email-protection#87e4f7e2c7e6eae6aabbe6a7eff5e2e1ba" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Fluoroscopy.
                                    Description: Percentage of
                                     final reports for
                                     procedures using
                                     fluoroscopy that include
                                     documentation of
                                     radiation exposure or
                                     exposure time.

[[Page 13755]]

 
NQF 0513..........................  Title: Thorax CT: Use of    CMS..................  .....................  New.................  Efficient Use of
                                     Contrast Material.         Contact Information:                                                 Healthcare
                                    Description: This measure    1-888-734-6433 or                                                   Resources.
                                     calculates the percentage   http://
                                     of thorax studies that      questions.cms.hhs.go
                                     are performed with and      v/app/ask/p/
                                     without contrast out of     21,26,1139.
                                     all thorax studies
                                     performed (those with
                                     contrast, those without
                                     contrast, and those with
                                     both).
NQF 0519..........................  Title: Diabetic Foot Care   CMS..................  .....................  New.................  Care Coordination.
                                     and Patient/Caregiver      Contact Information:
                                     Education Implemented       1-888-734-6433 or
                                     During Short Term           http://
                                     Episodes of Care.           questions.cms.hhs.go
                                    Description: Percentage of   v/app/ask/p/
                                     short term home health      21,26,1139.
                                     episodes of care during
                                     which diabetic foot care
                                     and education were
                                     included in the physician-
                                     ordered plan of care and
                                     implemented for patients
                                     with diabetes.
NQF 0561..........................  Title: Melanoma:            AMA-PCPI.............  PQRS.................  New.................  Care Coordination.
                                     Coordination of Care.      Contact Information:
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#3152415471505c501c0d5011594354570c" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     patient visits,             NCQA Contact
                                     regardless of patient       Information:
                                     age, with a new             www.ncqa.org.
                                     occurrence of melanoma
                                     who have a treatment plan
                                     documented in the chart
                                     that was communicated to
                                     the physicians(s)
                                     providing continuing care
                                     within one month of
                                     diagnosis.
NQF 0562..........................  Title: Melanoma:            AMA-PCPI.............  PQRS.................  New.................  Efficient Use of
                                     Overutilization of         Contact Information:                                                 Healthcare
                                     Imaging Studies in          <a href="/cdn-cgi/l/email-protection#3e5d4e5b7e5f535f13025f1e564c5b5803" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;                                                   Resources.
                                     Melanoma.                   NCQA Contact
                                    Description: Percentage of   Information:
                                     patients, regardless of     www.ncqa.org.
                                     age, with a current
                                     diagnosis of stage 0
                                     through IIC melanoma or a
                                     history of melanoma of
                                     any stage, without signs
                                     or symptoms suggesting
                                     systemic spread, seen for
                                     an office visit during
                                     the one-year measurement
                                     period, for whom no
                                     diagnostic imaging
                                     studies were ordered.
NQF 0564..........................  Title: Cataracts:           AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Complications within 30    Contact Information:
                                     Days Following Cataract     <a href="/cdn-cgi/l/email-protection#0162716441606c602c3d6021697364673c" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Surgery Requiring           NCQA Contact
                                     Additional Surgical         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.
NQF 0565..........................  Title: Cataracts: 20/40 or  AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     Better Visual Acuity       Contact Information:                                                 Effectiveness.
                                     within 90 Days Following    <a href="/cdn-cgi/l/email-protection#a0c3d0c5e0c1cdc18d9cc180c8d2c5c69d" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Cataract Surgery.           NCQA Contact
                                    Description: Percentage of   Information:
                                     patients aged 18 years      www.ncqa.org.
                                     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 0575..........................  Title: Diabetes:            NCQA.................  EHR PQRS, Group        ....................  Clinical Process/
                                     Hemoglobin A1c Control     Contact Information:    Reporting PQRS, UDS.                         Effectiveness.
                                     (<8.0%).                    www.ncqa.org..
                                    Description: The
                                     percentage of patients 18-
                                     75 years of age with
                                     diabetes (type 1 or type
                                     2) who had hemoglobin A1c
                                     <8.0%.
NQF 0608..........................  Title: Pregnant women that  Ingenix..............  .....................  New.................  Clinical Process/
                                     had HBsAg testing.         Contact 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           Minnesota Community    .....................  New.................  Clinical Process/
                                     Remission at Twelve         Measurement (MNCM).                                                 Effectiveness.
                                     Months.                    Contact Information:
                                    Description: Adult           www.mncm.org;
                                     patients age 18 and older   <a href="/cdn-cgi/l/email-protection#7f161119103f12111c1251100d18"><span class="__cf_email__" data-cfemail="6900070f062904070a0447061b0e">[email protected]</span></a>.
                                     with major depression or
                                     dysthymia and 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 0711..........................  Title: Depression           MNCM.................  .....................  New.................  Clinical Process/
                                     Remission at Six Months.   Contact Information:                                                 Effectiveness.
                                    Description: Adult           www.mncm.org;
                                     patients age 18 and older   <a href="/cdn-cgi/l/email-protection#630a0d050c230e0d000e4d0c1104"><span class="__cf_email__" data-cfemail="b7ded9d1d8f7dad9d4da99d8c5d0">[email protected]</span></a>.
                                     with major depression or
                                     dysthymia and an initial
                                     PHQ-9 score >9 who
                                     demonstrate remission at
                                     six 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           MNCM.................  .....................  New.................  Clinical Process/
                                     Utilization of the PHQ-9   Contact Information:                                                 Effectiveness.
                                     Tool.                       www.mncm.org;
                                    Description: Adult           <a href="/cdn-cgi/l/email-protection#60090e060f200d0e030d4e0f1207"><span class="__cf_email__" data-cfemail="abc2c5cdc4ebc6c5c8c685c4d9cc">[email protected]</span></a>.
                                     patients age 18 and older
                                     with the 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.
NQF 1335..........................  Title: Children who have    Maternal and Child     .....................  New.................  Clinical Process/
                                     dental decay or cavities.   Health Bureau,                                                      Effectiveness.
                                    Description: Assesses if     Health Resources and
                                     children aged 1-17 years    Services
                                     have had tooth decay or     Adminstration http://
                                     cavities in the past 6      mchb.hrsa.gov/.
                                     months.
NQF 1365..........................  Title: Child and            AMA-PCPI.............  .....................  New.................  Patient Safety.
                                     Adolescent Major           Contact Information:
                                     Depressive Disorder:        <a href="/cdn-cgi/l/email-protection#ed8e9d88ad8c808cc0d18ccd859f888bd0" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     Suicide Risk Assessment.
                                    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.................  .....................  New.................  Population/Public
                                     screening Description:     Contact Information:                                                 Health.
                                     The percentage of           www.ncqa.org..
                                     children who turned 6
                                     months of age during the
                                     measurement year who had
                                     documentation of a
                                     maternal depression
                                     screening for the mother.
NQF 1419..........................  Title: Primary Caries       University of          .....................  New.................  Clinical Process/
                                     Prevention Intervention     Minnesota.                                                          Effectiveness.
                                     as Part of Well/Ill Child  Contact Information:
                                     Care as Offered by          www.umn.edu.
                                     Primary Care Medical
                                     Providers.
                                    Description: The measure
                                     will a) track the extent
                                     to which the PCMP or
                                     clinic (determined by the
                                     provider number used for
                                     billing) applies FV as
                                     part of the EPSDT
                                     examination and b) track
                                     the degree to which each
                                     billing entity's use of
                                     the EPSDT with FV codes
                                     increases from year to
                                     year (more children
                                     varnished and more
                                     children receiving FV
                                     four times a year
                                     according to ADA
                                     recommendations for high-
                                     risk children).

[[Page 13756]]

 
NQF 1525..........................  Title: Atrial Fibrillation  AMA-PCPI.............  .....................  New.................  Clinical Process/
                                     and Atrial Flutter:        Contact Information:                                                 Effectiveness.
                                     Chronic Anticoagulation     <a href="/cdn-cgi/l/email-protection#096a796c4968646824356829617b6c6f34" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Therapy.                    American College of
                                    Description: Percentage of   Cardiology
                                     patients aged 18 years      Foundation (ACCF)
                                     and older with              www.cardiosource.org
                                     nonvalvular AF or atrial    ; American Heart
                                     flutter at high risk for    Association (AHA)
                                     thromboembolism,            www.heart.org.
                                     according to CHADS2 risk
                                     stratification, who were
                                     prescribed warfarin or
                                     another oral
                                     anticoagulant drug that
                                     is FDA approved for the
                                     prevention of
                                     thromboembolism during
                                     the 12-month reporting
                                     period.
TBD...............................  Title: Preventive Care and  CMS..................  EHR PQRS.............  New.................  Clinical Process/
                                     Screening: Cholesterol--   1-888-734-6433 or                                                    Effectiveness.
                                     Fasting Low Density         http://
                                     Lipoprotein (LDL) Test      questions.cms.hhs.go
                                     Performed AND Risk-         v/app/ask/p/
                                     Stratified Fasting LDL.     21,26,1139; QIP
                                    Description: Percentage of   Contact Information:
                                     patients aged 20 through    www.usqualitymeasure
                                     79 years whose risk         s.org.
                                     factors* have been
                                     assessed and a fasting
                                     LDL test has been
                                     performed. Percentage of
                                     patients aged 20 through
                                     79 years who had a
                                     fasting LDL test
                                     performed and whose risk-
                                     stratified* fasting LDL
                                     is at or below the
                                     recommended LDL goal.
TBD...............................  Title: Falls: Risk          AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Assessment for Falls.      Contact Information:
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#87e4f7e2c7e6eae6aabbe6a7eff5e2e1ba" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     patients aged 65 years      NCQA Contact
                                     and older with a history    Information:
                                     of falls who had a risk     www.ncqa.org.
                                     assessment for falls
                                     completed within 12
                                     months.
TBD...............................  Title: Falls: Plan of Care  AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     for Falls.                 Contact Information:
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#d0b3a0b590b1bdb1fdecb1f0b8a2b5b6ed" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     patients aged 65 years      NCQA Contact
                                     and older with a history    Information:
                                     of falls who had a plan     www.ncqa.org.
                                     of care for falls
                                     documented within 12
                                     months.
TBD...............................  Title: Adult Kidney         AMA-PCPI.............  .....................  New.................  Clinical Process/
                                     Disease: Blood Pressure    Contact Information:                                                 Effectiveness.
                                     Management.                 <a href="/cdn-cgi/l/email-protection#5635263316373b377b6a37763e2433306b" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patient visits for those
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of CKD (stage
                                     3, 4, or 5 not receiving
                                     RRT) and proteinuria with
                                     a blood pressure <130/80
                                     mmHg or >=130/80 mmHg
                                     with documented plan of
                                     care.
TBD...............................  Title: Adult Kidney         AMA-PCPI.............  .....................  New.................  Efficient Use of
                                     Disease: Patients on       Contact Information:                                                 Healthcare
                                     Erythropoiesis              <a href="/cdn-cgi/l/email-protection#4e2d3e2b0e2f232f63722f6e263c2b2873" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.                                                   Resources.
                                     Stimulating Agent (ESA)-
                                     Hemoglobin Level >12.0 g/
                                     dL.
                                    Description: Percentage of
                                     calendar months within a
                                     12-month period during
                                     which a hemoglobin (Hgb)
                                     level is measured for
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of advanced CKD
                                     (stage 4 or 5, not
                                     receiving RRT) or end-
                                     stage renal disease
                                     (ESRD) (who are on
                                     hemodialysis or
                                     peritoneal dialysis) who
                                     are also receiving ESA
                                     therapy have a hemoglobin
                                     (Hgb) level >12.0 g/dL.
TBD...............................  Title: Chronic Wound Care:  AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Use of wet to dry          Contact Information:
                                     dressings in patients       <a href="/cdn-cgi/l/email-protection#4526352005242824687924652d37202378" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     with chronic skin ulcers    NCQA Contact
                                     (overuse measure).          Information:
                                    Description: Percentage of   www.ncqa.org.
                                     patient visits for those
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of chronic skin
                                     ulcer without a
                                     prescription or
                                     recommendation to use wet
                                     to dry dressings.
TBD...............................  Title: Dementia: Staging    AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     of Dementia.               Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#ff9c8f9abf9e929ed2c39edf978d9a99c2" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     patients, regardless of
                                     age, with a diagnosis of
                                     dementia whose severity
                                     of dementia was
                                     classified as mild,
                                     moderate, or severe at
                                     least once within a 12
                                     month period.
TBD...............................  Title: Dementia: Cognitive  AMA-PCPI.............  PQRS.................  New.................  Clinical Process/
                                     Assessment.                Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#e88b988da8898589c5d489c8809a8d8ed5" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     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.
TBD...............................  Title: Dementia:            AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Functional Status          Contact Information:                                                 Engagement.
                                     Assessment.                 <a href="/cdn-cgi/l/email-protection#b9dac9dcf9d8d4d89485d899d1cbdcdf84" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients, regardless of
                                     age, with a diagnosis of
                                     dementia for whom an
                                     assessment of functional
                                     status is performed and
                                     the results reviewed at
                                     least once within a 12
                                     month period.
TBD...............................  Title: Dementia:            AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Counseling Regarding       Contact Information:                                                 Engagement.
                                     Safety Concerns.            <a href="/cdn-cgi/l/email-protection#91f2e1f4d1f0fcf0bcadf0b1f9e3f4f7ac" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients, regardless of
                                     age, with a diagnosis of
                                     dementia or their
                                     caregiver(s) who were
                                     counseled or referred for
                                     counseling regarding
                                     safety concerns within a
                                     12 month period.
TBD...............................  Title: Dementia:            AMA-PCPI.............  PQRS.................  New.................  Patient Safety.
                                     Counseling Regarding       Contact Information:
                                     Risks of Driving.           <a href="/cdn-cgi/l/email-protection#4320332603222e226e7f22632b3126257e" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                    Description: Percentage of
                                     patients, regardless of
                                     age, with a diagnosis of
                                     dementia or their
                                     caregiver(s) who were
                                     counseled regarding the
                                     risks of driving and the
                                     alternatives to driving
                                     at least once within a 12
                                     month period.
TBD...............................  Title: Dementia: Caregiver  AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Education and Support.     Contact Information:                                                 Engagement.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#680b180d2809050945540948001a0d0e55" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     patients, regardless of
                                     age, with a diagnosis of
                                     dementia whose
                                     caregiver(s) were
                                     provided with education
                                     on dementia disease
                                     management and health
                                     behavior changes AND
                                     referred to additional
                                     resources for support
                                     within a 12-month period.
TBD...............................  Title: Chronic Wound Care:  AMA-PCPI.............  .....................  New.................  Patient and Family
                                     Patient education          Contact Information:                                                 Engagement.
                                     regarding long term         <a href="/cdn-cgi/l/email-protection#91f2e1f4d1f0fcf0bcadf0b1f9e3f4f7ac" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     compression therapy.        NCQA Contact
                                    Description: Percentage of   Information:
                                     patients aged 18 years      www.ncqa.org.
                                     and older with a
                                     diagnosis of venous ulcer
                                     who received education
                                     regarding the need for
                                     long term compression
                                     therapy including
                                     interval replacement of
                                     compression stockings
                                     within the 12 month
                                     reporting period.
TBD...............................  Title: Rheumatoid           AMA-PCPI.............  PQRS.................  New.................  Patient and Family
                                     Arthritis (RA):            Contact Information:                                                 Engagement.
                                     Functional Status           <a href="/cdn-cgi/l/email-protection#680b180d2809050945540948001a0d0e55" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     Assessment.                 NCQA Contact
                                    Description: Percentage of   Information:
                                     patients aged 18 years      www.ncqa.org.
                                     and older with a
                                     diagnosis of RA for whom
                                     a functional status
                                     assessment was performed
                                     at least once within 12
                                     months.
TBD...............................  Title: Glaucoma Screening   NCQA.................  .....................  New.................  Clinical Process/
                                     in Older Adults.           Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   www.ncqa.org..
                                     patients 65 years and
                                     older, without a prior
                                     diagnosis of glaucoma or
                                     glaucoma suspect, who
                                     received a glaucoma eye
                                     exam by an eye-care
                                     professional for early
                                     identification of
                                     glaucomatous conditions.

[[Page 13757]]

 
TBD...............................  Title: Chronic Wound Care:  AMA-PCPI.............  .....................  New.................  Patient and Family
                                     Patient Education          Contact Information:                                                 Engagement.
                                     regarding diabetic foot     <a href="/cdn-cgi/l/email-protection#1271627752737f733f2e73327a6077742f" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>;
                                     care.                       NCQA Contact
                                    Description: Percentage of   Information:
                                     patients aged 18 years      www.ncqa.org.
                                     and older with a
                                     diagnosis of diabetes and
                                     foot ulcer who received
                                     education regarding
                                     appropriate foot care AND
                                     daily inspection of the
                                     feet within the 12 month
                                     reporting period.
TBD...............................  Title: Hypertension:        CMS..................  .....................  New.................  Clinical Process/
                                     Improvement in blood       1-888-734-6433 or                                                    Effectiveness.
                                     pressure.                   http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients aged 18 years      v/app/ask/p/
                                     and older with              21,26,1139.
                                     hypertension whose blood
                                     pressure improved during
                                     the measurement period.
TBD...............................  Title: Closing the          CMS..................  .....................  New.................  Care Coordination.
                                     referral loop: receipt of  1-888-734-6433 or
                                     specialist report.          http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients regardless of      v/app/ask/p/
                                     age with a referral from    21,26,1139.
                                     a primary care provider
                                     for whom a report from
                                     the provider to whom the
                                     patient was referred was
                                     received by the referring
                                     provider.
TBD...............................  Title: Functional status    CMS..................  .....................  New.................  Patient and Family
                                     assessment for knee        1-888-734-6433 or                                                    Engagement.
                                     replacement.                http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients aged 18 years      v/app/ask/p/
                                     and older with primary      21,26,1139.
                                     total knee arthroplasty
                                     (TKA) who completed
                                     baseline and follow-up
                                     (patient-reported)
                                     functional status
                                     assessments.
TBD...............................  Title: Functional status    CMS..................  .....................  New.................  Patient and Family
                                     assessment for hip         1-888-734-6433 or                                                    Engagement.
                                     replacement.                http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients aged 18 years      v/app/ask/p/
                                     and older with primary      21,26,1139.
                                     total hip arthroplasty
                                     (THA) who completed
                                     baseline and follow-up
                                     (patient-reported)
                                     functional status
                                     assessments.
TBD...............................  Title: Functional status    CMS..................  .....................  New.................  Patient and Family
                                     assessment for complex     1-888-734-6433 or                                                    Engagement.
                                     chronic conditions.         http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients aged 65 years      v/app/ask/p/
                                     and older with heart        21,26,1139.
                                     failure and two or more
                                     high impact conditions
                                     who completed initial and
                                     follow-up (patient-
                                     reported) functional
                                     status assessments.
TBD...............................  Title: Adverse Drug Event   CMS..................  .....................  New.................  Patient Safety.
                                     (ADE) Prevention:          1-888-734-6433 or
                                     Outpatient therapeutic      http://
                                     drug monitoring.            questions.cms.hhs.go
                                    Description: Percentage of   v/app/ask/p/
                                     patients 18 years of age    21,26,1139.
                                     and older receiving
                                     outpatient chronic
                                     medication therapy who
                                     had the appropriate
                                     therapeutic drug
                                     monitoring during the
                                     measurement year.
TBD...............................  Title: Preventive Care and  CMS..................  PQRS, Group Reporting  New.................  Population/Public
                                     Screening: Screening for   1-888-734-6433 or       PQRS, ACO.                                   Health.
                                     High Blood Pressure.        http://
                                    Description: Percentage of   questions.cms.hhs.go
                                     patients aged 18 years      v/app/ask/p/
                                     and older who are           21,26,1139;.
                                     screened for high blood    QIP..................
                                     pressure.                  Contact Information:
                                                                 www.usqualitymeasures.org.
TBD...............................  Title: Hypertension: Blood  AMA-PCPI.............  .....................  New.................  Clinical Process/
                                     Pressure Management.       Contact Information:                                                 Effectiveness.
                                    Description: Percentage of   <a href="/cdn-cgi/l/email-protection#a3c0d3c6e3c2cec28e9fc283cbd1c6c59e" http: assn.org">assn.org</a>">cpe@ama-assn.org</a>.
                                     patients aged 18 years
                                     and older with a
                                     diagnosis of hypertension
                                     seen within a 12 month
                                     period with a blood
                                     pressure <140/90mmHg OR
                                     patients with a blood
                                     pressure >=140/90mmHg and
                                     prescribed 2 or more anti-
                                     hypertensive medications
                                     during the most recent
                                     office visit.
--------------------------------------------------------------------------------------------------------------------------------------------------------
** 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. Proposed Reporting Methods for Clinical Quality Measures for 
Eligible Professionals
(a) Proposed Reporting Methods for Medicaid EPs
    For Medicaid EPs, 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 allow reporting through attestation. If 
a State does require such electronic reporting, the State is 
responsible for sharing the details on the process with its provider 
community. We anticipate that whatever means States have deployed for 
capturing Stage 1 clinical quality measures 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, the States will establish the method and requirements, subject to 
CMS prior approval, for electronically reporting.
(b) Proposed Reporting Methods for Medicare EPs in CY 2013
    In the CY 2012 Medicare Physician Fee Schedule final rule, we 
established a pilot program for Medicare EPs for CY 2012 that is 
intended to test and demonstrate our capacity to accept electronic 
reporting of Stage 1 clinical quality measure data (76 FR 73422 through 
73425). The title of this pilot program is the Physician Quality 
Reporting System--Medicare EHR Incentive Pilot, and it capitalizes on 
existing quality measures reporting infrastructure. The EHR Incentive 
Program Registration and Attestation System is located at https://ehrincentives.cms.gov/hitech/login.action.
(c) Proposed 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 clinical quality measures selected by the Secretary 
``in a form and manner specified by the Secretary'' as part of 
demonstrating meaningful use of Certified EHR Technology. As discussed 
in section II.B.4.b. of this proposed rule, Medicare EPs who are in 
their first year of Stage 1 may report clinical quality measures 
through attestation for a continuous 90-day EHR reporting period (for 
an explanation of reporting through attestation, see the discussion in 
the Stage 1 final rule (75 FR 44430 through 44431)).
    Medicare EPs who choose to report 12 clinical quality measures as 
described in Options 1.a. and 1.b. in section II.B.4.c. of this 
proposed rule would submit

[[Page 13758]]

through an aggregate reporting method, which would require the EP to 
log into a CMS-designated portal. Once the EP has logged into the 
portal, they would be required to submit through an upload process, 
data produced as output from their Certified EHR Technology in an XML-
based format specified by CMS.
    We are considering an ``interim submission'' option for Medicare 
EPs who are in their first year of Stage 1 and who participate in the 
Physician Quality Reporting System. Under this option, EPs would submit 
the Physician Quality Reporting System clinical quality measures 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. The EP would report the remainder of his/her 
clinical quality measures data by the deadline specified for the 
Physician Quality Reporting System to meet the requirements of the 
Physician Quality Reporting System. We request public comment on this 
potential option. Medicare EPs who are beyond their first year of Stage 
1 and who choose the Physician Quality Reporting System EHR reporting 
option (Option 2 in section II.B.4.(c). of this proposed rule) must 
report in the form and manner specified for the Physician Quality 
Reporting System (for more information on current reporting 
requirements, see the CY 2012 Medicare Physician Fee Schedule final 
rule with comment period (76 FR 73314)).
(d) Group Reporting Option for Medicare and Medicaid Eligible 
Professionals Beginning With CY 2014
    For Stage 1, EPs were required to report the clinical quality 
measures on an individual basis and did not have an option to report 
the measures 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 eligible professionals 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 are proposing three group 
reporting options to allow eligible professionals within a single group 
practice to report clinical quality measure data on a group level. All 
three methods would be available for Medicare EPs, while only the first 
one would be possible for Medicaid EPs, at States' discretion.
    We are proposing each of these options as an alternative to 
reporting clinical quality measure data as an individual eligible 
professional under the proposed options and reporting methods discussed 
earlier in this rule. These group reporting options would only be 
available for reporting clinical quality measures 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 propose for EPs are as 
follows:
    <bullet> Two or more EPs, each identified with a unique NPI 
associated with a group practice identified under one tax 
identification number (TIN) may be considered an EHR Incentive Group 
for the purposes of reporting clinical quality measures for the 
Medicare EHR Incentive Program. This group reporting option is only 
available for electronic reporting of clinical quality measures and is 
not available for those EPs in their first year of Stage 1. The 
clinical quality measures reported under this option would represent 
all EPs within the group. EPs who choose this group reporting option 
for clinical quality measures must still individually satisfy the 
objectives and associated measures for their respective stage of 
meaningful use. CMS proposes that States may also choose this option to 
accept group reporting for clinical quality measures, based upon a pre-
determined definition of a ``group practice,'' such as sharing one TIN.
    <bullet> Medicare EPs participating in the Medicare Shared Savings 
Program and the testing of the Pioneer Accountable Care Organization 
(ACO) model who use Certified EHR Technology to submit ACO measures in 
accordance with the requirements of the Medicare Shared Savings Program 
would be considered to have satisfied their clinical quality measures 
reporting requirement as a group for the Medicare EHR Incentive 
Program. The Medicare Shared Savings Program does not require the use 
of Certified EHR Technology. However, all clinical quality measures 
data must be extracted from Certified EHR Technology in order for the 
EP to qualify for the Medicare EHR Incentive Program if an EP intends 
to use this group reporting option. EPs must still individually satisfy 
the objectives and associated measures for their respective stage of 
meaningful use, in addition to submitting clinical quality measures as 
part of an ACO. EPs who are part of an ACO but do not enter the data 
used for reporting the clinical quality measures (which excludes the 
survey tool or claims-based measures that are collected to calculate 
the quality performance score in the Medicare Shared Savings Program) 
into Certified EHR Technology would not be able to meet meaningful use 
requirements. (For more information about the requirements of the 
Medicare Shared Savings Program, see 42 CFR part 425 and the final rule 
published at 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 Shared Savings Program that may apply in the 
future. EPs must be part of a group practice (that is, two or more 
eligible professionals, 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 Physician Quality Reporting 
System clinical quality measures using Certified EHR Technology under 
the Physician Quality Reporting System Group Practice Reporting Option, 
would be considered to have satisfied their clinical quality measures 
reporting requirement as a group for the Medicare EHR Incentive 
Program. For more information about the Physician Quality Reporting 
System Group Practice Reporting Option, see 42 CFR 414.90 and the CY 
2012 Medicare Physician Fee Schedule final rule (76 FR 73314). EPs who 
use this group reporting option for the Medicare EHR Incentive Program 
would be required to comply with any changes to the Physician Quality 
Reporting System Group Practice Reporting Option that may apply in the 
future and must still individually satisfy the objectives and 
associated measures for their respective stage of meaningful use.
    States would have the option to allow group reporting of clinical 
quality measures based upon the first option previously described, 
through an update to their State Medicaid HIT Plan, and would have to 
address how they would address the issue of EPs who switch group 
practices during an EHR reporting period.
7. Proposed Clinical Quality Measures 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 clinical quality measures by eligible hospitals 
and CAHs as part of demonstrating meaningful use of Certified EHR 
Technology. 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).

[[Page 13759]]

    Section 1886(n)(3)(B)(i)(I) of the Act requires the Secretary to 
give preference to clinical quality measures 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) 
(namely, the NQF). We are proposing clinical quality measures 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 measures for the EHR 
Incentive Programs. Measures listed in this proposed 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 Certified EHR Technology under Medicare 
and Medicaid. Therefore, to meet this requirement, we continue our 
practice from Stage 1 of proposing clinical quality measures that would 
apply for both the Medicare and Medicaid EHR Incentive Programs, as 
listed in sections II.B.6.(b). and II.B.6.(c). of this proposed rule.
    In accordance with CMS and HHS quality goals as well as the HHS 
National Quality Strategy recommendations, the hospital clinical 
quality measures that we are proposing beginning with FY 2014 can be 
categorized into the following six domains, which are described in 
section II.B.3. of this proposed rule:
    <bullet> Clinical Process/Effectiveness.
    <bullet> Patient Safety.
    <bullet> Care Coordination.
    <bullet> Efficient Use of Healthcare Resources.
    <bullet> Patient & Family Engagement.
    <bullet> Population & Public Health.
    The selection of clinical quality measures we are proposing 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 Program and Hospital Value-Based 
Purchasing Program, the National Quality Strategy, and other 
considerations discussed in sections II.B.6.(b). and II.B.6.(c). of 
this proposed rule. The proposed reporting methods for Medicare 
eligible hospitals and CAHs are described in sections II.B.7.(a). and 
II.B.7.(b). of this proposed rule. The proposed reporting methods for 
Medicaid-only eligible hospitals are described in section II.B.7.(c). 
of this 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 have analyzed the 
Hospital IQR Program, hospital measures used by State Medicaid 
agencies, and the Joint Commission's hospital quality measures when 
selecting the measures to be reported under the EHR Incentive Program. 
Furthermore, we have placed emphasis on those measures that are in line 
with the National Quality Strategy and the HITPC's recommendations.
(b) Proposed Clinical Quality Measures for Eligible Hospitals and CAHs 
for FY 2013
    For the EHR reporting periods in FY 2013, we propose that the 
eligible hospitals and CAHs would be required to submit information on 
each of the 15 clinical quality measures that were finalized for FYs 
2011 and 2012 in the Stage 1 final rule (75 FR 44418 through 44420, 
Table 10). We refer readers to the discussion in the Stage 1 final rule 
for further explanation of the requirements for reporting those 
clinical quality measures (75 FR 44411 through 44422).
(c) Clinical Quality Measures Proposed for Eligible Hospitals and CAHs 
Beginning With FY 2014
    We are proposing to change the reporting requirement beginning with 
FY 2014 to require eligible hospitals and CAHs to report 24 clinical 
quality measures from a menu of 49 clinical quality measures, including 
at least 1 clinical quality measure from each of the 6 domains. The 49 
clinical quality measures would include the current set of 15 clinical 
quality measures that were finalized for FYs 2011 and 2012 in the Stage 
1 final rule as well as additional pediatric measures, an obstetric 
measure, and cardiac measures.
    Our experience from Stage 1 in implementing the current set of 15 
clinical quality measures in specialty and low volume eligible 
hospitals has 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 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 clinical quality 
measures for stroke and VTE. We are considering 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 measures. 
Hospitals that do not have enough cases to exceed the threshold would 
be exempt from reporting certain clinical quality measures. We solicit 
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 clinical quality measures (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 ``zeros'' for the 
measures). We are also soliciting comment 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 more 
narrow patient base than acute care and critical access hospitals. 
Comments are solicited for application of the thresholds to Stage 1 of 
meaningful use in 2013, as the issue would be mitigated for Stages 1 
and 2 by a beginning in 2014 proposed menu set of hospital clinical 
quality measures.
    Aside from the previous threshold discussion, we are proposing 
clinical quality measures in Table 9 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. We 
propose that eligible hospitals and CAHs must report a total of 24 
clinical quality measures from those listed in Table 9. Eligible 
hospitals and CAHs would have to select and report at least 1 measure 
from each of the following 6 domains:
    <bullet> Patient and Family Engagement.
    <bullet> Patient Safety.
    <bullet> Care Coordination.
    <bullet> Population and Public Health.
    <bullet> Efficient Use of Healthcare Resources.
    <bullet> Clinical Process/Effectiveness.
    For the remaining clinical quality measures, eligible hospitals and 
CAHs

[[Page 13760]]

would select and report the measures from Table 9 that best apply to 
their patient mix. We are soliciting comment on the number of measures 
and the appropriateness of the measures and domains for eligible 
hospitals and CAHs.
    If an eligible hospital's or CAH's Certified EHR Technology does 
not contain patient data for at least 24 measures, including a minimum 
of at least 1 from each domain, then the eligible hospital or CAH must 
report the measures for which there is patient data and report the 
remaining required measures as ``zero denominators'' through the form 
and manner specified by the Secretary. In the unlikely event that there 
are no measures applicable to the eligible hospital's or CAH's patient 
mix, eligible hospitals or CAHs must still report 24 measures even if 
zero is the result in either the numerator or the denominator of the 
measure. If all measures have a value of zero from their Certified EHR 
Technology, then eligible hospitals or CAHs must report any 24 of the 
measures.
    In the Stage 1 final rule (75 FR 44418), the title for the clinical 
quality measure NQF <greek-i>438 was listed as ``Ischemic or 
hemorrhagic stroke--Antithrombotic therapy by day 2.'' The corrected 
measure title, which is also included in Table 9 is ``Stroke-5 Ischemic 
stroke--Antithrombotic therapy by day 2.''
    Table 9 lists all of the clinical quality measures that we are 
proposing for eligible hospitals and CAHs to report for the EHR 
Incentive Programs beginning with FY 2014. The measures titles and 
descriptions in Table 9 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. Measures 
which are designated as ``New'' in the ``New Measures'' column were not 
finalized in the Stage 1 final rule. Some of the clinical quality 
measures in this table will require the development of electronic 
specifications. Therefore, we propose to consider these clinical 
quality measures for possible inclusion beginning with FY 2014 based on 
our expectation that their electronic specifications will be available 
at the time of or within a reasonable period the publication of the 
final rule. All clinical quality measure specification updates, 
including a schedule for updates to electronic specifications, would be 
posted on the EHR Incentive Program Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp), and we would notify 
the public.
    Additionally, some of these measures have been submitted by the 
measure steward and are currently under review for endorsement 
consideration by the National Quality Forum. The finalized list of 
clinical quality measures that would apply for eligible hospitals and 
CAHs beginning with FY 2014 will be published in the final rule.

                 Table 9--Clinical Quality Measures Proposed for Eligible Hospitals and Critical Access Hospitals Beginning With FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Other quality measure
           NQF <greek-i>                       Title             Measure steward and   programs that use the       New measure             Domain
                                                                 contact  information     same measure ***
--------------------------------------------------------------------------------------------------------------------------------------------------------
0495..............................  Title: Emergency            Oklahoma Foundation    IQR..................                        Patient and Family
                                     Department (ED)-1           for Medical Quality                                                 Engagement.
                                     Emergency Department        (OFMQ) www.ofmq.com
                                     Throughput--Median time     and click on
                                     from ED arrival to ED       ``Contact''.
                                     departure for admitted ED
                                     patients.
                                    Description: Median time
                                     from emergency department
                                     arrival to time of
                                     departure from the
                                     emergency room for
                                     patients admitted to the
                                     facility from the
                                     emergency department..
0497..............................  Title: ED-2 Emergency       Oklahoma Foundation    IQR..................                        Patient and Family
                                     Department Throughput--     for Medical Quality                                                 Engagement.
                                     admitted patients--Admit    (OFMQ) www.ofmq.com
                                     decision time to ED         and click on
                                     departure time for          ``Contact''.
                                     admitted patients.
                                    Description: Median time
                                     from admit decision time
                                     to time of departure from
                                     the emergency department
                                     for emergency department
                                     patients admitted to
                                     inpatient status.
0435..............................  Title: Stroke-2 Ischemic    The Joint Commission   IQR..................                        Clinical Process/
                                     stroke--Discharged on       www.jointcommission.                                                Effectiveness.
                                     anti-thrombotic therapy.    org and click on
                                    Description: Ischemic        ``Contact Us''.
                                     stroke patients
                                     prescribed antithrombotic
                                     therapy at hospital
                                     discharge.
0436..............................  Title: Stroke-3 Ischemic    The Joint Commission   IQR..................                        Clinical Process/
                                     stroke--Anticoagulation     www.jointcommission.                                                Effectiveness.
                                     Therapy for Atrial          org and click on
                                     Fibrillation/Flutter.       ``Contact Us''.
                                    Description: Ischemic
                                     stroke patients with
                                     atrial fibrillation/
                                     flutter who are
                                     prescribed
                                     anticoagulation therapy
                                     at hospital discharge.
0437..............................  Title: Stroke-4 Ischemic    The Joint Commission   IQR..................                        Clinical Process/
                                     stroke--Thrombolytic        www.jointcommission.                                                Effectiveness.
                                     Therapy.                    org and click on
                                    Description: Acute           ``Contact Us''.
                                     ischemic stroke patients
                                     who arrive 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 Ischemic    The Joint Commission   IQR..................                        Clinical Process/
                                     stroke--Antithrombotic      www.jointcommission.                                                Effectiveness.
                                     therapy by end of           org and click on
                                     hospital day two.           ``Contact Us''.
                                    Description: Ischemic
                                     stroke patients
                                     administered
                                     antithrombotic therapy by
                                     the end of hospital day
                                     two.
0439..............................  Title: Stroke-6 Ischemic    The Joint Commission   IQR..................                        Clinical Process/
                                     stroke--Discharged on       www.jointcommission.                                                Effectiveness.
                                     Statin Medication.          org and click on
                                    Description: Ischemic        ``Contact Us''.
                                     stroke patients with 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 Ischemic    The Joint Commission   IQR..................                        Patient & Family
                                     or hemorrhagic stroke--     www.jointcommission.                                                Engagement.
                                     Stroke education.           org and click on
                                    Description: Ischemic or     ``Contact Us''.
                                     hemorrhagic stroke
                                     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 Ischemic   The Joint Commission   IQR..................                        Care Coordination.
                                     or hemorrhagic stroke--     www.jointcommission.
                                     Assessed for                org and click on
                                     Rehabilitation.             ``Contact Us''.
                                    Description: Ischemic or
                                     hemorrhagic stroke
                                     patients who were
                                     assessed for
                                     rehabilitation services.
0371..............................  Title: Venous               The Joint Commission   IQR..................                        Patient Safety.
                                     Thromboembolism (VTE)-1     www.jointcommission.
                                     VTE prophylaxis.            org and click on
                                    Description: This measure    ``Contact Us''.
                                     assesses the number of
                                     patients 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 13761]]

 
0372..............................  Title: VTE-2 Intensive      The Joint Commission   IQR..................                        Patient Safety.
                                     Care Unit (ICU) VTE         www.jointcommission.
                                     prophylaxis.                org and click on
                                    Description: This measure    ``Contact Us''.
                                     assesses the number of
                                     patients 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 Patients   The Joint Commission   IQR..................  New.................  Clinical Process/
                                     with Overlap of             www.jointcommission.                                                Effectiveness.
                                     Anticoagulation Therapy.    org and click on
                                    Description: This measure    ``Contact Us''.
                                     assesses the 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. Overlap
                                     therapy must be
                                     administered for at least
                                     five days with an
                                     international normalized
                                     ratio (INR) = 2 prior to
                                     discontinuation of the
                                     parenteral
                                     anticoagulation therapy
                                     or the patient must be
                                     discharged on both
                                     medications.
0374..............................  Title: VTE Patients         The Joint Commission   IQR..................  New.................  Clinical Process/
                                     Unfractionated Heparin      www.jointcommission.                                                Effectiveness.
                                     (UFH) Dosages/Platelet      org and click on
                                     Count Monitoring by         ``Contact Us''.
                                     Protocol (or Nomogram)
                                     Receiving Unfraction-ated
                                     Heparin (UFH) with
                                     Dosages/Platelet Count
                                     Monitored by 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 discharge  The Joint Commission   IQR..................  New.................  Patient and Family
                                     instructions.               www.jointcommission.                                                Engagement.
                                    Description: This measure    org and click on
                                     assesses the number of      ``Contact Us''.
                                     patients diagnosed with
                                     confirmed VTE that are
                                     discharged to home, to
                                     home with home health, or
                                     home hospice 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 of   The Joint Commission   IQR..................  New.................  Patient Safety.
                                     potentially preventable     www.jointcommission.
                                     VTE.                        org and click on
                                    Description: This measure    ``Contact Us''.
                                     assesses the number of
                                     patients diagnosed with
                                     confirmed VTE during
                                     hospitalization (not
                                     present on arrival) who
                                     did not receive VTE
                                     prophylaxis between
                                     hospital admission and
                                     the day before the VTE
                                     diagnostic testing order
                                     date.
0132..............................  Title: AMI-1-Aspirin at     The Joint Commission   IQR, TJC.............  New.................  Clinical Process/
                                     arrival for acute           (TJC)                                                               Effectiveness.
                                     myocardial infarction       www.jointcommission.
                                     (AMI).                      org and click on
                                    Description: Percentage of   ``Contact Us''.
                                     acute myocardial
                                     infarction (AMI) patients
                                     without aspirin
                                     contraindications who
                                     received aspirin within
                                     24 hours before or after
                                     hospital arrival.
0142..............................  Title: AMI-2-Aspirin        The Joint Commission   IQR..................  New.................  Clinical Process/
                                     Prescribed at Discharge     (TJC)                                                               Effectiveness.
                                     for AMI.                    www.jointcommission.
                                    Description: Percentage of   org and click on
                                     acute myocardial            ``Contact Us''.
                                     infarction (AMI) patients
                                     without aspirin
                                     contraindications who are
                                     prescribed aspirin at
                                     hospital discharge.
0469..............................  Title: Elective Delivery    The Joint Commission   TJC..................                        Clinical Process/
                                     Prior to 39 Completed       (TJC)                                                               Effectiveness.
                                     Weeks Gestation.            www.jointcommission.
                                    Description: Percentage of   org and click on
                                     babies electively           ``Contact Us''.
                                     delivered prior to 39
                                     completed weeks gestation.
0137..............................  Title: AMI-3-ACEI or ARB    The Joint Commission   IQR..................  New.................  Clinical Process/
                                     for Left Ventricular        (TJC)                                                               Effectiveness.
                                     Systolic Dysfunction-       www.jointcommission.
                                     Acute Myocardial            org and click on
                                     Infarction (AMI) Patients.  ``Contact Us''.
                                    Description: Percentage of
                                     acute myocardial
                                     infarction (AMI) patients
                                     with left ventricular
                                     systolic dysfunction
                                     (LVSD) and without both
                                     Angiotensin converting
                                     enzyme inhibitor (ACEI)
                                     and Angiotensin receptor
                                     blocker (ARB)
                                     contraindications who are
                                     prescribed an ACEI or ARB
                                     at hospital discharge.
                                     For purposes of this
                                     measure, LVSD is defined
                                     as chart documentation of
                                     a left ventricular
                                     ejection fraction (LVEF)
                                     less than 40% or a
                                     narrative description of
                                     left ventricular systolic
                                     (LVS) function consistent
                                     with moderate or severe
                                     systolic dysfunction.
0160..............................  Title: AMI-5-Beta Blocker   The Joint Commission   IQR..................  New.................  Clinical Process/
                                     Prescribed at Discharge     (TJC)                                                               Effectiveness.
                                     for AMI.                    www.jointcommission.
                                    Description: Percentage of   org and click on
                                     acute myocardial            ``Contact Us''.
                                     infarction (AMI) patients
                                     without beta blocker
                                     contraindications who are
                                     prescribed a beta blocker
                                     at hospital discharge.
0164..............................  Title: AMI-7a-Fibrinolytic  The Joint Commission   IQR, HVBP............  New.................  Clinical Process/
                                     Therapy received within     (TJC)                                                               Effectiveness.
                                     30 minutes of hospital      www.jointcommission.
                                     arrival.                    org and click on
                                    Description: Percentage of   ``Contact Us''.
                                     acute myocardial
                                     infarction (AMI) patients
                                     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       The Joint Commission   IQR, HVBP............  New.................  Clinical Process/
                                     Percutaneous Coronary       (TJC)                                                               Effectiveness.
                                     Intervention (PCI).         www.jointcommission.
                                    Description: Percentage of   org and click on
                                     acute myocardial            ``Contact Us''.
                                     infarction (AMI) patients
                                     receiving percutaneous
                                     coronary intervention
                                     (PCI) during the hospital
                                     stay with a time from
                                     hospital arrival to PCI
                                     of 90 minutes or less.
0639..............................  Title: AMI-10 Statin        The Joint Commission   IQR..................  New.................  Clinical Process/
                                     Prescribed at Discharge.    (TJC)                                                               Effectiveness.
                                    Description: Percent of      www.jointcommission.
                                     acute myocardial            org and click on
                                     infarction (AMI) patients   ``Contact Us''.
                                     18 years of age or older
                                     who are prescribed a
                                     statin medication at
                                     hospital discharge.
0148..............................  Title: PN-3b-Blood          The Joint Commission   IQR, HVBP............  New.................  Efficient Use of
                                     Cultures Performed in the   (TJC)                                                               Healthcare
                                     Emergency Department        www.jointcommission.                                                Resources.
                                     Prior to Initial            org and click on
                                     Antibiotic Received in      ``Contact Us''.
                                     Hospital.
                                    Description: Percentage of
                                     pneumonia patients 18
                                     years of age and older
                                     who have had blood
                                     cultures performed in the
                                     emergency department
                                     prior to initial
                                     antibiotic received in
                                     hospital.
0147..............................  Title: PN-6-Initial         The Joint Commission   IQR, HVBP............  New.................  Efficient Use of
                                     Antibiotic Selection for    (TJC)                                                               Healthcare
                                     Community-Acquired          www.jointcommission.                                                Resources.
                                     Pneumonia (CAP) in          org and click on
                                     Immunocompetent Patients.   ``Contact Us''.
                                    Description: Percentage of
                                     pneumonia patients 18
                                     years of age or older
                                     selected for initial
                                     receipts of antibiotics
                                     for community-acquired
                                     pneumonia (CAP).

[[Page 13762]]

 
0527..............................  Title: SCIP-INF-1           The Joint Commission   IQR, HVBP............  New.................  Patient Safety.
                                     Prophylactic Antibiotic     (TJC)
                                     Received within 1 Hour      www.jointcommission.
                                     Prior to Surgical           org and click on
                                     Incision.                   ``Contact Us''.
                                    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-          The Joint Commission   IQR, HVBP............  New.................  Efficient Use of
                                     Prophylactic Antibiotic     (TJC)                                                               Healthcare
                                     Selection for Surgical      www.jointcommission.                                                Resources.
                                     Patients.                   org and click on
                                    Description: Surgical        ``Contact Us''.
                                     patients who received
                                     prophylactic antibiotics
                                     consistent with current
                                     guidelines (specific to
                                     each type of surgical
                                     procedure).
0529..............................  Title: SCIP-INF-3-          The Joint Commission   IQR, HVBP, State use.  New.................  Efficient Use of
                                     Prophylactic Antibiotics    (TJC)                                                               Healthcare
                                     Discontinued Within 24      www.jointcommission.                                                Resources.
                                     Hours After Surgery End     org and click on
                                     Time.                       ``Contact Us''.
                                    Description: Surgical
                                     patients whose
                                     prophylactic antibiotics
                                     were discontinued within
                                     24 hours after Anesthesia
                                     End Time. The Society of
                                     Thoracic Surgeons (STS)
                                     Practice Guideline for
                                     Antibiotic Prophylaxis in
                                     Cardiac Surgery (2006)
                                     indicates that there is
                                     no reason to extend
                                     antibiotics beyond 48
                                     hours for cardiac surgery
                                     and very explicitly
                                     states that antibiotics
                                     should not be extended
                                     beyond 48 hours even with
                                     tubes and drains in place
                                     for cardiac surgery.
0300..............................  Title: SCIP-INF-4-Cardiac   The Joint Commission   IQR, HVBP............  New.................  Clinical Process/
                                     Patients with Controlled    (TJC)                                                               Effectiveness.
                                     6 AM Postoperative Serum    www.jointcommission.
                                     Glucose.                    org and click on
                                    Description: Percentage of   ``Contact Us''.
                                     cardiac surgery patients
                                     with controlled 6 a.m.
                                     serum glucose (</=200 mg/
                                     dl) on postoperative day
                                     (POD) 1 and POD 2.
0301..............................  Title: SCIP-INF-6-Surgery   The Joint Commission   IQR..................  New.................  Patient Safety.
                                     patients with appropriate   (TJC)
                                     hair removal.               www.jointcommission.
                                    Description: Percentage of   org and click on
                                     surgery patients with       ``Contact Us''.
                                     surgical hair site
                                     removal with clippers or
                                     depilatory or no surgical
                                     hair site removal.
0453..............................  Title: SCIP-INF-9-Urinary   The Joint Commission   IQR, TJC.............  New.................  Patient Safety.
                                     catheter removed on         (TJC)
                                     Postoperative Day 1         www.jointcommission.
                                     (POD1) or Postoperative     org and click on
                                     Day 2 (POD2) with day of    ``Contact Us''.
                                     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.
0136..............................  Title: HF-1 Heart Failure   The Joint Commission   IQR, HVBP............  New.................  Patient & Family
                                     (HF): Detailed Discharge    (TJC)                                                               Engagement.
                                     Instructions.               www.jointcommission.
                                    Description: Percentage of   org and click on
                                     heart failure patients      ``Contact Us''.
                                     discharged home with
                                     written instructions or
                                     educational material
                                     given to patient or
                                     caregiver at discharge or
                                     during the hospital stay
                                     addressing all of the
                                     following: Activity
                                     level, diet, discharge
                                     medications, follow-up
                                     appointment, weight
                                     monitoring, and what to
                                     do if symptoms worsen.
0434..............................  Title: Stroke-1 Venous      The Joint Commission   IQR..................  New.................  Patient Safety.
                                     Thromboembolism (VTE)       (TJC)
                                     Prophylaxis.                www.jointcommission.
                                    Description: Ischemic or a   org and click on
                                     hemorrhagic stroke          ``Contact Us''.
                                     patients who received VTE
                                     prophylaxis or have
                                     documentation why no VTE
                                     prophylaxis was given the
                                     day of or the day after
                                     hospital admission.
0284..............................  Title: SCIP-Card-2 Surgery  The Joint Commission   IQR, HVBP............  New.................  Clinical Process/
                                     Patients on a Beta          (TJC)                                                               Effectiveness.
                                     Blocker Therapy Prior to    www.jointcommission.
                                     Admission Who Received a    org and click on
                                     Beta Blocker During the     ``Contact Us''.
                                     Perioperative Period.
                                    Description: Percentage of
                                     patients on beta blocker
                                     therapy prior to
                                     admission who received a
                                     beta blocker during the
                                     perioperative period.
0218..............................  Title: SCIP-VTE-2 Surgery   The Joint Commission   IQR, HVBP............  New.................  Patient Safety.
                                     Patients Who Received       (TJC)
                                     Appropriate Venous          www.jointcommission.
                                     Thromboembolism (VTE)       org and click on
                                     Prophylaxis Within 24       ``Contact Us''.
                                     hours Prior to Surgery to
                                     24 Hours After Surgery
                                     End Time.
                                    Description: Percentage of
                                     surgery patients who
                                     received appropriate
                                     Venous Thromboembolism
                                     (VTE) prophylaxis within
                                     24 hours prior to surgery
                                     to 24 hours after surgery
                                     end time.
0496..............................  Title: ED-3 Description:    Oklahoma Foundation    OQR..................  New.................  Care Coordination.
                                     Median time from ED         for Medical Quality
                                     arrival to ED departure     (OFMQ) www.ofmq.com
                                     for discharged ED           and click on
                                     patients.                   ``Contact''.
                                    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 Commission   State use............  New.................  Patient & Family
                                     Plan of Care Document       (TJC)                                                               Engagement.
                                     Given to Patient/           www.jointcommission.
                                     Caregiver.                  org and click on
                                    Description: Documentation   ``Contact Us''.
                                     exists that the Home
                                     Management Plan of Care
                                     (HMPC) as a separate
                                     document, specific to the
                                     patient, was given to the
                                     patient/caregiver, prior
                                     to or upon discharge.
0341..............................  Title: PICU Pain            National Association   State use............  New.................  Patient & Family
                                     Assessment on Admission.    of Children's                                                       Engagement.
                                    Description: Percentage of   Hospitals and
                                     PICU patients receiving:    Related Institutions
                                     a. Pain assessment on       (NACHRI)
                                     admission, b. Periodic      www.nachri.org and
                                     pain assessment.            click on ``Contact
                                                                 Us''.
0342..............................  Title: PICU Periodic Pain   National Association   State use............  New.................  Patient & Family
                                     Assessment.                 of Children's                                                       Engagement.
                                    Description: Percentage of   Hospitals and
                                     PICU patients receiving:    Related Institutions
                                     a. Pain assessment on       (NACHRI)
                                     admission, b. Periodic      www.nachri.org and
                                     pain assessment.            click on ``Contact
                                                                 Us''.

[[Page 13763]]

 
0480..............................  Title: Exclusive            California Maternal    State use............  New.................  Clinical Process/
                                     Breastfeeding at Hospital   Quality Care                                                        Effectiveness.
                                     Discharge.                  Collaborative
                                    Description: Exclusive       www.cmqcc.org and
                                     Breastfeeding (BF) for      click on ``Contact
                                     the first 6 months of       Us''.
                                     neonatal life has long
                                     been the expressed goal
                                     of WHO, DHHS, APA, and
                                     ACOG. ACOG has recently
                                     reiterated its position
                                     (ACOG 2007). A recent
                                     Cochrane review
                                     substantiates the
                                     benefits (Kramer, 2002).
                                     Much evidence has now
                                     focused on the prenatal
                                     and intrapartum period as
                                     critical for the success
                                     of exclusive (or any) BF
                                     (Shealy, 2005; Taveras,
                                     2004; Petrova, 2007; CDC-
                                     MMWR, 2007). Exclusive
                                     Breastfeeding rate during
                                     birth hospital stay has
                                     been calculated by the
                                     California Department of
                                     Public Health for the
                                     last several years using
                                     newborn genetic disease
                                     testing data. HP2010 and
                                     the CDC have also been
                                     active in promoting this
                                     measure. Holding prenatal
                                     and intrapartum providers
                                     accountable is an
                                     important way to incent
                                     greater efforts during
                                     the critical prenatal and
                                     immediate postpartum
                                     periods where BF
                                     attitudes are solidified.
0481..............................  Title: First temperature    Vermont Oxford         State use............  New.................  Clinical Process/
                                     measured within one hour    Network                                                             Effectiveness.
                                     of admission to the NICU.   www.vtoxford.org and
                                    Description: Percent of      click on ``Contact
                                     NICU admissions with a      Us''.
                                     birth weight of 501-1500g
                                     with a first temperature
                                     taken within 1 hour of
                                     NICU admission.
0482..............................  Title: First NICU           Vermont Oxford         State use............  New.................  Clinical Process/
                                     Temperature < 36 degrees    Network                                                             Effectiveness.
                                     C.                          www.vtoxford.org and
                                    Description: Percent of      click on ``Contact
                                     all NICU admissions with    Us''.
                                     a birth weight of 501-
                                     1500g whose first
                                     temperature was measured
                                     within one hour of
                                     admission to the NICU and
                                     was below 36 degrees
                                     Centigrade.
0143..............................  Title: Use of relievers     The Joint Commission   State use............  New.................  Clinical Process/
                                     for inpatient asthma.       (TJC)                                                               Effectiveness.
                                    Description: Percentage of   www.jointcommission.
                                     pediatric asthma            org and click on
                                     inpatients, age 2-17, who   ``Contact Us''.
                                     were discharged with a
                                     principal diagnosis of
                                     asthma who received
                                     relievers for inpatient
                                     asthma.
0144..............................  Title: Use of systemic      The Joint Commission   State use............  New.................  Clinical Process/
                                     corticosteroids for         (TJC)                                                               Effectiveness.
                                     inpatient asthma.           www.jointcommission.
                                    Description: Percentage of   org and click on
                                     pediatric asthma            ``Contact Us''.
                                     inpatients (age 2-17
                                     years) who were
                                     discharged with principal
                                     diagnosis of asthma who
                                     received systemic
                                     corticosteroids for
                                     inpatient asthma.
0484..............................  Title: Proportion of        Vermont Oxford         State use............  New.................  Clinical Process/
                                     infants 22 to 29 weeks      Network                                                             Effectiveness.
                                     gestation treated with      www.vtoxford.org and
                                     surfactant who are          click on ``Contact
                                     treated within 2 hours of   Us''.
                                     birth.
                                    Description: Number of
                                     infants 22 to 29 weeks
                                     gestation treated with
                                     surfactant within 2 hours
                                     of birth.
0716..............................  Title: Healthy Term         California Maternal    State use............  New.................  Patient Safety.
                                     Newborn.                    Quality Care
                                    Description: Percent of      Collaborative
                                     term singleton livebirths   www.cmqcc.org and
                                     (excluding those with       click on ``Contact
                                     diagnoses originating in    Us''.
                                     the fetal period) who DO
                                     NOT have significant
                                     complications during
                                     birth or the nursery care.
1354..............................  Title: Hearing screening    CDC www.cdc.gov and    State use............  New.................  Clinical Process/
                                     prior to hospital           click on ``Contact                                                  Effectiveness.
                                     discharge (EHDI-1a).        CDC``.
                                    Description: This measure
                                     assesses the proportion
                                     of births that have been
                                     screened for hearing loss
                                     before hospital discharge.
1653..............................  Title: IMM-1 Pneumococcal   Oklahoma Foundation    IQR..................  New.................  Population/Public
                                     Immunization (PPV23).       for Medical Quality                                                 Health.
                                    Description: This            (OFMQ) www.ofmq.com
                                     prevention measure          and click on
                                     addresses acute care        ``Contact''.
                                     hospitalized inpatients
                                     65 years of age and older
                                     (IMM-1b) AND inpatients
                                     aged between 6 and 64
                                     years (IMM-1c) who are
                                     considered high risk and
                                     were screened for receipt
                                     of 23-valent pneumococcal
                                     polysaccharide vaccine
                                     (PPV23) and were
                                     vaccinated prior to
                                     discharge if indicated.
                                     The numerator captures
                                     two activities; screening
                                     and the intervention of
                                     vaccine administration
                                     when indicated. As a
                                     result, patients who had
                                     documented
                                     contraindications to
                                     PPV23, patients who were
                                     offered and declined
                                     PPV23 and patients who
                                     received PPV23 anytime in
                                     the past are captured as
                                     numerator events.
1659..............................  Title: IMM-2 Influenza      Oklahoma Foundation    IQR..................  New.................  Population/Public
                                     Immunization.               for Medical Quality                                                 Health.
                                    Description: This            (OFMQ) www.ofmq.com
                                     prevention measure          and click on
                                     addresses acute care        ``Contact''.
                                     hospitalized inpatients
                                     age 6 months and older
                                     who were screened for
                                     seasonal influenza
                                     immunization status and
                                     were vaccinated prior to
                                     discharge if indicated.
                                     The numerator captures
                                     two activities: Screening
                                     and the intervention of
                                     vaccine administration
                                     when indicated. As a
                                     result, patients who had
                                     documented
                                     contraindications to the
                                     vaccine, patients who
                                     were offered and declined
                                     the vaccine and patients
                                     who received the vaccine
                                     during the current year's
                                     influenza season but
                                     prior to the current
                                     hospitalization are
                                     captured as numerator
                                     events.
                                    Influenza (flu) is an
                                     acute, contagious, viral
                                     infection of the nose,
                                     throat and lungs
                                     (respiratory illness)
                                     caused by influenza
                                     viruses. Outbreaks of
                                     seasonal influenza occur
                                     annually during late
                                     autumn and winter months
                                     although the timing and
                                     severity of outbreaks can
                                     vary substantially from
                                     year to year and
                                     community to community.
                                     Influenza activity most
                                     often peaks in February,
                                     but can peak rarely as
                                     early as November and as
                                     late as April. In order
                                     to protect as many people
                                     as possible before
                                     influenza activity
                                     increases, most flu-
                                     vaccine is administered
                                     in September through
                                     November, but vaccine is
                                     recommended to be
                                     administered throughout
                                     the influenza season as
                                     well. Because the flu
                                     vaccine usually first
                                     becomes available in
                                     September, health systems
                                     can usually meet public
                                     and patient needs for
                                     vaccination in advance of
                                     widespread influenza
                                     circulation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
***
IQR = Inpatient Quality Reporting.
TJC = The Joint Commission.
HVBP = Hospital Value-Based Purchasing.
OQR = Outpatient Quality Reporting.


[[Page 13764]]

8. Proposed Reporting Methods for Eligible Hospitals and Critical 
Access Hospitals
(a) Reporting Methods in FY 2013
    In the CY 2012 Hospital Outpatient Prospective Payment System 
(OPPS) final rule with comment period (76 FR 74122), we implemented a 
pilot program for Medicare eligible hospitals and CAHs for 2012 that is 
intended to test and demonstrate our capacity to accept electronic 
reporting of clinical quality measure information. The title of this 
pilot program is the 2012 Medicare EHR Incentive Program Electronic 
Reporting Pilot for Eligible Hospitals and CAHs. The EHR Incentive 
Program Registration and Attestation System is located at https://ehrincentives.cms.gov/hitech/login.action.
(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 clinical quality measures selected 
by the Secretary ``in a form and manner specified by the Secretary'' as 
part of demonstrating meaningful use of Certified EHR Technology. 
Medicare eligible hospitals and CAHs that are in their first year of 
Stage 1 of meaningful use may report the 24 clinical quality measures 
from Table 9 through attestation for a continuous 90-day EHR reporting 
period as described in section II.B.1. of this proposed rule. Readers 
should refer to the discussion in the Stage 1 final rule for more 
information about reporting clinical quality measures through 
attestation (75 FR 44430 through 44431). Medicare eligible hospitals 
and CAHs would select one of the following two options for submitting 
clinical quality measures electronically.
    <bullet> Option 1: Submit the selected 24 clinical quality measures 
through a CMS-designated portal.
    For this option, the clinical quality measures 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 the 
eligible hospitals and CAHs to log into a CMS-designated portal. Once 
the eligible hospitals and CAHs have logged into the portal, they would 
be required to submit through an upload process, data that is based on 
specified structures produced as output from their Certified EHR 
Technology.
    <bullet> Option 2: Submit the selected 24 clinical quality measures 
in a manner similar to the 2012 Medicare EHR Incentive Program 
Electronic Reporting Pilot for Eligible Hospitals and CAHs using 
Certified EHR Technology.
    We propose that, as an alternative to the aggregate-level reporting 
schema described previously under Option 1, Medicare eligible hospitals 
and CAHs that successfully report measures in an electronic reporting 
method similar to the 2012 Medicare EHR Incentive Program Electronic 
Reporting Pilot for Eligible Hospitals and CAHs using Certified EHR 
Technology would satisfy their clinical quality measures 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 are considering an ``interim submission'' option for 
Medicare eligible hospitals and CAHs that are in their first year of 
Stage 1 beginning in FY 2014 and available in subsequent years 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 submit 
clinical quality measures data for a continuous 90-day EHR reporting 
period, and the data must be received no later than July 1 to meet the 
requirements of the EHR Incentive Program. We request public comment on 
this potential option.
    We are considering the following 4 options of patient population--
payer data submission characteristics:
    <bullet> All patients--Medicare only.
    <bullet> All patients--all payer.
    <bullet> Sampling--Medicare only, or
    <bullet> Sampling--all payer.
    Currently, the Hospital IQR program uses the ``sampling--all 
payer'' data submission characteristic. We request 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 
intend 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.
    We note that the Hospital IQR program does not currently have an 
electronic reporting mechanism. We invite comment on whether an 
electronic reporting option would be appropriate for the Hospital IQR 
Program and whether it would provide further alignment with the EHR 
Incentive Program.
(c) Electronic Reporting of Clinical Quality Measures for Medicaid 
Eligible Hospitals
    States that have launched their Medicaid EHR Incentive Programs 
plan to collect clinical quality measures electronically from Certified 
EHR Technology 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 Stage 1 clinical quality measures electronically 
will be similar for Stage 2. However, we note that subject to our prior 
approval, the process, requirements, and the timeline is within the 
States' purview.

C. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
    We propose 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 would 
automatically be available to the States for use in their Medicaid 
programs. The Medicare methods are segmented into clinical quality 
measures and meaningful use objectives.
b. Methods for Demonstration of the Stage 2 Criteria of Meaningful Use
    We do not propose changes to the attestation process for Stage 2 
meaningful use objectives, except the group reporting option discussed 
in section II.C.1.c. of this proposed rule. Several changes are 
proposed for clinical quality measure reporting, as discussed in 
section II.B.3. of this proposed 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 would revise Sec.  495.8 to accommodate the Stage 2 objective 
and measures, as well as changes we are making to Stage 1.
    As HIT matures we expect to base demonstration more on automated 
reporting by certified EHR technologies, such as the direct electronic 
reporting of measures both clinical and nonclinical and documented 
participation in HIE. As HIT advances we expect to move more of the 
objectives away from being demonstrated through attestation. However, 
at this time we do not believe that the advances in HIT and the 
certification of EHR technologies allow us to propose an alternative to 
attestation in this proposed rule. We continue to evaluate the possible 
alternatives to attestation and the changes to certification and/or

[[Page 13765]]

meaningful use. As discussed later, while we would continue to require 
analysis of all meaningful use measures at the individual EP, eligible 
hospital or CAH level, we are proposing a batch file process in lieu of 
individual Medicare EP attestation through the CMS Attestation Web site 
beginning with CY 2014. This batch reporting process will ensure that 
meaningful use of certified EHR technology continues to be measured at 
the individual level, while promoting efficiencies for group practices 
that must submit attestations on large groups of individuals.
    We would continue to leave open the possibility for CMS and/or the 
States to test options to utilize existing and emerging HIT products 
and infrastructure capabilities to satisfy other objectives of the 
meaningful use definition. The optional testing could involve the use 
of registries or the direct electronic reporting of some measures 
associated with the objectives of the meaningful use definition. We 
would not require any EP, eligible hospital or CAH to participate in 
this testing in either 2013 or 2014 in order to receive an incentive 
payment or avoid the payment adjustment.
c. Group Reporting Option of Meaningful Use Core and Menu Objectives 
and Associated Measures for Medicare and Medicaid EPs Beginning With CY 
2014
    For Stage 1, EPs were required to attest and report on core and 
menu objectives on an individual basis and did not have an option to 
report collectively with other EPs in the same group practice. Under 
section 1848(o)(2)(A) of the Act, the Secretary may provide for the use 
of alternative means for eligible professionals furnishing covered 
professional services in a group practice (as defined by the Secretary) 
to meet the requirements of meaningful use. For EHR reporting periods 
occurring in CY 2014 and subsequent years, we are proposing a group 
reporting option to allow Medicare EPs within a single group practice 
to report core and menu objective data through a batch file process in 
lieu of individual Medicare EP attestation through the CMS Attestation 
Web site. The purpose of proposing a group reporting option is to 
provide administrative relief to group practices that have large 
numbers of EPs who need to attest to meaningful use. This option is 
intended to allow a batch reporting of each individual EP's core and 
menu objective data, and each EP would still have to meet the required 
meaningful use thresholds independently. This option does not permit 
any EP to meet the required meaningful use thresholds through the use 
of a group average or any other method of group demonstration.
    We would establish a file format in which groups would be required 
to 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 upload.
    States would have the option of offering batch reporting of 
meaningful use data for Medicaid EPs. States would need to outline 
their approach in their State Medicaid HIT Plan.
    For purposes of this group reporting option, we propose to 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). This is the same definition as one proposed 
in the group reporting option of clinical quality measures. States 
choosing to exercise this option would 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 would 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 would 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.
    This group reporting option would be limited to data for the core 
and menu objectives, but it would not include the reporting of clinical 
quality measures, which is also required in order to demonstrate 
meaningful use and receive an EHR incentive payment. Clinical quality 
measures must be reported separately through one of the electronic 
submission options that are described in section II.B. of this proposed 
rule. Because we are proposing multiple group reporting methods for 
clinical quality measures, EPs would not have to report core and menu 
objective data in the same EHR Incentive Group as they report their 
clinical quality measures. An EP would be able to submit the core and 
menu objectives as part of a group and the clinical quality measures as 
an individual or vice versa (that is, use clinical quality group 
reporting, while using individual reporting for the core/menu 
objectives).Please note that EPs would not be required to batch report 
as part of a group, and would still be permitted to attest individually 
through the CMS Attestation Web site (as long as they did not also 
report as part of a group). In order to demonstrate meaningful use and 
avoid any payment adjustments applicable under the Medicare EHR 
Incentive Program, EPs would be required to individually meet all of 
the thresholds of the core and menu objectives. In other words, an EP 
cannot avoid payment adjustments through the use of a group average or 
any other method of group demonstration. Payment adjustments would be 
applied to individual EPs, as described in section II.C. of this 
proposed rule and not to Medicare EHR Incentive Groups.
    An EP's incentive payment would not be automatically assigned to 
the Medicare EHR Incentive Group with which they batch report under 
this option. The EP would still have to select the payee TIN during the 
registration process.
    EPs that practice in multiple practices or locations would be 
responsible for submitting complete information for all actions taken 
at practices/locations equipped with Certified EHR Technology. Under 42 
CFR 495.4, to be considered a meaningful EHR user, an EP must have 50 
percent or more of their patient encounters in practice(s) or 
location(s) where Certified EHR Technology is available. In the July 
28, 2010 final rule (75 FR 44329), we also made clear that an EP must 
include encounters for all locations equipped with Certified EHR 
Technology. We are not proposing to change these requirements in this 
rulemaking. Therefore, an EP who chooses the group reporting option 
would be required to include in such reporting core and menu objective 
information on all encounters where Certified EHR Technology is 
available, even if some encounters occurred at locations not associated 
with the EP's Medicare EHR Incentive Group. We are not proposing 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 
Certified EHR Technology could report all of their core

[[Page 13766]]

and menu objective data as part of an EHR Incentive Group in which they 
had only 5 percent of their patient encounters, provided they report 
all of the data from the other locations through the batch reporting 
process.
    We also seek public comment on a group reporting option that allows 
groups an additional reporting option in which groups report for their 
EPs a whole rather than broken out by individual EP.
    In the January 18, 2011 Federal Register (76 FR 2910), the Health 
IT Policy Committee published a request for comment, to which 422 
organizations and individuals submitted comments. In it, the committee 
invited comment on the following question, ``Should Stage 2 allow for a 
group reporting option to allow group practices to demonstrate 
meaningful use at the group level for all EPs in that group?''
    The majority of those responding to this question supported this 
approach as one reporting option for EPs. Commenters often cited that a 
group reporting option will reduce administrative burden. Many 
commenters expressed an opinion that permitting group reporting may 
harness EP competition that will improve performance with peers within 
the group practice. Furthermore, commenters also stated that this 
option would: Facilitate physician teamwork and care coordination, be 
helpful for specialists and community health centers, and highlight 
system-level performance, thus creating incentives to invest in system-
wide improvement programs.
    When commenting on the group reporting option we are providing the 
following list of suggested topics, but this list is by no means 
exhaustive:
    <bullet> What should the definition of a group be for the exercise 
of group reporting? For example, under the PQRS Group Reporting Option, 
a group is defined as a physician group practice, as defined by a 
single Tax Payer Identification Number, with 25 or more individual 
eligible professionals who have reassigned their billing rights to the 
TIN. We could adopt this definition or an alternative definition.
    <bullet> Should there be a self nomination process for groups as in 
PQRS or an alternative process for identifying groups?
    <bullet> Regarding the availability of Certified EHR Technology 
across the group, should the group be required to utilize the same 
Certified EHR Technology?
    <bullet> Should a group be eligible if Certified EHR Technology 
(same or different) is not available to all associated EPs at all 
locations?
    <bullet> Should a group be eligible if they use multiple Certified 
EHR Technologies that cannot share data easily?
    <bullet> With respect to EPs who practice in multiple groups or in 
a group and practice individually, how should meaningful use activities 
be calculated?
    <bullet> As the HITECH Act requires all meaningful users to be paid 
75 percent of all covered services, how should the covered services 
performed by EPs in another practice be assigned to the group TIN?
    <bullet> How will meaningful use activities performed at other 
groups be included?
    <bullet> Should these services be included in the attesting group, 
or should CMS just ignore this information or account for it in other 
ways?
    <bullet> How should the government address an EPs failure to meet a 
measure individually?
    <bullet> If an EP chooses not to participate in a particular 
objective should they be a meaningful EHR user under the group if their 
non-participation still allows group compliance with a percentage 
threshold?
    <bullet> How should yes/no objectives be handled in this situation?
    <bullet> Some EPs in a group participate in Medicaid while others 
participate in Medicare; what covered services should the meaningful 
use calculation capture?
    <bullet> Incentive payment assignment.
    <bullet> Should the incentive payment be reassigned to the group 
automatically or does the EP still need to assign it to the group at 
registration?
    <bullet> Should the same policy exist if the EP has covered 
services billed to other TINs?
    <bullet> How should covered services for EPs who leave a group 
during an active EHR reporting period be handled?
    <bullet> How should payment adjustments for Group reporting be 
handled?
    <bullet> What alternative options should be considered for 
reporting meaningful use, while capturing necessary data?
    For options presented, please share how each would be effectively 
implemented while meeting the objectives of the statute. For example, 
should EPs continue to report individually, use the batch file process 
proposed in this proposed rule or be included in a report of all EP 
data combined under one TIN?
2. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    In addition to the data already being collected under our 
regulations (Sec.  495.10), we propose to collect the business email 
address of EPs, eligible hospitals and CAHs to facilitate communication 
with providers. We do not propose to post this information online. We 
propose to amend Sec.  495.10 accordingly. We propose to begin 
collection 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 do 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.
3. Hospital-Based Eligible Professionals
    We propose changes to the definition of a hospital-based eligible 
professional only to recognize the determination of hospital-based once 
Medicare providers are subject to payment adjustments. We refer readers 
to section II.D.2. of this proposed rule for that discussion.
    While we are not proposing changes to the definition, we do seek 
comments on the following discussion. The definition of ``hospital-
based'' in the Social Security Act discusses the eligible professional 
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). In 
the Stage 1 final rule, we addressed comments on this portion of the 
definition (75 FR 44441). Nevertheless, during implementation of Stage 
1, we have been 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 in-patient) definition of meaningful use. These 
inquiries point out that such situations are uncommon and might not be 
generalized under the uniform definition used by place of service 
codes.
    We solicit comments on this issue. Specifically, comments should 
address and provide documentation supporting whether specialized 
hospital units are using stand-alone certified EHR technology separate 
from that of the hospital. In addition, the comments should address 
(and we would request documentation on) whether EPs are using the 
facilities and equipment of the hospital. We consider hospital 
facilities and equipment to refer to the physical

[[Page 13767]]

environment needed to support the necessary hardware; internet access 
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.
    Thus, comments should address whether EPs using stand-alone 
certified EHR technology separate from that of the hospital, are truly 
not accessing the facilities and equipment of the hospitals. We would 
appreciate discussions of EP workflow to demonstrate how the EPs avoid 
use of such facilities and equipment.
    Were we to adopt a policy on this issue, we believe additional 
attestation elements would need to be added to the determination of 
whether an EP is hospital-based. Such attestations would be subject to 
audit and the False Claims Act. In addition, were we to adopt a policy 
on this issue, EPs found not to be hospital-based would not only be 
potentially eligible for incentive payments, but also subject to 
payment adjustments under Medicare.
    We also request 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 would 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.
    We reiterate this policy in section II.A.3.d.(2). of this proposed 
rule, where we explain that all meaningful use policies for EPs apply 
only to outpatient settings (all settings except the inpatient and 
emergency department of a hospital). Some of our meaningful use 
criteria for EPs are measured based on office visits (clinical 
summaries) and others assume an outpatient type of setting (patient 
reminders). The certification rules at 45 CFR part 170 differentiate 
between ambulatory and inpatient EHRs, and it is unclear whether the 
EPs in this case would have inpatient or ambulatory technology. We 
request comments on this issue. Finally, we request comments as to 
whether patients affected by this situation would essentially be 
``double-counted;'' once for the hospital's EHR incentive payment, and 
once for the EP's incentive payment, and whether and how this issue 
should be addressed, such as potentially excluding discharges 
associated with EPs who receive an incentive payment based upon the 
same inpatient.
4. Interaction With Other Programs
    There are no proposed changes to the ability of providers to 
participate in the Medicare and Medicaid EHR incentive programs and 
other CMS programs. 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 proposed rule 
for the proposed alignment initiatives for clinical quality measures.

D. Medicare Fee-for-Service

1. General Background and Statutory Basis
    As we discussed in the Stage 1 final rule (75 FR 44447), sections 
4101(a) and 4102(a) of the HITECH Act amended sections 1848, 1886, and 
1814(l) of the Act to provide for incentive payments to EPs, hospitals, 
and CAHs that are meaningful users of certified EHR technology. 
Depending upon when the EP, hospital, or CAH first qualifies as a 
meaningful user of EHR technology, these incentive payments could begin 
as early as CY 2011 for EPs, FY 2011 for hospitals, or a cost reporting 
period beginning during FY 2011 for CAHs. In no case may these 
incentive payments be made later than CY 2016 for EPs, FY 2016 for 
hospitals or a cost reporting period beginning after the end of FY 2015 
for CAHs.
    As we also discussed in the Stage 1 final rule, sections 4101(b) 
and 4102(b) of the HITECH Act provide as well for reductions in 
payments to EPs, hospitals, and CAHs that are not meaningful users of 
certified EHR technology, 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 proposals for implementing these mandatory 
payment reductions.
2. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs 
Who Are Not Meaningful Users of Certified EHR Technology
    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 who are not meaningful EHR users during the 
relevant EHR reporting period for the year. (As defined in Sec.  
495.100 of the regulations, for these purposes an EP is a physician, 
which includes a doctor of medicine or osteopathy, a doctor of dental 
surgery or medicine, a doctor of podiatric medicine, a doctor of 
optometry, or a chiropractor.) 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 would 
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: 
``(1) for 2015, 99 percent (or, in the case of an EP who was subject to 
the application of the payment adjustment if the EP is not a successful 
electronic prescriber in 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.''
    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 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.

[[Page 13768]]

a. Applicable Payment Adjustments for EPs Who Are Not Meaningful Users 
of Certified EHR Technology in CY 2015 and Subsequent Calendar Years
    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 would 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 are proposing 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. We expect to base the determination each year on the most 
recent CY for which we have sufficient data. The computation would be 
based on the ratio of EPs who have qualified as meaningful users in the 
numerator, to Medicare-enrolled EPs in the denominator. We note that 
the statute requires us to base this determination on ``the proportion 
of eligible professionals who are meaningful EHR users (as determined 
under subsection (o)(2).'' Both hospital-based EPs and EPs who have 
been granted any of the exceptions that we are proposing remain EPs 
within the statutory definition of the term, as implemented in our 
regulations in Sec.  495.100 of our regulations. However, hospital-
based EPs and EPs granted a exception would not be subject to the 
determination of meaningful use status ``under subsection (o)(2).'' 
Therefore, we are proposing to exclude from the denominator of the 
requisite ratio both the total number of EPs granted an exception in 
the most recent CY for which we have sufficient data, and all hospital-
based EPs from the relevant period. We anticipate that we would compute 
the requisite ratio of EPs who are meaningful EHR users based on 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 would provide more specific detail on this computation 
in future guidance after the final regulation is published. We note 
that, in general terms, these two 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 would 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 also subject 
to the application of the payment adjustment for e-prescribing under 
section 1848(a)(5) of the Act would be 98 percent of the Medicare PFS 
amount. In CY 2016, the adjustment to the Medicare PFS amount that 
would otherwise apply will be 98 percent. Similarly, the adjustment to 
the Medicare PFS amount that would otherwise apply would 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.
    It is important to note 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 certified 
EHR technology, as provided in Sec.  495.8(a)(2)(iv). However, AIU does 
not constitute meaningful use of certified EHR technology. Therefore, 
those EPs who receive an incentive payment for AIU would 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 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 
participation). 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.

 Table 10--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That the Secretary Finds That Less Than
                   75 Percent of EPs Are Meaningful EHR Users for CY 2018 and Subsequent Years
----------------------------------------------------------------------------------------------------------------
                                                              2015     2016     2017     2018     2019    2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment adjustment for e-               99       98       97       96       95       95
 prescribing in 2014......................................
EP is subject to the payment adjustment for e-prescribing        98       98       97       96       95       95
 in 2014..................................................
----------------------------------------------------------------------------------------------------------------


 Table 11--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That the Secretary Always Finds That at
                Least 75 Percent of EPs Are Meaningful EHR Users for CY 2018 and Subsequent Years
----------------------------------------------------------------------------------------------------------------
                                                              2015     2016     2017     2018     2019    2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment adjustment for e-               99       98       97       97       97       97
 prescribing in 2014......................................
EP is subject to the payment adjustment for e-prescribing        98       98       97       97       97       97
 in 2014..................................................
----------------------------------------------------------------------------------------------------------------


[[Page 13769]]

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 would 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 the case of EPs, we have 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. 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 discuss in the separate sections later 
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 do 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 are proposing that EHR reporting periods for payment 
adjustments would begin and end prior to the year of the payment 
adjustment. Furthermore, we are proposing 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 believe that the following rules should 
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 second bulleted paragraph, we propose 
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 2013. This proposal would align reporting 
periods for multiple physician reporting programs. For EPs this would 
generally be a full calendar year (unless 2013 is the first year of 
demonstrating meaningful use, in which case a 90-day EHR reporting 
period would apply). Under this 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 
for 2013 would be subject to a payment adjustment in 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 CY 2015, the EHR reporting period for the payment 
adjustment would continue to be the calendar year 2 years prior to the 
payment adjustment period, subject again to the special exception for 
new meaningful users of the Certified EHR Technology as follows:
    We would create an exception for those EPs who have never 
successfully attested to meaningful use in the past nor during the 
regular EHR reporting period we are proposing in the first bulleted 
paragraph. For these EPs, as it is their first year of demonstrating 
meaningful use, for the 2015 payment adjustment, we propose 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 actually 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, this means specifically that 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, is October 1, 2014. Thus, the EP's EHR reporting period must 
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). 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.
    We believe that these proposed EHR reporting periods provide 
adequate time both for the systems changes that will be required for us 
to apply any applicable payment adjustments in CY 2015 and subsequent 
years, and for EPs 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 
reasonable opportunity to establish their meaningful use of the 
technology and to avoid application of the payment adjustments. We 
welcome comments on this proposal.
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 would 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, we believe 
that given the timeframes of the HITECH Act payment adjustments there 
are hardships for which an exception should be granted. We propose 
three types of exceptions in this proposed rule and are considering a 
potential fourth. We request public comments on all four exception 
options. Three types are by definition time limited and should not be 
at risk of existing for more than 5 years. The

[[Page 13770]]

potential fourth refers to barriers facing EPs as discussed further. We 
believe that these barriers will be lowered over time as internet 
access, health information exchange and Certified EHR Technology itself 
becomes available more widely. However, we note that the 5 year 
limitation is statutory and cannot be altered by regulations.
    In the Stage 1 final rule, we provided for this exception in our 
regulations at Sec.  495.102(d)(3). However, we did not specify the 
specific circumstances, process, or period for which an exception would 
be granted. We therefore propose to modify the provision (in a 
renumbered Sec.  495.102(d)(4)) to specify the circumstances under 
which an exception would be granted.
    First, we propose that the Secretary may grant an exception to EPs 
who practice in areas without sufficient Internet access. This is in 
keeping with the language at section 1848(a)(7)(B) of the Act that a 
significant hardship may exist ``in the case of an eligible 
professional who practices in a rural area without sufficient Internet 
access.'' It also recognizes that a non-rural 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.
    Because exceptions on the basis of insufficient Internet 
connectivity must intrinsically be considered on a case-by-case basis, 
we believe that it is appropriate to require EPs to demonstrate 
insufficient Internet connectivity to qualify for the exception through 
an application process. As we have noted, 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, summary of care documents, electronic 
prescribing, making health information available online and submission 
of public health information. Therefore, we believe that the 
application must demonstrate insufficient Internet connectivity to 
comply with the meaningful use objectives listed previously and 
insurmountable barriers to obtaining such infrastructure, such as a 
high cost of extending the Internet infrastructure to their facility. 
The hardship would be shown for the year that is 2 years prior to the 
payment adjustment year. We would 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.
    We are proposing to establish the hardship period 2 years prior to 
the payment adjustment year because, by definition, the majority of EPs 
without sufficient Internet connectivity would not have previously been 
meaningful EHR users. EPs who have never demonstrated meaningful use 
would generally have a short (90-day) EHR reporting period that occurs 
in the year before the payment adjustment year. However, if there is 
insufficient Internet connectivity in the year prior to that reporting 
period, we believe it is reasonable to assume that the EP would face 
hardships during the reporting period year, if the EP acquired Internet 
connectivity and then were required to obtain Certified EHR Technology, 
implement it, and become a meaningful EHR user all in the same year.
    We also encourage EPs to apply for the exception as soon as 
possible, which would be 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.
    Secondly, we propose to provide an exception for new EPs for a 
limited period of time after the EP has begun practicing. Newly 
practicing EPs would 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 are proposing that for 2 years 
after they begin practicing, EPs could receive an exception from the 
payment adjustments that would otherwise apply in CY 2015 and 
thereafter. We note that, for purposes of this exception, an EP who 
switches specialties and begins practicing under a new specialty would 
not be considered newly practicing. For example, an EP who begins 
practicing in CY 2015 would receive an exception from the payment 
adjustments in CYs 2015 and 2016. However, as discussed previously, the 
new EP would 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 would be subject to the payment 
adjustment in CY 2017. We will 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.
    Thirdly, we are proposing an additional exception in this proposed 
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 believe 
that it is appropriate to require EPs to qualify for the exception 
through an application process.
    We would 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 for EPs who would have otherwise be able 
to become meaningful EHR users and avoid the payment adjustment for a 
given year. Therefore, it is not necessary to account for circumstances 
that arise during a payment adjustment year, but rather those that 
arise in the two years prior to the payment adjustment year (that is in 
the calendar year immediately prior to the payment adjustment year, or 
the calendar year that is 2 years prior).
    Finally, we are soliciting comments on the appropriateness of 
granting an exception for EPs meeting certain criteria. These include--
    <bullet> 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 is able to 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.

[[Page 13771]]

Certain physicians often do not have a consultative interaction with 
the 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;
    <bullet> Lack of follow up with patients. Again, the meaningful use 
requirements for transporting information online are significantly 
easier to meet if a provider immediate contact with or follows up with 
or contact patients; and
    <bullet> Lack of control over the availability of Certified EHR 
Technology at their practice locations.
    We do not believe that any one of these barriers taken 
independently constitutes 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. One option is to provide a time-limited, two 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 is to provide such an exception with no specific time 
limit. However, we note that even under this less restrictive option, 
by statute no individual EP can receive an exception for more than five 
years. As discussed earlier, we believe the proliferation of both 
Certified EHR Technology 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 request comment on 
how soon EPs who meet the previous criteria would reasonably be able to 
achieve meaningful use.
    We believe that EPs who meet the criteria listed previously face 
unique challenges in trying to successfully achieve meaningful use. 
However, we encourage comment on whether these criteria, or additional 
criteria not accounted for in the meaningful use exclusions constitute 
a significant hardship to meeting meaningful use. For the final rule, 
we will consider whether to adopt an exception based on these or 
similar criteria, and, if so, whether such an an exception should apply 
to individual EPs or across-the-board based on specialty or other 
groupings that generally meet the appropriate criteria.
    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 penalty:

      Table 12--Timeline For Eligible Professionals (Other Than Hospital-Based) To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                     For an EP
                                                                   demonstrating
                                                                 meaningful use for
                                                                 the first time in
                                        Establish                the year prior to               Apply for an
    EP Payment adjustment year      meaningful use for    OR        the payment        OR     exception no later
         (calendar year)            the full calendar            adjustment year in                 than:
                                   year 2 years prior:          a continuous 90-day
                                                                  reporting period
                                                                 beginning no later
                                                                       than:
----------------------------------------------------------------------------------------------------------------
2015.............................  CY 2013 (with                July 3, 2014 (with           July 1, 2014.
                                    submission period            submission no
                                    the 2 months                 later than October
                                    following the end            1, 2014).
                                    of the reporting
                                    period).
2016.............................  CY 2014 (with                July 3, 2015 (with           July 1, 2015.
                                    submission period            submission no
                                    the 2 months                 later than October
                                    following the end            1, 2015).
                                    of the reporting
                                    period).
2017.............................  CY 2015 (with                July 3, 2016 (with           July 1, 2016.
                                    submission period            submission no
                                    the 2 months                 later than October
                                    following the end            1, 2016).
                                    of the reporting
                                    period).
2018.............................  CY 2016 (with                July 3, 2017 (with           July 1, 2017.
                                    submission period            submission no
                                    the 2 months                 later than October
                                    following the end            1, 2017).
                                    of the reporting
                                    period).
2019.............................  CY 2017(with                 July 3, 2018 (with           July 1, 2018.
                                    submission period            submission no
                                    the 2 months                 later than October
                                    following the end            1, 2018).
                                    of the reporting
                                    period).
----------------------------------------------------------------------------------------------------------------
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.

d. 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 believe 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 would also be subject to 
adjustments). Therefore, 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. Section 495.4 defines a hospital-based EP 
as ``an EP who furnishes 90 percent or more of his or her covered 
professional services in a hospital setting in the year preceding the 
payment year. A setting is considered a hospital setting if it is a 
site of service that would be identified by the codes used in the HIPAA 
standard transactions as an inpatient hospital, or emergency room 
setting.'' We further specified in the definition of hospital-based 
eligible professional that, 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 that 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 would 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 will retain the 
concept established in the stage 1 final rule (75 FR 44442) of making 
hospital-based determinations

[[Page 13772]]

based upon a prior fiscal year of data. However, we are concerned 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. While 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 would 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 would 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 do not 
believe this is sufficient time for the EP to implement Certified EHR 
Technology. Therefore, we are proposing 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 Certified EHR Technology and begin the EHR 
reporting period to avoid the CY 2015 payment adjustment. We consider 
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 non-hospital-based under this ``2 years prior'' policy when 
they would 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 non-hospital-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 do not 
believe the EP should be penalized for having been non-hospital based 
as of January 1, 2013, especially if the EP has never demonstrated 
meaningful use, and the EP's first EHR reporting period would have 
fallen within CY 2014. Therefore, for the final rule, we are 
considering 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.
3. Incentive Market Basket Adjustment Effective in FY 2015 and 
Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR 
Users
    In addition to providing for incentive payments for meaningful use 
of EHRs, 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 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 
(66\2/3\ percent of 75 percent) 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.''

Table 13--Percentage Decrease in Applicable Hospital Percentage Increase
             for Hospitals That Are Not Meaningful EHR Users
------------------------------------------------------------------------
                                                 2015     2016    2017+
------------------------------------------------------------------------
Hospital is subject to EHR payment adjustment      25%      50%      75%
------------------------------------------------------------------------

    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 
would 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 would 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 will also 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.). It is important to note the results of this policy for 
certain cases in which

[[Page 13773]]

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 would not 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 we thus continues to assign the same CCN, we 
would continue to recognize the demonstration of meaningful use under 
that CCN. The same policy would apply to 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 would 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 2779A ff.) We advise hospitals that are changing ownership, 
merging, or otherwise reorganizing to take this policy into account.
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 of this chapter, three-fourths of the applicable 
percentage change specified in paragraph (d)(1) of this section is 
reduced--
    (i) For fiscal year 2015, by 33\1/3\ percent;
    (ii) For fiscal year 2016, by 66\2/3\ percent; and
    (iii) 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 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.
    In this proposed rule, we have no further proposals specifically 
regarding the establishment of the applicable percentage increase 
adjustment for eligible hospitals who are not meaningful EHR users for 
FY 2015 and subsequent FYs beyond the provisions we have just cited. 
However, we believe that the existing regulatory provisions 
establishing the applicable percentage increase adjustment need to be 
supplemented to ensure that it is clear that 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, will be a prior EHR reporting period (as defined in 
Sec.  495.4 of the regulations). We have also proposed an amendment to 
Sec.  412.64(d) to recognize the availability of the exception, 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 issues and 
present our proposals 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'' the EHR reporting period that 
will apply ``with respect to a [calendar or 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 wish 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 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. 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 affect the settlement of final payment amounts under the cost 
report reconciliation process. Since the EHR payment adjustment in FYs 
2015 and subsequent years is an adjustment to the applicable percentage 
increase, 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 are proposing, 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 will establish EHR reporting periods that 
begin and end prior to the year of the payment adjustment. Furthermore, 
we are proposing that the EHR reporting periods for purposes of such 
determinations will be far enough in

[[Page 13774]]

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 believe that the 
following rules should apply for 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):
    <bullet> Except as provided in second bulleted paragraph, we 
propose that the EHR reporting period for the FY 2015 applicable 
percentage increase adjustment would be the same EHR reporting period 
that applies in order to receive the incentive for FY 2013. For 
hospitals this would generally be the full fiscal year (unless FY 2013 
is the first year of demonstrating meaningful use, in which case a 90-
day EHR reporting period would apply). Under this 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 would 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 would continue to be the FY 2 years before 
the payment period, subject again to the special provision for new 
meaningful users of certified EHR technology.
    <bullet> We would create an exception for those hospitals that have 
never successfully attested to meaningful use in the past nor during 
the regular EHR reporting period we are proposing in the first bulleted 
paragraph previously. For these hospitals, as it is their first year of 
demonstrating meaningful use, we propose 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 3, 2014 (allowing the hospital a 90-day EHR 
reporting period, followed by one extra day to successfully submit the 
attestation and any other information necessary to earn an incentive 
payment). 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 would 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 would need to be completed by July 1. (As we discuss later, 
exception requests would be due by the April 1 before the beginning of 
the next fiscal year.)
    In conjunction with adopting these rules for determining the EHR 
Reporting Period for determining whether a hospital is subject to the 
applicable percentage increase adjustment for FY 2015 and subsequent 
FYs, we are specifically proposing 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 believe 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 reasonable opportunity to establish their meaningful use 
of the technology and to avoid application of the payment adjustments. 
We welcome comments on this proposal.
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 would 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.
    In this proposed rule we are proposing to add a newSec.  
412.64(d)(4), specifying the circumstances under which we would 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 or 
both of the following criteria.
    As noted previously, the statute does not mandate the circumstances 
under which an exception must be granted, 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 would result in a 
significant hardship, such as in the case of a hospital in a rural area 
without sufficient Internet access.'' We are therefore proposing 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 non-rural area may also lack sufficient Internet 
access to make complying with meaningful use requirements a significant 
hardship for a hospital. Therefore, we are providing 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 believe that it is appropriate to require hospitals to demonstrate 
insufficient Internet connectivity to qualify for the exception through 
an application process. The

[[Page 13775]]

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 believe 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 would 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 would 
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.)
    For the same reasons we are proposing an exception for new EPs, we 
propose an exception for a new hospital for a limited period of time 
after it has begun services. We would 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, it is 
important to ensure that the exception is not 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, 
the following hospitals would not be considered new hospitals 
exception:
    <bullet> 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.
    <bullet> A hospital that closes and subsequently reopens.
    <bullet> A hospital that has been in operation for more than 2 
years but has participated in the Medicare program for less than 2 
years.
    <bullet> 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 would 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 this 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 would 
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 would allow the CAH to register its 
meaningful use designation obtained under its previous CCN in order to 
avoid being subject the hospital payment adjustment. It is worth noting 
that we have 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 welcome comment concerning the appropriateness of 
adapting these rules to the exception under the EHR program, and about 
whether modifications or other revisions to these rules would be 
appropriate in the EHR context.
    Finally, we are proposing an additional exception in this proposed 
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.
    We would 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. The purpose of this exception is for hospitals who 
would have otherwise be able to become meaningful EHR users and avoid 
the payment adjustment for a given year. Therefore, it is not necessary 
to account for circumstances that arise during a payment adjustment 
year, but rather those that arise in the 2 years prior to the payment 
adjustment year.
    The following table 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.

[[Page 13776]]



                      Table 14--Timeline for Eligible Hospitals To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                  For an eligible
                                                                      hospital
                                                                   demonstrating
                                                                 meaningful use for
                                        Establish                the first time in
Hospital payment  adjustment year   meaningful use the           the year prior to               Apply for an
           (fiscal year)           full  fiscal year 2    OR        the  payment       OR     exception no later
                                       years prior:             adjustment year use                 than:
                                                                 a  continuous 90-
                                                                   day reporting
                                                                period beginning no
                                                                    later than:
----------------------------------------------------------------------------------------------------------------
2015.............................  FY 2013 (with                April 3, 2014 (with          April 1, 2014.
                                    submission period            submission no
                                    the 2 months                 later than July 1,
                                    following the end            2014).
                                    of the reporting
                                    period).
2016.............................  FY 2014 (with                April 3, 2015 (with          April 1, 2015.
                                    submission period            submission no
                                    the 2 months                 later than July 1,
                                    following the end            2015).
                                    of the reporting
                                    period).
2017.............................  FY 2015 (with                April 3, 2016 (with          April 1, 2016.
                                    submission period            submission no
                                    the 2 months                 later than July 1,
                                    following the end            2016).
                                    of the reporting
                                    period).
2018.............................  FY 2016 (with                April 3, 2017 (with          April 1, 2017.
                                    submission period            submission no
                                    the 2 months                 later than July 1,
                                    following the end            2017).
                                    of the reporting
                                    period).
2019.............................  FY 2017 (with                April 3, 2018 (with          April 1, 2018.
                                    submission period            submission no
                                    the 2 months                 later than July 1,
                                    following the end            2014).
                                    of the reporting
                                    period).
----------------------------------------------------------------------------------------------------------------
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.

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. Such adjustments shall 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. In this context, we would 
consider 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 propose a new Sec.  412.64(d)(5) 
that includes this statutory requirement. States operating under a 
payment waiver under section 1814(b)(3) of the Act must 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.
    In this context, we are also proposing 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).
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 would 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 certified EHR technology for an applicable reporting 
period, then for a cost reporting period that begins in FY 2015, its 
reimbursement would be reduced from 101 percent of its reasonable costs 
to 100.66 percent. For a cost reporting period beginning in FY 2016, 
its reimbursement would 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 would 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 propose 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 for its cost reporting period that begins in FY 2015. This 
differs from what is being proposed for eligible hospitals where the 
EHR reporting period will be prior to the market basket adjustment 
year. We believe 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

[[Page 13777]]

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 have proposed an amended 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 would 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).
    CAHs are required 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 
thereof) would 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.
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 are proposing to revise these regulations to align them 
with the exceptions being proposed for EPs and subsection (d) 
hospitals. As with EPs and subsection (d) hospitals CAHs could apply 
for an exception on the basis of lack of sufficient Internet 
connectivity. Applications would 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, the 
insufficient Internet connectivity would need to be demonstrated for 
each applicable payment adjustment year. For example, 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.
    As with new EPs and new eligible hospitals, we are also proposing 
an exception for a new CAH for a limited period of time after it has 
begun services. We would 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 one year after the CAH accepts its first 
patient. If the CAH is established March 15 of 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 of 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).
    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, 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.
    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 penalty 
provision in FY 2015 and subsequent years if they fail to demonstrate 
meaningful use of EHR technology during an applicable reporting period. 
Therefore, we are proposing 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, 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 are proposing 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 propose 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 propose to revise Sec.  413.70(a)(6)(ii) to 
state that the following CAHs are not newly established CAHs for 
purposes of this exception:
    <bullet> A CAH that builds new or replacement facilities at the 
same or another location even if coincidental

[[Page 13778]]

with a change of ownership, a change in management, or a lease 
arrangement.
    <bullet> A CAH that closes and subsequently reopens.
    <bullet> A CAH that has been in operation for more than 1 year but 
has participated in the Medicare program for less than 1 year.
    <bullet> A CAH that has been converted from an eligible subsection 
(d) hospital.
    Finally, we are proposing an additional exception in this proposed 
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.
    As described previously, we are proposing 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 that EHR reporting 
period (or November 30th of the subsequent EHR reporting period) 
otherwise the payment penalty could be applied to the CAH's cost 
reporting period that begins in that payment adjustment year. We are 
proposing 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, a CAH will be subject to the payment penalty 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 
the payment penalty will be applied. 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.
    Table 15, 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.

                             Table 15--Timeline for CAHs To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
                                                                     For a CAH
                                                                   demonstrating
                                        Establish                meaningful use for
  CAH with cost reporting period    meaningful use for           the first time, a               Apply for an
     beginning during payment       the EHR reporting     OR     continuous 90-day     OR     exception no later
         adjustment year:                period:                  reporting period                  than:
                                                                  ending no later
                                                                       than:
----------------------------------------------------------------------------------------------------------------
FY 2015..........................  FY 2015 (with                September 30, 2015           November 30, 2015.
                                    submission no                (with submission
                                    later than                   no later than
                                    November 30, 2015).          November 30, 2015).
FY 2016..........................  FY 2016 (with                September 30, 2016           November 30, 2016.
                                    submission no                (with submission
                                    later than                   no later than
                                    November 30, 2016).          November 30, 2016).
FY 2017..........................  FY 2017 (with                September 30, 2017           November 30, 2017.
                                    submission no                (with submission
                                    later than                   no later than
                                    November 30, 2017).          November 30, 2017).
FY 2018..........................  FY 2018 (with                September 30, 2018           November 30, 2018.
                                    submission no                (with submission
                                    later than                   no later than
                                    November 30, 2018).          November 30, 2018).
FY 2019..........................  FY 2019 (with                September 30, 2019           November 30, 2019.
                                    submission no                (with submission
                                    later than                   no later than
                                    November 30, 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.

5. Proposed Administrative Review Process of Certain Electronic Health 
Record Incentive Program Determinations
    The Stage 1 final rule established requirements in 42 CFR 495.370 
for States to create appeals processes under the Medicaid EHR Incentive 
Program, but did not establish an appeal process for all of the EHR 
Incentive Program. In Sec.  495.404, we are proposing a process for 
Medicare EPs, eligible hospitals, CAHs, qualifying MA organizations on 
behalf of an EP, and qualifying MA-affiliated hospitals in a limited 
circumstance to file an appeal in the Medicare FFS EHR Incentive 
Program. (See proposed Sec.  495.213 of the regulations text for a 
discussion of the appeal process proposed for the MA EHR Incentive 
Program). In Sec.  495.404(f), we are proposing an appeal process for 
Medicaid providers in a limited circumstance, specifically when we 
conduct a meaningful use audit of the Medicaid eligible hospital and 
make an adverse audit finding.
    Although 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), we believe a limited 
appeal process is warranted in certain cases involving individual 
applicability; that is, where a provider, as defined in Sec.  495.400, 
is challenging not the standards and methods themselves, but whether 
the provider met the regulatory standards and methods promulgated by 
CMS in its rules.
    The proposed administrative appeals process applies to both Stage 1 
and Stage 2 of meaningful use. We will post 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 seek 
public comments both on the guidance and the proposed rule.
    We note that in all cases, we would require that requests for 
appeals, all filings, and all supporting documentation and data be 
submitted through an online mechanism in a manner specified by CMS.

[[Page 13779]]

a. Permissible Appeals
    We propose to limit permissible appeals to the following three 
types of appeals:
(1) Eligibility Appeals
    These appeals could be filed by EPs, eligible hospitals, or CAHs. 
The provider would need to demonstrate that it meets all the EHR 
Incentive Program requirements except for the issue raised and should 
have received a payment but could not because of a circumstance outside 
the provider's control. A circumstance outside a provider's control is 
any event, as defined by us, which reasonably prevented a provider from 
participating in the EHR Incentive Program, and which the provider 
could not under any circumstance control. For example, system issues 
wholly within the control of CMS that could not be resolved to allow a 
provider to participate in the EHR Incentive Program or natural 
disasters that prevent the provider from registering or attesting might 
be circumstances outside the control of the provider, depending upon 
the specific situation.
    In limited circumstances, an MA-affiliated eligible hospital could 
also file an eligibility appeal based on common corporate governance 
with a qualifying MA organization, for which at least two thirds of the 
Medicare hospital discharges (or bed-days) are of (or for) Medicare 
individuals enrolled under MA plans or whether it meets the requirement 
of section 1853(m)(3)(B)(i) of the Act to be an MA-affiliated hospital 
because it has less than one-third of Medicare bed-days covered under 
Part A rather than Part C.
(2) Meaningful Use Appeals
    These appeals could be filed by EPs, eligible hospitals, CAHs, and 
MA organizations on behalf of MA providers to challenge adverse audit 
or other findings that the provider did not, in fact, demonstrate that 
it is a meaningful EHR user, or, that it did not demonstrate it was 
using certified EHR technology. (See section II.F. of this proposed 
rule, explaining proposed amendments to Sec.  495.316 and Sec.  
495.332). These appeals could be filed by Medicaid providers in a 
limited circumstance, specifically when we conduct a meaningful use 
audit of the Medicaid eligible hospital and make an adverse audit 
finding. States would agree in their State Medicaid Health Information 
Technology Plans (SMHPs) to be bound by our audit and appeal 
determinations on meaningful use). Medicaid EPs would continue to use 
the State appeal process for all appeals under the Medicaid EHR 
Incentive Program.
(3) Incentive Payment Appeals
    These appeals could be filed by Medicare EPs. The appeal would need 
to challenge the claims count used at attestation for determining the 
incentive payment. The appeal could not contest an individual claims 
payment or coverage decisions, but only the inclusion of final claims 
used to calculate the incentive payment amount. The appeal could also 
challenge a recoupment of an incorrect incentive payment based on any 
Federal determination (including a recoupment based on duplicative 
payment). Any issue involving incentive payment based upon a hospital 
cost report must be filed with the Provider Reimbursement and Review 
Board (PRRB); thus appeals raising hospital cost report issues will be 
dismissed in accordance with these proposed rules. However, we wish to 
make clear that the PRRB would not have jurisdiction over issues to be 
decided under the administrative process described in this proposal 
(for example, eligibility issues or whether a provider was a meaningful 
EHR user).
b. Filing Requirements
(1) Filing Deadlines
    Appeals filed by a provider after the specified deadline would be 
dismissed and could not be re-filed, except under extenuating 
circumstances. If the filing deadline falls on a Saturday, Sunday, or a 
Federal holiday, then, the filing deadline would be extended to the 
next business day. We propose the following filing deadlines for each 
appeal:
    <bullet> An eligibility appeal must be filed no later than 30 days 
after the 2-month period following the payment year.
    <bullet> A meaningful use appeal must be filed no later than 30 
days from the date of the demand letter or other finding that could 
result in the recoupment of an EHR incentive payment.
    <bullet> An incentive payment appeal must be filed no later than 60 
days from the date the incentive payment was issued or 60 days from any 
Federal determination that the incentive payment calculation was 
incorrect (including determinations that payments were duplicative).
    A provider could request to extend the filing deadline by showing 
extenuating circumstances existed, which prevented the provider from 
filing the appeal by the applicable deadline. To demonstrate 
extenuating circumstances, a provider would need to present 
documentation (in its late filing) that occurrences, events, or 
transactions prevented the provider from filing by the applicable 
deadline. Extenuating circumstances will be decided on a case-by-case 
basis. Extenuating circumstances include, but are not limited to, 
system issues that affect a provider's incentive payment. We may extend 
the filing deadline for providers in response to extenuating 
circumstances that occur within the EHR Incentive Program. We will 
provide information on our Web site at least 7 calendar days before the 
filing deadline providing the new filing deadline.
    A provider could withdraw an appeal at any time after the initial 
appeal filing and before an informal review decision is issued. The 
issues raised in the appeal filing could be refiled by the provider if 
prior to the specified filing deadline as specified in Sec.  
495.408(b).
(2) Issues Raised at Time of Filing
    A provider would be required to raise all relevant issues at the 
time of the initial filing of an appeal. Except under extenuating 
circumstances, issues not raised at the initial appeal filing could not 
be raised at a later time and would be dismissed. To demonstrate 
extenuating circumstances, a provider would need to show (in its 
amendment filing) that circumstances beyond the provider's control 
prevented all relevant issues from being included at the time of the 
initial appeal filing. For example, the provider received documentation 
from another entity after the initial appeal filing, which raised 
additional issues that should have been included in the initial appeal 
filing. The provider would be required to provide (with its amendment 
filing) documentation of occurrences, events, or transactions that 
prevented the additional issues from being raised at the initial appeal 
filing. We propose that any amendment must be filed no later than 15 
days after the initial appeal filing deadline.
c. Preclusion of Administrative and Judicial Review
    Any provider using our administrative appeal process would have the 
burden of showing at the time of the initial appeal filing that any 
issue raised in the appeal is not precluded from administrative and 
judicial review under the HITECH Act and our regulations at 42 CFR 
413.70(a)(7), 495.106(f), 495.110, 495.212. Appeal issues found to be 
precluded would be dismissed.
d. Inchoate Review
    We propose that issues raised in an appeal would also be reviewed 
for

[[Page 13780]]

premature or inchoate issues. Issues are considered inchoate or 
premature if a provider is challenging a program issue that we still 
have an opportunity to resolve before the end of the respective payment 
period as indicated in the filing deadlines. The provider would have 
the burden of demonstrating in the initial appeal filing that the 
provider allowed us an opportunity to resolve the issue, and provide 
documentation of such resolution efforts (for example, documentation 
from contacting the EHR Information Center and demonstrating the issue 
was still not resolved or a demand letter has been issued asking for 
recoupment of an incentive payment.) A provider that is unable to meet 
the burden would have their appeal dismissed and have the opportunity 
to refile when the provider can demonstrate: (1) That it has met all 
the program requirements other than the issue raised and should have 
received an incentive payment; (2) CMS was not able to resolve the 
issue before the end of the payment year; and (3) the appeal challenges 
the same program issues from the dismissed inchoate or premature appeal 
and is filed no later than 30 days after the 2-month period following 
the payment year for which the initial appeal was filed.
e. Informal Review Process Standards
    Properly filed appeals (using the filing rules discussed 
previously) would first be subject to informal review, in accordance 
with the following process and standards: For eligibility appeals, the 
provider would be required to demonstrate at the initial appeal filing 
that it meets all of the requirements of the EHR Incentive Program 
except for the issue raised, that the issue raised was the result of a 
circumstance outside of the provider's control that prevented the 
provider from receiving an incentive payment, and submit evidence that 
the provider took action to participate in the EHR Incentive Program. 
We are also proposing special rules for MA-affiliated hospitals 
appealing determinations regarding common corporate governance with a 
qualifying MA organization, for which at least two-thirds of the 
Medicare hospital discharges (or bed-days) are of (or for) Medicare 
individuals enrolled under MA plans or that the hospital has less than 
one-third of Medicare bed-days for the year covered under Part A rather 
than Part C.
    For meaningful use appeals, the provider would be required to 
demonstrate that it met the meaningful use objectives and associated 
measures discussed in the demand letter issued by CMS or other findings 
that could result in a recoupment of the EHR incentive payment and that 
the provider used certified EHR technology during the EHR reporting 
period for the payment year for which the appeal was filed.
    For incentive payment appeals, the provider would be required to 
demonstrate that all relevant claims were submitted timely, according 
to the requirements set forth in the EHR Incentive Program but that the 
timely and appropriately filed claims were not included in calculating 
the amount of the EHR incentive payment. The EHR Incentive Program 
requires all claims be filed no later than 2 months after the end of 
the payment year. Nevertheless, we believe there may be situations in 
which timely filed claims are not reflected in our integrated data 
repository (IDR) due to claims processing delays. In this case, we will 
nevertheless calculate incentive payments based on the allowed charges 
for covered professional services included in the IDR (by our deadline 
for making incentive payments). However, EPs will be able to file 
appeals of these payment amounts, if they can show that timely filed 
claims were not included in the calculation, and that they would have 
received a higher incentive payment had such claims been included. We 
believe that at the time such appeals are filed, the IDR will have more 
up-to-date information, thereby allowing us to determine these appeals 
based on the allowed charges for the timely filed claims.
f. Request for Supporting Documentation--Documentation Essential To 
Validate an Issue Raised in the Appeal
    We propose that providers would have 7 calendar days to comply with 
the request for supporting documentation. Missing this 7-day deadline 
would result in dismissal of the appeal, except in extenuating 
circumstances. A provider would be required to demonstrate that 
extenuating circumstance existed that prevented the provider from 
submitting supporting documentation within the required 7-day deadline. 
Extenuating circumstances would be decided on a case-by-case basis, for 
example, if a provider received documentation from another entity after 
the 7 calendar days to respond to the request for supporting 
documentation.
g. Informal Review Decision
    We propose that an informal review decision would be rendered 
within 90 days after the initial appeal filing, unless extensions or 
amendments are granted.
h. Final Reconsideration
    We propose that providers dissatisfied with an informal review 
decision could file a request for reconsideration of issues denied in 
the informal review decision. All comments and documentation supporting 
the provider's position that the issues denied in the appeal should 
have been approved would be required to be submitted within 15 days 
from the date of the informal review decision. Requests for 
reconsideration would be reviewed with the same standards of review as 
the informal review. One-time extensions of 15 additional days could be 
requested, if the provider could demonstrate that it did not receive 
the informal review decision within 5 days of the date on the informal 
review decision.
    We would render a final decision on the request for reconsideration 
within 10 days after the request for reconsideration and all supporting 
documentation and data are received.
    If the provider does not request reconsideration, the informal 
review decision is a final decision by CMS.
i. Exhaustion of Administrative Review
    We expect all providers to exhaust the administrative review 
process proposed in this rule, prior to seeking review in Federal 
Court.

E. Medicare Advantage Organization Incentive Payments

1. Definitions (Sec.  495.200)
    We propose to add definitions of the terms ``Adverse eligibility 
determination,'' ``Adverse payment determination'' and ``MA payment 
adjustment year.'' Please see the discussion in section II.E.5 of this 
proposed rule. We also would 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 propose 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 qualifying MA 
organizations might be considered ``hospital based'' solely on the 
basis of the fact that 90 percent of their FFS covered professional 
services

[[Page 13781]]

were provided in a hospital setting. For example, a qualifying MA EP 
might bill FFS 10 times over a year because of emergency room services 
provided to various patients. Although the vast majority of the MA EP's 
covered services were reimbursed under his or her arrangement with the 
MA organization, 100 percent (or 10) of the MA EP's FFS covered 
services would be for hospital-based services, which would otherwise 
prohibit the MA organization from receiving reimbursement under the MA 
EHR incentive program for the MA EP. We do not believe we should 
exclude MA EPs from the MA EHR Incentive Program due to only a few FFS 
claims. In addition, MA organizations may not have access to an MA EP's 
FFS covered professional service data if the professional services were 
rendered outside of the employment arrangement between the qualifying 
MA organization and the qualifying MA EP. Therefore, we are clarifying 
in the definition of ``qualifying MA EP'' 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.
2. Identification of Qualifying MA Organizations, MA-EPs and MA-
Affiliated Eligible Hospitals (Sec.  495.202)
    We propose a technical change to Sec.  495.202(b)(1) to indicate 
that the qualifying MA organizations must identify those MA EPs and MA-
affiliated eligible hospitals that the qualifying MA organization 
believes will be meaningful users of certified EHR technology during 
the reporting period, if a qualifying MA organization intends to claim 
an incentive payment for a given qualifying MA EP or MA-affiliated 
eligible hospital.
    In Sec.  495.202(b)(2), we clarify that qualifying MA organizations 
must report the CMS Certification Number (CCN) for qualifying MA-
affiliated eligible hospitals. As this program matures, this is a 
detail that became necessary to report in order to properly administer 
the program.
    We propose a new Sec.  495.202(b)(3) to include a reporting 
requirement to ensure that we can identify which qualifying MA EPs a 
given qualifying MA organization believes have furnished more than 50 
percent of his or her 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 propose to redesignate the current Sec.  495.202(b)(3) as 
(b)(4), and revise the introductory language in (b)(2) to reflect this 
redesignation.
    We require in the current Sec.  495.202(b)(3) that MA organizations 
identify qualifying MA EPs or MA-affiliated eligible hospitals within 
60 days of the close of the payment year. We are proposing to change 
the 60-day requirement to a 2-month requirement in order to be more 
consistent with the Medicare FFS EHR Incentive Program. 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 are proposing 
conforming amendments to Sec.  495.204(b)(2) and Sec.  495.210(b) and 
(c).
    Because the redesignated Sec.  495.202 (b)(4) relates to both the 
payment phase and the payment adjustment phase of the program, we added 
the word ``qualifying'' to the text of the regulation. Therefore this 
regulation applies to both qualifying MA EPs and MA-affiliated eligible 
hospitals (payment and payment adjustment phases) and potentially 
qualifying MA EPs and MA-affiliated eligible hospitals (payment 
adjustment phase) of the program.
    We redesignated the current Sec.  495.202(b)(4) as Sec.  
495.202(b)(5), and indicated that the qualifying MA organization must 
identify the MA EPs and MA-affiliated eligible hospitals that it 
believes will be both ``qualifying'' and ``potentially qualifying.'' In 
order to calculate the payment adjustment, we will need to know how 
many qualifying MA EPs and MA-affiliated eligible hospitals are and are 
not meaningful users. We also propose to correct a cross-reference.
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 propose to clarify that methods relating to 
overhead costs may be submitted for MA EPs regardless of whether the MA 
EP is salaried or paid in another fashion, such as on a capitated 
basis, where appropriate.
    As stated previously, we also propose to require MA organizations, 
to submit revenue amounts relating to their qualifying MA EPs within 2 
months of the close of the calendar year, as opposed to 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) (the current paragraph (e) would be 
redesignated paragraph (f)), we propose to add a provision governing 
whether a qualifying MA organization is entitled to a HPSA increase for 
a given qualifying MA EP. 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 if the 
MA EP predominantly furnishes his or her covered professional services 
during the MA EHR payment year in a geographic HPSA. Consistent with 
the Medicare FFS EHR Incentive Program, we interpret the term 
``predominantly'' to mean more than 50 percent. For the MA EHR 
Incentive Program, we propose 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.
    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. In order for the MA organization to receive 
the 10 percent increase, the MA EP would need 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 would need to provide more than 
$24,000 of Medicare Part B covered professional services to MA plan 
enrollees of the qualifying MA organization in order to begin earning 
the HPSA bonus--up to $26,400 to earn the maximum HPSA-enhanced bonus 
of $19,800 for first payment years 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 MAO with respect to 
the MA EP were 2011 or 2012. If an MA organization can 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, the MA organization 
could receive the entire

[[Page 13782]]

$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 are proposing a conforming amendment 
in Sec.  495.202(b)(2)(ii) to require MA organizations to notify CMS 
whether the qualifying MA EP predominantly provides covered services to 
MA plan enrollees in a HPSA.
    We also would add a new paragraph (5) to redesignated paragraph 
(f). This new paragraph (5) would clarify that if--(1) A qualifying MA 
EP; (2) an entity that employs a qualifying MA EP (or in which a 
qualifying MA EP has a partnership interest); (3) an MA-affiliated 
eligible hospital; or (4) any other party contracting with the 
qualifying MA organization, fails to comply with an audit request to 
produce documents or data needed to audit the validity of an EHR 
incentive payment, we will recoup the EHR incentive payment related to 
the applicable documents or data not produced. While we believe that we 
presently have the authority to do this under the current Sec.  
495.204(e)(4), (to be redesignated as (f)(4)), we believe it would be 
helpful for the regulations to specifically address what happens in the 
case of a failure to produce documents or data related to an audit 
request.
    We propose to add a new paragraph (g) to Sec.  495.204 to clarify 
that in the unlikely event we pay a qualifying MA organization for a 
qualifying MA EP, and it is later determined that the MA EP--(1) Is 
entitled to a full incentive payment under the Medicare FFS EHR 
Incentive Program; or (2) has received payment under the Medicaid EHR 
Incentive Program, we will recover the funds paid to the qualifying MA 
organization for such an MA EP from the MA organization. (The former 
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 by FFS to have earned the full amount. 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 now due.) If 
the organization still has an MA contract, we will recoup the amount 
from the MA organization's monthly payment under section 1853(a)(1)(A) 
of the Act. If the organization no longer has an MA contract, we will 
recoup any amounts through other means, such as formal collection. As 
duplicate and overpayments are prohibited by statute (sections 
1853(l)(3)(B), 1853(m)(3)(B), 1903(t)(2) of the Act), we would recover 
overpaid MA EHR incentive payments for all MA EHR payment years, 
including payment year 2011.
    We also clarify that, in accordance with statutory requirements, if 
it is determined that an MA organization has 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 will 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 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 duplicate and 
overpayments are prohibited by statute, this rule applies beginning 
with payment year 2011.
4. Avoiding Duplicate Payments
    Qualifying MA EPs are eligible for the Medicare FFS EHR incentive 
payment if they meet certain requirements under that program. However, 
an EHR incentive payment is only allowed under one program. We believe 
the requirement that MA organizations notify MA EPs that the MA 
organization intends to claim them for the MA EHR Incentive Program 
will minimize misunderstandings among MA EPs (particularly if they 
expect to receive an incentive payment under the Medicare FFS Incentive 
Program). It is important for MA EPs to understand certain aspects of 
the program such as when a qualifying MA organization claims an MA EP 
under the MA EHR Incentive Program and the MA EP is not entitled to a 
full FFS EHR Incentive payment, the MA organization would prevent a 
partial payment under the Medicare FFS EHR Incentive Program from being 
paid directly to the MA EP.
    We propose to require each qualifying MA organization to attest 
that it has notified the MA EPs it intends to claim. We propose 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 propose to revise Sec.  495.208 by adding--(1) A new 
paragraph (a) requiring 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) requiring qualifying MA organizations to notify MA 
EPs when they are 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) 
requiring the qualifying MA organization to attest to CMS that these 
notification requirements have been satisfied by the MA organization. 
We also propose to redesignate the current paragraphs (a) through (c) 
of Sec.  495.208 as (d) through (f), respectively.
    As discussed previously, in a revised Sec.  495.210 we are 
proposing 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.
5. Payment Adjustments Effective for 2015 And Subsequent MA Payment 
Adjustment Years (Sec.  495.211).
    Beginning in 2015, the Act 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 are proposing to add a definition of ``MA 
Payment Adjustment Year'' to the definitions in Sec.  495.200. The 
definition is needed in part because the payment adjustment phase of 
the MA EHR program continues indefinitely--beyond the last year for 
which MA EHR incentive payments can be made to qualifying MA 
organizations. Additionally, since we are proposing to operationalize 
MA EHR payment adjustments in a different manner than under the FFS 
Medicare program, we believe a definition is warranted.
    We are proposing that an MA organization must have 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 in order 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 must continue to qualify for participation in the 
program as a ``qualifying MA organization'' as defined for purposes of 
this program. Such a payment adjustment is also

[[Page 13783]]

conditioned on the qualifying MA organization having potentially 
qualifying MA EPs and MA-affiliated eligible hospitals for the 
respective payment adjustment years. We take this approach because we 
believe 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 has first demonstrated that it meets 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. Note that 
although MA EHR payment years for both MA EPs and MA-affiliated 
eligible hospitals can theoretically continue through 2016, the last 
first MA EHR payment year for which an MA organization can receive an 
EHR incentive payment is 2014 for MA EPs, and 2015 for MA-affiliated 
hospitals.
    Furthermore, we believe payment adjustments under section 1853 of 
the Act will have limited applicability in the MA EHR Incentive Program 
because the HITECH Act limits 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 are making incentive payments, and the phase of 
the program when we are adjusting payments under sections 1853(l)(4) 
and 1853(m)(4) of the Act). Section 1853(l)(5) of the Act limits which 
MA organizations may participate by defining the term ``qualifying MA 
organization.'' 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 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 manner and to the 
same extent as such an HMO.'' (See 42 U.S.C. 300gg-91). 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. Organizations 
that do not meet the PHS definition of ``HMO'' cannot 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, 1853(l)(2) of the Act requires that MA EPs be as 
described in that paragraph. 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 do not expect many qualifying MA organizations to meet this test.
    The current Sec.  495.202(b)(4) (which is being redesignated 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. This reporting requirement would include 
only qualifying MA organizations that participated in and received MA 
EHR incentive payments.
    There may be MA organizations that participated in the payment 
phase of the program that no longer, in practice, are qualifying MA 
organizations, or that no longer have qualifying MA EPs or MA-
affiliated eligible hospitals. For example, if a qualifying MA 
organization that contracted with one entity to deliver physicians' 
services during the payment phase of the EHR Incentive Program, loses 
its contract with that entity, or if the entity subsequently contracts 
with other MA organizations, the MA organization may no longer meet the 
basic requirements to participate in the program (that is, may no 
longer be subject to adjustments due to not meeting the 80/80/20 rule). 
(See Sec.  495.200, for the definition of ``Qualifying MA EP'' in the 
Stage 1 final rule). Therefore, 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 would adjust payments beginning for payment 
adjustment year 2015 only for qualifying MA organizations that received 
MA EHR payments and that have potentially qualifying MA EPs or MA-
affiliated eligible hospitals that are not meaningful EHR users. We 
would rely on the existing self-reporting requirement in redesignated 
Sec.  495.202(b)(5) and subsequent audits to ensure compliance.
    We propose 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 will 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 are proposing 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 will 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 will 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 will obviate an adjustment. Through audit 
we will verify the accuracy of an applicable MA organization's 
assertions or nonreporting.
    We are proposing 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 attests to the percent of 
hospitals and professionals that either are or are not meaningful users 
of certified EHR technology. To the extent a formerly qualifying MA 
organization does 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 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. An MA-affiliated eligible hospital 
must attest to meaningful use by November 30th. Therefore, 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

[[Page 13784]]

specific MA organization. Although we expect (and prefer) to make an 
adjustment to one MA monthly payment totaling the adjustment for the 
year, we request comments on whether more than one monthly payment 
should be adjusted. 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's monthly payment).
    For payment adjustments based on potentially qualifying MA EPs that 
are not meaningful users of certified EHR technology, we also propose 
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 
could calculate the payment adjustment based on the prior MA payment 
year's payment, and apply that adjustment to one or more of the 
prospective Part C payments. While we prefer to make an adjustment to 
one MA prospective payment for the full amount of the payment 
adjustment when possible, we solicit comment on whether we should make 
adjustments over several months or in a single month (for the entire 
adjustment amount), 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 for 
2015. However, while the payment adjustment for the 2015 payment 
adjustment year would be collected as soon as possible, 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.
    Proposed Sec.  495.211(c) makes clear that the potentially 
qualifying MA EP and MA-affiliated eligible hospital payment 
adjustments are calculated separately, and that each adjustment is 
applied to the qualifying MA organization's monthly payment under 
section 1853(a)(1)(A) of the Act, as discussed previously.
    While 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 are not meaningful 
users of certified EHR technology. This paragraph makes clear that if a 
potentially qualifying MA EP is not a meaningful user of certified EHR 
technology in payment adjustment year 2015 (and subsequent payment 
adjustment years), the qualifying MA organization's monthly Part C 
payment may 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 are claiming. 
During the payment adjustment phase of this program, we would need to 
know the percentage of both qualifying and potentially qualifying MA 
EPs and MA-affiliated eligible hospitals that are not meaningful users 
of certified EHR technology. This percentage can 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 
are not meaningful EHR users. We would use this percentage to make the 
adjustment proportional to the percent that are 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 are not meaningful users), we would exclude EPs and 
hospitals that were neither qualifying nor potentially qualifying MA 
EPs 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 is a hospital-based 
EP would not be a qualifying or potentially qualifying MA EP since such 
an EP does not meet the 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. 
The formula we are proposing for purposes of applying the payment 
adjustments proposed in Sec.  495.211(d)(2) with respect to MA EPs is:

[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 are proposing for purposes of applying 
payment adjustments in Sec.  495.211(e)(2)(iii) with respect to MA-
affiliated hospitals is:

[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) 
require 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 are 
asking for 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. Commenters should take 
into account that MA-affiliated eligible hospitals may still be 
required to perform a reporting function on behalf of their MA-
affiliated organization in the National Level Repository (NLR), and are 
generally bound to ``subsection (d)'' hospital reporting requirements 
of the NLR, so we are primarily interested in stakeholders' thoughts on 
the requirements related to MA EPs.
    While we wish to minimize burden, we are concerned about our 
ability to audit the information reported to ensure compliance with MA 
program requirements. Therefore, should we adopt the proposal in the 
final rule to require qualifying MA organizations to report only a 
percentage of MA EPs and MA-affiliated hospitals that are not 
meaningful users along with identifying information in Sec.  
495.202(b)(2)(i) through (iii), we also propose to require such 
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 propose that payment adjustments for MA EPs be calculated by 
multiplying: (1) The percent established under Sec.  495.211(d)(4) of 
this proposed rule, (which 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 are 
not meaningful users. The statute at section 1853(l)(4)(B)(i) of the 
Act says that the ``percentage points'' in section 1848(a)(7)(A)(ii) of 
the Act apply to qualifying MA organizations with potentially 
qualifying MA EPs that are not meaningful users. We would also

[[Page 13785]]

apply the additional reductions required under section 
1848(a)(7)(A)(iii) of the Act to MA payment adjustments. We propose 
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, 5 percent in 2019 and subsequent 
years. We also note that we have not proposed the possibility of a 2 
percent reduction for 2015 (consistent with the Medicare FFS EHR 
Incentive Program), because that increased reduction applies in the 
case of EPs that were subject to an adjustment in 2014 under the e-
prescribing program. MA organizations are not independently subject to 
the e-prescribing payment adjustments. Proposed regulations may be 
found in Sec.  495.211(d)(4)(iv) through (vi).
    The Medicare Physician 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 
physician services. While this proportion would be uniform across all 
MA organizations, in accordance with the requirement in section 
1853(l)(1) of the Act that payment adjustments be with respect to the 
eligible professionals described in paragraph (2) of 1853(l) of the 
Act, we also propose 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. Therefore, we would adjust each MA 
organization's Physician Expenditure Proportion to recognize that not 
all of the EPs would meet the nonmeaningful use requirements to be 
potentially qualifying or qualifying MA EPs. For example, not all EPs 
might furnish 80 percent of their Title XVIII professional services to 
enrollees of the qualifying MA organization. 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.
    An example of our proposed MA payment adjustment for adjustment 
year 2015 is 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. 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.
    The formula would result in an adjustment that is the product of 
the following:
    <bullet> Monthly Part C payment for the payment adjustment year;
    <bullet> The percentage point reduction that applies to FFS 
hospitals as a result of section 1886(b)(3)(B)(ix)(I) of the Act;
    <bullet> 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
    <bullet> 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.
    The percentage point reduction specified by section 
1886(b)(3)(B)(ix)(I) of the Act is based on the point reduction that 
results when three-fourths of the otherwise applicable percentage 
increase for the fiscal year is 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. This has 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).
    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. As mentioned previously, we propose that 
this proportion reflect only the MA-affiliated eligible hospitals that 
are either qualifying or potentially qualifying MA-affiliated eligible 
hospitals.
    We also propose to use the market basket percentage increase that 
would otherwise apply to ``subsection (d)'' hospitals for an MA payment 
adjustment year. A hypothetical example would be as follows. The market 
basket percentage increase for FY 2015 is hypothetically 4 percent. 
Three-quarters of one-third of 4 percent would be 1 percent. The 
hypothetical Medicare Hospital Expenditure proportion for the year is 
15 percent, and one of two of the relevant MA-affiliated eligible 
hospitals is not a meaningful EHR user for the applicable period (FY 
2015). The monthly payment to the MA organization in 2015 is 
$10,000,000 a month.
    The calculation would be as follows:
    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 request comment on this aspect of 
the proposed rule.
6. Reconsideration Process for MA Organizations
    We propose a new section, Sec.  495.213, which would set forth a 
reconsideration process for qualifying MA organizations that 
participate in the MA EHR Incentive Program. Under our proposal certain 
MA organization reconsiderations would be heard under the appeal 
process proposed in section II.D.5. of this proposed rule, while others 
would be heard using the process described in this section. This would 
allow us to take advantage of another reconsideration mechanism, and 
ensure consistency in decision-making for reconsiderations relating to, 
for example, meaningful use determinations.
    Although the HITECH Act prohibits both administrative and judicial 
review of the standards and methods used to determine eligibility and 
payment (sections 1853(l)(8) and (m)(6) of the

[[Page 13786]]

Act, and 42 CFR 495.212), we believe it is prudent to include a process 
for seeking reconsideration, in certain circumstances, of the 
application of those standards and methods. For eligibility issues, we 
would limit reconsiderations to those involving CMS system errors that 
did not allow the performance of a required function, and the 
qualifying MA organization or MA-affiliated eligible hospital missed a 
deadline (such as a registration or attestation deadline) because of 
such system malfunction. Thus, in Sec.  495.200 we define ``Adverse 
eligibility determination'' to include only determinations or omissions 
by CMS caused by a malfunction of a CMS system.
    For qualifying MA-affiliated eligible hospitals (either acting on 
behalf of the qualifying MA organization or where the qualifying MA 
organization acts on the hospitals' behalf), we would require using the 
reconsideration process established for hospitals under the FFS EHR 
Incentive Program (described in section II.D.5. of this proposed rule). 
Reconsiderations of adverse meaningful use audits would also be heard 
using the process described in section II.D.5. of this proposed rule.
    The remainder of this preamble discussion relates to 
reconsiderations involving eligibility and payment issues for MA EPs. 
We would conduct reconsiderations of the application of payment 
requirements to, and eligibility requirements to participate in the 
program by a given MA EP under this section. We also request comment as 
to other issues that may require reconsideration, including a 
discussion of whether the issues are within our control. For example, 
if a qualifying MA organization's system incorrectly reports the 
identities of its qualifying MA EPs to us, we do not believe this could 
be used as a ground for reconsideration, because such a determination 
would be outside of our control. Of course, if a qualifying MA 
organization over-reports, we will recoup the applicable funds related 
to the over-reporting.
    We request comment on defining the terms ``adverse payment 
determination'' and ``adverse eligibility determination.'' We 
preliminarily believe the term ``adverse eligibility determination'' 
should be defined as ``a determination or omission by CMS that 
prohibits a qualifying MA organization from participating in the EHR 
Incentive Program, that a representative of the MA organization 
believes was the result of a malfunction of a CMS system.'' We 
preliminarily believe the term ``adverse payment determination'' should 
be defined as ``a determination by CMS that negatively affects an EHR 
payment determination.''
    We also propose to hear reconsiderations of payment adjustment 
amounts, when that phase of the program occurs.
    We propose a two-level reconsideration process. The first level 
would be a request for an informal reconsideration. The second level 
would be a final reconsideration.
    Requests for informal reconsideration would need to be submitted 
within 60 calendar days of an adverse eligibility or payment 
determination. If we find against the MA organization, it will have 30 
calendar days from the date on the informal reconsideration decision to 
file a request for final reconsideration. If the 30th or 60th calendar 
day (as applicable) is a Saturday, Sunday, or a Federal holiday, the 
reconsideration request will be due by the next business day. The MA 
organization would be required to submit all evidence and data in the 
initial request for informal reconsideration; no new evidence or data 
would be permitted at the final reconsideration stage. An MA 
organization could not use the reconsideration process to submit new 
payment-related information. Failure to file an informal or final 
reconsideration request pursuant to this CMS process would result in 
eligibility or payment determinations becoming final and binding, 
absent CMS reopening due to audit or other evidence of material 
misrepresentation.

F. Proposed Revisions and Clarifications to the Medicaid EHR Incentive 
Program

    The proposals discussed in this section of the proposed rule would 
take effect upon finalization of this rule, not when Stage 2 of 
meaningful use of certified EHR technology takes effect.
1. Net Average Allowable Costs
    In this proposed 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 
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 propose 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.

[[Page 13787]]



                Table 16--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     No change.
                                                                 CMS meta-analysis,
                                                                 described in both the
                                                                 proposed rule (75 FR
                                                                 1844) and the final
                                                                 rule (75 FR 44314).
Contributions from Other Sources.....  Does not exceed $29,000  Subtracted from Average  No documentation is
                                                                 Allowable Costs to       needed. We have
                                                                 reach ``Net'' Average    determined that
                                                                 Allowable Costs. An EP   average contributions
                                                                 was required to show     do not exceed $29,000.
                                                                 documentation of 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
                                                                 demonstrate that he or   needed. Determined to
                                                                 she had contributed at   have been met by
                                                                 least 15 percent of      virtue of EP receiving
                                                                 the net average          no more than $21,250
                                                                 allowable costs          in the first payment
                                                                 towards a certified      year.
                                                                 EHR.
Incentive payment \2\................  $21,250................  85 percent of the Net    All EPs will receive
                                                                 Average Allowable        the maximum incentive
                                                                 Costs; determined        payment of $21,250, as
                                                                 through statute. An EP   all EPs will be
                                                                 could receive less       determined to have
                                                                 than this amount if he   contributions from
                                                                 or she had               other sources under
                                                                 contributions from       $29,000.
                                                                 other 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. Eligibility Requirements for Children's Hospitals
    We propose 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 that 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.
3. Medicaid Professionals Program Eligibility
    Section 1903(t) of the Act authorizes Medicaid payments to 
encourage the adoption and use of certified EHR 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 for care of Medicaid populations. Otherwise, 
Medicaid funding could potentially be used to fund adoption and use of 
technology that does not benefit the Medicaid population directly. 
Therefore, we propose that at least one of the clinical locations used 
for the calculation of an EPs' patient volume have certified EHR 
technology during the payment year for which the EP is attesting to 
adopt, implement or upgrade in their first participation year, or to 
meaningful use in subsequent years. This will ensure that EPs receive 
Medicaid funding for certified EHR technology that is used on behalf of 
the EP's Medicaid patients. We have amended Sec.  495.304 and Sec.  
495.332 accordingly.
a. Calculating Patient Volume Requirements
    We propose to revise Sec.  495.306 (c) to allow States the option 
for their 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. This option would be in addition to the current regulatory 
language basing patient volume on the prior calendar or fiscal year. We 
believe this adjustment would provide greater flexibility in eligible 
providers' patient volume calculations.
    Likewise, we propose 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 1 Medicaid encounter took 
place with the Medicaid patient in the 24 months prior to the beginning 
of the 90-day period. Also, we propose to revise Sec.  
495.306(d)(1)(ii)(A) accordingly, so that the numerator and denominator 
are using equivalent periods. Conforming changes would be made to Sec.  
495.306(d)(2)(i) and (ii) for needy individual patient volume. We are 
proposing these changes 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 propose 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.''
    We propose to expand the current definition of ``encounter'' to 
also include any service rendered on any one day to an individual 
``enrolled'' in a Medicaid program. Such a definition would 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 all of the item or service or the service is 
not covered under Medicaid). The definition would

[[Page 13788]]

also 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 CHIP programs) could be counted 
in providers' patient volume calculations. This approach is consistent 
with existing policies that provide Title XIX protections to children 
enrolled in Title XXI-funded Medicaid expansions.
    As of 2010, 33 States have Title XXI Medicaid expansions via 
approved State plan amendments. Therefore, 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 expect this change would increase the number of eligible 
providers who qualify for the Medicaid EHR Incentive Program, 
particularly those serving children. We expect that this change would 
represent an increase because States were more limited in their 
inclusion of Medicaid expansion populations based upon the July 28, 
2010 final rule.
    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 clarify 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.
b. Practices Predominantly
    Similar to our proposed revisions for patient volume, we propose to 
revise the definition of ``practices predominantly'' at Sec.  495.302. 
EPs could use either: (1) The most recent calendar year; or (2) the 
most recent 12 months prior to attestation.
4. Medicaid Hospital Incentive Payment Calculation
a. Discharge Related Amount
    In order to ensure that Medicaid regulations are consistent with 
Medicare, we are proposing 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 are 
revising our policy 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 would 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 is available.
b. Acute Care Inpatient Bed Days and Discharges for the Medicaid Share 
and Discharge-Related Amount
    We currently require that only discharges from the acute care part 
of the hospital are allowable to be counted in both the discharge-
related amount and the Medicaid share. For example, in response to a 
frequently asked question (available at https://questions.cms.hhs.gov/app/answers/detail/a_id/10361) 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.'' Also, we explained 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.
    In order to ensure that the regulations accurately reflect our 
current policy, we propose 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.
    Such regulatory amendments do not represent a change in policy but 
rather a clarification of existing policy. The Medicaid share would 
count only those days that would 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.
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 1 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 would 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 would then assume the second State's payment cycle less the 
money that was paid from the first State. States should consult with us 
before addressing this specific scenario.
5. Hospital Demonstrations of Meaningful Use--Auditing and Appeals
    We are proposing revisions to Sec.  495.316 under which we would 
conduct meaningful use audits and any subsequent appeals of such audits 
of any participating hospitals, including those that are eligible for 
only the Medicaid EHR Incentive program. In section 1903(t)(6)(C)(II) 
of the Act, all demonstrations of meaningful use must be ``acceptable 
to the Secretary'' and may be based upon methods that are adopted under 
the Medicare program in section 1886(n) of the Act. Thus, under this 
standard, we would require that all Medicaid hospitals would be subject 
to audit and appeal by CMS just for demonstrations of meaningful use. 
Therefore, States will continue to provide the remaining audit 
functions for requirements under the Medicaid

[[Page 13789]]

EHR Incentive Program. In addition (as discussed later), as we would be 
conducting the audit, hospitals would be subject to the CMS appeals 
process for any disputes regarding audit findings related to meaningful 
use, and States would be bound by our determinations regarding 
meaningful use findings. We have proposed to revise the SMHP 
requirements in Sec.  495.332 to clarify that States must indicate that 
if they are in agreement that they would be bound by our audit and 
appeal determinations in these circumstances. We also would revise our 
regulations at Sec.  495.370 to make clear that appeals of adverse CMS 
audits would be subject to the CMS administrative appeals process and 
not the State administrative process.
    We believe it is essential for us to conduct the audits and appeals 
of hospital meaningful use because 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 
successful, under the authority of section 1903(t)(8) of the Act, are 
deemed to have met the meaningful use requirements for Medicaid. This 
proposed revision would alleviate the burden on States developing 
processes, for which many States have indicated interest, and devoting 
resources to audit hospitals' meaningful use attestations when we 
estimate that a majority of States would have two or fewer Medicaid-
only hospitals apply for incentive payments. Instead, we would leverage 
the resources we would have already devoted to auditing the vast 
majority of hospitals eligible for both incentive programs, to include 
the approximately 150 hospitals that are only eligible for Medicaid 
incentives. The meaningful use attestation data collected by States for 
the Medicaid-only eligible hospitals will be shared with our auditors 
to enable this process. We are not proposing to audit Medicaid eligible 
professionals because the anticipated number of Medicaid eligible 
professionals demonstrating meaningful use would not provide the same 
level of cost/resource efficiency. However, we are leveraging our work 
in designing and implementing Medicare EP meaningful use audits by 
sharing strategic approaches with States. States 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 
would also remain responsible for auditing EPs for compliance with 
meaningful use of certified EHR technology.
    Please note that right to audit discussed in this proposed rule is 
in addition to, and not in lieu of, any other applicable rights to 
audit, such as those held by the Office of the Inspector General (OIG). 
We do not intend for anything in this rule to limit or restrict the 
authority of another Federal agency or another office within the 
Department of Health & Human Services to audit, evaluate, investigate, 
or inspect.
6. 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 are proposing 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 
propose 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 are not 
changing the requirements of the circumstances of ``as needed'' IAPD 
updates as defined by Sec.  495.340.
b. Requirements of States Transitioning from HIT Planning Advanced 
Planning Documents (P-APDs) to HIT IAPDs
    We are proposing the following process for States that have had an 
HIT P-APD approved by CMS, 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, the State should explain in a 
narrative format to be included in the HIT IAPD 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 to be ongoing during the 
implementation period, these planning activities must be included as 
line items within the HIT IAPD budget.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    This analysis serves as a revision to the existing PRA package 
approved under OMB control number 0938-1158. The following is a 
discussion of the new information collection requirements contained in 
this proposed regulation that we believe are subject to PRA. The 
projected numbers of EPs, eligible hospitals, and 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 the section V of this proposed rule. The 
actual burden would remain constant for all of Stage 2 as the EHR 
reporting period would be the entire calendar year for EPs and Federal 
fiscal year for eligible hospitals and CAHs. The only variable from 
year to year in Stage 2 would 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 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 proposed rule. 
Beginning in 2012, Medicare EPs, eligible hospitals, and CAHs have the 
option to electronically

[[Page 13790]]

report their clinical quality measures through the respective 
electronic reporting pilots. The burden for the EP pilot is discussed 
in the CY 2012 Medicare Physician Fee Schedule final rule with comment 
period (76 FR 73422 through 73425). For eligible hospitals and CAHs, 
the burden is discussed in the CY 2012 Hospital Outpatient Prospective 
Payment final rule with comment period (76 FR 74489 through 74492).

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

    In Sec.  495.6, we propose that to successfully demonstrate 
meaningful use of certified EHR technology 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 
certified EHR technology 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 propose that providers must 
also successfully report the clinical quality measures selected by CMS 
to CMS or the States, as applicable. We estimate that the certified EHR 
technology adopted by the provider will 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 will enable the functionality 
required to complete the objectives and associated measures that 
require the provider to attest that they have done so.
    We propose 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 
propose that eligible hospitals and CAHs would be required to report on 
a total of 16 core objectives and associated measures, 2 of 4 menu set 
objectives and associated measures, and 24 clinical quality measures.
    There are 13 core objectives and up to 2 menu set objectives that 
would require an EP to enter numerators and denominators during 
attestation. Eligible hospitals and CAHs would have to attest they have 
met 11 core objectives and 4 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 certified EHR technology. We do not 
anticipate a provider would maintain two recordkeeping systems when 
certified EHR technology is present. Therefore, we assume that all 
patient records that would be counted in the denominator would be kept 
using certified EHR technology. We expect it would 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 would require a ``yes'' 
or ``no'' response during attestation. For eligible hospitals and CAHs, 
there are 4 core objectives and that would require a ``yes'' or ``no'' 
response during attestation and no such menu set objectives. We expect 
that it would take a provider or their designee 1 minute to attest to 
each objective that requires a ``yes'' or ``no'' response.
    Providers would 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 17 lists those objectives and associated measures for EPs and 
eligible hospitals and CAHs. We estimate the core set of objectives and 
associated measures will take an EP 8 hours 12 minutes to complete, and 
will take an eligible hospital or CAH 7 hours 54 minutes to complete. 
For EPs, we estimate the completion of 3 menu set objectives and 
associated measures will take between 3 minutes and 21 minutes to 
complete, depending on the combination of objectives they choose to 
attest to. For EPs, we estimate the selection, preparation, and 
electronic submission of the 12 ambulatory clinical quality measures 
would take 2 hours. We estimate it would take eligible hospitals and 
CAHs 20 minutes to attest to the 2 menu set objectives they choose. For 
eligible hospitals and CAHs, we estimate the selection, preparation, 
and electronic submission of 24 required clinical quality measures 
would take 4 hours.
BILLING CODE 4120-01-P

[[Page 13791]]

[GRAPHIC] [TIFF OMITTED] TP07MR12.010


[[Page 13792]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.011


[[Page 13793]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.012


[[Page 13794]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.013


[[Page 13795]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.014


[[Page 13796]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.015


[[Page 13797]]


[GRAPHIC] [TIFF OMITTED] TP07MR12.016

BILLING CODE 4120-01-C

[[Page 13798]]

    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 12 minutes to attest that during the EHR reporting period, 
they used the certified EHR technology, specify the EHR technology used 
and satisfied each of the applicable core objectives and associated 
measures. We estimate it will take an EP 21 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 no 
longer than 3 minutes. We also estimate that it will take an EP an 
additional 2 hours 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 33 minutes. The total burden hours for an EP to attest to the 
least burdensome criteria previously specified is 10 hours 15 minutes. 
We estimate that there could be approximately 537,600 non-hospital-
based Medicare and Medicaid EPs in 2014. We anticipate approximately 
37% (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 requirement for an EP is 10 hours 33 
minutes (8 hours 12 minutes + 21 minutes + 2 hours). 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 
$188,783,003 (198,912 EPs x 10 hours 33 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 requirement 
for an EP is 10 hours 15 minutes (8 hours 12 minutes + 3 minutes + 2 
hours). 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 $183,414,766 (198,912 EPs x 10 hours 15 minutes x $89.96 
(mean hourly rate for physicians based on May 2010 BLS data)). We 
invite public comments on the estimated percentages and numbers of 
(registered) EPs that will attest to the aforementioned criteria 
because such information would help us more accurately determine the 
burden on the EPs.
    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 54 minutes to attest that 
during the EHR reporting period, they used the certified EHR 
technology, 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 20 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 4 hours 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 12 hours 14 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 proposed rule. We estimate the 
total burden associated with these requirements for an eligible 
hospital or CAH is 12 hours 14 minutes (7 hours 54 minutes + 20 minutes 
+ 4 hours). 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 $2,375,564 (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)). We invite public comments on the estimated 
percentages and numbers of (registered) eligible hospitals and CAHs 
that will attest to the aforementioned criteria because such 
information would help use more accurately determine the burden on the 
eligible hospitals and CAHs. We also invite comments on the type of 
personnel or staff that would most likely attest on behalf of the 
eligible hospital or CAH.

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

    We estimate that the burden would 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 certified EHR technology 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 certified EHR technology. In other words, 
qualifying MA organizations can make the determination en masse if the 
certified EHR technology 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 professional, 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.

[[Page 13799]]

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 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 successfully attest ([210 hrs x 
$25.00] + [44 hrs x $59.00]).

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 certified EHR 
technology 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. 
However, we are proposing 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 are proposing 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. Therefore, annual IAPD updates are only required 
if the State has not submitted an IAPD-U in the past 12 months, which 
we create less of a burden on the States. We expect that it would take 
a State 70 hours to update an annual IAPD. We believe that the proposed 
requirements 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, proposed alternatives for 
calculating patient volume will alleviate State burden as patient 
volume will be more easily calculated.

                                           Table 18--Estimated Annual Reporting and Recordkeeping Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Hourly
                                                                                               Burden per                   labor cost
                     Reg section                           OMB       Number of    Number of     response    Total annual        of       Total cost ($)
                                                       Control No.  respondents   responses     (hours)    burden (hours)   reporting
                                                                                                                               ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   495.6--EHR Technology Used, Core Set               0938-New      198,912      198,912         8.20       1,631,078       $89.96   $146,731,812.86
 Objectives/Measures incl. CQMs (EPs)................
Sec.   495.6--Menu Set Objectives/Measures (EPs) HIGH     0938-New      198,912      198,912         0.35          69,619        89.96      6,262,943.23
Sec.   495.6--Menu Set Objectives/Measures (EPs) LOW.     0938-New      198,912      198,912         0.05           9,946        89.96        894,706.18
Sec.   495.6--Menu Set Objectives/Measures (EPs)          0938-New      198,912      198,912         0.20          39,782        89.96      3,578,824.70
 AVERAGE.............................................
Sec.   495.8--CQMs for EPs...........................     0938-New      198,912      198,912         2.00         397,824        89.96     35,788,247.04
Sec.   495.6--EHR Technology Used, Core Set               0938-New        2,696        2,696         7.90          21,298        62.23      1,325,399.43
 Objectives/Measures (hospitals/CAHs)................
Sec.   495.6--Menu Set Objectives/Measures (hospitals/    0938-New        2,696        2,696         0.33             890        89.96         80,035.61
 CAHs)...............................................
Sec.   495.8--CQMs for hospitals/CAHs................     0938-New        2,696        2,696         4.00          10,784        89.96        970,128.64
Sec.   495.210--Gather information for attestation        0938-New       13,000       13,000         0.75           9,750        25.00        243,750.00
 (MA EPs)............................................
Sec.   495.210--Attesting on behalf of MA EPs........     0938-New       13,000       13,000         0.25           3,250        59.00        191,750.00
Sec.   495.210--Total cost of attestation for Stage 2     0938-New       13,000       13,000         1.00          13,000          n/a        435,500.00
 (MA EPs)............................................
Sec.   495.210--Gather information for attestation        0938-New           30           30         7.00             210        25.00          5,250.00
 (MA-affiliated hospitals)...........................
Sec.   495.210--Attesting on behalf of MA-affiliated      0938-New           30           30         1.48              44        59.00          2,619.60
 hospitals...........................................
Sec.   495.210--Total cost of attestation for Stage 2     0938-New           30           30         8.48             254          n/a          7,869.60
 (MA-affiliated hospitals)...........................
Sec.   495.342--1. Frequency of Health Information        0938-New           56           56        70.00           3,920        56.24        220,460.80
 Technology (HIT) Implementation Advanced Planning
 Document (IAPD) Updates.............................
                                                      --------------------------------------------------------------------------------------------------
    Burden Total for 2014............................  ...........  ...........  ...........  ...........    2,118,831.28  ...........       189,138,279
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: All non-whole numbers in this table are rounded to 2 decimal places.


[[Page 13800]]

    If you would like to comment on these information collection and 
recordkeeping requirements, please do either of the following:
    1. Submit your comments electronically as specified in the 
ADDRESSES section of this proposed rule; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
[CMS-0044-P] Fax: (202) 395-6974; or Email: <a href="/cdn-cgi/l/email-protection#f5babca7b4aa868097989c86869c9a9bb59a9897db909a85db929a83"><span class="__cf_email__" data-cfemail="5d12140f1c022e283f30342e2e3432331d32303f7338322d733a322b">[email protected]</span></a>.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the ``DATES'' section of this 
preamble, and, when we proceed with a subsequent document, we will 
respond to the comments in the preamble to that document.

V. Regulatory Impact Analysis

A. Statement of Need

    This proposed rule would 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 certified EHR technology. The proposed 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 proposed 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 
proposed rule.
    As noted in section I. of this proposed rule, this proposed rule is 
one of two coordinated rules related to the adoption and meaningful use 
of certified EHR technology. The other is ONC's proposed 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 2 requirements for meaningful use, the changes in quality 
measures that will take effect beginning in 2014, and other changes 
being proposed for 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 proposed provisions of the 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 certified EHR technology. Additionally, the Medicaid 
program also provides incentives for the adoption, implementation, and 
upgrade of certified EHR technology. 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 
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 would 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 impossible to predict 
with precision the timing or rates of adoption and ultimately 
meaningful use. Further, little new data is currently available 
regarding rates of adoption or costs of implementation since the 
publication of our Stage 1 final rule. Because of this continued 
uncertainty and because there is little new data on which to base 
alternate forecasts, we are maintaining the high and low estimates for 
adoption rates that we established in our Stage 1 final rule (75 FR 
44548 through 44563). Therefore, we show two scenarios, which 
illustrate how different scenarios would impact overall costs. Our high 
scenario of meaningful use demonstration assumes that by 2019, nearly 
100 percent of hospitals and 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. To emphasize the uncertainties involved, we have also 
created a low scenario estimate for the demonstration of meaningful use 
each year, which assumes less robust adoption and meaningful use. Our 
low scenario of meaningful use

[[Page 13801]]

demonstration assumes that by 2019, nearly 95.6 percent of hospitals 
and 36 percent of EPs will be meaningful users.
    Data from the EHR Incentive Program to date has shown that about 4 
percent of EPs and 8 percent of hospitals received incentive payments 
in 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. 2011 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 is not very useful in estimating 
penetration rates when stage 2 is implemented.
    Overall, we expect spending under the EHR incentive program for 
transfer payments to Medicare and Medicaid providers between 2014 and 
2019 to be $3.3 billion under the low scenario, and $12.7 billion under 
the high scenario (these estimates include net payment adjustments for 
Medicare providers who do not achieve meaningful use in 2015 and beyond 
in the amount of $3.9 billion under the high scenario and $8.1 billion 
under the low scenario). 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 who would like to qualify as 
meaningful users of EHRs will need to purchase certified EHR 
technology. However, we believe that providers who have already 
purchased certified EHR technology 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 certified EHR technology 
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 proposed rule.

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 
an Initial Regulatory Flexibility Analysis to describe and analyze the 
impact of the proposed 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 (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 Initial 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 non-certified 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 Office of the National Coordinator for 
Health IT (ONC) and the American Hospital Association (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 Centers for 
Disease Control and Prevention (CDC) survey found the percentage of 
physicians who adopted basic electronic health records (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 45,000 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 MAO 
physicians or

[[Page 13802]]

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 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 would 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 
would 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 proposed rule would 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 proposed rule would 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 would arise from the implementation of certified EHR 
technology in a rural eligible hospital would 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 have proposed certain case-by-case applications that may 
be made when there are barriers to internet connectivity that would 
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 would require spending in any 1 year 
$100 million in 1995 dollars, updated annually for inflation. In 2011, 
that threshold is approximately $136 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 rule imposes no substantial mandates on States. This program 
is voluntary for States and States offer the 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 
$136 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 proposed rule that imposes 
substantial direct requirement costs on State and local governments, 
preempts State law, or otherwise has Federalism implications. This 
proposed rule would 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 proposed 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 proposed 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 criteria for the demonstration of 
meaningful use of certified EHR technology has been

[[Page 13803]]

finalized for stage 1 and is being proposed for stage 2, 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.
    <bullet> About 570,300 Medicare FFS EPs in 2014 (some of whom will 
also be Medicaid EPs).
    <bullet> About 14 percent of the total EPs are hospital-based 
Medicare EPs, and are not eligible for the program. This leaves 
approximately 491,000 non-hospital-based Medicare EPs in 2014.
    <bullet> 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.
    <bullet> About 46,600 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners and physicians assistants) will be 
eligible to receive the Medicaid incentive payments.
    <bullet> 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).
    <bullet> All eligible hospitals, except for children's and cancer 
hospitals, may qualify and apply for both Medicare and Medicaid 
incentive payments.
    <bullet> 12 MA organizations (about 28,000 EPs, and 29 hospitals) 
would 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 proposed 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 
would be $5 million to achieve meaningful use, because providers who 
would like to qualify as meaningful users of EHRs will need to purchase 
certified EHRs. We further acknowledge that ``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 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 propose 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.
d. Costs of EHR Adoption for Eligible Hospitals
    The American Hospital Association (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 the smallest of 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, 
administrative costs related to reporting, and the like are unknown at 
this time and difficult to quantify.
4. Medicare Incentive Program Costs
    a. Medicare Eligible Professionals (EPs)
    We propose to 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

[[Page 13804]]

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 
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 would qualify for Medicaid 
incentive payments and would 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 certified EHR technology are uncertain. 
The percentage of Medicare EPs who will satisfy the criteria for 
demonstrating meaningful use of certified EHR technology 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 certified EHR technology over the 
period CYs 2014 through 2019 is as shown in Table 19.

     Table 19--Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology, High and Low Scenario
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                              2014     2015     2016     2017     2018     2019
----------------------------------------------------------------------------------------------------------------
EPs who have claims with Medicare (thousands).............    570.3    576.0    581.7    587.5    593.3    599.0
Non-Hospital Based EPs (thousands)........................    492.2    497.1    502.1    507.1    512.0    517.0
EPs that are both Medicare and Medicaid EPs (thousands)...     98.4     99.4    100.4    101.4    102.4    103.4
Low Scenario:
    Percent of EPs who are Meaningful Users...............       18       21       24       28       32       36
    Meaningful Users (thousands)..........................     70.2     83.1     97.3    112.9    129.9    148.1
High Scenario:
    Percent of EPs who are Meaningful Users...............       49       53       58       62       66       70
    Meaningful Users (thousands)..........................    192.6    212.2    231.9    251.3    270.4    288.8
----------------------------------------------------------------------------------------------------------------

    Our estimates of the incentive payment costs and payment adjustment 
savings are presented in Table 20. These costs 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 certified EHR 
technology. 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 electronic health records (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 for the low scenario of the Medicare EP portion 
of the HITECH Act are shown in Table 20.

  Table 20--Estimated Costs (+) and Savings (-) for Medicare EPS Demonstrating Meaningful Use of Certified EHR
                                            Technology, Low Scenario
                                               [In 2012 Billions]
----------------------------------------------------------------------------------------------------------------
                                                                             Payment
                         Fiscal year                           Incentive    adjustment    Benefit     Net total
                                                                payments     receipts     payments
----------------------------------------------------------------------------------------------------------------
2014........................................................         $0.6  ...........  ...........         $0.6
2015........................................................          0.5         -0.6  ...........         -0.1
2016........................................................          0.3         -1.0  ...........         -0.6

[[Page 13805]]

 
2017........................................................          0.1         -1.4  ...........         -1.3
2018........................................................  ...........         -1.6  ...........         -1.6
2019........................................................  ...........         -1.6  ...........         -1.6
----------------------------------------------------------------------------------------------------------------

    Estimated net costs for the high scenario of the Medicare EP 
portion of the HITECH Act are shown in Table 21.

  Table 21--Estimated Costs (+) and Savings (-) for Medicare EPS Demonstrating Meaningful Use of Certified EHR
                                            Technology, High Scenario
                                               [In 2012 Billions]
----------------------------------------------------------------------------------------------------------------
                                                                             Payment
                         Fiscal year                           Incentive    Adjustment    Benefit     Net Total
                                                                Payments     Receipts     Payments
----------------------------------------------------------------------------------------------------------------
2014........................................................         $1.3  ...........  ...........         $1.3
2015........................................................         $1.1        -$0.4  ...........         $0.7
2016........................................................         $0.7        -$0.6  ...........         $0.1
2017........................................................         $0.3        -$0.8  ...........        -$0.5
2018........................................................  ...........        -$0.8  ...........        -$0.8
2019........................................................  ...........        -$0.8  ...........        -$0.8
----------------------------------------------------------------------------------------------------------------

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 would 
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 admission 
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 2008 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 21 provides these proportions.

                                                   Table 22--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............................................          176           19          440           48          293           32          909           23
Small/Medium....................................          817           31        1,352           51          462           18        2,631           67
Large (400+beds)................................          216           54          163           41           18            5          397           10
                                                 -------------------------------------------------------------------------------------------------------
    Total.......................................         1209           31         1955           50          773           20        3,937          100
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 13806]]

    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 would 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 2008 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 high scenario estimated net costs for section 4102 of the 
HITECH Act are shown in Table 23: Estimated costs (+) and savings (-) 
for eligible hospitals adopting certified EHRs. This provision is 
estimated to increase Medicare hospital expenditures by a net total of 
$5.4 billion during FYs 2014 through 2019.

  Table 23--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
                                     Certified EHR Technology, High Scenario
                                               [In 2012 billions]
----------------------------------------------------------------------------------------------------------------
                                                                             Payment
                         Fiscal year                           Incentive    adjustment    Benefit     Net total
                                                                payments     receipts     payments
----------------------------------------------------------------------------------------------------------------
2014........................................................         $1.9  ...........        (\1\)         $1.9
2015........................................................          2.1         -0.3        (\1\)          1.8
2016........................................................          1.3         -0.1        (\1\)          1.2
2017........................................................          0.5         -0.1        (\1\)          0.5
2018........................................................  ...........        (\1\)        (\1\)        (\1\)
2019........................................................  ...........  ...........        (\1\)        (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

    We are also providing the estimates for a low scenario in Table 24.

  Table 24--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
                                     Certified EHR Technology, Low Scenario
                                               [In 2012 billions]
----------------------------------------------------------------------------------------------------------------
                                                                             Payment
                         Fiscal year                           Incentive    adjustment    Benefit     Net total
                                                                payments     receipts     payments
----------------------------------------------------------------------------------------------------------------
2014........................................................         $1.2  ...........        (\1\)         $1.2
2015........................................................          1.4         -0.9        (\1\)          0.5
2016........................................................          1.2         -0.6        (\1\)          0.6
2017........................................................          0.6         -0.3        (\1\)          0.3
2018........................................................  ...........         -0.2        (\1\)         -0.2
2019........................................................  ...........         -0.1        (\1\)         -0.1
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

    Based on the comparison of Medicare incentive payments and 
implementation/operating costs for each eligible hospital (described 
previously), we made the assumptions shown in Tables 25 and 26, related 
to the prevalence of certified EHR technology 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 25 shows the scenario's 
estimates:

 Table 25--Assumed Proportion of Eligible Hospitals With Certified EHR Technology, by Percentage of System Cost
                              Covered by Medicare Incentive Payments High Scenario
----------------------------------------------------------------------------------------------------------------
                                              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            0.75            0.6
2015............................             1.0            1.0             0.95            0.9             0.8
2016............................             1.0            1.0             1.0             0.95            0.9
2017............................             1.0            1.0             1.0             1.0             0.95

[[Page 13807]]

 
2018............................             1.0            1.0             1.0             1.0             1.0
----------------------------------------------------------------------------------------------------------------

    For instance, under the high scenario 95 percent of eligible 
hospitals whose incentive payments would 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.
    Table 26 shows the low scenario estimates.

 Table 26--Assumed Proportion of Eligible Hospitals With Certified EHR Technology, by Percentage of System Cost
                               Covered by Medicare Incentive Payments Low Scenario
----------------------------------------------------------------------------------------------------------------
                                              Incentive payments as percentage of EHR technology cost
           Fiscal year           -------------------------------------------------------------------------------
                                       100+%          75-100%         50-75%          25-50%           0-25%
----------------------------------------------------------------------------------------------------------------
2014............................             0.9            0.75            0.55            0.4             0.3
2015............................             1.0            0.9             0.75            0.6             0.5
2016............................             1.0            1.0             0.9             0.85            0.75
2017............................             1.0            1.0             0.95            0.9             0.85
2018............................             1.0            1.0             1.0             0.95            0.9
2019............................             1.0            1.0             1.0             1.0             1.0
----------------------------------------------------------------------------------------------------------------

    For large, organized facilities such as hospitals, we believe that 
the revenue losses caused by these payment adjustments would be a 
substantial incentive to adopt certified EHR technology, even in 
instances where the Medicare incentive payments would 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 27, we 
estimated that the great majority of eligible hospitals would qualify 
for at least a portion of the Medicare incentive payments that they 
could potentially receive, and only a modest number would incur payment 
adjustments. Nearly all eligible hospitals are projected to have 
implemented certified EHR technology by FY 2019. Table 27 shows our 
high scenario 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 would 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, High
                                Scenario
------------------------------------------------------------------------
                                         Percent
                                     associated with    Percent payable
            Fiscal year                  eligible           in year
                                        hospitals
------------------------------------------------------------------------
2014..............................               82.6               82.6
2015..............................               92.6               54.2
2016..............................               96.9               43.4
2017..............................               99.0  .................
2018..............................              100.0  .................
------------------------------------------------------------------------

    For instance in FY 2014 under the high scenario, 82.6 percent of 
the total amount of incentive payments which could be payable in that 
year would be for eligible hospitals who have demonstrated meaningful 
use of certified EHR technology and therefore will be paid. In FY 2015 
under the high scenario, 92.6 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 would have 
already received 4 years of incentive payments, and therefore 54.2 
percent of all possible incentive payments actually paid in that year.
    Table 28 shows the low scenario estimates.

[[Page 13808]]



  Table 28--Estimated Percentage of Medicare Incentives Which Could Be
 Paid for the Meaningful Use of Certified EHR Technology Associated With
    Eligible Hospitals and Estimated Percentage Payable in Year, Low
                                Scenario
------------------------------------------------------------------------
                                         Percent
                                     associated with    Percent payable
            Fiscal year                  eligible           in year
                                        hospitals
------------------------------------------------------------------------
2014..............................               47.6               47.6
2015..............................               66.4               49.6
2016..............................               85.9               64.1
2017..............................               91.4  .................
2018..............................               95.6  .................
------------------------------------------------------------------------

    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 would 
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) would also achieve meaningful use by 
2016. Current program payment data, as well as current data from the 
Regional Extension Centers, does not provide enough information for us 
to alter these estimates. Therefore, we are maintaining these estimates 
for the current impact analysis. Our estimates regarding the incentives 
that will be paid to CAHs are incorporated into the overall Medicare 
and Medicaid program costs.
5. 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 proposed rule 43 States are already participating 
in the Medicaid incentive payment program and the remaining 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 29 shows our high estimates for the net 
Medicaid costs for eligible hospitals and EPs.

               Table 29--Estimated Federal Costs (+) and Savings (-) Under Medicaid, High Scenario
                                               [In 2012 $billions]
----------------------------------------------------------------------------------------------------------------
                                                        Incentive payments
                                                 --------------------------------     Benefit
                   Fiscal year                                       Eligible        payments        Net total
                                                     Hospitals     professionals
----------------------------------------------------------------------------------------------------------------
2014............................................             0.7             0.9           (\1\)             1.6
2015............................................             0.6             1.1           (\1\)             1.7
2016............................................             0.5             1.1           (\1\)             1.7
2017............................................             0.4             0.9           (\1\)             1.3
2018............................................             0.2             0.6           (\1\)             0.7
2019............................................             0.0             0.3           (\1\)             0.3
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

    Table 30 shows the low estimates for Medicaid costs and savings.

               Table 30--Estimated Federal Costs (+) and Savings (-) Under Medicaid, Low Scenario
                                               [In 2012 $billions]
----------------------------------------------------------------------------------------------------------------
                                                        Incentive payments
                                                 --------------------------------     Benefit
                   Fiscal year                                       Eligible        payments        Net total
                                                     Hospitals     professionals
----------------------------------------------------------------------------------------------------------------
2014............................................             0.4             0.4           (\1\)             0.8
2015............................................             0.5             0.5           (\1\)             1.0

[[Page 13809]]

 
2016............................................             0.7             0.6           (\1\)             1.3
2017............................................             0.8             0.5           (\1\)             1.3
2018............................................             0.4             0.4           (\1\)             0.9
2019............................................             0.1             0.3           (\1\)             0.4
----------------------------------------------------------------------------------------------------------------
\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 non-hospital-based Medicare EPs would 
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 high scenario estimates 
are listed in Table 31.

    Table 31--Assumed Number of Nonhospital Based Medicaid EPS Who Will Be Meaningful Users of Certified EHR
                                            Technology, High Scenario
                                    [All population figures are in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                          Calendar year
                                               -----------------------------------------------------------------
                                                   2014       2015       2016       2017       2018       2019
----------------------------------------------------------------------------------------------------------------
                    EPs who have claims with        570.3      576.0      581.7      587.5      593.3      599.0
                     Medicare.
                    Non Hospital-Based EPs....      492.2      497.1      502.1      507.1      512.0      517.0
A                   EPs who meet the Medicaid        98.4       99.4      100.4      101.4      102.4      103.4
                     patient volume threshold.
B                   Medicaid \1\ only EPs.....       46.3       47.1       47.8       48.6       49.3       50.1
                    Total Medicaid EPs (A + B)      144.7      146.5      148.2      150.0      151.7      153.5
                    Percent of EPs receiving        82.2%      85.6%      88.8%      43.8%      25.0%      14.4%
                     incentive payment during
                     year.
                    Number of EPs receiving         119.0      125.4      131.7       65.7       38.0       22.1
                     incentive payment during
                     year.
                    Percent of EPs who have         82.2%      85.6%      88.8%      91.9%      94.7%      95.9%
                     ever received incentive
                     payment.
                    Number of EPs who have          119.0      125.4      131.7      137.7      143.6      147.2
                     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 certified EHR technology as well. 
Table 32 shows our low scenario estimates.

    Table 32--Assumed Number of Nonhospital Based Medicaid EPS Who Will Be Meaningful Users of Certified EHR
                                             Technology Low Scenario
                                    [All population figures are in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                          Calendar year
                                               -----------------------------------------------------------------
                                                   2014       2015       2016       2017       2018       2019
----------------------------------------------------------------------------------------------------------------
                    EPs who have claims with        570.3      576.0      581.7      587.5      593.3      599.0
                     Medicare.
                    Non Hospital-Based EPs....      492.2      497.1      502.1      507.1      512.0      517.0
A                   EPs who meet the Medicaid        98.4       99.4      100.4      101.4      102.4      103.4
                     patient volume threshold.
B                   Medicaid \1\ only EPs.....       46.3       47.1       47.8       48.6       49.3       50.1
                    Total Medicaid EPs (A + B)      144.7      146.5      148.2      150.0      151.7      153.5
                    Percent of EPs receiving        36.0%      40.5%      45.3%      30.7%      21.9%      15.1%
                     incentive payment during
                     year.
                    Number of EPs receiving          52.1       59.4       67.2       46.0       33.2       23.1
                     incentive payment during
                     year.
                    Percent of EPs who have         36.0%      40.5%      45.3%      50.4%      55.7%      59.9%
                     ever received incentive
                     payment.
                    Number of EPs who have           52.1       59.4       67.2       75.5       84.4       91.9
                     received ever incentive
                     payment.
----------------------------------------------------------------------------------------------------------------


[[Page 13810]]

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 33. 
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 certified EHR technology are discussed under ``general 
considerations.'' Since we were using 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 
non-children's hospitals.

     Table 33--Estimated Percentage of Potential Medicaid Incentives
Associated With Eligible Hospitals and Estimated Percentage Payable Each
                           Year, High Scenario
------------------------------------------------------------------------
                                         Percent
                                     associated with    Percent payable
            Fiscal year                  eligible           in year
                                        hospitals
------------------------------------------------------------------------
2014..............................               83.1               44.0
2015..............................               92.9               38.5
2016..............................               97.1               26.2
2017..............................               99.0               14.0
2018..............................              100.0                4.2
2019..............................              100.0                0.0
------------------------------------------------------------------------

    Table 34 shows our low scenario estimates.

     Table 34--Estimated Percentage of Potential Medicaid Incentives
Associated With Eligible Hospitals and Estimated Percentage Payable Each
                           Year, Low Scenario
------------------------------------------------------------------------
                                         Percent
                                     associated with    Percent payable
            Fiscal year                  eligible           in year
                                        hospitals
------------------------------------------------------------------------
2014..............................               49.2               30.9
2015..............................               67.8               44.5
2016..............................               86.5               52.8
2017..............................               91.8               37.3
2018..............................               95.9               18.7
2019..............................              100.0                0.0
------------------------------------------------------------------------

6. Benefits for All EPs and All Eligible Hospitals
    In this proposed 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 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 four 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 proposed 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

[[Page 13811]]

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.
7. 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 would 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 proposed regulation 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.
8. 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 certified EHR technology 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 certified EHR technology in the early years of the 
Medicare EHR incentive program. We expect that a steadily growing 
proportion of practices will implement certified EHR technology over 
the next 10 years, even in the absence of the Medicare incentives. 
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 certified EHR technology 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 would achieve these efficiencies sooner than would otherwise 
occur, without the EHR incentives. 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:
    <bullet> Congressional Budget Office (staff and publications).
    <bullet> American Medical Association (staff and unpublished data).
    <bullet> American Hospital Association.
    <bullet> Actuarial Research Corporation.
    <bullet> CMS Statistics 2011.
    <bullet> 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).
    <bullet> Kaiser Permanente (staff and publications).
    <bullet> 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.
9. Summary
    Consistent with the estimates we are maintaining from the Stage 1 
final rule, the total cost to the Medicare and Medicaid programs 
between 2014 and 2019 is estimated to be $3.3 billion in transfers 
under the low scenario, and $12.7 billion under the high scenario. 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.

[[Page 13812]]



  Table 35--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
                   HITECH EHR Incentive Program (Fiscal Year)--(In 2012 Billions) Low Scenario
----------------------------------------------------------------------------------------------------------------
                                         Medicare eligible               Medicaid eligible
           Fiscal year           ----------------------------------------------------------------      Total
                                     Hospitals     Professionals     Hospitals     Professionals
----------------------------------------------------------------------------------------------------------------
2014............................            $1.2            $0.6            $0.4            $0.4            $2.6
2015............................             0.5            -0.1             0.5             0.5             1.4
2016............................             0.6            -0.6             0.7             0.6             1.3
2017............................             0.3            -1.3             0.8             0.5             0.3
2018............................            -0.2            -1.6             0.4             0.4            -1.0
2019............................            -0.1            -1.6             0.1             0.3            -1.3
----------------------------------------------------------------------------------------------------------------

    Table 36 shows the total costs from 2014 through 2019 for the high 
scenario.

  Table 36--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
                  HITECH EHR Incentive Program (Fiscal Year)--(In 2012 Billions) High Scenario
----------------------------------------------------------------------------------------------------------------
                                         Medicare eligible               Medicaid eligible
           Fiscal year           ----------------------------------------------------------------      Total
                                     Hospitals     Professionals     Hospitals     Professionals
----------------------------------------------------------------------------------------------------------------
2014............................            $1.9            $1.3            $0.7            $0.9            $4.8
2015............................             1.8             0.7             0.6             1.1             4.2
2016............................             1.2             0.1             0.5             1.1             2.9
2017............................             0.5            -0.5             0.4             0.9             1.3
2018............................  ..............            -0.8             0.2             0.6             0.0
2019............................  ..............            -0.8  ..............             0.3            -0.5
----------------------------------------------------------------------------------------------------------------

10. Explanation of Benefits and Savings Calculations
    In our analysis, we assume that benefits to the program would 
accrue in the form of savings to Medicare, through the Medicare EP 
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 proposed 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 proposed rule.
    Expected qualitative benefits include improved quality of care, 
better health outcomes, reduced errors and the like. Private industry 
costs would 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.

         Table 37--Accounting Statement: Classification of Estimated Expenditures CYs 2014 Through 2019
                                               [In 2012 millions]
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
               Category                                                 Benefits
----------------------------------------------------------------------------------------------------------------
Qualitative..........................  Expected qualitative benefits include improved quality of care, better
                                       health outcomes, reduced errors and the like.
----------------------------------------------------------------------------------------------------------------
                                                                         Costs
----------------------------------------------------------------------------------------------------------------
                                          Year          Estimates          Unit                Period
                                         dollar       (in millions)      discount             covered
                                       .........                           rate
----------------------------------------------------------------------------------------------------------------
                                       .........     Low        High    .........
                                       .........   estimate   estimate  .........
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Costs to Private       2012     $186.5     $191.8         7%  CYs 2014-2019
 Industry Associated with Reporting
 Requirements.
                                                 ---------------------------------
                                       .........     $186.5     $191.8         3%
----------------------------------------------------------------------------------------------------------------

[[Page 13813]]

 
Qualitative--Other private industry    These costs would include the impact of EHR activities such as reduced
 costs associated with the adoption    staff productivity related to learning how to use the EHR technology, the
 of EHR technology.                    need for additional staff to work with HIT issues, and administrative
                                       costs related to reporting.
----------------------------------------------------------------------------------------------------------------
                                                                       Transfers
----------------------------------------------------------------------------------------------------------------
                                          Year          Estimates          Unit                Period
                                         dollar       (in millions)      discount             covered
                                       .........                           rate
----------------------------------------------------------------------------------------------------------------
                                       .........     Low        High    .........
                                       .........   estimate   estimate  .........
----------------------------------------------------------------------------------------------------------------
Federal Annualized Monetized.........       2012     $705.7   $2,345.6         7%  CYs 2014-2019
                                                 ---------------------------------
                                       .........     $618.2   $2,216.9         3%
----------------------------------------------------------------------------------------------------------------
From Whom To Whom?...................  Federal Government to Medicare- and Medicaid-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 
would 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 object of the Regulatory 
Flexibility Analysis to minimize burden on small entities are met by 
this proposed rule. We invite public comments on the analysis and 
request any additional data that would help us determine more 
accurately the impact on the EPs and eligible hospitals affected by the 
proposed 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 proposes to amend 42 CFR chapter IV as set forth 
below:

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

    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

    2. Section 412.64 is amended as follows:
    A. Revising paragraph (d)(3) introductory text.
    B. Adding paragraphs (d)(4) and (d)(5).
    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 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 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). Such exceptions are subject to annual renewal, but in no case may 
a hospital be granted such an exception for more than 5 years. (See 
Sec.  495.4 for definitions of payment adjustment year, EHR reporting 
period, and meaningful EHR user.)

[[Page 13814]]

    (A) During the fiscal year that is 2 years 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 no later than April 1 of the year before the applicable 
payment adjustment year.
    (B) During either of the 2 fiscal years before the payment 
adjustment year, the hospital faces extreme and uncontrollable 
circumstances that prevent it from becoming a meaningful EHR user. 
Applications requesting this exception must be submitted no later than 
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 as a new hospital. 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 has been in operation for more than 2 years but 
has participated in the Medicare program for less than 2 years.
    (4) A hospital that changes its status from a CAH to a hospital 
that is subject to the capital prospective payment systems.
    (5) A State in which hospitals are paid for services under section 
1814(b)(3) of the Act must 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. Such a State must 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.
* * * * *

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

    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).

    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) 
for the applicable payment adjustment year no later than 60 days after 
the close of the applicable EHR reporting period. The Secretary may 
grant an exception for one or more than one of the following:
    (A) A CAH that is 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.
    (C) A new CAH, which, for the purposes of this exception, means a 
CAH that has operated (under previous or present ownership) for less 
than 1 year. 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 as a new CAH. 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 in operation for more than 1 year but has 
participated in the Medicare program for less than 1 year.
    (4) 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

    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

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

[[Page 13815]]

meaningful EHR user, any continuous 90-day period within the calendar 
year;
    (ii) 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.
    (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) 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.
    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) Except as provided in paragraphs (1)(ii) and (iii) of this 
definition, the calendar year that is 2 years before the payment 
adjustment year.
    (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) Except as provided in paragraphs (2)(ii) and (iii) of this 
definition, the Federal fiscal year that is 2 years before the payment 
adjustment year.
    (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 is an EP (as defined under this section) who 
furnishes 90 percent or more of his or her covered professional 
services in a hospital setting in the year preceding the payment year, 
or in the year 2 years before the payment adjustment year. For 
Medicare, this will be calculated based on the Federal FY before the 
payment year for purposes of determining qualification for incentive 
payments, or 2 years before the or payment adjustment year for purposes 
of determining whether a payment adjustment applies. For Medicaid, it 
is at the State's discretion if the data is gathered on the Federal FY 
or CY before the payment year. A setting is considered a hospital 
setting if it is a site of service that would be identified by the 
codes used in the HIPAA standard transactions as an inpatient hospital, 
or emergency room setting.
* * * * *
    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 during an applicable EHR reporting period for a 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.
* * * * *
    7. Section 495.6 is amended as follows:
    A. Redesignating paragraph (a)(2)(ii) as paragraph (a)(2)(ii)(A).
    B. Adding paragraph (a)(2)(ii)(B).
    C. Redesignating paragraph (b)(2)(ii) as paragraph (b)(2)(ii)(A).
    D. Adding paragraph (b)(2)(ii)(B).
    E. Redesignating paragraph (d)(1)(ii) as paragraph (d)(1)(ii)(A).
    F. Adding paragraphs (d)(1)(ii)(B) and (C).
    G. Redesignating paragraph (d)(8)(i)(E) as paragraph 
(d)(8)(i)(E)(1).
    H. Adding a paragraph (d)(8)(i)(E)(2).
    I. Redesignating paragraph (d)(8)(ii) as paragraph (d)(8)(ii)(A).
    J. Adding paragraphs (d)(8)(ii)(B) and (C).
    K. Redesignating paragraph (d)(8)(iii) as paragraph (d)(8)(iii)(A).
    L. Adding paragraphs (d)(8)(iii)(B) and (C).
    M. Redesignating paragraph (d)(10)(i) as paragraph (d)(10)(i)(A).
    N. Adding paragraph (d)(10)(i)(B).
    O. Redesignating paragraph (d)(10)(ii) as paragraph (d)(10)(ii)(A).
    P. Adding a paragraph (d)(10)(ii)(B).
    Q. Redesignating paragraph (d)(12)(i) as paragraph (d)(12)(i)(A).
    R. Adding a paragraph (d)(12)(i)(B).
    S. Redesignating paragraph (d)(12)(ii) as paragraph (d)(12)(ii)(A).
    T. Adding a paragraph (d)(12)(ii)(B).
    U. Redesignating paragraph (d)(12)(iii) as paragraph 
(d)(12)(iii)(A).
    V. Adding a paragraph (d)(12)(iii)(B).
    W. Redesignating paragraph (d)(14)(i) as paragraph (d)(14)(i)(A).
    X. Adding a paragraph (d)(14)(i)(B).
    Y. Redesignating paragraph (d)(14)(ii) as paragraph (d)(14)(ii)(A).
    Z. Adding a paragraph (d)(14)(ii)(B).
    AA. In paragraph (e) introductory text--
    (i) Removing the ``:'' and adding a ``.'' in its place.
    (ii) Adding a sentence at the end of the paragraph.
    BB. Redesignating paragraph (e)(5)(i) as paragraph (e)(5)(i)(A).
    CC. Adding a paragraph (e)(5)(i)(B).
    DD. Redesignating paragraph (e)(5)(ii) as paragraph (e)(5)(ii)(A).
    EE. Adding paragraph (e)(5)(ii)(B).
    FF. Redesignating paragraph (e)(9)(i) as (e)(9)(i)(A).

[[Page 13816]]

    GG. Adding paragraph (e)(9)(i)(B).
    HH. Redesignating paragraph (e)(10)(i) as (e)(10)(i)(A).
    II. Adding paragraph (e)(10)(i)(B).
    JJ. Redesignating paragraph (f)(1)(ii) as paragraph (f)(1)(ii)(A).
    KK. Adding paragraphs (f)(1)(ii)(B) and (C).
    LL. Redesignating paragraph (f)(7)(i)(E) as paragraph 
(f)(7)(i)(E)(1).
    MM. Adding a paragraph (f)(7)(i)(E)(2).
    NN. Redesignating paragraph (f)(7)(ii) as (f)(7)(ii)(A).
    OO. Adding paragraphs (f)(7)(ii)(B) and (C).
    PP. Redesignating paragraph (f)(9)(i) as paragraph (f)(9)(i)(A).
    QQ. Adding a paragraph (f)(9)(i)(B).
    RR. Redesignating paragraph (f)(9)(ii) as paragraph (f)(9)(ii)(A).
    SS. Adding a paragraph (f)(9)(ii)(B).
    TT. Redesignating paragraph (f)(12)(i) as paragraph (f)(12)(i)(A).
    UU. Adding a paragraph (f)(12)(i)(B).
    VV. Redesignating paragraph (f)(12)(ii) as paragraph 
(f)(12)(ii)(A).
    WW. Adding a paragraph (f)(12)(ii)(B).
    XX. Redesignating paragraph (f)(13)(i) as paragraph (f)(13)(i)(A).
    YY. Adding a paragraph (f)(13)(i)(B).
    ZZ. Redesignating paragraph (f)(13)(ii) as paragraph 
(f)(13)(ii)(A).
    AAA. Adding a paragraph (f)(13)(ii)(B).
    BBB. In paragraph (g) introductory text--
    (i) Removing the ``:'' and adding a ``.'' in its place.
    (ii) Adding a sentence at the end of the paragraph.
    CCC. Redesignating paragraph (g)(8)(i) as paragraph (g)(8)(i)(A).
    DDD. Adding a paragraph (g)(8)(i)(B).
    EEE. Redesignating paragraph (g)(9)(i) as paragraph (g)(9)(i)(A).
    FFF. Adding a paragraph (g)(9)(i)(B).
    GGG Redesignating paragraph (g)(10)(i) as paragraph (g)(10)(i)(A).
    HHH. Adding a paragraph (g)(10)(i)(B).
    III. Revising paragraphs (h) and (i).
    JJJ. 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 in 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 exclusions 
apply. 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 (e)(10) of this section, unless the EP meets five 
or more exclusions specified in paragraph (e) of this section, in which 
case the EP must meet all remaining objectives and associated measures.
* * * * *
    (b) * * *
    (2) * * *
    (ii) * * *
    (B) Beginning in 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), (g)(9), or (g)(10) of this section.
    (d) * * *
    (1) * * *
    (ii) * * *
    (B) For 2013, 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 CPOE or the measure specified in 
paragraph (d)(1)(ii)(A) of this section.
    (C) Beginning 2014, only the measure specified in paragraph 
(d)(1)(ii)(B) of this section.
* * * * *
    (8)(i) * * *
    (E) * * *
    (2) For 2013, plot and display growth charts for patients 0-20 
years, including BMI.
    (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) of this section.
    (iii) * * *
    (B) For 2013, 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/length, weight, 
and blood pressure have no relevance to their scope of practice is 
excluded from recording them;
    (3) 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
    (4) 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 exclusion in paragraph (d)(8)(iii)(B) 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 in 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.
* * * * *
    (e) * * *. Beginning in 2014, an EP must meet five of the following 
objectives and associated measures, one of which must be either 
paragraph (e)(9) or (e)(10) of this section unless the EP meets five or 
more exclusions specified in this paragraph (e), in which case the EP 
must meet all remaining objectives and associated measures:
* * * * *
    (5)(i) * * *
    (B) Beginning 2014, this objective is no longer included in the 
menu set.

[[Page 13817]]

    (ii) * * *
    (B) Beginning 2014, this measure is no longer included in the menu 
set.
* * * * *
    (9)(i) * * *
    (B) Beginning in 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 in 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) Beginning 2013, 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 CPOE, or the measure specified in 
paragraph (f)(1)(ii)(A) of this section.
    (C) Beginning 2014, only the measure specified in paragraph 
(f)(1)(ii)(B) of this section.
* * * * *
    (7) * * *
    (i) * * *
    (E) * * *
    (2) Beginning 2013, plot and display growth charts for patients 0-
20 years, including BMI.
    (ii) * * *
    (B) For 2013, 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) are recorded as 
structured data.
    (C) Beginning 2014, only the measure specified in paragraph 
(f)(7)(ii)(B) 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 (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 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.
* * * * *
    (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 in 2014, eligible hospitals or CAHs must meet 
five of the following objectives and associated measures, one which 
must be specified in paragraph (g)(8), (g)(9), or (g)(10) of this 
section:
* * * * *
    (8)(i) * * *
    (B) Beginning in 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 in 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 in 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 paragraphs (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 4 or more exclusions apply. For 
example, an EP that has an exclusion for 1 of the objectives in 
paragraph (k) of this section must meet 3 of the 4 nonexcluded 
objectives from such paragraph to meet the definition of a meaningful 
EHR user. If an EP has an exclusion for 4 of the objectives in 
paragraph (k) of this section, then he or she must meet the remaining 
the nonexcluded objective 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 two 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

[[Page 13818]]

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 unless 3 or more exclusions apply. For 
example, an eligible hospital that has an exclusion for 1 of the 
objectives in paragraph (m) of this section must meet 2 of the 3 non-
excluded objectives from such paragraph to meet the definition of a 
meaningful EHR user. If an eligible hospital has an exclusion for 3 of 
the objectives in paragraph (m) of this section, then the hospital must 
meet the remaining nonexcluded objective 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 (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.
    (ii) Measure. More than 60 percent of medication, laboratory, and 
radiology orders created by the EP during the EHR reporting period are 
recorded using CPOE.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who writes fewer than 100 medication, laboratory, and 
radiology orders during the EHR reporting period.
    (2)(i) Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (ii) 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 Certified EHR Technology.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who writes fewer than 100 prescriptions during the EHR 
reporting period or does not have a pharmacy within their organization 
and there are no pharmacies that accept electronic prescriptions within 
25 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) Gender.
    (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 BMI.
    (ii) Measure. 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. 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 five or more clinical quality measures, if 
applicable, at a relevant point in patient care for the entire EHR 
reporting period; and
    (B) The EP has enabled the functionality for drug-drug and drug-
allergy interaction checks for the entire EHR reporting period.
    (7)(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 the EP during the EHR reporting period whose results 
are either in a positive/negative 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 or numeric 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.
    (ii) Measure. More than 10 percent of all unique patients who have 
had an office visit with the EP within the 24 months before the 
beginning of the EHR reporting period were sent a reminder, per patient 
preference.
    (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 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.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who neither orders nor creates any of the information 
listed for inclusion as part of this measure is excluded from both 
paragraphs (i)(10)(ii)(A) and (B) of this section Any EP that conducts 
the majority (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

[[Page 13819]]

availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from paragraph 
(i)(10)(ii)(B) of this section.
    (11)(i) Objective. Provide clinical summaries for patients for each 
office visit.
    (ii) Measure. Clinical summaries provided to patients within 24 
hours 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 office visits by the EP.
    (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. The EP performs medication reconciliation for more 
than 65 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 should provide summary care record for each transition 
of care or referral.
    (ii) Measures. (A) 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 65 percent of transitions of care and 
referrals; and
    (B) The EP that transitions or refers their patient to another 
setting of care or provider of care electronically transmits using 
Certified EHR Technology to a recipient with no organizational 
affiliation and using a different Certified EHR Technology vendor than 
the sender a summary of care record for more than 10 percent of 
transitions of care and referrals.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who neither transfers a patient to another setting nor 
refers a patient to another provider during the EHR reporting period is 
excluded from both measures.
    (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) The EP does not administer any of the immunizations to any of 
the populations for which data is collected by the jurisdiction's 
immunization registry or immunization information system during the EHR 
reporting period.
    (B) The EP 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 
Certified EHR Technology at the start of their EHR reporting period.
    (C) The EP 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's Certified EHR Technology can send 
at the start of their EHR reporting period.
    (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 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 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 10 percent 
of unique patients 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.
    (k) Stage 2 menu set criteria for EPs. An EP must meet 3 of the 
following objectives and associated measures, unless the EP meets 4 or 
more exclusions specified in this paragraph (k), in which case the EP 
must meet all remaining objectives and associated measures.
    (1)(i) Objective. Imaging results and information are accessible 
through Certified EHR Technology.
    (ii) Measure. More than 40 percent of all scans and 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 does not perform diagnostic interpretation of scans 
or tests whose result is an image during 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) The EP is not in a category of providers who collect ambulatory 
syndromic surveillance information on their patients during the EHR 
reporting period.
    (B) The EP 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) The EP operates in a jurisdiction for which no public health 
agency is capable of accepting the version of the standard that the 
EP's Certified EHR Technology can send at the start of their EHR 
reporting period.

[[Page 13820]]

    (4)(i) Objective. Capability to identify and report cancer cases to 
a State 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 cancer registry for the 
entire EHR reporting period.
    (iii) Exclusion in accordance with paragraph (h)(2) of this 
section. Any EP who--
    (A) Does not diagnose or directly treat cancer; or
    (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.
    (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--
    (A) Does not diagnose or directly treat any disease associated with 
a specialized registry; or
    (B) Operates in a jurisdiction for which no registry is capable of 
receiving electronic specific case information in the specific 
standards required under Stage 2 at the beginning of their EHR 
reporting period.
    (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 (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.
    (ii) Measure. More than 60 percent of medication, laboratory, and 
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 CPOE.
    (2)(i) Objective. Record all of the following demographics:
    (A) Preferred language.
    (B) Gender.
    (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 BMI.
    (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 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. 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 five or more clinical quality measures, if 
applicable, at a relevant point in patient care for the entire EHR 
reporting period; and
    (B) The eligible hospital or CAH has enabled the functionality for 
drug-drug and drug-allergy interaction checks for the duration of the 
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 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 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.
    (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 4Mbps 
broadband availability according to the latest information available 
from the FCC at the start 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. The eligible hospital or CAH performs medication 
reconciliation for more than 65 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).

[[Page 13821]]

    (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 should provide summary care 
record for each transition of care or referral.
    (ii) Measures. (A) 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 65 percent of 
transitions of care and referrals; and
    (B) The eligible hospital or CAH that transitions or refers their 
patient to another setting of care or provider of care electronically 
transmits using Certified EHR Technology to a recipient with no 
organizational affiliation and using a different Certified EHR 
Technology vendor than the sender a summary of care record for more 
than 10 percent of transitions of care and referrals.
    (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 
the 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 receiving electronic immunization data in the specific 
standards required for Certified EHR Technology at the start of their 
EHR reporting period.
    (C) The eligible hospital or CAH does not have an immunization 
registry or immunization information system capable of accepting the 
version of the standard that the eligible hospital's or CAH's Certified 
EHR Technology can send at the start of their EHR reporting period.
    (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 as authorized, and in 
accordance with applicable State law and practice.
    (iii) Exclusion in accordance with paragraph (i)(2) of this 
section. Any eligible hospital or CAH that 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.
    (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) The eligible hospital or CAH does not have an emergency or 
urgent care department.
    (B) The 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.
    (C) The eligible hospital or CAH operates in a jurisdiction for 
which no public health agency is capable of accepting the version of 
standard that the eligible hospital's or CAH's Certified EHR Technology 
can send at the start of their EHR reporting period.
    (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 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 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. eMAR is implemented and in use for the entire EHR 
reporting period in at least one ward/unit of the hospital.
    (m) Stage 2 menu set criteria for eligible hospitals or CAHs. An 
eligible hospital or CAH must meet the measure criteria for two 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. 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.
    (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.
    (2)(i) Objective. Imaging results and information are accessible 
through Certified EHR Technology.
    (ii) Measure. More than 40 percent of all scans and 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 or changed prescriptions) 
are compared against at least one 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 25 miles.
    8. Section 495.8 is amended as follows:
    A. Revising paragraph (a)(2)(i)(B) and (a)(2)(ii).

[[Page 13822]]

    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.
* * * * *
    9. 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.
    10. Section 495.102 is amended as follows:
    A. Revising paragraphs (d)(1), (d)(2)(iii), and (d)(3).
    B. Adding paragraphs (d)(2)(iv), (d)(4), and (d)(5).
    The revisions and additions read as follows:


Sec.  495.102  Incentive payments to EPs.

* * * * *
    (d) Payment adjustment effective in CY 2015 and subsequent years 
for nonqualifying EPs. (1)(i) Subject to paragraphs (d)(3) and (d)(4) 
of this section, beginning in 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 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 with 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 
demonstrating that it meets one or more of the criteria in this 
paragraph (d)(4). 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 the calendar year that is 2 years before the payment 
adjustment year, the EP was located in an area without sufficient 
Internet access to comply with the meaningful EHR 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) During either of the 2 calendar years before the payment 
adjustment year, the EP 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.
    (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]

    11. 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.
    12. Section 495.200 is amended by--
    A. Adding definitions for ``Adverse eligibility determination,'' 
``Adverse payment determination,'' ``MA payment adjustment year,'' and 
``Potentially qualifying MA EPs and potentially qualifying MA-
affiliated eligible hospitals'' in alphabetical order.
    B. Revising paragraph (5) of the definition of ``Qualifying MA 
EP''.
    The additions and revision read as follows:


Sec.  495.200  Definitions.

    Adverse eligibility determination means a determination or omission 
by CMS that was the result of a malfunction of a CMS system that 
prohibits a qualifying MA organization, qualifying MA EP, or qualifying 
MA-affiliated eligible hospital from participating in the Medicare 
Advantage EHR Incentive Program.
    Adverse payment determination means a determination by CMS that 
negatively affects an EHR payment determination under this subpart.
* * * * *
    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 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

[[Page 13823]]

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.
* * * * *
    13. Section 495.202 is amended as follows:
    A. Revising paragraph (b)(1).
    B. In paragraph (b)(2) introductory text, removing the cross-
reference ``(b)(3)'' and adding the cross-reference ``(b)(4)'' in its 
place.
    C. In paragraph (b)(2)(iii), removing the term ``NPI.'' and adding 
the phrase ``NPI or CCN.'' in its place.
    D. Redesignating paragraphs (b)(3) and (b)(4) as paragraphs (b)(4) 
and (b)(5).
    E. Adding a new paragraph (b)(3).
    F. Revising newly redesignated paragraph (b)(4).
    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.
* * * * *
    (3) When reporting under either paragraph (b)(1) or (b)(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;
    (ii) Include information specified in paragraph (b)(2)(i) through 
(iii) of this section for each professional or hospital; and
* * * * *
    14. Section 495.204 is amended as follows:
    A. Revising the section heading.
    B. Revising paragraphs (b)(2) and (b)(4).
    C. Redesignating paragraph (e) as paragraph (f).
    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.
    15. Section 495.208 is amended as follows:
    A. Redesignating paragraphs (a) through (c) as paragraphs (d) 
through (f).
    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.

[[Page 13824]]

    (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.
* * * * *
    16. 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.
    17. A new Sec.  495.211 is added 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.
    (d) Payment adjustments effective for 2015 and subsequent years 
with respect to MA EPs. (1) For payment adjustment year 2015, and 
subsequent payment 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.
    18. A new Sec.  495.213 is added to subpart C to read as follows:


Sec.  495.213  Reconsideration process for a qualifying MA 
organization.

    (a) In general. A qualifying MA organization may seek 
reconsideration of an adverse eligibility or payment determination in 
accordance with the requirements of this section.

[[Page 13825]]

    (b) Rejection of requests barred from administrative and judicial 
review. Reconsideration requests prohibited under Sec.  495.212 will be 
rejected.
    (c) Rejection of requests including new payment information. 
Reconsideration requests that seek to include new payment-related 
information will be rejected.
    (d) Channeling of hospital and meaningful use reconsideration 
requests. (1) All reconsideration requests involving MA-affiliated 
eligible hospitals must meet the requirements of and be channeled 
through the reconsideration process in subpart E of this part and will 
be rejected for reconsideration under this section.
    (2) All reconsideration requests involving the meaningful use of 
Certified EHR Technology must follow the requirements of and be 
channeled through the reconsideration process in subpart E of this part 
and will be rejected for reconsideration under this section.
    (e) Informal reconsideration. (1)(i) A qualifying MA organization 
must request an informal reconsideration in writing within 60 calendar 
days of an adverse eligibility or payment determination.
    (ii) If the 60th calendar day occurs on a Saturday, Sunday or 
Federal holiday, the request for an informal reconsideration is due the 
calendar day following the Sunday or Federal holiday.
    (2) The request for an informal reconsideration--(i) Must specify 
the finding(s) or issue(s) with which the qualifying MA organization 
disagrees and the reason(s) for the disagreement; and
    (ii) May include additional documentary evidence that the 
qualifying MA organization wishes CMS to consider.
    (3) An informal reconsideration decision is final and binding, 
absent reopening due to audit or other evidence of material 
misrepresentation, unless a request for a final reconsideration is 
requested in accordance with paragraph (f) of this section.
    (f) Final reconsideration. (1)(i) A qualifying MA organization 
seeking a final reconsideration must request the final reconsideration 
in writing within 30 calendar days of the date on the notice issued as 
a result of the informal reconsideration.
    (ii) If the 30th calendar day occurs on a Saturday, Sunday or 
Federal holiday, the request for a final reconsideration is due the 
calendar day following the Sunday or Federal holiday.
    (2) The request for a final reconsideration must--
    (i) Specify the finding(s) or issue(s) with which the qualifying MA 
organization disagrees and the reason(s) for the disagreement;
    (ii) Include a copy of the documents and evidence submitted for the 
informal reconsideration and a copy of the decision issued in 
accordance with the informal reconsideration.
    (iii) Not include new evidence or documents not presented at the 
informal reconsideration level.
    (3) A final reconsideration is final and binding, absent reopening 
due to audit or other evidence of material misrepresentation.
    19. Section 495.302 is amended as follows:
    A. In the definition of ``Children's hospital,'' by revising 
paragraph (1), redesignating paragraph (2) as paragraph (3), and adding 
a new paragraph (2).
    B. In the definition of ``Practices predominantly,'' by removing 
the phrase ``in the most recent calendar year occurs'' and adding the 
phrase ``(within the most recent calendar year or within the 12-month 
period preceding attestation)''.
    The revision and addition reads as follows:


Sec.  495.302  Definitions.

* * * * *
    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
* * * * *
    20. Section 495.304 is amended as follows:
    A. In paragraphs (c)(1) and (c)(2), by removing the phrase 
``individuals receiving Medicaid'' and adding the phrase ``individuals 
enrolled in a Medicaid program'' in its place.
    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. 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.
    21. Section 495.306 is amended as follows;
    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.
    B. In paragraph (e)(1)(i), by removing ``; or'' and adding ``.'' in 
its place.
    C. Adding paragraph (e)(1)(iii).
    D. Revising paragraph (e)(2)(i) introductory text.
    E. In paragraph (e)(2)(i)(A), by removing ``; or'' and adding ``.'' 
in its place.
    F. Adding paragraph (e)(2)(i)(C).
    G. Revising paragraph (e)(2)(ii) introductory text.
    H. In paragraph (e)(2)(ii)(A), by removing ``; or'' and adding 
``.'' in its place.
    I. Adding paragraph (e)(2)(ii)(C).
    J. Revising paragraph (e)(3) introductory text.
    K. In paragraphs (e)(3)(i) and (ii), by removing ``; '' and adding 
``.'' in its place.
    L. In paragraph (e)(3)(iii), by removing ``; or'' and adding ``.'' 
in its place.
    M. Redesignating paragraphs (e)(3)(iii) and (e)(3)(iv) as 
paragraphs (e)(3)(iv) and (e)(3)(v).
    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 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,

[[Page 13826]]

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 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 
per inpatient discharge 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 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 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 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 service was provided.
* * * * *
    22. Section 495.310 is amended as follows:
    A. Removing and reserving paragraphs (a)(1)(ii) and (a)(2)(ii).
    B. Adding paragraph (f)(8).
    C. Revising the second sentence of paragraph (g)(1)(i)(B) 
introductory text.
    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.
    E. In paragraph (g)(1)(i)(C), by removing the term ``discharges'' 
and adding the term ``acute-care inpatient discharges'' in its place.
    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.

    (a) * * *
    (1) * * *
    (ii) [Reserved].
    (2) * * *
    (ii) [Reserved].
* * * * *
    (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) * * *
    (B) * * *. 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):
* * * * *
    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.
* * * * *
    24. Section 495.332 is amended as follows:
    A. Adding a new paragraph (b)(6).
    B. Revising paragraph (c) introductory text.
    C. Removing paragraph (d)(9).
    D. Adding a new paragraph (g).
    The revisions and additions 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) Subject to paragraph (g) of this section, for monitoring and 
validation of information States must include the following:
* * * * *

[[Page 13827]]

    (g) 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.
    25. 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 a minimum of 
12 months from the date of the last CMS approved HIT IAPD and must 
contain the following:
* * * * *
    26. Section 495.370 is amended by adding a new 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.
    27. Add a new subpart E to read as follows:
Subpart E--Administrative Review of Certain Electronic Health Record 
Incentive Program Determinations
Sec.
495.400 Basis and purpose.
495.402 Definitions.
495.404 Provider scope and eligibility to file.
495.406 Filing appeals.
495.408 General filing rules.
495.410 Other requirements.
495.412 Informal review process and decision.
495.414 Final reconsiderations.

Subpart E--Administrative Review of Certain Electronic Health 
Record Incentive Program Determinations


Sec.  495.400  Basis and purpose.

    This subpart--
    (a) Contains an administrative appeal process for Medicare EPs, 
eligible hospitals, and CAHs, and, in certain cases, Medicaid eligible 
hospitals and potentially qualifying MA EPs and MA-affiliated eligible 
hospitals; and
    (b) Defines the types of appeals and issues that may be raised on 
appeal as well as the documents or data, or both, that must be 
submitted to support issues raised in the appeal filing.


Sec.  495.402  Definitions.

    For purposes of this subpart, the following definitions apply:
    Circumstance outside a provider's control means any event that 
reasonably prevented a provider from participating in the EHR Incentive 
Program and which the provider could not under any circumstances 
control.
    Eligibility appeal means any of the following:
    (1) An appeal filed by a provider that can demonstrate it met all 
program requirements for the EHR Incentive Program and should have 
received a payment but could not because of circumstances outside a 
provider's control. A provider must also demonstrate an action to 
participate in the EHR Incentive Program.
    (2) An appeal of whether a hospital may be considered a potentially 
qualifying MA-affiliated eligible hospital, as defined under Sec.  
495.200, based on common corporate governance with a qualifying MA 
organization, for which at least two-thirds of the Medicare hospital 
discharges (or bed-days) are of (or for) Medicare individuals enrolled 
under MA plans, as well as whether less than one-third of Medicare bed-
days for the year are covered under Part A rather than Part C.
    Incentive payment appeal means an appeal challenging only the total 
estimated allowed charges for a qualifying EP's covered professional 
services under Sec.  495.102(b) of this part. The appeal could not 
contest an individual claims payment or coverage decisions, but only 
the inclusion of final claims used to calculate the incentive payment 
amount or the inclusion of claims used to calculate the incentive 
payment amount. Incentive payment appeals may also include appeals 
challenging a subsequent Federal determination that the incentive 
payment calculation amount was incorrect (including determinations that 
the incentive payment was duplicative).
    Meaningful use appeal means an appeal challenging a determination 
or finding that a provider was not a meaningful EHR user, or that it 
did not use Certified EHR Technology.
    Permissible appeal means an eligibility appeal, a meaningful use 
appeal, or an incentive payment appeal.
    Provider means one of the following entities that is permitted to 
file an appeal in accordance with the requirements specified in this 
subpart:
    (1) An EP.
    (2) An eligible hospital.
    (3) A CAH.
    (4) A qualifying MA organization on behalf of a potentially 
qualifying MA EP.
    (5) A potentially qualifying MA-affiliated eligible hospital.
    (6) A Medicaid eligible hospital.


Sec.  495.404  Provider scope and eligibility to file.

    Subject to the limitations and requirements contained in this 
subpart, only permissible appeals are permitted to be filed, only the 
following providers may file appeals, and only for the types of appeals 
specified in this section:
    (a) An EP as defined under Sec.  495.100 is permitted to file an 
eligibility appeal, a meaningful use appeal, or an incentive payment 
appeal.
    (b) An eligible hospital as defined under Sec.  495.100 is 
permitted to file an eligibility appeal or a meaningful use appeal.
    (c) A CAH as defined under Sec.  495.4 is permitted to file an 
eligibility appeal or a meaningful use appeal.
    (d) A qualifying MA organization as defined under Sec.  495.200 is 
permitted to file a meaningful use appeal for a potentially qualifying 
MA EP as defined under Sec.  495.200 who has been determined not to be 
a meaningful EHR user.
    (e) A potentially qualifying MA-affiliated eligible hospital as 
defined under Sec.  495.200 is permitted to file an eligibility appeal 
described in paragraph (ii) of the definition (that is, an appeal based 
on common corporate governance with a qualifying MA organization, for 
which at least two-thirds of the Medicare hospital discharges (or bed 
days) are of (or for) Medicare individuals enrolled under MA plans and/
or whether less than one-third of Medicare bed-days for the year are 
covered under Part A rather than Part C) and a meaningful use appeal if 
determined not to be a meaningful EHR user.
    (f) A Medicaid-eligible hospital under subpart D of this part is 
permitted to file a meaningful use appeal, but only in the case that an 
adverse audit has been conducted by CMS.


Sec.  495.406  Filing appeals.

    A provider must make all filings or requests, and submit all 
documentation, comments, and data through an online mechanism and in a 
manner specified by CMS.

[[Page 13828]]

Sec.  495.408  General filing rules.

    (a) All relevant issues raised in initial filing of appeal. Except 
under extenuating circumstances described in paragraph (c)(1) of this 
section, a provider must raise all relevant issues at the time of the 
initial filing of an appeal.
    (b) Deadlines for filing appeals. (1) General rules. (i) Except 
under extenuating circumstances described in paragraph (c)(2) of this 
section, an appeal filed by a provider after the specified deadline is 
dismissed and cannot be refiled.
    (ii) If the filing deadline falls on a Saturday, Sunday, or a 
Federal holiday then the deadline for filing the appeal is extended to 
the next business day.
    (iii) CMS may extend the filing deadline for providers in response 
to extenuating circumstances that occur within the EHR Incentive 
Program. CMS will provide information on our Web site at least 7 
calendar days before the filing deadline providing the new filing 
deadline.
    (2) Deadline for an eligibility appeal. An eligibility appeal must 
be filed no later than 30 days after the 2-month period following the 
payment year.
    (3) Deadline for a meaningful use appeal. A meaningful use appeal 
must be filed no later than 30 days from the date of the demand letter 
or other finding that could result in the recoupment of an EHR 
incentive payment.
    (4) Deadline for an incentive payment appeal. An incentive payment 
appeal must be filed no later than 60 days from the date the incentive 
payment was issued or 60 days from any Federal determination that the 
incentive payment amount was incorrect (including determinations that 
the payment was duplicative).
    (c) Extenuating circumstances for filing--(1) Amendment to raise 
additional issues. A provider--
    (i) May file an amendment to raise additional issues, if the 
provider can demonstrate an extenuating circumstance existed that 
prevented all relevant issues from being included at the time of the 
initial filing of the appeal;
    (ii) Must show, in its amendment request, that extenuating 
circumstances existed by submitting documentation of occurrences, 
events, or transactions that prevented the additional issues from being 
raised in the initial appeal filing; and
    (iii) Must file its amendment claiming an extenuating circumstance 
within 15 days after the initial filing of the appeal.
    (2) Request an extension of the filing deadline. (i) A provider--
    (A) May file a request to extend the deadline under paragraph (b) 
of this section, if the provider can demonstrate an extenuating 
circumstance existed that prevented the appeal from being filed by the 
applicable deadline; and
    (B) Must show, in its extension request, that extenuating 
circumstances existed by submitting documentation of occurrences, 
events, or transactions that prevented the appeal from being filed by 
the applicable deadline.
    (ii) The length of an extension granted by CMS is based upon 
documentation filed and the reason(s) requested.
    (iii) A request to extend the deadline must be filed before the 
deadline expires for the appeal the provider is filing.
    (d) Withdrawal of appeal filing. A provider may withdraw an appeal 
at any time after the initial appeal filing and before an informal 
review decision is issued. The issues raised in the appeal filing may 
be re-filed by the provider before the deadline specified in paragraph 
(b) of this section.


Sec.  495.410  Other requirements.

    (a) General rule. CMS reviews each issue raised in the appeal 
filing to determine if each issue is precluded from the appeals 
process. Appeal issues found to be precluded will be dismissed.
    (b) Judicial and administrative review. Providers have the burden 
of demonstrating that each issue raised in the appeal filing is not 
precluded from administrative and judicial review under the Act and 
implementing regulations at 42 CFR 413.70(a)(7), 495.106(f), 495.110, 
and 495.212.
    (c) Inchoate issues. (1) A provider has the burden of doing all of 
the following:
    (i) Demonstrating that the provider met all the EHR Incentive 
Program requirements other than the issue raised and should have 
received an incentive payment for the payment year for which the appeal 
is filed.
    (ii) Demonstrating that before the end of the payment year for 
which the appeal is filed, the provider allowed CMS an opportunity to 
resolve the issue that is raised in the appeal.
    (iii) Demonstrating that CMS was not able to resolve the issue by 
the end of the 2 months following the payment year for which the appeal 
is filed.
    (2) The provider must provide documentation of the resolution 
efforts described in paragraph (c)(1)(ii) of this section.
    (d) Hospital cost report issues. Any issue involving an incentive 
payment based upon a hospital cost report must be filed with the 
Provider Reimbursement and Review Board. Issues raised in an appeal 
filing that involve a hospital cost report will be dismissed in 
accordance with these rules.


Sec.  495.412  Informal review process and decision.

    (a) General rule. The informal review process is the first level 
review in the appeals process.
    (b) Supporting documentation--(1) Request for additional supporting 
documentation essential to validate an issue raised in the appeal. 
During the informal review process, CMS may request supporting 
documentation from a provider for an issue that is raised in the 
appeal. Except in extenuating circumstances described in this paragraph 
(b), a provider has 7 calendar days to comply with the request for 
supporting documentation.
    (2) Failure to submit supporting documentation. An issue raised in 
the appeal is dismissed if a provider fails to submit supporting 
documentation within 7 calendar days from the date of the request by 
CMS.
    (3) Request for extension before the supporting documentation 
deadline. A request for an extension to submit supporting documentation 
may be filed if a provider can demonstrate an extenuating circumstance 
existed that prevented the supporting documentation from being filed by 
the provider within 7 calendar days.
    (i) A provider must show extenuating circumstances existed by 
providing, with its request for extension, documentation of 
occurrences, events, or transactions that prevented a request from 
being complied within 7 calendar days. A request for an extension must 
be filed before the 7 calendar days to respond to the request has 
expired.
    (ii) A request for an extension of the time period to submit 
supporting documentation must be filed within 7 calendar days from the 
date the request was made by CMS.
    (iii) The length of an extension granted by CMS is based upon 
documentation submitted and the reasons requested.
    (c) Informal review standards. All appeal requests are reviewed 
according to the guidelines associated with the specific appeal type.
    (1) Eligibility appeals. A provider must do all of the following:
    (i) Demonstrate that the provider can meet all of the requirements 
of the EHR except for the issue raised.
    (ii) Except for eligibility appeals described in part (ii) of the 
definition (that is, appeals involving common corporate governance with 
a qualifying MA organization, for which at least two-

[[Page 13829]]

thirds of the Medicare hospital discharges (or bed-days) are of (or 
for) Medicare individuals enrolled under MA plans and/or whether less 
than one-third of Medicare bed-days for the year are covered under Part 
A rather than Part C), demonstrate that the issue raised in the appeal 
filing was the result of a circumstance outside of a provider's control 
and prevented the provider from receiving an incentive payment.
    (iii) Submit evidence that an action was taken to participate in 
the EHR Incentive Program.
    (iv) For eligibility appeals described in part (ii) of the 
definition, demonstrate in accordance with subpart C of this part that 
either:
    (A) The MA-affiliated hospital is under common corporate governance 
with a qualifying MA organization, for which at least two-thirds of the 
Medicare hospital discharges (or bed-days) are of (or for) Medicare 
individuals enrolled under MA plans; and/or
    (B) The MA-affiliated eligible hospital has less than one-third of 
Medicare bed-days for the year covered under Part A rather than Part C.
    (2) Meaningful use appeals. A provider must do all of the 
following:
    (i) Demonstrate that the provider successfully meets the meaningful 
use objective and associated measure discussed in the demand letter or 
other finding for recoupment of the EHR incentive payment.
    (ii) Demonstrate that the provider used Certified EHR Technology 
during the EHR reporting period for the payment year for which the 
appeal was filed.
    (3) Incentive payment appeals. Providers appealing the amount of 
the incentive payment must do the following:
    (i) Demonstrate that all relevant claims were submitted timely and 
appropriately and were either not used or misused in accordance with 
Sec.  495.102(a)(2) of this part.
    (ii) Demonstrate that the timely and appropriately submitted claims 
were not used in calculating the amount of the EHR incentive payment.
    (d) Informal review decision. (1) CMS issues an informal review 
decision within 90 days of the initial appeal filing, unless an 
extension or amendment was granted to the provider or CMS.
    (2) An informal review decision under this section represents CMS's 
final decision, unless a provider files a reconsideration request under 
Sec.  495.414 of this subpart.


Sec.  495.414  Final reconsiderations.

    (a) Reconsideration request. A provider dissatisfied with the CMS 
informal review decision under Sec.  495.412 of this part may file a 
request for reconsideration of issues denied in that decision. The 
request for reconsideration may include comments and documentation to 
support the position that the issues raised in the appeal should not 
have been denied.
    (b) Deadline for reconsideration requests. (1) Except as provided 
in paragraph (b)(2) of this section, reconsideration requests must be 
filed within 15 days from the date of the informal review decision.
    (2) A provider may request a one-time extension of 15 additional 
days to file the reconsideration request, if the provider can 
demonstrate that the informal review decision was not received by the 
provider (or provider's representative) within 5 days from the date of 
the decision.
    (c) Final decision. CMS renders a final decision within 10 days of 
the date the provider files the request for reconsideration.
    (d) Reconsideration request not filed. If a provider does not file 
a request for reconsideration within the time period specified in 
paragraph (b) of this section, then the informal review decision is 
CMS's final decision.

(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: February 8, 2012.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: February 21, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-4443 Filed 2-23-12; 4:15 pm]
BILLING CODE 4120-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>