```

[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Proposed Rules]
[Pages 20345-20399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08514]

[[Page 20345]]

Vol. 80

Wednesday,

No. 72

April 15, 2015

Part III

 Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 495

Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program--Modifications to Meaningful Use in 2015 Through 2017; Proposed 
Rule

Federal Register / Vol. 80 , No. 72 / Wednesday, April 15, 2015 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 495

[CMS-3311-P]
RIN 0938-AS58

Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Modifications to Meaningful Use in 2015 Through 2017

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would change the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Program EHR reporting period 
in 2015 to a 90-day period aligned with the calendar year, and also 
would align the EHR reporting period in 2016 with the calendar year. In 
addition, this proposed rule would modify the patient action measures 
in the Stage 2 objectives related to patient engagement. Finally, it 
would streamline the program by removing reporting requirements on 
measures which have become redundant, duplicative, or topped out 
through advancements in EHR function and provider performance for Stage 
1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on June 15, 2015.

ADDRESSES: In commenting, please refer to file code CMS-3311-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-3311-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-3311-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) 786-7195 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, Medicare EHR Incentive Program 
and Medicare payment adjustment.
    Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive 
Program.
    Thomas Romano (CMS), (410) 786-0465, Medicaid EHR Incentive 
Program.

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)
ACO--Accountable Care Organization
AIU--Adopt, Implement, Upgrade (certified EHR Technology)
CAH--Critical Access Hospitals
CAHPS--Consumer Assessment of Healthcare Providers and Systems
CCN--CMS Certification Number
CDC--Centers for Disease Control
CEHRT--Certified Electronic Health Record Technology
CFR--Code of Federal Regulations
CHIP--Children's Health Insurance Program
CHIPRA--Children's Health Insurance Program Reauthorization Act of 
2009
CMS--Centers for Medicare and Medicaid Services
CPOE--Computerized Physician Order Entry
CQM--Clinical Quality Measure
CY--Calendar Year
EHR--Electronic Health Record
EP--Eligible Professional
ePHI--Electronic Protected Health Information
EPO--Exclusive Provider Organization
FACA--Federal Advisory Committee Act
FFP--Federal Financial Participation
FFY--Federal Fiscal Year
FFS--Fee-for-Service
FQHC--Federally Qualified Health Center
FTE--Full Time Equivalent
FY--Fiscal Year
HEDIS--Healthcare Effectiveness Data and Information Set
HHS--Department of Health and Human Services
HIE--Health Information Exchange
HIT--Health Information Technology
HITPC--Health Information Technology Policy Committee
HIPAA--Health Insurance Portability and Accountability Act of 1996
HITECH--Health Information Technology for Economic and Clinical 
Health Act
HMO--Health Maintenance Organization
HOS--Health Outcomes Survey
HPSA--Health Professional Shortage Area
HRSA--Health Resources and Services Administration
IAPD--Implementation Advanced Planning Document
ICR--Information Collection Requirement
IHS--Indian Health Service
IPA--Independent Practice Association
IPPS--Inpatient Prospective Payment System

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IQR--Inpatient Quality Reporting
IT--Information Technology
MA--Medicare Advantage
MAC--Medicare Administrative Contractor
MCO--Managed Care Organization
MITA--Medicaid Information Technology Architecture
MMIS--Medicaid Management Information Systems
MSA--Medical Savings Account
MU--Meaningful Use
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
NQF--National Quality Forum
ONC--Office of the National Coordinator for Health Information 
Technology
PAHP--Prepaid Ambulatory Health Plan
PAPD--Planning Advanced 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
PQRS--Physician Quality Reporting System
PHI --Protected Health Information
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

I. Executive Summary and Background

A. Executive Summary

1. Purpose of Regulatory Action
a. Need for Regulatory Action
    In this proposed rule, we would implement changes to Stage 1 and 
Stage 2 of the Medicare and Medicaid EHR Incentive Programs. In the 
March 30, 2015 Federal Register (80 FR 16731 through 16804), we 
published in the proposed rule for Stage 3 of meaningful use which 
included changes to the objectives and measures of meaningful use for 
providers beginning in 2017. These changes included removing redundant, 
duplicative, and topped out measures, and focusing the EHR Incentive 
Programs on advanced use of EHR technology. In order to reduce 
reporting burden, eliminate redundant and duplicative reporting, and to 
better align the objectives and measures of meaningful use for 2015 
through 2017 with the proposed Stage 3 requirements which would be 
optional in 2017 and required beginning in 2018, we are proposing to 
make similar modifications to Stage 1 and Stage 2 of the EHR Incentive 
Programs.
    In addition, in order to accommodate these changes, we propose 
additional modifications to the EHR reporting period and timeline of 
the Medicare and Medicaid EHR Incentive Programs in 2015 and 2016. We 
believe these changes would better align reporting periods for 
providers, support a flexible, clear framework to reduce provider 
burden, and ensure future sustainability of 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 Technology (CEHRT). Sections 
1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the 
statutory basis for the Medicare incentive payments made to meaningful 
EHR users. These statutory provisions govern EPs, MA organizations (for 
certain qualifying EPs and hospitals that meaningfully use CEHRT), 
subsection (d) hospitals, and CAHs respectively. Sections 1848(a)(7), 
1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish 
downward payment adjustments, beginning with calendar or fiscal year 
2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs 
that are not meaningful users of CEHRT for certain associated reporting 
periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the 
statutory basis for Medicaid incentive payments. (There are no payment 
adjustments under Medicaid). (For a more detailed explanation of the 
statutory basis for the EHR incentive payments, see the July 28, 2010 
Stage 1 final rule (75 FR 44316 through 44317).)
2. Summary of Major Provisions
a. Aligning Meaningful Use in 2015 Through 2017 With the Stage 3 
Proposals for Meaningful Use in 2017 and Subsequent Years
    The Stage 1 final rule sets the foundation for the Medicare and 
Medicaid EHR Incentive Programs by establishing requirements for the 
electronic capture of clinical data, including providing patients with 
electronic copies of health information. We outlined Stage 1 meaningful 
use criteria, and finalized core and menu objectives for EPs, eligible 
hospitals, and CAHs. (For a full discussion of the objectives and 
measures of Stage 1, we refer readers to the Stage 1 final rule at 75 
FR 44313 through 44588.) In the Stage 1 rulemaking, we discussed the 
idea that alignment of stage of meaningful use and payment year should 
synchronize for all providers in 2015. However, while we stated a goal 
to align the stages of meaningful use across all providers in 2015 (75 
FR 44322), we did not finalize such changes in the Stage 2 final rule. 
Furthermore, we stated in subsequent rulemaking (see for example the 
2014 CERHT Flexibility rule at 79 FR 52923 and 52596) that the 
requirements for each stage for the program must be informed by 
analysis of program data related to performance and participation 
milestones.
    In the September 4, 2012 stage 2 final rule, we maintained the same 
core-menu structure finalized for several Stage 1 core and menu 
objectives. We finalized that EPs must meet the measure or qualify for 
an exclusion to 17 core objectives and 3 of 6 menu objectives. We 
finalized that eligible hospitals and CAHs must meet the measure or 
qualify for an exclusion to 16 core objectives and 3 of 6 menu 
objectives. We combined several Stage 1 measures into Stage 2. With the 
experience providers gained from the Stage 1 final rule, we also 
increased functional objective measure thresholds in Stage 2 to 
increase efficiency, effectiveness, and flexibility. Also, beginning in 
2014, we finalized a set of clinical quality measures (CQMs) for all 
providers participating in any Stage of the program to report to CMS. 
(For a full discussion of the meaningful use objectives and measures, 
and the CQMs we finalized under Stage 2, we refer readers to the Stage 
2 final rule at 77 FR 53968 through 54162.)
    In the Stage 3 proposed rule, we built on the groundwork 
established in the Stage 1 and Stage 2 final rules, including 
continuing our goal started under Stage 2 to increase interoperability 
among providers. We also proposed to make changes to the Medicare and 
Medicaid EHR Incentive Programs that simplify reporting requirements 
and reduce program complexity. These changes were intended to balance 
the statutory requirements in the HITECH Act with responsiveness to 
providers expressing confusion and concerns over increased reporting 
burden related to the number of program requirements, the multiple 
stages of program participation, and the timing of EHR reporting 
periods. Therefore, we proposed for Stage 3 a

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single set of 8 objectives and related measures to meet the definition 
of meaningful use. We proposed that this single set of 8 objectives 
would be optional for 2017 and mandatory beginning in 2018. Also, the 
Stage 3 proposed rule would move all providers to an EHR reporting 
period of one full calendar year, with a limited exception for Medicaid 
providers demonstrating meaningful use for the first time, to support 
program alignment and simplify reporting requirements among provider 
types. The Stage 3 proposed rule and the 2015 Edition Health 
Information Technology (Health IT) Certification Criteria, 2015 Edition 
Base Electronic Health Record (EHR) Definition, and ONC Health IT 
Certification Program Modifications (hereinafter referenced as the 
``2015 Edition proposed rule'') published by the Office of the National 
Coordinator for Health Information Technology (ONC) may be reviewed at 
80 FR 16731 through 16804 and 80 FR 16804 through 1692, respectively. 
The Stage 3 proposed rule would align the stages of meaningful use 
across all providers beginning in 2018.
    In this proposed rule, we are seeking to make changes to the 
requirements for Stage 1 and Stage 2 of meaningful use for 2015 through 
2017 to align with the approach for Stage 3 of meaningful use in 2017 
and subsequent years. The analysis conducted during the planning 
process for Stage 3 also allowed insight into the progress toward 
program milestones and provider performance on the objectives and 
measures. This analysis allowed us to identify an approach to be 
responsive to stakeholder concerns about program complexity and revisit 
the consideration that the stage of meaningful use and EHR reporting 
periods should align where possible. Therefore, we are proposing a 
number of changes to both the EHR reporting period, and to the number 
of objectives and measures to which a provider must attest to 
demonstrate meaningful use. Specifically, we are proposing to move all 
providers to an EHR reporting period based on the calendar year 
beginning in 2015. Also, we propose to align the objectives and 
measures used in 2015 through 2017 with those identified in the Stage 3 
proposed rule for use in 2017 and subsequent years. This includes a 
proposal that, beginning with an EHR reporting period in 2015, 
providers would no longer be required to attest to certain objectives 
and measures which have been identified through our analysis to have 
reduced utility because they may now be redundant, duplicative, or 
``topped out''. (For further discussion of this selection process for 
Stage 3, we direct readers to sections I.A.2. and II.A.2. of the Stage 
3 proposed rule at (80 FR 16733 through 16735 and 16767 through 16768, 
respectively). The related selection process for the proposed changes 
to meaningful use in 2015 through 2017 uses a similar approach to 
reducing the reporting burden while also seeking to meet our statutory 
requirement to include more stringent measures of meaningful use. Our 
approach for applying these principals for meaningful use in 2015 
through 2017 is discussed in more detail in section II.B.1.c. of this 
proposed rule.
b. EHR Reporting Period in 2015 and 2016
    We are proposing to align the definition of an EHR reporting period 
with the calendar year for all providers beginning in 2015 and 
continuing through 2016 onward. Specifically, this proposal would 
change the EHR reporting period for eligible hospitals and CAHs from a 
period based on the fiscal year to the calendar year beginning in 2015. 
This aligns with the provision outlined in the Stage 3 proposed rule to 
move all providers to an EHR reporting period of 1 full calendar year 
beginning in 2017 with a limited exception for Medicaid providers 
demonstrating meaningful use for the first time (80 FR 16734 and 80 FR 
16737 through 16739). For 2015 and 2016, we are proposing to allow new 
participants in the EHR Incentive Program to attest to meaningful use 
for an EHR reporting period of any continuous 90-day period within the 
calendar year. In addition, for 2015 only, we are proposing to allow 
all EPs (regardless of their prior participation in the program) to 
attest to an EHR reporting period of any continuous 90-day period 
within the calendar year. For 2015 only, we are proposing to allow 
eligible hospitals and CAHs (regardless of their prior participation in 
the program) to attest to an EHR reporting period of any continuous 90-
day period within the period beginning October 1, 2014 and the close of 
the 2015 calendar year. This 90-day EHR reporting period for 2015 would 
allow providers additional time to address any remaining issues with 
the implementation of technology certified to the 2014 Edition and to 
accommodate the changes to the objectives and measures of meaningful 
use proposed in this rule.
    In 2016, we propose EPs, eligible hospitals, and CAHs that are 
demonstrating meaningful use for the first time may use an EHR 
reporting period of any continuous 90-day period between January 1, 
2016 and December 31, 2016. However, all returning participants would 
use an EHR reporting period of a full calendar year from January 1, 
2016 through December 31, 2016. In 2017, all providers, both new and 
existing participants, would use an EHR reporting period of 1 full 
calendar year as proposed in the Stage 3 proposed rule at (80 FR 16737 
through 16739) with a limited exception for Medicaid providers 
demonstrating meaningful use for the first time.
c. Meaningful Use Objectives and Measures for 2015 Through 2017
    In the Stage 3 proposed rule, we outlined our method and approach 
for identifying the objectives and measures retained for Stage 3 of 
meaningful use in 2017. We also identified those objectives and 
measures which are now redundant, duplicative, or topped out; and 
therefore; would no longer be required for the successful demonstration 
of meaningful use for Stage 3. For further discussion of this approach, 
we refer readers to (80 FR 16733 through 16735 and 16767 through 
16768).
    In this proposed rule, we discuss how we have used the same method 
to identify objectives and measures from Stages 1 and 2 of meaningful 
use which we believe should no longer be required for a provider to 
demonstrate meaningful use in 2015 through 2017 as these measures have 
been identified as redundant, duplicative, or topped out. These changes 
would remove the menu and core structure of Stages 1 and 2 and reduce 
the overall number of objectives to which a provider must attest. We 
discuss this approach in section II.B.1.c. of this proposed rule.
    In addition, we are proposing changes to individual objectives and 
measures for Stage 2 of meaningful use as follows:
     Changing the threshold from the Stage 2 Objective for 
Patient Electronic Access measure number 2 from ``5 percent'' to 
``equal to or greater than 1''.
     Changing the threshold from the Stage 2 Objective Secure 
Electronic Messaging from being a percentage-based measure, to yes-no 
measure stating the ``functionality fully enabled''.
     Consolidating all public health reporting objectives into 
one objective with measure options following the structure of the Stage 
3 Public Health Reporting Objective (80 FR 16745 through 16767).
     Changing the eligible hospital electronic prescribing 
objective from a ``menu'' objective to a mandatory

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objective with an exclusion available for certain eligible hospitals 
and CAHs.
    These proposed changes would apply for providers beginning with the 
EHR reporting period in 2015. We note that these proposals include 
provisions to maintain the existing definitions for the objectives and 
measures including numerator and denominator calculation, provisions to 
maintain measure thresholds for 2015, and provisions to allow 
exclusions for certain eligible providers in 2015 in order to 
facilitate the transition for providers already engaged in the 
workflows, data capture and measure calculation for meaningful use for 
an EHR reporting period in 2015.
d. Certification Requirements
    Under this proposed rule, we are not proposing changes to the 
individual certification requirements for the objectives and measures 
of meaningful use for an EHR reporting period in 2015 through 2017. 
Until a transition to EHR technology certified to the 2015 Edition is 
required (proposed in the Stage 3 proposed rule beginning with an EHR 
reporting period in 2018 at (80 FR 16767 and 16768), we are proposing 
that providers would continue to use EHR technology certified to the 
2014 Edition for an EHR reporting period in 2015, 2016, and 2017. As 
outlined in the Stage 3 proposed rule, providers may upgrade early to 
EHR technology certified to the 2015 Edition for an EHR reporting 
period prior to 2018. (For further information on this, and to review 
the applicable definition of CEHRT, we direct readers to the Stage 3 
proposed rule at (80 FR 16767 and 16768).
e. Medicaid EHR Incentive Program in 2015 through 2017
    The proposals included in this proposed rule would also apply for 
the Medicaid EHR Incentive Program, including the proposed changes to 
the EHR reporting period in 2015 and 2016, and the objectives and 
measures required to demonstrate meaningful use in 2015 through 2017. 
Consistent with the Stage 3 proposed rule, we propose to continue to 
offer states flexibility under the Medicaid EHR Incentive Program for 
the public health reporting objective. For meaningful use in 2015 
through 2017, we would continue the policy stated in the Stage 2 final 
rule (77 FR 53979) to allow states to 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 certification requirements specified under the 2014 
Edition certification criteria). (For more information see the Stage 3 
proposed rule (80 FR 16737 through 16739).)
f. Clinical Quality Measurement
    We are not proposing changes to the CQM selection or reporting 
scheme (9 or 16 CQMs across at least 3 domains) from the CQM 
requirements previously established for all providers seeking to 
demonstrate meaningful use in the Medicare and Medicaid EHR Incentive 
Programs defined in earlier rulemaking (see, for example, 77 FR 54049 
through 54089). For an EHR reporting period in 2015, and for providers 
demonstrating meaningful use for the first time in 2016, we are 
proposing that providers may--
     Attest to any continuous 90-day period of CQM data during 
the calendar year through the Medicare EHR Incentive Program 
registration and attestation site; or
     Electronically report CQM data using the established 
methods for electronic reporting.
    For 2016 and subsequent years, providers beyond their first year of 
meaningful use may attest to one full calendar year of CQM data or they 
may electronically report their CQM data using the established methods 
for electronic reporting outlined in section II.C. of this proposed 
rule.
g. Demonstration of Meaningful Use
    We are proposing 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 states for use in their Medicaid 
programs. We are proposing to continue the use of attestation as the 
method for demonstrating that an EP, eligible hospital, or CAH has met 
the objectives and measures of meaningful use. In lieu of individual 
Medicare EP attestation through the CMS registration and attestation 
system, we are proposing to continue the existing optional batch file 
process for attestation. We are additionally proposing changes to the 
attestation deadlines to accommodate the proposed change to reporting 
based on the calendar year for eligible hospitals and CAHs beginning 
with an EHR reporting period in 2015, as well as the proposed change to 
a 90-day EHR reporting period for all providers in 2015. We are 
proposing changes to the attestation deadlines for new meaningful EHR 
users in 2015 and 2016 to avoid the Medicare payment adjustments in 
2016 and 2017. Finally, we are proposing an alternate attestation 
option for certain Medicaid providers to demonstrate meaningful use in 
2015 and subsequent years to avoid Medicare payment adjustments.
h. Payment Adjustments and Hardship Exceptions
    We are proposing changes to the definition of an EHR reporting 
period for a payment adjustment at Sec.  495.4 as well as the 
attestation deadlines for certain providers to demonstrate meaningful 
use for an EHR reporting period to avoid the Medicare payment 
adjustment.
i. Summary of Cost Benefit Analysis
    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). 
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 regulatory impact analysis of this proposed rule for 
modification to the Medicare and Medicaid EHR Incentive Programs from 
2015 through 2017 outlines the reduction in the reporting burden for 
providers demonstrating meaningful use in 2015 and estimates the total 
annual cost savings. The low and high estimates for these total savings 
are $52,547,132 and $68,617,864 respectively. In addition to these 
reductions, we believe there are substantial cost savings accruing to 
eligible hospitals and EPs related to having additional time to achieve 
meaningful use.

B. Overview of the Regulatory History

    The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-
5)(ARRA) amended Titles XVIII and XIX of the Act to authorize incentive 
payments to EPs, eligible hospitals, and CAHs, and MA organizations to 
promote the adoption and meaningful use of CEHRT. In the July 28, 2010 
Federal Register (75 FR 44313 through 44588), we published a final rule 
(``Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program'', or ``Stage 1 final rule'') 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. (For a full 
explanation of the amendments made by ARRA, see the Stage 1 final rule 
at 75 FR 44316.) In that Stage 1 final rule, we also detailed that the 
Medicare and Medicaid EHR

[[Page 20350]]

Incentive Program would consist of three different stages of meaningful 
use requirements.
    In the September 4, 2012 Federal Register (77 FR 53967 through 
54162), we published a final rule (``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program-Stage 2; Final Rule'' or 
``Stage 2 final rule'') that specified the Stage 2 criteria that EPs, 
eligible hospitals, and CAHs would have to meet in order to qualify for 
incentive payments. In addition, the Stage 2 final rule finalized 
payment adjustments and other program participation requirements under 
Medicare for covered professional and hospital services provided by 
EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use 
of CEHRT, and finalized the revision of certain Stage 1 criteria, and 
finalized criteria that applied regardless of stage.
    In the December 7, 2012 Federal Register (77 FR 72985), CMS and ONC 
jointly published an interim final rule with comment period (IFC) 
titled ``Health Information Technology: Revisions to the 2014 Edition 
Electronic Health Record Certification Criteria; and Medicare and 
Medicaid Programs; Revisions to the Electronic Health Record Incentive 
Program'' (December 7, 2012 IFC). The Department of Health and Human 
Services (HHS) issued the IFC to replace the Data Element Catalog (DEC) 
standard and the Quality Reporting Document Architecture (QRDA) 
Category III standard adopted in the final rule published on September 
4, 2012 in the Federal Register with updated versions of those 
standards. The December 7, 2012 IFC also revised the Medicare and 
Medicaid EHR Incentive Programs by--
     Adding an alternative measure for the Stage 2 meaningful 
use (MU) objective for hospitals to provide structured electronic 
laboratory results to ambulatory providers;
     Correcting the regulation text for the measures associated 
with the objective for hospitals to provide patients the ability to 
view online, download, and transmit information about a hospital 
admission; and
     Making the case number threshold exemption for CQM 
reporting applicable for eligible hospitals and CAHs beginning with FY 
2013.
    The December 7, 2012 IFC also provided notice of our intention to 
issue technical corrections to the electronic specifications for CQMs 
released on October 25, 2012.
    In the September 4, 2014 Federal Register (79 FR 52910 through 
52933) CMS and ONC published a final rule titled ``Medicare and 
Medicaid Programs; Modifications to the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Program for 2014 and Other 
Changes to the EHR Incentive Program; and Health Information 
Technology: Revisions to the Certified EHR Technology Definition and 
EHR Certification Changes Related to Standards; Final Rule'' (``2014 
CEHRT Flexibility final rule''). Due to issues related to EHR 
technology certified to the 2014 Edition availability delays, the 2014 
CEHRT Flexibility final rule included policies allowing EPs, eligible 
hospitals, and CAHs that could not fully implement EHR technology 
certified to the 2014 Edition for an EHR reporting period in 2014 to 
continue to use one of the following options for reporting periods in 
CY 2014 and FY 2014, respectively--
     EHR technology certified to the 2011 Edition; or
     A combination of EHR technology certified to the 2011 
Edition and EHR technology certified to the 2014 Edition for the EHR 
reporting periods.
    These CEHRT options applied only to those providers that could not 
fully implement EHR technology certified to the 2014 Edition to meet 
meaningful use for an EHR reporting period in 2014 due to delays in 
2014 Edition availability. Although the 2014 CEHRT flexibility final 
rule did not alter the attestation or hardship exception application 
deadlines for 2014, it did make changes to the attestation process to 
support these flexible options for CEHRT. This 2014 CEHRT Flexibility 
final rule also discussed the provisions of the December 7, 2012 IFC 
and finalized policies relating to the provisions contained in the 
December 7, 2012 IFC.
    In the November 13, 2014 Federal Register, we published an interim 
final rule with comment period, under the Medicare Program; Revisions 
to Payment Policies Under the Physician Fee Schedule, Clinical 
Laboratory Fee Schedule, Access to Identifiable Data for the Center for 
Medicare and Medicaid Innovation Models & Other Revisions to Part B for 
CY 2015 (79 FR 67976 through 67978) (``November 13, 2014 IFC''). Under 
this November 13, 2014 IFC, we recognized a hardship exception for EPs 
and eligible hospitals for 2014 under the established category of 
extreme and uncontrollable circumstances in accordance with the 
Secretary's discretionary authority. To accommodate this hardship 
exception, we further extended the hardship application deadline for 
EPs and eligible hospitals to November 30 for 2014 only. We also 
amended the regulations to allow CMS to specify a later hardship 
application deadline for certain hardship categories for EPs, eligible 
hospitals, and CAHs.
    In the March 30, 2015 Federal Register, we published a proposed 
rule entitled ``Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program Stage 3'' (80 FR 16731 through 16804). In this 
March 30, 2015 Stage 3 proposed rule, we specified the proposed 
meaningful use criteria that EPs, eligible hospitals, and critical 
access hospitals must meet in order to demonstrate meaningful use of 
certified EHR technology for Stage 3 of the EHR Incentive Programs. It 
also specifies the proposed requirements for electronic submission of 
CQMs and creates a single set of meaningful use requirements for Stage 
3 which would be optional for providers in 2017 and required for all 
providers beginning in 2018. Finally, the Stage 3 proposed rule would 
also change the EHR reporting period so that all providers would report 
under a calendar year timeline.
    For Stages 1 and 2, CMS and the ONC worked closely to ensure that 
the definition of meaningful use of CEHRT and the associated standards 
and certification criteria were coordinated. (Current ONC regulations 
may be found at 45 CFR part 170.) For the Stage 3 proposed rule and the 
ONC 2015 Edition proposed rule, CMS and ONC have aligned the proposed 
rules (80 FR 16731 through 16804 and 80 FR 16804 through 16921) and 
would again work together to align the final regulations.
    (Readers may also visit: www.cms.hhs.gov/EHRincentiveprograms and 
www.healthit.gov for more information on the efforts at the Department 
of Health and Human Services (HHS) to advance HIT initiatives.)

II. Provisions of the Proposed Regulations

A. Introduction

    When the EHR Incentive Program began in 2011, the requirements for 
the objectives and measures of meaningful use were designed to begin a 
process toward health care delivery system transformation aligning with 
foundational goals defined in the HITECH Act. First, the statute 
requires the Secretary to seek to improve the use of EHR and health 
care quality over time by requiring more stringent measures of 
meaningful use (see section 1848(o)(2)(A)(iii) of the Act). To meet 
this goal, we established stages of meaningful use to move providers 
along a progression from adoption to advanced use of certified EHR 
technology. Second, the statute includes requirements for the use of 
EHR

[[Page 20351]]

technology, which defines both the functions that should be available 
within the EHR and the purpose to which those functions should be 
applied. These requirements include functions that are similar to the 
following (see section 1848(o)(4) of the Act)--
     The capacity to provide clinical decision support;
     To support provider order entry;
     To capture and query information relevant to health care 
quality; and
     To exchange protected health information with, and 
integrate such information from other sources.

The statute also defines key foundational principles of meaningful use 
such as electronic prescribing, the electronic exchange of health 
information to support the improvement of care and care coordination, 
and the use of EHR technology to submit information on clinical quality 
measures and other measures (see section 1848(o)(2)(A) of the Act).

    Since the EHR Incentive Programs began in 2011, a number of 
environmental changes have occurred which prompted us to reevaluate the 
program requirements in relation to progress toward goals. These 
changes include a wide range of factors including--
     Expansion of basic certified EHR technology 
infrastructure;
     Advancements in EHR and related health information 
technology;
     Widespread adoption of certain standards and 
functionality;
     Increased use of CEHRT to support quality improvement; and
     Performance on certain measures reaching maximum 
potential.
    The Certified Health IT Product List (ONC CHPL) developed by ONC 
assists providers in identifying certified EHR technology products that 
have been certified by an ONC-Authorized Certification Body (ONC-ACB). 
Certified EHR technology products, certified to the 2014 Edition, are 
required for use in the Medicare and Medicaid EHR Incentive Programs to 
meet meaningful use criteria for Stage 1 and 2 for an EHR reporting 
period in 2015. We reviewed data related to the ONC CHPL as of March 
20, 2015 and found 1956 unique products that are currently certified to 
the 2011 Edition and 2157 unique products that are certified to the 
2014 Edition. A unique product is a product that is certified and 
receives a unique certification ID (product updates and product version 
changes are included in the unique product count). Data from March 2013 
to March 2015 shows an increase of 104 percent in the total number of 
certified EHR technology products and an increase of 133 percent in 
total unique certified EHR technology products in the last 2 years 
alone. We believe the increase in the number of certified EHR 
technology products available is a positive step for providers seeking 
to meet meaningful use requirements and advance EHR technology. The 
data provided and additional information related to the ONC CHPL may be 
found on the HealthIT.gov Web site at http://healthit.gov/chpl.
    For a wide range of data and reports on health IT adoption rates, 
use of certification functions and standards, updates to eCQM 
specifications and testing, as well as the performance data for 
providers in relation to the available software, we direct readers to 
the ONC Web site (http://www.healthit.gov), the CMS eCQM Library 
(http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html), and the CMS EHR Incentive 
Programs data and reports Web site (http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html).
    As the program has increased the overall adoption of EHRs and as 
EHR technology has automated certain clinical functions and supported 
standardized data capture, we propose modifications, which would 
recognize these changes and realign the program with ongoing program 
goals. Our quality reporting programs regularly reevaluate measures 
based on factors like clinical relevance, updates to electronic 
specifications, and measure performance. We consider modifications to 
the objectives and measures of this program similar to those regularly 
made in our quality reporting programs.
    In addition to these environmental changes, stakeholder 
associations and provider groups have through correspondence, public 
forums, and public comment requested that we consider changes to the 
requirements to demonstrate meaningful use of certified EHR technology 
in the EHR Incentive Programs which would reduce the overall complexity 
of the program and the burden on providers. We believe some of these 
recommended changes may contradict certain statutory requirements for 
this program. For example, certain provisions such as electronic 
prescribing or health information exchange cannot be fully ``optional'' 
because they are expressly required under the statute (see section 
1848(o)(2)(A) of the Act). The statutory directive to require 
increasingly more stringent measures of meaningful use (see section 
1848(o)(2)(A)(iii) of the Act) prohibits the removal of all measure 
thresholds. Further examples are also discussed in the Stage 3 proposed 
rule at (80 FR 16737 through 16742).
    However, there are methods that could be employed to modify Stages 
1 and 2 of the program to address stakeholder concerns, meet the 
statutory requirements for the program defined in the HITECH Act, and 
continue to support progress toward the program's foundational goals. 
In addition, these methods would move providers along a continuum from 
data capture to advanced use of certified EHR technology including 
electronic prescribing, health information exchange, and quality 
improvement with increasingly stringent measures as identified in the 
Act and discussed in section II.B.1.b. of this proposed rule. 
Therefore, we are proposing modifications to Stages 1 and 2 and are 
seeking public comment on these proposals, which are intended to be 
responsive to the changing environment and to stakeholder concern over 
program complexity and redundant reporting requirements. We propose 
these modifications to address these concerns and to continue to 
support the overall goal of the widespread adoption and meaningful use 
of EHR technology in efforts to transform our health care delivery 
system and improve health care quality.

B. Meaningful Use Requirements for EHR Reporting Periods in 2015 
Through 2017

1. Definitions Across the Medicare Fee for Service, Medicare Advantage, 
and Medicaid Programs
a. Uniform Definitions
    As discussed in prior rules, we finalized several uniform 
definitions applicable for the Medicare FFS, Medicare Advantage, and 
Medicaid EHR Incentive Programs. We set forth these uniform definitions 
in part 495 subpart A of the regulations. (For further discussion of 
the uniform definitions finalized previously, we refer readers to the 
Stage 1 and Stage 2 final rules at 75 FR 44317 through 44321 and 77 FR 
53972 respectively.) (For discussion of the proposed changes to uniform 
definitions outlined in the Stage 3 proposed rule, we refer readers to 
the Stage 3 proposed rule at (80 FR 16736 through 16737).
    In this proposed rule, we are proposing to maintain the previously 
finalized uniform definitions except as stated in this proposed rule.

[[Page 20352]]

b. Changes to Definitions for 2015 Through 2017
    We are proposing changes to a number of definitions previously 
finalized for meaningful use in the Stage 1 and Stage 2 rules in order 
to modify the program in response to the changing health IT environment 
and related stakeholder concerns. These changes address the following:
     An overall simplification of the program aligned to the 
overarching goals of sustainability as discussed in the Stage 3 
proposed rule (80 FR 16737) and in section II.B.1.b.(1). of this 
proposed rule and a related change to requirements necessary to 
accommodate these changes outlined in section II.B.1.b.(2) of this 
proposed rule.
     Moving all providers to an EHR reporting period aligned 
with the calendar year as outlined in section II.B.1.b.(3).A. of this 
proposed rule.
     Providing flexibility for providers in 2015 to accommodate 
the proposed changes as outlined in section II.B.1.b of this proposed 
rule.
     Removing requirements for objectives and measures which 
are redundant or duplicative or which have ``topped out'' as described 
at (80 FR 16767) of the Stage 3 proposed rule and outlined in section 
II.B.1.c.(1). of this proposed rule.
     Restructuring the remaining measures and objectives to 
streamline requirements for 2015 through 2017 and to accommodate the 
changes for an EHR reporting period in 2015 as outlined in section 
II.B.1.c.(2). of this proposed rule.
     Refocusing the existing program on building toward 
advanced use of EHR technology, aligned with the Stage 3 proposed rule, 
through maintaining the objectives and measures outlined in section 
II.B.2. of this proposed rule.
(1) Stages of Meaningful Use
    In the phased approach to meaningful use, we finalized the criteria 
for meaningful use through staggered rulemaking, which covered Stages 1 
and 2 of the EHR Incentive Program. (For further explanation of the 
criteria we finalized in Stages 1 and 2, we refer readers to 75 FR 
44314 through 44588, 77 FR 53968 through 54162, and 79 FR 52910 through 
52933). The current progression of the stages as finalized in prior 
rulemaking is outlined in Table 1.

                                             Table 1--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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011...................................        1        1        1  1 or 2 *..................        2        2        3        3  TBD
2012...................................                 1        1  1 or 2 *..................        2        2        3        3  TBD
2013...................................                          1  1 *.......................        2        2        3        3  TBD
2014...................................                             1 *.......................        1        2        2        3  3
2015...................................                                                               1        1        2        2  3
2016...................................                                                                        1        1        2  2
2017...................................                                                                                 1        1  2
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In the Stage 3 proposed rule, we noted our intent for Stage 3 to be 
the final stage in meaningful use and that no further stages would be 
developed. We further proposed that all providers may optionally move 
to Stage 3 in 2017, and that all providers are required to move to 
Stage 3 beginning in 2018 regardless of their prior participation or 
stage of meaningful use. (For further discussion on this proposal, we 
direct readers to (80 FR 16774).
    In this proposed rule to modify Stages 1 and 2 for meaningful use 
in 2015 through 2017, we propose to further reduce complexity in the 
program and work toward this overall shift to a single set of 
objectives and measures in Stage 3 in 2018. We propose to require all 
providers to attest to a single set of objectives and measures 
beginning with an EHR reporting period in 2015. These objectives and 
measures would leverage existing objectives and measures of meaningful 
use. Because this change may occur after providers have already begun 
their work toward meeting meaningful use in 2015, we propose 
accommodations within individual objectives for providers in different 
stages of meaningful use. These accommodations include retaining the 
different specifications between Stage 1 and Stage 2, and allowing 
special exclusions for certain objectives or measures for eligible 
providers previously scheduled to participate in Stage 1 for an EHR 
reporting period in 2015.
    In this rule, we propose all providers would be required to attest 
to certain objectives and measures finalized in the Stage 2 final rule, 
which would align with those objectives and measures proposed for Stage 
3 of meaningful use. In effect, this would create a new progression 
using the existing objectives and measures where providers attest to a 
modified version of Stage 2 with accommodations for Stage 1 providers 
(equivalent to a reduced version of Stage 3) in 2015; a modified 
version of Stage 2 in 2016 (equivalent to a reduced version of Stage 
3); either a modified version of Stage 2 (equivalent to a reduced 
version of Stage 3) or the full version of Stage 3 outlined in the 
Stage 3 proposed rule in 2017; and the full version of Stage 3 outlined 
in the Stage 3 proposed rule beginning in 2018.
    The revised timeline based on this proposal and the Stage 3 
proposed rule is outlined in Table 2.

                             Table 2--Stage of Meaningful Use Criteria by First Year
----------------------------------------------------------------------------------------------------------------
                                                              Stage of meaningful use
 First year as a meaningful EHR  -------------------------------------------------------------------------------
              user                       2015                2016                2017                2018
----------------------------------------------------------------------------------------------------------------
2011............................  Modified Stage 2..  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.
2012............................  Modified Stage 2..  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.
2013............................  Modified Stage 2..  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.
2014............................  Modified Stage 2 *  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.
2015............................  Modified Stage 2 *  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.

[[Page 20353]]

 
2016............................  - NA -............  Modified Stage 2..  Modified Stage 2    Stage 3
                                                                           Or Stage 3.
----------------------------------------------------------------------------------------------------------------
* The Modifications to Stage 2 proposed in this rule include alternate exclusions and specifications for certain
  objectives and measures for providers that were scheduled to demonstrate Stage 1 of meaningful use in 2015.

    For simplification and reader clarity, we would therefore refer to 
the ``Stage'' designation in relation to the EHR Incentive Program 
rules and to the objectives and measures as follows:
     Meaningful use objectives and measures for 2015 through 
2017
     Stage 3 meaningful use objectives and measures for 2017 
and subsequent years
    This alignment of Stages 1 and 2 to the proposals for Stage 3 
essentially creates a new paradigm for providers in 2015 through 2017. 
This includes a simplified structure and focus on the objectives and 
measures with sustainable growth potential aligned to the programs 
foundational goals prior to the full implementation of Stage 3 in 2018. 
This change could alleviate the need to include the option in 2017 to 
allow providers to choose to demonstrate Stage 3 of the program in 
2017. To better understand the impact and potential complexity, we seek 
comment on whether or not we should implement only the modifications 
proposed in this rule from 2015 through 2017 and begin Stage 3 in 2018 
without an option year in 2017, or if we should allow providers the 
option to demonstrate Stage 3 beginning in 2017 as discussed in the 
Stage 3 proposed rule (80 FR 16774).
    We seek comment on these proposals.
(2) Meaningful EHR User
    In the Stage 3 proposed rule (80 FR 16731 through 16804), we 
proposed to modify the definition of ``Meaningful EHR User'' in 42 CFR 
495.4 to include the Stage 3 objectives and measures proposed at Sec.  
495.7. We further propose to redesignate some of the numbering of the 
regulation text under Part 495 to more clearly identify which sections 
of the regulation apply to specific years of the program. This would 
allow more direct references for the objectives and measures, while 
also preserving the content that applies for prior program years. We 
note this numerical redesignation would not affect the content of the 
regulation text except where noted in this proposed rule, nor would it 
change the proposed objectives and measures of Stage 3 of meaningful 
use at (80 FR 16745 through 16767). The redesignated numerical 
references for the regulation text are as follows:

------------------------------------------------------------------------
      Current section designation         Proposed section redesignation
------------------------------------------------------------------------
Sec.   495.6--Objectives and Measures..  Sec.   495.20--Objectives and
                                          Measures Prior to 2015
                                         Sec.   495.22--Objectives and
                                          Measures Beginning in 2015
Sec.   495.7 *--Stage 3 Objectives and   Sec.   495.24--Stage 3
 Measures.                                Objectives and Measures
Sec.   495.8--Demonstration of           Sec.   495.40--Demonstration of
 Meaningful Use.                          Meaningful Use
Sec.   495.10--Participation             Sec.   495.60--Participation
 Requirements.                            Requirements
------------------------------------------------------------------------
* Indicates a new section that was proposed in the Stage 3 proposed
  rule.

    In this proposed rule, we refer to Sec.  495.20 for the objectives 
and measures that apply for years prior to 2015, Sec.  495.22 for the 
objectives and measures proposed in this rule for 2015 through 2017, 
and Sec.  495.24 for the objectives and measures proposed in the Stage 
3 proposed rule for 2017 and subsequent years. Pending public comment 
and agency review of these proposals, all changes in Part 495 would be 
reconciled through the final rule.
(3) EHR Reporting Periods in 2015 Through 2017
    In 42 CFR 495.4, we define an EHR reporting period for eligible 
hospitals and CAHs based on the federal fiscal year (October 1 through 
September 30). However, the fiscal year EHR reporting period has 
resulted in varying reporting timelines between provider types and a 
shortened timeline for system developers to meet hospital and CAH 
technology needs. In the Stage 3 proposed rule, we outline changes to 
the EHR reporting period beginning with the EHR reporting period in 
2017 in order to move eligible hospitals and CAHs to EHR reporting 
periods based on a calendar year. (For further discussion of this 
proposal and the relationship to program alignment with quality 
reporting programs, we direct readers to 80 FR 16739.)
    In this proposed rule, our intent is to modify the program to 
remove redundant and duplicative measures; reduce reporting burden for 
measures that have ``topped out'' while preserving the program's 
foundational goals and the requirement for stringent or robust 
measurement; and better align the existing program with other CMS 
quality reporting programs. In order to move these efforts forward and 
to accommodate the proposed changes beginning in 2015 while still 
allowing providers time to complete an EHR reporting period after the 
effective date of a final rule, we are proposing changes to the uniform 
definition of an ``EHR reporting period'' in Sec.  495.4 beginning in 
2015. We are also proposing similar changes to the definition of an 
``EHR reporting period for a payment adjustment year'' in Sec.  495.4 
beginning in 2015 as discussed in section II.E.1. of this proposed 
rule. We are proposing changes to the attestation deadlines for 
purposes of the incentive payments and payment adjustments in section 
I.A.1.i. of this proposed rule.
(a) Calendar Year Reporting Beginning in 2015
    Beginning in 2015, we are proposing to change the definition of 
``EHR reporting period'' at Sec.  495.4 for EPs, eligible hospitals, 
and CAHs such that the EHR reporting period would begin and end in 
relation to a calendar year. This change would allow eligible hospitals 
and CAHs the same amount of time as EPs from the release of a new 
edition by ONC to the required date for full implementation of the EHR 
technology certified in accordance with those criteria. In addition, 
this change would allow providers additional time to accommodate the 
changes proposed

[[Page 20354]]

in this rule for demonstrating meaningful use in 2015. Finally, this 
change would align EHR reporting periods for the EHR Incentive Program 
with EHR reporting periods in CMS quality reporting programs, which 
have similar or related requirements.
    In this proposal, all providers (EPs, eligible hospitals, and CAHs) 
would be required to complete an EHR reporting period within January 1 
and December 31 of the calendar year in order to demonstrate meaningful 
use. In order to accommodate eligible hospitals and CAHs that may have 
planned their EHR reporting period in 2015 during the federal fiscal 
year and want to continue to use that time period for reporting, we 
propose for 2015 only these providers may begin an EHR reporting period 
as early as October 1 of 2014 and end by December 31 of 2015. Beginning 
with 2016, the EHR reporting period must be completed within January 1 
and December 31 of the calendar year.
    We seek comment on this proposal.
(b) 90-Day EHR Reporting Period for All Providers in 2015
    In the 2014 CEHRT Flexibility rule (79 FR 52919) we noted that many 
commenters had requested a 90-day EHR reporting period in 2015. In that 
rule, we discussed the reasons we did not propose or finalize a change 
to allow for an EHR reporting period of 90 days in 2015. We stated that 
we did not finalize changes to the EHR reporting period, because we 
believed such changes were not necessary to mitigate risk associated 
with the delay in the availability of EHR technology certified to the 
2014 Edition (79 FR 52919). In addition, we stated that such changes 
would put the forward progress of the program at risk, and potentially 
cause further delay in implementing effective health IT infrastructure 
and misalignment with the CMS quality reporting programs (79 FR 52919). 
We maintain the assertion that the delay in 2014 Edition availability 
does not necessitate changes to the EHR reporting period 2015; and that 
the proposed change to the EHR reporting period in 2015 in conjunction 
with the other modifications to the EHR Incentive Program proposed in 
this rule does represent a potential risk to the continued development 
of effective health IT infrastructure.
    Subsequent to the publication of the 2014 CEHRT Flexibility final 
rule, we conducted a full analysis of provider performance on Stage 1 
and Stage 2 measures and identified areas where measures were topped 
out or had become redundant or duplicative based on the widespread 
adoption of EHR technology certified to the 2014 Edition and successful 
implementation of the more complex Stage 2 objective functions. We 
determined that there was significant potential for a positive impact 
through reducing the reporting burden, simplifying the program, and 
realigning the program with long term goals for advanced use of EHRs. 
However, in order to implement these changes, a shortened EHR reporting 
period would be necessary in 2015 to allow both providers and CMS time 
to make necessary changes to systems. We believe the benefits to be 
gained from the proposals in this rule outweigh the potential risk of 
misalignment introduced by the shortened reporting period, if the risk 
is limited to only be allowable for an EHR reporting period in 2015. 
Therefore, we are proposing to allow a 90-day EHR reporting period in 
2015 only to accommodate implementation of the other changes proposed 
in this rule.
    For 2015 only, we are proposing to change the definition of ``EHR 
reporting period'' at Sec.  495.4 for EPs, eligible hospitals, and CAHs 
such that the EHR reporting period in 2015 would be any continuous 90-
day period within the calendar year. We intend this change to allow 
providers adequate time to plan for any necessary changes to their 
implementation of meaningful use required in order to accommodate the 
changes outlined in this proposed rule. We further believe this change 
is responsive to provider and stakeholder feedback received through 
correspondence, public forums, and public comment, which requested that 
we allow a 90-day EHR reporting period in 2015 in order to provide 
flexibility for continuing difficulties providers are experiencing with 
successful implementation of EHR technology certified to the 2014 
Edition.
    We propose that for an EHR reporting period in 2015, eligible 
professionals may select an EHR reporting period of any continuous 90-
day period from January 1, 2015 through December 31, 2015; while 
eligible hospitals and CAHs may select an EHR reporting period of any 
continuous 90-day period from October 1, 2014 through December 31, 
2015. This is intended to accommodate the shift from reporting based on 
the federal fiscal year to the calendar year for eligible hospitals and 
CAHs.
    In 2016, for eligible professionals, eligible hospitals, and CAHs 
that have not successfully demonstrated meaningful use in a prior year 
and are first-time participants in the program, the EHR reporting 
period would be any continuous 90-day period between January 1, 2016 
and December 31, 2016. However, for all returning participants that 
have successfully demonstrated meaningful use in a prior year, the EHR 
reporting period would be a full calendar year from January 1, 2016 
through December 31, 2016. In 2017, the EHR reporting period would be 1 
full calendar year for all providers, as proposed in the Stage 3 
proposed rule (80 FR 16739).
    We invite comment on these proposals.
c. Definition of Meaningful Use
(1) Considerations in Defining Meaningful Use
    In order to update the definition of meaningful use of certified 
EHR technology and make modifications to program requirements to 
reflect a changing health IT environment, we analyzed the existing 
objectives and measures of meaningful use to consider if they should be 
modified for the program beginning in 2015. As outlined in the Stage 3 
proposed rule, we looked at the set of potential objectives and 
measures for inclusion in the program for 2017 and subsequent years, 
and sought to determine if they were redundant, duplicative, or had 
reached a performance level considered to be ``topped out.'' We stated 
that redundant measures include those objectives where there is now a 
viable health IT-based solution which may replace paper-based actions 
and therefore a provider should no longer be required to also report on 
the objective where the measures includes paper-based actions, such as 
the Stage 2 Clinical Summary objective (77 FR 53998 through 54002). We 
stated that duplicative measures include those objectives where a 
measure which is also captured in the course of meeting another 
objective, such as recording vital signs which is also a required part 
of the Consolidated Clinical Document Architecture (C-CDA) in the 
Summary of Care objective (77 FR 54014 through 54016). Finally, we 
stated that ``topped out'' measures do not provide a meaningful gain in 
the effort to improve the use of EHR and health care quality over time 
by requiring more stringent measures of meaningful use. (For further 
discussion of this approach to identifying the objectives and measures 
for Stage 3, we direct readers to (80 FR 16740 through 16744).
    In this proposed rule, we have taken a similar approach to review 
the current objectives and measures of meaningful use with a few 
additional considerations. These included reviewing the functions and 
standards included the 2014 Edition when

[[Page 20355]]

determining if a measure is redundant or duplicative; and adding a 
review of isolated performance rates for providers in the first year of 
meaningful use in addition to reviewing quartile performance rates for 
topped out measures. (For further discussion on ``topped out'' measures 
in the Stage 3 proposed rule, we direct readers to (80 FR 16741 and 
16742). For further information on the performance rates for new 
participants as well as quartile performance rates for individual 
measures, we direct readers to the CMS EHR Incentive Program Web site 
data and reports page.\1\
---------------------------------------------------------------------------

    \1\ CMS EHR Incentive Programs Web site: ``Data and Reports'' 
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

    Our analysis of the objectives and measures of meaningful use 
Stages 1 and 2 identified a number of measures, which meet these 
criteria as either redundant, duplicative, or topped out with new 
participants consistently performing at a statistically comparable rate 
to returning participants. Table 3 identifies the current objectives 
and measures which meet these criteria. We are therefore proposing to 
no longer require providers to attest to these objectives and measures 
as currently codified in the CFR under Sec.  495.6 in order to 
demonstrate meaningful use beginning in 2015.

 Table 3--Objectives and Measures Identified by Provider Type Which Are
                  Redundant, Duplicative or Topped Out
------------------------------------------------------------------------
 
------------------------------------------------------------------------
        Provider type                   Objectives and measures
------------------------------------------------------------------------
Eligible Professional.......  Record Demographics.  42 CFR Sec.   495.6
                                                     (j)(3)(i) and (ii).
                              Record Vital Signs..  42 CFR Sec.   495.6
                                                     (j)(4)(i) and (ii).
                              Record Smoking        42 CFR Sec.   495.6
                               Status.               (j)(5)(i) and (ii).
                              Clinical Summaries..  42 CFR Sec.   495.6
                                                     (j)(11)(i) and
                                                     (ii).
                              Structured Lab        42 CFR Sec.   495.6
                               Results.              (j)(7)(i) and (ii).
                              Patient List........  42 CFR Sec.   495.6
                                                     (j)(8)(i) and (ii).
                              Patient Reminders...  42 CFR Sec.   495.6
                                                     (j)(9)(i) and (ii).
                              Summary of Care.....  42 CFR Sec.   495.6
                              Measure 1--Any         (j)(14)(i) and
                               Method.               (ii).
                              Measure 3--Test.....
                              Electronic Notes....  42 CFR Sec.   495.6
                                                     (j)(9)(i) and (ii).
                              Imaging Results.....  42 CFR Sec.   495.6
                                                     (k)(6)(i) and (ii).
                              Family Health         42 CFR Sec.   495.6
                               History.              (k)(2)(i) and (ii).
Eligible Hospital/CAH.......  Record Demographics.  42 CFR Sec.   495.6
                                                     (l)(2)(i) and (ii).
                              Record Vital Signs..  42 CFR Sec.   495.6
                                                     (l)(3)(i) and (ii).
                              Record Smoking        42 CFR Sec.   495.6
                               Status.               (l)(4)(i) and (ii).
                              Structured Lab        42 CFR Sec.   495.6
                               Results.              (l)(6)(i) and (ii).
                              Patient List........  42 CFR Sec.   495.6
                                                     (l)(7)(i) and (ii).
                              Summary of Care.....  42 CFR Sec.   495.6
                              Measure 1--Any         (l)(11)(i) and
                               Method.               (ii).
                              Measure 3--Test.....
                              eMAR................  42 CFR Sec.   495.6
                                                     (l)(16)(i) and
                                                     (ii).
                              Advanced Directives.  42 CFR Sec.   495.6
                                                     (m)(1)(i) and (ii).
                              Electronic Notes....  42 CFR Sec.   495.6
                                                     (m)(2)(i) and (ii).
                              Imaging Results.....  42 CFR Sec.   495.6
                                                     (m)(2)(i) and (ii).
                              Family Health         42 CFR Sec.   495.6
                               History.              (m)(3)(i) and (ii).
                              Structure Labs to     42 CFR Sec.   495.6
                               Ambulatory            (m)(6)(i) and (ii).
                               Providers.
------------------------------------------------------------------------

    We note that many of these objectives and measures include actions 
that may be valuable to providers and patients, such as providing a 
clinical summary to a patient after an office visit. We encourage 
providers to continue to conduct these activities as best suits their 
practice and the preferences of their patient population. The removal 
of these measures is in no way intended as a removal of endorsement of 
these best practices or to discourage providers from conducting and 
tracking these activities for their own quality improvement goal. 
Instead, we would no longer require providers to calculate and attest 
to the results of these measures in order to demonstrate meaningful use 
beginning in 2015.
    We seek comment on this proposal.
(2) Changes to Definition of Meaningful Use for 2015 Through 2017
    In order to implement the proposed changes to no longer require 
providers to attest to their performance on the identified objectives 
and measures and to accomplish the related goal of restructuring the 
program to align with long-term goals, there are a number of changes, 
which must be made to other requirements of meaningful use. These 
changes fall into the following two major categories:
     Changes to streamline the structure for 2015 through 2017 
to align with the proposed structure for Stage 3 of meaningful use in 
2017 and subsequent years; and
     Changes to accommodate this shift to allow providers to 
successfully demonstrate meaningful use for an EHR reporting period in 
2015.
    In addition, we have heard from stakeholder associations and 
provider representatives that providers have faced significant 
challenges in implementing the patient engagement objectives, which 
require patient action. These are outlined in the Stage 2 final rule at 
77 FR 54046 under the Health Outcomes Policy Priority ``Engage patients 
and families in their care'': The Patient Electronic Access objective 
Stage 2 measure 2 for more than 5 percent of patients to view, download 
or transmit their health information; and, the EPs secure electronic 
messaging objective for more than 5 percent of patients to send a 
secure message using CEHRT. These concerns have included both the 
barriers to successful implementation of the required health IT or 
CEHRT functions necessary to support the measures and especially the

[[Page 20356]]

secure transmission function; and the challenges to effectively 
changing patient behavior including patient IT knowledge gaps, lack of 
widespread access to technologies, and cultural barriers among specific 
patient populations. We recognize these concerns and are proposing 
changes to these objectives to allow providers to focus on improvements 
without jeopardizing their ability to successfully demonstrate 
meaningful use. These changes are outlined in section II.B.1.c.(2).(c). 
of this proposed rule.
(a) Structural Requirements of Meaningful Use in 2015 Through 2017
    If we remove the requirement to attest to the identified measures 
and objectives, the distribution requirements between menu and core 
objectives can no longer be applicable. In addition, stakeholder 
associations and provider representatives have expressed through 
correspondence, public forum, and public comment on regulation that the 
core and menu structure is unnecessarily complex and a source of 
confusion for providers. Therefore, we propose to eliminate the 
distinction between core and menu objectives, and further propose that 
all retained objectives and measures would be required for the program. 
We note that for Stage 1 providers, this means three current menu 
objectives would now be required; and for Stage 2 eligible hospitals 
and CAHs, one current menu objective would now be a required objective. 
These objectives are as follows:

 Stage 1 Menu: Perform Medication Reconciliation
 Stage 1 Menu: Patient Specific Educational Resources
 Stage 1 Menu: Public Health Reporting Objectives (multiple 
options)
 Stage 2 Menu Eligible Hospitals and CAHs Only: Electronic 
Prescribing

    We note that the objectives and measures retained in each case for 
all providers would be the Stage 2 objectives and measures; however, we 
are proposing to establish alternate exclusions and specifications to 
mitigate any additional burden on providers for an EHR reporting period 
in 2015. These related proposals are discussed further in section 
II.B.3.c.(2).(b). of this proposed rule.
    For the public health reporting objectives and measures, we are 
proposing to consolidate the different Stage 2 core and menu objectives 
into a single objective with multiple measure options. We proposed this 
approach for the Stage 3 public health reporting objective as we 
believe it provides greater flexibility for providers and supports 
continued efforts to engage providers and public health agencies in the 
essential data capture and information exchange which supports quality 
improvement, emergency response, and population health management 
initiatives. For further discussion of the rationale for the Stage 3 
objective, we direct readers to (80 FR 16731 through 16804). We discuss 
the proposal for the consolidated public health reporting objective for 
meaningful use in 2015 through 2017 in section II.B.2.j. of this 
proposed rule. We propose that EPs must select to report on any 
combination of 2 of the 5 available options outlined in section 
II.B.2.j. of this proposed rule and eligible hospitals and CAHs must 
select to report on any combination of 3 of the 6 available options in 
section II.B.2.j. of this proposed rule. If a provider is scheduled to 
attest to Stage 1 of meaningful use in 2015, we propose to allow these 
EPs in 2015 to select to report on only 1 of the 5 available options 
outlined in section II.B.2.j. of this proposed rule and these eligible 
hospitals and CAHs in 2015 to select to report on any combination of 2 
of the 6 available options in section II.B.2.j. of this proposed rule.
    Therefore, we propose that the structure of meaningful use for 2015 
through 2017 would be 9 required objectives for EPs using the Stage 2 
objectives for EPs with alternate exclusions and specifications for 
Stage 1 providers in 2015. We propose that the structure of meaningful 
use for 2015 through 2017 would be 8 required objectives for eligible 
hospitals and CAHs using the Stage 2 objectives for eligible hospitals 
and CAHs with alternate exclusions and specifications for Stage 1 
providers and some stage 2 providers in 2015. In addition, EPs would be 
required to report on a total of 2 measures from the public health 
reporting objective or meet the criteria for exclusion from up to 5 
measures, and eligible hospitals and CAHs would be required to report 
on a total of 3 measures from the public health reporting objective or 
meet the criteria for exclusion from up to 6 measures. We reiterate 
that the alternate exclusions and specifications mentioned are further 
defined in section II.B.1.c.(2).(b). of this section of this proposed 
rule, and the objectives and measures are defined in section II.B.2. of 
this proposed rule.

                  Table 4--Current Stage Structure, Retained Objectives, and Proposed Structure
----------------------------------------------------------------------------------------------------------------
                                           Current stage 1
                                              structure           Retained objectives       Proposed structure
----------------------------------------------------------------------------------------------------------------
EP...................................  13 core objectives.....  6 core objectives......  9 core objectives.
                                       5 of 9 menu objectives   3 menu objectives......  1 public health
                                        including 1 public      2 public health           objective (2 measure
                                        health objective.        objectives.              options).
EH/CAH...............................  11 core objectives.....  5 core objectives......  8 core objectives.
                                       5 of 10 menu objectives  3 menu objectives......  1 public health
                                        including 1 public      3 public health           objective (3 measure
                                        health objective.        objectives.              options).
EP...................................  17 core objectives       9 core objectives......  9 core objectives.
                                        including public        0 menu objectives......  1 public health
                                        health objectives.      4 public health           objective (2 measure
                                       3 of 6 menu objectives.   objectives.              options).
EH/CAH...............................  16 core objectives       7 core objectives......  8 core objectives.
                                        including public        1 menu objective.......  1 public health
                                        health objectives.      3 public health           objective (3 measure
                                       3 of 6 menu objectives.   objectives.              options).
----------------------------------------------------------------------------------------------------------------

[[Page 20357]]

(b) Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We are proposing several alternate exclusions and specifications 
for providers scheduled to demonstrate Stage 1 of meaningful use in 
2015, which would allow these providers to continue to demonstrate 
meaningful use despite the proposals to use only the Stage 2 objectives 
and measures identified for meaningful use in 2015 through 2017. These 
provisions fall into the following two major categories:
     Maintaining the specifications for objectives and measures 
which have a lower threshold or other measure difference between Stage 
1 and Stage 2.
     Establishing an exclusion for Stage 2 measures which do 
not have an equivalent Stage 1 measure associated with any Stage 1 
objective or where the provider did not plan to attest to the menu 
objective which would now be otherwise required.
    For the first category, we propose that providers who are scheduled 
to demonstrate Stage 1 of meaningful use for an EHR reporting period in 
2015 may attest to meaningful use using the specifications established 
for the Stage 1 objectives and measures defined at 42 CFR 495.6 for 
each retained objective or measure where there is a difference in 
specifications between Stages 1 and 2. For example, in Stage 1 the 
electronic prescribing objective for EPs requires that ``More than 40 
percent of all permissible prescriptions written by the EP are 
transmitted electronically using certified EHR technology'' (75 FR 
44338). While the Stage 2 electronic prescribing objectives requires 
that ``More than 50 percent of all permissible prescriptions written by 
the EP are compared to at least one drug formulary and transmitted 
electronically using Certified EHR Technology'' (77 FR 53990). 
Therefore, we are proposing that for an EHR reporting period in 2015, 
providers scheduled to demonstrate Stage 1 of meaningful use may attest 
based on the specifications associated with the Stage 1 measure. We 
note that for an EHR reporting period beginning in 2016, all providers 
must attest to the specifications including the measure thresholds 
associated with the Stage 2 measure. For an EHR reporting period in 
2016, all providers, including those who would otherwise be scheduled 
for Stage 1 in 2016, would be required to meet the Stage 2 
specifications with no alternate exclusions.
    For the second category, we note that some objectives, such as the 
Patient Electronic Access objective, have the same requirements for one 
measure (more than 50 percent of patients are provided access to view, 
download, and transmit their health information) for both Stage 1 and 
Stage 2, but also have an additional measure for Stage 2 (more than 5 
percent of patients view, download, or transmit their health 
information). Other objectives, such as the Summary of Care objective, 
are designated as a menu objective for Stage 1 but are a core objective 
for Stage 2 and also may have additional measure requirements in Stage 
2 that are not applicable for Stage 1 (77 FR 54013 through 54017). 
Finally, some objectives consist of requirements from multiple 
objectives from Stage 1 that were consolidated into a single objective 
for Stage 2 such as drug-drug and drug-allergy decision support 
interventions. For these consolidated objectives, all providers would 
be required to attest to the Stage 2 objective and measures. For 
objectives where there is a measure that is not equivalent between 
Stage 1 and Stage 2 or where the objective moves from menu to core 
between Stage 1 and Stage 2, we propose to include an exclusion for 
providers who were scheduled to demonstrate Stage 1 of meaningful use 
for the EHR reporting period in 2015. For example, Stage 1 providers 
may exclude from the requirement to send an electronic summary of care 
record for more than 10 percent of transitions of care as required in 
the Stage 2 Summary of Care objective measure 2 (75 FR 44364).
    These alternate exclusions and specifications for certain 
objectives and measures of meaningful use for an EHR reporting period 
in 2015 are defined for each objective and measure in the description 
of each objective and measure included in section II.B.2. of this 
proposed rule.
    We invite public comment on this proposal.
(c) Changes to Patient Engagement Requirements for 2015 Through 2017
    Through correspondence, public forums, and public comment on our 
proposed regulations, stakeholders have expressed concern that certain 
factors like demographics, low utilization of internet capable 
technology among their patient population, or other external barriers 
which are beyond their control are impacting providers' ability to meet 
certain measures which require providers to track patient action. In 
addition, providers and system developers have noted through similar 
means an overall immaturity in the market with health IT equipped with 
the functions required to support the transmission of health 
information by a patient or the delivery of a secure message from a 
patient to a third party. Providers have indicated that while they 
support the goal of improved patient engagement, these issues are 
impacting their ability to meet the measure requirements. We note that 
data obtained from provider attestations shows performance on these 
measures is concentrated around the median rate (around 20 percent \2\) 
which indicates the potential for ongoing performance that exceeds the 
existing threshold. However, there is a wide variance at the high and 
low ends, which indicates that there may be external factors impacting 
performance. Therefore, we are seeking to mitigate these concerns by 
making changes to the related measures. We believe these changes would 
allow providers the necessary time to work toward patient education 
about the availability of these resources as well as allowing the 
industry as a whole time to develop a stronger infrastructure 
supporting patient engagement.
---------------------------------------------------------------------------

    \2\ CMS EHR Incentive Programs Web site: ``Data and Reports: 
Performance data through February 2015'' https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/AttestationPerformanceData_Feb2015.pdf
---------------------------------------------------------------------------

    There are two objectives for EPs and one objective for eligible 
hospitals and CAHs, which specifically contain measures requiring a 
provider to track patient action. We propose to modify these measures 
as follows:
 Patient Action To View, Download, or Transmit Health 
Information
    ++ Remove the 5 percent threshold for Measure 2 from the EP Stage 2 
Patient Electronic Access (VDT) objective. Instead require that at 
least 1 patient seen by the provider during the EHR reporting period 
views, downloads, or transmits his or her health information to a third 
party. This would demonstrate the capability is fully enabled and 
workflows to support the action have been established by the provider.
    ++ Remove the 5 percent threshold for Measure 2 from the eligible 
hospital and CAH Stage 2 Patient Electronic Access (VDT) objective. 
Instead require that at least 1 patient discharged from the hospital 
during the EHR reporting period views, downloads, or transmits his or 
her health information to a third party. This would demonstrate the 
capability is fully enabled and workflows to support the action have 
been established by the provider.
    We seek comment on potential alternate proposals for this proposed 
change to the threshold for Measure 2 of the Stage 2 Patient Electronic 
Access objective. For example, we seek

[[Page 20358]]

comment on potential alternates such as a percentage threshold less 
than 5 percent, or a numerator greater than 10 patients, or another 
similar numerical alternative. We further seek comment on suggestions 
for other potential alternatives which would accomplish the goals here 
stated of reducing the burden on providers to account for patient 
actions while still continuing to encourage IT supported patient 
engagement.
 Secure Electronic Messaging Using CEHRT
    ++ Convert the measure for the Stage 2 EP Secure Electronic 
Messaging objective from the 5 percent threshold to a yes/no 
attestation to the statement: ``The capability for patients to send and 
receive a secure electronic message was enabled during the EHR 
reporting period''.
    These changes are reflected in the discussion of these objectives 
in section II.B.2. of this proposed rule. We note that these changes 
are intended to allow providers to work toward meaningful patient 
engagement through health IT using the methods best suited to their 
practice and their patient population. We further note that the Stage 3 
proposed rule includes an objective exclusively focused on patient 
engagement with an expanded set of measures and increased thresholds 
which providers would be required to meet beginning in 2018 (and 
optionally in 2017). (For further information on that proposed 
objective, we direct readers to 80 FR 16755 through 16758.)
    We invite public comment on this proposal.
2. Meaningful Use Objectives and Measures for 2015, 2016, and 2017
    We propose the following objectives and measures for EPs, eligible 
hospitals, and CAHs to successfully demonstrate meaningful use for an 
EHR reporting period in 2015 through 2017. We note that there are 9 
proposed objectives for EPs plus one consolidated public health 
reporting objective, and 8 proposed objectives for eligible hospitals 
and CAHs plus one consolidated public health reporting objective which 
would be required with alternate exclusions for certain providers in 
2015 and which would be mandatory for all providers for an EHR 
reporting period beginning in 2016.
a. Protect Electronic Health Information
    We are proposing to retain with certain modifications the Stage 2 
objective and measure for Protect Electronic Health Information for 
meaningful use in 2015 through 2017. (For further information and 
discussion of the existing Stage 2 Protect Electronic Health 
Information objective and measure, please refer to 77 FR 54002 and 
54003).
    Proposed Objective: Protect electronic health information created 
or maintained by the CEHRT through the implementation of appropriate 
technical capabilities.
    In the Stage 2 final rule (77 FR 54002 through 54003), we discussed 
the benefits of safeguarding electronic protected health information 
(ePHI), as doing so is essential to all other aspects of meaningful 
use. Unintended and unlawful disclosures (or both) of ePHI could 
diminish consumers' confidence in EHRs and health information exchange. 
Ensuring that ePHI is adequately protected and secured would 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 in 45 CFR 164.308(a)(1), including 
addressing the security (to include encryption) of data stored in 
Certified EHR Technology in accordance with requirements in 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, eligible hospital, or CAHs risk management process.
    A review must be conducted for each EHR reporting period and any 
security updates and deficiencies that are identified should be 
included in the provider's risk management process and implemented or 
corrected as dictated by that process. We refer providers to the 
requirements in 45 CFR 164.308(a)(1), including addressing the security 
(to include encryption) of data at rest in accordance with requirements 
in 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), of the HIPAA 
Security Rule for compliance. The HHS Office for Civil Rights (OCR) has 
issued guidance on conducting a security risk analysis in accordance 
with the HIPAA Security Rule (http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). Other free tools 
and resources available to assist providers include a Security Risk 
Assessment (SRA) Tool developed by ONC and OCR http://www.healthit.gov/providers-professionals/security-risk-assessment-tool.
    The scope of the security risk analysis for purposes of this 
meaningful use measure applies to ePHI created or maintained by CEHRT. 
However, we note that other ePHI may be subject to the HIPPA Rules and 
we refer providers to those rules for additional security requirements.
    We invite public comment on this proposal.
b. Clinical Decision Support
    We are proposing to retain the Stage 2 objective and measures for 
Clinical Decision Support (CDS) for meaningful use in 2015 through 
2017. This is a consolidated objective, which incorporates the Stage 1 
objective to implement drug-drug and drug-allergy interaction checks. 
(For further information and discussion of the existing consolidated 
Stage 2 CDS objective and measures, please refer to 77 FR 53995 through 
53998.)
    Proposed Objective: Use clinical decision support to improve 
performance on high-priority health conditions.
    We propose to retain the Stage 2 clinical decision support (CDS) 
objective such that CDS would be used to improve performance on high-
priority health conditions. It would be left to the provider's clinical 
discretion to select the most appropriate CDS interventions for his or 
her patient population. CDS interventions selected should be related to 
four or more of the clinical quality measures (CQMs) on which providers 
would be expected to report. The goal of the proposed CDS objective is 
for providers to implement improvements in clinical performance for 
high-priority health conditions that would result in improved patient 
outcomes. We propose to maintain that providers must implement the CDS 
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.
    Proposed Measure: In order for EPs, eligible hospitals, and CAHs to 
meet the objective they must satisfy both of the following measures:
     Measure 1: Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an EP, eligible 
hospital or CAH's scope of practice or patient population, the clinical 
decision support interventions must be related to high-priority health 
conditions.
     Measure 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.
    For the first measure, it is suggested that one of the five 
clinical decision support interventions be related to improving 
healthcare efficiency.

[[Page 20359]]

    Exclusion: For the second measure, any EP who writes fewer than 100 
medication orders during the EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We propose that providers who are scheduled to demonstrate Stage 1 
of meaningful use for an EHR reporting period in 2015 may attest to 
meaningful use using the specifications established for the Stage 1 
objectives and measures as they are currently defined at 42 CFR 495.6 
for each retained objective or measure where there is a difference in 
specifications between Stages 1 and 2. We note that the Stage 1 
Clinical Decision Support objective has a different requirement than 
the Stage 2 Clinical Decision Support objective measure 1 defined 
previously. For Stage 1, the objective reads ``Implement one clinical 
decision support rule relevant to specialty or high clinical priority 
along with the ability to track compliance with that rule'' for EPs and 
``Implement one clinical decision support rule related to a high 
priority hospital condition along with the ability to track compliance 
with that rule'' for eligible hospitals and CAHs (42 CFR 495.6). 
Therefore, for an EHR reporting period in 2015 only, we propose that an 
EP, eligible hospital or CAH who is scheduled to participate in Stage 1 
in 2015 may satisfy the following Stage 1 measure instead of the Stage 
2 measure 1 stated previously:
     Alternate Objective and Measure (For Measure 1): 
Objective: Implement one clinical decision support rule relevant to 
specialty or high clinical priority, or high priority hospital 
condition, along with the ability to track compliance with that rule. 
Measure: Implement one clinical decision support rule.
    We propose that for an EHR reporting period in 2015, an EP, 
eligible hospital or CAH who is scheduled to participate in Stage 1 in 
2015 must also satisfy the Stage 2 measure 2 previously stated because 
it is the same as an existing Stage 1 measure (77 FR 53998). There are 
no alternate exclusions for this objective.
    We invite public comment on this proposal.
c. Computerized Provider Order Entry (CPOE)
    We are proposing to retain the Stage 2 objective and measures for 
Computerized Provider Order Entry (CPOE) for meaningful use in 2015 
through 2017, with the modifications proposed here as alternate 
exclusions and specifications for Stage 1 providers for an EHR 
reporting period in 2015. (For further information and discussion of 
the existing Stage 2 CPOE objective and measures, please refer to 77 FR 
53985 through 53987.)
    Proposed Objective: Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional who can enter orders into the medical 
record per state, local, and professional guidelines.
    We 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.
    Proposed Measures: In Stage 2 of meaningful use, we adopted three 
measures for this objective:
     Measure 1: More than 60 percent of medication orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry.
     Measure 2: More than 30 percent of laboratory orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry.
     Measure 3: More than 30 percent of radiology orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry. We propose to retain the three measures of this current Stage 2 
objective to calculate a percentage threshold for all three types of 
orders: Medication, laboratory, and radiology. We propose to retain 
exclusionary criteria for those providers who so infrequently issue an 
order type that it is not practical to implement CPOE for that order 
type. To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
     Measure 1:
    Denominator: Number of medication orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 60 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 medication orders 
during the EHR reporting period.
     Measure 2:
    Denominator: Number of laboratory orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 30 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 laboratory orders 
during the EHR reporting period.
     Measure 3:
    Denominator: Number of radiology orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 30 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 radiology orders during 
the EHR reporting period.
    An EP through a combination of meeting the thresholds and 
exclusions (or both) must satisfy all three measures for this 
objective. A hospital must meet the thresholds for all three measures.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We propose that providers who are scheduled to demonstrate Stage 1 
of meaningful use for an EHR reporting period in 2015 may attest to 
meaningful use using the specifications and thresholds established for 
the Stage 1 objectives and measures as they are currently defined at 42 
CFR 495.6 for each retained objective or measure

[[Page 20360]]

where there is a difference in specifications between Stages 1 and 2.
    In the Stage 1 final rule, the CPOE measure requires that ``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'' (75 FR 44334). In addition, in the Stage 2 final 
rule, we established an optional alternative to this measure for Stage 
1 of ``More than 30 percent of medication orders created by the EP or 
authorized providers of the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
recorded using CPOE.'' (77 FR 53988). Therefore, we are proposing that 
for an EHR reporting period in 2015, providers scheduled to demonstrate 
Stage 1 of meaningful use may attest to the specification associated 
with the Stage 1 measure.
    We further propose that providers scheduled to demonstrate Stage 1 
of meaningful use for an EHR reporting period in 2015 may claim an 
exclusion for any retained Stage 2 measure where there is not an 
equivalent Stage 1 measure currently defined at 42 CFR 495.6. The Stage 
2 CPOE objective includes measures for laboratory and radiology orders, 
whereas the Stage 1 CPOE objective does not include these measures. 
Thus, we propose that for an EHR reporting period in 2015 only, 
providers scheduled to demonstrate Stage 1 of meaningful use in 2015 
may exclude the Stage 2 CPOE measures for laboratory and radiology 
orders (measures 2 and 3 listed previously). We propose that for an EHR 
reporting period beginning in 2016, all providers must attest to the 
Stage 2 objective and measures, and meet the thresholds associated with 
all three of the Stage 2 measures discussed previously in order to 
successfully demonstrate meaningful use.
    Alternate Measure 1: 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; or more than 30 percent of 
medication orders created by the EP during the EHR reporting period, or 
created by the authorized providers of the eligible hospital or CAH for 
patients admitted to their inpatient or emergency departments (POS 21 
or 23) during the EHR reporting period, are recorded using computerized 
provider order entry.
    Alternate Exclusion for Measure 2: Provider may claim an exclusion 
for measure 2 (laboratory orders) of the Stage 2 CPOE objective for an 
EHR reporting period in 2015.
    Alternate Exclusion for Measure 3: Provider may claim an exclusion 
for measure 3 (radiology orders) of the Stage 2 CPOE objective for an 
EHR reporting period in 2015.
    We invite public comment on this proposal.
d. Electronic Prescribing
    We are proposing to retain the Stage 2 objective and measure for 
Electronic Prescribing (eRx) for EPs as well as for eligible hospitals 
and CAHs for meaningful use in 2015 through 2017. We note that the 
Stage 2 objective for eligible hospitals and CAHs is currently a menu 
objective, but we propose it would be required for 2015 through 2017, 
with an exception for Stage 1 eligible hospitals and CAHs for an EHR 
reporting period in 2015. (For further information and discussion of 
the existing Stage 2 eRx objectives and measures, please refer to 77 FR 
53989 through 53990 for EPs and 77 FR 54035 through 54036 for eligible 
hospitals and CAHs.)
(1) EP Proposed Objective
    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, CEHRT can recognize 
the information and can provide decision support to promote safety and 
quality in the form of adverse interactions and other treatment 
possibilities. The CEHRT can also provide decision support that 
promotes the efficiency of the health care system by alerting the EP to 
generic alternatives or to alternatives favored by the patient's 
insurance plan that are equally effective. Transmitting the 
prescription electronically promotes efficiency and safety through 
reduced communication errors. It also allows the pharmacy or a third 
party to automatically compare the medication order to others they have 
received for the patient. This comparison allows for many of the same 
decision support functions enabled at the generation of the 
prescription, but bases them on potentially greater information.
    Proposed EP Measure: More than 50 percent of all permissible 
prescriptions, or all prescriptions, written by the EP are queried for 
a drug formulary and transmitted electronically using Certified EHR 
Technology.
    We propose to retain the exclusion introduced for Stage 2 that 
would allow EPs to exclude this objective if no pharmacies within 10 
miles of an EP's practice location at the start of his/her EHR 
reporting period accept electronic prescriptions. This is 10 miles in 
any straight line from the practice location independent of the travel 
route from the practice location to the pharmacy. We stated that EPs 
practicing at multiple locations would be eligible for the exclusion if 
any of their practice locations that are equipped with CEHRT meet this 
criteria. An EP would not be eligible for this exclusion if he or she 
is part of an organization that owns or operates its own pharmacy 
within the 10 mile radius regardless of whether that pharmacy can 
accept electronic prescriptions from EPs outside of the organization.
    We also propose to retain the exclusion for EPs who write fewer 
than 100 permissible prescriptions during the EHR reporting period.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of prescriptions written for drugs requiring a 
prescription in order to be dispensed other than controlled substances 
during the EHR reporting period; or Number of prescriptions written for 
drugs requiring a prescription in order to be dispensed during the EHR 
reporting period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary and transmitted electronically 
using CEHRT.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP to meet this measure.
    Exclusions: Any EP who:
     Writes fewer than 100 permissible prescriptions during the 
EHR reporting period; or
     Does not have a pharmacy within his or her organization 
and there are no pharmacies that accept electronic prescriptions within 
10 miles of the EP's practice location at the start of his or her EHR 
reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We propose that providers who are scheduled to demonstrate Stage 1 
of meaningful use for an EHR reporting period in 2015 may attest to 
meaningful

[[Page 20361]]

use using the specifications established for the Stage 1 objectives and 
measures as they are currently defined at 42 CFR 495.6 for each 
retained objective or measure where there is a difference in 
specifications between Stages 1 and 2.
    In Stage 1, the electronic prescribing measure for EPs requires 
that ``More than 40 percent of all permissible prescriptions written by 
the EP are transmitted electronically using certified EHR technology'' 
(75 FR 44338).
    Therefore, we are proposing that for an EHR reporting period in 
2015, EPs scheduled to demonstrate Stage 1 of meaningful use may attest 
to the specifications and threshold associated with the Stage 1 
measure. We note that for an EHR reporting period beginning in 2016, 
all EPs must meet the specifications and threshold for the retained 
Stage 2 measure in order to successfully demonstrate meaningful use.
    Alternate EP Measure: More than 40 percent of all permissible 
prescriptions written by the EP are transmitted electronically using 
Certified EHR Technology.
    There are no alternate exclusions for this EP objective.
(2) Eligible Hospital/CAH Proposed Objective
    Proposed Eligible Hospital/CAH Objective: Generate and transmit 
permissible discharge prescriptions electronically (eRx).
    In the Stage 2 final rule at 77 FR 54035, we describe that the use 
of electronic prescribing has several advantages over having the 
patient carry the prescription to the pharmacy or directly faxing a 
handwritten or typewritten prescription to the pharmacy. When the 
hospital generates the prescription electronically, CEHRT can provide 
support for a number of purposes such as promoting safety and quality 
in the form of decision support around adverse interactions and other 
treatment possibilities; increasing 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; and 
reducing communication errors by allows the pharmacy or a third party 
to automatically compare the medication order to others they have 
received for the patient. This allows for many of the same decision 
support functions enabled at the generation of the prescription, but 
with access to potentially greater information. For this reason, we 
continue to support the use of electronic prescribing for discharge 
prescriptions in a hospital setting.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of 
hospital discharge medication orders for permissible prescriptions (for 
new, changed and refilled prescriptions) are queried for a drug 
formulary and transmitted electronically using Certified EHR 
Technology.
    We propose to retain the exclusion that would allow a hospital to 
exclude this objective if there is no internal pharmacy that can accept 
electronic prescriptions and is not located within 10 miles of any 
pharmacy that accepts electronic prescriptions at the start of their 
EHR reporting period.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of new, changed, or refill prescriptions 
written for drugs requiring a prescription in order to be dispensed 
other than controlled substances for patients discharged during the EHR 
reporting period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary and transmitted electronically.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an eligible hospital or CAH to meet this measure.
    Exclusion: Any eligible hospital or CAH that does not have an 
internal pharmacy that can accept electronic prescriptions and is not 
located within 10 miles of any pharmacy that accepts electronic 
prescriptions at the start of their EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We propose that eligible hospitals and CAHs scheduled to report on 
Stage 1 objectives for an EHR reporting period in 2015 may claim an 
exclusion for the Stage 2 eRx measure as there is not an equivalent 
Stage 1 measure defined at 42 CFR 495.6. We further propose that 
eligible hospitals and CAHs scheduled to report Stage 2 objectives for 
an EHR reporting period in 2015 who were not intending to attest to the 
eRx menu objective and measure may also claim an exclusion. We note 
that for an EHR reporting period beginning in 2016, all providers must 
attest to the objective and measure and meet the specifications and 
threshold for the Stage 2 measure in order to successfully demonstrate 
meaningful use.
    Alternate Eligible Hospital/CAH Exclusion: Provider may claim an 
exclusion for the eRx objective and measure if for an EHR reporting 
period in 2015 they were either scheduled to demonstrate Stage 1 which 
does not have an equivalent measure, or if they are scheduled to 
demonstrate Stage 2 but did not intend to select the Stage 2 eRx menu 
objective for an EHR reporting period in 2015.
    There are no alternate specifications for this eligible hospital 
and CAH objective.
    We invite public comment on this proposal.
e. Summary of Care
    We are proposing to retain only the second measure of the existing 
Stage 2 objective for Summary of Care for meaningful use in 2015 
through 2017 with the modifications discussed in this proposed rule. 
(For further information and discussion of the existing Stage 2 Summary 
of Care objective and measures, we refer readers to the discussion in 
the Stage 2 final rule at 77 FR 54013 through 54021.)
    Proposed Objective: The EP, eligible hospital or CAH who 
transitions their patient to another setting of care or provider of 
care or refers their patient to another provider of care provides a 
summary care record for each transition of care or referral.
    In the Stage 2 final rule, we outlined the following benefits of 
this objective. By assuring lines of communication between providers 
caring for the same patient, all of the providers of care can operate 
with better information and more effectively coordinate the care they 
provide. Electronic health records, especially when linked directly or 
through health information exchanges, reduce the burden of such 
communication. The purpose of this objective is to ensure a summary of 
care record is provided to the receiving provider when a patient is 
transitioning to a new provider or has been referred to another 
provider while remaining in the care of the referring provider.
    Proposed Measure: The EP, eligible hospital or CAH that transitions 
or refers their patient to another setting of care or provider of care 
that--(1) uses CEHRT to create a summary of care record; and (2) 
electronically transmits such summary to a receiving provider for more 
than 10 percent of transitions of care and referrals.
    We are proposing to retain an updated version of the second measure 
of the Stage 2 Summary of Care objective with modifications based on 
guidance provided through CMS responses to frequently asked questions 
we have received since the publication of the Stage 2 final rule. We 
are proposing to retain this measure for electronic transmittal because 
we believe that the electronic exchange of health

[[Page 20362]]

information between providers would 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 in creating the summary of care record can 
significantly reduce the cost and complexity of interfaces between 
different systems and promote widespread exchange and interoperability.
    The proposed updates to this measure reflect stakeholder input 
regarding operational challenges in meeting this measure, and seek to 
increase flexibility for providers while continuing to drive 
interoperability across care settings and encouraging further 
innovation. Currently, the measure specifies the manner in which the 
summary of care must be electronically transmitted. Providers must 
either--(1) electronically transmit the summary of care using CEHRT to 
a recipient; or (2) where the recipient receives the summary of care 
record via exchange facilitated by an organization that is a NwHIN 
Exchange participant or in a manner that is consistent with the 
governance mechanism ONC establishes for the nationwide health 
information network. We propose to update this measure to state simply 
that a provider would be required to create the summary of care record 
using CEHRT and transmit the summary of care record electronically.
    To calculate the percentage of the measure, CMS and ONC have worked 
together to define the following for this objective:
    Denominator: Number of transitions of care and referrals during the 
EHR reporting period for which the EP or eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) was the transferring 
or referring provider.
    Numerator: The number of transitions of care and referrals in the 
denominator where a summary of care record was created using Certified 
EHR Technology and is exchanged electronically.
    Threshold: The percentage must be more than 10 percent in order for 
an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who transfers a patient to another setting or 
refers a patient to another provider less than 100 times during the EHR 
reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    We propose that providers scheduled to demonstrate Stage 1 of 
meaningful use for an EHR reporting period in 2015 may claim an 
exclusion for Measure 2 of the Stage 2 Summary of Care core objective, 
as there is not an equivalent Stage 1 measure. The measure related to 
the electronic transmission of a summary of care record in the Summary 
of Care core objective requires an electronic summary of care document 
to be sent for transitions and referrals and is only applicable for 
Stage 2. There is not an equivalent objective and measure in Stage 1. 
We note that for an EHR reporting period beginning in 2016, all 
providers must attest to the complete objective and meet the 
specifications and threshold for the both Stage 2 measures in order to 
successfully demonstrate meaningful use.
    Alternate Exclusion: Provider may claim an exclusion for the 
measure of the Stage 2 Summary of Care objective which requires the 
electronic transmission of a summary of care document if for an EHR 
reporting period in 2015 they were scheduled to demonstrate Stage 1, 
which does not have an equivalent measure.
    There are no alternate specifications for this objective.
    We invite public comment on this proposal.
f. Patient Specific Education
    We are proposing to retain the Stage 2 objective and measure for 
Patient Specific Education for meaningful use for 2015 through 2017. 
(For further information and discussion of the existing Stage 2 Patient 
Specific Education objective and measure, please refer to 77 FR 54011 
and 54012.)
    Proposed Objective: Use clinically relevant information from 
Certified EHR Technology to identify patient-specific education 
resources and provide those resources to the patient.
    In the Stage 2 proposed rule, we explained that providing 
clinically relevant education resources to patients is a priority for 
the meaningful use of CEHRT. While CEHRT must be used to identify 
patient-specific education resources, these resources or materials do 
not have to be stored within or generated by the CEHRT. We are aware 
that there are many electronic resources available for patient 
education materials, such as through the National Library of Medicine's 
MedlinePlus (http://www.nlm.nih.gov/medlineplus, that can be queried 
via CEHRT (that is, specific patient characteristics are linked to 
specific consumer health content). The EP or hospital should utilize 
CEHRT in a manner where the technology suggests patient-specific 
educational resources based on the information stored in the CEHRT. 
Certified EHR technology is certified to use the patient's problem 
list, medication list, or laboratory test results to identify the 
patient-specific educational resources. The EP or hospital may use 
these elements or additional elements within CEHRT to identify 
educational resources specific to patients' needs. The EP or hospital 
can then provide these educational resources to patients in a useful 
format for the patient (such as, electronic copy, printed copy, 
electronic link to source materials, through a patient portal or PHR).
    Proposed EP Measure: Patient-specific education resources 
identified by Certified EHR Technology are provided to patients for 
more than 10 percent of all unique patients with office visits seen by 
the EP during the EHR reporting period.
    We propose to retain the 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. 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:
    Denominator: Number of unique patients with office visits seen by 
the EP during the EHR reporting period.
    Numerator: Number of patients in the denominator who were provided 
patient-specific education resources identified by the Certified EHR 
Technology.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an EP to meet this measure.
    Exclusion: Any EP who has no office visits during the EHR reporting 
period.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of all 
unique patients admitted to the eligible hospital's or CAH's inpatient 
or emergency department (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

[[Page 20363]]

together to define the following for this objective:
    Denominator: Number of unique patients admitted to the eligible 
hospital or CAH inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period.
    Numerator: Number of patients in the denominator who are 
subsequently provided patient-specific education resources identified 
by CEHRT.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an eligible hospital or CAH to meet this measure.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    While the Patient Specific Education objective is designated as an 
optional menu objective in Stage 1 of meaningful use, the same 
objective is a mandatory core objective in Stage 2 of meaningful use. 
We expect that not all Stage 1 scheduled providers were planning to 
choose this menu objective when attesting in an EHR reporting period in 
2015. Therefore, we propose that any provider scheduled to demonstrate 
Stage 1 of meaningful use for an EHR reporting period in 2015 who was 
not intending to attest to the Stage 1 Patient Specific Education menu 
objective, may claim an exclusion to the measure. We note that for an 
EHR reporting period beginning in 2016, all providers must attest to 
the objective and measure and meet the Stage 2 specifications and 
threshold in order to successfully demonstrate meaningful use.
    Alternate Exclusion: Provider may claim an exclusion for the 
measure of the Stage 2 Patient Specific Education objective if for an 
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 
but did not intend to select the Stage 1 Patient Specific Education 
menu objective.
    There are no alternate specifications for this objective.
    We invite public comment on this proposal.
g. Medication Reconciliation
    We are proposing to retain the Stage 2 objective and measure for 
Medication Reconciliation for meaningful use in 2015 through 2017. (For 
further information and discussion of the existing Stage 2 Medication 
Reconciliation objective and measure, please refer to 77 FR 54012 and 
54013.)
    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 his or her direct patient care, it also 
improves the accuracy of information they provide to others through 
health information exchange.
    In the Stage 2 proposed rule, we noted that that when conducting 
medication reconciliation during a transition of care, the EP, eligible 
hospital or CAH that receives the patient into their care should 
conduct the medication reconciliation. We reiterated that the measure 
of this objective does not dictate what information must be included in 
medication reconciliation. Information included in the process of 
medication reconciliation is appropriately determined by the provider 
and patient. We defined medication reconciliation as the process of 
identifying the most accurate list of all medications that the patient 
is taking, including name, dosage, frequency, and route, by comparing 
the medical record to an external list of medications obtained from a 
patient, hospital or other provider.
    Proposed Measure: The EP, eligible hospital or CAH performs 
medication reconciliation for more than 50 percent of transitions of 
care in which the patient is transitioned into the care of the EP or 
admitted to the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23).
    For the purposes of this measure, 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 and referrals are cases 
where one provider refers a patient to another, but the referring 
provider maintains his or her care of the patient as well.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of transitions of care during the EHR reporting 
period for which the EP or eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) was the receiving party of the 
transition.
    Numerator: The number of transitions of care in the denominator 
where medication reconciliation was performed.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who was not the recipient of any transitions of 
care during the EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    While the Medication Reconciliation objective is designated as an 
optional menu objective in Stage 1 of meaningful use, the same 
objective is a mandatory core objective in Stage 2 of meaningful use. 
We expect that not all Stage 1 scheduled providers were planning to 
choose this menu objective when attesting in an EHR reporting period in 
2015. Therefore, we propose that any provider scheduled to demonstrate 
Stage 1 of meaningful use for an EHR reporting period in 2015 who was 
not intending to attest to the Stage 1 Medication Reconciliation menu 
objective, may claim an exclusion to the measure. We note that for an 
EHR reporting period beginning in 2016, all providers must attest to 
the objective and measure and meet the Stage 2 specifications and 
threshold in order to successfully demonstrate meaningful use.
    Alternate Exclusion: Provider may claim an exclusion for the 
measure of the Stage 2 Medication Reconciliation objective if for an 
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 
but did not intend to select the Stage 1 Medication Reconciliation menu 
objective.
    There are no alternate specifications for this objective.
    We invite public comment on this proposal.
h. Patient Electronic Access (VDT)
    We are proposing to retain the Stage 2 objective for Patient 
Electronic Access for meaningful use in 2015 through 2017. We are 
proposing to retain the first measure of the Stage 2 objective without 
modification. We are proposing to retain the second measure for the 
Stage 2 objective with modification to the measure threshold. (For 
further information and discussion of the existing Stage 2 Patient 
Electronic Access objective and measures, please refer to 77 FR 54007 
through 54011.)
    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.
    Proposed Eligible Hospital/CAH Objective: Provide patients the 
ability to view online, download, and transmit information about a 
hospital admission.
    In the Stage 2 proposed rule, we stated that the goal of this 
objective was

[[Page 20364]]

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.
    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. The patient must be able to access this 
information on demand, such as through a patient portal or personal 
health record (PHR). We note that while a covered entity may be able to 
fully satisfy a patient's request for information through VDT, the 
measure does not replace the covered entity's responsibilities to meet 
the broader requirements under HIPAA to provide an individual, upon 
request, with access to PHI in a designated record set. Providers 
should also be aware that while meaningful use is limited to the 
capabilities of CEHRT to provide online access there may be patients 
who cannot access their EHRs electronically because of their 
disability. Additionally, other health information may not be 
accessible. Finally, we noted that providers who are covered by civil 
rights laws must provide individuals with disabilities equal access to 
information and appropriate auxiliary aids and services as provided in 
the applicable statutes and regulations.
Proposed EP Measures
     EP Measure 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.
     EP Measure 2: At least one patient seen by the EP during 
the EHR reporting period (or their authorized representatives) views, 
downloads, or transmits his or her health information to a third party.
    In order to meet this objective, the following information must be 
made available to patients electronically within 4 business days of the 
information being made available to the EP:
    ++ Patient name.
    ++ Provider's name and office contact information.
    ++ Current and past problem list.
    ++ Procedures.
    ++ Laboratory test results.
    ++ Current medication list and medication history.
    ++ Current medication allergy list and medication allergy history.
    ++ Vital signs (height, weight, blood pressure, BMI, growth 
charts).
    ++ Smoking status.
    ++ Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
    ++ Care plan field(s), including goals and instructions.
    ++ Any known care team members including the primary care provider 
(PCP) of record.
    As we stated in the Stage 2 proposed rule, this is not intended to 
limit the information made available by the EP. An EP can make 
available additional information and still align with the objective. In 
circumstances where there is no information available to populate one 
or more of the fields previously listed, either because the EP can be 
excluded from recording such information (for example, vital signs) or 
because there is no information to record (for example, no medication 
allergies or laboratory tests), the EP may have an indication that the 
information is not available and still meet the objective and its 
associated measure. Please note that while some of the information made 
available through this measure is similar to the information made 
available in the summary of care document that must be provided 
following transitions of care or referrals, the list of information 
provided is specific to the view online, download, and transmit 
objective. Patients and providers have different information needs and 
contexts, so we have established separate required fields for each of 
these objectives.
    We propose to retain the exclusion that any EP who neither orders 
nor creates any of the information listed for inclusion as part of this 
measure may exclude from this measure as well as the exclusion for 
limited broadband access in an EPs service area.
    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:
     EP Measure 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.
    Denominator: Number of unique patients seen by the EP during the 
EHR reporting period.
    Numerator: The number of patients in the denominator who have 
timely (within 4 business days after the information is available to 
the EP) online access to their health information.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP to meet this measure.
     EP Measure 2: At least one patient seen by the EP during 
the EHR reporting period (or his or her authorized representatives) 
views, downloads, or transmits his or her health information to a third 
party.
     Exclusions: Any EP who--
    (a) Neither orders nor creates any of the information listed for 
inclusion as part of the measures; or
    (b) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units 
with 4Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period.
Proposed Eligible Hospital/CAH Measures:
     Eligible Hospital/CAH Measure 1: 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.
     Eligible Hospital/CAH Measure 2: At least 1 patient who is 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH (or his or her authorized representative) 
views, downloads, or transmits to a third party his or her information 
during the EHR reporting period.
    The following information must be available to satisfy the 
objective and measure:
    ++ Patient name.
    ++ Admit and discharge date and location.
    ++ Reason for hospitalization.
    ++ Care team including the attending of record as well as other 
providers of care.
    ++ Procedures performed during admission.
    ++ Current and past problem list.
    ++ Vital signs at discharge.
    ++ Laboratory test results (available at time of discharge).
    ++ Summary of care record for transitions of care or referrals to 
another provider.
    ++ Care plan field(s), including goals and instructions.

[[Page 20365]]

    ++ Discharge instructions for patient.
    ++ Demographics maintained by hospital (sex, race, ethnicity, date 
of birth, preferred language).
    ++ Smoking status.
    This is not intended to limit the information made available by the 
hospital. A hospital can make available additional information and 
still align with the objective. Please note that while some of the 
information made available through this measure is similar to the 
information made available in the summary of care document that must be 
provided following transitions of care or referrals, this list of 
information provided is specific to the view online, download, and 
transmit objective. Patients and providers have different information 
needs and contexts, so CMS has established separate required fields for 
each of these objectives.
    To calculate the percentage of the first measure for providing 
patients timely access to discharge information, CMS and ONC have 
worked together to define the following for this objective:
     Eligible Hospital/CAH Measure 1: 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.
    Denominator: Number of unique patients discharged from an eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period.
    Numerator: The number of patients in the denominator whose 
information is available online within 36 hours of discharge.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an eligible hospital or CAH to meet this measure.
     Eligible Hospital/CAH Measure 2: At least 1 patient who is 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH (or his or her authorized representative) 
views, downloads, or transmits to a third party his or her information 
during the EHR reporting period.
     Exclusion: 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 on the first day of the EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    The Patient Electronic Access objective has two associated 
measures, the first (provide access to view, download, and transmit 
health information) is applicable for both Stage 1 and Stage 2 while 
the second (patients view, download, or transmit their health 
information) is only applicable for Stage 2. Therefore, we propose that 
providers scheduled to demonstrate Stage 1 of meaningful use for an EHR 
reporting period in 2015 may additionally claim an exclusion for the 
second measure of the Stage 2 Patient Electronic Access objective as 
there is not an equivalent Stage 1 measure defined at 42 CFR 495.6. We 
note that for an EHR reporting period beginning in 2016, all providers 
must attest to the objective and both measures and meet the 
specifications and threshold associated with the retained Stage 2 
objective and measures in order to successfully demonstrate meaningful 
use.
     Alternate Exclusion Measure 2: Provider may claim an 
exclusion for the second measure if for an EHR reporting period in 2015 
they were scheduled to demonstrate Stage 1, which does not have an 
equivalent measure.
    There are no alternate specifications for this objective.
    We invite public comment on this proposal.
i. Secure Electronic Messaging
    We are proposing to retain the Stage 2 objective for secure 
electronic messaging with modifications to the measure for meaningful 
use in 2015 through 2017. (For further information and discussion of 
the existing Stage 2 secure electronic messaging objective and measure, 
please refer to 77 FR 54033.)
    Proposed Objective: Use secure electronic messaging to communicate 
with patients on relevant health information.
    In the Stage 2 proposed rule, we outlined the following benefits of 
using secure electronic messaging to communicate with patients: 
Electronic messaging (for example, email) is one of the most widespread 
methods of communication for both businesses and individuals. The 
ability to communicate through forms of electronic messaging is 
essential to 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. However, common email services may not be secure enough to be 
appropriate for the exchange of ePHI. Therefore, the exchange of ePHI 
through electronic messaging requires additional security measures 
while maintaining its ease of use for communication. While secure 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.
    For EPs, secure electronic messaging is critically important to two 
National Quality Strategy (NQS) priorities--
     Ensuring that each person/family is engaged as partners in 
their care; and
     Promoting effective communication and coordination of 
care.
    Secure electronic messaging could make care more affordable by 
using more efficient communication vehicles when appropriate. 
Specifically, research demonstrates that secure messaging has improved 
patient adherence to treatment plans, which reduces readmission rates. 
In addition, secure messaging has led to increased patient satisfaction 
with their care and is one of the top ranked features according to 
patients. In addition, despite some trepidation, providers have seen a 
reduction in time responding to inquiries and less time spent on the 
phone.\3\
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    \3\ Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008) 
``Supporting the patient's role in guideline compliance: a 
controlled study'' American Journal of Managed Care 14(11):737-44; 
Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE, Graziano F, 
Chan CL (1999) ``Impact of a patient-centered, computer-based health 
information/support system'' American Journal of Preventive Medicine 
16(1):1-9. Ralston JD, Carrell D, Reid R, Anderson M, Moran M, 
Hereford J (2007) ``Patient web services integrated with a shared 
medical record: patient use and satisfaction'' Journal of the 
American Medical Informatics Association 14(6):798-806).
---------------------------------------------------------------------------

    Proposed Measure: During the EHR reporting period, the capability 
for patients to send and receive a secure electronic message with the 
provider was fully enabled.
    We propose to retain the exclusion for EPs who have no office 
visits, and for those EPs who lack the infrastructure required for 
secure electronic messaging due to being located in areas with limited 
broadband availability as identified by the FCC.
    Measure: During the EHR reporting period, the capability for 
patients to send and receive a secure electronic message with the 
provider was fully enabled.
    Exclusion: Any EP who has no office visits during the EHR reporting 
period,

[[Page 20366]]

or any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use in 2015
    For the secure electronic messaging objective, there is no Stage 1 
objective or measure which relates to the requirements of the Stage 2 
objective and measure. We therefore propose that an EP scheduled to 
demonstrate Stage 1 of meaningful use for an EHR reporting period in 
2015 may claim an exclusion for the secure electronic messaging 
objective measure as there is not an equivalent Stage 1 objective or 
measure defined at 42 CFR 495.6. We note that for an EHR reporting 
period beginning in 2016, all providers must attest to the objective 
and measure of the retained Stage 2 secure electronic messaging 
objective in order to successfully demonstrate meaningful use.
     Alternate Exclusion: An EP may claim an exclusion for the 
measure if for an EHR reporting period in 2015 they were scheduled to 
demonstrate Stage 1, which does not have an equivalent measure.
    There are no alternate specifications for this objective and there 
is no equivalent objective for eligible hospitals and CAHs in the Stage 
2 objectives and measures for meaningful use.
    We invite public comment on this proposal.
j. Public Health and Clinical Data Registry (CDR) Reporting
    As mentioned previously, we are proposing to adopt the consolidated 
Stage 3 version of the public health reporting objectives for all 
providers to demonstrate meaningful use for an EHR reporting period in 
2015 through 2017. We note that this change does not fundamentally 
change a provider's ability to demonstrate meeting the requirements of 
meaningful use with any actions they may have already taken or are in 
the progress of taking to meet the prior requirements of meaningful use 
defined in the Stage 1 and Stage 2 rules for public health reporting. 
These requirements are currently defined at (75 FR 44325 through 44326) 
for EPs and (75 FR 44364 through 44368) for eligible hospitals and CAHs 
in the Stage 1 final rule. In the Stage two final rule the requirements 
may be found at (77 FR 54021 through 54026) for EPs and (77 FR 54029 
through 54031) for eligible hospitals and CAHs. We further note that 
this change does not require the addition of any new technology or 
standard not already available in CEHRT to demonstrate meaningful use 
in 2014.
    This objective is designed based on the objective proposed in the 
Stage 3 proposed rule at which builds on the requirements set forth in 
the Stage 2 final rule (see for example 77 FR 54047 through 54048 under 
the Health Outcomes Policy Priority ``Improve population and public 
health''). In the Stage 3 proposed rule, we proposed changes to the 
Stage 1 and Stage 2 public health and specialty registry objectives to 
consolidate the prior objectives and measures into a single objective 
in alignment with efforts to streamline the program and support 
flexibility for providers (80 FR 16739 and 16740).
    Proposed Objective: The EP, eligible hospital, or CAH is in active 
engagement with a Public Health Agency (PHA) or clinical data registry 
(CDR) to submit electronic public health data in a meaningful way using 
certified EHR technology, except where prohibited and in accordance 
with applicable law and practice.
    In the Stage 3 proposed rule, we highlighted our intention to 
remove the prior ongoing submission requirement and replace it with an 
``active engagement'' requirement. We believe that ``active 
engagement'' as defined in the Stage 3 rule at (80 FR 16739 and 16740) 
and reiterated in this section is more aligned with the process 
providers undertake to report to a clinical registry or to a PHA.
    For purposes of meeting this new objective, EPs, eligible hospitals 
and CAHs would be required to demonstrate that ``active engagement'' 
with a PHA or CDR has occurred. Active engagement means that the 
provider is in the process of moving towards sending ``production 
data'' to a PHA or CDR, or-- is sending production data to a PHA or 
CDR. We note that the term ``production data'' refers to data generated 
through clinical processes involving patient care, and it is here used 
to distinguish between this data and ``test data'' which may be 
submitted for the purposes of enrolling in and testing electronic data 
transfers. We propose that ``active engagement'' may be demonstrated by 
any of the following options:
    Active Engagement Option 1--Completed Registration to Submit Data: 
The EP, eligible hospital, or CAH registered to submit data with the 
PHA or, where applicable, the CDR to which the information is being 
submitted; registration was completed within 60 days after the start of 
the EHR reporting period; and the EP, eligible hospital, or CAH is 
awaiting an invitation from the PHA or CDR to begin testing and 
validation. This option allows providers to meet the measure when the 
PHA or the CDR has limited resources to initiate the testing and 
validation process. Providers that have registered in previous years do 
not need to submit an additional registration to meet this requirement 
for each EHR reporting period.
    Active Engagement Option 2--Testing and Validation: The EP, 
eligible hospital, or CAH is in the process of testing and validation 
of the electronic submission of data. Providers must respond to 
requests from the PHA or, where applicable, the CDR within 30 days; 
failure to respond twice within an EHR reporting period would result in 
that provider not meeting the measure.
    Active Engagement Option 3--Production: The EP, eligible hospital, 
or CAH has completed testing and validation of the electronic 
submission and is electronically submitting production data to the PHA 
or CDR.
    We note that the change in definition is intended to better capture 
the activities a provider may conduct in order to engage with a PHA or 
CDR, and that any prior action taken to meet the non-consolidated 
public health reporting objectives of meaningful use Stages 1 and 2 
would count toward meeting the active engagement requirement of this 
objective.
    Proposed Measures: We are proposing a total of 6 possible measures 
for this objective. For meaningful use in 2015 through 2017, EPs would 
be required to choose from Measures 1 through 5, and would be required 
to successfully attest to any combination of two measures. For 
meaningful use in 2015 through 2017, eligible hospitals and CAHs would 
be required to choose from Measures 1 through 6, and would be required 
to successfully attest to any combination of three measures. In 2015 
only for providers scheduled to be in Stage 1, EPs would be required to 
choose from Measures 1 through 5, but would be permitted to 
successfully attest to one measure; and eligible hospitals and CAHs 
would be required to choose from Measures 1 through 6, but would be 
permitted to successfully attest to any combination of two measures. 
The measures are as shown in Table 5. As noted, measures 4 and 5 for 
Public Health Registry Reporting and Clinical Data Registry Reporting 
may be counted more than once if more than one Public Health Registry 
or Clinical Data Registry is available.

[[Page 20367]]

    The measures are as follows:

         Table 5--Measures for Objective 8--Public Health and Clinical Data Registry Reporting Objective
----------------------------------------------------------------------------------------------------------------
                                                                                          Maximum times  measure
                                                                 Maximum times  measure     can count  towards
                            Measure                                can count  towards    objective  for eligible
                                                                   objective  for EP          hospital or CAH
----------------------------------------------------------------------------------------------------------------
Measure 1--Immunization Registry Reporting....................                        1                        1
Measure 2--Syndromic Surveillance Reporting...................                        1                        1
Measure 3--Case Reporting.....................................                        1                        1
Measure 4--Public Health Registry Reporting *.................                        3                        4
Measure 5--Clinical Data Registry Reporting **................                        3                        4
Measure 6--Electronic Reportable Laboratory Results...........                      N/A                        1
----------------------------------------------------------------------------------------------------------------
* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry (measure 4) to
  meet the number of measures required to meet the objective.
** EPs, eligible hospitals, and CAHs may choose to report to more than one clinical data registry (measure 5) to
  meet the number of measures required to meet the objective.

    For EPs, we propose that an exclusion for a measure does not count 
toward the total of two measures. Instead, in order to meet this 
objective an EP would need to meet two of the total number of measures 
available to them. If the EP qualifies for multiple exclusions and the 
remaining number of measures available to the EP is less than two, the 
EP can meet the objective by meeting the one remaining measure 
available to them and claiming the applicable exclusions. If no 
measures remain available, the EP can meet the objective by claiming 
applicable exclusions for all measures. An EP who is scheduled to be in 
Stage 1 in 2015 must report at least one measure unless they can 
exclude from all available measures. Available measures include ones 
for which the EP does not qualify for an exclusion.
    For eligible hospitals and CAHs, we propose that an exclusion for a 
measure does not count toward the total of three measures. Instead, in 
order to meet this objective an eligible hospital or CAH would need to 
meet three of the total number of measures available to them. If the 
eligible hospital or CAH qualifies for multiple exclusions and the 
total number of remaining measures available to the eligible hospital 
or CAH is less than three, the eligible hospital or CAH can meet the 
objective by meeting all of the remaining measures available to them 
and claiming the applicable exclusions. If no measures remain 
available, the eligible hospital or CAH can meet the objective by 
claiming applicable exclusions for all measures. An eligible hospital 
or CAH that is scheduled to be in Stage 1 in 2015 must report at least 
two measures unless they can either--(1) exclude from all but one 
available measure and report that one measure; or (2) can exclude from 
all available measures. Available measures include ones for which the 
eligible hospital or CAH does not qualify for an exclusion.
    We note that we are proposing to allow EPs, eligible hospitals, and 
CAHs to choose to report to more than one public health registry to 
meet the number of measures required to meet the objective. We are also 
proposing to allow EPs, eligible hospitals, and CAHs to choose to 
report to more than one clinical data registry to meet the number of 
measures required to meet the objective. We believe that this 
flexibility allows for EPs, eligible hospitals, and CAHs to choose 
reporting options that align with their practice and that would aid the 
provider's ability to care for their patients.
    To calculate the measures:
     Measure 1--Immunization Registry Reporting: The EP, 
eligible hospital, or CAH is in active engagement with a public health 
agency to submit immunization data and receive immunization forecasts 
and histories from the public health immunization registry/immunization 
information system (IIS).
    We believe the immunization registry reporting measure remains a 
priority for the EHR Incentive Programs because the exchange of 
information between certified EHR technology and immunization 
registries allows a provider to use the most complete immunization 
history available to inform decisions about the vaccines a patient may 
need. Public health agencies and providers also use immunization 
information for emergency preparedness and to estimate population 
immunization coverage levels of certain vaccines.
    We propose that to successfully meet the requirements of this 
measure, bidirectional data exchange between the provider's certified 
EHR technology system and the immunization registry/IIS is required. We 
understand that many states and local public health jurisdictions are 
exchanging immunization data bidirectionally with providers, and that 
the number of states and localities able to support bidirectional 
exchange continues to increase. In the 2015 Edition proposed rule (80 
FR 16851), the ONC is proposing to adopt a bidirectional exchange 
standard for reporting to immunization registries/IIS. We believe this 
functionality is important for patient safety and improved care because 
it allows for the provider to use the most complete immunization record 
possible to make decisions on whether a patient needs a vaccine. 
Immunization registries and health IT systems also are able to provide 
immunization forecasting functions which can inform discussions between 
providers and patients on what vaccines they may need in the future and 
the timeline for the receipt of such immunizations. Therefore, we 
believe that patients, providers, and the public health community would 
benefit from technology that can accommodate bidirectional immunization 
data exchange.
    We welcome comment on this proposal.
    Exclusion: Any EP, eligible hospital, or CAH meeting one or more of 
the following criteria may be excluded from the immunization registry 
reporting measure if the EP, eligible hospital, or CAH:
    ++ Does not administer any immunizations to any of the populations 
for which data is collected by their jurisdiction's immunization 
registry or immunization information system during the EHR reporting 
period;
    ++ Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT

[[Page 20368]]

definition at the start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the EP, eligible hospital or CAHs at the start 
of the EHR reporting period.
     Measure 2--Syndromic Surveillance Reporting: The EP, 
eligible hospital or CAH is in active engagement with a public health 
agency to submit syndromic surveillance data from a non-urgent care 
ambulatory setting for EPs, or an emergency or urgent care department 
for eligible hospitals and CAHs (POS 23).
    This measure remains a policy priority for the EHR Incentive 
Programs because electronic syndromic surveillance is valuable for 
early detection of outbreaks, as well as monitoring disease and 
condition trends.
    We are distinguishing between EPs and eligible hospital or CAHs 
reporting locations because as discussed in the Stage 2 final rule, few 
PHAs appeared to have the ability to accept non-emergency or non-urgent 
care ambulatory syndromic surveillance data electronically (77 FR 
53979). We continue to observe differences in the infrastructure and 
current environments for supporting electronic syndromic surveillance 
data submission to PHAs between eligible hospitals or CAHs and EPs. 
Because eligible hospitals and CAHs send syndromic surveillance data 
using different methods as compared to EPs, we are defining slightly 
different exclusions for each setting as described by the following:
    Exclusion for EPs: Any EP meeting one or more of the following 
criteria may be excluded from the syndromic surveillance reporting 
measure if the EP--
    ++ Does not treat or diagnose or directly treat any disease or 
condition associated with a syndromic surveillance system in his or her 
jurisdiction;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from EPs in 
the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs at 
the start of the EHR reporting period.
    Exclusion for eligible hospitals/CAHs: Any eligible hospital or CAH 
meeting one or more of the following criteria may be excluded from the 
syndromic surveillance reporting measure if the eligible hospital or 
CAH--
    ++ Does not have an emergency or urgent care department;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from 
eligible hospitals or CAHs in the specific standards required to meet 
the CEHRT definition at the start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs at the start of the EHR reporting period.
     Measure 3--Case Reporting: The EP, eligible hospital, or 
CAH is in active engagement with a public health agency to submit case 
reporting of reportable conditions.
    This is a new reporting option that was not part of Stage 2. The 
collection of electronic case reporting data greatly improves reporting 
efficiencies between providers and the PHA. Public health agencies 
collect ``reportable conditions'' as defined by the state, territorial, 
and local PHAs to monitor disease trends and support the management of 
outbreaks. In many circumstances, there has been low reporting 
compliance because providers do not know when, where, or how to report. 
In some cases, the time burden to report can also contribute to low 
reporting compliance. Electronic case reporting, however, presents a 
core benefit to public health improvement, and a variety of 
stakeholders have identified electronic case reporting as a high value 
element of patient and continuity of care. Further, we believe that 
electronic case reporting reduces burdensome paper-based and labor 
intensive case reporting. Electronic reporting would support more rapid 
exchange of case reporting information between PHAs and providers and 
can include structured questions or data fields to prompt the provider 
to supply additional required or care-relevant information.
    To support case reporting, the ONC has proposed a certification 
criterion that includes capabilities to enable certified EHR systems to 
send initial case reporting data and receive a request from the public 
health agency for supplemental or ad hoc structured data in the 2015 
Edition proposed rule (80 FR 16855).
    Exclusion: Any EP, eligible hospital, or CAH meeting one or more of 
the following criteria may be excluded from the case reporting measure 
if the EP, eligible hospital, or CAH:
    ++ Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data at the 
start of the EHR reporting period.
     Measure 4--Public Health Registry Reporting: The EP, 
eligible hospital, or CAH is in active engagement with a public health 
agency to submit data to public health registries.
    In the Stage 2 final rule, we were purposefully general in our use 
of the term ``specialized registry'' (other than a cancer registry) to 
encompass both registry reporting to public health agencies and 
clinical data registries in order to prevent inadvertent exclusion of 
certain registries through an attempt to be more specific (77 FR 
54030). In response to insight gained from the industry through 
listening sessions, public forums, and responses to a Federal Register 
notice soliciting public comments on the proposed information 
collections to develop a centralized repository on public health 
readiness to support meaningful use (79 FR 7461); we propose to carry 
forward the concept behind this broad category from Stage 2, but also 
propose to split public health registry reporting from clinical data 
registry reporting into two separate measures which better define the 
potential types of registries available for reporting. We propose to 
define a ``public health registry'' as a registry that is administered 
by, or on behalf of, a local, state, territorial, or national PHA and 
which collects data for public health purposes. While immunization 
registries are a type of public health registry, we propose to keep 
immunization registry reporting separate from the public health 
registry reporting measure to retain continuity from Stage 1 and 2 
policy in which immunization registry reporting was a distinct and 
separate objective (77 FR 54023). We believe it is important to retain 
the public health registry reporting option for Stage 3 because these 
registries allow the public health community to monitor health and 
disease trends, and inform the development of programs and policy for

[[Page 20369]]

population and community health improvement.
    We reiterate that any EP, eligible hospital, or CAH may report to 
more than one public health registry to meet the total number of 
required measures for the objective. For example, if a provider meets 
this measure through reporting to both the National Hospital Care 
Survey and the National Healthcare Safety Network registry, the 
provider could get credit for meeting two measures. ONC would consider 
the adoption of standards and implementation guides in future 
rulemaking. Should these subsequently be finalized, they may then be 
adopted as part of the certified EHR technology definition as it 
relates to meeting the public health registry reporting measure through 
future rulemaking for the EHR Incentive Programs.
    We further note that ONC adopted standards for ambulatory cancer 
case reporting in its 2014 Edition final rule (see Sec.  170.314(f)(6)) 
and CMS provided EPs the option to select the cancer case reporting 
menu objective in the Stage 2 final rule (77 FR 54029 through 54030). 
We included cancer registry reporting as a separate objective from 
specialized registry reporting because it was more mature in its 
development than other registry types, not because other reporting was 
intended to be excluded from meaningful use. For the Stage 3 public 
health agency reporting measure, given the desire to provide more 
flexible options for providers to report to the registries most 
applicable for their scope of practice, we propose that EPs would have 
the option of counting cancer case reporting under the public health 
registry reporting measure. Under this measure, we note that cancer 
case reporting is not an option for eligible hospitals and CAHs, 
because hospitals have traditionally diagnosed and treated cancers (or 
both) and have the infrastructure needed to report cancer cases.
    Exclusions: Any EP, eligible hospital, or CAH meeting at least one 
of the following criteria may be excluded from the public health 
registry reporting measure if the EP, eligible hospital, or CAH--
    ++ Does not diagnose or directly treat any disease or condition 
associated with a public health registry in their jurisdiction during 
the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    ++ Operates in a jurisdiction where no public health registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions at the beginning 
of the EHR reporting period.
     Measure 5--Clinical Data Registry Reporting: The EP, 
eligible hospital, or CAH is in active engagement to submit data to a 
clinical data registry.
    As discussed in the Public Health Registry Reporting measure, we 
propose to split specialized registry reporting into two separate, 
clearly defined measures: Public health registry reporting and clinical 
data registry reporting. In Stage 2 for EPs, reporting to specialized 
registries is a menu objective and this menu objective includes 
reporting to clinical data registries. For Stage 3, we propose to 
include clinical data registry reporting as an independent measure. The 
National Quality Registry Network defines clinical data registries as 
those that record information about the health status of patients and 
the health care they receive over varying periods of time \4\. We 
propose to further differentiate between clinical data registries and 
public health registries as follows: For the purposes of meaningful 
use, ``public health registries'' are those administered by, or on 
behalf of, a local, state, territorial, or national public health 
agencies; and, ``clinical data registries'' are administered by, or on 
behalf of, other non-public health agency entities. We believe that 
clinical data registries are important for providing information that 
can inform patients and their providers on the best course of treatment 
and for care improvements, and can support specialty reporting by 
developing reporting for areas not usually covered by PHAs but that are 
important to a specialist's provision of care. Clinical data registries 
can also be used to monitor health care quality and resource use.
---------------------------------------------------------------------------

    \4\ https://download.ama-assn.org/resources/doc/cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf
---------------------------------------------------------------------------

    As noted previously, we reiterate that any EP, eligible hospital, 
or CAH may report to more than 1 clinical data registry to meet the 
total number of required measures for this objective. ONC would 
consider the adoption of standards and implementation guides in future 
rulemaking. Should these subsequently be finalized, they may then be 
adopted as part of the certified EHR technology definition as it 
relates to meeting the clinical data registry reporting measure through 
future rulemaking for the EHR Incentive Programs.
    Exclusion: Any EP, eligible hospital, or CAH meeting at least one 
of the following criteria may be excluded from the clinical data 
registry reporting measure if the EP, eligible hospital, or CAH--
    ++ Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period;
    ++ Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period; or
    ++ Operates in a jurisdiction where no clinical data registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions at the beginning 
of the EHR reporting period.
     Measure 6--Electronic Reportable Laboratory Result 
Reporting: The eligible hospital or CAH is in active engagement with a 
public health agency to submit electronic reportable laboratory 
results. This measure is available to eligible hospitals and CAHs only. 
Electronic reportable laboratory result reporting to PHAs is required 
for eligible hospitals and CAHs in Stage 2 (77 FR 54021). We propose to 
retain this measure for the EHR Incentive Programs to promote the 
exchange of laboratory results between eligible hospitals/CAHs and PHAs 
for improved timeliness, reduction of manual data entry errors, and 
more complete information.
    Exclusion: Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure if the eligible hospital or CAH--
    ++ Does not perform or order laboratory tests that are reportable 
in their jurisdiction during the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of accepting the specific ELR standards required to meet the 
CEHRT definition at the start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from eligible hospitals or CAHs at the start of the EHR reporting 
period.

[[Page 20370]]

    We seek public comment on this proposal.

                     Table 6--Meaningful Uses Objectives and Measures for 2015 Through 2017
----------------------------------------------------------------------------------------------------------------
                                                                                            Proposed alternate
                                      Proposed                                             measures, exclusions
         Provider type             objectives for     Proposed measures for providers in   and/or specifications
                                   2015, 2016 and            2015, 2016 and 2017           for certain providers
                                        2017                                                   in 2015 ONLY
----------------------------------------------------------------------------------------------------------------
Eligible Professional..........  CPOE..............   Measure 1: More than 60     If for an EHR
                                                      percent of medication orders         reporting period in
                                                      created by the EP or by authorized   2015, the provider is
                                                      providers of the eligible            scheduled to
                                                      hospital's or CAH's inpatient or     demonstrate Stage 1:
                                                      emergency department (POS 21 or      Alternate
                                                      23) during the EHR reporting         Measure 1: More than
                                                      period are recorded using            30 percent of all
                                                      computerized provider order entry.   unique patients with
                                                      Measure 2: More than 30      at least one
                                                      percent of laboratory orders         medication in their
                                                      created by the EP or by authorized   medication list seen
                                                      providers of the eligible            by the EP or admitted
                                                      hospital's or CAH's inpatient or     to the eligible
                                                      emergency department (POS 21 or      hospital's or CAH's
                                                      23) during the EHR reporting         inpatient or
                                                      period are recorded using            emergency department
                                                      computerized provider order entry.   (POS 21 or 23) during
                                                      Measure 3: More than 30      the EHR reporting
                                                      percent of radiology orders          period have at least
                                                      created by the EP or by authorized   one medication order
                                                      providers of the eligible            entered using CPOE;
                                                      hospital's or CAH's inpatient or     or more than 30
                                                      emergency department (POS 21 or      percent of medication
                                                      23) during the EHR reporting         orders created by the
                                                      period are recorded using            EP during the EHR
                                                      computerized provider order entry.   reporting period, or
                                                                                           created by the
                                                                                           authorized providers
                                                                                           of the eligible
                                                                                           hospital or CAH for
                                                                                           patients admitted to
                                                                                           their inpatient or
                                                                                           emergency departments
                                                                                           (POS 21 or 23) during
                                                                                           the EHR reporting
                                                                                           period, are recorded
                                                                                           using computerized
                                                                                           provider order entry.
                                                                                           Alternate
                                                                                           Exclusion for Measure
                                                                                           2: Provider may claim
                                                                                           an exclusion for
                                                                                           measure 2 (laboratory
                                                                                           orders) of the Stage
                                                                                           2 CPOE objective for
                                                                                           an EHR reporting
                                                                                           period in 2015.
                                                                                           Alternate
                                                                                           Exclusion for Measure
                                                                                           3: Provider may claim
                                                                                           an exclusion for
                                                                                           measure 3 (radiology
                                                                                           orders) of the Stage
                                                                                           2 CPOE objective for
                                                                                           an EHR reporting
                                                                                           period in 2015.
                                 Electronic          EP Measure: More than 50 percent of  If for an EHR
                                  Prescribing.        all permissible prescriptions, or    reporting period in
                                                      all prescriptions, written by the    2015, the provider is
                                                      EP are queried for a drug            scheduled to
                                                      formulary and transmitted            demonstrate Stage 1:
                                                      electronically using Certified EHR  Alternate EP Measure:
                                                      Technology.                          More than 40 percent
                                                                                           of all permissible
                                                                                           prescriptions written
                                                                                           by the EP are
                                                                                           transmitted
                                                                                           electronically using
                                                                                           Certified EHR
                                                                                           Technology.
                                 Clinical Decision    Measure 1: Implement five   If for an EHR
                                  Support.            clinical decision support            reporting period in
                                                      interventions related to four or     2015, the provider is
                                                      more clinical quality measures at    scheduled to
                                                      a relevant point in patient care     demonstrate Stage 1:
                                                      for the entire EHR reporting        Alternate Objective
                                                      period. Absent four clinical         and Measure 1:
                                                      quality measures related to an EP,  Objective: Implement
                                                      eligible hospital or CAH's scope     one clinical decision
                                                      of practice or patient population,   support rule relevant
                                                      the clinical decision support        to specialty or high
                                                      interventions must be related to     clinical priority, or
                                                      high-priority health conditions.     high priority
                                                      It is suggested that one of the      hospital condition,
                                                      five clinical decision support       along with the
                                                      interventions be related to          ability to track
                                                      improving healthcare efficiency.     compliance with that
                                                      Measure 2: The EP,           rule.
                                                      eligible hospital, or CAH has       Measure: Implement one
                                                      enabled and implemented the          clinical decision
                                                      functionality for drug-drug and      support rule.
                                                      drug allergy interaction checks
                                                      for the entire EHR reporting
                                                      period. Exclusion: For the second
                                                      measure, any EP who writes fewer
                                                      than 100 medication orders during
                                                      the EHR reporting period.
                                 Patient Electronic   EP Measure 1: More than 50  Alternate Exclusion
                                  Access (VDT).       percent of all unique patients       Measure 2: Provider
                                                      seen by the EP during the EHR        may claim an
                                                      reporting period are provided        exclusion for the
                                                      timely (within 4 business days       second measure if for
                                                      after the information is available   an EHR reporting
                                                      to the EP) online access to their    period in 2015 they
                                                      health information subject to the    were scheduled to
                                                      EP's discretion to withhold          demonstrate Stage 1,
                                                      certain information.                 which does not have
                                                                                           an equivalent
                                                                                           measure.

[[Page 20371]]

 
                                                      EP Measure 2: At least one
                                                      patient seen by the EP during the
                                                      EHR reporting period (or their
                                                      authorized representatives) views,
                                                      downloads, or transmits his or her
                                                      health information to a third
                                                      party.
                                 Protect Electronic  Measure: Conduct or review a         NONE.
                                  Health              security risk analysis in
                                  Information.        accordance with the requirements
                                                      in 45 CFR 164.308(a)(1), including
                                                      addressing the security (to
                                                      include encryption) of ePHI data
                                                      stored in Certified EHR Technology
                                                      in accordance with requirements in
                                                      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,
                                                      eligible hospital, or CAHs risk
                                                      management process.
                                 Patient Specific    EP Measure: Patient-specific         Alternate Exclusion:
                                  Education.          education resources identified by    Provider may claim an
                                                      Certified EHR Technology are         exclusion for the
                                                      provided to patients for more than   measure of the Stage
                                                      10 percent of all unique patients    2 Patient Specific
                                                      with office visits seen by the EP    Education objective
                                                      during the EHR reporting period.     if for an EHR
                                                                                           reporting period in
                                                                                           2015 they were
                                                                                           scheduled to
                                                                                           demonstrate Stage 1
                                                                                           but did not intend to
                                                                                           select the Stage 1
                                                                                           Patient Specific
                                                                                           Education menu
                                                                                           objective.
                                 Medication          Measure: The EP, eligible hospital   Alternate Exclusion:
                                  Reconciliation.     or CAH performs medication           Provider may claim an
                                                      reconciliation for more than 50      exclusion for the
                                                      percent of transitions of care in    measure of the Stage
                                                      which the patient is transitioned    2 Medication
                                                      into the care of the EP or           Reconciliation
                                                      admitted to the eligible             objective if for an
                                                      hospital's or CAH's inpatient or     EHR reporting period
                                                      emergency department (POS 21 or      in 2015 they were
                                                      23).                                 scheduled to
                                                                                           demonstrate Stage 1
                                                                                           but did not intend to
                                                                                           select the Stage 1
                                                                                           Medication
                                                                                           Reconciliation menu
                                                                                           objective.
                                 Summary of Care...  Measure: The EP, eligible hospital   Alternate Exclusion:
                                                      or CAH that transitions or refers    Provider may claim an
                                                      their patient to another setting     exclusion for Measure
                                                      of care or provider of care (1)      2 of the Stage 2
                                                      uses CEHRT to create a summary of    Summary of Care
                                                      care record; and (2)                 objective if for an
                                                      electronically transmits such        EHR reporting period
                                                      summary to a receiving provider      in 2015 they were
                                                      for more than 10 percent of          scheduled to
                                                      transitions of care and referrals.   demonstrate Stage 1,
                                                                                           which does not have
                                                                                           an equivalent
                                                                                           measure.
                                 Secure Messaging..  Measure: During the EHR reporting    Alternate Exclusion:
                                                      period, the capability for           An EP may claim an
                                                      patients to send and receive a       exclusion for the
                                                      secure electronic message with the   measure if for an EHR
                                                      provider was fully enabled.          reporting period in
                                                                                           2015 they were
                                                                                           scheduled to
                                                                                           demonstrate Stage 1,
                                                                                           which does not have
                                                                                           an equivalent
                                                                                           measure.
                                 Public Health.....   Measure Option 1--          NONE.
                                                      Immunization Registry Reporting:
                                                      The EP, eligible hospital, or CAH
                                                      is in active engagement with a
                                                      public health agency to submit
                                                      immunization data and receive
                                                      immunization forecasts and
                                                      histories from the public health
                                                      immunization registry/immunization
                                                      information system (IIS).
                                                      Measure Option 2--
                                                      Syndromic Surveillance Reporting:
                                                      The EP, eligible hospital/, or CAH
                                                      is in active engagement with a
                                                      public health agency to submit
                                                      syndromic surveillance data from a
                                                      non-urgent care ambulatory setting
                                                      for EPs, or an emergency or urgent
                                                      care department for eligible
                                                      hospitals and CAHs (POS 23).
                                                      Measure Option 3--Case
                                                      Reporting: The EP, eligible
                                                      hospital, or CAH is in active
                                                      engagement with a public health
                                                      agency to submit case reporting of
                                                      reportable conditions.

[[Page 20372]]

 
                                                      Measure Option 4--Public
                                                      Health Registry Reporting: The EP,
                                                      eligible hospital, or CAH is in
                                                      active engagement with a public
                                                      health agency to submit data to
                                                      public health registries.
                                                      Measure Option 5--Clinical
                                                      Data Registry Reporting: The EP,
                                                      eligible hospital, or CAH is in
                                                      active engagement to submit data
                                                      to a clinical data registry.
Eligible Hospital/CAH..........  CPOE..............   Measure 1: More than 60     If for an EHR
                                                      percent of medication orders         reporting period in
                                                      created by the EP or by authorized   2015, the provider is
                                                      providers of the eligible            scheduled to
                                                      hospital's or CAH's inpatient or     demonstrate Stage 1:
                                                      emergency department (POS 21 or      Alternate
                                                      23) during the EHR reporting         Measure 1: More than
                                                      period are recorded using            30 percent of all
                                                      computerized provider order entry.   unique patients with
                                                      Measure 2: More than 30      at least one
                                                      percent of laboratory orders         medication in their
                                                      created by the EP or by authorized   medication list seen
                                                      providers of the eligible            by the EP or admitted
                                                      hospital's or CAH's inpatient or     to the eligible
                                                      emergency department (POS 21 or      hospital's or CAH's
                                                      23) during the EHR reporting         inpatient or
                                                      period are recorded using            emergency department
                                                      computerized provider order entry.   (POS 21 or 23) during
                                                      Measure 3: More than 30      the EHR reporting
                                                      percent of radiology orders          period have at least
                                                      created by the EP or by authorized   one medication order
                                                      providers of the eligible            entered using CPOE;
                                                      hospital's or CAH's inpatient or     or more than 30
                                                      emergency department (POS 21 or      percent of medication
                                                      23) during the EHR reporting         orders created by the
                                                      period are recorded using            EP or created by the
                                                      computerized provider order entry.   authorized providers
                                                                                           of the eligible
                                                                                           hospital or CAH for
                                                                                           patients admitted to
                                                                                           their inpatient or
                                                                                           emergency departments
                                                                                           (POS 21 or 23) during
                                                                                           the EHR reporting
                                                                                           period are recorded
                                                                                           using computerized
                                                                                           provider order entry.
                                                                                           Alternate
                                                                                           Exclusion for Measure
                                                                                           2: Provider may claim
                                                                                           an exclusion for
                                                                                           measure 2 (laboratory
                                                                                           orders) of the Stage
                                                                                           2 CPOE objective for
                                                                                           an EHR reporting
                                                                                           period in 2015.
                                                                                           Alternate
                                                                                           Exclusion for Measure
                                                                                           3: Provider may claim
                                                                                           an exclusion for
                                                                                           measure 3 (radiology
                                                                                           orders) of the Stage
                                                                                           2 CPOE objective for
                                                                                           an EHR reporting
                                                                                           period in 2015.
                                 Clinical Decision    Measure 1: Implement five   If for an EHR
                                  Support.            clinical decision support            reporting period in
                                                      interventions related to four or     2015, the provider is
                                                      more clinical quality measures at    scheduled to
                                                      a relevant point in patient care     demonstrate Stage 1:
                                                      for the entire EHR reporting        Alternate Measure 1:
                                                      period. Absent four clinical         Implement one
                                                      quality measures related to an EP,   clinical decision
                                                      eligible hospital or CAH's scope     support rule. We
                                                      of practice or patient population,   propose that for an
                                                      the clinical decision support        EHR reporting period
                                                      interventions must be related to     in 2015, an EP,
                                                      high-priority health conditions.     eligible hospital or
                                                      It is suggested that one of the      CAH who is scheduled
                                                      five clinical decision support       to participate in
                                                      interventions be related to          Stage 1 in 2015 must
                                                      improving healthcare efficiency.     also satisfy the
                                                      Measure 2: The EP,           Stage 2 measure 2
                                                      eligible hospital, or CAH has        previously stated
                                                      enabled and implemented the          because it is the
                                                      functionality for drug-drug and      same as an existing
                                                      drug allergy interaction checks      Stage 1 measure (77
                                                      for the entire EHR reporting         FR 53998). There are
                                                      period. Exclusion: For the second    no alternate
                                                      measure, any EP who writes fewer     exclusions for this
                                                      than 100 medication orders during    objective.
                                                      the EHR reporting period.

[[Page 20373]]

 
                                 Patient Electronic   Eligible Hospital/CAH       Alternate Exclusion
                                  Access (VDT).       Measure 1: More than 50 percent of   Measure 2: Provider
                                                      all patients who are discharged      may claim an
                                                      from the inpatient or emergency      exclusion for the
                                                      department (POS 21 or 23) of an      second measure if for
                                                      eligible hospital or CAH have        an EHR reporting
                                                      their information available online   period in 2015 they
                                                      within 36 hours of discharge.        were scheduled to
                                                      Eligible Hospital/CAH        demonstrate Stage 1,
                                                      Measure 2: At least 1 patient who    which does not have
                                                      is discharged from the inpatient     an equivalent
                                                      or emergency department (POS 21 or   measure.
                                                      23) of an eligible hospital or CAH
                                                      (or his or her authorized
                                                      representative) views, downloads,
                                                      or transmits to a third party his
                                                      or her information during the EHR
                                                      reporting period.
                                 Protect Electronic  Measure: Conduct or review a         NONE.
                                  Health              security risk analysis in
                                  Information.        accordance with the requirements
                                                      in 45 CFR 164.308(a)(1), including
                                                      addressing the security (to
                                                      include encryption) of ePHI data
                                                      stored in Certified EHR Technology
                                                      in accordance with requirements in
                                                      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,
                                                      eligible hospital, or CAHs risk
                                                      management process.
                                 Patient Specific    Eligible Hospital/CAH Measure: More  Alternate Exclusion:
                                  Education.          than 10 percent of all unique        Provider may claim an
                                                      patients admitted to the eligible    exclusion for the
                                                      hospital's or CAH's inpatient or     measure of the Stage
                                                      emergency department (POS 21 or      2 Patient Specific
                                                      23) are provided patient specific    Education objective
                                                      education resources identified by    if for an EHR
                                                      Certified EHR Technology.            reporting period in
                                                                                           2015 they were
                                                                                           scheduled to
                                                                                           demonstrate Stage 1
                                                                                           but did not intend to
                                                                                           select the Stage 1
                                                                                           Patient Specific
                                                                                           Education menu
                                                                                           objective.
                                 Medication          Measure: The EP, eligible hospital   Alternate Exclusion:
                                  Reconciliation.     or CAH performs medication           Provider may claim an
                                                      reconciliation for more than 50      exclusion for the
                                                      percent of transitions of care in    measure of the Stage
                                                      which the patient is transitioned    2 Medication
                                                      into the care of the EP or           Reconciliation
                                                      admitted to the eligible             objective if for an
                                                      hospital's or CAH's inpatient or     EHR reporting period
                                                      emergency department (POS 21 or      in 2015 they were
                                                      23).                                 scheduled to
                                                                                           demonstrate Stage 1
                                                                                           but did not intend to
                                                                                           select the Stage 1
                                                                                           Medication
                                                                                           Reconciliation menu
                                                                                           objective.
                                 Summary of Care...  Measure: The EP, eligible hospital   Alternate Exclusion:
                                                      or CAH that transitions or refers    Provider may claim an
                                                      their patient to another setting     exclusion for Measure
                                                      of care or provider of care (1)      2 of the Stage 2
                                                      uses CEHRT to create a summary of    Summary of Care
                                                      care record; and (2)                 objective if for an
                                                      electronically transmits such        EHR reporting period
                                                      summary to a receiving provider      in 2015 they were
                                                      for more than 10 percent of          scheduled to
                                                      transitions of care and referrals.   demonstrate Stage 1,
                                                                                           which does not have
                                                                                           an equivalent
                                                                                           measure.
                                 Electronic          Eligible Hospital/CAH Measure: More  Alternate EH
                                  Prescribing.        than 10 percent of hospital          Exclusion: Measure
                                                      discharge medication orders for      Exclusion: Provider
                                                      permissible prescriptions (for       may claim an
                                                      new, changed and refilled            exclusion for the eRx
                                                      prescriptions) are queried for a     objective and measure
                                                      drug formulary and transmitted       if for an EHR
                                                      electronically using Certified EHR   reporting period in
                                                      Technology.                          2015 they were either
                                                                                           scheduled to
                                                                                           demonstrate Stage 1
                                                                                           which does not have
                                                                                           an equivalent
                                                                                           measure, or if they
                                                                                           are scheduled to
                                                                                           demonstrate Stage 2
                                                                                           but did not intend to
                                                                                           select the Stage 2
                                                                                           eRx menu objective
                                                                                           for an EHR reporting
                                                                                           period in 2015.
                                 Public Health.....   Measure Option 1--          NONE.
                                                      Immunization Registry Reporting:
                                                      The EP, eligible hospital, or CAH
                                                      is in active engagement with a
                                                      public health agency to submit
                                                      immunization data and receive
                                                      immunization forecasts and
                                                      histories from the public health
                                                      immunization registry/immunization
                                                      information system (IIS).

[[Page 20374]]

 
                                                      Measure Option 2--
                                                      Syndromic Surveillance Reporting:
                                                      The EP, eligible hospital/, or CAH
                                                      is in active engagement with a
                                                      public health agency to submit
                                                      syndromic surveillance data from a
                                                      non-urgent care ambulatory setting
                                                      for EPs, or an emergency or urgent
                                                      care department for eligible
                                                      hospitals and CAHs (POS 23).
                                                      Measure Option 3--Case
                                                      Reporting: The EP, eligible
                                                      hospital, or CAH is in active
                                                      engagement with a public health
                                                      agency to submit case reporting of
                                                      reportable conditions.
                                                      Measure Option 4--Public
                                                      Health Registry Reporting: The EP,
                                                      eligible hospital, or CAH is in
                                                      active engagement with a public
                                                      health agency to submit data to
                                                      public health registries
                                                      Measure Option 5--Clinical
                                                      Data Registry Reporting: The EP,
                                                      eligible hospital, or CAH is in
                                                      active engagement to submit data
                                                      to a clinical data registry.
                                                      Measure Option 6--
                                                      Electronic Reportable Laboratory
                                                      Result Reporting: The eligible
                                                      hospital or CAH is in active
                                                      engagement with a public health
                                                      agency to submit electronic
                                                      reportable laboratory results.
----------------------------------------------------------------------------------------------------------------

3. Certified EHR Technology
    Certified EHR technology is defined for the Medicare and Medicaid 
EHR Incentive Programs at 42 CFR 495.4, which references ONC's 
definition of CEHRT in 45 CFR 170.102. The definition establishes the 
requirements for EHR technology that must be used by providers to meet 
the meaningful use objectives and measures. The Stage 2 final rule 
requires that CEHRT must be used by EPs, eligible hospitals, and CAHs 
to satisfy their CQM reporting requirements in the Medicare and 
Medicaid EHR Incentive Programs. In addition, the CQM data reported to 
CMS must originate from EHR technology that is certified to ``capture 
and export'' in accordance with 45 CFR 170.314(c)(1) and ``electronic 
submission'' in accordance with 45 CFR 170.314(c)(3) (77 FR 54053).
    Rather than establishing a meaningful use specific CEHRT definition 
for the EHR Incentive Programs in the ONC 2015 Edition proposed rule, 
we instead proposed to define the term ``Certified EHR Technology'' in 
the Stage 3 proposed rule at Sec.  495.4 (80 FR 16767 and 16768). This 
proposed change is designed to simplify the overall regulatory 
relationship between ONC and CMS rules for stakeholders and to ensure 
that relevant CMS policy for the Medicare and Medicaid EHR Incentive 
Programs is clearly defined in CMS regulations.
    We are proposing no further changes to the definition of CEHRT in 
this proposed rule. We reiterate that providers must use EHR technology 
certified to the 2014 Edition for an EHR reporting period in 2015. As 
proposed in the Stage 3 proposed rule, providers must use EHR 
technology certified at least to the 2014 Edition in 2016 and 2017. 
Providers may adopt EHR technology certified to the 2015 Edition prior 
to the beginning of Stage 3 in 2017 or 2018, and that technology could 
be used to satisfy the definition of CEHRT under Sec.  495.4 to 
demonstrate meaningful use (80 FR 16767 through 16768).
4. Medicaid EHR Incentive Program in 2015 Through 2017
    The proposals included in this proposed rule would apply for 
providers participating in the Medicaid EHR Incentive Program in 2015 
through 2017.
    Consistent with both Stage 1 and 2, we propose to continue to offer 
states flexibility in the Medicaid EHR Incentive Program for meaningful 
use in 2015 through 2017. This flexibility would apply to the public 
health reporting objective and measures where we propose to continue to 
allow states to specify the means of transmission of the data or 
otherwise change the public health reporting objective and measures as 
long as it does not require EHR functionality above and beyond that 
which is included in 45 CFR part 170 as stated in the Stage 2 final 
rule (77 FR 53979).
    Finally, we propose to provide an alternate attestation option for 
Medicaid providers who are seeking to demonstrate meaningful use to 
avoid the Medicare payment adjustment and who are prohibited from 
switching between the Medicare and Medicaid EHR incentive programs. For 
these providers, we propose that they may use the Medicare Registration 
and Attestation system to attest to meaningful use without switching 
programs solely for the purposes of avoiding the Medicare payment 
adjustment. We are proposing this alternate attestation option in 
response to concerns about providers who participate in the Medicaid 
EHR Incentive Program; but, due to their patient volume or another 
similar factor, they are unable to attest to meaningful use through 
their state Medicaid program for a given year. If such a provider uses 
the alternate attestation option to demonstrate meaningful use for an 
EHR reporting period, they may avoid the Medicare payment adjustment 
associated with that EHR reporting period without switching out of the

[[Page 20375]]

Medicaid EHR Incentive Program. This option is discussed in further 
detail in section II.D. of this proposed rule.
    We invite public comment on these proposals.

C. Clinical Quality Measurement

    Under sections 1848(o)(2)(A),1886(n)(3)(A), and 1814(l)(3)(A) of 
the Act and 42 CFR 495.4, EPs, eligible hospitals, and CAHs must report 
on CQMs selected by CMS using certified EHR technology, as part of 
being a meaningful EHR user under the Medicare and Medicaid EHR 
Incentive Programs. In the Stage 2 final rule, we outlined the CQMs 
available for use in the EHR Incentive Programs beginning in 2014 for 
EPs, eligible hospitals, and CAHs at (77 FR 54057 through 54068 for EPs 
and 77 FR 54081 through 54087 for eligible hospitals/CAHs) as well as 
the form and method for submission at (77 FR 54076 through 54080 for 
EPs and 77 FR 54087 through 54089 for eligible hospitals/CAHs). 
Following the publication of the Stage 2 final rule, we also 
established requirements for reporting on CQMs under the EHR Incentive 
Program in the PFS and IPPS rules (see for example 79 FR 50319 through 
50321 and 79 FR 67779). In sections II.B.1.a. and b. of the preamble of 
the Stage 3 proposed rule, we outlined the requirements for CQM 
reporting for all providers for the EHR Incentive Programs in 2017 and 
subsequent years (80 FR 16768 and 16769) as well as the intent to 
continue program alignment with other CMS quality reporting programs in 
the IPPS and PFS rules.
    In this proposed rule for meaningful use in 2015 through 2017, we 
are proposing to maintain the existing requirements established in 
earlier rulemaking for the reporting of CQMs. The options for CQM 
submission for providers in the Medicare EHR Incentive Program are as 
follows:
     EP Options for Medicare EHR Incentive Program 
Participation (single program participation)
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System.
    ++ Option 2: Electronically report CQMs through Physician Quality 
Reporting System (PQRS) Portal.
     EP Options for Electronic Reporting for Multiple Programs 
(for example: EHR Incentive Program plus PQRS participation)
    ++ Option 1: Report individual eligible professionals' CQMs through 
PQRS Portal.
    ++ Option 2: Report group's CQMs through PQRS Portal.
We note that under option 2, this may include an EP reporting using the 
group reporting option, either electronically using QRDA, or via the 
GPRO Web Interface through Pioneer ACO participation.
     Eligible hospital and CAH Options for Medicare EHR 
Incentive Program Participation (single program participation)
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System.
    ++ Option 2: Electronically report CQMs through QualityNet Portal.
     Eligible hospital and CAH Options for Electronic Reporting 
for Multiple Programs (for example: EHR Incentive Program plus IQR 
participation)
    ++ Electronically report through QualityNet Portal.
    For the Medicaid EHR Incentive Program, states would continue to be 
responsible for determining whether and how electronic reporting of 
CQMs would occur, or if they wish to allow reporting through 
attestation. Any changes that states make to their CQM reporting 
methods must be submitted through the State Medicaid Health IT Plan 
(SMHP) process for our review and approval prior to being implemented.
    We are also proposing to maintain the existing CQM reporting 
requirements of nine CQMs covering at least three NQS domains for EPs 
and 16 CQMs covering at least three NQS domains for eligible hospitals 
and CAHs (77 FR 54058 for EPs and 77 FR 54056 for eligible hospitals 
and CAHs).
    As discussed in section II.B.2(a) of this proposed rule, beginning 
in 2015, we are proposing to change the definition of ``EHR reporting 
period'' in Sec.  495.4 for eligible hospitals and CAHs such that the 
EHR reporting period would begin and end in relation to a calendar 
year. In connection with this proposal, we also propose that in 2015 
and for all methods of reporting, eligible hospitals and CAHs would be 
required to complete a reporting period for clinical quality measures 
aligned with the calendar year in order to demonstrate meaningful use. 
In order to accommodate eligible hospitals and CAHs that may have 
planned their clinical quality measure reporting in 2015 based on the 
federal fiscal year, we propose for 2015 only that eligible hospitals 
and CAHs that are submitting CQMs via attestation, may begin a 
reporting period as early as October 1 of 2014 and end by December 31 
of 2015. Eligible hospitals and CAHs submitting CQMs via electronic 
reporting must meet the requirements established in the FY 2015 final 
rule (79 FR 50319 through 50321).
    As discussed in section II.B.1.b.(3). of this proposed rule, for 
2015 only, we are proposing to change the EHR reporting period for all 
EPs, eligible hospitals, and CAHs to any continuous 90-day period 
within the calendar year. In connection with this proposal, we also 
propose a 90-day reporting period for clinical quality measures for all 
EPs, eligible hospitals, and CAHs that report clinical quality measures 
by attestation. We are proposing eligible professionals may select any 
continuous 90-day period from January 1, 2015 through December 31, 
2015, while eligible hospitals and CAHs may select any continuous 90-
day period from October 1, 2014 through December 31, 2015, to report 
CQMs via attestation using the EHR Incentive Program registration and 
attestation system. In accordance with our existing policy, it is 
acceptable for a provider to use a continuous 90-day reporting period 
for CQMs even if it is different from their continuous 90-day EHR 
reporting period for the meaningful use objectives and measures if that 
provider is reporting via attestation. We also propose that a provider 
may choose to attest to a CQM reporting period of greater than 90-days 
up to and including 1 full calendar year of data.
    We further propose to continue our existing policy that providers 
in any year of participation for the EHR Incentive Programs for 2015 
through 2017 may instead electronically report CQM data using the 
options previously outlined for electronic reporting either for single 
program participation in the Medicare EHR Incentive Programs, or for 
participation in multiple programs if the requirements of the aligned 
quality program are met.
    We note that EPs seeking to participate in multiple programs with a 
single electronic submission would be required to submit a full 
calendar year of CQM data using the 2014 electronic specifications for 
the CQMs (which are also known as eCQMs) for a reporting period in 
2015. These specifications include the annual updates released in June 
of 2014 and are available at the CMS eCQMs Library (http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html)
    Eligible hospitals and CAHs seeking to participate in multiple 
programs with a single electronic submission for a reporting period in 
2015 would be required to submit 1 calendar quarter of data for 2015 
from either Q1 (January 1, 2015-March 31, 2015), Q2 (April 1, 2015 June 
30, 2015), or Q3 (July 1, 2015-September 30, 2015) and would require of 
the use of the April 2014 release of the eCQMs available at the

[[Page 20376]]

CMS eCQM Library (http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html). For further information, we 
direct readers to the FY 2015 IPPS final rule at 79 FR 50319 through 
50321.
    We note that an EHR certified for CQMs under the 2014 Edition 
certification criteria does not need to be recertified each time it is 
updated to a more recent version of the eCQMs. (For further information 
on CQM reporting, we direct readers to the EHR Incentive Program Web 
site where guides and tip sheets are available for each reporting 
option (www.CMS.gov/ehrincentiveprograms)).
    We invite public comment on this proposal.

D. Demonstration of Meaningful Use for 2015 Through 2017

1. Common Methods of Demonstration in Medicare and Medicaid
    We are proposing 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.
2. Methods for Demonstration of the Criteria for Meaningful Use in 2015 
Through 2017
    As mentioned previously in section II.B.2. of this proposed rule, 
we are redesignating the numbering of certain sections of the 
regulation text under 42 CFR part 495. In prior rules, we defined the 
criteria for the demonstration of meaningful use at 42 CFR 495.8, which 
would be redesignated as Sec.  495.40. In this proposed rule, we define 
the criteria for the demonstration of meaningful use at Sec.  495.40 
including references to the objectives and measures of meaningful use 
as well as the requirement to report CQMs. In order to demonstrate 
meaningful use in 2015 through 2017, we are proposing that the 
requirements at Sec.  495.40 include a reference to the objectives and 
measures of meaningful use for 2015 through 2017 outlined at Sec.  
495.22 which the provider must satisfy.
    We are proposing to continue the use of attestation as the method 
for demonstrating that an EP, eligible hospital, or CAH has met the 
objectives and measures of meaningful use. Instead of individual 
Medicare EP attestation through the CMS Registration and Attestation 
System, we are also proposing to continue the existing optional batch 
file process for attestation. Further, we are proposing changes to the 
deadlines for EPs, eligible hospitals, and CAHs to demonstrate 
meaningful use in 2015 and 2016; as well as specific changes to the 
deadlines for providers to demonstrate meaningful use for the first 
time in order to avoid a payment adjustment in 2015 and 2016.
a. Attestation Deadlines for Meaningful Use in 2015 and 2016
    In order to accommodate the proposed changes to the EHR reporting 
period, we are proposing changes to the attestation deadlines for 
eligible hospitals and CAHs for 2015 and 2016. Currently, in order to 
demonstrate meaningful use, eligible hospitals and CAHs are required to 
complete an EHR reporting period within a federal fiscal year. These 
providers must then attest to that EHR reporting period by the end of 
the open attestation period 2 months after the close of the federal 
fiscal year. For 2015, this means that eligible hospitals and CAHs must 
complete an EHR reporting period between October 1, 2014 and September 
30, 2015 and must attest by November 30, 2015. However, we are 
proposing in section II.B.3.a. of this proposed rule that eligible 
hospitals and CAHs would instead be required to complete an EHR 
reporting period for 2015 between October 1, 2014 and the end of the 
calendar year on December 31, 2015, and to complete an EHR reporting 
period for 2016 between January 1, 2016 and December 31, 2016.
    Therefore, we are proposing a change to the attestation deadlines 
as follows:
     For an EHR reporting period in 2015, an eligible hospital 
or CAH must attest by February 29, 2016.
     For an EHR reporting period in 2016, an eligible hospital 
or CAH must attest by February 28, 2017.
    In addition, despite the proposed change to a 90-day EHR reporting 
period in 2015 discussed previously in this proposed rule, providers 
would not be able to attest to meaningful use for an EHR reporting 
period in 2015 prior to January 1, 2016. This would allow us adequate 
time to make the system changes necessary to accept attestations 
reflecting the proposals in this proposed rule. This would mean that 
even if providers successfully complete a continuous 90-day EHR 
reporting period in the first quarter of FY or CY 2015, they would 
attest after the close of the fourth quarter of CY 2015. This change 
would not delay incentive payments for Medicare EPs, because 2015 
cannot be an EP's first payment year under section 1848(o)(1)(B)(v) of 
the Act. Thus, all EPs who qualify for an incentive payment for 2015 
would be returning participants in the program and would have had the 
full CY 2015 (as their EHR reporting period under our current policy). 
We understand that this may delay incentive payments for eligible 
hospitals and CAHs. However, most eligible hospitals and CAHs in the 
program are beyond their first year of demonstrating meaningful use; 
thus, would not have been attesting until after September 30, 2015 
under our current policy. Therefore, for most eligible hospitals and 
CAHs, this change would shift the incentive payment by 1 quarter within 
the same federal fiscal year. Thus, we believe the potential negative 
impact of this change would be minimal and outweighed by the 
opportunity to capitalize on efficiencies created by aligning the EHR 
reporting periods across EPs, eligible hospitals, and CAHs.
    We invite public comment on this proposal.
b. New Participant Attestation Deadlines for Meaningful Use in 2015 and 
2016 To Avoid a Payment Adjustment
    In Sec.  495.4 the definition of an EHR reporting period for a 
payment adjustment year establishes special deadlines for attestation 
for EPs and eligible hospitals that are demonstrating meaningful use 
for the first time in the year immediately preceding a payment 
adjustment year. Generally stated, a provider must complete an EHR 
reporting period in the first 3 quarters of the preceding year, and the 
deadlines for attestation are October 1 for EPs and July 1 for eligible 
hospitals of the preceding year. For CAHs, the EHR reporting period is 
within the federal fiscal year that is the payment adjustment year and 
the deadline for attestation for CAHs is the same for purposes of the 
incentive payment and the payment adjustment (November 30, 2015). After 
the October 1 or July 1 deadlines, EPs and eligible hospitals may still 
attest for an EHR reporting period in the fourth quarter of the CY or 
FY, respectively. However, if they attest after the respective 
deadlines, then they would not avoid the Medicare payment adjustment in 
the subsequent payment adjustment year.
    In the Stage 2 proposed rule (77 FR 13769 for EPs and 77 FR 13773 
through 13774 for eligible hospitals/CAHs), we explained the rationale 
for these special deadlines for attestation. We explained that these 
EHR reporting periods provide adequate time both for the systems 
changes that will be required for us to apply any applicable payment 
adjustments and for providers to be informed in advance of the payment 
year whether a payment adjustment

[[Page 20377]]

would apply. Those deadlines 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. However, we are proposing 
a later deadline for attestation only for 2015 to allow enough time for 
all providers to complete a 90-day EHR reporting period after the 
anticipated effective date of the final rule. As a result of this later 
deadline, in 2016, providers that are new participants in the EHR 
Incentive Program may be subject to a payment adjustment on claims 
submitted prior to attestation to meaningful use for an EHR reporting 
period in 2015. After successful attestation, the payment adjustment 
would be removed and any adjustments previously applied to claims in 
2016 would be reprocessed and reconciled for the provider. However, as 
our policies seek to minimize the claims reprocessing burden, we note 
these are exceptional circumstances caused by the need for a later 
attestation deadline to accommodate a 90-day EHR reporting period in 
2015 after the effective date of the final rule, and this is not an 
acceptable long-term solution. For the reasons previously stated in the 
Stage 2 proposed rule, the special deadlines for first-time meaningful 
EHR users (October 1 for EPs and July 1 for eligible hospitals) are 
necessary in 2016 and subsequent years where no extenuating 
circumstances exist. For these reasons, we propose changes to the 
attestation deadlines for purposes of the payment adjustment years in 
section II.E.2.(a). through (c). of this proposed rule.
    We invite public comment on these proposals.
3. Alternate Method of Demonstration for Certain Medicaid Providers 
Beginning in 2015
    At 42 CFR 495.10, redesignated as Sec.  495.60, we defined the 
requirements for EPs switching between the Medicare and Medicaid EHR 
Incentive Programs. An EP who qualifies as both a Medicaid EP and a 
Medicare EP must notify us as to whether he or she elects to 
participate in the Medicare or the Medicaid EHR Incentive Program, and 
after receiving at least one incentive payment, may switch between the 
two EHR incentive programs only one time, and only for a payment year 
before 2015. For further discussion of this policy we direct readers to 
(75 FR 44324 through 44325). We are not proposing any changes to the 
switching requirements under Sec.  495.60.
    However, we note that an EP who qualifies as both a Medicaid EP and 
a Medicare EP would be subject to the Medicare payment adjustment if 
the EP fails to demonstrate meaningful use for the applicable EHR 
reporting period for a payment adjustment year. We recognize it is 
possible that an EP who receives an incentive payment under the 
Medicaid EHR Incentive Program for a given year may fail in a 
subsequent year to meet the eligibility criteria for the Medicaid EHR 
Incentive Program. For example, the EP would be unable to qualify for a 
Medicaid EHR incentive payment for 2015, if he or she receives a 
Medicaid EHR incentive payment for meaningful use for the 2013 payment 
year, but does not meet the 30 percent Medicaid patient volume 
requirement for purposes of the 2015 payment year. Under Sec.  
495.60(e), in this example in order to avoid the Medicare payment 
adjustment, the EP would be unable to switch to the Medicare EHR 
Incentive Program for the 2015 payment year; thus, the EP would not 
have a way to demonstrate meaningful use for an applicable EHR 
reporting period for the payment adjustment year. Therefore, for 
purposes of avoiding the Medicare payment adjustment, we are proposing 
to establish an additional attestation option to allow EPs who have 
received at least one incentive payment under the Medicaid EHR 
Incentive Program (for either AIU or meaningful use) to demonstrate 
meaningful use by attestation using the EHR Incentive Program 
Registration and Attestation system. We note that this attestation 
would not constitute a switch from the Medicaid EHR Incentive Program 
to the Medicare EHR Incentive Program, and EPs who attest under this 
option would not earn an incentive payment in either program for the 
year. We are proposing this attestation option for the purposes of 
demonstrating meaningful use to avoid the Medicare payment adjustment 
only. In the prior example, the EP whose Medicaid patient volume was 
less than the required threshold would be able to attest to meaningful 
use for an EHR reporting period in 2015 to avoid the 2017 payment 
adjustment. This EP would continue to be designated a Medicaid EHR 
Incentive Program participant. In 2016 in order to earn an incentive 
payment and avoid a Medicare payment adjustment, if the EP meets the 
Medicaid patient volume threshold with regard to the 2016 payment year, 
then the EP would be required to demonstrate meaningful use in the 
Medicaid program for an EHR reporting period.
    As stated above, we are proposing that EPs who have previously 
received an incentive payment under Medicaid for adopting, 
implementing, or upgrading to certified EHR technology may also use 
this alternate attestation option even if it is their first year of 
demonstrating meaningful use. However, these EPs would be required to 
demonstrate meaningful use for the EHR reporting periods established 
for the Medicare EHR Incentive Program for EPs who have never 
successfully demonstrated meaningful use in a prior year. In the Stage 
3 proposed rule (80 FR 16739), we propose that beginning in 2017, EPs 
who demonstrate meaningful use for the first time under the Medicare 
EHR Incentive Program must use an EHR reporting period of one full 
calendar year. Accordingly, under our proposal in this rule, Medicaid 
providers using this alternate attestation option in 2017 or subsequent 
years would also be required to use an EHR reporting period of 1 full 
calendar year even if they are demonstrating meaningful use for the 
first time.
    We invite public comment on this proposal.
4. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    We propose no changes to the data collection requirements or to the 
registration requirements under Sec.  495.10, redesignated as Sec.  
495.60. As noted in section II.C.2 of the Stage 3 proposed rule, we 
note that we intend to continue to post meaningful use participation 
data both at an individual and aggregate level for the purposes of data 
transparency, program integrity, and for use with aligned CMS quality 
reporting programs.
5. Hospital-Based Eligible Professionals
    Section 1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of 
the HITECH Act, states that hospital-based EPs are not eligible for 
Medicare incentive payments. Similarly, the majority of hospital-based 
EPs will not be eligible for Medicaid incentive payments under section 
1903(t)(2)(A) of the Act (the only exception to this rule is for those 
practicing predominantly in an FQHC or RHC). Sections 4101(a) and 
4201(a) of the HITECH Act originally defined the term ``hospital-based 
eligible professional'' to mean an EP, such as a pathologist, 
anesthesiologist, or emergency physician, who furnishes substantially 
all of his or her Medicare covered professional services during the 
relevant EHR reporting period in a hospital setting (whether inpatient 
or outpatient) through the use of the facilities and equipment of the 
hospital, including the hospital's qualified EHRs. Following 
publication of the Stage 1

[[Page 20378]]

proposed rule (75 FR 1844 through 2011), Congress modified the 
definition of hospital-based EPs. Specifically, on April 15, 2010, 
President Obama signed into law the Continuing Extension Act of 2010 
(Pub. L. 111-157). Section 5 of the Continuing Extension Act of 2010 
(Pub. L. 111-157) made the following changes to the Act as it applies 
to both the Medicare and Medicare EHR incentives for EPs:
 Qualifications for Clinic-based Physicians
    ++ Medicare--Section 1848(o)(1)(C)(ii) of the Act (42 U.S.C. 1395w-
4(o)(1)(C)(ii)) is amended by striking ``setting (whether inpatient or 
outpatient)'' and inserting ``inpatient or emergency room setting''.
    ++ Medicaid--Section 1903(t)(3)(D) of the Act (42 U.S.C. 
1396b(t)(3)(D)) is amended by striking ``setting (whether inpatient or 
outpatient)'' and inserting ``inpatient or emergency room setting''.
    These amendments were effective as if included in the enactment of 
the HITECH Act. The previous sections indicate that the determination 
of whether an EP is a hospital-based EP shall be made on the basis of 
the site of service, as defined by the Secretary, and without regard to 
any employment or billing arrangement between the EP and any other 
provider. For example, the hospital-based determination for an EP would 
not be affected by whether the EP is an employee of the hospital, under 
a contractual relationship with the hospital, or with respect to 
whether he or she has made a reassignment to the hospital for Part B 
billing purposes. In addition, section 1848(a)(7)(D) of the Act, as 
added by section 4101(b) of the HITECH Act, exempts hospital-based EPs 
from the downward payment adjustment applied under section 
1848(a)(7)(A)(i) of the Act to covered professional services provided 
during a payment year by EPs who are not meaningful EHR users for the 
relevant payment year beginning in 2015.
    Based on section 4101(a) of the HITECH Act (and prior to the 
amendments in the Continuing Extension Act of 2010), we proposed in the 
Stage 1 proposed rule (75 FR 1904 through1907) that an EP would be 
considered a hospital-based EP; therefore, ineligible to receive a 
Medicare or Medicaid EHR incentive payment if more than 90 percent of 
their services are provided in the following place of service (POS) 
codes for HIPAA standard transactions--
     21--Inpatient Hospital;
     22--Outpatient Hospital;
     23--Emergency Room.

In the Stage 1 final rule (75 FR 44439 through 44442), we incorporated 
the changes to the hospital-based definition, that were included in the 
Continuing Extension Act of 2010, into our definition of ``hospital-
based EP'' under Sec.  495.4. We defined an EP as hospital-based if he 
or she furnishes 90 percent or more of his or her covered professional 
services in sites of service identified as an inpatient hospital (POS 
21) or emergency room (POS 23) setting in the year preceding the 
payment year. We did not include POS 22 for outpatient hospital 
settings in our final definition.
    As noted previously, section 1848(a)(7)(D) of the Act exempts 
hospital-based EPs who are not meaningful EHR users from the downward 
payment adjustments under Medicare. In the Stage 2 final rule (77 FR 
54102), for purposes of the Medicare payment adjustments, we amended 
the definition of hospital-based EP under Sec.  495.4 to define a 
hospital-based EP as an EP who furnishes 90 percent or more of his or 
her covered professional services in sites of service identified as an 
inpatient hospital (POS 21) or emergency room (POS 23) setting in 
either of the 2 years before the year preceding a payment adjustment 
year.
    However, recently several hospital associations, individual 
providers, and other stakeholders have raised concerns with our current 
definition of a hospital-based EP. Specifically, these stakeholders 
asserted that the limitation of hospital-based to POS codes 21 and 23, 
covering inpatient and emergency room settings only, does not 
adequately capture all settings where services might be furnished by a 
hospital-based EP. They stated that POS 22, which covers an outpatient 
hospital place of service, is also billed by hospital-based EPs, 
especially in relation to certain CPT codes. These stakeholders 
expressed the belief that our current definition of hospital-based EP 
in the regulations is too narrow and will unfairly subject many EPs who 
are not hospital-based under our definition, but who stakeholders would 
consider to be hospital-based, to the downward payment adjustment under 
Medicare in 2015. Accordingly, these stakeholders recommended that we 
consider adding additional place of service codes or settings to the 
regulatory definition of hospital-based EP.
    We appreciate this feedback from stakeholders and are requesting 
public comment on our current definition of a hospital-based EP under 
Sec.  495.4 for the EHR Incentive Programs.
    We are seeking public comment on whether additional place of 
service codes or settings should be included in our definition of a 
hospital-based EP. As stated previously, stakeholders specifically 
identified POS 22 for outpatient hospital settings as an area of 
concern; therefore, we are especially interested in comments on POS 22 
for outpatient hospital settings. In addition, we seek comments on 
whether and how the inclusion of additional POS codes or settings in 
our definition of hospital-based EP might affect the eligibility of EPs 
for the EHR incentive payments under Medicare or Medicaid.
    We welcome public comment.

E. Payment Adjustments and Hardship Exceptions

    Sections 4101(b) and 4102(b) of the HITECH Act, amending sections 
1848, 1853, and 1886 of the Act, require reductions in payments to EPs, 
eligible hospitals, and CAHs that are not meaningful users of certified 
EHR technology, beginning in CY 2015 for EPs, FY 2015 for eligible 
hospitals, and in cost reporting periods beginning in FY 2015 for CAHs.
1. Statutory Basis for Payment Adjustment and Hardship Exceptions
    Section 1848(a)(7) of the Act provides for payment adjustments, 
effective for CY 2015 and subsequent years, for EPs as defined in Sec.  
495.100, who are not meaningful EHR users during the relevant EHR 
reporting period for the year. Section 1848(a)(7) of the Act provides 
that 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'' of the fee schedule 
amount that would otherwise apply. The term ``applicable percent'' is 
defined in section 1848(a)(7)(A)(ii) of the Act as: (I) For 2015, 99 
percent (or, in the case of an EP who was subject to the application of 
the payment adjustment [if the EP was not a successful electronic 
prescriber] under section 1848(a)(5) of the Act for 2014, 98 percent); 
(II) for 2016, 98 percent; and (III) for 2017 and each subsequent year, 
97 percent.
    In addition, section 1848(a)(7)(A)(iii) of the Act provides that 
if, for CY 2018 and subsequent years, the Secretary finds 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

[[Page 20379]]

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.
    We established regulations implementing these statutory provisions 
under 42 CFR 495.102. We refer readers to the Stages 1 and 2 final 
rules (75 FR 44442 through 44448, 77 FR 54093 through 54102) for more 
information.
    Section 1886(b)(3)(B)(ix)(I) of the Act, as amended by section 
4102(b)(1) of the HITECH Act, provides for an adjustment to the 
applicable percentage increase to the IPPS payment rate for those 
eligible hospitals that are not meaningful EHR users for the associated 
EHR reporting period for a payment adjustment year, beginning in FY 
2015. Specifically, section 1886(b)(3)(B)(ix)(I) of the Act provides 
that, for FY 2015 and each subsequent fiscal year, 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 applies to ``three-quarters of the percentage increase 
otherwise applicable'' prior to the application of statutory 
adjustments under sections 1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and 
1886(b)(3)(B)(xii) of the Act, or three-quarters of the applicable 
market basket update. The reduction to three-quarters of the applicable 
update for an eligible hospital that is not a meaningful EHR user would 
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 
must reduce the applicable percentage increase (prior to the 
application of other statutory adjustments) by--
     25 percent (33 1/3 of 75 percent) in FY 2015;
     50 percent (66 2/3 percent of 75 percent) in FY 2016; and
     75 percent (100 percent of 75 percent) in FY 2017 and 
subsequent years.
Section 4102(b)(1)(B) of the HITECH Act also provides that the 
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.''
    Section 412.64(d) of our regulations sets forth the adjustment to 
the percentage increase in the market basket index for those eligible 
hospitals that are not meaningful EHR users for the EHR reporting 
period for a payment year, beginning in FY 2015.
    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 of the Act also provides that such determinations are subject 
to annual renewal, and that in no case may a hospital be granted an 
exception for more than 5 years.
    Section 4102(b)(2) of the HITECH Act amended section 1814(l) of the 
Act to include an adjustment to a CAH's Medicare reimbursement for 
inpatient services if the CAH is not a meaningful EHR user for an EHR 
reporting period. The adjustment would be made for cost reporting 
periods that begin in FY 2015, FY 2016, FY 2017, and each subsequent FY 
thereafter. Specifically, sections 1814(l)(4)(A) and (B) of the Act 
provide that, if a CAH does not demonstrate meaningful use of CEHRT for 
an applicable EHR reporting period, then for a cost reporting period 
beginning in FY 2015, the CAH's reimbursement shall be reduced from 101 
percent of its reasonable costs to 100.66 percent of reasonable costs. 
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 fiscal year, 
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 cases of a CAH in a rural 
area without sufficient internet access. However, in no case may a CAH 
be granted this exception for more than 5 years.
    In the Stage 1 final rule (75 FR 44564 and 44574), we finalized the 
regulations regarding the CAH adjustment at Sec.  495.106(e) and Sec.  
413.70(a)(6).
2. EHR Reporting Period for a Payment Adjustment Year
    Section 1848(a)(7)(E)(ii) of the Act provides the Secretary with 
broad authority to choose the EHR reporting period that would apply for 
purposes of determining the payment adjustments for EPs for CY 2015 and 
subsequent years. In the Stage 2 final rule (77 FR 54095 through 
54097), we adopted a policy that the EHR reporting periods for the 
payment adjustments will begin and end prior to the year of the payment 
adjustment. We stated that this is based on our desire 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, and the resulting 
implications for beneficiary coinsurance. Specifically, we finalized 
under Sec.  495.4 of our regulations that for EPs, the EHR reporting 
period for a payment adjustment year is the full calendar year that is 
2 years before the payment adjustment year. For example, the full 
calendar year of 2015 would be the EHR reporting period for the CY 2017 
payment adjustment year. We also finalized an exception to this rule 
for EPs who have never successfully attested to meaningful use. 
Generally stated, under this exception, for an EP who is demonstrating 
meaningful use for the first time, the EHR reporting period for a 
payment adjustment year is any continuous 90-day period. For a full 
description of this exception, including limitations on when the 
continuous 90-day period must occur in relation to the payment 
adjustment year and the deadlines for registration and attestation, we 
refer readers to the definition of ``EHR reporting period for a payment 
adjustment year'' under Sec.  495.4 of our regulations and the 
discussion in the Stage 2 final rule (77 FR 54095 through 54096). We 
established that these policies apply for the CY 2015 payment 
adjustment year and subsequent payment adjustment years.
    Similarly, section 1886(b)(3)(B)(ix)(IV) of the Act makes clear 
that the Secretary has discretion to specify as the EHR reporting 
period any period (or periods) that will apply with respect to a fiscal 
year. In the Stage 2 final rule at 77 FR 54104 through 54105, we 
finalized the applicable EHR reporting period for purposes of 
determining whether an eligible hospital is subject to the

[[Page 20380]]

payment adjustment. As with EPs, we finalized that the EHR reporting 
period for the payment adjustment year for eligible hospitals will 
begin and end prior to the year of the payment adjustment. We finalized 
under Sec.  495.4 of our regulations that for eligible hospitals, the 
EHR reporting period for a payment adjustment year is the full federal 
fiscal year that is 2 years before the payment adjustment year. We 
established this policy beginning with the FY 2015 payment adjustment 
year and continuing in subsequent years. For example, the full federal 
fiscal year of 2015 would be the EHR reporting period for the FY 2017 
payment adjustment year. We finalized an exception to the general rule 
of a full federal fiscal year EHR reporting period for eligible 
hospitals that have never successfully attested to meaningful use. 
Generally stated, under this exception, for an eligible hospital that 
is demonstrating meaningful use for the first time, the EHR reporting 
period for a payment adjustment year is any continuous 90-day period. 
For a full description of this exception, including limitations on when 
the continuous 90-day period must occur in relation to the payment 
adjustment year and the deadlines for registration and attestation, we 
refer readers to the definition of ``EHR reporting period for a payment 
adjustment year'' under Sec.  495.4 of the regulations and the 
discussion in the Stage 2 final rule (77 FR 54104 through 54105).
    In Stage 2, we amended the definition of the EHR reporting period 
that would apply for purposes of the payment adjustment for CAHs under 
Sec.  495.4 (77 FR 54109 and 54110). For CAHs, this is 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 EHR reporting period within the payment adjustment 
year would apply). The adjustment applies 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 EHR user for FY 2015, 
and thereafter, then the payment adjustment is applied to the CAH's 
reasonable costs incurred in a cost reporting period that begins in the 
affected FY as described in Sec.  413.70(a)(6)(i). We further finalized 
that CAHs 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 would be made through the cost report settlement process
    In the Stage 3 proposed rule (80 FR 16774 through 16779), we 
proposed to eliminate the exception discussed previously for a 90-day 
EHR reporting period for new meaningful EHR users in the Medicare EHR 
Incentive Program beginning with the EHR reporting period in 2017, with 
a limited exception for new meaningful EHR users under the Medicaid EHR 
Incentive Program. We also proposed for eligible hospitals and CAHs to 
shift the EHR reporting period for a payment adjustment year from a 
fiscal year basis to a calendar year basis. We proposed that for EPs 
and eligible hospitals demonstrating meaningful use under the Medicare 
EHR Incentive Program, including those who have successfully 
demonstrated meaningful use in a prior year as well as those who have 
not, the EHR reporting period for a payment adjustment year would be 
the full calendar year that is 2 years before the payment adjustment 
year. For further information on these proposals, we direct readers to 
the Stage 3 proposed rule (80 FR 16739 and 16740).
    In the Stage 3 proposed rule, we also proposed a change to the EHR 
reporting period that would apply for the payment adjustments for CAHs, 
beginning with the FY 2017 payment adjustment year. Similar to what we 
proposed for eligible hospitals, we proposed that the EHR reporting 
period for a payment adjustment year for CAHs would be a full calendar 
year, rather than a full federal fiscal year. We proposed the EHR 
reporting period for a payment adjustment year would be the calendar 
year that overlaps the last 3 quarters of the federal fiscal year that 
is the payment adjustment year. For example, in order for a CAH to 
avoid application of the adjustment to its reasonable costs incurred in 
a cost reporting period that begins in FY 2017, the CAH must 
demonstrate it is a meaningful EHR user for an EHR reporting period of 
the full 2017 calendar year. For further information on these 
proposals, we direct readers to the Stage 3 proposed rule (80 FR 16777 
through 16779).
    In the Stage 3 proposed rule, we proposed amendments to the 
definition of ``EHR reporting period for a payment adjustment year'' 
under Sec.  495.4 to reflect these proposals for EPs, eligible 
hospitals, and CAHs.
    In this proposed rule, we are proposing several changes to the 
definition of the EHR reporting period for a payment adjustment year 
for EPs, eligible hospitals, and CAHs at Sec.  495.4, in connection 
with other proposals made in this rule. Specifically, as stated in 
section I.A.2.b. of this proposed rule, we propose to change the EHR 
reporting period in 2015 to 90 days for all providers. This 90-day EHR 
reporting period in 2015 would allow adequate time to accommodate the 
changes to the objectives and measures of meaningful use proposed in 
this rule. We are also proposing to move all providers to an EHR 
reporting period based on the calendar year beginning in 2015 to 
support program alignment and simplify reporting requirements among 
provider types (section I.A.2.a. of this proposed rule).
a. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for EPs
    We propose a change to our current policy for 2015 only. We propose 
that for all EPs, including those who have demonstrated meaningful use 
in a prior year and those who have not, the EHR reporting period for a 
payment adjustment year would be any continuous 90-day period in CY 
2015 and would apply for purposes of the payment adjustments in CY 2016 
for EPs demonstrating meaningful use for the first time in 2015 and for 
purposes of the payment adjustments in CY 2017 for both returning and 
new participant EPs who demonstrate meaningful use in 2015. We propose 
the deadline for attestation would be February 29, 2016.
    We would maintain our current policy for 2016. Under that policy, 
if an EP is demonstrating meaningful use for the first time in 2016, 
the EHR reporting period for a payment adjustment year is any 
continuous 90-day period in CY 2016 and applies for purposes of the 
payment adjustments in CYs 2017 and 2018. To avoid the payment 
adjustment in CY 2017, the 90-day period must occur within the first 
three quarters of CY 2016 and the EP must attest by October 1, 2016. If 
an EP has previously demonstrated meaningful use, the EHR reporting 
period for a payment adjustment year is the full CY 2016 and applies 
for purposes of the payment adjustment in CY 2018.
    We invite comment on this proposal.
b. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for Eligible Hospitals
    We propose a change to our current policy for 2015. We propose that 
for all eligible hospitals, including those that have demonstrated 
meaningful use in a

[[Page 20381]]

prior year and those that have not, the EHR reporting period for a 
payment adjustment year would be any continuous 90-day period beginning 
October 1, 2014 and ending December 31, 2015. This EHR reporting period 
would apply for purposes of the payment adjustments in FY 2016 for 
eligible hospitals demonstrating meaningful use for the first time in 
2015 and for purposes of the payment adjustments in FY 2017 for both 
returning and new participant eligible hospitals that demonstrate 
meaningful use in 2015. We propose the deadline for attestation would 
be February 29, 2016.
    We also propose to change our current policy for 2016. We propose 
that if an eligible hospital is demonstrating meaningful use for the 
first time in 2016, the EHR reporting period for a payment adjustment 
year would be any continuous 90-day period in CY 2016 and apply for 
purposes of the payment adjustments in FYs 2017 and 2018. To avoid the 
payment adjustment in FY 2017, the 90-day period must occur within the 
first three quarters of CY 2016, and the eligible hospital must attest 
by October 1, 2016. If an eligible hospital has previously demonstrated 
meaningful use, the EHR reporting period for a payment adjustment year 
would be the full CY 2016, the attestation deadline would be February 
28, 2017, and this EHR reporting period would apply for purposes of the 
payment adjustment in FY 2018.
c. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for CAHs
    For CAHs, we are proposing to shift the EHR reporting period for a 
payment adjustment year from the federal fiscal year that is the 
payment adjustment year to the calendar year that begins on the first 
day of the second quarter of the federal fiscal year that is the 
payment adjustment year. In the Stage 3 proposed rule, we outline how 
CAHs are different from EPs and eligible hospitals in that the EHR 
reporting period is aligned with the payment adjustment year, rather 
than in advance of the payment adjustment year. In the Stage 3 proposed 
rule, we propose a similar change to this definition for an EHR 
reporting period for a payment adjustment year beginning in 2017 and 
explain how this change to the calendar year would work for CAHs. For 
further discussion of this proposal, we direct readers to the Stage 3 
proposed rule (80 FR 16739 through 16740).
    In this proposed rule, we propose a change to our current policy 
for 2015. We propose that for all CAHs, including those that have 
demonstrated meaningful use in a prior year and those that have not, 
the EHR reporting period for a payment adjustment year would be any 
continuous 90-day period beginning October 1, 2014 and ending December 
31, 2015. This EHR reporting period would apply for purposes of the 
payment adjustments for the cost reporting period that begins in 
federal FY 2015. We propose the deadline for attestation would be 
February 29, 2016.
    Any CAH that does not demonstrate meaningful for an EHR reporting 
period in 2015 would receive a downward adjustment to payments for its 
reasonable costs incurred in the cost reporting period that begins in 
federal FY 2015. If a CAH fails to demonstrate meaningful use in 2015 
and has a fiscal year that ends between October 1, 2015 and March 1, 
2016, then the payment adjustment would be applied through the cost 
report reconciliation process.
    We also propose to change our current policy for 2016. We propose 
that if a CAH is demonstrating meaningful use for the first time in 
2016, the EHR reporting period for a payment adjustment year would be 
any continuous 90-day period in CY 2016 and apply for purposes of the 
payment adjustments for the cost reporting period that begins in 
federal FY 2016. The deadline for attestation would be February 28, 
2017. If a CAH has previously demonstrated meaningful use, the EHR 
reporting period for a payment adjustment year would be the full CY 
2016, the attestation deadline would be February 28, 2017, and this EHR 
reporting period would apply for purposes of the payment adjustments 
for the cost reporting period that begins in federal FY 2016.
    Any CAH that does not demonstrate meaningful for an EHR reporting 
period in 2016 would receive a downward adjustment to payments for its 
reasonable costs incurred in the cost reporting period that begins in 
federal FY 2016. If a CAH fails to demonstrate meaningful use in 2016 
and has a fiscal year that ends between October 1, 2016 and March 1, 
2017, then the payment adjustment would be applied through the cost 
report reconciliation process.
3. Hardship Exceptions
    As stated previously, sections 1848(a)(7)(B) and 
1886(b)(3)(B)(ix)(II) of the Act provide the Secretary with 
discretionary authority to exempt, on a case by case basis, a provider 
from the application of the Medicare payment adjustment if the 
Secretary determines that compliance with the requirements for being a 
meaningful EHR user would result in a significant hardship. We have 
established various types of hardship exceptions for which providers 
may apply as well as deadlines for application. For more information, 
we refer readers to the Stage 2 final rule at 77 FR 54093 through 
54113.
    In this proposed rule, we propose no changes to the existing 
hardship exceptions under our regulations.

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 evaluate fairly whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    The following is a discussion of the requirements contained in this 
proposed regulation that we believe are subject to PRA and information 
collection requirements (ICRs). 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 IV.C.3.a. and b. of this proposed rule. The actual burden would 
remain constant for per year as EPs, eligible hospitals, and CAHs would 
need to attest that they have successfully demonstrated meaningful use 
under the proposed definition in 2015 through 2017. For the purposes of 
this analysis, we are focusing only on 2015, the first year in which a 
provider may use the proposed definition of meaningful use. We do not 
believe the burden for EPs, eligible hospitals, and CAHs participating 
in Stages 1 and 2 prior to 2015 would 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 had 
the option to electronically report their clinical quality measures 
through the respective aligned quality reporting programs;

[[Page 20382]]

however, for the purposes of defining the burden for 2015 through 2017, 
we maintain the estimates for attestation to CQM data.
    In this proposed rule, the definition of meaningful use with 
associated reporting requirements would replace all prior definitions 
and requirements beginning in 2015. At that point, all eligible 
providers would be required to report meaningful use requirements on an 
annual basis. For 2017, providers may simply repeat this proposed 
definition of meaningful use or move on to Stage 3. The same reporting 
burden would apply to all providers. Consequently, the proposed ICRs 
reflect the provider burden associated with complying with and 
reporting of the proposed requirements beginning in 2015 and each 
subsequent year. We note that the proposals in this rule result in a 
reduction of the reporting burden on providers attesting to meaningful 
use as compared to the existing program requirements finalized in the 
Stage 2 final rule (77 FR 54132).
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs).

A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  495.20 
Through Sec.  495.60)

    In Sec.  495.40 we propose that to successfully demonstrate 
meaningful use of certified EHR technology for meaningful use in 2015 
through 2017, 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.  495.22. 
In Sec.  495.40, we stipulate 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 captures many of the objectives and associated 
measures and generate automated numerator and denominator information 
where required, or generate automated summary reports. We also expect 
that the provider would enable the functionality required to complete 
the objectives and associated measures for which they are required to 
attest.
    We propose that EPs would be required to report on a total of 10 
objectives and associated measures and eligible hospitals and CAHs 
would report on a total of 9 objectives and associated measures. In 
this proposed rule, there are 6 objectives that would require an EP to 
enter numerators and denominators during attestation. Eligible 
hospitals and CAHs would have to attest that they have met 6 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 2 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 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 approximately 1 
hour 30 minutes to attest to CQM requirements.
    Additionally, providers would 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 objectives 
that would require a ``yes'' or ``no'' response during attestation. For 
eligible hospitals and CAHs, there are 2 objectives and that would 
require a ``yes'' or ``no'' response during attestation. 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 
ePHI. We estimate completion of the analysis required to meet 
successfully the associated measure for this objective would take 
approximately 6 hours, which is identical to our estimate for the Stage 
1 and Stage 2 requirements. 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 7 lists those objectives and associated measures for EPs and 
eligible hospitals and CAHs. We estimate the objectives and associated 
measures would take an EP 6 hours 49 minutes to complete, and would 
take an eligible hospital or CAH 6 hours 48 minutes to complete.
    In this proposed rule EPs, eligible hospitals, and CAHs have nearly 
identical reporting burdens. Eligible hospitals and CAHs are required 
to report to one additional registry than EPs are required to report; 
however, EPs have an additional objective, Secure Electronic Messaging, 
which requires a ``yes'' or ``no'' response. Consequently, we have not 
prepared lowest and highest burdens. Rather, we have computed a burden 
for EPs and a burden for eligible hospitals and CAHs.

                                            Table 7--Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                   Eligible                               Burden  estimate     Burden  estimate
    Eligible professionals       hospitals and          Measures          per  respondent      per  respondent
                                     CAHs                                      (EPs)             (hospitals)
----------------------------------------------------------------------------------------------------------------
                                  Objectives and Measures
----------------------------------------------------------------------------------------------------------------
Use computerized provider      Use computerized  More than 60% of       10 minutes.........  10 minutes.
 order entry (CPOE) for         provider order    medication, 30% of
 medication, laboratory and     entry (CPOE)      laboratory, and 30%
 radiology orders directly      for medication,   of radiology orders
 entered by any licensed        laboratory and    created by the EP or
 healthcare professional who    radiology         authorized providers
 can enter orders into the      orders directly   of the eligible
 medical record per state,      entered by any    hospital's or CAH's
 local and professional         licensed          inpatient or
 guidelines.                    healthcare        emergency department
                                professional      (POS 21 or 23)
                                who can enter     during the EHR
                                orders into the   reporting period are
                                medical record    recorded using CPOE.
                                per state,
                                local and
                                professional
                                guidelines.

[[Page 20383]]

 
Generate and transmit                            More than 50% of all   10 minutes.........
 permissible prescriptions                        permissible
 electronically (eRx).                            prescriptions, or
                                                  all prescriptions
                                                  written by the EP
                                                  and queried for a
                                                  drug formulary and
                                                  transmitted
                                                  electronically using
                                                  CEHRT.
                               Generate and      More than 10% of                            10 minutes.
                                transmit          hospital discharge
                                permissible       medication orders
                                discharge         for permissible
                                prescriptions     prescriptions (for
                                electronically    new, changed, and
                                (eRx).            refilled
                                                  prescriptions) are
                                                  queried for a drug
                                                  formulary and
                                                  transmitted
                                                  electronically using
                                                  CEHRT.
Use clinical decision support  Use clinical      1. Implement five      1 minute...........  1 minute.
 to improve performance on      decision          clinical decision
 high-priority health           support to        support
 conditions.                    improve           interventions
                                performance on    related to four or
                                high-priority     more clinical
                                health            quality measures at
                                conditions.       a relevant point in
                                                  care for the entire
                                                  EHR reporting
                                                  period. Absent four
                                                  clinical quality
                                                  measures related to
                                                  an EP, eligible
                                                  hospital or CAH's
                                                  scope of practice or
                                                  patient population,
                                                  the clinical
                                                  decision support
                                                  interventions must
                                                  be related to
                                                  improving healthcare
                                                  efficiency.
                                                 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.
Provide patients the ability                     1. More than 50% of    10 minutes.........
 to view online, download,                        all unique patients
 and transmit their health                        seen by the EP
 information within 4                             during the EHR
 business days of the                             reporting period are
 information being available                      provided timely
 to the EP.                                       (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. At least 1 patient
                                                  seen by the EP
                                                  during the EHR
                                                  reporting period (or
                                                  their authorized
                                                  representatives)
                                                  views, downloads, or
                                                  transmits to a third
                                                  party their health
                                                  information.
                               Provide patients  1. More than 50% of                         10 minutes.
                                the ability to    all patients who are
                                view online,      discharged from the
                                download, and     inpatient or
                                transmit          emergency department
                                information       (POS 21 or 23) of an
                                about a           eligible hospital or
                                hospital          CAH have their
                                admission.        information
                                                  available online
                                                  within 36 hours of
                                                  discharge.
                                                 2. At least 1 patient
                                                  (or their authorized
                                                  representatives) who
                                                  are discharged from
                                                  the inpatient or
                                                  emergency department
                                                  (POS 21 or 23) of an
                                                  eligible hospital or
                                                  CAH views, downloads
                                                  or transmits to a
                                                  third party their
                                                  information during
                                                  the reporting period.
Use CEHRT to identify patient- Use CEHRT to      Patient-specific       10 minutes.........  10 minutes.
 specific education resources   identify          education resources
 and provide those resources    patient-          identified by CEHRT
 to the patient.                specific          are provided to
                                education         patients for more
                                resources and     than 10% of all
                                provide those     unique patients with
                                resources to      office visits seen
                                the patient.      by the EP during the
                                                  EHR reporting period.
                                                 More than 10% of all
                                                  unique patients
                                                  admitted to the
                                                  eligible hospital's
                                                  or CAH's inpatient
                                                  or emergency
                                                  departments (POS 21
                                                  or 23) are provided
                                                  patient-specific
                                                  education resources
                                                  identified by CEHRT.
Use secure electronic                            The secure electronic  10 minutes.........
 messaging to communicate                         messaging function
 with patients on relevant                        was fully enabled
 health information.                              for the EHR
                                                  reporting period.

[[Page 20384]]

 
The EP who receives a patient  The eligible      The EP, eligible       10 minutes.........  10 minutes.
 from another setting of care   hospital or CAH   hospital or CAH
 or provider of care or         who receives a    performs medication
 believes an encounter is       patient from      reconciliation for
 relevant should perform        another setting   more than 50% of
 medication reconciliation.     of care or        transitions of care
                                provider of       in which the patient
                                care or           is transitioned into
                                believes an       the care of the EP
                                encounter is      or admitted to the
                                relevant should   eligible hospital's
                                perform           or CAH's inpatient
                                medication        or emergency
                                reconciliation.   department (POS 21
                                                  or 23).
The EP who transitions their   The eligible      1. The EP, eligible    10 minutes.........  10 minutes.
 patient to another setting     hospital or CAH   hospital or CAH that
 of care or provider of care    who transitions   transitions or
 or refers their patient to     their patient     refers their patient
 another provider of care       to another        to another setting
 provides a summary care        setting of care   of care or provider
 record for each transition     or provider of    of care provides a
 of care or referral.           care or refers    summary of care
                                their patient     record for more than
                                to another        10% of such
                                provider of       transitions and
                                care provides a   referrals either (a)
                                summary care      electronically
                                record for each   transmitted using
                                transition of     CEHRT to a recipient
                                care or           or (b) where the
                                referral.         recipient receives
                                                  the summary of care
                                                  record via exchange
                                                  facilitated by an
                                                  organization that is
                                                  a NwHIN Exchange
                                                  participant or in a
                                                  manner that is
                                                  consistent with the
                                                  governance mechanism
                                                  ONC establishes for
                                                  the nationwide
                                                  health information
                                                  network.
Active engagement with a       Active            EPs must attest to at  1 minute...........  1 minute.
 public health agency to        engagement with   least 2 options out
 report public health data.     a public health   of 5.
                                agency to        Eligible Hospitals
                                report public     and CAHs must attest
                                health data.      to at least 3
                                                  options out of 6.
Protect electronic protected   Protect           Conduct or review a    6 hours............
 health information created     electronic        security risk
 or maintained by the CEHRT     protected         analysis in
 through the implementation     health            accordance with the
 of appropriate technical       information       requirements under
 capabilities.                  created or        45 CFR
                                maintained by     164.308(a)(1),
                                the CEHRT         including addressing
                                through the       the security (to
                                implementation    include encryption)
                                of appropriate    of data stored in
                                technical         CEHRT in accordance
                                capabilities.     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.
----------------------------------------------------------------------------------------------------------------
Time to Attest to Objectives and Measures.............................  6 hours 49 minutes.  6 hours 48 minutes.
Time to Attest and Report Clinical Quality Measures...................  1 hour 30 minutes..  1 hour 30 minutes.
                              ----------------------------------------------------------------------------------
    Total--Objectives + CQM Reporting.................................  8 hours 19 minutes.  8 hours 18 minutes.
----------------------------------------------------------------------------------------------------------------

    In this proposed rule, we estimate that it would take no longer 
than 6 hours 49 minutes for an EP to attest to each of the applicable 
objectives and associated measures. The total burden hours for an EP to 
attest to the meaningful use objectives and measures and to report CQMs 
would be 8 hours 19 minutes. We estimate that there could be 
approximately 595,100 nonhospital-based Medicare EPs in 2014. Based on 
the historical data, we anticipate approximately 60 percent (357,060) 
of these EPs may attest to the objectives and measures of meaningful 
use. In addition, we believe approximately 30,000 Medicaid only EPs, or 
approximately 51 percent of the Medicaid-only EPs, will successfully 
demonstrate meaningful use in 2015. The total estimated annual cost 
burden for all EPs to attest to meaningful use would be $297,076,291 
(387,060 x 8 hours 19 minutes x $92.25 (mean hourly rate for physicians 
based on May 2013 BLS data)). Similarly, eligible hospitals and CAHs 
would attest that they have met the meaningful use objectives and 
associated measures, and would submit the clinical quality measures. We 
estimate that it would take no longer than 6 hours 48 minutes to attest 
to each of the applicable objectives and associated measures. 
Therefore, the total burden hours for an eligible hospital or CAH to 
attest to the meaningful use objectives and measures and to report 
CQMs, would be 8 hours 18 minutes. We estimate that there are about 
4,900 eligible hospitals and CAHs that may attest to the aforementioned 
criteria in FY 2015 of which 95 percent are expected to successfully 
demonstrate meaningful use. The total estimated annual cost burden for 
all eligible hospitals and CAHs to attest to meaningful use would be 
$2,451,872 (4,655 eligible hospitals and CAHs x $63.46 (8 hours 18 
minutes x $63.46 (mean hourly rate for lawyers based on May 2013 BLS) 
data)).
    We provide the estimate of the burden for the approximately 13,635 
MA EPs in the MA organization burden section. The total annual burden 
estimates for meaningful use under this proposed rule are shown in 
Table 10.

[[Page 20385]]

    For the purpose of this proposed collection of information, we 
assumed that all eligible providers would comply with the requirements 
of Meaningful Use as previously defined if the policies proposed in 
this rule were not finalized. Therefore, in this proposed rule, we 
estimate that the policies contained herein, once finalized, would 
result in an overall reduction in the reporting burden for providers of 
1.45 hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals 
and CAHs per respondent. While batch reporting for objectives and 
measures, and group reporting for CQMs, are available for EPs in the 
current program; the program is based upon successful individual 
provider demonstration of meaningful use and so individual totals are 
used to identify the estimated reduction in provider reporting burden. 
This reduction of burden is outlined in Table 8.

              Table 8--Reduction in Reporting Burden Hours
------------------------------------------------------------------------
                                                       Estimated burden
Burden under current program and   Estimated burden     per respondent
     proposed modifications       per respondent EPs  eligible hospitals
                                                           and CAHs
------------------------------------------------------------------------
Total Under Current Stage 2       9 hours 46 minutes  NA.
 Requirements at 42 CFR 495.6.
Core Set (including CQMs) +
 Least Burdensome Menu Set
 Criteria.
Total Under Current Stage 2       10 hours 13         10 hours 55
 Requirements at 42 CFR 495.6.     minutes.            minutes.
Core Set (including CQMs) + Most
 Burdensome Menu Set Criteria.
Total Under Proposed              8 hours 19 minutes  8 hours 18
 Modifications at 495.22.                              minutes.
All Objectives and Measures +
 CQMs.
Reduction from Least Burdensome   1 hour 27 minutes.  NA.
 Estimate.
Reduction from Most Burdensome    1 hour 54 minutes.  2 hour 37 minutes.
 Estimate.
------------------------------------------------------------------------

    Using the hourly costs associated with the reporting burden as 
mentioned previously, this reduction of 1.45 hours to 1.9 hours for EPs 
and 2.62 hours for eligible hospitals and CAHs represents a per 
response savings of $133.76 to $175.28 for EPs and $166.27 for eligible 
hospitals and CAHs. The total cost reduction in cost for providers 
demonstrating meaningful use is estimated at $48,534,332 at the lowest 
and $63,359,464 at the highest. These estimates are further outlined in 
Table 9.

                                    Table 9--Reduction in Burden Cost Savings
----------------------------------------------------------------------------------------------------------------
                                          Burden reduction                      Reduction per      Total cost
           Number of responses                  hours          Hourly cost       respondent         reduction
----------------------------------------------------------------------------------------------------------------
387,060.................................              1.45            $92.25           $133.76       $51,773,146
387,060.................................               1.9             92.25            175.28        67,843,877
4,655...................................              2.62             63.46            166.27           773,987
                                         -----------------------------------------------------------------------
    Total Least.........................  ................  ................  ................        52,547,132
                                         -----------------------------------------------------------------------
        Total Most......................  ................  ................  ................        68,617,864
----------------------------------------------------------------------------------------------------------------

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

    In this proposed rule, we estimate that the burden would be 
significantly less for qualifying MA organizations attesting to the 
meaningful use of their MA EPs, because 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 
would 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 
in 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 further note, that these 
differences also mean the total reduction in burden for MA 
organizations resulting from the proposals in this rule would be 
negligible. We estimate that, on average, it would 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 would not likely be the eligible professional, but non-
clinical staff. We believe that the individual gathering the 
information could be equivalent to a GS 11, step 1 (2015 unadjusted for 
locality rate), 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 (2015 
unadjusted for locality rate), or approximately $50.00/hour. Therefore, 
for the estimated 13,635 potentially qualifying MA EPs with assumed 100 
percent successfully demonstrating meaningful use, we believe it would 
cost the participating qualifying MA organizations approximately 
$426,050 annually to collect the required information and make the 
attestations ([10,226 hours x $25.00]+[3,408 hours x $50.00]).

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

    In this proposed rule, we are proposing no changes to State 
Medicaid Agency reporting which affect 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; or the enrollment or reenrollment of 
providers, or for the collection and submission of the data for 
providers to demonstrate

[[Page 20386]]

that they have adopted, implemented, or upgraded certified EHR 
technology. We believe the burden associated with these requirements 
has already been accounted for in our discussion in the Stage 1 and 
Stage 2 final rules at (75 FR 44516 through 44544 and 77 FR 54125 
through 54135). For the collection and submission of the data for 
providers to demonstrate 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.  495.20 through Sec.  495.60.

                                             Table 10--Estimated Annual Reporting Burden for Meaningful Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Burden per                     Hourly labor
           Regulation section               OMB Control      Number of       Number of       response      Total annual       cost of     Total cost ($)
                                                No.         respondents      responses        (hours)     burden (hours)   reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   495.22--Objectives/Measures/CQMs        0938-1158         387,060         387,060            8.32       3,220,339          $92.25    $297,076,291
 (EPs)..................................
Sec.   495.22--Objectives/Measures/CQMs        0938-1158           4,655           4,655            8.3           38,637           63.46       2,451,872
 (hospitals/CAHs).......................
Sec.   495.210--Gather Attestation             0938-1158          13,635          13,635            0.75          10,226           25.00         255,656
 Information (MA EPs and EHs)...........
Sec.   495.210--Attest (MA EPs and EHs).       0938-1158          13,635          13,635            0.25           3,409           50.00         170,438
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ..............         418,985         418,985  ..............       3,272,611  ..............     299,954,257
--------------------------------------------------------------------------------------------------------------------------------------------------------
* To avoid double counting, this number of respondents is only included once in the total.
** There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
  associated column from Table 10.

    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-3311-P] Fax: (202) 395-6974; or Email: 
OIRA_submission@omb.eop.gov.

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 proposed 
rule, 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 demonstrating meaningful use for an EHR 
reporting period in 2015 through 2017.

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).
    In relation to the existing program requirements outlined in the 
Stage 2 final rule (77 FR 53967 through 54162), we do not expect this 
rule to result in more incentives paid or in more providers failing 
meaningful use and being assessed a payment adjustment. This is due to 
the nature of the modifications being proposed in this rule, which, 
while they reduce the reporting burden on providers, do not affect the 
clinical processes and IT functions required to successfully meet the 
objectives and measures of meaningful use. The proposals in this rule 
do not fundamentally change the technology required to support 
participation in the meaningful use program. Under the current program, 
the requirement to report data on the measures and objectives which 
have been identified as now redundant to other more advanced measures 
being retained, or are duplicative of other measures using the same 
certified EHR technology function, is essentially requiring providers 
to report on the same action or process twice. Therefore, it is not the 
occurrence of the action or process which is reduced by the proposals 
in this rule, but the burden associated with the duplicative and 
redundant reporting. In addition, the objectives and measures which are 
considered topped out have reached high performance and the statistical 
evidence demonstrates that the expected result of any provider 
attesting to meaningful use would be a score near the maximum. However, 
the analysis of these measures and their identification as topped out 
also takes into account the statistical likelihood that the functions 
of measures and the processes behind them would continue even without a 
requirement to report the results. Therefore, while the proposals 
result in a reduction in reporting requirements, this does not 
correlate to a change in the overall achievement of the measures and 
objective as compared to the current program. Finally, when compared 
against historical data, the shortened reporting period in 2015, which 
has been proposed to accommodate the implementation of the policies of 
this rule, is expected to have a minimal impact on successful 
demonstration of meaningful use. This expectation of minimal impact is 
based on a number of factors:
     The shortened period is for 2015 only and not for 2016 or 
2017.
     Historical data on attestations shows no strong 
correlation between a shorter reporting period and the ability of 
providers to attest to a second year of

[[Page 20387]]

meaningful use, no correlation for providers returning to attest to a 
third or fourth year of meaningful use, and providers who would 
otherwise be in their first year of meaningful use would already have a 
90-day reporting period.\5\
---------------------------------------------------------------------------

    \5\ CMS Data and Reports: Quarterly Public Use Files for 
participation, Monthly Reports for performance rates: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

     Performance data shows statistically negligible disparity 
among providers attesting for a 90-day reporting period and those 
attesting for a full year reporting period on the measures which have 
been identified as redundant, duplicative, and topped out.\6\
---------------------------------------------------------------------------

    \6\ CMS Data and Reports: Quarterly Public Use Files for 
participation, Monthly Reports for performance rates: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

    For these reasons, we do not believe the proposals in this rule 
would impact the overall estimates for incentive payments, payment 
adjustments, and the net transfer costs associated with the program. 
However, these proposals do affect the costs associated with the 
reporting burden on providers. The impacts directly attributable with 
the proposals in this rule relate to both an hourly reduction per 
response an overall reduction in the cost associated with reporting for 
providers demonstrating meaningful use. The burden analysis in this 
proposed rule, as compared to the Stage 2 estimates, reduces the 
reporting burden for attestation for providers by approximately 1.45 
hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals and 
CAHs per respondent. This burden estimate and analysis of the impact of 
the policies result in a total cost reduction estimated at $48,534,332 
at the lowest and $63,359,464 at the highest. However, we believe this 
proposed rule will have additional impacts--most notably, cost savings 
for hospitals and providers that would have additional time to achieve 
meaningful use--which cannot be adequately estimated because of the 
wide variation among provider types, and therefore a designation as an 
economically significant rule under the Executive Order and a major 
rule under the Congressional Review Act is still applicable. The burden 
estimate and analysis of the impact of the policies proposed in this 
proposed rule are outlined further in section III. of this proposed 
rule.
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 rule 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 (RFA).
    Data available suggests that more providers have adopted EHR 
technology since the publication of the Stage 1 final rule. An ONC data 
brief (No. 16, May 2014) noted that hospital adoption of EHR systems 
has increased 5 fold since 2008. Nine in ten acute care hospitals 
possessed CEHRT in 2013, increasing 29 percent since 2011. As of 
January 1, 2015, more than 95 percent of eligible hospitals had 
successfully demonstrated meaningful use. In January 2014, a Centers 
for Disease Control and Prevention (CDC) data brief entitled, ``Use and 
Characteristics of Electronic Health Record Systems Among Office-based 
Physician Practices: United States, 2001 through 2013 found that 78 
percent of office-based used any type of EHR systems, up from 18 
percent in 2001. The majority of EPs have already purchased certified 
EHR technology, implemented this new technology, and trained their 
staff on its use with over 60 percent earning an incentive payment for 
participation in the program prior to 2015.
    The cost reductions provided by the proposals in this rule offer a 
benefit to these providers. Furthermore, we believe that the 
combination of payment incentives and long-term overall gains in 
efficiency may compensate for some of the initial expenditures.
(1) Small Entities
    We estimate that EPs would spend approximately $54,000 to purchase 
and implement a certified EHR and $10,000 annually for ongoing 
maintenance according to the Congressional Budget Office (CBO) (75 FR 
44546).
    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. Annual operating and maintenance amount was estimated at 12 
to 20 percent of initial costs (that is, $3,000 to $9,000) per 
physician. For all eligible hospitals, the range is from $1 million to 
$100 million. Though reports vary widely, we anticipate that the 
average will be $5 million for eligible hospitals to achieve meaningful 
use. We estimate $1 million for maintenance, upgrades, and training 
each year per eligible hospital. However, as stated earlier many 
providers have already purchased systems with expenditures focused on 
maintenance and upgrades. We believe that future retrospective studies 
on the costs to implement and EHR and the return on investment (ROI) 
would demonstrate the actual costs incurred by providers participating 
in the EHR Incentive Programs. The potential costs savings in this 
proposed rule would benefit these providers as a reduction in the 
overall cost of program participation.
(2) Conclusion
    As discussed later in this analysis, we believe that there are many 
positive effects of adopting EHR on health care providers. Furthermore, 
we believe that the proposals in this rule will result in an overall 
reduction in the reporting burden for providers of all types. 
Accordingly, we believe that the object of the RFA to minimize burden 
on small entities is met by this proposed rule.
b. Small Rural Hospitals
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis (RIA) if a rule will have a significant impact on the 
operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions

[[Page 20388]]

of section 603 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. There 
is no identifiable disparity among this group and the overall success 
rates for eligible hospitals and CAHs in demonstrating meaningful use; 
furthermore, 95 percent of eligible hospitals and CAHs have 
successfully demonstrated meaningful use as of January 1, 2015. 
Finally, on the whole we anticipate an estimated reduction in the 
reporting burden on eligible hospitals as a group to be less than $1 
million. Therefore, we do not believe that this proposed rule would 
have a significant impact on a substantial number of small entities.
c. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates will require spending in any 1 year 
$100 million in 1995 dollars, updated annually for inflation. In 2015, 
that threshold is approximately $144 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 proposed 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 would be required to invest in systems and 
technology to comply. States would have to identify and educate 
providers, evaluate their attestations and pay the incentive. However, 
the federal government would fund 90 percent of the state's related 
administrative costs, providing controls on the total state outlay. In 
addition, the changes being made by this proposed rule have very little 
impact on any state functions.
d. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on state and local governments, 
preempts state law, or otherwise has Federalism implications. This 
proposed rule would not have a substantial direct effect on state or 
local governments, preempt state law, or otherwise have a Federalism 
implication.
2. Effects on EPs, Eligible Hospitals, and CAHs
a. Background and Assumptions
    There are no new costs associated with this proposed rule. 
Furthermore, the estimates for the provisions affecting Medicare and 
Medicaid EPs, eligible hospitals, and CAHs are somewhat uncertain for 
the following reasons:
     The program is voluntary although payment adjustments will 
be imposed on Medicare providers if they are unable to demonstrate 
meaningful use for the applicable reporting period.
     The potential reduction in burden for EPs rely on relate 
to assumptions of what options for meaningful use they would otherwise 
attest to should the policies in this proposed rule not be adopted.
     The net costs and savings for any individual provider may 
not directly correlate to the total for the organization as larger 
organizations may employ economies of scale in meaningful use 
attestations.
    However, based on the actual count of providers eligible for the 
program as of December 31, 2014 which were identified through the 
process of implementing payment adjustments for 2015, we estimated the 
numbers of EPs and eligible hospitals, including CAHs under Medicare, 
Medicaid, and MA for 2015 through 2017 and used the updated estimates 
throughout the analysis. These total potential eligible providers are 
as follows:
     About 660,000 Medicare FFS EPs (some of whom will also be 
Medicaid EPs). About 595,100 non-hospital based Medicare EPs.
     About 58,300 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physicians assistants).
     4,900 eligible hospitals comprising the following:
    ++ 3,397 acute care hospitals.
    ++ 1,395 CAHs.
    ++ 97 children's hospitals (Medicaid only).
    ++ 11 cancer hospitals (Medicaid only).
     16 MA organizations and 13,635 MA EPs
b. Industry Costs and Adoption Rates
    In this proposed rule, we are proposing no new policies which would 
require changes to the development, certification, and implementation 
of certified EHR technology as compared to the policies in the existing 
program outlined in the Stage 2 final rule (77 FR 54136 through 54146).
3. Medicare Incentive Program Costs
    As noted at the beginning of this analysis, it is difficult to 
predict the actual impacts of the policies in this proposed rule with 
certainty. We believe the assumptions and methods described herein are 
reasonable for estimating the financial impact of the provisions on 
providers participating in the Medicare and Medicaid programs, but 
acknowledge the wide range of possible outcomes.
a. Medicare Eligible Professionals (EPs)
    In brief, the estimates of Medicare EP burden reduction are based 
on current participation as of January 1, 2015. We estimate that 
significant cost reductions for Medicare EPs participating in the EHR 
Incentive Program will result from the policies in this proposed rule 
when compared to the requirements of the current program. Our estimates 
of the reduction in burden cost savings are presented in Table 12. They 
reflect our assumptions about the proportion of EPs who will 
demonstrate meaningful use of certified EHR technology outlined in 
Table 11 based on historical data.

                 Table 11--Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
                                                                              Calendar year
                                                        --------------------------------------------------------
                                                                2015               2016               2017
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare (in                       660.0              667.8              675.5
 thousands)............................................
Nonhospital-based Medicare EPs (in thousands)..........              595.1              602.1              609.1
Percent of EPs who are Meaningful Users................               60                 65                 70

[[Page 20389]]

 
Meaningful Users (in thousands)........................              357.1              391.4              426.4
----------------------------------------------------------------------------------------------------------------

                               Table 12--Estimated Cost Reduction for Medicare EPs
----------------------------------------------------------------------------------------------------------------
                                                                              Calendar year
                                                        --------------------------------------------------------
                                                                2015               2016               2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users (in thousands)........................             357.1              391.4              426.4
Lowest Estimated Cost Savings..........................     $47,760,345.60     $52,353,664.00     $57,035,264.00
Highest Estimated Cost Savings.........................     $62,585,476.80     $68,604,592.00     $74,739,392.00
----------------------------------------------------------------------------------------------------------------

b. Medicare Eligible Hospitals and CAHs
    In brief, the estimates of hospital burden reduction are based on 
current participation as of January 1, 2015. We estimate that 
significant cost reductions for Medicare eligible hospitals and CAHs 
participating in the EHR Incentive Program would result from the 
policies in this proposed rule when compared to the requirements of the 
current program. Our estimates of the reduction in burden cost savings 
are presented in Table 12. They reflect our assumptions about the 
proportion of eligible hospitals and CAHs that will demonstrate 
meaningful use of certified EHR technology outlined in Table 13 based 
on historical data.

     Table 13--Medicare Eligible Hospitals and CAHs Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................             3,397             3,397             3,397
CAHs......................................................             1,395             1,395             1,395
Percent Demonstrating Meaningful Use......................                95                97                99
Meaningful Users..........................................             4,552             4,648             4,744
----------------------------------------------------------------------------------------------------------------

                   Table 14--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
                                                                              Calendar year
                                                        --------------------------------------------------------
                                                                2015               2016               2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users.......................................           4,552              4,648              4,744
Estimated Cost Savings.................................        $756,861.04        $772,822.96        $788,784.88
----------------------------------------------------------------------------------------------------------------

4. Medicaid Only EPs
    We estimate that significant cost reductions for Medicaid only EPs 
participating in the EHR Incentive Program will result from the 
policies in this proposed rule when compared to the requirements of the 
current program. Our estimates of the reduction in burden cost savings 
are presented in Table 16. They reflect our assumptions about the 
proportion of Medicaid only EPs who will demonstrate meaningful use of 
certified EHR technology outlined in Table 15 based on historical data.

                            Table 15--Medicaid Only EPs Demonstrating Meaningful Use
----------------------------------------------------------------------------------------------------------------
                                                                              Calendar year
                                                        --------------------------------------------------------
                                                                2015               2016               2017
----------------------------------------------------------------------------------------------------------------
Medicaid only EPs......................................              58.3               59.4               60.6
Percent of EPs who are Meaningful Users................              51                 53                 55
Meaningful Users (in thousands)........................              30                 31.48              33.33
----------------------------------------------------------------------------------------------------------------

[[Page 20390]]

                            Table 16--Estimated Cost Reduction for Medicaid Only EPs
----------------------------------------------------------------------------------------------------------------
                                                                              Calendar year
                                                        --------------------------------------------------------
                                                                2015               2016               2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users (in thousands)........................          30,000             31,480             33,330
Lowest Estimated Cost Savings..........................      $4,012,800.00      $4,210,764.80      $4,458,220.80
Highest Estimated Cost Savings.........................      $5,258,400.00      $5,517,814.40      $5,842,082.40
----------------------------------------------------------------------------------------------------------------

    It should be noted that since the Medicaid EHR Incentive 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 only those Medicaid 
providers who are expected to demonstrate meaningful use. Providers who 
are dual-eligible have been included in the Medicare EP program 
estimates based on the total current volume of Medicare EPs who have 
demonstrated meaningful use in either Medicare or Medicaid as of 
January 1, 2015.
b. Medicaid Only Hospitals
    The burden reduction for Medicaid only eligible hospitals assumes a 
similar participation rate for the demonstration of meaningful use as 
is applicable for Medicare eligible hospitals. We estimate that 
significant cost reductions for Medicaid only eligible hospitals 
participating in the EHR Incentive Program will result from the 
policies in this proposed rule when compared to the requirements of the 
current program. Our estimates of the reduction in burden cost savings 
are presented in Table 18. They reflect our assumptions about the 
proportion of Medicaid only eligible hospitals that will demonstrate 
meaningful use of certified EHR technology outlined in Table 17 based 
on historical data.

       Table 17--Medicaid Only Eligible Hospitals Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................               108               108               108
Percent Demonstrating Meaningful Use......................                95                97                99
Meaningful Users..........................................               103               105               107
----------------------------------------------------------------------------------------------------------------

                   Table 18--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users..........................................             4,552             4,648             4,744
Estimated Cost Savings....................................        $17,125.81        $17,458.35        $17,790.89
----------------------------------------------------------------------------------------------------------------

5. 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. A subsequent 2013 study completed by the RAND Corporation for ONC 
(Shekelle at al. 2013 ``Health Information Technology: An Updated 
Systemic Review with a Focus on Meaningful Use Functionalities) found 
77 percent of articles published between January 2010 to August 2013 
that evaluated the effects of health IT on healthcare quality, safety, 
and efficiency reported findings that were at least partially positive. 
The Centers for Disease Control and Prevention publication in January 
2014, (Hsiao et al, ``Use and Characteristics of Electronic Health 
Record Systems Among Office-based Physician Practices: United States, 
2001-2013) concluded that the adoption of basic EHR systems by office-
based physicians increased 21 percent between 2012 and 2013, varying 
widely across the states ranging from 21 percent in New Jersey to 83 
percent in North Dakota. 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-1.) Another

[[Page 20391]]

study compared the productivity of 75 providers within a large urban 
primary care practice over a 4-year period showed increases in 
productivity of 1.7 percent per month per provider after EHR adoption 
(DeLeon et al. 2010, ``The business end of health information 
technology''). Some vendors have estimated that EHRs could result in 
cost savings of between $100 and $200 per patient per year. The 
proposals in this rule focus on a long term goal of moving providers 
along a continuum from data capture to advanced use of certified EHR 
technology. The reduction of reporting burden recognizes progress 
toward key milestones and is intended to allow providers to refocus on 
leveraging health IT to support health information exchange, patient 
engagement, and quality improvement. As participation and adoption 
increases, there will be more opportunities to capture and report on 
cost savings and benefits.
6. Benefits to Society
    According to the CBO study ``Evidence on the Costs and Benefits of 
Health Information Technology'' (http://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf) when used effectively, EHRs can enable 
providers to deliver health care more efficiently. For example, the 
study states that EHRs can reduce the duplication of diagnostic tests, 
prompt providers to prescribe cost-effective generic medications, 
remind patients about preventive care, reduce unnecessary office 
visits, and assist in managing complex care. This is consistent with 
the findings in the ONC study cited previously. Further, the CBO report 
claims that there is a potential to gain both internal and external 
savings from widespread adoption of health IT, noting that internal 
savings will likely be in the reductions in the cost of providing care, 
and that external savings could accrue to the health insurance plan or 
even the patient, such as the ability to exchange information more 
efficiently. However, it is important to note that the CBO identifies 
the highest gains accruing to large provider systems and groups and 
claims that office-based physicians may not realize similar benefits 
from purchasing health IT products. At this time, there is limited data 
regarding the efficacy of health IT for smaller practices and groups, 
and the CBO report notes that this is a potential area of research and 
analysis that remains unexamined. The benefits resulting specifically 
from this proposed regulation are even harder to quantify because they 
represent, in many cases, the reduction in the time spent per each 
individual respondent to attest to the meaningful use objectives and 
measures. While this time may represent a reduced burden and the 
opportunity to reallocate recourses, there is no viable way to estimate 
that benefit over a wide range of provider types, practice sizes and 
other potential variables. For example, the reduction of about 2 hours 
per respondent for a small practice might be insignificant; however, 
for a practice of 1,000 providers it may represent as many as 2,000 man 
hours which could be reallocated to making other improvements in 
clinical processes and patient outcomes. Conversely, a large practice 
may instead leverage the batch reporting option and only see an overall 
reduction of 20 man hours as an organization while a small practice may 
find an even greater reduction than the estimate which may amount to a 
significantly increased benefit and more time for the provider to spend 
in patient care.
    In the Stage 2 final rule, we discussed research 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). The 2013 ONC report cited 
previously reported findings from their literature review on health IT 
and safety of care, health IT and quality of care,, and health It and 
efficiency of care in ambulatory and non-ambulatory care settings. The 
report indicated that a majority of studies that evaluated the effects 
of health IT on healthcare quality, safety, and efficiency reported 
findings that were at least partially positive. The report concluded 
that their findings ``suggested that health IT, particularly those 
functionalities included in the Meaningful Use . . . , can improve 
healthcare quality and safety.''

C. 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. This rule is considered economically 
significant as mentioned previously because the impacts directly 
attributable with the proposals in this rule would result in an overall 
reduction in the reporting burden and associated costs for providers 
demonstrating meaningful use. Monetary annualized benefits and 
nonbudgetary costs are presented as discounted flows using 3 percent 
and 7 percent factors.

 Table 19--Accounting Statement: Classification of Estimated Cost Reductions and Benefits CYs 2015 Through 2017
                                                  [In millions]
----------------------------------------------------------------------------------------------------------------
                                                                   Benefits
          Category           -----------------------------------------------------------------------------------
                                               Low estimate    High estimate
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Cost               2015            52.8            68.9              7%  CY 2015
 Reductions to Private        ..............            52.8            68.9              3%
 Industry Associated with
 Reporting Requirements.

[[Page 20392]]

 
Qualitative--Other private
 industry and societal
 benefits associated with
 the reduction in provider
 reporting burden and with
 having additional time to
 achieve meaningful use.
----------------------------------------------------------------------------------------------------------------

    In this proposed rule, there is no estimated increase in costs 
associated with incentive payments or payment adjustments for the 
Medicare and Medicaid EHR Programs attributable to the proposed 
policies.

D. Conclusion

    The previous analysis, together with the remainder of this 
preamble, provides an RIA. We invite public comments on the analysis 
and request any additional data that will help us determine more 
accurately the impact on the EPs and eligible hospitals affected by the 
proposed rule and on Medicare and Medicaid payments to these entities.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget reviewed this rule.

List of Subjects in 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 further amend 42 CFR part 495, as 
previously proposed to be amended on March 30, 2015 (80 FR 16732), as 
follows:

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

0
1. 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).

0
2. Section 495.4 is amended as follows:
0
A. Amend the definition of ``EHR reporting period'' by:
0
i. In paragraph (1)(i) introductory text removing the phrase ``before 
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
ii. Redesignating paragraph (1)(ii) as paragraph (1)(iii).
0
iii. Adding a new paragraph (1)(ii).
0
iv. In paragraph (2)(i) introductory text removing the phrase ``before 
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
v. Redesignating paragraph (2)(ii) as paragraph (2)(iii).
0
vi. Adding a new paragraph (2)(ii).
0
B. Amend the definition of ``EHR reporting period for a payment 
adjustment year'' by:
0
i. In paragraph (1)(i) introductory text removing the phrase ``before 
CY 2017'' and adding in its place the phrase ``before 2015''.
0
ii. Redesignating paragraph (1)(ii) as paragraph (1)(iii).
0
iii. Adding a new paragraph (1)(ii).
0
iv. In paragraph (2)(i) introductory text removing the phrase ``before 
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
v. Redesignating paragraph (2)(ii) as paragraph (2)(iii).
0
vi. Adding a new paragraph (2)(ii).
0
vii. In paragraph (3)(i) introductory text removing the phrase ``before 
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
viii. Redesignating paragraph (3)(ii) as paragraph (3)(iii).
0
ix. Adding a new paragraph (3)(ii).
0
C. Amend the definition of ``Meaningful EHR user'' by:
0
i. In paragraph (1), by removing the reference ``Sec.  495.8'' and 
adding in its place the reference ``Sec. Sec.  495.40''.
0
ii. In paragraph (1), by removing the reference ``Sec.  495.6 or 
495.7'' and adding in its place the reference ``Sec. Sec.  495.20, 
495.22, and 495.24''.
    The additions read as follows:

Sec.  495.4  Definitions.

* * * * *
    EHR reporting period. * * *
    (1) * * *
    (ii) The following are applicable for 2015 and 2016:
    (A) For the CY 2015 payment year, any continuous 90-day period 
within CY 2015.
    (B) For the CY 2016 payment year:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2016.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, the CY 2016.
* * * * *
    (2) * * *
    (ii) The following are applicable for 2015 and 2016:
    (A) For the FY 2015 payment year, any continuous 90-day period 
within the period beginning October 1, 2014 and ending December 31, 
2015.
    (B) For the FY 2016 payment year for the eligible hospital or CAH--
    (1) First demonstrating it is a meaningful EHR user, any continuous 
90-day period within CY 2016; or
    (2) That has successfully demonstrated it is a meaningful EHR user 
in any prior year, the CY 2016.
* * * * *
    EHR reporting period for a payment adjustment year * * *
    (1) * * *
    (ii) The following are applicable for 2015 and 2016:
    (A) For an EHR reporting period in 2015:
    (1) Except as specified under paragraph (1)(ii)(A)(2) of this 
definition, any continuous 90-day period within the calendar year that 
is 2 years before the payment adjustment year.
    (2) 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 within the calendar year that is 1 year before 
the payment adjustment year. The EP must successfully register for and 
attest to meaningful use by February 29, 2016.
    (B) For an EHR reporting period in 2016:
    (1) Except as specified in paragraphs (1)(ii)(B)(2) and (3) of this 
definition, the calendar year that is 2 years before the payment 
adjustment year.
    (2) 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

[[Page 20393]]

before the payment adjustment year, then any continuous 90-day period 
within such (2 years prior) calendar year.
    (3) 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. The EP must successfully register for and 
attest to meaningful use by October 1, 2016.
* * * * *
    (2) * * *
    (ii) The following are applicable for 2015 and 2016:
    (A) For an EHR reporting period in 2015:
    (1) Except as specified in paragraph (2)(ii)(A)(2) of this 
definition, any continuous 90-day period within the period beginning on 
October 1, 2014 and ending on the last day of the calendar year that is 
2 years before the payment adjustment year.
    (2) If in the calendar year that is 2 years before the payment 
adjustment year and in all prior years, the eligible hospital has not 
successfully demonstrated it is a meaningful EHR user, then any 
continuous 90-day period within the period beginning on October 1, 2014 
and ending on the last day of the calendar year that is 1 year prior to 
the payment adjustment year. The eligible hospital must successfully 
register for and attest to meaningful use by February 29, 2016.
    (B) For an EHR reporting period in 2016:
    (1) Except as specified in paragraphs (2)(ii)(B)(2) and (3) of this 
definition, the calendar year that is 2 years before the payment 
adjustment year.
    (2) If an eligible hospital is demonstrating that it 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.
    (3) If in the calendar year that is 2 years before the payment 
adjustment year and in all prior 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 calendar year that is 
1 year before the payment adjustment year and ends at least 3 months 
before the end of such prior calendar year. The eligible hospital must 
successfully register for and attest to meaningful use by October 1, 
2016.
* * * * *
    (3) * * *
    (ii) The following are applicable for 2015 and 2016:
    (A) The EHR reporting period for the FY 2015 payment adjustment 
year is any continuous 90-day period within the period beginning on 
October 1, 2014 and ending on December 31, 2015. The CAH must 
successfully register for and attest to meaningful use by February 29, 
2016.
    (B) For an EHR reporting period in 2016:
    (1) Except as provided in paragraph (3)(ii)(B)(2) of this 
definition, the CY 2016 is the EHR reporting period for the FY 2016 
payment adjustment year.
    (2) If the CAH is demonstrating it is a meaningful EHR user for the 
first time, the EHR reporting period for the FY 2016 payment adjustment 
year is any continuous 90-day period within CY 2016.
* * * * *

Sec.  495.6  [Redesignated as Sec.  495.20]

0
3. Redesignate Sec.  495.6 as Sec.  495.20.
0
4. Newly redesignated Sec.  495.20 is amended by revising the section 
heading and adding new introductory text to read as follows.

Sec.  495.20  Meaningful use objectives and measures for EPs, eligible 
hospitals, and CAHs before 2015.

    The following criteria are applicable before 2015:
* * * * *
0
5. Add Sec.  495.22 to read as follows:

Sec.  495.22  Meaningful use objectives and measures for EPs, eligible 
hospitals, and CAHs for 2015 through 2017.

    (a) General rules. (1) The criteria specified in this section are 
applicable for all EPs, eligible hospitals, and CAHs for 2015 through 
2017.
    (2) For 2017 only, EPs, eligible hospitals, and CAHs have the 
option to use the criteria specified for 2018 (as outlined at Sec.  
495.24) instead of the criteria specified in this section.
    (b) Criteria for EPs for 2015 through 2017--(1) General rule 
regarding criteria for meaningful use for 2015 through 2017 for EPs. 
Except as specified in paragraph (b)(2) of this section, EPs must meet 
all objectives and associated measures of the meaningful use criteria 
specified under paragraph (e) of this section to meet the definition of 
a meaningful EHR user.
    (2) Exclusion for nonapplicable objectives. (i) An EP may exclude a 
particular objective contained in paragraph (e) of this section, if the 
EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (e) 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) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (c) Criteria for eligible hospitals and CAHs for 2015 through 
2017--(1) General rule regarding criteria for meaningful use for 2015 
through 2017 for eligible hospitals and CAHs. Except as specified in 
paragraph (c)(2) of this section, eligible hospitals and CAHs must meet 
all objectives and associated measures of the meaningful use criteria 
specified under paragraph (e) of this section to meet the definition of 
a meaningful EHR user.
    (2) Exclusion for nonapplicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective contained in 
paragraph (e) of this section, if the eligible hospital or CAH meets 
all of the following requirements:
    (A) Must ensure that the objective in paragraph (e) of this section 
includes an option for the eligible hospital or CAH to attest that the 
objective is not applicable.
    (B) Meets the criteria in the applicable objective that would 
permit the attestation.
    (C) Attests.
    (ii) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (d) Many of the objectives and associated measures in paragraph (e) 
of this section rely on measures that count unique patients or actions. 
(1) If a measure (or associated objective) in paragraph (e) of this 
section references paragraph (d) of this section, then the measure may 
be calculated by reviewing only the actions for patients whose records 
are maintained using certified EHR technology. A patient's record is 
maintained using certified EHR technology if sufficient data was 
entered in the certified EHR technology to allow the record to be 
saved, and not rejected due to incomplete data.
    (2) If the objective and associated measure does not reference this 
paragraph (d) of this section, then the measure must be calculated by 
reviewing all patient records, not just those maintained using 
certified EHR technology.
    (e) Meaningful use objectives and measures for 2015 through 2017--
(1) Protect patient health information--(i)

[[Page 20394]]

Objective. Protect electronic protected health information created or 
maintained by the Certified EHR Technology through the implementation 
of appropriate technical capabilities.
    (ii) Measures--(A) EP measure. Conduct or review a security risk 
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), 
including addressing the security (to include encryption) of ePHI 
created or maintained in Certified EHR Technology in accordance with 
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), 
and implement security updates as necessary and correct identified 
security deficiencies as part of the EP's risk management process.
    (B) Eligible hospital or CAH measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including addressing the security (to include 
encryption) of ePHI created or maintained in Certified EHR Technology 
in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 
CFR 164.306(d)(3), and implement security updates as necessary and 
correct identified security deficiencies as part of the eligible 
hospital's or CAH's risk management process.
    (2) Clinical decision support--(i) Objective. Use clinical decision 
support to improve performance on high-priority health conditions.
    (ii) EP measures--(A) Measure. In order for EPs to meet the 
objective they must satisfy both of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures at a relevant point in 
patient care for the entire EHR reporting period. Absent four clinical 
quality measures related to an EP's scope of practice or patient 
population, the clinical decision support interventions must be related 
to high-priority health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP who writes fewer than 100 medication orders during the EHR 
reporting period may be excluded from the measure under paragraph 
(e)(2)(i)(A)(2) of this section.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015--(1) Alternate exclusion. An EP previously scheduled to 
be in Stage 1 in 2015 may meet an alternate measure specified in 
paragraph (e)(2)(ii)(C)(2) in place of the measure outlined under 
paragraph (e)(2)(ii)(A)(1) of this section.
    (2) Alternate objective and measure--(i) Alternate objective. 
Implement one clinical decision support rule relevant to specialty or 
high clinical priority along with the ability to track compliance with 
that rule.
    (ii) Alternate measure. Implement one clinical decision support 
rule.
    (iii) Eligible hospital and CAH measures--(A) Measure. In order for 
eligible hospitals and CAHs to meet the objective they must satisfy 
both of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures at a relevant point in 
patient care for the entire EHR reporting period. Absent four clinical 
quality measures related to an eligible hospital or CAH's scope of 
practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Alternate specifications for an EHR reporting period in 2015--
(1) Alternate objective and measure. An eligible hospital or CAH 
previously scheduled to be in Stage 1 in 2015 may meet an alternate 
measure described in paragraph (e)(2)(iii)(B)(2) of this section in 
place of the measure described in paragraph (e)(2)(iii)(A)(1) of this 
section.
    (i) Objective. Implement one clinical decision support rule related 
to a high priority hospital condition along with the ability to track 
compliance with that rule.
    (ii) Measure. Implement one clinical decision support rule.
    (3) Computerized provider order entry--(i) Objective. Use 
computerized provider order entry for medication, laboratory, and 
radiology orders directly entered by any licensed healthcare 
professional who can enter orders into the medical record per State, 
local, and professional guidelines.
    (ii) EP measures--(A) Measures. An EP must meet the following 3 
measures, subject to paragraph (d) of this section:
    (1) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (2) More than 30 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (3) More than 30 percent of radiology orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
(1) For the measure specified in paragraph (e)(3)(ii)(A)(1) of this 
section, any EP who writes fewer than 100 medication orders during the 
EHR reporting period.
    (2) For the measure specified in paragraph (e)(3)(ii)(A)(2) of this 
section, any EP who writes fewer than 100 laboratory orders during the 
EHR reporting period.
    (3) For the measure specified in paragraph (e)(3)(ii)(A)(3) of this 
section, any EP who writes fewer than 100 radiology orders during the 
EHR reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015--(1) An EP previously scheduled to be in Stage 1 in 2015 
may meet an alternate measure (e)(3)(ii)(C)(2) in place of the measure 
outlined under paragraph (e)(3)(ii)(A)(1) of this section, and may 
exclude the measures outlined under paragraphs (e)(3)(ii)(A)(2) and (3) 
of this section.
    (2) Subject to paragraph (d) of this section--
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list seen by the EP during the EHR 
reporting period have at least one medication order entered using CPOE; 
or
    (ii) More than 30 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (3) Alternate exclusions. An EP previously scheduled to be in Stage 
1 in 2015 may exclude the measure--
    (i) Specified in paragraph (e)(3)(ii)(A)(2) of this section for an 
EHR reporting period in 2015.
    (ii) Specified in paragraph (e)(3)(ii)(A)(3) of this section for an 
EHR reporting period in 2015.
    (iii) Eligible hospital and CAH measures--(A) An eligible hospital 
or CAH must meet the following 3 measures, subject to paragraph (d) of 
this section:
    (1) More than 60 percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (2) More than 30 percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.

[[Page 20395]]

    (3) More than 30 percent of radiology orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (B) Alternate exclusions and specifications for an EHR reporting 
period in 2015. (1) An eligible hospital or CAH previously scheduled to 
be in Stage 1 in 2015 may--
    (i) Meet an alternate measure specified in paragraph 
(e)(3)(iii)(B)(2) of this section in place of the measure outlined 
under paragraph (e)(3)(iii)(A)(1) of this section; and
    (ii) May exclude the measures outlined under paragraphs 
(e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of this section.
    (2) Alternate measure 1. Subject to paragraph (d) of this section,
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list admitted to the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) have at least 
one medication order entered using CPOE; or
    (ii) More than 30 percent of medication orders created by the 
authorized providers of the eligible hospital or CAH for patients 
admitted to their inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (3) Alternate exclusions. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified--
    (i) In paragraph (e)(3)(iii)(A)(2) of this section for an EHR 
reporting period in 2015; or
    (ii) In paragraph (e)(3)(iii)(A)(3) of this section for an EHR 
reporting period in 2015.
    (4) Electronic prescribing--(i) Objective. For EPs, generate and 
transmit permissible prescriptions electronically (eRx); and, for 
eligible hospitals and CAHs, generate and transmit permissible 
discharge prescriptions electronically (eRx).
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, more than 50 percent of all permissible prescriptions, or all 
prescriptions, written by the EP are queried for a drug formulary and 
transmitted electronically using Certified EHR Technology.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who--
    (1) Writes fewer than 100 permissible prescriptions during the EHR 
reporting period; or
    (2) Does not have a pharmacy within his or her organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his or her EHR 
reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
meet an alternate measure under paragraph (e)(4)(ii)(C)(2) of this 
section in place of the measure outlined under paragraph (e)(4)(ii)(A) 
of this section.
    (1) Alternate measure. Subject to paragraph (d) of this section, 
more than 40 percent of all permissible prescriptions written by the EP 
are transmitted electronically using Certified EHR Technology.
    (2) Alternate exclusion. There are no alternate exclusions for this 
measure
    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, more than 10 percent of hospital 
discharge medication orders for permissible prescriptions (for new, 
changed, and refilled prescriptions) are queried for a drug formulary 
and transmitted electronically using Certified EHR Technology.
    (B) Exclusion in accordance with paragraph (c)(2) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and is not located within 10 
miles of any pharmacy that accepts electronic prescriptions at the 
start of their EHR reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in--
    (1) Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015; or
    (2) Stage 2 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015 if 
they did not previously intend to select the Stage 2 Electronic 
Prescribing Menu Objective for an EHR reporting period in 2015.
    (5) Summary of care--(i) Objective. The EP, eligible hospital or 
CAH who transitions a patient to another setting of care or provider of 
care or refers a patient to another provider of care provides a summary 
care record for each transition of care or referral.
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, the EP who transitions or refers his or her patient to another 
setting of care or provider of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider 
for more than 10 percent of transitions of care and referrals.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who transfers a patient to another setting or refers a patient 
to another provider less than 100 times during the EHR reporting 
period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
exclude the measure specified in paragraph (e)(5)(ii)(A) of this 
section for an EHR reporting period in 2015.
    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, the eligible hospital or CAH that 
transitions or refers its patient to another setting of care or 
provider of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider 
for more than 10 percent of transitions of care and referrals.
    (B) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(5)(iii)(A) of this section for an EHR reporting period in 2015.
    (6) Patient specific education--(i) Objective. Use clinically 
relevant information from Certified EHR Technology to identify patient-
specific education resources and provide those resources to the 
patient.
    (ii) EP measure--(A) Measure. Patient-specific education resources 
identified by Certified EHR Technology are provided to patients for 
more than 10 percent of all unique patients with office visits seen by 
the EP during the EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
exclude the measure specified in paragraph (e)(6)(ii)(A) of this 
section for an EHR reporting period in 2015 if the EP did not 
previously intend to select the Stage 1 Patient-Specific Education 
Resources Menu Objective for an EHR reporting period in 2015.

[[Page 20396]]

    (iii) Eligible hospital and CAH measure--(A) 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.
    (B) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(6)(iii)(A) of this section for an EHR reporting period in 2015 if 
they did not previously intend to select the Stage 1 Patient-Specific 
Education Resources Menu Objective for an EHR reporting period in 2015.
    (7) Medication reconciliation--(i) Objective. The EP, 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) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, the EP performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is transitioned 
into the care of the EP.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who was not the recipient of any transitions of care during the 
EHR reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
exclude the measure specified in paragraph (e)(7)(ii)(A) of this 
section for an EHR reporting period in 2015 if they did not previously 
intend to select the Stage 1 Medication Reconciliation Menu Objective 
for an EHR reporting period in 2015.
    (iii) Eligible hospital or CAH measure. An eligible hospital or CAH 
must meet the following measure, subject to paragraph (d) of this 
section:
    (A) Measure. Subject to paragraph (d) of this section, the eligible 
hospital or CAH performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    (B) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(7)(iii)(A) of this section for an EHR reporting period in 2015 if 
they did not previously intend to select the Stage 1 Medication 
Reconciliation Menu Objective for an EHR reporting period in 2015.
    (8) Patient electronic access--(i) 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.
    (A) EP measures. An EP must meet the following 2 measures:
    (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) At least 1 patient seen by the EP during the EHR reporting 
period (or their authorized representatives) views, downloads, or 
transmits his or her health information to a third party.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
(1) Any EP who neither orders nor creates any of the information listed 
for inclusion as part of the measure in paragraph (e)(8)(ii)(A)(1) or 
(2) of this section, except for ``Patient name'' and ``Provider's name 
and office contact information,'' is excluded from both paragraphs 
(e)(8)(ii)(A)(1) and (2) of this section.
    (2) Any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the Federal Communications Commission on the 
first day of the EHR reporting period is excluded from paragraph 
(e)(8)(ii)(A)(2) of this section.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
exclude the measure specified in paragraph (e)(8)(ii)(A)(2) of this 
section for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH objective. Provide patients the 
ability to view online, download, and transmit information within 36 
hours of hospital discharge .
    (A) Eligible hospital and CAH measures. An eligible hospital or CAH 
must meet the following 2 measures:
    (1) More than 50 percent of all unique 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.
    (2) At least 1 patient(or the patient's authorized representative) 
who is discharged from the inpatient or emergency department (POS 21 or 
23) of an eligible hospital or CAH views, downloads or transmits to a 
third party his or her information during the EHR reporting period.
    (B) Exclusion applicable under (c)(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 on the first 
day of the EHR reporting period is excluded from paragraph 
(e)(8)(iii)(A)(2) of this section.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(8)(iii)(A)(2) of this section for an EHR reporting period in 2015.
    (9) Secure messaging--(i) EP objective. Use secure electronic 
messaging to communicate with patients on relevant health information.
    (ii) EP measure--(A) Measure. The capability for patients to send 
and receive a secure electronic message with the EP was fully enabled 
during the EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP may exclude from the measure if he or she--
    (1) Has no office visits during the EHR reporting period; or
    (2) 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 Federal Communications Commission on the first day 
of the EP's EHR reporting period.
    (C) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
exclude the measure specified in paragraph (e)(9)(ii)(A) of this 
section for an EHR reporting period in 2015.
    (10) Public Health and Clinical Data Registry reporting--(i) EP 
Public Health and Clinical Data Registry reporting-- (A) Objective. The 
EP is in active engagement with a public health agency or clinical data 
registry to submit electronic public health data in a meaningful way 
using certified EHR technology, except where prohibited, and in 
accordance with applicable law and practice.

[[Page 20397]]

    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(i)(A) of this section, an EP must choose from measures 1 
through 5 (as specified in paragraphs (e)(10)(i)(B)(1) through 
(e)(10)(i)(B)(5) of this section) and must successfully attest to any 
combination of two measures. These measures may be met by any 
combination, including meeting measures specified in paragraph 
(e)(10)(i)(B)(4) or (5) of this section multiple times in accordance 
with applicable law and practice.
    (1) Immunization registry reporting: The EP is in active engagement 
with a public health agency to submit immunization data and receive 
immunization forecasts and histories from the public health 
immunization registry/immunization information system (IIS).
    (2) Syndromic surveillance reporting. The EP is in active 
engagement with a public health agency to submit syndromic surveillance 
data from a non-urgent care ambulatory setting.
    (3) Case reporting. The EP is in active engagement with a public 
health agency to submit case reporting of reportable conditions.
    (4) Public health registry reporting. The EP is in active 
engagement with a public health agency to submit data to public health 
registries.
    (5) Clinical data registry reporting. The EP is in active 
engagement to submit data to a clinical data registry.
    (C) Exclusions in accordance with paragraph (b)(2) of this section. 
(1) Any EP meeting one or more of the following criteria may be 
excluded from the immunization registry reporting measure in paragraph 
(e)(10)(i)(B)(1) of this section if the EP:
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by his or her jurisdiction's immunization 
registry or immunization information system during the EHR reporting 
period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of his or 
her EHR reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the EP at the start of the EHR reporting period.
    (2) Any EP meeting one or more of the following criteria may be 
excluded from the syndromic surveillance reporting measure described in 
paragraph (e)(10)(i)(B)(2) of the section if the EP:
    (i) Does not treat or diagnose or directly treat any disease or 
condition associated with a syndromic surveillance system in his or her 
jurisdiction.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic syndromic surveillance data from EPs 
in the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs at 
the start of the EHR reporting period.
    (3) An EP meeting one or more of the following criteria may be 
excluded from the case reporting measure at (e)(10)(i)(B)(3) if the EP:
    (i) Does not treat or diagnose any reportable diseases for which 
data is collected by his or her jurisdiction's reportable disease 
system during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of his or 
her EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data at the 
start of the EHR reporting period.
    (4) Any EP meeting at least one of the following criteria may be 
excluded from the public health registry reporting measure specified in 
paragraph (e)(10)(i)(B)(4) of this section if the EP:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in his or her jurisdiction 
during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health registry 
for which the EP is eligible has declared readiness to receive 
electronic registry transactions at the start of the EHR reporting 
period.
    (5) Any EP meeting at least one of the following criteria may be 
excluded from the clinical data registry reporting measure specified in 
paragraph (e)(10)(i)(B)(5) of this section if the EP:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in his or her jurisdiction 
during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry 
for which the EP is eligible has declared readiness to receive 
electronic registry transactions at the start of the EHR reporting 
period.
    (D) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may 
choose from measures 1 through 5 (as specified in paragraphs 
(e)(10)(i)(B)(1) through (e)(10)(i)(B)(5) of this section) and must 
successfully attest to any one measure in accordance with applicable 
law and practice for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH Public Health and Clinical Data 
Registry reporting objective--(A) Objective. The eligible hospital or 
CAH is in active engagement with a public health agency or clinical 
data registry to submit electronic public health data in a meaningful 
way using certified EHR technology, except where prohibited, and in 
accordance with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(ii)(A) of this section, an eligible hospital or CAH must choose 
from measures 1 through 6 (as described in paragraphs (e)(10)(ii)(B)(1) 
through (e)(10)(ii)(B)(6) of this section) and must successfully attest 
to any combination of three measures. These measures may be met by any 
combination, including meeting the measures specified in paragraph 
(e)(10)(ii)(B)(4) or (5) of this section multiple times, in accordance 
with applicable law and practice:
    (1) Immunization registry reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit 
immunization data and receive immunization forecasts and histories from 
the public health immunization registry/immunization information system 
(IIS).
    (2) Syndromic surveillance reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit syndromic 
surveillance data from an emergency or urgent care department (POS 23).
    (3) Case reporting. The eligible hospital or CAH is in active 
engagement with a public health agency to submit case reporting of 
reportable conditions.
    (4) Public health registry reporting. The eligible hospital or CAH 
is in active engagement with a public health agency

[[Page 20398]]

to submit data to public health registries.
    (5) Clinical data registry reporting. The eligible hospital or CAH 
is in active engagement to submit data to a clinical data registry.
    (6) Electronic reportable laboratory result reporting. The eligible 
hospital or CAH is in active engagement with a public health agency to 
submit electronic reportable laboratory results.
    (C) Exclusions in accordance with paragraph (c)(2) of this section. 
(1) Any eligible hospital or CAH meeting one or more of the following 
criteria may be excluded from the immunization registry reporting 
measure specified in paragraph (e)(10)(ii)(B)(1) of this section if the 
eligible hospital or CAH:
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the eligible hospital or CAH at the start of the 
EHR reporting period.
    (2) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure specified in paragraph (e)(10)(ii)(B)(2) of this 
section if the eligible hospital or CAH:
    (i) Does not have an emergency or urgent care department.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic syndromic surveillance data from 
eligible hospitals or CAHs in the specific standards required to meet 
the CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs at the start of the EHR reporting period.
    (3) An eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the case reporting measure 
specified in paragraph (e)(10)(ii)(B)(3) of this section if the 
eligible hospital or CAH:
    (i) Does not treat or diagnose any reportable diseases for which 
data is collected by its jurisdiction's reportable disease system 
during the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data at the 
start of the EHR reporting period.
    (4) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the public health registry 
reporting measure specified in paragraph (e)(10)(ii)(B)(4) of this 
section if the eligible hospital or CAH:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in their jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period
    (iii) Operates in a jurisdiction where no public health registry 
for which the eligible hospital or CAH is eligible has declared 
readiness to receive electronic registry transactions at the start of 
the EHR reporting period.
    (5) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the clinical data registry 
reporting measure specified in paragraph (e)(10)(ii)(B)(5) of this 
section if the eligible hospital or CAH:
    (i) Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period.
    (ii) Operates in a jurisdiction where no clinical data registry for 
which no clinical data registry is capable of accepting electronic 
registry transactions in the specific standards required to meet the 
CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry 
for which the eligible hospital or CAH is eligible has declared 
readiness to receive electronic registry transactions at the beginning 
of the EHR reporting period.
    (6) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure specified in paragraph 
(d)(10)(ii)(B)(6) of this section if the eligible hospital or CAH:
    (i) Does not perform or order laboratory tests that are reportable 
in the eligible hospital's or CAH's jurisdiction during the EHR 
reporting period
    (ii) Operates in a jurisdiction for which no public health agency 
that is capable of accepting the specific ELR standards required to 
meet the CEHRT definition at the start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from eligible hospitals or CAHs at the start of the EHR reporting 
period.
    (D) Alternate exclusions and specifications for an EHR reporting 
period in 2015. An eligible hospital or CAH previously scheduled to be 
in Stage 1 in 2015 may choose from measures 1 through 6 (as specified 
in paragraphs (e)(10)(ii)(B)(1) through (e)(10)(ii)(B)(6) of this 
section) and must successfully attest to any 2 measures. These measures 
may be met by any combination, including meeting the measures specified 
in paragraph (e)(10)(ii)(B)(4) or (5) of this section multiple times, 
in accordance with applicable law and practice.

Sec.  495.7  [Redesginated as Sec.  495.24]

0
6. Redesignate Sec.  495.7 as Sec.  495.24.

Sec.  495.8  [Redesginated as Sec.  495.40]

0
7. Redesignate Sec.  495.8 as Sec.  495.40.
0
8. Newly redesignated Sec.  495.40 is amended by:
0
A. In paragraph (a) introductory text by removing the cross-reference 
``under Sec.  495.6 or Sec.  495.7'' and adding in its place the cross-
reference ``under Sec.  495.20 or Sec.  495.24''.
0
B. In paragraph (a)(1)(i)(B) by removing the cross-reference ``under 
Sec.  495.6 or Sec.  495.7'' and adding in its place the cross-
reference ``under Sec.  495.20 or Sec.  495.24''.
0
C. In paragraph (a)(1)(iii) by removing the cross-reference ``in Sec.  
495.6 or Sec.  495.7 and Sec.  495.8'' and adding in its place the 
cross-reference ``in Sec.  495.20 or Sec.  495.24 and Sec.  495.40''.
0
D. Revising paragraph (a)(2)(i)(B).
0
E. In paragraph (a)(2)(i)(D) by removing the cross-reference ``under 
Sec.  495.6(a)(4) or (h)(3)'' and adding in its place the cross-
reference ``in Sec.  495.20(a)(4) or (h)(3)''.
0
F. Redesignating paragraph (a)(2)(i)(E) as paragraph (a)(2)(i)(F).
0
G. Adding a new paragraph (a)(2)(i)(E).
0
H. Revising newly redesignated paragraph (a)(2)(i)(F).

[[Page 20399]]

0
I. Adding paragraph (a)(2)(i)(G).
0
J. In paragraph (a)(2)(iv) by removing the cross-reference ``in Sec.  
495.6 or Sec.  495.7 and Sec.  495.8'' and adding in its place the 
cross-reference ``in Sec.  495.20 or Sec.  495.24 and Sec.  495.40''.
0
K. In paragraph (b)(1)(i)(B) by removing the cross-reference ``under 
Sec.  495.6 or Sec.  495.7'' and adding in its place the cross-
reference ``under Sec.  495.20 or Sec.  495.24''.
0
L. In paragraph (b)(1)(iii) by removing the cross-reference ``in Sec.  
495.6 or Sec.  495.7 and Sec.  495.8'' and adding in its place the 
cross-reference ``in Sec.  495.20 or Sec.  495.24 and Sec.  495.40''.
0
M. Revising paragraph (b)(2)(i)(B).
0
N. In paragraph (b)(2)(i)(D) by removing the cross-reference ``under 
Sec.  495.6(b)(4) or (i)(3)'' and adding in its place the cross-
reference ``in Sec.  495.20(b)(4) or (h)(3)''.
0
O. Redesignating paragraph (b)(2)(i)(E) as paragraph (b)(2)(i)(F).
0
P. Adding a new paragraph (b)(2)(i)(E).
0
Q. Revising newly redesignated paragraph (b)(2)(i)(F).
0
R. Adding paragraph (b)(2)(i)(G).
    The revisions and additions read as follows:

Sec.  495.40  Demonstration of meaningful use criteria.

    (a) * * *
    (2) * * *
    (i) * * *
    (B) For calendar years before 2015, satisfied the required 
objectives and associated measures under Sec.  495.20 for the EP's 
stage of meaningful use.
* * * * *
    (E) For CYs 2015 through 2017, satisfied the required objectives 
and associated measures under Sec.  495.22(e) for meaningful use.
    (F) For CY 2017 only, an EP may satisfy either of the following 
objectives and measures for meaningful use:
    (1) Objectives and measures specified in Sec.  495.22(e).
    (2) Objectives and measures specified in Sec.  495.24(d)
    (G) For CY 2018 and subsequent years, satisfied the required 
objectives and associated measures under Sec.  495.24(d) for meaningful 
use.
* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (B) For fiscal years before 2015, satisfied the required objectives 
and associated measures under Sec.  495.20 for the eligible hospital or 
CAH's stage of meaningful use.
* * * * *
    (E) For CYs 2015 through 2017, satisfied the required objectives 
and associated measures under Sec.  495.22(e) for meaningful use.
    (F) For CY 2017 only, an eligible hospital or CAH may satisfy 
either of the following objectives and measures for meaningful use:
    (1) Objectives and measures specified at Sec.  495.22(e); or
    (2) Objectives and measures specified at Sec.  495.24(d).
    (G) For CY 2018 and subsequent years, satisfied the required 
objectives and associated measures under Sec.  495.24(h) for meaningful 
use.
* * * * *

Sec.  495.10  [Redesginated as Sec.  495.60]

0
9. Redesignate Sec.  495.10 as Sec.  495.60.

    Dated: April 2, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: April 8, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-08514 Filed 4-10-15; 4:15 pm]
 BILLING CODE 4120-01-P
```