[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Proposed Rules]
[Pages 16731-16804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06685]



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Vol. 80

Monday,

No. 60

March 30, 2015

Part II





Department of Health and Human Services





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Centers for Medicare and Medicaid Services





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42 CFR Part 495





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Office of the Secretary





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45 CFR Part 170





Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program--Stage 3; 2015 Edition Health Information Technology (Health 
IT) Certification Criteria, 2015 Edition Base Electronic Health Record 
(EHR) Definition, and ONC Health IT Certification Program 
Modifications; Proposed Rules

Federal Register / Vol. 80 , No. 60 / Monday, March 30, 2015 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 495

[CMS-3310-P]
RIN 0938-AS26


Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Stage 3

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

ACTION: Proposed rule.

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SUMMARY: This Stage 3 proposed rule would specify the meaningful use 
criteria that eligible professionals (EPs), eligible hospitals, and 
critical access hospitals (CAHs) must meet in order to qualify for 
Medicare and Medicaid electronic health record (EHR) incentive payments 
and avoid downward payment adjustments under Medicare for Stage 3 of 
the EHR Incentive Programs. It would continue to encourage electronic 
submission of clinical quality measure (CQM) data for all providers 
where feasible in 2017, propose to require the electronic submission of 
CQMs where feasible in 2018, and establish requirements to transition 
the program to a single stage for meaningful use. Finally, this Stage 3 
proposed rule would also change the EHR reporting period so that all 
providers would report under a full calendar year timeline with a 
limited exception under the Medicaid EHR Incentive Program for 
providers demonstrating meaningful use for the first time. These 
changes together support our broader efforts to increase simplicity and 
flexibility in the program while driving interoperability and a focus 
on patient outcomes in the meaningful use program.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on May 29, 2015.

ADDRESSES: In commenting, please refer to file code CMS-3310-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-3310-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-3310-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
Ed Howard (CMS), (410) 786-6368, Medicare Advantage
Deborah Krauss (CMS), (410) 786-5264, clinical quality measures
Alesia Hovatter (CMS), (410) 786-6861, clinical quality measures
Elise Sweeney Anthony (ONC), (202) 475-2485, certification definition

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

API Application-Program Interface
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
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

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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
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 specify the policies that would be 
applicable for Stage 3 of the Medicare and Medicaid EHR Incentive 
Programs. Under Stage 3, we are proposing a set of requirements that 
EPs, eligible hospitals, and CAHs must achieve in order to meet 
meaningful use, qualify for incentive payments under the Medicare and 
Medicaid EHR Incentive Programs, and avoid downward payment adjustments 
under Medicare. These Stage 3 requirements focus on the advanced use of 
certified EHR technology (CEHRT) to promote health information exchange 
and improved outcomes for patients.
    Stage 3 of meaningful use is expected to be the final stage and 
would incorporate portions of the prior stages into its requirements. 
In addition, following a proposed optional year in 2017, beginning in 
2018 all providers would report on the same definition of meaningful 
use at the Stage 3 level regardless of their prior participation, 
moving all participants in the EHR Incentive Programs to a single stage 
of meaningful use in 2018. The incorporation of the requirements into 
one stage for all providers is intended to respond to stakeholder input 
regarding the complexity of the program, the success of certain 
measures which are part of the meaningful use program to date, and the 
need to set a long-term, sustainable foundation based on a consolidated 
set of key advanced use objectives for the Medicare and Medicaid EHR 
Incentive Programs.
    In addition, we propose changes to the EHR reporting period, 
timelines, and structure of the Medicare and Medicaid EHR Incentive 
Programs. We believe these changes would provide a flexible, clear 
framework to reduce provider burden, streamline reporting, and ensure 
future sustainability of the Medicare and Medicaid EHR Incentive 
Programs. These changes together lay a foundation for our broader 
efforts to support interoperability and quality initiatives focused on 
improving patient outcomes.
b. Legal Authority for the Regulatory Action
    The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5) amended Titles XVIII and XIX of the Social Security Act (the 
Act) to authorize incentive payments to EPs, eligible hospitals, and 
CAHs, and Medicare Advantage (MA) organizations to promote the adoption 
and meaningful use of 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 critical access 
hospitals (CAHs), respectively. Sections 1848(a)(7), 1853(l) and (m), 
1886(b)(3)(B), and 1814(l) of the Act also establish downward payment 
adjustments, beginning with calendar or fiscal year (FY) 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 titled, ``Medicare and Medicaid Programs; Electronic 
Health Record Incentive Program; Final Rule'' (75 FR 44316 through 
44317)).
2. Summary of Major Provisions
a. 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 their 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 Stage 1 of 
meaningful use, we refer readers to the Stage 1 final rule (75 FR 44313 
through 44588).)
    In the September 4, 2012 Stage 2 final rule (77 FR 53967 through 
54162), we focused on the next step after the foundation of data 
capture in Stage 1, the exchange of that essential health data among 
health care providers and patients to improve care coordination. To 
this end, we maintained the same core-menu structure for several 
finalized Stage 1 core and menu objectives. We finalized that EPs must 
meet the measure for 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 included 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. We also finalized a set of clinical quality measures 
(CQMs) for all providers participating in any stage of the program to 
report to CMS beginning in 2014. (For a full discussion of the 
meaningful use objectives and measures, and the CQMs we finalized under 
Stage 2, we refer

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readers to the Stage 2 final rule at 77 FR 53967 through 54162.)
    In this Stage 3 proposed rule, we build on the groundwork 
established in the Stage 1 and Stage 2 final rules, including 
continuing our goal started under Stage 2 to increase interoperable 
health data sharing among providers. In addition, this Stage 3 proposed 
rule would also focus on the advanced use of EHR technology to promote 
improved patient outcomes and health information exchange. We also 
propose to continue improving program efficiency, effectiveness, and 
flexibility by making changes to the Medicare and Medicaid EHR 
Incentive Programs that simplify reporting requirements and reduce 
program complexity. These changes proposed respond to comments received 
in earlier rulemaking that expressed confusion and concerns regarding 
increased reporting burden related to the number of program 
requirements, the multiple stages of program participation, and the 
timing of EHR reporting periods. In order to address these stakeholder 
concerns, one significant change we propose for Stage 3 includes 
establishing a single set of objectives and measures (tailored to EP or 
eligible hospital/CAH) to meet the definition of meaningful use. This 
new, streamlined definition of meaningful use proposed for Stage 3 
would be optional for any provider who chooses to attest to these 
objectives and measures for an EHR reporting period in 2017; and would 
be required for all eligible providers--regardless of prior 
participation in the EHR Incentive Program--for an EHR reporting period 
in 2018 and subsequent years.
    In addition to reducing program complexity, the Stage 3 proposed 
rule would further support efforts to align the EHR Incentive Programs 
with other CMS quality reporting programs that use certified EHR 
technology, such as the Hospital Inpatient Quality Reporting (IQR) and 
Physician Quality Reporting System (PQRS) programs, as well as continue 
alignment across care settings for providers demonstrating meaningful 
use. This alignment would both reduce provider burden associated with 
reporting on multiple CMS programs and enhance CMS operational 
efficiency. The Stage 3 proposed rule and ONC's 2015 Edition of 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 elsewhere in this edition of 
the Federal Register would also continue to support the privacy and 
security of patient health information within certified health IT.
b. Meaningful Use Requirements, Objectives and Measures for 2017 and 
Subsequent Years
    Under this Stage 3 proposed rule, with the exception of Medicaid 
providers in their first year of demonstrating meaningful use as 
detailed in section II.F.1. of this proposed rule, all providers (EPs, 
eligible hospitals, and CAHs) would report on a calendar year EHR 
reporting period beginning in calendar year 2017. This proposal builds 
on efforts to align the EHR reporting period with reporting periods for 
other quality reporting programs identified in the Stage 2 final rule 
(77 FR 53971 through 53975 and 54049 through 54051) and the FY 2015 
Hospital Inpatient Prospective Payment Systems (IPPS) final rule (79 FR 
49854 through 50449). In addition, all providers, other than Medicaid 
EPs and eligible hospitals demonstrating meaningful use for the first 
time, would be required to attest based on a full year of data for a 
single set of meaningful use objectives and measures to demonstrate 
Stage 3 of meaningful use, which is proposed as optional for an EHR 
reporting period in 2017 and mandatory for an EHR reporting period in 
2018, and subsequent years for all providers participating in the 
Medicare and Medicaid EHR Incentive Programs.
    The methodology for the selection of the proposed Stage 3 
objectives and measures for the Medicare and Medicaid EHR Incentive 
Programs included the following:
    <bullet> Review attestation data for Stages 1 and 2 of meaningful 
use.
    <bullet> Conduct listening sessions and interviews with providers, 
EHR system developers, regional extension centers, and health care 
provider associations.
    <bullet> Review recommendations from government agencies and 
advisory committees focused on health care improvement, such as the 
Health Information Technology (HIT) Policy Committee, the National 
Quality Forum (NQF), and the Centers for Disease Control (CDC).
    The information we gathered from these sources focused on analyzing 
measure performance, implementing discrete EHR functionalities and 
standards, and examining objectives and measures presenting the best 
opportunity to improve patient outcomes and enhance provider support.
    Based on this analysis, we are proposing a set of 8 objectives with 
associated measures designed to do all of the following:
    <bullet> Align with national health care quality improvement 
efforts.
    <bullet> Promote interoperability and health information exchange.
    <bullet> Focus on the 3-part aim of reducing cost, improving 
access, and improving quality.
    We intend to have this Stage 3 proposed rule be the last stage of 
the meaningful use framework, which leverages the structure identified 
in the Stage 1 and Stage 2 final rules, while simultaneously 
establishing a single set of objectives and measures designed to 
promote best practices and continued improvement in health outcomes in 
a sustainable manner. Measures in the Stage 1 and Stage 2 final rules 
that included paper-based workflows, chart abstraction, or other manual 
actions would be removed or transitioned to an electronic format 
utilizing EHR functionality for Stage 3. In addition, we are proposing 
the removal of ``topped out'' measures, or measures that are no longer 
useful in gauging performance, in order to reduce the reporting burden 
on providers for measures already achieving widespread adoption.
c. Clinical Quality Measurement
    EPs, eligible hospitals, and CAHs must report CQMs in order to 
qualify for incentive payments under the Medicare and Medicaid EHR 
Incentive Programs and avoid downward payment adjustments under 
Medicare.
    We are committed to continuing the electronic calculation and 
reporting of key clinical data through the use of CQMs. We are also 
focused on improving alignment of reporting requirements for CMS 
programs using EHR technology, maintaining flexibility with reporting 
requirements while streamlining reporting mechanisms for providers, and 
increasing quality data integrity.
    This proposed rule addresses quality reporting alignment on several 
fronts. Our long-term vision seeks to have hospitals, clinicians, and 
other health care providers report through a single, aligned mechanism 
for multiple CMS programs. In the Stage 2 final rule, we outlined 
preliminary alignment options for quality reporting programs with the 
EHR Incentive Programs as the first step toward that vision (77 FR 
54053).
    In order to facilitate continuous quality improvement, we need a 
method to allow changes to meaningful use CQMs and the associated 
reporting requirements on an ongoing basis. For other CMS quality 
reporting programs, changes occur through the annual Medicare payment 
rules, such as the

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Physician Fee Schedule (PFS) and the IPPS rules. Including CQMs in 
these annual rules would allow us to capture changes and updates 
annually. Therefore, we intend to further support alignment between the 
Medicare and Medicaid EHR Incentive Programs and other CMS quality 
reporting programs, such as PQRS and Hospital IQR, by including the 
reporting requirements for CQMs for providers demonstrating meaningful 
use in future rulemaking. We propose to continue encouraging CQM data 
submission through electronic submission for Medicare participants in 
2017, and to require electronic submission of CQMs where feasible 
beginning in 2018 for Medicare providers demonstrating meaningful use. 
(We further discuss Medicaid CQM submission in section II.F.3. of this 
proposed rule.)
d. Payment Adjustments and Hardship Exceptions
    The statute requires Medicare payment adjustment beginning in 2015. 
For the Stage 3 proposed rule, we propose to maintain all payment 
adjustment provisions for all EPs, eligible hospitals, and CAHs 
finalized in the Stage 2 final rule (77 FR 54093 through 54113 and 
54115 through 54119) except for a change to the relationship between 
the EHR reporting period year and the payment adjustment year for CAHs. 
We are proposing a change to the timing of the EHR reporting period and 
related deadlines for attestations and hardship exceptions for CAHs in 
relation to the payment adjustment year, in order to accommodate a 
transition to EHR reporting for meaningful use on the calendar instead 
of the fiscal year timeline. The payment adjustment provisions being 
maintained in the Stage 3 proposed rule include the process we 
finalized in Stage 2 by which a prior EHR reporting period determines a 
payment adjustment. We also maintain the four categories of exceptions 
based on all of the following:
    <bullet> The lack of availability of internet access or barriers to 
obtain IT infrastructure.
    <bullet> A time-limited exception for newly practicing EPs or new 
hospitals that would not otherwise be able to avoid payment 
adjustments.
    <bullet> Unforeseen circumstances such as natural disasters that 
would be handled on a case-by-case basis.
    <bullet> (EP only) exceptions due to a combination of clinical 
features limiting a provider's interaction with patients or, if the EP 
practices at multiple locations, lack of control over the availability 
of CEHRT at practice locations constituting 50 percent or more of their 
encounters.
e. Modifications to the Medicaid EHR Incentive Program
    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory 
basis for the Medicaid EHR Incentive Program. For this Stage 3 proposed 
rule, we propose that under the proposed changes to EHR reporting 
periods that would begin in 2017, Medicaid EPs and eligible hospitals 
demonstrating meaningful use for the first time in the Medicaid EHR 
Incentive Program would be required to attest for an EHR reporting 
period of any continuous 90-day period in the calendar year for 
purposes of receiving an incentive, as well as avoiding the payment 
adjustment under the Medicare Program.
    We are proposing to continue to allow states to set up a CQM 
submission process that Medicaid EPs and eligible hospitals may use to 
report on CQMs for 2017 and subsequent years. We also propose 
amendments to state reporting on providers who are participating in the 
Medicaid EHR Incentive Program as well as state reporting on 
implementation and oversight activities.
f. Summary of Costs and Benefits
    Upon finalization, the provisions in this proposed rule are 
anticipated to have an annual effect on the economy of $100 million or 
more, making it an economically significant rule under the Executive 
Order and a major rule under the Congressional Review Act. Accordingly, 
we have prepared a Regulatory Impact Analysis that to the best of our 
ability presents the costs and benefits of the final rule. The total 
federal cost of the Medicare and Medicaid EHR Incentive Programs 
between 2017 and 2020 is estimated to be $3.7 billion in transfers. In 
this proposed rule we do not estimate total costs and benefits to the 
provider industry, but rather provide a possible per EP and per 
eligible hospital outlay for implementation and maintenance. 
Nonetheless, we believe there are substantial benefits that can be 
obtained by society (perhaps accruing to eligible hospitals and EPs), 
including cost reductions related to improvements in patient safety and 
patient outcomes and cost savings benefits through maximizing 
efficiencies in clinical and business processes facilitated by 
certified health IT.

   Table 1--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
                                          HITECH EHR Incentive Program
                                           [Fiscal year--in billions]
----------------------------------------------------------------------------------------------------------------
                                          Medicare eligible                Medicaid eligible
           Fiscal year            ------------------------------------------------------------------    Total
                                      Hospitals     Professionals      Hospitals     Professionals
----------------------------------------------------------------------------------------------------------------
2017.............................            $1.6             $0.3            $0.4             $0.8         $3.1
2018.............................             0.0             -0.2             0.1              0.5          0.4
2019.............................             0.0             -0.2             0.0              0.3          0.1
2020.............................             0.0             -0.1             0.0              0.2          0.1
----------------------------------------------------------------------------------------------------------------

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 Incentive Program would consist of three 
different stages of meaningful use requirements.
    In the September 4, 2012 Federal Register (77 FR 53967 through 
54162),

[[Page 16736]]

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--
    <bullet> Adding an alternative measure for the Stage 2 meaningful 
use (MU) objective for hospitals to provide structured electronic 
laboratory results to ambulatory providers;
    <bullet> 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
    <bullet> 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--
    <bullet> EHR technology certified to the 2011 Edition; or
    <bullet> 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; Final Rule (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.
    For Stages 1 and 2, CMS and ONC worked closely to ensure that the 
definition of meaningful use of CEHRT and the standards and 
certification criteria for CEHRT were coordinated. Current ONC 
regulations may be found at 45 CFR part 170. For this Stage 3 proposed 
rule, CMS and ONC will again work together to align our regulations.
    We urge those interested in this Stage 3 proposed rule to also 
review the ONC 2015 Edition proposed rule, which is published elsewhere 
in this Federal Register. Readers may also visit: http://www.cms.hhs.gov/EHRincentiveprograms and http://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. Meaningful Use Requirements, Objectives, and Measures for 2017 and 
Subsequent Years

1. Definitions Across the Medicare Fee-for-Service, Medicare Advantage, 
and Medicaid Programs
a. Uniform Definitions
    As discussed in both the Stage 1 and 2 final 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. We 
propose to maintain these definitions, unless stated otherwise in this 
proposed rule. (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).
    As discussed in sections II.A.1.c.(1). and (2). of this proposed 
rule, we are proposing a single set of criteria for meaningful use 
(``Stage 3'') in order to eliminate the varying stages of the EHR 
Incentive Programs. We propose that this Stage 3 definition of 
meaningful use would be optional for providers in 2017 and mandatory 
for all providers beginning in 2018. To support Stage 3, we propose 
revising the uniform definitions under 42 CFR 495.4 for ``EHR reporting 
period'' and ``EHR reporting period for a payment adjustment year,'' as 
explained later in this section. The proposed revisions to these 
uniform definitions include eliminating the current 90-day EHR 
reporting period for EPs, eligible hospitals, and CAHs demonstrating 
meaningful use for the first time, and instead creating a single EHR 
reporting period aligned to the calendar year. The proposed removal of 
the 90-day EHR reporting period would not apply to

[[Page 16737]]

Medicaid EPs and eligible hospitals demonstrating meaningful use for 
the first time. We believe eliminating the 90-day EHR reporting period 
for most providers would simplify reporting, by aligning providers on 
the same EHR reporting timeline across all settings. In addition, a 
single EHR reporting period on the calendar year would align the EHR 
Incentive Program with other CMS quality reporting programs using 
certified EHR technology such as the Hospital IQR Program and PQRS. 
Finally, a single EHR reporting period based on the calendar year 
allows for a single attestation period, thereby enabling the HHS 
systems to better capture data, conduct enhanced stress testing and 
issue resolution, and improve quality assurance of systems before each 
deployment. We detail the proposed revisions to each of the uniform 
definitions later in this section.
b. Meaningful EHR User
    In the Stage 3 proposed rule, we propose to modify the definition 
of ``Meaningful EHR User'' under 42 CFR 495.4 to include the Stage 3 
objectives and measures defined at Sec.  495.7.
    The definition of a ``Meaningful EHR User'' under the Act requires 
the use of certified electronic health record technology (CEHRT) (see, 
for example, section 1848(o)(2) of the Act). We note that the term 
CEHRT is a defined term for the purpose of meeting the objectives of 
the EHR Incentive Programs (defined at Sec.  495.4). The term 
references ONC's certification criteria for a ``Base EHR,'' other ONC 
certification criteria required in the EHR Incentive Programs and the 
definition of a ``Meaningful EHR User.'' References to CEHRT within 
this proposed rule are to certification criteria that are required for 
purposes of the EHR Incentive Programs. We recognize that CEHRT is just 
one form of health IT. For this reason, this proposed rule also 
includes references to ``health IT'' where appropriate to capture the 
broader category of technologies where applicable.
c. Definition of Meaningful Use
(1) Considerations in Defining Meaningful Use
    In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the 
Congress identified the broad goal of expanding the use of EHRs through 
the concept of meaningful use. Section 1903(t)(6)(C) of the Act also 
requires that Medicaid providers adopt, implement, upgrade or 
meaningfully use CEHRT if they are to receive incentives under Title 
XIX. CEHRT used in a meaningful way is one piece of the broader HIT 
infrastructure needed to reform the health care system and improve 
health care quality, efficiency, and patient safety. This vision of 
reforming the health care system and improving health care quality, 
efficiency, and patient safety should inform the definition of 
meaningful use.
    As we explained in the Stage 1 and Stage 2 rules, we seek to 
balance the sometimes competing considerations of health system 
advancement (for example, improving health care quality, encouraging 
widespread EHR adoption, promoting innovation) and minimizing burdens 
on health care providers given the short timeframe available under the 
HITECH Act.
    Based on public and stakeholder input received during our Stage 1 
rule, we laid out a phased approach to meaningful use. Such a phased 
approach encompasses reasonable criteria for meaningful use based on 
currently available technology capabilities and provider practice 
experience, and builds up to a more robust definition of meaningful use 
as technology and capabilities evolve. The HITECH Act acknowledges the 
need for this balance by granting the Secretary the discretion to 
require more stringent measures of meaningful use over time. 
Ultimately, consistent with other provisions of law, meaningful use of 
CEHRT should result in health care that is patient centered, evidence-
based, prevention-oriented, efficient, and equitable.
    As stated in the Stage 2 final rule (77 FR 53973), we anticipated 
the Stage 3 criteria for meaningful use would focus on promoting 
improvements in quality, efficiency, and safety leading to improved 
health outcomes. We also anticipated that Stage 3 would focus on 
clinical decision support for national high priority conditions; 
improving patient access to self-management tools; improving access to 
comprehensive patient data through robust, secure, patient-centered 
health information exchange; and improvements in population health.
    For this Stage 3 proposed rule, we seek to streamline the criteria 
for meaningful use. We intend to do this by--
    <bullet> Creating a single stage of meaningful use objectives and 
measures (Stage 3), which would be optional for all providers in 2017 
and mandatory for all providers in 2018;
    <bullet> Allowing providers flexible options for 2017;
    <bullet> Changing the EHR reporting period to a full calendar year 
for all providers; and
    <bullet> Aligning with other CMS quality reporting programs using 
certified health IT such as PQRS and Hospital IQR for clinical quality 
measurement.
(a) Meaningful Use Stages
    Under the phased approach to meaningful use, we updated 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 under Stages 1 and 2, including the recent 
final rule extending Stage 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 is outlined in Table 2.

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


[[Page 16738]]

    In the Stage 2 final rule (77 FR 53974), we also stated that we 
would indicate in future rulemaking our intent for the potential 
development of stages or further criteria beyond Stage 3. In this 
proposed rule, we intend for Stage 3 to be the final stage in 
meaningful use and that no further stages would be developed. However, 
we understand that multiple technological and clinical care standard 
changes associated with EHR technology may result in the need to 
consider changes to the objectives and measures of meaningful use under 
the EHR Incentive Programs. Accordingly, we note that, as circumstances 
warrant, we would consider addressing such changes in future 
rulemaking.
    As shown in Table 2, providers in any given year may be 
participating in 1 of 3 different stages of the EHR Incentive Programs 
in addition to other CMS quality reporting programs using certified 
health IT such as PQRS and Hospital IQR. Through listening sessions, 
correspondence, and public comment forums, providers expressed 
frustration regarding the competing reporting requirements of multiple 
CMS programs, and the overall challenge of planning and reporting on 
the complex and numerous meaningful use requirements, including the 
need to manage changing processes, workflows, and reporting systems. In 
addition, group practices with EPs in different stages of meaningful 
use have to simultaneously support multiple stages of the program in 
order to demonstrate meaningful use for each EP. Meanwhile, if the 
current 3-stage framework continues, HHS and state systems would be 
required to support all 3 stages of the EHR Incentive Programs in 
perpetuity with extensive implementation of complex processes to accept 
submissions, analyze data, and coordinate systems.
    Providers have expressed ongoing concern that the EHR Incentive 
Programs are complicated, not focused on clinical reality and workflow, 
and stifling to innovation in health IT development. Specifically, 
providers have expressed concerns about the number of Stage 1 and 2 
objectives and measures becoming obsolete or lacking any link to 
improving outcomes. In addition, providers have expressed concern that 
continued focus on Stage 1 measures impedes current and potential 
future innovation in advanced utilization of health information 
technology. Providers worry that Stage 3 of meaningful use would 
exacerbate these existing concerns.
    The certified EHR technology requirements within the EHR Incentive 
Programs and included in ONC's Health IT Certification Program have 
resulted in considerable increases in certified EHR technology adoption 
among providers and are paving the way for more comprehensive, patient-
centered care across the care continuum. We recognize that while these 
advancements have been beneficial there are concerns, as stated 
previously, that require careful examination to ensure the 
sustainability and efficacy of the program going forward--as HHS moves 
to further encourage new uses of health IT and support the developing 
health IT infrastructure beyond the strides already made. Therefore, we 
seek to set a new foundation for this evolving program by proposing a 
number of changes to meaningful use. First, we propose a definition of 
meaningful use that would apply beginning in 2017. This definition of 
meaningful use, although referred to as ``Stage 3'', would be the only 
definition for the Medicare and Medicaid EHR Incentive Programs, and 
would incorporate certain requirements and aspects of Stages 1 and 2. 
Beginning with 2018, we propose to require all EPs, eligible hospitals, 
and CAHs, regardless of their prior participation in the EHR Incentive 
Program, to satisfy the requirements, objectives, and measures of Stage 
3. However, for 2017, we propose that Stage 3 would be optional for 
providers. This option would allow for a provider to move on to Stage 3 
in 2017 or remain at Stage 2, or for some providers to remain at Stage 
1, depending on their participation timeline. For example, under this 
proposal, a provider in Stage 2 in 2016 could choose to remain in Stage 
2 in 2017 or progress to Stage 3. In contrast to our rulemaking in 2014 
to accommodate the use of multiple Editions to meet the definitions of 
CEHRT during the EHR reporting periods in that year, this policy is 
based on the provider selection of the objectives and measures for 
their demonstration of meaningful use in 2017. Both the EHR technology 
certified to the 2014 Edition and the EHR technology certified to the 
2015 Edition will support attestations for Stage 1 or Stage 2 in 2017. 
In addition, the development and certification process for EHR 
technology products is not dependent on this selection by individual 
providers. Therefore, we do not expect that this policy would affect 
the availability of EHR technology certified to the 2015 Edition in 
2017 or the ability of an individual provider to implement EHR 
technology certified to the 2015 Edition during the year regardless of 
which stage they choose for their EHR reporting period in 2017. 
Therefore, we are proposing in section II.A.2.b. that all providers 
would be required to use EHR technology certified to the 2015 Edition 
for a full calendar year for the EHR reporting period in 2018. The 
revised timeline based on these proposals is outlined in Table 3.

                                                 Table 3--Stage of Meaningful Use Criteria by First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Stage of meaningful use
                                                  ------------------------------------------------------------------------------------------------------
       First year as a  meaningful EHR user                                                                                                    2021 and
                                                     2011     2012     2013     2014     2015     2016     2017      2018     2019     2020     future
                                                                                                                                                 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.............................................        1        1        1      * 2        2        2    2 or 3        3        3        3           3
2012.............................................  .......        1        1      * 2        2        2    2 or 3        3        3        3           3
2013.............................................  .......  .......        1        1        2        2    2 or 3        3        3        3           3
2014.............................................  .......  .......  .......        1        1        2    2 or 3        3        3        3           3
2015.............................................  .......  .......  .......  .......        1        1   1, 2 or        3        3        3           3
                                                                                                                3
2016.............................................  .......  .......  .......  .......  .......        1   1, 2 or        3        3        3           3
                                                                                                                3
2017.............................................  .......  .......  .......  .......  .......  .......   1, 2 or        3        3        3           3
                                                                                                                3
2018 and future years............................  .......  .......  .......  .......  .......  .......  ........        3        3        3           3
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Please note, a provider scheduled to participate in Stage 2 in 2014, who instead elected to demonstrate stage 1 because of delays in availability of
  EHR technology certified to the 2014 Edition, is still considered a stage 2 provider in 2014 despite the alternate demonstration of meaningful use. In
  2015, all such providers are considered to be participating in their second year of Stage 2 of meaningful use.


[[Page 16739]]

    Please note that the Medicare EHR Incentive Program and the 
Medicaid EHR Incentive Program have different rules regarding the 
number of payment years available, the last year for which incentive 
payments may be received, and the last year to initiate the program and 
receive an incentive payment. Medicaid EPs and eligible hospitals can 
receive a Medicaid EHR incentive payment for ``adopting, implementing, 
and upgrading'' (AIU) to Certified EHR Technology for their first 
payment year, which is not reflected in Table 3. The applicable payment 
years and the incentive payments available for each program are 
discussed in the Stage 1 final rule (75 FR 44318 through 44320). 
Although Table 3 outlines a provider's progression through the stages 
of meaningful use, it does not necessarily reflect the relation to 
incentive payments in the Medicare or Medicaid EHR Incentive Programs. 
We note that some providers may not ever qualify to receive an 
incentive payment depending on, among other factors, when and whether 
they successfully demonstrate meaningful use in the EHR Incentive 
Programs. We intend for the timeline in Table 3 to also apply to those 
EPs, eligible hospitals, and CAHs that never receive an incentive 
payment under the EHR Incentive Programs.
    We are further proposing that Stage 3 would adopt a simplified 
reporting structure on a focused set of objectives and associated 
measures to replace all criteria under Stages 1 and 2. Specifically, we 
are proposing criteria for meaningful use for EPs, eligible hospitals, 
and CAHs (optional in 2017 and mandatory beginning in 2018), regardless 
of a provider's prior participation in the Medicare and Medicaid EHR 
Incentive Programs, as described in detail in section II.A.1.c. of this 
proposed rule. We believe that a single set of objectives would reduce 
provider burden and allow for greater focus on improving outcomes, 
enhancing interoperability, and increasing patient engagement. In 
addition, with all providers participating at the same level, the 
impact of the scale of participation helps to support growth in health 
information exchange and patient engagement infrastructure, as more 
providers participate the ease of participation increases. Finally, the 
associated measures proposed for Stage 3 in this proposed rule would 
use advanced EHR functionality and IT-based processes. The 
requirements, objectives, and measures are outlined further in sections 
II.A.1.c.(2). of this proposed rule. In order to maintain clarity in 
relation to the various rules and stages, provisions outlined in the 
Stage 1 or Stage 2 final rules, and proposals under this Stage 3 
proposed rule, we will maintain the ``Stage'' designation in order to 
indicate the rule that contains the provision. The requirements, 
objectives, and measures proposed as part of this proposed definition 
of meaningful use would be referred to as ``Stage 3''.
    We welcome public comment on these proposals.
(b) EHR Reporting Period
    In the Stage 1 and Stage 2 final rules, we established that the EHR 
reporting period for eligible hospitals and CAHs is based on the 
federal fiscal year (October 1 through September 30). This fiscal year 
EHR reporting period originally was designed to support coordination 
between program implementation and CMS payment systems following the 
development of the EHR Incentive Programs in 2010 to allow for 
efficient payment of incentives for eligible hospitals and CAHs. 
However, as the EHR Incentive Program evolved, we found the fiscal year 
EHR reporting period resulted in varying reporting timelines between 
provider types (for example, the EHR reporting period for EPs is based 
on the calendar year) and a shortened timeline for system developers to 
meet hospital and CAH technology requirements. Enhanced coordination 
between CMS programs and other system implementation changes have 
subsequently made it unnecessary to maintain a reporting timeframe for 
eligible hospitals and CAHs based on the federal fiscal year. 
Therefore, we are proposing changes to the EHR reporting period 
beginning with the EHR reporting period in 2017 in order to do all of 
the following:
    <bullet> Simplify reporting for providers, especially groups and 
diverse systems.
    <bullet> Support further alignment of CMS quality reporting 
programs using certified health IT such as Hospital IQR and PQRS.
    <bullet> Simplify HHS system requirements for data capture.
    <bullet> Provide for greater flexibility, stress testing, and 
Quality Assurance (QA) of systems before deployment.
    In the FY 2015 IPPS final rule (79 FR 49853 through 50449), we 
aligned the reporting and submission timelines for CQMs for the 
Medicare EHR Incentive Programs for eligible hospitals and CAHs with 
the reporting and submission timelines for the Hospital IQR Program on 
a calendar year basis. This was designed to allow for better alignment 
between these programs in light of the directive in section 
1886(n)(3)(B)(iii) of the Act to avoid redundant or duplicative 
reporting. Calendar year reporting on quality data for hospitals allows 
for greater efficiency in measure development, the electronic 
specification of measures, and the update and deployment of measure 
logic and value sets for electronic clinical quality measures. The FY 
2014 IPPS final rule (78 FR 50904) clarified that eligible hospitals 
and CAHs demonstrating meaningful use for the first time in FY 2014 and 
reporting on CQMs electronically must report on a 3-month quarter in FY 
2014, rather than on a continuous 90-day period. Such changes not only 
better align program reporting but also allow for better data integrity 
as previously discussed in the Stage 2 final rule (77 FR 53974 through 
53975) and further discussed in section II.B.1.b. of this proposed 
rule.
(i) Calendar Year Reporting
    We are proposing to change the definitions of ``EHR reporting 
period'' and ``EHR reporting period for a payment adjustment year'' 
under Sec.  495.4 for EPs, eligible hospitals, and CAHs such that the 
EHR reporting period would be one full calendar year, with a limited 
exception under the Medicaid EHR Incentive Program for providers 
demonstrating meaningful use for the first time as discussed later in 
this section and in section II.A.2.b. of this proposed rule. This would 
allow for the full alignment of the EHR reporting timeline for the 
meaningful use objectives and associated measures and the CQMs, and 
align the timing of reporting by EPs, eligible hospitals, and CAHs. We 
propose this change would apply beginning in CY 2017. For example, for 
the incentive payments for the 2017 payment year, the EHR reporting 
period for EPs, eligible hospitals, and CAHs would be the full 2017 
calendar year. We note that the incentive payments under Medicare FFS 
and Medicare Advantage (MA) (sections 1848(o), 1886(n), 1814(l)(3), 
1853(l) and (m) of the Act) will end before 2017. However, under this 
proposed change, EPs and eligible hospitals that seek to qualify for an 
incentive payment under Medicaid would have a full calendar year EHR 
reporting period if they are not demonstrating meaningful use for the 
first time. For the payment adjustments under Medicare, we discuss the 
timing of the EHR reporting period in relation to the payment 
adjustment year in section II.D.2. of this proposed rule.
    This proposal would mean that eligible hospitals and CAHs would 
have

[[Page 16740]]

a reporting gap for the objectives and measures of meaningful use 
consisting of the 3-month quarter from October 1, 2016 through December 
31, 2016. Depending on future rulemaking, eligible hospitals and CAHs 
may still be required to report on CQMs over this time. The next EHR 
reporting period for eligible hospitals and CAHs to collect data on the 
objectives and measures of meaningful use would then begin on January 
1, 2017 and end on December 31, 2017. Eligible hospitals and CAHs would 
then report on a full calendar year basis from that point forward.
(ii) Eliminate 90-Day EHR Reporting Period
    We are further proposing to eliminate the 90-day EHR reporting 
period for new meaningful EHR users beginning in 2017, with a limited 
exception for Medicaid EPs and eligible hospitals demonstrating 
meaningful use for the first time. This would allow for a single EHR 
reporting period of a full calendar year for all providers across all 
settings. Specifically, we propose to eliminate the EHR reporting 
period of any continuous 90 days for EPs, eligible hospitals, and CAHs 
that are demonstrating meaningful use for the first time. Those 
providers instead would have an EHR reporting period of a full calendar 
year, as described previously. However, as discussed in section 
II.A.2.b. of this proposed rule, we propose to maintain the 90-day EHR 
reporting period for a provider's first payment year based on 
meaningful use for EPs and eligible hospitals participating in the 
Medicaid EHR Incentive Program. We propose corresponding revisions to 
the definitions of ``EHR reporting period'' and ``EHR reporting period 
for a payment adjustment year'' under Sec.  495.4. We propose these 
changes would apply beginning in CY 2017.
    As stated previously, all providers would attest based on a single 
EHR reporting period consisting of one full calendar year for the 
applicable objectives and measures of meaningful use in 2017 and 
subsequent years. These providers would submit their data in the 2 
months following the close of the EHR reporting period. For further 
information on the submission methods, see section II.D.9.b. of this 
proposed rule.
    We welcome public comment on these proposals.
(iii) State Flexibility for Stage 3 of Meaningful Use
    Consistent with our approach under both Stage 1 and 2, we propose 
to continue to offer states flexibility under the Medicaid EHR 
Incentive Program in Stage 3 by adding a new provision at Sec.  
495.316(d)(2)(iii) subject to the same conditions and standards as the 
Stage 2 flexibility policy. Under Stage 3, state flexibility would 
apply only with respect to the public health and clinical data registry 
reporting objective outlined under section II.A.1.c.(1).(b).(i). of 
this proposed rule.
    For Stage 3 of meaningful use, we would continue to allow states to 
specify the means of transmission of the data and otherwise change the 
public health agency reporting objective as long as it does not require 
functionality greater than what is required for Stage 3 and included in 
the 2015 Edition proposed rule elsewhere in this issue of the Federal 
Register.
    We welcome comment on this proposal.
(2) Criteria for Meaningful Use Stage 3
    In the Stage 1 and Stage 2 final rules, meaningful use included the 
concept of a core and a menu set of objectives. Each objective had 
associated measures that a provider needed to meet as part of 
demonstrating meaningful use of CEHRT. In Stage 2 of meaningful use, we 
also combined some of the objectives of Stage 1 and incorporated them 
into objectives for Stage 2. For example, we combined the objectives of 
maintaining an up-to-date problem list, active medication list, and 
active medication allergy list with the objective of providing a 
summary of care record for each transition of care or referral through 
required fields in the summary of care document (77 FR 53990 through 
53991 and 77 FR 54013 through 54016). We did this to allow for the more 
advanced use of EHR technology functions to support clinical processes, 
and to eliminate the need for providers to individually report on 
measures that were often already incorporated in workflows and for 
which many providers were already meeting the threshold (known as 
``topping out''). In the Stage 2 final rule (77 FR 53973), we signaled 
that the Stage 2 core and menu objectives would all be included in the 
Stage 3 proposal for meaningful use.
    Since the publication of the Stage 2 final rule, we have reviewed 
meaningful use performance from both a qualitative and quantitative 
perspective including analyzing performance rates, reviewing CEHRT 
functionalities and standards, and considering information gained by 
engaging with providers through listening sessions, correspondence, and 
open forums like the HIT Policy Committee. The data support a number of 
key points for consideration:
    <bullet> Providers are performing higher than the thresholds for 
some of the meaningful use measures using some EHR functionalities 
that--prior to the Stage 1 and Stage 2 final rules--were not common 
place (such as the maintenance of problem lists).
    <bullet> Providers in different specialties and settings 
implemented CEHRT and met objectives in different ways.
    <bullet> Providers express support for reducing the reporting 
burden on measures that have ``topped out.''
    <bullet> Providers expressed support for advanced functionality 
that would offer value to providers and patients.
    <bullet> Providers expressed support for flexibility regarding how 
objectives are implemented in their practice settings.
    <bullet> Providers in health systems and large group practices 
expressed frustration about the reporting burden of having to compile 
multiple reports spanning multiple stages and objectives.
    Since the EHR Incentive Programs began in 2011, stakeholder 
associations and providers have requested that we consider changes to 
the number of objectives and measures that providers must meet to 
demonstrate meaningful use of certified EHR technology under the EHR 
Incentive Programs. These recommendations also extended to 
considerations for the structure of Stage 3 of meaningful use. Many of 
these recommendations include allowing a provider to fail any two 
objectives (in effect making all objectives ``menu'' objectives) and 
still meet meaningful use, or to allow providers to receive an 
incentive payment or avoid a downward payment adjustment based on 
varied percentages of performance, and removing all measure thresholds. 
We have reviewed these recommendations and have declined to follow this 
course for a number of reasons.
    First, the statute specifically 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, for example, section 
1848(o)(2)(A)(iii) of the Act). This is one reason why we established 
stages of meaningful use to move providers along a progression from 
adoption to advanced use of certified EHR technology. Therefore, we 
intend to continue to use measure thresholds that may increase over 
time, and to incorporate advanced use functions of certified EHR 
technology into meaningful use objectives and measures.
    Second, there are certain objectives and measures which capture 
policies specifically required by the statute as core goals of 
meaningful use of certified EHR technology, such as electronic

[[Page 16741]]

prescribing for EPs, health information exchange, and clinical quality 
measurement (see sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act). 
Specific to the health information exchange, the statute requires 
certified EHR technology connected in a manner that provides for the 
electronic exchange of health information to improve the quality of 
health care, such as promoting care coordination.
    Further, the statute requires that the certified EHR technology 
which providers must use shall be a ``qualified EHR'' as defined in 
section 3000(13) of the Public Health Service Act as an electronic 
record of health-related information on an individual that includes 
patient demographic and clinical health information, such as medical 
history and problem lists; and has the capacity to--
    <bullet> Provide clinical decision support;
    <bullet> Support physician order entry;
    <bullet> Capture and query information relevant to health care 
quality; and
    <bullet> Exchange electronic health information with, and integrate 
such information from, other sources (see section 1848(o)(4) of the 
Act).
    The objectives that address these requirements are integral to the 
foundational goals of the program, which would be undermined if 
providers were allowed to fail to meet these objectives and still be 
considered meaningful EHR users. For these reasons, we intend to 
continue to require providers to meet the objectives and measures of 
meaningful use as required for the program, rather than allowing 
providers to fail any two objectives of their choice or making all 
objectives menu objectives.
    Finally, while we understand providers are seeking to reduce the 
overall burden of reporting, we do not believe these recommendations 
accomplish that goal. Adding all objectives and measures to the menu 
set and allowing for varying degrees of participation may add 
complexity for the individual provider seeking to determine how they 
can meet the requirements and demonstrate meaningful use of certified 
EHR technology. We instead are proposing (as discussed in sections 
II.A.1. and II.B. of this proposed rule) to reduce provider burden and 
simplify the program by aligning reporting periods and CQM reporting. 
In addition, the statute provides that in selecting measures for the 
EHR Incentive Program, the Secretary shall seek to avoid redundant or 
duplicative reporting otherwise required, including reporting under the 
PQRS and Hospital IQR Program (see sections 1848(o)(2)(B)(iii) and 
1886(n)(3)(B)(iii) of the Act). Although the statute refers to 
redundant or duplicative reporting in the context of other CMS quality 
reporting programs, we believe it is also useful and appropriate to 
consider whether there are redundant or duplicative aspects of the 
objectives and measures of Stages 1 and 2 of meaningful use as we 
develop policies for Stage 3.
    To that end, we have analyzed the objectives and measures of 
meaningful use in Stage 1 and Stage 2 of the program to determine where 
measures are redundant, duplicative, or have ``topped out.'' ``Topped 
out'' is the term used to describe measures that have achieved 
widespread adoption at a high rate of performance and no longer 
represent a basis upon which provider performance may be 
differentiated. We considered redundant objectives and measures to 
include those where a viable health IT-based solution may replace 
paper-based actions, such as the Stage 2 Clinical Summary objective (77 
FR 54001 and 54002). We considered duplicative objectives and measures 
to include those where some aspect is also captured in the course of 
meeting another objective or measure, such as recording vital signs 
which is also required as part of the summary of care document under 
the Stage 2 Summary of Care objective (77 FR 54013 through 54021). 
Finally, measures which have ``topped out'' 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 as 
directed in the statute (see section 1848(o)(2)(A)(iii) of the Act). 
For further discussion of ``topped out'' measures, we direct readers to 
section II.A.2.a. of this proposed rule.
    Therefore, our proposals for Stage 3 would continue the precedent 
of focusing on the advanced use of certified EHR technology. They would 
reduce the reporting burden; eliminate measures that are now redundant, 
duplicative, and ``topped out''; create a single set of objectives for 
all providers with limited variation between EPs, eligible hospitals, 
and CAHs as necessary; and provide flexibility within the objectives to 
allow providers to focus on implementations that support their 
practice.
(a) Topped Out Objectives and Measures
    In other contexts and CMS programs, CQMs are regularly evaluated to 
determine whether they have ``topped out,'' which means generally that 
measure performance among providers is so high and unvarying that 
meaningful distinctions and improvements in performance can no longer 
be made. Examples of this type of evaluation are found in the Hospital 
Inpatient Quality Reporting (IQR) program, the Hospital-Value Based 
Purchasing (HVBP) program, the End-Stage Renal Disease (ESRD) Quality 
Initiative, and within the National Quality Forum (NQF) endorsement and 
maintenance process for CQMs. We believe that quality measures, once 
``topped-out,'' represent care standards that have been widely adopted. 
We believe such measures should be considered for removal from program 
reporting because their associated reporting burden may outweigh the 
value of the quality information they provide and because, in some 
cases, the inclusion of these measures may impact the ability to 
differentiate among provider performance as a whole for programs which 
use baseline and benchmarking based on measure performance scores. 
Therefore, measures are regularly subject to an evaluation process to 
identify their continued efficacy. This evaluation process is used to 
determine whether a measure is ``topped out'' and, if so, whether that 
measure should be removed from program reporting requirements. We note 
that both the identification and the determination of a measure are 
part of the process as a measure may be identified as topped out, but 
still be determined useful as a measure for a specific program because 
of other factors that merit continued use of the measure.
    While the EHR Incentive Program does not use a benchmarking system 
to rate the overall and relative performance of providers as part of 
the definitions of meaningful use; we are proposing to adopt an 
approach to evaluate whether objectives and measures have become 
``topped out'' and, if so, whether a particular objective or measure 
should be considered for removal from reporting requirements. We 
propose to apply the following two criteria, which are similar to the 
criteria used in the Hospital IQR and HVBP Programs (79 FR 50203): 1--
Statistically indistinguishable performance at the 75th and 99th 
percentile, and 2--performance distribution curves at the 25th, 50th, 
and 75th percentiles as compared to the required measure threshold.
    An example of a current Stage 1 objective which would be considered 
``topped out'' under this approach is the objective to record 
demographics (75 FR 44340 through 44343). For the record demographics 
objective, we reviewed performance data submitted by providers through 
attestation and

[[Page 16742]]

determined that across all years of participation, the 75th percentile 
is performing at 99.8 percent with the 99th percentile performing at 
100 percent. In addition, the 25th, 50th, and 75th percentiles are all 
performing with minimal variance and significantly higher than the 
measure threshold of 50 percent, with performance rates at 97 percent, 
99 percent, and 100 percent respectively for eligible hospitals and 92 
percent, 98 percent and 100 percent respectively for EPs in Stage 1.\1\ 
For more information on the performance data, please see the EHR 
Incentive Programs Objective and Measure Performance Report by 
Percentile available at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html. We further note 
that this particular objective may also be considered duplicative as 
further discussed in section II.A.2.c. of this proposed rule, as the 
functionality which supports the objective within the EHR is also used 
in other objectives such as the objective to provide patient-specific 
education resources (77 FR 54011 through 54012) and the Stage 2 summary 
of care objective (77 FR 54013 through 54021). Therefore, this is an 
example of an objective that we determined is topped out and may no 
longer provide value as an independent objective in the program.
---------------------------------------------------------------------------

    \1\ Data may be found on the CMS Web site data and program 
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

    We welcome public comments on our proposed approach for topped out 
objectives and measures.
(b) Electronic Versus Paper-Based Objectives and Measures
    In Stages 1 and 2, we require or allow providers the option to 
include paper-based formats for certain objectives and measures. For 
these objectives and measures, providers would print, fax, mail, or 
otherwise produce a paper document and manually count these actions to 
include in the measure calculation. Examples of these include: The 
provision of a non-electronic summary of care document for a transition 
or referral to meet the measure at Sec.  495.6(j)(14)(i) for EPs and 
for eligible hospitals and CAHs atSec.  495.6(l)(11)(i): ``The 
[provider] who transitions or refers their patient to another setting 
of care or provider of care provides a summary of care record for more 
than 50 percent of transitions of care and referrals;'' and the 
provision of paper-based patient education materials measure for at 
Sec.  495.6(j)(12)(i) for EPs and Sec.  495.6(l)(9)(i) requiring: 
``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 [or discharged from 
the eligible hospital or CAH] during the EHR reporting period.'' Each 
of these measures may be met using a non-electronic format or action, 
and we propose to discontinue this policy for Stage 3. We recognize the 
strides that providers have made in the use of CEHRT and as we move 
forward in MU, it is appropriate to remove the earlier iterations of 
objectives and measures that were designed to support beginning EHR use 
and instead focus on objectives that are based solely on electronic use 
of data. This does not imply that we do not support the continued use 
of paper-based materials in a practice setting. Some patients may 
prefer to receive a paper version of their clinical summary or may want 
to receive education items or reminders on paper or some other method 
that is not electronic. We strongly recommend that providers continue 
to provide patients with visit summaries, patient health information, 
and preventative care recommendations in the format that is most 
relevant for each individual patient and easiest for that patient to 
access. In some cases, this may include the continued use of non-IT-
based resources. We are simply proposing that paper-based formats would 
not be required or allowed for the purposes of the objectives and 
measures for Stage 3 of meaningful use. We welcome public comments on 
this proposal.
(c) Advanced EHR Functions
    As discussed in section II.A.1.c.(2).(a). of this proposed rule, we 
are proposing to simplify requirements for meaningful use through an 
analysis of existing objectives and measures for Stages 1 and 2 to 
determine if they are redundant, duplicative, or ``topped out''. We 
note that some of the objectives and measures which meet these criteria 
involve EHR functions that are required by the statutory definition of 
``certified EHR technology'' (see section 1848(o)(4) of the Act, which 
references the definition of ``qualified EHR'' in section 3000(13) of 
the Public Health Service Act) which a provider must use to demonstrate 
meaningful use. The objectives and measures proposed for Stage 3 would 
include uses of these functions in a more advanced form. For example, 
patient demographic information is included in an electronic summary of 
care document called a consolidated clinical document architecture 
(CCDA) provided during a transition of care in the Stage 2 Summary of 
Care objective and measures (77 FR 54013 through 54021), which 
represents a more advanced use of the EHR function than in the Stage 1 
and 2 objective to record patient demographic information (77 FR 53991 
through 53993).
    We adopted a multi-part approach to identify the objectives and 
measures which would be proposed for providers to demonstrate 
meaningful use for Stage 3. This methodology included the analysis 
mentioned previously of existing Stage 1 and 2 objectives and measures, 
and provider performance; a review and consideration of the HIT Policy 
Committee recommendations (which are publically available for review 
at: http://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committee-recommendations-national-coordinator-health-it); and 
an evaluation of how the potential objectives and measures align with 
the foundational goals of the program defined in the HITECH Act.
    In the Stage 2 proposed and final rules, we often identified the 
HIT Policy Committee recommendations as part of our discussion of the 
specific objectives and measures, for example in the Stage 2 CPOE 
objective at 77 FR 43985. In this proposed rule for Stage 3 of 
meaningful use, although we have considered the HIT Policy Committee's 
recommendations in developing our proposed policies, we are not 
referencing the recommendations in each individual proposed objective 
and measure as there are multiple factors that contribute to the 
selection of each proposed objective and measure. In addition, many of 
the HIT Policy Committee recommendations address functions and 
standards that are part of the advanced use of certified EHR technology 
captured by one or more objectives proposed for Stage 3 of meaningful 
use. For example, the HIT Policy Committee has recommended an expansion 
of demographic data captured as structured data as well as a change to 
the related standards for use. However, this function and standard is 
required for certification of EHR technology for meaningful use and it 
is a required field for an electronic summary of care document for 
health information exchange. It is also to be included in the 
information accessible to a patient within their electronic patient 
record. Therefore, to provide clarity for readers, we provide a 
notation within Table 4 to identify alignment between the proposed 
Stage 3 objectives and measures and the recommendations of the HIT 
Policy Committee for Stage 3 of meaningful

[[Page 16743]]

use. We direct readers to the HIT Policy Committee recommendations 
available on HealthIT.gov for further information (http://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committee-recommendations-national-coordinator-health-it).
    As mentioned previously, the statute includes certain foundational 
goals and requirements for meaningful use of certified EHR technology 
and the functions of that technology. Therefore, after review of the 
existing Stage 1 and Stage 2 objectives and measures of meaningful use, 
the recommendations of the HIT Policy Committee, and the foundational 
goals and requirements under the HITECH Act; we have identified eight 
key policy areas which represent the advanced use of EHR technology and 
align with the program's foundational goals and overall national health 
care improvement goals, such as those found in the CMS National Quality 
Strategy.\2\ These eight policy areas provide the basis for the 
proposed objectives and measures for Stage 3 of meaningful use. They 
are included in Table 4 as follows:
---------------------------------------------------------------------------

    \2\ The National Quality Strategy: ``HHS National Strategy for 
Quality Improvement in Health Care'' http://www.ahrq.gov/workingforquality/about.htm.

     Table 4--Objectives and Measures for Meaningful Use in 2017 and
                            Subsequent Years
------------------------------------------------------------------------
                                           Delivery system reform goal
         Program goal/objective                     alignment
------------------------------------------------------------------------
Protect Patient Health Information.....  Foundational to Meaningful Use
                                          and Certified EHR Technology
                                          *.
                                         Recommended by HIT Policy
                                          Committee.
Electronic Prescribing (eRx)...........  Foundational to Meaningful Use.
                                         National Quality Strategy
                                          Alignment.
Clinical Decision Support (CDS)........  Foundational to Certified EHR
                                          Technology.
                                         Recommended by HIT Policy
                                          Committee.
                                         National Quality Strategy
                                          Alignment.
Computerized Provider Order Entry        Foundational to Certified EHR
 (CPOE).                                  Technology.
                                         National Quality Strategy
                                          Alignment.
Patient Electronic Access to Health      Recommended by HIT Policy
 Information.                             Committee.
                                         National Quality Strategy
                                          Alignment.
Coordination of Care through Patient     Recommended by HIT Policy
 Engagement.                              Committee.
                                         National Quality Strategy
                                          Alignment.
Health Information Exchange (HIE)......  Foundational to Meaningful Use
                                          and Certified EHR Technology.
                                         Recommended by HIT Policy
                                          Committee.
                                         National Quality Strategy
                                          Alignment.
Public Health and Clinical Data          Recommended by HIT Policy
 Registry Reporting.                      Committee.
                                         National Quality Strategy
                                          Alignment.
------------------------------------------------------------------------
* See, for example, sections 1848(o)(2) and (4) of the Act.

These objectives build on the measures and EHR functionalities from the 
Stage 1 final rule and the Stage 2 final rule to advance the core 
functions of EHRs in a clinically relevant way that benefits providers 
and patients.
    Under this proposal, which would apply to Stage 3 of meaningful use 
in 2017 and subsequent years, providers must successfully attest to 
these eight objectives and the associated measures (or meet the 
exclusion criteria for the applicable measure). As mentioned 
previously, 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). While we are proposing to simplify the program by removing 
topped-out, redundant, and duplicative measures and aligning reporting 
periods for providers; we are maintaining the push to improve the use 
of EHRs over time through these eight objectives and the associated 
measures proposed for Stage 3 of meaningful use. These proposed 
objectives and measures include advanced EHR functions, use a wide 
range of structured standards in CEHRT, employ increased thresholds 
over similar Stage 1 and 2 measures, support more complex clinical and 
care coordination processes, and require enhanced care coordination 
through patient engagement through a flexibility structure of active 
engagement measures.
    These proposed objectives and their associated measures are further 
discussed in section II.A.1.(c).(2). of this proposed rule. CMS and ONC 
will continue to monitor and review performance on the objectives and 
measures finalized for Stage 3 to continue to evaluate them for rigor 
and efficacy and, if necessary, propose changes in future rulemaking.
(d) Flexibility Within Meaningful Use Objectives and Measures
    We are proposing to incorporate flexibility within certain 
objectives proposed for Stage 3 for providers to choose the measures 
most relevant to their unique practice setting. This means that as part 
of successfully demonstrating meaningful use, providers would be 
required to attest to the results for the numerators and denominators 
of all measures associated with an objective; however, a provider would 
only need to meet the thresholds for two of the three associated 
measures. The proposed Stage 3 objectives including flexible measure 
options are as follows:
    <bullet> Coordination of Care through Patient Engagement--Providers 
must meet the thresholds of two of three measures and must attest to 
the numerators and denominators of all three measures.
    <bullet> Health Information Exchange--Providers must meet the 
thresholds of two of three measures and must attest to the numerators 
and denominators of all three measures.
    <bullet> Public Health Reporting--EPs must report on three measures 
and eligible hospitals and CAHs must report on four measures.
    We propose that if a provider meets the exclusion criteria for a 
particular measure within an objective which allows providers to meet 
the thresholds for two of three measures (namely, the Coordination of 
Care through Patient Engagement objective and the Health Information 
Exchange objective), the provider may exclude the measure and must meet 
the thresholds of the remaining two measures to meet the

[[Page 16744]]

objective. If a provider meets the exclusion criteria for two measures 
for such an objective, the provider may exclude those measures and must 
meet the threshold of the remaining measure to meet the objective. If a 
provider meets the exclusion criteria for all three measures for such 
an objective, the provider may exclude those measures and would be 
considered to have met the objective.
    We discuss the proposed policy for exclusions for the public health 
reporting objective as well as the exclusion criteria in further detail 
within the individual objectives and measures in section 
II.A.1.(c).(2). of this proposed rule.
(e) EPs Practicing in Multiple Practices/Locations
    For Stage 3, we propose to maintain the policy from the Stage 2 
final rule (77 FR 53981) which states that to be a meaningful user, an 
EP must have 50 percent or more of his or her outpatient encounters 
during the EHR reporting period at a practice/location or practices/
locations equipped with CEHRT. An EP who does not conduct at least 50 
percent of their patient encounters in any one practice/location would 
have to meet the 50 percent threshold through a combination of 
practices/locations equipped with CEHRT. For example, if the EP 
practices at a federally qualified health center (FQHC) and within his 
or her individual practice at two different locations, we would include 
in our review all three of these locations, and CEHRT would have to be 
available at one location or a combination of locations where the EP 
has 50 percent or more of his or her patient encounters. If CEHRT is 
only available at one location, then only encounters at this location 
would be included in meaningful use assuming this one location 
represents 50 percent or more of the EP's patient encounters. If CEHRT 
is available at multiple locations that collectively represent 50 
percent or more of the EP's patient encounters, then all encounters 
from those locations would be included in meaningful use. In the Stage 
2 final rule at (77 FR 53981), we defined patient encounter as any 
encounter where a medical treatment is provided or evaluation and 
management services are provided. This includes both individually 
billed events and events that are globally billed, but are separate 
encounters under our definition.
    In addition, in the Stage 2 final rule at (77 FR 53981) we defined 
a practice/location as equipped with CEHRT if the record of the patient 
encounter that occurs at that practice/location is created and 
maintained in CEHRT. This can be accomplished in the following three 
ways: CEHRT could be permanently installed at the practice/location, 
the EP could bring CEHRT to the practice/location on a portable 
computing device, or the EP could access CEHRT remotely using computing 
devices at the practice/location. We propose to maintain these 
definitions for Stage 3.
(f) Denominators
    The objectives for Stage 3 of meaningful use include percentage-
based measures wherever possible. In the Stage 2 final rule, we 
included a discussion of the denominators used for the program that 
included the use of one of four denominators for each of the measures 
associated with the meaningful use objectives outlined in the Stage 2 
final rule at 77 FR 53982 for EPs and 77 FR 53983 for eligible 
hospitals and CAHs. We focused on denominators because the action that 
moves something from the denominator to the numerator requires the use 
of CEHRT by the provider. For Stage 3 we refer readers to each of the 
proposed objectives and measures for Stage 3 for the specific 
calculation of each denominator for each measure. Here, we simply 
outline the general proposals for determining the scope of the measure 
denominators.
    For EPs, the references used to define the scope of the potential 
denominators for measures include the following:
    <bullet> Unique patients seen by the EP during the EHR reporting 
period. The scope for this calculation may be limited to only those 
patients whose records are maintained in the EHR for the denominator of 
the measures for objectives other than those referencing ``unique 
patients'' as previously established in the Stage 2 final rule at (77 
FR 53981). We propose to maintain the policy that EPs who practice at 
multiple locations or switch CEHRT during the EHR reporting period may 
determine for themselves the method for counting unique patients in the 
denominators to count unique patient across all locations equipped with 
different CEHRT, or to count at each location equipped with CEHRT. In 
cases where a provider switches CEHRT products at a single location 
during the EHR reporting period, they also have the flexibility to 
count a patient as unique on each side of the switch and not across it. 
EPs in these scenarios must choose one of these methods for counting 
unique patients and apply it consistently throughout the entire EHR 
reporting period.
    A patient is seen by the EP when the EP has a real time physical 
encounter with the patient in which they render any service to the 
patient. We also consider a patient seen through telehealth as a 
patient ``seen by the EP'' (telehealth may include the commonly known 
telemedicine as well as telepsychiatry, telenursing, and other diverse 
forms of technology-assisted health care). However, in cases where the 
EP and the patient do not have a real time physical or telehealth 
encounter, but the EP renders a consultative service for the patient, 
such as reading an EKG, virtual visits, or asynchronous telehealth, the 
EP may choose whether to include the patient in the denominator as 
``seen by the EP.'' This is necessary so that these providers can avoid 
reporting a zero in the denominator and be able to satisfy meaningful 
use. However, we stress that once providers choose, they must maintain 
that denominator choice for the entire EHR reporting period and for all 
relevant meaningful use measures.
    <bullet> Office visits. The denominators of the measures that 
reference ``office visits'' may be limited to only those patients whose 
records are maintained using CEHRT. An office visit is defined as any 
billable visit that includes the following:
    ++ Concurrent care or transfer of care visits,
    ++ Consultant visits, or
    ++ Prolonged physician service without direct, face-to-face patient 
contact (for example, telehealth).
    <bullet> All medication, laboratory, and diagnostic imaging orders 
created during the reporting period
    <bullet> Transitions of care and referrals including at least--
    ++ When the EP is the recipient of the transition or referral, the 
first encounter with a new patient and encounters with existing 
patients where a summary of care record (of any type) is provided to 
the receiving EP; and
    ++ When the EP is the initiator of the transition or referral, 
transitions and referrals ordered by the EP.
    Transitions of care are the movement of a patient from one setting 
of care to another. Referrals are cases where one provider refers a 
patient to another, but the referring provider maintains their care of 
the patient as well. For the purposes of distinguishing settings of 
care in determining the movement of a patient, we propose that a 
transition or referral may take place when a patient is transitioned or 
referred between providers with different billing identities, such as a 
different National Provider Identifier (NPI) or hospital CMS 
Certification Number (CCN). We

[[Page 16745]]

also propose that in the cases where a provider has a patient who seeks 
out and receives care from another provider without a prior referral, 
the first provider may include that transition as a referral if the 
patient subsequently identifies the other provider of care.
    For further explanation of the terms ``unique patient,'' ``seen by 
the EP,'' ``office visit,'' ``transitions of care,'' and ``referrals,'' 
we refer readers to the discussion at 77 FR 53982 through 53983. For 
eligible hospitals and CAHs, the references used to define the scope of 
the potential denominators for measures include the following:
    <bullet> Unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department during the EHR reporting 
period.
    <bullet> All medication, laboratory, and diagnostic imaging orders 
created during the reporting period.
    <bullet> Transitions of care and referrals including at least--
    ++ When the hospital is the recipient of the transition or 
referral: all admissions to the inpatient and emergency departments; 
and
    ++ When the hospital is the initiator of the transition or 
referral: all discharges from the inpatient department; and after 
admissions to the emergency department when follow-up care is ordered 
by an authorized provider.
    We propose that the explanation of the terms ``unique patients,'' 
``transitions of care,'' and ``referrals'' stated previously for EPs 
would also apply for eligible hospitals and CAHs, and we refer readers 
to the discussion of those terms in the hospital context in the Stage 2 
final rule (77 FR 53983 and 53984). We propose for Stage 3 to maintain 
the policy that admissions may be calculated using one of two methods 
(the observation services method and the all emergency department 
method), as described for Stage 2 at 77 FR 53984. The method an 
eligible hospital or CAH chooses must be used uniformly across all 
measures for all objectives.
    We reiterate that all discharges from an inpatient setting are 
considered a transition of care. We further propose for transitions 
from an emergency department, that eligible hospitals and CAHs must 
count any discharge where follow up care is ordered by an authorized 
provider regardless of the completeness of information available on the 
receiving provider. The eligible hospital or CAH should determine an 
internal policy applicable for the identification and capture of a 
patient's primary care provider or other relevant care team members for 
the purposes of ordering potential follow-up care. This will allow 
eligible hospitals and CAHs to better differentiate between discharges 
where care is ordered and discharges to home where no follow up care is 
ordered.
(g) Patient-Authorized Representatives
    In the Stage 3 Coordination of Care through Patient Engagement 
objective and the Patient Electronic Access objective outlined in 
section II.A.1.c.(2).(i). of this proposed rule, we propose the 
inclusion of patient-authorized representatives in the numerators as 
equivalent to the inclusion of the patient. We recognize that patients 
often consult with and rely on trusted family members and other 
caregivers to help coordinate care, understand health information, and 
make health care decisions. Accordingly, as part of these objectives, 
we encourage providers to provide access to health information to 
patient-authorized representatives in accordance with all applicable 
laws. We expect that patient-authorized representatives accessing such 
information under these objectives could include a wide variety of 
sources, including caregivers and various family members. However, we 
expect that patient-authorized representatives with access to such 
health information will always act on the patient's behalf and in the 
patient's best interests, and will remain free from any potential or 
actual conflict of interest with the patient. We further expect that 
the patient-authorized representatives would have the patient's best 
interests at heart and will act in a manner protective of the patient.
(h) Discussion of the Relationship of Meaningful Use to CEHRT
    We propose to continue our policy of linking each meaningful use 
objective to the CEHRT definition and to ONC-established certification 
criteria. As with Stage 1 and Stage 2, EPs, eligible hospitals, and 
CAHs must use technology certified to the certification criteria in the 
ONC Health IT Certification Program to meet the objectives and 
associated measures for Stage 3 of meaningful use. In some instances, 
meaningful use objectives and measures may not be directly enabled by 
certification criteria of the Health IT Certification Program. For 
example, in e-Rx and public health reporting, the CEHRT definition 
requires criteria established by the Health IT Certification Program to 
be applied to the message being sent or received and for purposes of 
message transmission. However, to actually engage in e-Rx or public 
health reporting, there are many steps that must be taken to meet the 
requirements of the measure, such as contacting both parties and 
troubleshooting issues that may arise through the normal course of 
business. In these cases, the EP, eligible hospital, and CAH remain 
responsible for meeting the objectives and measures of meaningful use, 
but the way they do so is not entirely constrained by the CEHRT 
definition.
(i) Discussion of the Relationship Between a Stage 3 Meaningful Use 
Objective and Its Associated Measure
    We propose to continue our Stage 1 and 2 policy that regardless of 
any actual or perceived gaps between the measure of an objective and 
full compliance with the objective, meeting the criteria of the measure 
means that the provider has met the objective for meaningful use in 
Stage 3.
Objective 1: Protect Patient Health Information
    The Health Insurance Portability and Accountability Act (HIPAA) was 
enacted in part to provide federal protections for individually 
identifiable health information (IIHI). The Secretary of HHS adopted 
what are commonly known as the HIPAA Privacy, Security and Breach 
Notification Rules (HIPAA Rules) to implement certain aspects of the 
HIPAA statute and the HITECH statute pertaining to a patient's IIHI. 
The Privacy Rule provides protections for most individually 
identifiable health information, in any form or media, whether 
electronic, paper, or oral, held by covered entities and business 
associates. The Security Rule specifies a series of administrative, 
physical, and technical standards that provide protections for most 
electronic individually identifiable health information, held by 
covered entities and business associates. Covered entities consist of 
most health care providers, health plans, and health care 
clearinghouses. Business associates consist of persons or organizations 
that perform certain functions or activities on behalf of, or provide 
certain services to, covered entities or other business associates that 
involve the use or disclosure of individually identifiable health 
information. Individually identifiable health information is 
information that relates to an individual's physical or mental health 
or condition, the provision of health care to an individual, or the 
payment for the provision of health care to an individual. Individually 
identifiable health information is information that identifies an 
individual directly or with

[[Page 16746]]

respect to which there is a reasonable basis to believe it can be used 
to identify an individual. The individually identifiable health 
information protected by the HIPAA Rules is known as ``protected health 
information'' and that information in electronic form is known as 
``electronic protected health information'' (ePHI). The Privacy Rule 
can be found at 45 CFR Part160 and subparts A and E of part 164 and the 
Security Rule can be found at 45 CFR Part160 and Subparts A and C of 
Part 164. Section 164.308(a)(1) of the Security Rule requires covered 
entities and business associates, among other things, to conduct a 
security risk analysis to assess the potential risks to the ePHI they 
create, receive, maintain, or transmit.
    Consistent with HIPAA and its implementing regulations, and as we 
stated under both the Stage 1 and Stage 2 final rules (75 FR 44368 
through 44369 and 77 FR 54002 through 54003), protecting ePHI remains 
essential to all aspects of meaningful use under the EHR Incentive 
Programs. We remain cognizant that unintended or unlawful disclosures 
of ePHI could diminish consumer confidence in EHRs and the overall 
exchange of ePHI. Therefore, in both the Stage 1 and 2 final rules, we 
created a meaningful use core objective aimed at protecting patients' 
health care information. Most recently, we finalized at (77 FR 54002 
and 54003), a Stage 2 meaningful use core objective requiring providers 
to ``protect ePHI created or maintained by the certified EHR technology 
through the implementation of appropriate technical capabilities.'' The 
measure for this objective requires providers to 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 data stored in CEHRT in accordance with requirements 
under 45 CFR 164.312 (a)(2)(iv) and 45 CFR 164.306(d)(3), implementing 
security updates as necessary, and correcting identified security 
deficiencies as part of the provider's risk management process. For 
further detail on this objective, we refer readers to the Stage 2 
proposed and final rules (77 FR 13716 through 13717 and 77 FR 54002).
    In this Stage 3 proposed rule, we continue to emphasize the 
importance of protecting ePHI under the EHR Incentive Programs. With 
more and more users using electronic health records, we believe that 
adequate protection of ePHI remains instrumental to the continued 
success of the EHR Incentive Program.
    However, public comments on the Stage 2 final rule and subsequent 
comments received through public forums, suggest some confusion remains 
among providers between the requirements of this meaningful use 
objective and the requirements established under 45 CFR 164.308(a)(1), 
45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3) of the HIPAA Security 
Rule. Although we stressed that the objective and measure finalized 
relating to ePHI are specific to the EHR Incentive Programs, and 
further added that compliance with the requirements in the HIPAA 
Security Rule falls outside the scope of this rulemaking, we 
nonetheless continued to receive inquiries about the relationship 
between our objective and the HIPAA Rules. Therefore, for Stage 3, in 
order to alleviate provider confusion and simplify the EHR Incentive 
Program, we are proposing to maintain the previously finalized Stage 2 
objective on protecting ePHI. However, we propose further explanation 
of the security risk analysis timing and review requirements for 
purposes of meeting this objective and associated measure for Stage 3.
    Proposed Objective: Protect electronic protected health information 
(ePHI) created or maintained by the certified EHR technology (CEHRT) 
through the implementation of appropriate technical, administrative, 
and physical safeguards.
    For the proposed Stage 3 objective, we have added language to the 
security requirements for the implementation of appropriate technical, 
administrative, and physical safeguards. We propose to include 
administrative and physical safeguards because an entity would require 
technical, administrative, and physical safeguards to enable it to 
implement risk management security measures to reduce the risks and 
vulnerabilities identified. Technical safeguards alone are not enough 
to ensure the confidentiality, integrity, and availability of ePHI. 
Administrative safeguards (for example, risk analysis, risk management, 
training, and contingency plans) and physical safeguards (for example, 
facility access controls, workstation security) are also required to 
protect against threats and impermissible uses or disclosures to ePHI 
created or maintained by CEHRT.
    Proposed Measure: Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including 
addressing the security (including encryption) of data stored in CEHRT 
in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 
CFR 164.306(d)(3), implement security updates as necessary, and correct 
identified security deficiencies as part of the provider's risk 
management process.
    Under this proposed measure, a risk analysis must assess the risks 
and vulnerabilities to ePHI created or maintained by the CEHRT and must 
be conducted or reviewed for each EHR reporting period, which, as 
proposed in this rule, would be a full calendar year, and any security 
updates and deficiencies identified should be included in the 
provider's risk management process and implemented or corrected as 
dictated by that process.
    To address inquiries about the relationship between this measure 
and the HIPAA Security Rule, we explain that the requirement of this 
proposed measure is narrower than what is required to satisfy the 
security risk analysis requirement under 45 CFR 164.308(a)(1). The 
requirement of this proposed measure is limited to annually conducting 
or reviewing a security risk analysis to assess whether the technical, 
administrative, and physical safeguards and risk management strategies 
are sufficient to reduce the potential risks and vulnerabilities to the 
confidentiality, availability, and integrity of ePHI created by or 
maintained in CEHRT. In contrast, the security risk analysis 
requirement under 45 CFR 164.308(a)(1) must assess the potential risks 
and vulnerabilities to the confidentiality, availability, and integrity 
of all ePHI that an organization creates, receives, maintains, or 
transmits. This includes ePHI in all forms of electronic media, such as 
hard drives, floppy disks, CDs, DVDs, smart cards or other storage 
devices, personal digital assistants, transmission media, or portable 
electronic media.
    We propose that the timing or review of the security risk analysis 
to satisfy this proposed measure must be as follows:
    <bullet> EPs, eligible hospitals, and CAHs must conduct the 
security risk analysis upon installation of CEHRT or upon upgrade to a 
new Edition of certified EHR Technology. The initial security risk 
analysis and testing may occur prior to the beginning of the first EHR 
reporting period using that certified EHR technology.
    <bullet> In subsequent years, a provider must review the security 
risk analysis of the CEHRT and the administrative, physical, and 
technical safeguards implemented, and make updates to its analysis as 
necessary, but at least once per EHR reporting period.
    We note that providers have several resources available for 
strategies and

[[Page 16747]]

methods for securing ePHI. Completing a security risk analysis requires 
a time investment, and may necessitate the involvement of security, 
health IT, or system IT staff or support teams at your facility. The 
Office for Civil Rights (OCR) provides broad scale guidance on security 
risk analysis requirements at: http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf.
    In addition, other tools and resources are available to assist 
providers in the process. For example, the Office of the National 
Coordinator for Health IT (ONC) provides guidance and a Security Risk 
Assessment (SRA) tool created in conjunction with OCR on its Web site 
at: http://www.healthit.gov/providers-professionals/security-risk-assessment-tool. The SRA Tool is a self-contained application available 
at no cost to the provider. There are a total of 156 questions and 
resources are included with each question to--
    <bullet> Assist in understanding the context of the question
    <bullet> Consider the potential impacts to ePHI if the requirement 
is not met
    <bullet> See the actual safeguard language of the HIPAA Security 
Rule
    In addition, the SRA Tool assists a provider by suggesting when 
corrective action may be required for a particular item. This tool is 
not required by the HIPAA Security Rule, but is one means by which 
providers and professionals in small and medium sized practices may 
perform a security risk analysis.
    We further note that the 2015 Edition proposed rule published 
elsewhere in this issue of the Federal Register includes an auditable 
events and tamper-resistance criterion which is known as an ``audit 
log'' which can be a valuable resource in ensuring the protection of 
ePHI. While we recognize there may be legitimate instances where the 
function must be disabled for a short time, we strongly recommend 
providers ensure this function is enabled at all times when the CEHRT 
is in use. The audit log function serves to ensure consistent 
protection of ePHI as well as providing support in mitigating risk in 
other areas such as patient safety, adverse events, and in the event of 
any potential breach.
    We emphasize that our discussion of this measure as it relates to 
45 CFR 164.308(a)(1) is only relevant for purposes of the meaningful 
use requirements and is not intended to supersede or satisfy the 
broader, separate requirements under the HIPAA Security Rule and other 
rulemaking. Compliance with the requirements in the HIPAA Security Rule 
fall outside of the scope of this rulemaking. Compliance with 42 CFR 
part 2 and state mental health privacy and confidentiality laws also 
fall outside the scope of this rulemaking. EPs, eligible hospitals, or 
CAHs affected by 42 CFR part 2 should consult with the Substance Abuse 
and Mental Health Services Administration (SAMHSA) or State 
authorities.
    We welcome public comments on this proposal.
Objective 2: Electronic Prescribing
    For Stage 3, we propose to maintain the objective and measure 
finalized in the Stage 2 final rule for electronic prescribing for EPs, 
with minor changes. In the Stage 2 final rule, we included for eligible 
hospitals and CAHs a menu set objective for the electronic prescription 
of discharge medications. We are proposing to include the Stage 2 menu 
objective, with a modification to increase the threshold, as a required 
objective for Stage 3 of meaningful use for eligible hospitals and 
CAHs.
    For a full discussion of electronic prescribing as a meaningful use 
objective in the Stage 2 final rule, we direct readers to (77 FR 53989 
through 53990 for EPs and 77 FR 54035 through 54036 for eligible 
hospitals and CAHs).
    Proposed Objective: EPs must generate and transmit permissible 
prescriptions electronically, and eligible hospitals and CAHs must 
generate and transmit permissible discharge prescriptions 
electronically (eRx).
    As discussed in the Stage 2 final rule (77 FR 53989), transmitting 
the prescription electronically promotes efficiency and patient 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 that works in conjunction with 
clinical decision support interventions enabled at the generation of 
the prescription. While the EP performance rate across all years and 
stages of participation indicate wide spread adoption, with the median 
rate at 89 percent for Stage 1 and 92 percent for Stage 2 \3\, we 
believe continued support of this objective is warranted to support the 
continued development of the ePrescribing marketplace. The continued 
expansion of the number and variety of products helps to reduce entry 
barriers and proliferate important standards for ePrescribing for a 
wide range of providers beyond those eligible for the EHR Incentive 
Programs. This represents a benefit to patients and to population 
health through a potential overall reduction in the occurrence of 
prescription drug related adverse events. For eligible hospitals and 
CAHs, the performance rate among Stage 2 providers selecting the 
measure is higher than the 10 percent threshold and has increased since 
the previous report (median rate is 76 \4\ percent). This opportunity 
to expand on early success, combined with the continued expansion of 
the pharmacy market acceptance of electronic prescriptions leads CMS to 
believe providers can meet an even higher threshold and should be 
encouraged to do so.
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    \3\ Data may be found on the CMS Web site data and program 
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
    \4\ Data may be found on the CMS Web site data and program 
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
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    We propose to continue to define ``prescription'' as the 
authorization by a provider to dispense a drug that would not be 
dispensed without such authorization. This includes authorization for 
refills of previously authorized drugs. We propose to continue to 
generally define a ``permissible prescription'' as all drugs meeting 
the definition of prescription not listed as a controlled substance in 
Schedules II-V (DEA Web site at http://www.deadiversion.usdoj.gov/schedules/index.html (77 FR 53989) with a slight modification to allow 
for inclusion of scheduled drugs where such drugs are permissible to be 
electronically prescribed. We note that the electronic prescribing of 
controlled substances (EPCS) is now legal in many states. This 
functionality provides prescribers with a way to manage treatments for 
patients with pain electronically and also deters creation of 
fraudulent prescriptions, which is a major concern in combating opioid 
misuse and abuse. While the technology may, in many instances, be in 
place to support EPCS, workflow challenges and additional modifications 
may need to occur to meet the requirements of Drug Enforcement Agency 
regulations (75 FR 16236). However, as Stage 3 would not begin until 
January of 2017 and would not be required until January of 2018, it is 
possible that significant progress in the availability of products 
enabling the electronic prescribing of controlled substances may occur. 
Therefore, we are proposing that providers who practice in a state 
where controlled substances may be electronically prescribed who wish 
to include these prescriptions in the numerator and denominator may do 
so under the definition of ``permissible prescriptions'' for their 
practice. If a provider chooses to include such

[[Page 16748]]

prescriptions, they must do so uniformly across all patients and across 
all allowable schedules for the duration of the EHR reporting period.
    For Stage 2, we requested comment on whether over-the-counter (OTC) 
medicines should be included in the definition of a prescription for 
this objective and determined that they should be excluded. For further 
information on that discussion, we direct readers to (77 FR 53989 and 
53990). We maintain that OTC medicines will not be routinely 
electronically prescribed and propose to continue to exclude them from 
the definition of a prescription. However, we encourage public comment 
on this assumption and whether OTC medicines should be included in this 
objective for Stage 3.
    In the Stage 2 final rule at (77 FR 53989), we discussed several 
different workflow scenarios that are possible when an EP prescribes a 
drug for a patient and that these differences in transmissions create 
differences in the need for standards. We propose to maintain this 
policy for Stage 3 for EPs and extend it to eligible hospitals and CAHs 
so that only a scenario in which a provider--
    <bullet> Prescribes the drug;
    <bullet> Transmits it to a pharmacy independent of the provider's 
organization; and
    <bullet> The patient obtains the drug from that pharmacy requires 
the use of standards to ensure that the transmission meets the goals of 
electronic prescribing. In that situation, standards can ensure the 
whole process functions reliably. In all cases under this objective, 
the provider needs to use CEHRT as the sole means of creating the 
prescription, and when transmitting to an external pharmacy that is 
independent of the provider's organization, such transmission must be 
pursuant to ONC Health IT Certification Program criteria.
    Proposed EP Measure: More than 80 percent of all permissible 
prescriptions written by the EP are queried for a drug formulary and 
transmitted electronically using CEHRT.
    In Stage 1 of meaningful use, we adopted a measure of more than 40 
percent of all permissible prescriptions written by the EP are 
transmitted electronically using CEHRT. In the Stage 1 final rule (75 
FR 44338), we acknowledged that there were reasons why a patient may 
prefer a paper prescription such as the desire to shop for the best 
price (especially for patients in the Part D ``donut hole''), the 
indecision about whether to have the prescription filled locally or by 
mail order, and the desire to use a manufacturer coupon (except in the 
Part D program) to obtain a discount.
    In Stage 2, we adopted a measure of more than 50 percent of all 
permissible prescriptions written by the EP are queried for a drug 
formulary and transmitted electronically using CEHRT. Our analysis of 
attestation data from Stages 1 and 2 shows that the median performance 
on this measure for Stage 1 EPs is 89 percent and for Stage 2 EPs is 92 
percent, which demonstrates that the 50 percent threshold does not 
exceed the ceiling created by patient preferences \5\. We believe that 
with continued experience with this objective and the continued 
expansion of the pharmacy market acceptance of electronic 
prescriptions, providers can meet an even higher threshold and should 
be encouraged to do so in line with the statutory directive to seek to 
improve the use of EHRs and health care quality over time by requiring 
more stringent measures of meaningful use (see section 
1848(o)(2)(A)(iii) of the Act). Therefore, we are proposing a threshold 
of 80 percent for this measure for Stage 3.
---------------------------------------------------------------------------

    \5\ Data can be found on the CMS Web site data and program 
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
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    We propose to maintain for Stage 3 the exclusion from Stage 2 for 
EPs who write fewer than 100 permissible prescriptions during the EHR 
reporting period. We also propose to maintain for Stage 3 the exclusion 
from Stage 2 if no pharmacies within a 10-mile radius of an EP's 
practice location at the start of his or her EHR reporting period 
accept electronic prescriptions (77 FR 53990). This is 10 miles in any 
straight line from the practice location independent of the travel 
route from the practice location to the pharmacy. For EPs practicing at 
multiple locations, they are eligible for the exclusion if any of their 
practice locations equipped with CEHRT meet this criterion. 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.
    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 80 percent in 
order for an EP to meet this measure.
    Exclusions: Any EP who: (1) Writes fewer than 100 permissible 
prescriptions during the EHR reporting period; or (2) does not have a 
pharmacy within their organization and there are no pharmacies that 
accept electronic prescriptions within 10 miles of the EP's practice 
location at the start of his or her EHR reporting period.
    Proposed Eligible Hospital/CAH Measure: More than 25 percent of 
hospital discharge medication orders for permissible prescriptions (for 
new and changed prescriptions) are queried for a drug formulary and 
transmitted electronically using CEHRT.
    In the Stage 2 final rule, we included in this measure new, 
changed, and refill prescriptions ordered during the course of 
treatment of the patient while in the hospital (77 FR 54036). We are 
proposing to limit this measure for Stage 3 to only new and changed 
prescriptions. We believe this limitation is appropriate because 
prescriptions that originate prior to the hospital stay, and that 
remain unchanged, would be within the purview of the original 
prescriber, and not hospital staff or attending physicians. We propose 
to include this limitation as we believe that in most cases a hospital 
would not issue refills for medications that were not authorized or 
altered during a patient's hospital stay. With this new proposal, we 
invite public comment on whether a hospital would issue refills upon 
discharge for medications the patient was taking when they arrived at 
the hospital and, if so, whether distinguishing those refill 
prescriptions from new or altered prescriptions is unnecessarily 
burdensome for the hospital.
    Our review of the Stage 2 attestation data for eligible hospitals 
and CAHs indicates performance levels of 53 percent at the median and 
31 percent for the lowest quartile (www.cms.gov/ehrincentiveprograms 
Data and Reports). Thus, we are proposing to increase the threshold for 
the measure from 10 percent to 25 percent for Stage 3 of meaningful use 
for eligible hospitals and CAHs.
    We propose to maintain the Stage 2 exclusion for any eligible 
hospital or CAH that does not have an internal pharmacy that can accept 
electronic

[[Page 16749]]

prescriptions and is not located within 10 miles of any pharmacy that 
accepts electronic prescriptions at the start of their EHR reporting 
period (77 FR 54036).
    We recognize that not every patient will have a formulary that is 
relevant for him or her. If a relevant formulary is available, then the 
information can be provided. If there is no formulary for a given 
patient, the comparison could return a result of formulary unavailable 
for that patient and medication combination, and the provider may count 
the prescription in the numerator if they generate and transmit the 
prescription electronically as required by the measure.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: The number of new or changed prescriptions written for 
drugs requiring a prescription in order to be dispensed other than 
controlled substances for patients discharged during the EHR reporting 
period.
    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 25 percent in 
order for an eligible hospital or CAH to meet this measure.
    Exclusion: Any eligible hospital or CAH that does not have an 
internal pharmacy that can accept electronic prescriptions and there 
are no pharmacies that accept electronic prescriptions within 10 miles 
at the start of their EHR reporting period.
    We invite public comment on these proposals.
Objective 3: Clinical Decision Support
    Proposed Objective: Implement clinical decision support (CDS) 
interventions focused on improving performance on high-priority health 
conditions.
    Clinical decision support at the relevant point of care is an area 
of health IT in which significant evidence exists for substantial 
positive impact on the quality, safety, and efficiency of care 
delivery. For Stage 2, we finalized an objective for the use of CDS to 
improve performance on high-priority health conditions, and two 
associated measures (77 FR 53995 through 53998). The first measure 
requires a provider to implement five CDS interventions related to four 
or more CQMs at a relevant point in patient care for the entire EHR 
reporting period. Absent four CQMs related to the provider's scope of 
practice or patient population, the CDS interventions must be related 
to high-priority health conditions. At least one of the CDS 
interventions should be related to improving healthcare efficiency. To 
meet the Stage 2 Clinical Decision Support objective, 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. Although we leave it to the 
provider's clinical discretion to determine the relevant point in 
patient care when such interventions will be most effective, the 
interventions must be presented through Certified EHR Technology to a 
licensed healthcare professional who can exercise clinical judgment 
about the decision support intervention before an action is taken on 
behalf of the patient. For the second measure, we consolidated the 
Stage 1 ``drug-drug/drug-allergy interaction checks'' objective into 
the Stage 2 CDS objective in the Stage 2 final rule (77 FR 53995 
through 53998). The second measure requires a provider to enable and 
implement the functionality for drug-drug and drug-allergy interaction 
checks for the entire EHR reporting period. We also finalized an 
exclusion for the second measure for any EP who writes fewer than 100 
medication orders during the EHR reporting period.
    For Stage 3 of meaningful use, we propose to maintain the Stage 2 
objective with slight modifications and further explanation of the 
relevant point of care, the types of CDS allowed, and the selection of 
a CDS applicable to a provider's scope of practice and patient 
population.
    First, we offer further explanation of the concept of the relevant 
point of care and note that providers should implement the CDS 
intervention at a relevant point in clinical workflows when the 
intervention can influence clinical decision making before diagnostic 
or treatment action is taken in response to the intervention. Second, 
many providers may associate CDS with pop-up alerts; however, these 
alerts are not the only method of providing CDS. CDS should not be 
viewed as simply an interruptive alert, notification, or explicit care 
suggestion. Well-designed CDS encompasses a variety of workflow-
optimized information tools, which can be presented to providers, 
clinical and support staff, patients, and other caregivers at various 
points in time. These may include but are not limited to: Computerized 
alerts and reminders for providers and patients; information displays 
or links; context-aware knowledge retrieval specifications which 
provide a standard mechanism to incorporate information from online 
resources (commonly referred to as InfoButtons); clinical guidelines; 
condition-specific order sets; focused patient data reports and 
summaries; documentation templates; diagnostic support; and 
contextually relevant reference information. These functionalities may 
be deployed on a variety of platforms (that is, mobile, cloud-based, 
installed).\6\ We encourage innovative efforts to use CDS to improve 
care quality, efficiency, and outcomes. HIT functionality that builds 
upon the foundation of an EHR to provide persons involved in care 
processes with general and person-specific information, intelligently 
filtered and organized, at appropriate times, to enhance health and 
health care. CDS is not intended to replace clinician judgment, but 
rather, is a tool to assist care team members in making timely, 
informed, and higher quality decisions.
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    \6\ FDASIA Health IT report available on the FDA Web site at: 
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf.
---------------------------------------------------------------------------

    We propose to retain both measures of the Stage 2 objective for 
Stage 3 and we are proposing that these additional options mentioned 
previously on the actions, functions, and interventions may constitute 
CDS for purposes of meaningful use would meet the measure requirements 
outlined in the proposed measures.
    Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy 
both measures in order to meet the objective:
    Measure 1: Implement five clinical decision support interventions 
related to four or more CQMs at a relevant point in patient care for 
the entire EHR reporting period. Absent four CQMs 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.
    Exclusion: For the second measure, any EP who writes fewer than 100 
medication orders during the EHR reporting period.
    We recommend that providers explore a wide range of potential CDS 
interventions and determine the best mix for their practice and patient 
population. There are a wide range of CQMs which providers may 
implement in conjunction with the CDS. We refer readers to the CMS eCQM 
Library (www.cms.gov/ehrincentiveprograms/ecqmlibrary) for a list of 
the CQMs

[[Page 16750]]

currently in use and under development for CMS programs and the 
associated National Quality Strategy domain categories.
    In alignment with the HHS National Quality Strategy goals,\7\ 
providers are encouraged to implement CDS related to quality 
measurement and improvement goals on the following areas:
---------------------------------------------------------------------------

    \7\ HHS National Quality Strategy: http://www.ahrq.gov/workingforquality/.
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    <bullet> Preventive care.
    <bullet> Chronic condition management.
    <bullet> Heart disease and hypertension.
    <bullet> Appropriateness of diagnostic orders or procedures such as 
labs, diagnostic imaging, genetic testing, pharmacogenetic and 
pharmacogenomic test result support or other diagnostic testing.
    <bullet> Advanced medication-related decision support, to include 
pharmacogenetic and pharmacogenomic test result support.
    An example of a potential CDS a provider may include which 
highlights the proposed expansion of the variety of workflow-optimized 
tools available for providers, and the link between a CDS and a high 
priority health condition, may be found in the use of treatment 
protocols and algorithms within the Million Hearts initiative. The 
Million Hearts initiative emphasizes the use of treatment protocols 
which can be embedded throughout the clinical workflow for hypertension 
control to standardize a team's or system's approach to achieving 
outcomes of interest. These treatment protocols or algorithms can 
expand the number of care team members that can assist in achieving 
desired outcomes; lend clarity, efficiency, and cost-effectiveness to 
selection of medications; and specify intervals and processes for 
patient follow up for care related to hypertension. For further 
information on this example, we direct readers to the Million Hearts 
initiative protocols http://millionhearts.hhs.gov/resources/protocols.html. In this example, these CDS interventions are applied to 
utilize standardized treatment approaches or protocols specific to 
hypertension control; however, we emphasize that similar strategies and 
approaches to the implementation of a variety of CDS can be widely 
applied. Another relevant example is clinical decision support in 
certified EHR technology that is used for consultation regarding 
appropriate use criteria for applicable imaging services as outlined in 
section 218 of the ``Protecting Access to Medicare Act of 2014'' which 
includes provisions focused on promoting evidence based care. We 
welcome public comments on the proposals.
    As in the Stage 2 final rule (77 FR 53997), we do not propose to 
require the provider to report a change in performance on individual 
CQMs either independently or in relation to the paired CDS. Rather, we 
recommend each provider set internal goals for improved performance 
using the CQM, or related set of CQMs, as indicators for their own 
reference when selecting and implementing a CDS intervention. We note 
that for CDS and CQM pairings, we recommend providers focus on the use 
of CQMs which measure patient outcomes (also known as outcome 
measures), as preferred over CQMs which measure clinical process 
without consideration of a particular outcome (also known as process 
measures). Outcome measure CQMs are designed to provide a patient-
centered and outcome-focused indicator for quality improvement goal-
setting and planning. Where possible, we recommend providers implement 
CDS interventions which relate to care quality improvement goals and a 
related outcome measure CQM. However, for specialty hospitals and 
certain EPs, if there are no CQMs which are outcome measures related to 
their scope of practice, the provider should implement a CDS 
intervention related to a CQM process measure; or if none of the 
available CQMs apply, the provider should apply an intervention that he 
or she believes will be effective in improving the quality, safety, or 
efficiency of patient care.
    CMS and ONC are committed to harmonizing the quality improvement 
ecosystem, refining and developing outcome measures, and aligning 
standards for CDS and quality measurement. Work is underway in the ONC 
Standards and Interoperability Framework to align and develop a shared 
quality improvement data model and technical expression standards for 
both CDS and quality measurement. Upon successful completion, such 
standards may be considered for inclusion in future quality measurement 
and certification rulemaking.
    Given the wide range of CDS interventions currently available and 
the continuing development of new technologies, we do not believe that 
any EP, eligible hospital, or CAH would be unable to identify and 
implement five CDS interventions as previously described. Therefore, we 
do not propose any exclusion for the first measure of this objective.
Objective 4: Computerized Provider Order Entry
    In the Stage 2 final rule, we expanded the use of computerized 
provider order entry (CPOE) from the Stage 1 objective requiring only 
medication orders to be entered using CPOE to include laboratory orders 
and radiology orders. For a full discussion of this expansion, we 
direct readers to (77 FR 53985 through 53989). We maintain CPOE 
continues to represent an opportunity for providers to leverage 
technology to capture these orders to reduce error and maximize 
efficiencies within their practice, therefore we are proposing to 
maintain the use of CPOE for these orders as an objective of meaningful 
use for Stage 3.
    Proposed Objective: Use computerized provider order entry (CPOE) 
for medication, laboratory, and diagnostic imaging orders directly 
entered by any licensed healthcare professional, credentialed medical 
assistant, or a medical staff member credentialed to and performing the 
equivalent duties of a credentialed medical assistant; who can enter 
orders into the medical record per state, local, and professional 
guidelines.
    We propose to continue to define CPOE as the provider's use of 
computer assistance to directly enter clinical orders (for example, 
medications, consultations with other providers, laboratory services, 
imaging studies, and other auxiliary services) from a computer or 
mobile device. The order is then documented or captured in a digital, 
structured, and computable format for use in improving safety and 
efficiency of the ordering process.
    We propose to continue our policy from the Stage 2 final rule that 
the orders to be included in this objective are medication, laboratory, 
and radiology orders as such orders are commonly included in CPOE 
implementation and offer opportunity to maximize efficiencies for 
providers. However, for Stage 3, we are proposing to expand the 
objective to include diagnostic imaging, which is a broader category 
including other imaging tests such as ultrasound, magnetic resonance, 
and computed tomography in addition to traditional radiology. This 
change addresses the needs of specialists and allows for a wider 
variety of clinical orders relevant to particular specialists to be 
included for purposes of measurement.
    In Stage 3, we propose to continue the policy from the Stage 2 
final rule at 77 FR 53986 that orders entered by any licensed 
healthcare professional or credentialed medical assistant would

[[Page 16751]]

count toward this objective. A credentialed medical assistant may enter 
orders if they are credentialed to perform the duties of a medical 
assistant by a credentialing body other than the employer. If a staff 
member of the eligible provider is appropriately credentialed and 
performs assistive services similar to a medical assistant, but carries 
a more specific title due to either specialization of their duties or 
to the specialty of the medical professional they assist, orders 
entered by that staff member would be included in this objective. We 
further note that medical staff whose organizational or job title, or 
the title of their credential, is other than medical assistant may 
enter orders if these staff are credentialed to perform the equivalent 
duties of a credentialed medical assistant by a credentialing body 
other than their employer and perform such duties as part of their 
organizational or job title. We defer to the provider's discretion to 
determine the appropriateness of the credentialing of staff to ensure 
that any staff entering orders have the clinical training and knowledge 
required to enter orders for CPOE. This determination must be made by 
the EP or representative of the eligible hospital or CAH based on--
    <bullet> Organizational workflows;
    <bullet> Appropriate credentialing of the staff member by an 
organization other than the employing organization;
    <bullet> Analysis of duties performed by the staff member in 
question; and
    <bullet> Compliance with all applicable federal, state, and local 
laws and professional guidelines.
    However, as stated in the Stage 2 final rule at 77 FR 53986, it is 
apparent that the prevalent time when CDS interventions are presented 
is when the order is entered into CEHRT, and that not all EHRs also 
present CDS when the order is authorized (assuming such a multiple step 
ordering process is in place). This means that the person entering the 
order would be required to enter the order correctly, evaluate a CDS 
intervention either using their own judgment or through accurate relay 
of the information to the ordering provider, and then either make a 
change to the order based on the information provided by the CDS 
intervention or bypass the intervention. The execution of this role 
represents a significant impact on patient safety; therefore, we 
continue to maintain for Stage 3 that a layperson is not qualified to 
perform these tasks. We believe that the order must be entered by a 
qualified individual. We further propose that if the individual 
entering the orders is not the licensed healthcare professional, the 
order must be entered with the direct supervision or active engagement 
of a licensed healthcare professional.
    We propose to maintain for Stage 3 our existing policy for Stages 1 
and 2 that the CPOE function should be used the first time the order 
becomes part of the patient's medical record and before any action can 
be taken on the order. The numerator of this objective also includes 
orders entered using CPOE initially when the patient record became part 
of the certified EHR. This does not include paper orders entered 
initially into the patient record and then transferred to CEHRT by 
other individuals at a later time, nor does it include orders entered 
into technology not compliant with the CEHRT definition and transferred 
into the CEHRT at a later time. In addition, based on the discussion in 
the Stage 2 final rule (77 FR 53986), we propose to maintain for Stage 
3 that ``protocol'' or ``standing'' orders may be excluded from this 
objective. The defining characteristic of these orders is that they are 
not created due to a specific clinical determination by the ordering 
provider for a given patient, but rather are predetermined for patients 
with a given set of characteristics (for example, administer medication 
X and order lab Y for all patients undergoing a certain specific 
procedure or refills for given medication). We agree that this category 
of orders warrant different considerations than orders that are due to 
a specific clinical determination by the ordering provider for a 
specific patient. Therefore, we allow providers to exclude orders that 
are predetermined for a given set of patient characteristics or for a 
given procedure from the calculation of CPOE numerators and 
denominators. However, the exclusion of this type of order may not be a 
blanket policy for patients presenting with a specific diagnosis or 
symptom which requires the evaluation and determination of the provider 
for the order.
    We propose to maintain the Stage 2 description of ``laboratory 
services'' as any service provided by a laboratory that could not be 
provided by a non-laboratory for the CPOE objective for Stage 3 (77 FR 
53984). We also propose to maintain for Stage 3 the Stage 2 description 
of ``radiologic services'' as any imaging service that uses electronic 
product radiation (77 FR 53986). Even though we are proposing to expand 
the CPOE objective from radiology orders to all diagnostic imaging 
orders, this description would still apply for radiology services 
within the expanded objective.
    We invite public comment on these proposals.
    Proposed Measures: An EP, eligible hospital or CAH must meet all 
three measures.
    Proposed Measure 1: More than 80 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 computerized provider order entry;
    Proposed Measure 2: More than 60 percent of laboratory orders 
created by the EP or authorized providers of the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry; 
and
    Proposed Measure 3: More than 60 percent of diagnostic imaging 
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 computerized 
provider order entry.
    We propose to continue a separate percentage threshold for all 
three types of orders: medication, laboratory, and diagnostic imaging. 
We continue to believe that an aggregate denominator cannot best 
capture differentiated performance on the individual order types within 
the objective, and therefore maintain a separate denominator for each 
order type. We propose to retain exclusionary criteria from Stage 2 for 
those EPs who so infrequently issue an order type specified by the 
measures (write fewer than 100 of the type of order), that it is not 
practical to implement CPOE for that order type.
    Based on our review of attestation data from Stages 1 and 2 
demonstrating provider performance on the CPOE measures, we propose to 
increase the threshold for medication orders to 80 percent and to 
increase the threshold for diagnostic imaging orders and laboratory 
orders to 60 percent. Median performance for Stage 1 on medication 
orders is 95 percent for EPs and 93 percent foreligible hospitals and 
CAHs. Stage 2 median performance on laboratory and radiology orders is 
80 percent and 83 percent for eligible hospitals and CAHs and 100 
percent for EPs for both measures.\8\ We believe it is reasonable to 
expect the actual use of CPOE for medication orders to increase from 60 
percent in Stage 2 to 80 percent in Stage 3 and the actual use of CPOE 
for diagnostic imaging and laboratory

[[Page 16752]]

orders to increase from 30 percent in Stage 2 to 60 percent in Stage 3. 
We note that despite the expansion of the category for radiology orders 
to diagnostic imaging orders, we do not anticipate a negative impact on 
the ability of providers to meet the higher threshold as the adoption 
of the expanded functionality does not require additional workflow 
implementation and allows for inclusion of a wider range of orders 
already being captured by many providers. Therefore, for medication 
orders we propose the threshold at 80 percent and for diagnostic 
imaging and laboratory orders we propose the threshold at 60 percent 
for Stage 3.
---------------------------------------------------------------------------

    \8\ Data can be found on the CMS Web site data and program 
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

    In the Stage 2 final rule, we addressed the concern posed when 
calculating a denominator of all orders entered into the CEHRT while 
limiting the numerator to only those entered into CEHRT using CPOE (77 
FR 53987 through 53988). Potentially, this would exclude those orders 
that are never entered into the CEHRT in any manner. The provider would 
be responsible for including those orders in their denominator. 
However, we believe that providers using CEHRT use it as the patient's 
medical record; therefore, an order not entered into CEHRT would be an 
order that is not entered into a patient's medical record. For this 
reason, we expect that orders given for patients that are never entered 
into the CEHRT to be few in number or non-existent. While our 
experience with both Stage 1 and Stage 2 of meaningful use has shown 
that a denominator of all orders created by the EP or in the hospital 
would not be unduly burdensome for providers and would create a better 
measurement for CPOE usage, particularly for EPs who infrequently order 
medications, this does not guarantee such a denominator would be 
feasible for all providers. We invite comments on whether to continue 
to allow, but not require, providers to limit the measure of this 
objective to those patients whose records are maintained using CEHRT.
    Proposed Measure 1: To calculate the percentage, CMS and ONC have 
worked together to define the following for this measure:
    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 80 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.
    Proposed Measure 2: To calculate the percentage, CMS and ONC have 
worked together to define the following for this measure:
    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 60 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.
    Proposed Measure 3: To calculate the percentage, CMS and ONC have 
worked together to define the following for this measure:
    Denominator: Number of diagnostic imaging 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 diagnostic imaging 
orders during the EHR reporting period.
    We seek comment on if there are circumstances which might warrant 
an additional exclusion for an EP such as a situation representing a 
barrier to successfully implementing the technology required to meet 
the objective. We also seek comment on if there are circumstances where 
an eligible hospital or CAH which focuses on a particular patient 
population or specialty may have an EHR reporting period where the 
calculation results in a zero denominator for one of the measures, how 
often such circumstances might occur, and whether an exclusion would be 
appropriate.
    An EP through a combination of meeting the thresholds and 
exclusions must satisfy all three measures for this objective. An 
eligible hospital or CAH must meet the thresholds for all three 
measures.
    We welcome public comment on these proposals.
Objective 5: Patient Electronic Access to Health Information
    The Stage 1 and Stage 2 final rules included a number of objectives 
focused on increasing patient access to health information and 
supporting provider and patient communication. These objectives include 
patient reminders (77 FR 54005 through 54007), patient-specific 
education resources (77 FR 54011 through 54012), clinical summaries of 
office visits (77 FR 53998 through 54002), secure messaging (77 FR 
54031 through 54033), and the ability for patients to view, download, 
and transmit their health information to a third party (77 FR 54007 
through 54011). For Stage 3, we generally identified two related policy 
goals within the overall larger goal of improved patient access to 
health information and patient-centered communication. The first is to 
ensure patients have timely access to their full health record and 
related important health information; and the second is to engage in 
patient-centered communication for care planning and care coordination. 
While these two goals are intricately linked, we see them as two 
distinct priorities requiring different foci and measures of success. 
For the first goal, we are proposing to incorporate the Stage 2 
objectives related to providing patients with access to health 
information, including the objective for providing access for patients 
(or their authorized representatives) to view online, download, and 
transmit their health information and the objective for patient-
specific education resources, into a new Stage 3 objective entitled, 
``Patient Electronic Access'' (Objective 5), focused on using certified 
EHR technology to support increasing patient access to important health 
information. For the second goal, we are proposing an objective 
entitled Coordination of Care through Patient Engagement (Objective 6) 
incorporating the policy goals of the Stage 2 objectives related to 
secure messaging, patient reminders, and the ability for patients (or 
their authorized representatives) to view online, download, and 
transmit their health information using the functionality of the 
certified EHR technology.
    In this Stage 3 Patient Electronic Access Objective, we are 
proposing to incorporate certain measures and objectives from Stage 2 
into a single objective focused on providing patients with timely 
access to information related to their care. This proposed objective is 
a consolidation of the first measure of the Stage 2 Core Objective

[[Page 16753]]

for EPs of ``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'' and the Stage 2 Core Objective 
for EPs to ``Use clinically relevant information from CEHRT to identify 
patient-specific education resources and provide those resources to the 
patient.'' For eligible hospitals and CAHs, this proposed objective 
consolidates the first measure of the Stage 2 Core Objective for 
eligible hospitals/CAHs of ``Provide patients the ability to view 
online, download, and transmit information about a hospital admission'' 
and the Stage 2 Core Objective ``Use clinically relevant information 
from CEHRT to identify patient-specific education resources and provide 
those resources to the patient.'' For further discussion around the 
development of the Stage 2 objectives, we direct readers to the Stage 2 
final rule at (77 FR 53973).
    In Stage 2, there are objectives that allow providers to 
communicate and provide information to patients through paper-based 
means, such as clinical summaries of office visits and patient-specific 
education resources. Although these methods of communication and 
information exchange are embraced by many providers and patients and we 
continue to support their use, we will no longer require or allow 
providers to capture and calculate these actions or attest to these 
measures for meaningful use Stage 3. While we believe that providing 
patients access to health information in many formats is beneficial to 
patient-centered communication, care delivery, and quality improvement, 
meaningful use Stage 3 focuses exclusively on electronic, certified EHR 
technology supported communication.
    We are also proposing to expand the options through which providers 
may engage with patients under the EHR Incentive Programs. 
Specifically, we are proposing an additional functionality, known as 
application-program interfaces (APIs), which would allow providers to 
enable new functionalities to support data access and patient exchange. 
An API is a set of programming protocols established for multiple 
purposes. APIs may be enabled by a provider or provider organization to 
provide the patient with access to their health information through a 
third-party application with more flexibility than often found in many 
current ``patient portals.'' From the provider perspective, using this 
option would mean the provider would not be required to separately 
purchase or implement a ``patient portal,'' nor would they need to 
implement or purchase a separate mechanism to provide the secure 
download and transmit functions for their patients because the API 
would provide the patient the ability to download or transmit their 
health information to a third party. If the provider elects to 
implement an API, the provider would only need to fully enable the API 
functionality, provide patients with detailed instructions on how to 
authenticate, and provide supplemental information on available 
applications which leverage the API. For further discussion on the 
technical requirements for APIs, we direct readers to the 2015 Edition 
proposed rule published elsewhere in this issue of the Federal 
Register. The certification criteria proposed by ONC would establish 
API criteria which would allow patients, through a third-party 
application, to pull certain components of their unique health data 
directly from the provider's CEHRT, and potentially could--on demand--
pull such information from multiple providers caring for a patient. 
Therefore, we are proposing for the Patient Electronic Access objective 
to allow providers to enable API functionality in accordance with the 
proposed ONC requirements in the 2015 Edition proposed rule published 
elsewhere in this issue of the Federal Register.
    From the patient perspective, an API enabled by a provider will 
empower the patient to receive information from their provider in the 
manner that is most valuable to that particular patient. Patients would 
be able to collect their health information from multiple providers and 
potentially incorporate all of their health information into a single 
portal, application, program, or other software. We also believe that 
provider-enabled APIs allow patients to control the manner in which 
they receive their health information while still ensuring the 
interoperability of data across platforms. In addition, we recognize 
that a large number of patients consult with and rely on trusted family 
members and other caregivers to help coordinate care, understand health 
information, and make decisions. Therefore, we encourage providers to 
provide access to health information to appropriately authorized 
patient representatives.
    As some low-cost and free API functions already exist in the health 
IT industry, we expect third-party application developers to continue 
to create low-cost solutions that leverage APIs as part of their 
business models. Therefore, we encourage health IT system developers to 
leverage these existing API platforms and applications to allow 
providers no-cost, or low-cost solutions to implement and enable an API 
as part of their CEHRT systems. In addition, we do not believe it would 
be appropriate for EPs and hospitals to charge patients a fee for 
accessing their information using an API.
    The goal of this objective is to allow patients easy access to 
their health information as soon as possible, so that they can make 
informed decisions regarding their care and share their most recent 
clinical information with other health care providers and personal 
caregivers as they see fit. We believe this is also integral to the 
hospital Partnership for Patients initiative and reducing hospital 
readmissions. This objective aligns with the Fair Information Practice 
Principles (FIPPS),\9\ in affording baseline privacy protections to 
individuals.\10\
---------------------------------------------------------------------------

    \9\ 1 In 1973, the Department of Health, Education, and Welfare 
(HEW) released its report, Records, Computers, and the Rights of 
Citizens, which outlined a Code of Fair Information Practices that 
would create ''safeguard requirements'' for certain ''automated 
personal data systems'' maintained by the Federal Government. This 
Code of Fair Information Practices is now commonly referred to as 
fair information practice principles (FIPPs) and established the 
framework on which much privacy policy would be built. There are 
many versions of the FIPPs; the principles described here are 
discussed in more detail in The Nationwide Privacy and Security 
Framework for Electronic Exchange of Individually Identifiable 
Health Information, December 15, 2008. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
    \10\ The FIPPs, developed in the United States nearly 40 years 
ago, are well-established and have been incorporated into both the 
privacy laws of many states with regard to government-held records 2 
and numerous international frameworks, including the development of 
the OECD's privacy guidelines, the European Union Data Protection 
Directive, and the Asia-Pacific Economic Cooperation (APEC) Privacy 
Framework. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
---------------------------------------------------------------------------

    We seek comment on what additional requirements might be needed to 
ensure that if the eligible hospital, CAH or EP selects the API 
option--(1) the functionality supports a patient's right to have his or 
her protected health information sent directly to a third party 
designated by the patient; and (2) patients have at least the same 
access to and use of their health information that they have under the 
view, download, and transmit option.
    Proposed Objective: The EP, eligible hospital, or CAH provides 
access for patients to view online, download, and transmit their health 
information, or retrieve their health information through an API, 
within 24 hours of its availability.
    We continue to believe that patient access to their electronic 
health

[[Page 16754]]

information is a high priority for the EHR Incentive Programs. 
Furthermore, providing educational resources about a patient's health 
including recommendations for preventative care and screenings, 
identifying risk factors, and other important health resources can help 
to increase patient health literacy, empower patients to make more 
informed decisions, and support the efforts of providers in managing a 
patient care plan. We also believe that patient access to health 
information should be provided in the manner requested by the patient 
when possible.
    We note that for this objective, the provider is only required to 
provide access to the information through these means; the patient is 
not required to take action in order for the provider to meet this 
objective. In the Patient Electronic Access to Health Information 
objective, we note that ``provides access'' means that the patient has 
all the tools they need to gain access to their health information 
including any necessary instructions, user identification information, 
or the steps required to access their information if they have 
previously elected to ``opt-out'' of electronic access. If this 
information is provided to the patient in a clear and actionable 
manner, the provider may count the patient for this objective. 
Additionally, this objective should not require the provider to make 
extraordinary efforts to assist patients in use or access of the 
information, but the provider must inform patients of these options, 
and provide sufficient guidance so that all patients could leverage 
this access. The providers may withhold from online disclosure any 
information either prohibited by federal, state, or local laws or if 
such information provided through online means may result in 
significant harm. We also note, as we have previously, that this is a 
meaningful use requirement, which does not affect an individual's right 
under HIPAA to access his or her health information. Providers must 
continue to comply with all applicable requirements under the HIPAA 
Privacy Rule, including the access provisions of 45 CFR 164.524.
    Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy 
both measures in order to meet the objective:
    Proposed Measure 1: For more than 80 percent of all unique patients 
seen by the EP or discharged from the eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23):
    (1) The patient (or patient-authorized representative) is provided 
access to view online, download, and transmit their health information 
within 24 hours of its availability to the provider; or
    (2) The patient (or patient-authorized representative) is provided 
access to an ONC-certified API that can be used by third-party 
applications or devices to provide patients (or patient-authorized 
representatives) access to their health information, within 24 hours of 
its availability to the provider.
    Proposed Measure 2: The EP, eligible hospital or CAH must use 
clinically relevant information from CEHRT to identify patient-specific 
educational resources and provide electronic access to those materials 
to more than 35 percent of unique patients seen by the EP or discharged 
from the eligible hospital or CAH inpatient or emergency department 
(POS 21 or 23) during the EHR reporting period.
    We propose that for measure 1, the patient must be able to access 
this information on demand, such as through a patient portal, personal 
health record (PHR), or API and have everything necessary to access the 
information even if they opt out. All three functionalities (view, 
download, and transmit) or an API must be present and accessible to 
meet the measure. The functionality must support a patient's right to 
have his or her protected health information sent directly to a third 
party designated by the patient consistent with the provision of access 
requirements at 45 CFR 164.524(c) of the HIPAA Privacy Rule.
    However, if the provider can demonstrate that at least one 
application that leverages the API is available (preferably at no cost 
to the patient) and that more than 80 percent of all unique patients 
have been provided instructions on how to access the information; the 
provider need not create, purchase, or implement redundant software to 
enable view, download, and transmit capability independently of the 
API.
    We propose to increase the threshold for measure 1 from the Stage 1 
and Stage 2 threshold of 50 percent to a threshold of 80 percent for 
Stage 3. We believe that all patients should be provided access to 
their electronic health record; however, we are setting the threshold 
at 80 percent based on the highest threshold defined for measures based 
on unique patients seen by the provider during the EHR reporting period 
in the Stage 2 final rule (for example see 77 FR 53993). Based on the 
continued progress toward automation and standardization of data 
capture supported by CEHRT which facilitates a faster response time, we 
further propose to decrease patient wait time for the availability of 
information to within 24 hours of the office visit or of the 
information becoming available to the provider for potential inclusion 
in the case of lab or other test results which require sufficient time 
for processing and returning results.
    For measure 2, we propose to increase the threshold that was 
finalized in Stage 2 from 10 percent to 35 percent. We believe that the 
35 percent threshold both ensures that providers are using CEHRT to 
identify patient-specific education resources and is low enough to not 
infringe on the provider's freedom to choose education resources and to 
which patients these resources will be provided.
    We continue to propose that both measures for this objective must 
be met using CEHRT. For the purposes of meeting this objective, this 
would mean the capabilities provided by a patient portal, PHR, or any 
other means of online access that would permit a patient or authorized 
representatives to view, download, and transmit their personal health 
information and/or any API enabled, must be certified in accordance 
with the certification requirements adopted by ONC.
    We are proposing a continuation of the exclusion in Stage 2 for 
both EPs and eligible hospitals/CAHs in that any EP, eligible hospital, 
or CAH would be excluded from the first measure if it is located in a 
county that does not have 50 percent or more of their housing units 
with 4Mbps broadband availability according to the latest information 
available from the FCC at the start of the EHR reporting period. We 
continue to recognize that in areas of the country where a significant 
section of the patient population does not have access to broadband 
internet, this measure may be significantly harder or impossible to 
achieve. Finally, we propose an additional exclusion for EPs for Stage 
3, that any EP who has no office visits during the EHR reporting period 
may be excluded from the measures. We encourage comments on these 
exclusions and will evaluate them again in light of the public comments 
received.
    Proposed Measure 1: To calculate the percentage, CMS and ONC have 
worked together to define the following for this measure:
    Denominator: The number of unique patients seen by the EP or the 
number of unique patients discharged from an eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of patients in the denominator who are 
provided access to information within 24 hours of its availability to 
the EP or eligible hospital/CAH.

[[Page 16755]]

    Threshold: The resulting percentage must be more than 80 percent in 
order for a provider to meet this measure.
    Exclusions: An EP may exclude from the measure if they have no 
office visits during the EHR reporting period.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude the measure.
    Any eligible hospital or CAH will be excluded from the measure if 
it is located in a county that does not have 50 percent or more of 
their housing units with 4Mbps broadband availability according to the 
latest information available from the FCC at the start of the EHR 
reporting period.
    Proposed Measure 2: To calculate the percentage, CMS and ONC have 
worked together to define the following for this measure:
    Denominator: The number of unique patients seen by the EP or the 
number of unique patients discharged from an eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of patients in the denominator who were 
provided electronic access to patient-specific educational resources 
using clinically relevant information identified from CEHRT.
    Threshold: The resulting percentage must be more than 35 percent in 
order for a provider to meet this measure.
    Exclusions: An EP may exclude from the measure if they have no 
office visits during the EHR reporting period.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude the measure.
    Any eligible hospital or CAH will be excluded from the measure if 
it is located in a county that does not have 50 percent or more of 
their housing units with 4Mbps broadband availability according to the 
latest information available from the FCC at the start of the EHR 
reporting period.
    Alternate Proposals:
    We note that for measure one we are seeking comment on the 
following set of alternate proposals for providers to meet the measure 
using the functions of CEHRT outlined previously in this section. These 
alternate proposals involve the requirements to use a view, download, 
and transmit function or an API to provide patients access to their 
health information. We believe the current view, download, and transmit 
functions are widely in use and represent the current standard for 
patient access to their health record. However, we believe that the use 
of APIs could potentially replace this function and move toward a more 
accessible means for patients to access their information. Therefore, 
we are seeking comment on alternatives which would present a different 
mix of CEHRT functionality for providers to use for patients seeking to 
access their records. The proposed first measure discussed previously 
would allow providers the option either to give patients access to the 
view, download, and transmit functionality, or to give patients access 
to an API. Specifically, we are seeking comment on whether the API 
option should be required rather than optional for providers, and if 
so, should providers also be required to offer the view, download, and 
transmit function.
    Proposed Measure 1: For more than 80 percent of all unique patients 
seen by the EP or discharged from the eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23):
    (1) The patient (or patient-authorized representative) is provided 
access to view online, download, and transmit their health information 
within 24 hours of its availability to the provider; or
    (2) The patient (or the patient-authorized representative) is 
provided access to an ONC-certified API that can be used by third-party 
applications or devices to provide patients (or patient authorized 
representatives) access to their health information, within 24 hours of 
its availability to the provider.
    Alternate A: For more than 80 percent of all unique patients seen 
by the EP or discharged from the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23):
    (1) The patient (or the patient-authorized representative) is 
provided access to view online, download, and transmit his or her 
health information within 24 hours of its availability to the provider; 
and
    (2) The patient (or patient-authorized representatives) is provided 
access to an ONC-certified API that can be used by third-party 
applications or devices to provide patients (or patient authorized 
representatives) access to their health information within 24 hours of 
its availability to the provider.
    Alternate B: For more than 80 percent of all unique patients seen 
by the EP or discharged from the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23):
    (1) The patient (or patient-authorized representative) is provided 
access to view online, download, and transmit their health information 
within 24 hours of its availability to the provider; and the patient 
(or patient-authorized representative) is provided access to an ONC-
certified API that can be used by third-party applications or devices 
to provide patients (or patient authorized representatives) access to 
their health information within 24 hours of its availability to the 
provider; or,
    (2) The patient (or patient-authorized representatives) is provided 
access to an ONC-certified API that can be used by third-party 
applications or devices to provide patients (or patient authorized 
representatives) access to their health information within 24 hours of 
its availability to the provider.
    Alternate C: For more than 80 percent of all unique patients seen 
by the EP or discharged from the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23), the patient (or patient-authorized 
representative) is provided access to an ONC-certified API that can be 
used by third-party applications or devices to provide patients (or 
patient-authorized representatives) access to their health information, 
within 24 hours of its availability to the provider.
    These three alternate proposals would represent different use cases 
for the CEHRT function to support view, download, and transmit and/or 
API functionality. We note that under these proposed alternates the 
following mix of functions would be applicable: Alternate A would 
require both functions to be available instead of allowing the provider 
to choose between the two; Alternate B would require the provider to 
choose to have either both functions, or just an API function; and 
Alternate C would require the provider to only have the API function. 
For Alternate C, the use of a separate view, download, and transmit 
function would be entirely at the provider's discretion and not 
included as part of the definition of meaningful use.
    We welcome public comment on these proposals.
Objective 6: Coordination of Care Through Patient Engagement
    As mentioned previously, the Stage 1 and Stage 2 final rules 
included a number of objectives focused on patient access to health 
information and communication among providers, care teams, and 
patients. These patient engagement objectives focused on changing 
behaviors among providers and patients to promote patient

[[Page 16756]]

involvement in health care. Specifically, the objectives included 
supporting provider and patient communication about their health, 
improving overall patient health literacy, and supporting patient-
driven coordination with providers and other members of the patient's 
care team. The Stage 1 and Stage 2 objectives included patient 
reminders (77 FR 54005 through 54007), patient-specific education 
resources (77 FR 54011 through 54012), clinical summaries of office 
visits (77 FR 53998 through 54002), secure messaging (77 FR 54031 
through 54033), and the ability for patients to view, download, and 
transmit their health information to a third party (77 FR 54007 through 
54011). For Stage 3, as mentioned previously, we are proposing to 
incorporate the Stage 2 objectives related to providing patients with 
access to health information into a new Stage 3 objective entitled, 
``Patient Electronic Access'' (Objective 5). For the proposed objective 
entitled Coordination of Care through Patient Engagement (Objective 6), 
we are proposing to incorporate the policy goals of the Stage 2 
objectives related to secure messaging, patient reminders, and the 
measure of patient engagement requiring patients (or their authorized 
representatives) to view, download, and transmit their health 
information using the functionality of the certified EHR technology.
    As mentioned previously, while we believe there may be many methods 
of communication and information sharing among providers, or other care 
team members, and patients (including paper-based or telephone 
communications), meaningful use Stage 3 focuses exclusively on 
electronic, certified EHR technology supported communication in the 
requirements outlined in this proposed objective for Coordination of 
Care through Patient Engagement.
    Proposed Objective: Use communications functions of certified EHR 
technology to engage with patients or their authorized representatives 
about the patient's care.
    Specifically, this proposed rule focuses on encouraging the use of 
EHR functionality for secure dialogue and efficient communication 
between providers, care team members, and patients about their care and 
health status, as well as important health information such as 
preventative and coordinated care planning. In addition, certified EHR 
technology functions designed to support patient engagement can be a 
platform to securely capture and record patient-generated health data 
and information provided in non-clinical care settings.
    We are also proposing to expand the options through which providers 
may engage with patients under the EHR Incentive Programs including the 
use of APIs as mentioned previously. An API can enable a patient--
through a third-party application--to access and retrieve their health 
information from a care provider in a way that is most valuable to that 
particular patient.
    Therefore, we are proposing a meaningful use objective for Stage 3 
to support this provider and patient engagement continuum based on the 
foundation already created within the EHR Incentive Programs but using 
new methods and expanded options to advance meaningful patient 
engagement and patient-centered care. We also propose that for purposes 
of this objective, patient engagement may include patient-centered 
communication between and among providers facilitated by authorized 
representatives of the patient and of the EP, eligible hospital, or 
CAH. As care delivery evolves, the participation of a diverse group of 
care team members enables more robust care for the patient. Engagement 
between the patient and, for example, nutritionists, social workers, 
physical therapists, or other members of the provider's care team is 
crucial to effective patient engagement and are therefore included in 
this objective.
    For Stage 3 of meaningful use, we propose the following measures 
for the Patient Engagement Objective:
    Proposed Measures: We are proposing that providers must attest to 
the numerator and denominator for all three measures, but would only be 
required to successfully meet the threshold for two of the three 
proposed measures to meet the Coordination of Care through Patient 
Engagement Objective. These three measures support the communication 
continuum between providers, patients, and the patient's authorized 
representatives through the use of view, download, and transmit 
functionality. They also support using API functionality through 
patient engagement with their health data, but also potentially through 
secure messaging functions and standards, and the capture and inclusion 
of data collected from non-clinical settings, including patient-
generated health data.
    Proposed Measure 1: During the EHR reporting period, more than 25 
percent of all unique patients seen by the EP or discharged from the 
eligible hospital or CAH inpatient or emergency department (POS 21 or 
23) actively engage with the electronic health record made accessible 
by the provider. An EP, eligible hospital or CAH may meet the measure 
by either:
    (1) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP or discharged from the 
eligible hospital or CAH inpatient or emergency department (POS 21 or 
23) during the EHR reporting period view, download or transmit to a 
third party their health information; or
    (2) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP or discharged from the 
eligible hospital or CAH inpatient or emergency department (POS 21 or 
23) during the EHR reporting period access their health information 
through the use of an ONC-certified API that can be used by third-party 
applications or devices.
    Proposed Measure 2: For more than 35 percent of all unique patients 
seen by the EP or discharged from the eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period, a secure message was sent using the electronic 
messaging function of CEHRT to the patient (or the patient's authorized 
representatives), or in response to a secure message sent by the 
patient (or the patient's authorized representative).
    Proposed Measure 3: Patient-generated health data or data from a 
non-clinical setting is incorporated into the certified EHR technology 
for more than 15 percent of all unique patients seen by the EP or 
discharged by the eligible hospital or CAH inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period.
    For measure 1, we are proposing to increase the threshold for the 
measure from 5 percent to 25 percent based on provider performance on 
the related Stage 2 measure requiring more than 5 percent of patients 
to view, download, or transmit to a third party the health information 
made available to them by the provider. Stage 2 median performance for 
an EP on this measure is 32 percent and 11 percent for eligible 
hospitals.\11\ Therefore, we are proposing more than 25 percent of all 
unique patients (or the patient's authorized representatives) seen by 
the EP, eligible hospital or CAH during the EHR reporting period must 
view, download, or transmit to a third party their health information 
or access their health information through the use of an ONC-certified 
API that can be used by third-party applications or devices. For the 
API option, we propose that providers must attest that they have 
enabled an API and that at least one application

[[Page 16757]]

which leverages the API is available to patients (or the patient-
authorized representatives) to retrieve health information from the 
provider's certified EHR.
---------------------------------------------------------------------------

    \11\ Data can be found on CMS Web site Data and Program Reports 
page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------

    CMS recognizes that there may be inherent challenges in measuring 
patient access to CEHRT through third-party applications that utilize 
an ONC-certified API, and we solicit comment on the nature of those 
challenges and what solutions can be put in place to overcome them. For 
example, are there specific requirements around the use of APIs or are 
there specific certification requirements for APIs that could make the 
measurement of this objective easier. We also solicit comment on 
suggested alternate proposals for measuring patient access to CEHRT 
through third-party applications that utilize an API, including the 
pros and cons of measuring a minimum number of patients (one or more) 
who must access their health information through the use of an API in 
order to meet the measure of this objective.
    For measure 2, the EP, eligible hospital, CAH, or the provider's 
authorized representative must communicate with the patient (or the 
patient's authorized representatives), through secure electronic 
messaging for more than 35 percent of the unique patients seen by the 
provider during the EHR reporting period. ``Communicate'' means when a 
provider sends a message to a patient (or the patient's authorized 
representatives) or when a patient (or the patient's authorized 
representatives) sends a message to the provider. In patient-to-
provider communication, the provider must respond to the patient (or 
the patient's authorized representatives) for purposes of this measure. 
We propose to increase the threshold for this measure over the 
threshold for the Stage 2 measure because for Stage 3 provider 
initiated messages would count toward the measure numerator.
    For measure 2, we propose to include in the measure numerator 
situations where providers communicate with other care team members 
using the secure messaging function of certified EHR technology, and 
the patient is engaged in the message and has the ability to be an 
active participant in the conversation between care providers. However, 
we seek comment on how this action could be counted in the numerator, 
and the extent to which that interaction could or should be counted for 
eligible providers engaged in the communication. For example, should 
only the initiating provider be allowed to include the communication as 
an action in the numerator? Or, should any provider who contributes to 
such a message during the EHR reporting period be allowed to count the 
communication? In addition, we seek comment on what should be 
considered a contribution to the patient-centered communication; for 
example, a contribution must be active participation or response, a 
contribution may be viewing the communication, or a contribution may be 
simple inclusion in the communication.
    We specify that the secure messages sent should contain relevant 
health information specific to the patient in order to meet the measure 
of this objective. We believe the provider is the best judge of what 
health information should be considered relevant in this context. For 
the purposes of this measure, we are proposing that secure messaging 
content may include, but is not limited to, questions about test 
results, problems, and medications; suggestions for follow-up care or 
preventative screenings; confirmations of diagnosis and care plan 
goals; and information regarding patient progress. However, we note 
that messages with content exclusively relating to billing questions, 
appointment scheduling, or other administrative subjects should not be 
included in the numerator. For care team secure messaging with the 
patient included in the conversation, we also believe the provider may 
exercise discretion if further communications resulting from the 
initial action should be excluded from patient disclosure to prevent 
harm. We note that if such a message is excluded, all subsequent 
actions related to that message would not count toward the numerator.
    For measure 3, EPs, eligible hospitals, and CAHs (or their 
authorized representatives) must incorporate health data obtained from 
a non-clinical setting in a patient's electronic health record for more 
than 15 percent of unique patients seen during the EHR reporting 
period. We note that the use of the term ``clinical'' means different 
things in relation to place of service for billing for Medicare and 
Medicaid services. However, for purposes of this measure only, we are 
proposing that a non-clinical setting shall be defined as a setting 
with any provider who is not an EP, eligible hospital or CAH as defined 
for the Medicare and Medicaid EHR Incentive Programs. Therefore, for 
this measure, a non-clinical setting is any provider or setting of care 
which is not an EP, eligible hospital, or CAH in either the Medicare or 
Medicaid EHR Incentive Programs and where the care provider does not 
have shared access to the EP, eligible hospital, or CAHs certified EHR. 
This may include, but is not limited to, health and care-related data 
from care providers such as nutritionists, physical therapists, 
occupational therapists, psychologists, and home health care providers 
as well as data obtained from patients themselves. We specifically 
mention this last item and refer to this sub-category as patient-
generated health data, which may result from patient self-monitoring of 
their health (such as recording vital signs, activity and exercise, 
medication intake, and nutrition), either on their own, or at the 
direction of a member of the care team. We are proposing this measure 
in response to requests from providers to support the capture and 
incorporation of patient-generated health data, and the capture and 
incorporation of data from a non-clinical setting into an EHR. 
Providers have expressed a desire to have this information captured in 
a useful and structured way and made available in the EHR. The capture 
and incorporation of this information is an integral part of ensuring 
that providers and patients have adequate information to partner in 
making clinical care decisions, especially for patients with chronic 
disease and complex health conditions for whom self-monitoring is an 
important part of an ongoing care plan.
    We are seeking comment on how the information for measure 3 could 
be captured, standardized, and incorporated into an EHR. For the 
purposes of this measure, the types of data that would satisfy the 
measure is broad. It may include, but is not limited to social service 
data, data generated by a patient or a patient's authorized 
representatives, advance directives, medical device data, home health 
monitoring data, and fitness monitor data. In addition, the sources of 
data vary and may include mobile applications for tracking health and 
nutrition, home health devices with tracking capabilities such as 
scales and blood pressure monitors, wearable devices such as activity 
trackers or heart monitors, patient reported outcome data, and other 
methods of input for patient and non-clinical setting generated health 
data. We emphasize that these represent several examples of the data 
types that could be covered under this measure. We also note that while 
the scope of data covered by this measure is broad, it may not include 
data related to billing, payment, or other insurance information. As 
part of determining the proper scope of this measure, we are seeking 
comment on the following questions:
    <bullet> Should the data require verification by an authorized 
provider?

[[Page 16758]]

    <bullet> Should the incorporation of the data be automated?
    <bullet> Should there be structured data elements available for 
this data as fields in an EHR?
    <bullet> Should the data be incorporated in the CEHRT with or 
without provider verification?
    <bullet> Should the provenance of the data be recorded in all cases 
and for all types of data?
    We also seek comment on whether this proposed measure should have a 
denominator limited to patients with whom the provider has multiple 
encounters, such as unique patients seen by the provider two or more 
times during the EHR reporting period. We also seek comment on whether 
this measure should be divided into two distinct measures. The first 
measure would include only the specific sub-category of patient-
generated health data, or data generated predominantly through patient 
self-monitoring rather than by a provider. The second measure would 
include all other data from a non-clinical setting. This would result 
in the objective including four measures with providers having an 
option of which two measures to focus on for the EHR reporting period.
    We also seek comment on whether the third measure should be 
proposed for eligible hospitals and CAHs, or remain an option only for 
eligible professionals. For those commenters who believe it should not 
be applicable for eligible hospitals and CAHs, we seek further comment 
on whether eligible hospitals and CAHs should then choose one of the 
remaining two measures or be required to attest to both.
    Providers must attest to the numerator and denominator for all 
three measures, and must meet the threshold for two of the three 
measures to meet the objective for Stage 3 of meaningful use:
    Proposed Measure 1: We have identified the following for measure 1 
of this objective:
Option 1: View, Download, or Transmit to a Third Party
    Denominator: Number of unique patients seen by the EP, or the 
number of unique patients discharged from an eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of unique patients (or their authorized 
representatives) in the denominator who have viewed online, downloaded, 
or transmitted to a third party the patient's health information.
    Threshold: The resulting percentage must be more than 25 percent in 
order for an EP, eligible hospital, or CAH to meet this measure.
Option 2: API
    Denominator: The number of unique patients seen by the EP or the 
number of unique patients discharged from an eligible hospital or CAH 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of unique patients (or their authorized 
representatives) in the denominator who have accessed their health 
information through the use of an an ONC-certified API.
    Threshold: The resulting percentage must be more than 25 percent in 
order for an EP, eligible hospital, or CAH to meet this measure.
    Exclusions: Applicable for either option discussed previously, the 
following providers may exclude from the measure:
    Any EP who has no office visits during the EHR reporting period may 
exclude from the measure.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude from the measure.
    Any eligible hospital or CAH operating in a location that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measure.
    Measure 2: Denominator: Number of unique patients seen by the EP or 
the number of unique patients discharged from an eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of patients in the denominator for whom a 
secure electronic message is sent to the patient, the patient's 
authorized representatives, or in response to a secure message sent by 
the patient.
    Threshold: The resulting percentage must be more than 35 percent in 
order for an EP, eligible hospital, or CAH to meet this measure.
    Exclusion: Any EP who has no office visits during the EHR reporting 
period may exclude from the measure.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude from the measure.
    Any eligible hospital or CAH operating in a location that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measure.
    Measure 3: Denominator: Number of unique patients seen by the EP or 
the number of unique patients discharged from an eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    Numerator: The number of patients in the denominator for whom data 
from non-clinical settings, which may include patient-generated health 
data, is captured through the certified EHR technology into the patient 
record.
    Threshold: The resulting percentage must be more than 15 percent in 
order for an EP, eligible hospital, or CAH to meet this measure.
    Exclusion: Any EP who has no office visits during the EHR reporting 
period may exclude from the measure.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude from the measure.
    Any eligible hospital or CAH operating in a location that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measure.
    We seek comment on this proposed objective and the related proposed 
measures.
Objective 7: Health Information Exchange
    Improved communication between providers caring for the same 
patient can help providers make more informed care decisions and 
coordinate the care they provide. Electronic health records and the 
electronic exchange of health information, either directly or through 
health information exchanges, can reduce the burden of such 
communication. The purpose of this objective is to ensure a summary of 
care record is transmitted or captured electronically and incorporated 
into the EHR for patients seeking care among

[[Page 16759]]

different providers in the care continuum, and to encourage 
reconciliation of health information for the patient. This objective 
promotes interoperable systems and supports the use of CEHRT to share 
information among care teams.
    Proposed Objective: The EP, eligible hospital, or CAH provides a 
summary of care record when transitioning or referring their patient to 
another setting of care, retrieves a summary of care record upon the 
first patient encounter with a new patient, and incorporates summary of 
care information from other providers into their EHR using the 
functions of certified EHR technology.
    In the Stage 2 final rule at 77 FR 53983, we described transitions 
of care as the movement of a patient from one setting of care 
(hospital, ambulatory primary care practice, ambulatory specialty care 
practice, long-term care, home health, rehabilitation facility) to 
another. Referrals are cases where one provider refers a patient to 
another provider, but the referring provider also continues to provide 
care to the patient. In this rule, we also recognize there may be 
circumstances when a patient refers himself or herself to a setting of 
care without a provider's prior knowledge or intervention. These 
referrals may be included as a subset of the existing referral 
framework and they are an important part of the care coordination loop 
for which summary of care record exchange is integral. Therefore, a 
provider should include these instances in their denominator for the 
measures if the patient subsequently identifies the provider from whom 
they received care. In addition, the provider may count such a referral 
in the numerator for each measure if they undertake the action required 
to meet the measure upon disclosure and identification of the provider 
from whom the patient received care.
    In the Stage 2 final rule, we indicated that a transition or 
referral within a single setting of care does not qualify as a 
transition of care (77 FR 53983). We received public comments and 
questions requesting clearer characterization of when a setting of care 
can be considered distinct from another setting of care. For example, 
questions arose whether EPs who work within the same provider practice 
are considered the same or two distinct settings of care. Similarly, 
questions arose whether an EP who practices in an outpatient setting 
that is affiliated with an inpatient facility is considered a separate 
entity. Therefore, for the purposes of distinguishing settings of care 
in determining the movement of a patient, we explain that for a 
transition or referral, it must take place between providers which 
have, at the minimum, different billing identities within the EHR 
Incentive Programs, such as a different National Provider Identifiers 
(NPI) or hospital CMS Certification Numbers (CCN) to count toward this 
objective.
    Please note that a ``referral'' as defined here and elsewhere in 
this proposed rule only applies to the EHR Incentive Programs and is 
not applicable to other federal regulations.
    We stated in the Stage 2 proposed rule at 77 FR 13723 that if the 
receiving provider has access to the medical record maintained by the 
provider initiating the transition or referral, then the summary of 
care record would not need to be provided and that patient may be 
excluded from the denominators of the measures for the objective. We 
further note that this access may vary from read-only access of a 
specific record, to full access with authoring capabilities, depending 
on provider agreements and system implementation among practice 
settings. In many cases, a clinical care summary for transfers within 
organizations sharing access to an EHR may not be necessary, such as a 
hospital sharing their CEHRT with affiliated providers in ambulatory 
settings who have full access to the patient information. However, 
public comments received and questions submitted by the public on the 
Stage 2 Summary of Care Objective reveal that there may be benefits to 
the provision of a summary of care document following a transition or 
referral of a patient, even when access to medical records is already 
available. For example, a summary of care document would notify the 
receiving provider of relevant information about the latest patient 
encounter as well as highlight the most up-to-date information. In 
addition, the ``push'' of a summary of care document may function as an 
alert to the recipient provider of the transition that a patient has 
received care elsewhere and would encourage the provider to review a 
patient's medical record for follow-up care or reconciliation of 
clinical information.
    Therefore, we are revising this objective for Stage 3 to allow the 
inclusion of transitions of care and referrals in which the recipient 
provider may already have access to the medical record maintained in 
the referring provider's CEHRT, as long as the providers have different 
billing identities within the EHR Incentive Program. We note that for a 
transition or referral to be included in the numerator, if the 
receiving provider already has access to the CEHRT of the initiating 
provider of the transition or referral, simply accessing the patient's 
health information does not count toward meeting this objective. 
However, if the initiating provider also sends a summary of care 
document, this transition can be included in the denominator and the 
numerator, as long as this transition is counted consistently across 
the organization.
    Proposed Measures: We are proposing that providers must attest to 
the numerator and denominator for all three measures, but would only be 
required to successfully meet the threshold for two of the three 
proposed measures to meet the Health Information Exchange Objective.
    Proposed Measure 1: For more than 50 percent of transitions of care 
and referrals, the EP, eligible hospital or CAH that transitions or 
refers their patient to another setting of care or provider of care: 
(1) creates a summary of care record using CEHRT; and (2) 
electronically exchanges the summary of care record.
    Proposed Measure 2: For more than 40 percent of transitions or 
referrals received and patient encounters in which the provider has 
never before encountered the patient, the EP, eligible hospital or CAH 
incorporates into the patient's EHR an electronic summary of care 
document from a source other than the provider's EHR system.
    Proposed Measure 3: For more than 80 percent of transitions or 
referrals received and patient encounters in which the provider has 
never before encountered the patient, the EP, eligible hospital, or CAH 
performs a clinical information reconciliation. The provider must 
implement clinical information reconciliation for the following three 
clinical information sets:
    <bullet> Medication. Review of the patient's medication, including 
the name, dosage, frequency, and route of each medication.
    <bullet> Medication allergy. Review of the patient's known allergic 
medications.
    <bullet> Current Problem list. Review of the patient's current and 
active diagnoses.
    For the first measure, we are maintaining the requirements 
established in the Stage 2 final rule to capture structured data within 
the certified EHR and to generate a summary of care document using 
CEHRT for purposes of this measure (77 FR 54014). For purposes of this 
measure, we are requiring that the summary of care document created by 
CEHRT be sent electronically to the receiving provider.
    In the Stage 2 final rule at 77 FR 54016, we specified all summary 
of care documents must include the following

[[Page 16760]]

information in order to meet the objective, if the provider knows it:
    <bullet> Patient name.
    <bullet> Referring or transitioning provider's name and office 
contact information (EP only).
    <bullet> Procedures.
    <bullet> Encounter diagnosis.
    <bullet> Immunizations.
    <bullet> Laboratory test results.
    <bullet> Vital signs (height, weight, blood pressure, BMI).
    <bullet> Smoking status.
    <bullet> Functional status, including activities of daily living, 
cognitive and disability status.
    <bullet> Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
    <bullet> Care plan field, including goals and instructions.
    <bullet> Care team including the primary care provider of record 
and any additional known care team members beyond the referring or 
transitioning provider and the receiving provider.
    <bullet> Discharge instructions (Hospital Only).
    <bullet> Reason for referral (EP only).
    For the 2015 Edition proposed rule, ONC has proposed a set of 
criteria called the Common Clinical Data Set which include the required 
elements for the summary of care document, the standards required for 
structured data capture of each, and further definition of related 
terminology and use. Therefore, for Stage 3 of meaningful use we are 
proposing that summary of care documents used to meet the Stage 3 
Health Information Exchange objective must include the requirements and 
specifications included in the Common Clinical Data Set (CCDS) 
specified by ONC for certification to the 2015 Edition proposed rule 
published elsewhere in this issue of the Federal Register.
    We note that ONC's 2015 Edition proposed rule may include 
additional fields beyond those initially required for Stage 2 of 
meaningful use as new standards have been developed to accurately 
capture vital information on patient health. For example, the 2015 
Edition proposed rule includes a criterion and standard for capturing 
the unique device identifier (UDI) for implantable medical devices. The 
inclusion of the UDI in the CCDS reflects the understanding that UDIs 
are an important part of patient information that should be exchanged 
and available to providers who care for patients with implanted medical 
devices. Hundreds of thousands of Medicare beneficiaries receive some 
type of implantable medical device each year. Some implants require 
ongoing monitoring and medication for the device to perform 
effectively, such as a mechanical heart valve. Other implanted devices 
are affected by imaging procedures and are not MRI safe such as some 
pace makers. Even the variation between specific makes and models of 
similar devices may impact the clinical processes required to mitigate 
against patient safety risk. Without readily available data, the 
patient is put at risk if the provider does not have adequate knowledge 
of the existence and specific details of medical implants. Therefore, 
the documentation of UDIs in a patient medical record and the inclusion 
of that data field within the CCDS requirements for the summary of care 
documents is a key step toward improving the quality of care and 
ensuring patient safety. This example highlights the importance of 
capturing health data in a structured format using specified, 
transferable standards.
    In circumstances where there is no information available to 
populate one or more of the fields included in the CCDS, either because 
the EP, eligible hospital, or CAH can be excluded from recording such 
information (for example, vital signs) or because there is no 
information to record (for example, laboratory tests), the EP, eligible 
hospital, or CAH may leave the field blank and still meet the 
requirements for the measure.
    However, all summary of care documents used to meet this objective 
must be populated with the following information using the CCDS 
certification standards for those fields:
    <bullet> Current problem list (Providers may also include 
historical problems at their discretion).
    <bullet> A current medication list.
    <bullet> A current medication allergy list.
    We define allergy as an exaggerated immune response or reaction to 
substances that are generally not harmful. Information on problems, 
medications, and medication allergies could be obtained from previous 
records, transfer of information from other providers (directly or 
indirectly), diagnoses made by the EP or hospital, new medications 
ordered by the EP or in the hospital, or through querying the patient.
    We propose to maintain that all summary of care documents contain 
the most recent and up-to-date information on all elements. In the 
event that there are no current diagnoses for a patient, the patient is 
not currently taking any medications, or the patient has no known 
medication allergies; the EP, eligible hospital, or CAH must record or 
document within the required fields that there are no problems, no 
medications, or no medication allergies recorded for the patient to 
satisfy the measure of this objective. The EP or hospital must verify 
that the fields for problem list, medication list, and medication 
allergy list are not blank and include the most recent information 
known by the EP or hospital as of the time of generating the summary of 
care document.
    For summary of care documents at transitions of care, we encourage 
providers to send a list of items that he or she believes to be 
pertinent and relevant to the patient's care, rather than a list of all 
problems, whether active or resolved, that have ever populated the 
problem list. While a current problem list must always be included, the 
provider can use his or her judgment in deciding which items 
historically present on the problem list, medical history list (if it 
exists in CEHRT), or surgical history list are relevant given the 
clinical circumstances.
    Similarly, for Stage 3 we have received comments from stakeholders 
and through public forums and correspondence on the potential of 
allowing only clinically relevant laboratory test results and clinical 
notes (rather than all laboratory tests results and clinical notes) in 
the summary of care document for purposes of meeting the objective. We 
believe that while there may be a benefit and efficiency to be gained 
in the potential to limit laboratory test results or clinical notes to 
those most relevant for a patient's care; a single definition of 
clinical relevance may not be appropriate for all providers, all 
settings, or all individual patient diagnosis. Furthermore, we note 
that should a reasonable limitation around a concept of ``clinical 
relevance'' be added; a provider must still have the CEHRT 
functionality to include and send all labs or clinical notes. 
Therefore, we defer to provider discretion on the circumstances and 
cases wherein a limitation around clinical relevance may be beneficial 
and note that such a limitation would be incumbent on the provider to 
define and develop in partnership with their health IT developer as 
best fits their organizational needs and patient population. We specify 
that while the provider has the discretion to define the relevant 
clinical notes or relevant laboratory results to send as part of the 
summary of care record, providers must be able to provide all clinical 
notes or laboratory results through an electronic transmission of a 
summary of care document if that level of detail is subsequently 
requested by a provider receiving a transition of care or referral or 
the patient is transitioning to another setting of care. We note that 
this proposal would apply for lab results,

[[Page 16761]]

clinical notes, problem lists, and the care plan within the summary of 
care document.
    For the second measure, we are proposing to address the other end 
of the transition of care continuum. In the Stage 2 rule, we limited 
the action required by providers to sending an electronic transmission 
of a summary of care document. We did not have a related requirement 
for the recipient of that transmission. We did not adopt a 
certification requirement for the receiving end of a transition or 
referral or for the measure related to sending the summary, as that is 
a factor outside the sending provider's immediate control. However, in 
Stage 3 of meaningful use, we are proposing a measure for the provider 
as the recipient of a transition or referral requiring them to actively 
seek to incorporate an electronic summary of care document into the 
patient record when a patient is referred to them or otherwise 
transferred into their care. This proposal is designed to complete the 
electronic transmission loop and support providers in using CEHRT to 
support the multiple roles a provider plays in meaningful health 
information exchange.
    For the purposes of defining the cases in the denominator, we are 
proposing that what constitutes ``unavailable'' and therefore, may be 
excluded from the denominator, will be that a provider--
    <bullet> Requested an electronic summary of care record to be sent 
and did not receive an electronic summary of care document; and
    <bullet> Queried at least one external source via HIE functionality 
and did not locate a summary of care for the patient, or the provider 
does not have access to HIE functionality to support such a query.
    We seek comment on whether electronic alerts received by EPs from 
hospitals when a patient is admitted, seen in the emergency room or 
discharged from the hospital--so called ``utilization alerts''--should 
be included in measure two, or as a separate measure. Use of this form 
of health information exchange is increasingly rapidly, driven by 
hospital and EP efforts to improve care transitions and reduce 
readmissions. We also seek comment on which information from a 
utilization alert would typically be incorporated into a patient's 
record and how this is done today.
    For both the first and second measures, we are proposing that a 
provider may use a wide range of health IT system for health 
information exchange to receive or send an electronic summary of care 
document, but must use their certified EHR technology to create the 
summary of care document sent or to incorporate the summary of care 
document received into the patient record. We are also proposing that 
the receipt of the summary of care document (CCDA) may be passive 
(provider is sent the CCDA and incorporates it) or active (provider 
requests a direct transfer of the CCDA or provider queries an HIE for 
the CCDA). In the Stage 2 proposed rule, we noted the benefits of 
requiring standards for the transport mechanism for health information 
exchange consistently nationwide (77 FR 13723). We requested public 
comment in that proposed rule on the Nationwide Health Information 
Network specifications and a governance mechanism for health 
information exchange to be established by ONC. In the final rule, a 
governance mechanism option was included in the second measure for the 
Stage 2 summary of care objective at 77 FR 54020. In this Stage 3 
proposed rule, we again seek comment on a health information exchange 
governance mechanism. Specifically we seek comment on whether providers 
who create a summary of care record using CEHRT for purposes of Measure 
1 should be permitted to send the created summary of care record 
either--(1) through any electronic means; or (2) in a manner that is 
consistent with the governance mechanism ONC establishes for the 
nationwide health information network. We additionally seek comment on 
whether providers who are receiving a summary of care record using 
CEHRT for the purposes of Measure 2 should have a similar requirement 
for the transport of summary of care documents requested from a 
transitioning provider. Finally, we seek comment on how a governance 
mechanism established by ONC at a later date could be incorporated into 
the EHR Incentive Programs for purposes of encouraging interoperable 
exchange that benefits patients and providers, including how the 
governance mechanism should be captured in the numerator, denominator, 
and thresholds for both the first (send) and second (receive) measures 
of this Health Information exchange objective.
    For the third measure, we are proposing a measure of clinical 
information reconciliation which incorporates the Stage 2 objective for 
medication reconciliation and expands the options to allow for the 
reconciliation of other clinical information such as medication 
allergies, and problems which will allow providers additional 
flexibility in meeting the measure in a way that is relevant to their 
scope of practice. In the Stage 2 final rule, we outlined the benefits 
of medication reconciliation, which enables providers to validate that 
the patient's list of active medications is accurate (77 FR 54011 
through 54012). This activity improves patient safety, improves care 
quality, and improves the validity of information that the provider 
shares with others through health information exchange. We believe that 
reconciliation of medication allergies and problems affords similar 
benefits.
    For this proposed measure, we specify that the EP, eligible 
hospital, or CAH that receives the patient into their care should 
conduct the clinical information reconciliation. It is for the 
receiving provider that up-to-date information will be most crucial to 
make informed clinical judgments for patient care. We reiterate that 
this measure does not dictate what subset of information must be 
included in reconciliation. Information included in the process is 
determined by the provider's clinical judgment of what is most relevant 
to patient care.
    For this measure, we propose to define clinical information 
reconciliation as the process of creating the most accurate patient-
specific information in one or more of the specified categories by 
using the clinical information reconciliation capability of their 
certified EHR technology which will compare the ``local'' information 
to external/incoming information that is being incorporated into the 
certified EHR technology from any external source. We refer providers 
to the standards and certification criteria for clinical information 
reconciliation proposed in ONC's 2015 Edition proposed rule published 
elsewhere in this issue of the Federal Register.
    As with medication reconciliation, we believe that an electronic 
exchange of information following the transition of care of a patient 
is the most efficient method of performing clinical information 
reconciliation.
    We recognize that workflows to reconcile clinical information vary 
widely across providers and settings of care, and we request comment on 
the challenges that this objective might present for providers, and how 
such challenges might be mitigated, while preserving the policy intent 
of the measure. In particular, we solicit comment on the following:
    <bullet> Automation and Manual Reconciliation. The Stage 2 measure 
does not specify whether reconciliation must be automated or manual. 
Some providers have expressed concern over the automatic inclusion of 
data in the patient record from referring providers, while others have 
indicated that

[[Page 16762]]

requiring manual reconciliation imposes significant workflow burden. We 
also seek comment on whether the use and display of meta-tagged data 
could address concerns related to the origin of data and thereby permit 
more automated reconciliation of these data elements.
    <bullet> Review of Reconciled Information. Depending on clinical 
setting, this measure could be accomplished through manual 
reconciliation or through automated functionality. In either scenario, 
should the reconciliation or review of automated functionality be 
performed only by the same staff allowed under the Stage 3 requirements 
for the Computerized Provider Order Entry objective?
    <bullet> What impact would the requirement of clinical information 
reconciliation have on workflow for specialists? Are there particular 
specialties where this measure would be difficult to meet?
    <bullet> What additional exclusions, if any, should be considered 
for this measure?
    We also encourage comment on the proposal to require reconciliation 
of all three clinical information reconciliation data sets, or if we 
should potentially require providers to choose 2 of 3 information 
reconciliation data sets relevant to their specialty or patient 
population. We expect that most providers would find that conducting 
clinical information reconciliation for medications, medication 
allergies, and problem lists is relevant for every patient encountered. 
We solicit examples describing challenges and burdens that providers 
who deliver specialist care or employ unique clinical workflow 
practices may experience in completing clinical information 
reconciliation for all three data sets and whether an exclusion should 
be considered for providers for whom such reconciliation may not be 
relevant to their scope of practice or patient population. 
Additionally, we solicit comments around the necessity to conduct 
different types of clinical information reconciliation of data for each 
individual patient. For example, it is possible that the data for 
certain patients should always be reviewed for medication allergy 
reconciliation, when it may not be as relevant to other patient 
populations.
    We propose that to meet this objective, a provider must attest to 
the numerator and denominator for all three measures but would only be 
required to successfully meet the threshold for two of the three 
proposed measures. We invite public comment on this proposal.
    Measure 1: To calculate the percentage of the first measure, CMS 
and ONC have worked together to define the following for this measure:
    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 exchanged electronically.
    Threshold: The percentage must be more than 50 percent in order for 
an EP, eligible hospital, or CAH to meet this measure.
    Exclusion: An EP neither transfers a patient to another setting nor 
refers a patient to another provider during the EHR reporting period.
    * Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude the measures.
    Any eligible hospital or CAH will be excluded from the measure if 
it is located in a county that does not have 50 percent or more of 
their housing units with 4Mbps broadband availability according to the 
latest information available from the FCC at the start of the EHR 
reporting period.
    Measure 2: To calculate the percentage of the second measure, CMS 
and ONC have worked together to define the following for this measure:
    Denominator: Number of patient encounters during the EHR reporting 
period for which an EP, eligible hospital, or CAH was the receiving 
party of a transition or referral or has never before encountered the 
patient and for which an electronic summary of care record is 
available.
    Numerator: Number of patient encounters in the denominator where an 
electronic summary of care record received is incorporated by the 
provider into the certified EHR technology.
    Threshold: The percentage must be more than 40 percent in order for 
an EP, eligible hospital, or CAH to meet this measure.
    Exclusion: Any EP, eligible hospital or CAH for whom the total of 
transitions or referrals received and patient encounters in which the 
provider has never before encountered the patient, is fewer than 100 
during the EHR reporting period is excluded from this measure.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude the measures.
    Any eligible hospital or CAH will be excluded from the measure if 
it is located in a county that does not have 50 percent or more of 
their housing units with 4Mbps broadband availability according to the 
latest information available from the FCC at the start of the EHR 
reporting period.
    Measure 3: To calculate the percentage, CMS and ONC have worked 
together to define the following for this measure:
    Denominator: Number of transitions of care or 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 recipient of 
the transition or referral or has never before encountered the patient.
    Numerator: The number of transitions of care or referrals in the 
denominator where the following three clinical information 
reconciliations were performed: medication list, medication allergy 
list, and current problem list.
    Threshold: The resulting percentage must be more than 80 percent in 
order for an EP, eligible hospital, or CAH to meet this measure.
    Exclusion: Any EP, eligible hospital or CAH for whom the total of 
transitions or referrals received and patient encounters in which the 
provider has never before encountered the patient, is fewer than 100 
during the EHR reporting period is excluded from this measure.
    Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude the measure.
    Any eligible hospital or CAH will be excluded from the measure if 
it is located in a county that does not have 50 percent or more of 
their housing units with 4Mbps broadband availability according to the 
latest information available from the FCC at the start of the EHR 
reporting period.
    We welcome comment on these proposals.
    Objective 8: Public Health and Clinical Data Registry Reporting

[[Page 16763]]

    This objective builds on the requirements set forth in the Stage 2 
final rule (77 FR 54021 through 54026). In addition, this objective 
includes improvements to the Stage 2 measures, supports innovation that 
has occurred since the Stage 2 rule was released, and adds flexibility 
in the options that an eligible provider has to successfully report.
    Further, this objective places increased focus on the importance of 
the ongoing lines of communication that should exist between providers 
and public health agencies (PHAs) or as further discussed later in this 
section, between providers and clinical data registries (CDRs). 
Providers' use of certified EHR technology can increase the flow of 
secure health information and reduce the burden that otherwise could 
attach to these important communications. The purpose of this Stage 3 
objective is to further advance communication between providers and 
PHAs or CDRs, as well as strengthen the capture and transmission of 
such health information within the care continuum.
    In this Stage 3 proposed rule, we are proposing 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. We propose to include a new measure for case 
reporting to reflect the diverse ways that providers can electronically 
exchange data with PHAs and CDRs. In addition, we are using new terms 
such as public health registries and clinical data registries to 
incorporate the Stage 2 designations for cancer registries and 
specialized registries under these categories which are used in the 
health care industry to designate a broader range of registry types. We 
further explain the use of these terms within the specifications 
outlined for each applicable measure.
    Proposed Objective: The EP, eligible hospital, or CAH is in active 
engagement with a PHA or 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.
    For Stage 3, we are proposing to remove the prior ``ongoing 
submission'' requirement and replace it with an ``active engagement'' 
requirement. Depending on the measure, the ongoing submission 
requirement from the Stage 1 and Stage 2 final rules required the 
successful ongoing submission of applicable data from certified EHR 
technology to a PHA or CDR for the entire EHR reporting period. As part 
of the Stage 2 final rule, we provided examples demonstrating how 
ongoing submission could satisfy the measure (77 FR 54021). However, 
stakeholders noted that the ongoing submission requirement does not 
accurately capture the nature of communication between providers and a 
PHA or CDR, and does not consider the many steps necessary to arrange 
for registry submission to a PHA or CDR. Given this feedback, we 
believe that ``active engagement'' as defined later in this section is 
more aligned with the process providers undertake to report to a CDR 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 also propose to provide support to providers seeking to meet the 
requirements of this objective by creating a centralized repository of 
national, state, and local PHA and CDR readiness. In the Stage 2 final 
rule (77 FR 54021), we noted the benefits of developing a centralized 
repository where a PHA could post readiness updates regarding their 
ability to accept electronic data using specifications prescribed by 
ONC for the public health objectives. We also published, pursuant to 
the Paperwork Reduction Act of 1995, a notice in the Federal Register 
on February 7, 2014 soliciting public comment on the proposed 
information collection required to develop the centralized repository 
on public health readiness (79 FR 7461). We considered the comments and 
we now propose moving forward with the development of the centralized 
repository. The centralized repository is integral to meaningful use 
and is expected to be available by the start of CY 2017. We expect that 
the centralized repository will include readiness updates for PHAs and 
CDRs at the state, local, and national level. We welcome your comments 
on the use and structure of the centralized repository.
    Proposed Measures: We are proposing a total of six possible 
measures for this objective. EPs would be required to choose from 
measures 1 through 5, and would be required to successfully attest to 
any combination of three measures. Eligible hospitals and CAHs would be 
required to choose from measures one through six, and would be required 
to successfully attest to any combination of four measures. The 
measures are as shown in Table 5. As noted, measures four and five 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 16764]]



   Table 5--Measures for Objective 8: Public Health And Clinical Data
                      Registry Reporting Objective
------------------------------------------------------------------------
                                                           Maximum times
                                           Maximum times    measure can
                                            measure can    count towards
                 Measure                   count towards   objective for
                                           objective for     eligible
                                                EP          hospital or
                                                                CAH
------------------------------------------------------------------------
Measure 1--Immunization Registry                       1               1
 Reporting..............................
Measure 2--Syndromic Surveillance                      1               1
 Reporting..............................
Measure 3--Case Reporting...............               1               1
Measure 4--Public Health Registry                      3               4
 Reporting*.............................
Measure 5--Clinical Data Registry                      3               4
 Reporting**............................
Measure 6--Electronic Reportable                     N/A               1
 Laboratory Results.....................
------------------------------------------------------------------------
* EPs, eligible hospitals, and CAHs may choose to report to more than
  one public health registry 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 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 three measures. Instead, in order to meet this 
objective, an EP would need to meet three 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 
three, the EP can meet the objective by meeting all of the remaining 
measures available to them and claiming the applicable exclusions. 
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 four measures. Instead, in 
order to meet this objective an eligible hospital or CAH would need to 
meet four 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 four, the eligible hospital or CAH can meet the 
objective by meeting all of the remaining measures available to them 
and claiming the applicable exclusions. 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 will aid the 
provider's ability to care for their patients.
    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 Stage 3 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 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 
published by ONC elsewhere in this issue of the Federal Register, 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 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 for Measure 1: 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: (1) 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; (2) 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; or (3) operates in a 
jurisdiction where no immunization registry or immunization information 
system has declared readiness to receive immunization data 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 
Stage 3 because electronic syndromic surveillance is valuable for early 
detection of outbreaks, as well as monitoring disease and condition 
trends. We are

[[Page 16765]]

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 later in this 
section.
    Exclusion for EPs for Measure 2: Any EP meeting one or more of the 
following criteria may be excluded from the syndromic surveillance 
reporting measure if the EP: (1) Does not treat or diagnose or directly 
treat any disease or condition associated with a syndromic surveillance 
system in their jurisdiction; (2) 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 (3) 
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 for Measure 2: 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: (1) Does not have an emergency or urgent care 
department; (2) 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 
(3) 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. However, electronic case reporting 
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 will 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, published elsewhere in this issue of the Federal 
Register.
    Exclusion for Measure 3: 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: (1) 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; (2) 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 (3) 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 reponses to the February 2014 
Public Health Reporting RFI; 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 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 will 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 final rule ``2014 Edition, Release 2 EHR 
Certification Criteria and the ONC HIT Certification Program; 
Regulatory Flexibilities, Improvements, and Enhanced Health Information 
Exchange'' (79 FR 54468) and we 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

[[Page 16766]]

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 registry 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. We note that cancer case reporting is not an option for 
eligible hospitals and CAHs under this measure because hospitals have 
traditionally diagnosed or treated cancers and have the infrastructure 
needed to report cancer cases.
    Exclusions for Measure 4: 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: 
(1) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in their jurisdiction during 
the EHR reporting period; (2) 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 (3) 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.\12\ 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.
---------------------------------------------------------------------------

    \12\ 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 one clinical data registry to meet the 
total number of required measures for this objective. ONC will 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.
    Exclusions for Measure 5: 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: (1) Does not diagnose or directly treat any disease or 
condition associated with a clinical data registry in their 
jurisdiction during the EHR reporting period; (2) 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 (3) 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 Stage 3 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 for Measure 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 if the eligible hospital 
or CAH: (1) Does not perform or order laboratory tests that are 
reportable in their jurisdiction during the EHR reporting period; (2) 
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 (3) operates in 
a jurisdiction where no public health agency has declared readiness to 
receive electronic reportable laboratory results from an eligible 
hospital or CAH at the start of the EHR reporting period.
    The Use of CEHRT for the Public Health and Clinical Data Registry 
Reporting Objective
    As proposed previously, the Public Health and Clinical Data 
Registry Reporting objective requires active engagement with a public 
health agency to submit electronic public health data from certified 
EHR technology. ONC defined the standards and certification criteria to 
meet the definition of CEHRT in its 2011, 2014, and 2014 Release 2 
Edition EHR certification criteria rules (see section II.B. of the 
``2014 Edition, Release 2 EHR Certification Criteria and the ONC HIT 
Certification Program; Regulatory Flexibilities, Improvements, and 
Enhanced Health Information Exchange'' for a full description of ONC's 
regulatory history; (79 FR 54434)). For example, ONC adopted standards 
for immunization reporting (see Sec.  170.314(f)(1) and (f)(2)), 
inpatient syndromic surveillance (see Sec.  170.314(f)(3) and (f)(7)), 
ELR (see Sec.  170.314(f)(4)), and cancer case reporting (see Sec.  
170.314(f)(5) and (f)(6)) in its 2014 Edition final rule.
    We support ONC's intent to promote standardized and interoperable 
exchange of public health data across the country. Therefore, to meet 
all of the measures within this public health objective EPs, eligible 
hospitals, and CAHs must use CEHRT as we propose to define it under 
Sec.  495.4 in this proposed rule and use the standards included in the 
2015 Edition proposed rule published elsewhere in this edition of the 
Federal Register. We anticipate that as new public health registries 
and clinical data registries are created, ONC and CMS will work with 
the public health community and clinical specialty societies to develop 
ONC-certified

[[Page 16767]]

electronic reporting standards for those registries so that providers 
have the option to count participation in those registries under the 
measures of this objective. ONC will look to adopt such standards, as 
appropriate, in future rules published by ONC.
    We welcome public comment on these proposals.

II. Provisions of the Proposed Regulations

A. Meaningful Use Requirements, Objectives and Measures

2. Certified EHR Technology (CEHRT) Requirements
    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 under 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 under 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).
    On September 4, 2014, CMS and ONC published a final rule in the 
Federal Register (79 FR 52910 through 52933) that, among other things, 
modified the meaningful use requirements for 2014 and the CEHRT 
definition.
    First, we granted flexibility to providers who experienced product 
availability issues that affected their ability to fully implement EHR 
technology certified to the 2014 Edition of certification criteria (79 
FR 52913 through 52926). We allowed those EPs, eligible hospitals, and 
CAHs to continue using either EHR technology certified to the 2011 
Edition, or a combination of EHR technology certified to the 2011 
Edition and 2014 Edition, for the EHR reporting periods in CY 2014 and 
FY 2014. EPs, eligible hospitals, and CAHs could take one of these 
approaches if they were unable to fully implement EHR technology 
certified to the 2014 Edition for an EHR reporting period in 2014 due 
to delays in the availability of EHR technology certified to the 2014 
Edition.
    Second, we established that in order to receive an incentive 
payment for 2014 under Medicaid for adopting, implementing, or 
upgrading CEHRT, a provider must adopt, implement, or upgrade to EHR 
technology certified to the 2014 Edition and meet the CEHRT definition 
(79 FR 52925 through 52926).
    Finally, ONC revised the CEHRT definition under 45 CFR 170.102 to 
align with our policy allowing for the use of EHR technology certified 
to the 2011 Edition, or a combination of EHR technology certified to 
the 2011 Edition and 2014 Edition, in 2014 (79 FR 52930).
    For further detail on the changes to the requirements for 2014 and 
CEHRT definition, we refer readers to the 2014 CEHRT Flexibility final 
rule (79 FR 52910 through 52933).
a. CEHRT Definition for the EHR Incentive Programs
    As we have stated previously in rulemaking, the statute and 
regulations require EPs, eligible hospitals, and CAHs to use 
``Certified EHR Technology'' if they are to be considered meaningful 
EHR users and eligible for incentive payments under Medicare or 
Medicaid, and to avoid payment adjustments under Medicare (for example, 
see section 1848(o)(2)(A)(i) of the Act, and 42 CFR 495.4). However, in 
contrast to prior rulemaking cycles where ONC has established a 
meaningful-use-specific CEHRT definition for the EHR Incentive Programs 
that CMS has adopted by cross-reference under 42 CFR 495.4, we propose 
to take a different approach under which we would define the term 
``Certified EHR Technology,'' and that definition would be specific to 
the EHR Incentive Programs.
    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 EHR Incentive Programs is clearly 
referenced in CMS regulations. For example, ONC's definition of CEHRT 
under 45 CFR 170.102 includes the compliance dates for EPs, eligible 
hospitals, and CAHs to use EHR technology certified to a particular 
edition of certification criteria to meet the CEHRT definition and for 
purposes of the EHR Incentive Programs, such as the requirement to use 
EHR technology certified to the 2014 Edition beginning in 2015. Under 
the proposed new approach, we would establish through rulemaking for 
the EHR Incentive Programs (either with stand-alone rulemaking or 
through other vehicles such as the annual Medicare payment rules) the 
compliance dates by which providers must use EHR technology certified 
to a particular edition of certification criteria to meet the CEHRT 
definition, which would be reflected in our regulations under 42 CFR 
part 495 rather than ONC's regulations under 45 CFR part 170.
b. Defining CEHRT for 2015 Through 2017 and for 2018 and Subsequent 
Years
    In adopting a CEHRT definition specific for the EHR Incentive 
Programs, we propose to include, as currently for the ONC CEHRT 
definition under 45 CFR 170.102, the relevant Base EHR definitions 
adopted by ONC in 45 CFR 170.102 and other ONC certification criteria 
relevant to the EHR Incentive Programs. We refer readers to ONC's 2015 
Edition proposed rule published elsewhere in this issue of the Federal 
Register for the proposed 2015 Edition Base EHR definition and 
discussion of the 2014 Edition Base EHR definition. We are including 
the Base EHR definition(s) because as ONC explained in the 2014 Edition 
final rule ``2014 Edition, Release 2 EHR Certification Criteria and the 
ONC HIT Certification Program; Regulatory Flexibilities, Improvements, 
and Enhanced Health Information Exchange'' (77 FR 54443 through 54444) 
the ``Base EHR'' essentially serves as a substitute for the term 
``Qualified EHR'' in the definition of CEHRT. The term ``Qualified 
EHR'' is defined in section 3000(13) of the PHSA, to include certain 
capabilities listed in that section, and is included in the statutory 
definition of ``certified EHR technology'' for the EHR Incentive 
Programs (for example, see section 1848(o)(4) of the Act). The Base EHR 
definition(s) also include additional capabilities as proposed by ONC 
that we agree all providers should have that are participating in the 
EHR Incentive Programs to support their attempts to meet meaningful use 
objectives and measures as well as interoperable health information 
exchange.
    We propose to define the editions of certification criteria that 
may be used for years 2015 through 2017 to meet the CEHRT definition. 
At a minimum, EPs, eligible hospitals, and CAHs would be required to 
use EHR technology certified to the 2014 Edition certification criteria 
for their respective EHR reporting periods in 2015 through 2017. A 
provider may also upgrade to the 2015 Edition prior to 2018 to meet the 
required certified EHR technology definition for the EHR reporting 
periods in 2015, 2016, or 2017, or they may use a combination of 2014 
and 2015 Editions prior to 2018 if they have modules from both Editions 
which meet the requirements for the objectives and measures or if they 
fully upgrade during an EHR reporting period.

[[Page 16768]]

    Based on experience with delays in the availability of EHR 
technology certified to the 2014 Edition for providers to implement and 
use to meet meaningful use for an EHR reporting period in 2014, we 
propose to include as part of the CEHRT definition a longer period of 
time for providers to use technology certified to the 2014 Edition in 
an effort to give providers more time in updating their technology to 
the 2015 Edition before the EHR reporting period in 2018. We also 
propose to make the use of a combination of technology certified to the 
2014 Edition and 2015 Edition to meet the CEHRT definition more 
flexible in 2015 through 2017 by taking into account ONC's proposed new 
privacy and security certification approach for health IT (see ONC's 
2015 Edition proposed rule published elsewhere in this issue of the 
Federal Register). Specifically, as a provider updates to technology 
certified to the 2015 Edition, the provider would not necessarily need 
to continue to meet the privacy and security capability requirements of 
the 2014 Edition Base EHR definition because the technology they adopt 
certified to the 2015 Edition would include necessary privacy and 
security capabilities. Additionally, because ONC is proposing, for the 
2015 Edition, to no longer require certification of Health IT Modules 
to capabilities that support meaningful use objectives with percentage-
based measures, we propose to include these capabilities (45 CFR 
170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2)), as applicable, in 
the CEHRT definition for 2015 through 2017 so that providers have 
technology that can appropriately record and calculate meaningful use 
measures. We note that there are many combinations of 2014 and 2015 
Edition certified technologies that could be used to successfully meet 
the transitions of care requirements included in the 2014 and 2015 
Edition Base EHR definitions for the purposes of meeting meaningful use 
objectives and measures. We believe we have identified all combinations 
in the proposed regulation text under Sec.  495.4 that could be used to 
meet the CEHRT definition through 2017 and be used for the purposes of 
meeting meaningful use objectives and measures. We welcome comments on 
the accuracy of the identified available options.
    We propose that starting with 2018, all EPs, eligible hospitals, 
and CAHs would be required to use technology certified to the 2015 
Edition to meet the CEHRT definition and demonstrate meaningful use for 
an EHR reporting period in 2018 and subsequent years. The CEHRT 
definition would include, for the reasons discussed previously, meeting 
the 2015 Edition Base EHR definition and having other important 
capabilities, that include the capabilities to--
    <bullet> Record or create and incorporate family health history;
    <bullet> Capture patient health information such as advance 
directives;
    <bullet> Record numerators and denominators for meaningful use 
objectives with percentage-based measures and calculate the 
percentages;
    <bullet> Calculate and report clinical quality measures; and
    <bullet> Any other capabilities needed to be a Meaningful EHR User.
    For information on 2015 Edition certification criteria that include 
these capabilities and are associated with proposed Meaningful Use 
objectives for Stage 3, please see the 2015 Edition proposed rule 
published elsewhere in this issue of the Federal Register. We expect 
that the certification criteria with capabilities that support CQM 
calculation and reporting would be jointly proposed with CQM reporting 
requirements in a separate rulemaking.
c. Proposed Definition for CEHRT
    For the reasons stated previously, we propose to adopt a definition 
of Certified EHR Technology under 42 CFR 495.4 for the Medicare and 
Medicaid EHR Incentive Programs that would apply for the EHR reporting 
periods in 2015 up to and including 2017 and for the EHR reporting 
periods in 2018 and subsequent years. We refer readers to ONC's 2015 
Edition proposed rule published elsewhere in this issue of the Federal 
Register for further explanation of the concepts and terms used in our 
proposed definition of Certified EHR Technology, including the 2014 
Edition Base EHR definition, 2015 Edition Base EHR definition, 
certification criteria, and the regulation text under 45 CFR part 170.

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

1. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 
2017 and Subsequent Years
    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 regard to the selection of CQMs, we expect to continue to 
include CQMs that align with the National Quality Strategy; as well as, 
the our Quality Strategy. We also expect to consider programmatic goals 
and outcome measures that would advance patient and population health.
a. Clinical Quality Measure Reporting Requirements for EPs
    Section 1848(o)(2)(B)(iii) of the Act requires that in selecting 
measures for EPs for the Medicare EHR Incentive Program, and in 
establishing the form and manner of reporting, the Secretary shall seek 
to avoid redundant or duplicative reporting, including reporting under 
subsection (k)(2)(C) for the Physician Quality Reporting System (PQRS). 
Consistent with that requirement, in the Stage 2 final rule, we 
finalized a policy to align certain aspects of reporting CQMs for the 
Medicare EHR Incentive Program for EPs with reporting under the PQRS. 
Specifically, we stated that Medicare EPs who participate in both the 
PQRS and the Medicare EHR Incentive Program will satisfy the CQM 
reporting component of meaningful use if they submit and satisfactorily 
report PQRS CQMs under the PQRS's EHR reporting option using CEHRT (77 
FR 54058).
    Section 1848(m)(7) of the Act requires the Secretary to develop a 
plan to integrate reporting on quality measures under the PQRS with 
reporting requirements under the Medicare EHR Incentive Program 
relating to the meaningful use of electronic health records. Therefore, 
it is our goal to align the reporting requirements for the CQM 
component of meaningful use under the Medicare EHR Incentive Program 
and for PQRS wherever possible. Historically, most requirements for the 
Medicare and Medicaid EHR Incentive Programs have been established 
through stand-alone rulemaking, such as the rules for Stage 1 (75 FR 
44314 through 44588) and Stage 2 (77 FR 53968 through 54162), which 
span multiple program years. This limited our ability to align the EHR 
Incentive Program with the requirements established in the annual 
Medicare payment rules for other CMS quality programs affecting 
physicians and other EPs.
    To further our goals of alignment and avoiding redundant or 
duplicative reporting across the various CMS quality reporting 
programs, we intend to address CQM reporting requirements for the 
Medicare and Medicaid EHR Incentive Program for EPs for 2017 and 
subsequent years in the Medicare Physician Fee Schedule (PFS) 
rulemaking, which also establishes the requirements for PQRS and other

[[Page 16769]]

quality programs affecting EPs. We note that the form and manner of 
reporting of CQMs for Medicare EPs would also be included in the PFS, 
while for Medicaid we would continue to allow the states to determine 
form and method requirements subject to CMS approval. We propose to 
continue the policy of establishing certain CQM requirements that apply 
for both the Medicare and Medicaid EHR Incentive Programs including a 
common set of CQMs and the reporting periods for CQMs in the EHR 
Incentive Programs. However, we believe that receiving and reviewing 
public comments for various CMS quality programs at one time (for 
example, EHR Incentive Program, PQRS, Physician Compare); and 
finalizing the requirements for these programs simultaneously, would 
allow us to better align these programs for EPs to support streamlined 
reporting and program efficacy. We propose to continue to support 
active communication with providers to facilitate the sharing of 
information related to CQM selection and reporting, the announcement of 
opportunities for public comment on CQM selection and reporting, and 
upcoming or relevant CQM program milestones in partnership with state 
Medicaid programs and the Medicare quality reporting programs. We 
propose to continue to post the defined CQM sets and the published 
electronic specifications for CQM that are in use for all aligned 
programs on the CMS Web site as currently posted on the eCQM Library 
page: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html.
b. CQM Reporting Requirements for Eligible Hospitals and Critical 
Access Hospitals
    Section 1886(n)(3)(B)(iii) of the Act requires that, in selecting 
measures for eligible hospitals for the Medicare EHR Incentive Program, 
and establishing the form and manner for reporting measures, the 
Secretary shall seek to avoid redundant or duplicative reporting with 
reporting otherwise required, including reporting under section 
1886(b)(3)(B)(viii) of the Act, the Hospital IQR Program.
    Similar to our intentions for EPs discussed previously, and to 
further our alignment goal among CMS quality reporting programs for 
eligible hospitals and CAHs, and avoid redundant or duplicative 
reporting among hospital programs, we intend to address CQM reporting 
requirements for the Medicare and Medicaid EHR Incentive Program for 
eligible hospitals and CAHs for 2016, 2017, and future years, in the 
Inpatient Prospective Payment System (IPPS) rulemaking. IPPS rulemaking 
also establishes the requirements for the Hospital IQR Program and 
other quality programs affecting hospitals. We intend to include all 
Medicare EHR Incentive Program requirements related to CQM reporting in 
the IPPS rulemaking including, but not limited to, new program 
requirements, reporting requirements, reporting and submission periods, 
reporting methods, and information regarding the CQMs. As with EPs, for 
the Medicaid EHR Incentive Program we would continue to allow the 
states to determine form and method requirements subject to CMS 
approval. However, as previously noted, this proposal would continue 
the policy of establishing certain CQM requirements that apply for both 
the Medicare and Medicaid EHR Incentive Programs including a common set 
of CQMs and the reporting periods for CQMs in the EHR Incentive 
Programs. We believe that receiving and reviewing public comments for 
various CMS quality programs at one time and finalizing the 
requirements for these programs simultaneously would allow us to better 
align these programs for eligible hospitals and CAHs, allow more 
flexibility into the Medicare and Medicaid EHR Incentive Programs, and 
add overall value and consistency by providing us the opportunity to 
address public comments that affect multiple programs at one time. We 
propose to continue to support active communication with providers to 
facilitate the sharing of information related to CQM selection and 
reporting, the announcement of opportunities for public comment on CQM 
selection and reporting, and upcoming or relevant CQM program 
milestones in partnership with state Medicaid programs and the Medicare 
quality reporting programs. We propose to continue to post the defined 
CQM sets and the published electronic specifications for CQM that are 
in use for all aligned programs on the CMS Web site as currently posted 
on the eCQM Library page: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html.
2. CQM Reporting Period
    In the Stage 2 final rule, we finalized a reporting period for CQMs 
for EPs, eligible hospitals, and CAHs (see 77 FR 54049 through 54051). 
In the FY 2015 IPPS final rule, we began to shift CQM reporting to a 
calendar year basis for eligible hospitals and CAHs for the Medicare 
EHR Incentive Program (79 FR 50319 through 50321). We established that 
for eligible hospitals and CAHs that submit CQMs electronically in 
2015, the reporting period is one calendar quarter from Q1, Q2, or Q3 
of CY 2015 (79 FR 50321).
    As discussed in sections II.A.1.c.(1).(b).(i). and II.F. of this 
proposed rule, we are proposing to require an EHR reporting period of 1 
full calendar year for meaningful use for providers participating in 
the Medicare EHR Incentive Program, with a limited exception for 
Medicaid providers demonstrating meaningful use for the first time. We 
are proposing to require the same length for the CQM reporting period 
for EPs, eligible hospitals, and CAHs beginning in 2017. As noted, we 
are proposing a limited exception for Medicaid providers demonstrating 
meaningful use for the first time who would have a CQM reporting period 
of any continuous 90 days that is the same 90-day period as their EHR 
Reporting Period.
    We believe full year reporting would allow for the collection of 
more comparable data across CMS quality programs and increase alignment 
across those programs. The more robust data set provided by a full year 
reporting period offers more opportunity for alignment than the data 
set provided by a shorter reporting period, especially compared across 
years. We further believe this full calendar year reporting period for 
CQMs would reduce the complexity of reporting requirements for the 
Medicare EHR Incentive Program by streamlining the reporting timeline 
for providers for CQMs and meaningful use objectives and measures. We 
welcome comment on the following proposals.
a. CQM Reporting Period for EPs
    With the previously stated considerations in mind, and in an effort 
to align with other CMS quality reporting programs such as the PQRS, we 
propose to require for CQM reporting under the EHR Incentive Program a 
reporting period of one full calendar year for all EPs participating in 
the Medicare and Medicaid EHR Incentive Program, with a limited 
exception for Medicaid providers demonstrating meaningful use for the 
first time who would have a CQM reporting period of any continuous 90 
days that is the same 90-day period as their EHR Reporting Period. 
These reporting periods would apply beginning in CY 2017 for all EPs 
participating in the EHR Incentive Program.

[[Page 16770]]

b. CQM Reporting Period for Eligible Hospital/CAH
    For eligible hospitals and CAHs in 2017 and subsequent years, we 
are proposing to require a reporting period of 1 full calendar year 
which consists of 4 quarterly data reporting periods for providers 
participating in the Medicare and Medicaid EHR Incentive Program, with 
a limited exception for Medicaid providers demonstrating meaningful use 
for the first time who would have a CQM reporting period of any 
continuous 90 days that is the same 90-day period as their EHR 
Reporting Period. More details of the form and manner will be provided 
in the IPPS rulemaking cycle.
c. Reporting Flexibility EPs, Eligible Hospitals, CAHs 2017
    In order to align with the flexibility option of participation in 
Meaningful Use in 2017 (see section II.C.1.b. of this proposed rule), 
we are proposing that EPs, eligible hospitals, and CAHs would be able 
to have more flexibility to report CQMs in one of two ways in 2017--via 
electronic reporting or attestation. First EPs, eligible hospitals, and 
CAHs may choose to report eCQMs electronically using the CQMs finalized 
for use in 2017 using the most recent version of the eCQMs (electronic 
specifications), which would be the electronic specifications of the 
CQMs published by CMS in 2016. Alternately, a provider may choose to 
continue to attest also using the most recent (2016 version) eCQM 
electronic specifications. We note that the intent to allow attestation 
in 2017 is to provide flexibility for providers transitioning between 
versions of CEHRT in 2017 and believe that requiring the most recent 
version of the annual updates should not be a significant burden given 
that developers do not need to recertify a product each time CQM 
specifications are updated. However, we seek comment on if CMS should 
consider allowing providers to report using another earlier version of 
the specifications.
    We note that, unlike the flexible options established in rulemaking 
in 2014 (79 FR 52927 through 52930), providers may select the CQMs they 
choose to report separately from the Stage objectives and measures of 
meaningful use for their EHR reporting period in 2017.
    We invite public comment on our proposals.
3. Reporting Methods for CQMs
    In the Stage 2 final rule, we finalized the reporting methods for 
CQMs for EPs (77 FR 54075 through 54078), eligible hospitals, and CAHs 
(77 FR 54087 through 54089) for the Medicare EHR Incentive Program, 
which included reporting electronically, where feasible, or by 
attestation. To further align the Medicare and Medicaid EHR Incentive 
Programs with programs such as PQRS and the Hospital IQR program, 
starting in 2017, we propose to continue to encourage electronic 
submission of CQM data for all EPs, eligible hospitals, and CAHs where 
feasible; however, as outlined in section II.C.1.b. of this proposed 
rule, we would allow attestation for CQMs in 2017. For 2018 and 
subsequent years, we are proposing that providers participating in the 
Medicare program must electronically report where feasible and that 
attestation to CQMs would no longer be an option except in certain 
circumstances where electronic reporting is not feasible. This would 
include providers facing circumstances which render them unable to 
electronically report (such as a data submission system failure, 
natural disaster, or certification issue outside the control of the 
provider) who may attest to CQMs if they also attest that 
electronically reporting was not feasible for their demonstration of 
meaningful use for a given year. We believe that the collection and 
electronic reporting of data through health information technology 
would greatly simplify and streamline reporting for many CMS quality 
reporting programs and reduce the burden of quality measure reporting 
for providers who participate in these programs. We also believe this 
would further encourage the adoption and use of certified EHR 
technology by allowing EPs, eligible hospitals, and CAHs to report data 
for multiple programs through a single electronic submission. Through 
electronic reporting, EPs, eligible hospitals, and CAHs would be able 
to leverage EHRs to capture, calculate, and electronically submit 
quality data to CMS for the Medicare EHR Incentive Program. We note 
that we intend to address the form and manner of electronic reporting 
in future Medicare payment rules.
    For the Medicaid EHR Incentive Program, as in the Stage 2 
rulemaking (77 FR 54089), we propose that states would continue in 
Stage 3 to be responsible for determining whether and how electronic 
reporting of CQMs would occur, or whether they wish to continue to 
allow reporting through attestation. If a state does require such 
electronic reporting, the state is responsible for sharing the details 
of the process with its provider community. We anticipate that whatever 
means states have deployed for capturing CQMs electronically for Stages 
1 and 2 would be similar for reporting in Stage 3. However, we note 
that subject to our prior approval, this is within the states' purview. 
We propose for Stage 3 that the states would establish the method and 
requirements, subject to our prior approval, for the electronic capture 
and reporting of CQMs from CEHRT.

                 Proposed eCQM Reporting Timelines for Medicare & Medicaid EHR Incentive Program
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Year............................  2017 only.........  2017 only.........  2018 and            2018 and
                                                                           subsequent years.   subsequent years.
Reporting Method Available......  Attestation.......  Electronic          Attestation.......  Electronic
                                                       Reporting.                              Reporting.
Provider Type who May Use Method  All Medicare        All Medicare        Medicare Providers  All Medicare
                                   providers.          Providers.          with                Providers.
                                                                           circumstances
                                                                           rendering them
                                                                           unable to eReport.
                                  Medicaid providers  Medicaid providers  Medicaid providers  Medicaid providers
                                   must refer to       must refer to       must refer to       must refer to
                                   state               state               state               state
                                   requirements for    requirements for    requirements for    requirements for
                                   reporting.          reporting.          reporting.          reporting.
CQM Reporting Period............  1 CY for Medicare.  1 CY for Medicare.  1 CY for Medicare.  1 CY for Medicare.
                                  1 CY for returning  1 CY for returning  1 CY for returning  1 CY for returning
                                   Medicaid.           Medicaid.           Medicaid.           Medicaid.
                                  90 days for first   90 days for first   90 days for first   90 days for first
                                   time meaningful     time meaningful     time meaningful     time meaningful
                                   user Medicaid.      user Medicaid.      user Medicaid.      user Medicaid.

[[Page 16771]]

 
eCQM Version Required (CQM        2016 Annual Update  2016 Annual Update  2016 Annual Update  2017 Annual
 electronic specifications                                                 or more recent      Update.
 update).                                                                  version.
CEHRT Edition Required..........  2014 Edition......  2014 Edition......  2015 Edition......  2015 Edition.
                                  Or................  Or................
                                  2015 Edition......  2015 Edition......
----------------------------------------------------------------------------------------------------------------

    We invite public comments on our proposals.
a. Quality Reporting Data Architecture Category III (QRDA-III) Option 
for Eligible Hospitals and CAHs
    In the Stage 2 final rule (77 FR 54088), we finalized two options 
for eligible hospitals and CAHs to electronically submit CQMs beginning 
in FY 2014 under the Medicare EHR Incentive Program. Option 1 was to 
submit aggregate level CQM data using QRDA-III electronically. Option 2 
was to submit data electronically using a method similar to the 2012 
and 2013 Medicare EHR Incentive Program electronic reporting pilot for 
eligible hospitals and CAHs, which used QRDA-I (patient-level data).
    We noted in the FY 2014 and 2015 IPPS/LTCH PPS final rules (78 FR 
50904 through 50905 and 79 FR 50321 through 50322) that we had 
determined that the electronic submission of aggregate-level data using 
QRDA-III would not be feasible in 2014 or 2015 for eligible hospitals 
and CAHs under the Medicare EHR Incentive Program. We stated that we 
would reassess this policy for future reporting periods.
    In this proposed rule, we are proposing to remove the QRDA-III 
option for eligible hospitals and CAHs, as we have found this is not an 
option for electronic reporting as we move forward with the EHR 
Incentive Program, we believe the calculations, per the QRDA-III, are 
not advantageous to quality improvement. As the EHR Incentive Program 
further aligns with the Hospital IQR program, we intend to continue 
utilizing the electronic reporting standard of QRDA-I patient level 
data that we finalized in the FY 2015 IPPS rule (79 FR 50322), which 
will allow the same level of CQM reporting, and use and analysis of 
these data for quality improvement initiatives.
    As we understand the need to support state flexibility, we are also 
proposing that states would continue to have the option, subject to our 
prior approval, to allow or require QRDA-III for CQM reporting.
4. CQM Specification and Changes to the Annual Update
    In the Stage 2 final rule, we stated that we do not intend to use 
notice and comment rulemaking as a means to update or modify electronic 
CQM (eCQM) specifications (77 FR 54055). In general, it is the role of 
the measure steward to make changes to a CQM in terms of the initial 
patient population, numerator, denominator, potential exclusions, 
logic, and value sets. We recognize that it may be necessary to update 
CQM specifications after they have been published to ensure their 
continued clinical relevance, accuracy, and validity. CQM specification 
updates may include administrative changes, such as adding the NQF 
endorsement number to a CQM, correcting faulty logic, adding or 
deleting codes as well as providing additional implementation guidance 
for a CQM.
    These changes are described through the annual updates to the 
electronic specifications for EHR submission published by CMS. CQMs are 
currently tracked on a version basis as updates are made and we require 
EPs, eligible hospitals, and CAHs to submit the versions of the CQMs as 
identified on our Web site. The Web site contains all versions of the 
CQMs since reporting via attestation does not require the most recent 
version of the CQMs, but electronic reporting of the CQMs does require 
the most recent version to be reported. Because we require the most 
recent version of the CQM specifications to be used for electronic 
reporting methods, we understand that EHR vendors must make CQM updates 
on an annual basis. We also understand that providers must regularly 
implement those updates to stay current with the most recent CQM 
version.
    We continue to evaluate the CQM update timeline and look for ways 
to provide CQM updates timely, so that vendors can develop, test, and 
deploy these updates and providers can implement those updates as 
necessary. We have the flexibility to update CQMs so they remain 
clinically relevant, accurate, and valid. While we are not proposing 
any change to our policy on updating CQM specifications in this 
proposed rule, we seek comment on our annual update timeline and 
suggestions for how to improve the CQM update process.
5. EHR Technology Certification Requirements for Reporting of CQMs
    In the 2014 Edition EHR Certification Criteria Final Rule, ONC 
finalized certain certification criteria to support the MU objectives 
and CQMs set forth by CMS. In that rule, ONC also specified that in 
order for an EP, eligible hospital, or CAH to have EHR technology that 
meets the Base EHR definition, the EHR technology must be certified to 
a minimum of nine CQMs for EPs or 16 CQMs for eligible hospitals and 
CAHs (77 FR 54264 through 54265; see also 45 CFR 170.102). This is the 
same number required for quality reporting to the Medicare and Medicaid 
EHR Incentive Programs, the PQRS EHR reporting and, beginning in 2015, 
the electronic reporting option under the Hospital IQR Program. In 
certain cases, an EP, eligible hospital or CAH may purchase an EHR 
product that is certified to the minimum number of CQMs and discover 
that, for at least one of those CQMs, they do not have data on which to 
report. In these cases, the EP (77 FR 54058 through 54059), eligible 
hospital or CAH (77 FR 54051) would report a zero denominator for one 
or more CQMs.
    We believe EHRs should be certified to more than the minimum number 
of CQMs required by one or more CMS quality reporting programs so that 
EPs, eligible hospitals, and CAHs have a choice of which CQMs to 
report, and could therefore choose to report on CQMs most applicable to 
their patient population or scope of practice.
    We realize that requiring EHRs to be certified to more than the 
minimum number of CQMs required by the Medicare and Medicaid EHR 
Incentive Programs may increase the burden on EHR vendors. However, in 
the interest of EPs, eligible hospitals, and CAHs being able to choose 
to report eCQMs that represent their patient populations, we would like 
to see EP vendors certify to all eCQMs that are in the EP selection 
list, or eligible hospital/CAH vendors certify to all eCQMs in the 
selection list for those stakeholders.
    We are also considering a phased approach such that the number of 
CQMs required for the vendors to have

[[Page 16772]]

certified would increase each year until EHR products are required to 
certify all CQMs required for reporting by EPs, eligible hospitals, and 
CAHs. For example, in year one of this phased plan, we might require 
that EHRs be certified to at least 18 of 64 available CQMs for EPs and 
22 of 29 available CQMs for eligible hospitals and CAHs; in year two, 
we might require at least 36 CQMs for EPs and all 29 CQMs for eligible 
hospitals and CAHs; in subsequent years of the plan, we would increase 
the number of required CQMs for EPs until the EHR is certified to all 
applicable CQMs for EPs, eligible hospitals, and CAHs.
    We have also considered alternate plans that would require EHRs to 
be certified to more than the minimum number of CQMs required for 
reporting, but would not require the EHR to be certified to all 
available CQMs. For example, we might require that EHRs be certified to 
a certain core set of CQMs plus an additional 9 CQMs for EPs, and a 
certain core set of CQMs plus an additional 16 CQMs for eligible 
hospitals and CAHs, which the EHR vendor could choose from the list of 
available CQMs.
    We note that the specifics of this plan would be outlined in 
separate notice-and-comment rulemaking such as the PFS or IPPS rules. 
We specifically seek comment on this issue of a plan to increase the 
number of CQMs to which an EHR is certified.
6. Electronic Reporting of CQMs
    As previously stated in the Medicare and Medicaid EHR Incentive 
Programs Stage 2 final rule (77 FR 54051 through 54053), CQM data 
submitted by EPs, eligible hospitals, and CAHs are required to be 
captured, calculated and reported using certified EHR technology. We 
received numerous questions from stakeholders expressing confusion over 
what it means to capture data in certified EHR technology. 
Specifically, stakeholders question whether they may manually abstract 
data into the EHR from a patient's chart. We do not consider the manual 
abstraction of data from the EHR to be capturing the data using 
certified EHR technology. We believe that electronic information 
interfaced or electronically transmitted from non-certified EHR 
technology, such as lab information systems, automated blood pressure 
cuffs, and electronic scales, into the certified EHR, would satisfy the 
``capture'' requirement, as long as that data is visible to providers 
in the EHR.

C. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use
a. 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.
b. Methods for Demonstration of the Stage 3 Criteria of Meaningful Use 
for 2017 and Subsequent Years
    We are proposing to continue the use of attestation as the method 
for demonstrating that an EP, eligible hospital, or CAH has met the 
Stage 3 objectives and measures of meaningful use. We are proposing to 
continue the existing optional batch file process for attestation in 
lieu of individual Medicare EP attestation through our registration and 
attestion system. This batch reporting process ensures that meaningful 
use of certified EHR technology continues to be measured at the 
individual level, while promoting efficiencies for group practices that 
must submit attestations on large groups of individuals (77 FR 54089).
    We would continue to leave open the possibility for CMS and the 
states to test options for demonstrating meaningful use that utilize 
existing and emerging HIT products and infrastructure capabilities. 
These options could involve the use of registries or the direct 
electronic reporting of measures associated with the objectives of 
meaningful use. We would not require any EP, eligible hospital, or CAH 
to participate in this testing in order to receive an incentive payment 
or avoid the payment adjustment.
    For 2017 only, we are proposing changes to the attestation process 
for the meaningful use objectives and measures, which would allow 
flexibility for providers during this transitional year. These 
proposals are supported by a similar flexibility proposed in the 
requirements for the Edition of CEHRT a provider may use in 2017 as 
further discussed in section II.A.I.C.(1).(b).(3). of this proposed 
rule. In addition, we discuss the attestation changes proposed for CQM 
reporting in detail under section II.B.2.a. of this proposed rule.
(1) Meaningful Use Objective and Measures in 2017
    In order to allow all providers to successfully transition to Stage 
3 of meaningful use for a full year-long EHR reporting period in 2018, 
we are proposing to allow flexibility for the EHR Incentive Programs in 
2017. This transition period would allow providers to establish and 
test their processes and workflows for Stage 3 of meaningful use prior 
to 2018. Specifically, for 2017, we are proposing that providers may 
either repeat a year at their current stage or move up stage levels. 
However, for 2017, a provider may not move backward in their 
progression. Under this proposal, providers who participated in Stage 1 
in 2016 may choose to attest to the Stage 1 objective and measures, or 
they may move on to Stage 2 or Stage 3 objectives and measures for an 
EHR reporting period in 2017. Providers who participated in Stage 2 in 
2016 may choose to attest to the Stage 2 objectives and measures or 
move on to Stage 3 objectives and measures for an EHR reporting period 
in 2017. However, under no circumstances, may providers return to Stage 
1. In 2018, all providers, regardless of their prior participation or 
the stage level chosen in 2017, would be required to attest to Stage 3 
objectives and measures for an EHR reporting period in 2018.
(2) CEHRT and Stage Flexibility in 2017
    Based on the delays providers experienced with fully implementing 
the EHR technology certified to the 2014 Edition (as further described 
in the 2014 CEHRT Flexibility final rule (79 FR 52910 through 52933) we 
believe it is necessary to preemptively prepare for the upgrade to EHR 
technology certified to the 2015 Edition and the transition to Stage 3. 
Preparation for the upgrade would ensure that providers and developers 
have adequate time to certify, install, fully implement the software, 
and establish the processes and workflows for the objectives and 
measures for providers moving to the next stage of the EHR Incentive 
Programs. Accordingly, we propose allowing providers flexible CEHRT 
options for 2017. These options may impact the selection of objectives 
and measures to which a provider can attest. Specifically, under the 
CEHRT options for 2017, we propose that providers would have the option 
to continue to use EHR technology certified to the 2014 Edition, in 
whole or in part, for an EHR reporting period in 2017. We note that 
providers who use only the EHR technology certified to the 2014 Edition 
for an EHR reporting period in 2017 may not choose to attest to the 
Stage 3 objectives and measures as those objectives and measures 
require the support of EHR technology certified to the 2015 Edition.

[[Page 16773]]

    Providers using only EHR technology certified in whole or in 
relevant part to the 2014 Edition certification criteria may attest to 
the objectives and measures of meaningful use in the following manner:
    <bullet> If a provider first demonstrated meaningful use in 2015 or 
2016, they may attest to Stage 1 objectives and measures or Stage 2 
objectives and measures.
    <bullet> If a provider first demonstrated meaningful use in any 
year prior to 2015, they may attest to the Stage 2 objectives and 
measures.
    Providers using EHR technology certified in whole or in relevant 
part to the 2015 Edition certification criteria may elect to attest to 
the objectives and measures of meaningful use in the following manner:
    <bullet> If a provider first demonstrated meaningful use in 2015 or 
2016, they may attest to Stage 1 objectives and measures, Stage 2 
objectives and measures, or Stage 3 objectives and measures if they 
have all the 2015 Edition functionality required to meet all Stage 3 
objectives.
    <bullet> If a provider first demonstrated meaningful use in any 
year prior to 2015, they may attest to Stage 2 objectives and measures, 
or Stage 3 objectives and measures if they have all the 2015 Edition 
functionality required to meet all Stage 3 objectives.
    We note that all providers would be required to fully upgrade to 
EHR technology certified to the 2015 Edition for the EHR reporting 
period in 2018. We also reiterate that providers may elect to attest to 
Stage 3 of the program using EHR technology certified to the 2015 
Edition beginning in 2017. We further stress that the use of 2011 
CEHRT, although an option under the 2014 CEHRT Flexibility final rule 
(79 FR 52913 through 52914), is not an option under this proposal. 
However, as part of this proposal, we would like to seek comment on 
alternate flexibility options. Specifically, we are seeking comment on 
whether the flexible option to attest to Stages 1 or 2 should be 
limited to only those providers who could not fully implement EHR 
technology certified to the 2015 Edition in 2017. We are also seeking 
comment on whether those providers with fully implemented EHR 
technology certified to the 2015 Edition in 2017 should be required to 
attest to Stage 3 only in 2017. Finally, we seek comment on whether 
providers should not have the option to attest to Stage 3 in 2017 
regardless of an upgrade to EHR technology certified to the 2015 
Edition in 2017, and should instead be required to wait to demonstrate 
Stage 3 until 2018 using EHR technology certified to the 2015 Edition.
    We welcome comments on these proposals.
(3) CQM Flexibility in 2017
    In the 2014 CEHRT Flexibility final rule, we did not allow 
providers to separate their CQM reporting selection from the year of 
meaningful use objectives they reported on. We did not allow this 
reporting for a number of reasons including how we defined CQMs, as 
well as the number of CQMs reporting changes occurring between Stage 1 
in 2011 through 2013, and Stage 1 and 2 in 2014. For further 
discussion, we direct readers to 79 FR 52927 through 52930.
    To report CQMs for 2017, we propose to allow greater flexibility by 
proposing to split the use of CEHRT for CQM reporting from the use of 
CEHRT for the objectives and measures. This means that providers would 
be able to separately report CQMs using EHR technology certified to the 
2015 Edition even if they use EHR technology certified to the 2014 
Edition for the meaningful use objectives and measures for an EHR 
reporting period in 2017. Providers may also use EHR technology 
certified to the 2015 Edition for their meaningful use objectives and 
measures in 2017 and use EHR technology certified to the 2014 Edition 
for their CQM reporting for an EHR reporting period in 2017.
    For an EHR reporting period in 2017, EPs, eligible hospitals, and 
CAHs may choose to report eCQMs electronically using the CQMs finalized 
for use in 2017 using the most recent version of the eCQMs (electronic 
specifications), which would be the electronic specifications of the 
CQMs published by CMS in 2016. Alternately, a provider may choose to 
continue to attest to the CQMs established for use in 2017 also using 
the most recent (2016 version) eCQM electronic specifications. These 
options are available for provider using either EHR technology 
certified to the 2014 Edition or EHR technology certified to the 2015 
Edition. These flexible options for an EHR reporting period in 2017 are 
further discussed in sections II.B.2.a. of this proposed rule. An EP, 
eligible hospital, or CAH must use certified EHR technology, 
successfully attest to the meaningful use objectives and measures, and 
successfully submit CQMs to be a meaningful EHR user. We note that 
states may determine the form and method of CQM submission for 
participants in the Medicaid program subject to our approval as outline 
in sections II.B.3 and II.F.3. of this proposed rule. However, the 
selection of CQMs and the minimum reporting period are the same for 
providers in both Medicare and Medicaid as outlined in section II.B.3. 
of this proposed rule.
    Similar to our rationale under the 2014 CEHRT Flexibility final 
rule (79 FR 52910 through 52933), we believe the proposals outlined for 
attestation in 2017 would allow providers the flexibility to choose the 
option which applies to their particular circumstances and use of 
CEHRT. Upon attestation, providers may select one of the proposed 
options available for their participation year and EHR Edition. The EHR 
Incentive Program Registration and Attestation System would then prompt 
the provider to attest to meeting the objectives, measures, and CQMs 
applicable under that option. We further propose that auditors would be 
provided guidance related to reviewing attestations associated with the 
options for using CEHRT in 2017, as was done for 2014.
    We welcome comment on this proposal.
c. EHR Reporting Period in 2017 and Subsequent Years
    We are proposing, with limited exceptions outlined in section 
II.F.1. of this proposed rule, that the EHR reporting period in 2017 
would be a full calendar year for all providers. We encourage providers 
to begin Stage 3 in 2017. However, under the current timeline shown in 
Table 3, we recognize that providers first demonstrating meaningful use 
under Stage 1 in 2016 or 2017 or under Stage 2 in 2016 or 2017 must 
begin Stage 3 in 2018. We further recognize providers scheduled to 
begin Stage 3 in 2017 that instead choose to meet the Stage 2 criteria 
in 2017 must begin Stage 3 in 2018. However, in 2018, all providers, 
except as outlined in section II.F.1. of this proposed rule, must 
report based on a full calendar year EHR reporting period for the Stage 
3 objectives and measures. In addition, in 2018, all providers must use 
EHR technology certified to the 2015 Edition for the full EHR reporting 
period in order to successfully demonstrate meaningful use.
    For CQM reporting in 2018 and subsequent years, as outlined in 
section II.B.3 of this proposed rule, we are proposing that providers 
participating in the Medicare program must electronically report, where 
feasible, and that attestation to CQMs would no longer be an option 
except in circumstances where electronic reporting is not feasible. 
This would include providers facing circumstances which render them 
unable to

[[Page 16774]]

electronically report (such as a data submission system failure, 
natural disaster, or certification issue outside the control of the 
provider) who may attest to CQMs if they also attest that 
electronically reporting was not feasible for their demonstration of 
meaningful use for a given year.
    We welcome public comment on this proposal.
2. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    We propose to continue posting Stage 1 and Stage 2 aggregate and 
individual performance and participation data resulting from the EHR 
Incentive programs online regularly for public use. We further note our 
intent to potentially publish the performance and participation data on 
Stage 3 objectives and measures of meaningful use in alignment with 
quality programs which utilize publicly available performance data such 
as physician compare.
    In addition to the data already being collected under our 
regulations, as outlined in section III. of this proposed rule, we 
propose to collect the following information from providers to ensure 
providers keep their information up-to-date through the system of 
record for their National Provider Identifier (NPI) in the National 
Plan & Provider Enumeration System:
    <bullet> Primary Practice Address (address, city, state zip, 
country code, etc.).
    <bullet> Primary Business/Billing Address (address, city, state, 
zip, country code, etc.).
    <bullet> Primary License information (for example, provide medical 
license in at least one state (or territory)).
    <bullet> Contact Information (phone number, fax number, and contact 
email address).
    <bullet> Health Information Exchange Information:
    ++ Such as DIRECT address required (if available).
    ++ If DIRECT address is not available, Electronic Service 
Information is required.
    ++ If DIRECT address is available, Electronic Service Information 
is optional in addition to DIRECT address.
    We do not propose any changes to the registration for the Medicare 
and Medicaid EHR Incentive Programs.
3. Interaction With Other Programs
    There are no proposed changes to the ability of providers to 
participate in the Medicare and Medicaid EHR Incentive Programs and 
other CMS programs. We continue to work on aligning the data collection 
and reporting of the various CMS programs, especially in the area of 
clinical quality measurement. See sections II.B.1. through II.B.6. of 
this proposed rule for the proposed alignment initiatives for CQMs.

D. 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 for 
EPs
    Section 1848(a)(7) of the Act provides for payment adjustments, 
effective for CY 2015 and subsequent years, for EPs as defined in 42 
CFR 495.100, who are not meaningful EHR users during the relevant EHR 
reporting period for the year. Section 1848(a)(7) 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 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 final rules for Stages 1 
and 2 (75 FR 44442 through 44448 and 77 FR 54093 through 54102) for 
more information.
2. EHR Reporting Period for Determining Whether an EP Is Subject to the 
Payment Adjustment for CY 2018 and Subsequent Calendar Years
    Section 1848(a)(7)(E)(ii) of the Act provides the Secretary with 
broad authority to choose the EHR reporting period that will apply for 
purposes of determining the payment adjustments 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 the 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. Stated generally, 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 the 
regulations and the discussion in the Stage 2 final rule (77 FR 54095 
through 54096). We

[[Page 16775]]

established that these policies apply for the CY 2015 payment 
adjustment year and subsequent payment adjustment years.
    However, in this Stage 3 proposed rule, we propose to eliminate the 
exception discussed previously for a 90-day EHR reporting period for 
new meaningful EHR users beginning with the EHR reporting period in 
2017, with a limited exception for Medicaid EPs demonstrating 
meaningful use for the first time. We propose that for EPs 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 example, for all EPs demonstrating meaningful use, 
the full CY 2017 would be the EHR reporting period for the CY 2019 
payment adjustment year. To avoid a payment adjustment in CY 2019, EPs 
must demonstrate meaningful use of certified EHR technology for an EHR 
reporting period of the entire CY 2017. This policy would continue to 
apply in subsequent years.
    As discussed in sections II.A.1.a. and II.F.1. of this proposed 
rule, we are proposing to maintain a 90-day EHR reporting period for 
the first payment year based on meaningful use for Medicaid EPs 
demonstrating meaningful use for the first time. We recognize that 
these EPs may be subject to payment adjustments under Medicare if they 
fail to demonstrate meaningful use, and thus we propose that the same 
90-day EHR reporting period used for the Medicaid incentive payment 
would also apply for purposes of the Medicare payment adjustment for 
the payment adjustment year two years after the calendar year in which 
the provider demonstrates meaningful use. We note under our current 
policy, if an EP has never successfully demonstrated meaningful use, 
the EHR reporting period for a payment adjustment year is 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. We do not propose to maintain this policy, 
and thus for Medicaid EPs who are new meaningful EHR users, the 90-day 
EHR reporting period for a payment adjustment year must occur within 
the calendar year that is 2 years before the payment adjustment year. 
These proposals for Medicaid EPs would apply beginning with the EHR 
reporting period in CY 2017.
    We provide the following example:
    Example A: If an EP has never successfully demonstrated meaningful 
use prior to CY 2017 and demonstrates under the Medicaid EHR Incentive 
Program that he or she is a meaningful EHR user for the first time in 
CY 2017, the EHR reporting period for the Medicaid incentive payment 
would be any continuous 90-day period within CY 2017. The same 90-day 
period would also serve as the EHR reporting period for the CY 2019 
payment adjustment year under Medicare. This 90-day period would not 
serve as the EHR reporting period for the CY 2018 payment adjustment 
year under Medicare even if the EP registers for and attests to 
meaningful use by October 1, 2017. The EP would have to demonstrate 
meaningful use for an EHR reporting period of the full CY 2018 to earn 
an incentive payment under Medicaid for the CY 2018 payment year and 
avoid the payment adjustment under Medicare for the CY 2020 payment 
adjustment year.
    We propose these changes to further our goal to align reporting 
requirements under the EHR Incentive Program and the reporting 
requirements for various CMS quality reporting programs, to respond to 
stakeholders who cited difficulty with following varying reporting 
requirements, and to simplify HHS system requirements for data capture. 
We further note that newly practicing EPs have the ability to apply for 
a hardship exception from the Secretary under Sec.  495.102(d)(4)(ii), 
which provides for an exception from the payment adjustments for the 2 
years after they begin practicing. We propose amendments to the 
definition of ``EHR reporting period for a payment adjustment year'' 
under Sec.  495.4 to reflect these proposals. We welcome public 
comments on this proposal.
3. Exception to the Application of the Payment Adjustment to EPs in CY 
2017 and Subsequent Years
    As previously discussed, sections 1848(a)(7)(B) of the Act provides 
that the Secretary may, on a case-by-case basis, exempt an EP from the 
application of the payment adjustment in CY 2015 and subsequent 
calendar years if the Secretary determines that compliance with the 
requirements for being a meaningful EHR user will result in a 
significant hardship, such as an EP who practices in a rural area 
without sufficient internet access. As provided by the statute, the 
exception is subject to annual renewal, but in no case may an EP be 
granted an exception for more than 5 years. The statute does not 
require the Secretary to grant exceptions. However, as we stated in the 
Stage 2 final rule at 77 FR 54097, we believe that certain 
circumstances evidence the existence of a hardship, thereby justifying 
the need for an exception by the Secretary. Therefore, in the Stage 2 
final rule, we finalized various types of hardship exceptions that EPs 
could apply for, which included insufficient internet access, newly 
practicing EPs, extreme circumstances outside of an EP's control, lack 
of control over the availability of CEHRT for EPs practicing in 
multiple locations, lack of face-to-face patient interactions and lack 
of need for follow-up care, and certain primary specialties. For 
further discussion of the hardship exceptions, we refer readers to the 
Stage 2 final rule at 77 FR 54097 through 54101 and 42 CFR 
495.102(d)(4).
    In this Stage 3 proposed rule, we propose no changes to the types 
of exceptions previously finalized for EPs, nor do we propose any new 
types of exceptions for 2017 and subsequent years. Accordingly, we 
propose that the exceptions continue as previously finalized.
4. Statutory Basis for Payment Adjustments and Hardship Exceptions for 
Eligible Hospitals
    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 will 
be ``33\1/3\ percent for FY 2015, 66\2/3\ percent for FY 2016, and 100 
percent for FY 2017 and each subsequent FY.'' In other words, for 
eligible hospitals that are not meaningful EHR users, the Secretary 
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,

[[Page 16776]]

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 fiscal year involved and the Secretary 
shall not take into account such reduction in computing the applicable 
percentage increase for a subsequent fiscal year.
    Section 1886(b)(3)(B)(ix)(II) of the Act, as amended by Section 
4102(b)(1) of the HITECH Act, provides that the Secretary may, on a 
case-by-case basis, exempt a hospital from the application of the 
applicable percentage increase adjustment for a fiscal year if the 
Secretary determines that requiring such hospital to be a meaningful 
EHR user will result in a significant hardship, such as in the case of 
a hospital in a rural area without sufficient internet access. This 
section also provides that such determinations are subject to annual 
renewal, and that in no case may a hospital be granted an exception for 
more than 5 years.
5. Applicable Market Basket Update Adjustment for Eligible Hospitals 
That Are Not Meaningful EHR Users for FY 2019 and Subsequent Fiscal 
Years
    Section 412.64(d) of the 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.
6. EHR Reporting Period for Determining Whether a Hospital Is Subject 
to the Market Basket Update Adjustment for FY 2018 and Subsequent 
Fiscal Years
    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 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 the 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. However, in this Stage 3 proposed rule, beginning in 
2017, we propose to change the EHR reporting period for a payment 
adjustment year for eligible hospitals from a fiscal year basis to a 
calendar year basis. Specifically, we propose to revise the definition 
of ``EHR reporting period for a payment adjustment year'' under Sec.  
495.4 such that the EHR reporting period for a payment adjustment year 
for an eligible hospital would be the full calendar year that is 2 
years before the payment adjustment year. For example, the entire CY 
2017 would be the EHR reporting period used to determine whether the 
payment adjustment would apply for an eligible hospital for FY 2019. 
This change would apply beginning with the CY 2017 EHR reporting period 
for purposes of the FY 2019 payment adjustment year, and continue to 
apply in subsequent years. We note that eligible hospitals would have 
ample time to adjust to the new calendar year reporting timeframe given 
that under our current policy, the EHR reporting period occurs prior to 
the payment adjustment year. We further believe that aligning all 
providers, including eligible hospitals, to a calendar year EHR 
reporting timeframe for purposes of the payment adjustment, would 
simplify reporting for all providers, especially for larger providers 
with diverse systems and groups. In addition, placing all providers, 
including eligible hospitals, onto a calendar year timeframe would 
further simplify HHS system requirements for data capture and would 
move the EHR Incentive Program another step closer to alignment with 
various CMS quality reporting programs. We welcome comments on this 
proposal.
    Further, in the Stage 2 final rule, 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. Stated generally, 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 
and 54105).
    However, in this Stage 3 proposed rule, we propose to eliminate 
this exception for eligible hospitals that are new meaningful EHR users 
beginning with the EHR reporting period in 2017, with a limited 
exception for Medicaid eligible hospitals demonstrating meaningful use 
for the first time. As explained previously, we propose that for 
eligible hospitals that have successfully demonstrated meaningful use 
in a prior year as well as those that 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 example, for 
all eligible hospitals, the full CY 2017 would be the EHR reporting 
period for the FY 2019 payment adjustment year. This policy would 
continue to apply in subsequent years.
    Though, as discussed in sections II.A.1.a. and II.F.1. of this 
proposed rule, for Medicaid eligible hospitals demonstrating meaningful 
use for the first time, we are proposing to maintain a 90-day EHR 
reporting period for the first payment year based on meaningful use. We 
recognize that these eligible hospitals may be subject to payment 
adjustments under Medicare if they fail to demonstrate meaningful use, 
and thus we propose that the same 90-day EHR reporting period used for 
the Medicaid incentive payment would also apply for purposes of the 
Medicare payment adjustment for the payment adjustment year 2 years 
after the calendar year in which the provider demonstrates meaningful 
use. We note under our current policy, if an eligible hospital has 
never successfully demonstrated meaningful use, the EHR reporting 
period for a payment adjustment year is any continuous 90-day period 
that both begins in the federal fiscal year 1 year before the payment 
adjustment year and ends at least 3 months before the end of such prior 
year. We do not propose to maintain this policy, and thus for Medicaid 
eligible hospitals that are new meaningful EHR users, the 90-day EHR 
reporting period for a payment adjustment year must occur within the 
calendar year that is 2 years before the payment adjustment year. These 
proposals for Medicaid eligible hospitals would apply beginning with 
the EHR reporting period in CY 2017.
    We provide the following example:
    Example A: If an eligible hospital has never successfully 
demonstrated meaningful use prior to CY 2017 and demonstrates under the 
Medicaid EHR

[[Page 16777]]

Incentive Program that it is a meaningful EHR user for the first time 
in CY 2017, the EHR reporting period for the Medicaid incentive payment 
would be any continuous 90-day period within CY 2017. The same 90-day 
period would also serve as the EHR reporting period for the FY 2019 
payment adjustment year under Medicare. This 90-day period would not 
serve as the EHR reporting period for the FY 2018 payment adjustment 
year under Medicare even if the eligible hospital registers for and 
attests to meaningful use by July 1, 2017. The eligible hospital would 
have to demonstrate meaningful use for an EHR reporting period of the 
full CY 2018 to earn an incentive payment under Medicaid for the 2018 
payment year and avoid the payment adjustment under Medicare for the FY 
2020 payment adjustment year.
    Like our proposal to move eligible hospitals to a calendar year 
timeframe, we believe that removing the continuous 90-day EHR reporting 
period for most eligible hospitals would simplify reporting for 
providers, especially those hospitals with diverse groups and systems. 
In addition, eliminating the 90-day EHR reporting period would move the 
EHR Incentive Program one step closer to alignment within the program 
and with CMS quality reporting programs and would simplify HHS system 
requirements for data capture. Therefore, moving eligible hospitals to 
a calendar year EHR reporting period for the payment adjustment years, 
as well as requiring all providers (EPs and hospitals) to report based 
on the same full year calendar timeframe would accomplish these goals 
and be responsive to prior public comments asking us to simplify the 
EHR Incentive Program.
    We propose amendments to the definition of ``EHR reporting period 
for a payment adjustment year'' under Sec.  495.4 to reflect these 
proposals.
    We note that hospitals that are eligible under both the Medicaid 
and Medicare incentive programs, and that are attesting for the 
Medicaid program, do not need to separately attest in the Medicare 
program in 2017 and subsequent years, because the statute does not 
allow for Medicare EHR incentive payments to eligible hospitals after 
FY 2016. If a hospital eligible under both programs is demonstrating 
meaningful use for the first time, and using a continuous 90-day EHR 
reporting period under the Medicaid program, it could attest for the 
Medicaid program only, and still avoid the Medicare payment adjustment 
that is 2 years after the calendar year in which the EHR reporting 
period occurs. However, if a hospital eligible under both programs 
chooses also to attest for the Medicare program, it would be required 
to complete an EHR reporting period of 1 full calendar year to avoid 
the Medicare payment adjustment that is 2 years after that calendar 
year.
    We welcome public comments on these proposals.
7. Exception to the Application of the Market Basket Update Adjustment 
to Hospitals in FY 2019 and Subsequent Fiscal Years
    As stated previously, section 1886(b)(3)(B)(ix)(II) of the Act, as 
amended by section 4102(b)(1) of the HITECH Act, provides that the 
Secretary, may, on a case-by-case basis, exempt a hospital from the 
application of the applicable percentage increase payment adjustment 
for a fiscal year if the Secretary determines that compliance with the 
requirements for being a meaningful EHR user will result in a 
significant hardship, such as an eligible hospital located in a rural 
area without sufficient internet access. Section 1886(b)(3)(B)(ix)(III) 
also provides that the exception is subject to annual renewal, but in 
no case may a hospital be granted an exception for more than 5 years. 
The Secretary's hardship exception authority is discretionary.
    As we explained in the Stage 2 final rule at 77 FR 54105 through 
54106, we believe that certain circumstances may constitute a hardship 
that would warrant the Secretary's use of the exception authority. 
Therefore, in the Stage 2 final rule, we finalized various types of 
hardship exceptions for which eligible hospitals may apply, which 
included lack of insufficient internet access, extreme circumstances 
outside of a hospital's control, and the establishment of new 
hospitals. For further discussion of the hardship exceptions, we refer 
readers to the Stage 2 final rule at 77 FR 54105 through 54108 as well 
as 42 CFR 412.64(d)(4).
    In this Stage 3 proposed rule, we propose no changes to the types 
of exceptions previously finalized for eligible hospitals, nor do we 
propose any new exceptions for eligible hospitals. Accordingly, for 
Stage 3, we propose to continue the hardship exceptions for 2017 and 
subsequent years as previously finalized.
8. Statutory Basis for Payment Adjustments to CAHs
    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 will 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 case 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.
9. Reduction of Reasonable Cost Reimbursement in FY 2015 and Subsequent 
Years for CAHs That Are Not Meaningful EHR Users
a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015 
and Subsequent Years for CAHs That Are Not Meaningful EHR Users
    In the Stage 1 final rule (75 FR 44564), we finalized the 
regulations regarding the CAH adjustment at Sec.  495.106(e) and Sec.  
413.70(a)(6).
b. EHR Reporting Period for Determining Whether a CAH Is Subject to the 
Applicable Reduction of Reasonable Cost Payment in FY 2015 and 
Subsequent Years
    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

[[Page 16778]]

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 fiscal year as described in Sec.  413.70(a)(6)(i). We further 
finalized that CAHs submit their attestations on meaningful use by 
November 30 of the following fiscal year. 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, will then affect interim payments to the 
CAH made after December 1 of the applicable fiscal year. If the cost 
reporting period ends prior to December 1 of the applicable fiscal 
year, then any applicable payment adjustment will be made through the 
cost report settlement process.
    Under this Stage 3 proposed rule, we are proposing a change to the 
EHR reporting period that would apply for the payment adjustments for 
CAHs, beginning with the FY 2017 payment adjustment year. First, 
similar to what we proposed for eligible hospitals previously, we 
propose 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 propose 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 CY 2017. This proposed change would mean 
that the EHR reporting period would no longer precisely align with the 
payment adjustment year. We propose amendments to the definition of 
``EHR reporting period for a payment adjustment year'' under Sec.  
495.4 to reflect these proposals.
    In the Stage 2 final rule, we note the process for the 
implementation of a payment adjustment to CAH cost reports in relation 
to the EHR reporting period attestation deadline (77 FR 54109 and 
54110). Under our Stage 3 proposal, we would need to move the CAH 
attestation deadline in order to accommodate the change to a calendar 
year-based EHR reporting period. Therefore, we propose to move the CAH 
attestation deadline to the last day in February following the end of 
the EHR reporting period as we currently allow for EPs. Any accounting 
shifts that occur as a result from the change to a calendar year-based 
EHR reporting period can be accommodated through the cost reporting and 
settlement process. The CAH must attest no later than 2 months 
(February 28 or February 29 if applicable) following the close of the 
EHR reporting period at the end of each calendar year to avoid the 
payment adjustment. Such an attestation or lack thereof, will then 
affect interim payments to the CAH made after March 1 of the applicable 
federal fiscal year. If the cost reporting period ends prior to March 1 
of the applicable fiscal year, then any applicable payment adjustment 
will be made through the cost report settlement process.
    We are proposing this change to the EHR reporting period for the 
payment adjustment year to further align most providers to a calendar 
year-based EHR reporting period. We believe that the change to calendar 
year reporting for CAHs is feasible given that the cost reporting and 
cost settlement processes is unique to CAHs under the Medicare EHR 
Incentive Program. Unlike eligible hospitals or EPs, who use a claims 
processing system to determine the payment adjustment under the 
Medicare EHR Program, CAHs are required to file an annual Medicare cost 
report that is typically for a consecutive 12-month period. The cost 
report reflects the inpatient statistical and financial data that forms 
the basis of the CAH's Medicare reimbursement. Interim Medicare payment 
may be made to the CAH during the cost reporting period based on the 
previous year's data. Cost reports are filed with the CAH's Medicare 
contractor after the close of the cost reporting period, and the data 
on the cost report are subject to the reconciliation and settlement 
process prior to a final Medicare payment being made. The proposed 
change to a calendar year EHR reporting period for CAHs would not 
significantly impact the ability to implement the payment adjustments 
in the cost report reconciliation process for either CAHs or CMS. It 
would only shift the potential date where the reconciliation of any 
payment adjustment in the cost reporting process may occur. These 
payments would still be subject to the reconciliation and settlement 
process prior to a final Medicare payment being made.
    For example, currently CAHs must file their attestations on 
meaningful use by November 30 of the federal fiscal year following the 
close of the federal fiscal year in which the EHR reporting period 
occurs. Under our current system, if a CAH is attesting that it was a 
meaningful EHR user for FY 2015, the attestation must be submitted not 
later than November 30, 2015. A payment adjustment applied if the CAH 
does not successfully attest would affect interim payment to the CAH 
made after December 1 of 2015. If the cost reporting period ends prior 
to December 1, 2015, then any applicable payment adjustment will be 
made under the cost reporting settlement process.
    In an example of a similar scenario under the new proposal, a CAH 
that does not successfully demonstrate meaningful use based on a 
calendar year EHR reporting period in 2017 (January 1, 2017 through 
December 31, 2017) would be subject to a payment adjustment applied to 
its reasonable costs incurred in the cost reporting period beginning in 
FY 2017 (October 1, 2017 through September 30, 2018). To avoid the 
payment adjustment in this example, the CAH must attest no later than 
February 28, 2018 to demonstrate meaningful use for an EHR reporting 
period in 2017. If the CAH does not attest by February 28, 2018, a 
payment adjustment would then affect interim payments to the CAH made 
after March 1, 2018. If the cost reporting period ends prior to March 
1, 2018, then any applicable payment adjustment would be made through 
the cost report settlement process. We note that this is reflective of 
a similar policy in the Stage 2 final rule addressing the process for 
CAH payment adjustments with an attestation deadline of November 30 in 
a given year and direct readers to 77 FR 54110 for further information 
on this policy.
    Second, as noted previously, and outlined in the definition of 
``EHR reporting period for a payment adjustment year'' under Sec.  
495.4, we established an exception for first-time CAH meaningful EHR 
users. Under our current policy, if a CAH is demonstrating it is a 
meaningful EHR user for the first time in the payment adjustment year, 
the applicable EHR reporting period is any continuous 90-day period 
within the federal fiscal year that is the payment adjustment year.
    For this Stage 3 proposed rule, we propose to eliminate this 
exception for CAHs that are new meaningful EHR users beginning with the 
EHR reporting period in 2017, with a limited exception for CAHs 
demonstrating meaningful use for the first time under the Medicaid EHR 
Incentive Program. As discussed in II.A.1.a. and II.F.1. of this 
proposed rule, for CAHs that demonstrate meaningful use for the first 
time under Medicaid, we are proposing to maintain a 90-day EHR 
reporting period for the first payment year based on meaningful use. We 
recognize that these CAHs may be

[[Page 16779]]

subject to payment adjustments under Medicare if they fail to 
demonstrate meaningful use, and thus we propose that the same 90-day 
EHR reporting period used for the Medicaid incentive payment would also 
apply for purposes of the Medicare payment adjustment.
    We propose amendments to the definition of ``EHR reporting period 
for a payment adjustment year'' under Sec.  495.4 to reflect these 
proposals. Example A: If a CAH has never successfully demonstrated 
meaningful use prior to CY 2017 and demonstrates under the Medicaid EHR 
Incentive Program that it is a meaningful EHR user for the first time 
in CY 2017, the EHR reporting period for the Medicaid incentive payment 
would be any continuous 90-day period within CY 2017. The same 90-day 
period would also serve as the EHR reporting period for the FFY 2017 
payment adjustment year under Medicare.
    Like our proposal to move CAHs to a calendar year timeframe, we 
believe that removing the continuous 90-day EHR reporting period for 
most CAHs would simplify reporting for providers, especially those CAHs 
with diverse groups and systems. In addition, eliminating the 90-day 
EHR reporting period would move the EHR Incentive Program one step 
closer to alignment within the program and with CMS quality reporting 
programs, and would simplify HHS system requirements for data capture. 
Therefore, moving CAHs to a calendar year EHR reporting period for the 
payment adjustment year, as well as requiring most providers (EPs, 
CAHs, and eligible hospitals) to report based on the same full year 
calendar timeframe would accomplish these goals and be responsive to 
prior public comments asking us to simplify the EHR Incentive Program.
    We welcome public comments on these proposals.
10. Administrative Review Process of Certain Electronic Health Record 
Incentive Program Determinations
    In the Stage 2 final rule (77 FR 54112 through 54113), we discussed 
an administrative appeals process for both Stages 1 and 2 of meaningful 
use. We believe this appeals process is primarily procedural and does 
not need to be specified in regulation. We have developed guidance on 
the appeals process, which is available on our Web site at www.cms.gov/
EHRIncentivePrograms. We propose no changes in this proposed rule and 
intend to continue to specify the appeals process in guidance available 
on our Web site.

E. Medicare Advantage Organization Incentive Payments

    We are not proposing any changes to the existing policies and 
regulations for Medicare Advantage (MA) organizations. Our existing 
policies and regulations include provisions concerning the EHR 
incentive payments to qualifying MA organizations and the payment 
adjustments for 2015 and subsequent MA payment adjustment years. (For 
more information on MA organization incentive payments, we refer 
readers to the final rules for Stages 1 and 2 (75 FR 44468 through 
44482 and 77 FR 54113 through 54119).)

F. The Medicaid EHR Incentive Program

    The proposals discussed in sections II.F.1. through II.F.3. of this 
proposed rule would be applicable upon the effective date of the final 
rule, not when Stage 3 of meaningful use of certified EHR technology 
begins, unless otherwise indicated.
1. EHR Reporting Period for First Year of Meaningful Use
    We are proposing amendments to the definitions of ``EHR reporting 
period'' and ``EHR reporting period for a payment adjustment year'' in 
Sec.  495.4 to shift the EHR reporting periods for eligible hospitals 
and CAHs to periods that are based on the calendar year, not the 
federal fiscal year, and to establish a full calendar year as the EHR 
reporting period or EHR reporting period for a payment adjustment year 
for almost all providers beginning in 2017. However, we are also 
proposing a limited exception under which Medicaid EPs and eligible 
hospitals demonstrating meaningful use for the first time could use any 
continuous 90-day EHR reporting period within the calendar year. This 
EHR reporting period for Medicaid providers demonstrating meaningful 
use for the first time would apply both for purposes of receiving an 
incentive payment in the Medicaid program and for purposes of avoiding 
the payment adjustment under the Medicare program for the payment 
adjustment year that is two years after the calendar year in which the 
provider first demonstrates meaningful use for an EHR reporting period. 
Under this proposal, Medicaid EPs and eligible hospitals would have an 
EHR reporting period of any continuous 90-day period in the calendar 
year that is the payment year, for their first payment year based on 
meaningful use, beginning in 2017. We note that hospitals that are 
eligible under both the Medicaid and Medicare incentive programs, and 
that are attesting for the Medicaid program, do not need to separately 
attest in the Medicare program in 2017 and subsequent years, because 
the statute does not allow for Medicare EHR incentive payments to 
eligible hospitals after FY 2016. If a hospital eligible under both 
programs is demonstrating meaningful use for the first time, and using 
a continuous 90-day EHR reporting period under the Medicaid program, it 
could attest for the Medicaid program only, and still avoid the 
Medicare payment adjustment that is 2 years after the calendar year in 
which the EHR reporting period occurs. However, if a hospital eligible 
under both programs chooses also to attest for the Medicare program, it 
would be required to complete an EHR reporting period of 1 full 
calendar year to avoid the Medicare payment adjustment that is 2 years 
after that calendar year. We note that, consistent with the other 
proposed amendments to Sec.  495.4 discussed previously, this proposal 
would change the EHR reporting period for eligible hospitals from one 
that is based on the federal fiscal year to one that is based on the 
calendar year, beginning in 2017. For further discussion of the 
relationship between the 90-day EHR reporting period under the Medicaid 
EHR Incentive Program and the payment adjustments under Medicare, we 
refer readers to section II.D. of this proposed rule.
    This policy would allow Medicaid providers flexibility in their 
first year of demonstrating meaningful use. It also would reduce the 
burden on states to implement significant policy and system changes in 
preparation for Stage 3, as the 90-day period for the first year of 
meaningful use is consistent with our previous policies and meaningful 
use timelines.
2. Reporting Requirements
a. State Reporting on Program Activities
    As discussed in section II.A.1.c.(1).(b).(iii). of this proposed 
rule, we are adding a new provision at Sec.  495.316(d)(2)(iii) to 
provide states with flexibility regarding the Stage 3 public health and 
clinical data registry reporting objective.
    We also propose to amend Sec.  495.316(c), as well as add a new 
paragraph Sec.  495.316(f), to formalize the process of how states 
report to us annually on the providers that have attested to adopt, 
implement, or upgrade (AIU), or that have attested to meaningful use. 
Under this proposal, states would follow a structured submission 
process, in the manner prescribed by CMS, which would include a new 
annual reporting

[[Page 16780]]

deadline. We propose to require states to submit annual reports to CMS 
within 45 days of the end of the second quarter of each federal fiscal 
year.
    We propose to regularize the timing of the annual reporting process 
described in Sec.  495.316 to ensure more timely annual reports and 
allow for clearer communication to states on when the reports should be 
submitted to CMS. In addition, CMS and states would be able to more 
effectively track the progress of states' incentive program 
implementation and oversight as well as provider progress in achieving 
meaningful use. Predictable deadlines for annual reporting would permit 
CMS and the states to more quickly compare and assess overall program 
impact each year.
    We are also considering changes to the data that the annual 
reporting requirements outlined in Sec.  495.316(d) require states to 
include in their annual reports. Specifically, we are considering 
whether to remove the requirement that states report information about 
practice location for providers that qualify for incentive payments on 
the basis of having adopted, implemented, or upgraded certified EHR 
technology or on the basis of demonstrating they are meaningful users 
of certified EHR technology. While we believe that this data is useful 
to both CMS and the states for program implementation purposes, we 
believe the benefits of including it in state reports might be 
outweighed by the burdens to states of reporting it. Therefore, we are 
seeking more information on state burdens and costs associated with 
complying with this requirement. We solicit comments both on the 
burdens associated with the requirement to report practice location 
information for providers that receive incentive payments through the 
Medicaid EHR Incentive Program, and on the benefits of including this 
information in state reports.
    We propose to amend Sec.  495.352 to formalize the process of how 
states submit quarterly progress reports on implementation and 
oversight activities and to specify the elements that should be 
included in the quarterly reports. Under this proposal, states would 
follow a structured submission process, in the manner prescribed by 
CMS. We propose that states would report on the following activities: 
State system implementation dates; provider outreach; auditing; state-
specific SMHP tasks; state staffing levels and changes; the number and 
type of providers that qualified for an incentive payment on the basis 
of demonstrating that they are meaningful EHR users of certified EHR 
technology and the amounts of incentive payments; and the number and 
type of providers that qualified for an incentive payment on the basis 
of having adopted, implemented, or upgraded certified EHR technology 
and the amounts of incentive payments.
    We propose these changes to the quarterly reporting process 
described in Sec.  495.352 so that CMS and states can better track 
state implementation and oversight activity progress in a way that 
would permit CMS and the states to compare overall programmatic and 
provider progress. We also expect that streamlined and enhanced 
quarterly progress reporting would lead to an improvement in overall 
data quality that would help inform future meaningful use activity 
across states.
    We would like to include a deadline for states' quarterly reporting 
under the proposed amendments to Sec.  495.352, and are considering 
requiring states to submit quarterly progress reports to CMS within 30 
days after the end of each federal fiscal year quarter. We believe that 
a set deadline would improve timeliness and communication, but we do 
not want to set a deadline that is overly burdensome for a report that 
must be submitted quarterly. We seek public comment on the deadline we 
are considering.
b. State Reporting on Meaningful EHR Users
    Starting in FY 2015 for eligible hospitals and CY 2015 for EPs, 
providers that fail to demonstrate meaningful use for an applicable EHR 
reporting period will be subject to downward payment adjustments under 
Medicare. As discussed in the Stage 2 final rule (77 FR 54094), EPs who 
are meaningful EHR users under the Medicaid EHR Incentive Program for 
an applicable EHR reporting period will be considered meaningful EHR 
users for that period for purposes of avoiding the Medicare payment 
adjustments. Currently, hospitals eligible for both Medicaid and 
Medicare incentive payments attest in both the Medicare and Medicaid 
systems to earn an incentive payment in both programs. The statute does 
not authorize Medicare EHR incentive payments to eligible hospitals 
after FY 2016. To avoid duplicative reporting, hospitals eligible under 
both programs will not be required to attest in both programs beginning 
in 2017. Therefore, we must have accurate and timely data from states 
regarding both EPs and eligible hospitals that have successfully 
demonstrated meaningful use for each payment year to ensure that 
meaningful EHR users in the Medicaid EHR Incentive Program are 
appropriately exempted from the Medicare payment adjustment for the 
applicable payment adjustment year. This additional reporting is 
necessary because the electronic data currently contained in the 
National Level Repository are insufficient to determine which Medicaid 
providers should be exempted from the Medicare payment adjustments in 
an accurate and timely manner. Accordingly, we propose to add new 
paragraphs (g) and (h) to Sec.  495.316 to require that states submit 
reports on a quarterly basis that identify certain providers that 
attested to meaningful use through the Medicaid EHR Incentive Program 
for each payment year. Under this proposal, states would submit 
quarterly reports for Medicaid EPs and eligible hospitals that 
successfully attest to meaningful use for each payment year.
    We propose that states would report quarterly, in the manner 
prescribed by CMS, information on each provider that successfully 
attests to meaningful use, regardless of whether the provider has been 
paid yet. The report would be required to specify the Medicaid state 
and payment year. For each EP or eligible hospital listed in the 
report, the state would also specify the Payment Year Number, the NPI 
for EPs and the CCN for eligible hospitals, the Attestation Submission 
Date, the State Qualification (as either meaningful use or blank), and 
the State Qualification Date (the beginning date of the reporting 
period in which successful meaningful use attestation was achieved by 
the EP or eligible hospital). The EP or eligible hospital's ``payment 
year number'' refers to the number of years that the provider has been 
paid in the EHR Incentive Program; so, for example, this would be ``2'' 
for the 2014 payment year if the provider received payments for 2013 
and 2014. States would have this data, even for providers that have 
previously received an incentive payment through the Medicare EHR 
Incentive Program. If the state is reporting a disqualification, then 
the state would leave the State Qualification field blank. If 
applicable, in the cases of EPs or eligible hospitals previously 
identified as meaningful EHR users, the state would be required to 
specify the State Disqualification and State Disqualification Date 
(that is, the beginning date of the EHR reporting period during which 
an EP or eligible hospital was found not to meet the definition of a 
meaningful EHR user).
    Under this proposal, states would submit this information beginning 
with payment year 2013 data. The reports would cover back to the 2013 
payment year because that would be the EHR

[[Page 16781]]

reporting period for the 2015 Medicare payment adjustment year under 
Sec.  495.4. Providers that successfully attested to meaningful use for 
2013 would be exempt from the Medicare payment adjustment in 2015.
    Under this proposal, states would not be required to include 
information about certain providers in their reports. We recognize that 
several provider types that are eligible for the Medicaid EHR Incentive 
Program are not subject to the Medicare payment adjustments. 
Accordingly, states would not be required to report on those EPs who 
are eligible for the Medicaid EHR Incentive Program on the basis of 
being a nurse practitioner, certified nurse-midwife, or physician 
assistant.
3. Clinical Quality Measurement for the Medicaid Program
    States are, and will continue in Stage 3 to be, responsible for 
determining whether and how electronic reporting of CQMs would occur, 
or whether they wish to allow reporting through attestation. This is 
consistent with our policy in the Stage 2 final rule (77 FR 54075). If 
a state does require electronic reporting, the state is responsible for 
sharing the details on the process with its provider community. We 
anticipate that whatever means states have deployed for capturing 
Stages 1 and 2 clinical quality measures electronically would be 
similar for reporting in 2017 and subsequent years. However, we note 
that subject to our prior approval, this is within the states' purview. 
States that wish to establish the method and requirements for 
electronically reporting would continue to be required to do so through 
the SMHP submission, subject to our prior approval.
    To further our goals of alignment and avoiding duplicative 
reporting across quality reporting programs, we would recommend that 
states include a narrative in their SMHP for CY 2017 describing how 
their proposed meaningful use CQM data submission strategy aligns with 
their State Medicaid Quality Strategy and report which certified EHR 
technology requirements they mandate for eCQM reporting.
    For more information on requirements around the State Medicaid 
Quality Strategy, see http://medicaid.gov/Federal-Policy-Guidance/Downloads/SHO-13-007.pdf.

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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    The following is a discussion of the requirements contained in this 
proposed regulation that we believe are subject to PRA and collection 
of information 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 V.C. of this proposed rule. The actual burden would remain 
constant for all of Stage 3 as EPs, eligible hospitals, and CAHs would 
only need to attest that they have successfully demonstrated meaningful 
use in 2017 and annually thereafter. The only variable from year-to-
year in Stage 3 would be the number of respondents, as noted in the 
impact analysis assumptions. For the purposes of this analysis, we are 
focusing only on 2017, the first year in which a provider may 
participate in Stage 3 of the Medicare EHR Incentive Program. We do not 
believe the burden for EPs, eligible hospitals, and CAHs participating 
in Stages 1 and 2 prior to 2017 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 
have the option to electronically report their clinical quality 
measures through the respective electronic reporting pilots. For 
eligible hospitals and CAHs, the burden is discussed in the CY 2012 
Hospital Outpatient Prospective Payment System final rule with comment 
period (76 FR 73450 through 73451).
    As discussed in section I.A.1.a. of this proposed rule, Stage 3 is 
intended to build on Stages 1 and 2 with a focus on advanced use of 
certified EHR technology to promote improved patient outcomes while 
assuring that the framework is flexible and does not hinder innovation. 
In this proposed rule, the definition of meaningful use with associated 
reporting requirements would replace all prior definitions and 
requirements beginning in 2018. At that point, all eligible providers 
would be required to report only Stage 3 requirements on an annual 
basis. For 2017, providers may simply repeat their current status at 
Stage 1 or Stage 2, or move on to Stage 3. The same reporting time 
would apply to all providers. Consequently, the proposed ICRs reflect 
the provider burden associated with complying with and reporting of 
Stage 3 requirements beginning in 2017 and each subsequent year.
    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.  495.6, 
Sec.  495.7 and Sec.  495.8)

    In Sec.  495.7 we propose that to successfully demonstrate 
meaningful use of certified EHR technology for Stage 3, 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--
    <bullet> The provider used certified EHR technology and specified 
the technology was used; and
    <bullet> The provider satisfied each of the applicable objectives 
and associated measures in Sec.  495.7.
    In Sec.  495.8, 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 that require the provider to 
attest that they have done so.
    We propose that there would be 5 objectives and 10 measures that 
would require an EP to enter numerators and denominators during 
attestation. Eligible hospitals and CAHs would have to attest they have 
met 5 objectives and 10 measures that would require numerators and 
denominators. For objectives and associated measures requiring a 
numerator and denominator in this proposed rule, we limit our estimates 
to actions taken in the presence of certified EHR technology. We do not 
anticipate a provider would

[[Page 16782]]

maintain two recordkeeping systems when certified EHR technology is 
present. Therefore, we assume that all patient records that would be 
counted in the denominator would be kept using certified EHR 
technology. We expect it would take an individual provider or designee 
approximately 10 minutes to attest to each meaningful use objective and 
associated measure that requires a numerator and denominator to be 
generated. The security risk assessment and its associated measure 
would not require a numerator and denominator and we would expect it 
would take an individual provider or designee approximately 6 hours to 
complete. The clinical decision support and active engagement with a 
public health agency measures would take an eligible professional, 
eligible hospital or critical access hospital 1 minute each to report 
each CDS intervention or registry.
    We propose that EPs would be required to report on a total of 8 
objectives and 16 associated measures. For the purpose of this proposed 
collection of information, we assumed that all eligible providers would 
comply with the requirements of meaningful use Stage 3. We propose that 
eligible hospitals and CAHs would be required to report on a total of 8 
objectives and 17 associated measures. We estimated the total annual 
cost burden for all eligible hospitals and CAHs to attest to EHR 
technology, meaningful use objectives and associated measures, and 
electronically submit the clinical quality measures would be $2,135,204 
(4,900 eligible hospitals and CAHs x 6 hours 52 minutes x $63.46 (mean 
hourly rate for lawyers based on May 2013 BLS) data)). We estimate the 
total annual cost burden for all EPs to attest to EHR technology, 
meaningful use objectives and associated measures, and electronically 
submit the clinical quality measures would be $385,834,395 (609,100 EPs 
x 6 hours 52 minutes x $92.25 (mean hourly rate for physicians based on 
May 2013 BLS) data).
    In this proposed rule, there are 5 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 five 
objectives that require numerators and denominators. For objectives and 
associated measures requiring a numerator and denominator, we limit our 
estimates to actions taken in the presence of certified EHR technology. 
We do not anticipate a provider would maintain two recordkeeping 
systems when certified EHR technology is present. Therefore, we assume 
that all patient records that would be counted in the denominator would 
be kept using certified EHR technology. We expect it would take an 
individual provider or designee approximately 10 minutes to attest to 
each meaningful use objective and associated measure that requires a 
numerator and denominator to be generated, as well as each CQM for 
providers attesting in their first year of the program.
    Additionally, providers 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 three objectives 
that would require a ``yes'' or ``no'' response during attestation. As 
discussed previously, the associated measures are that EPs are required 
to conduct a security risk analysis, report to three registries to 
fulfil the public health objective, and must implement at least five 
clinical decision support interventions. For eligible hospitals and 
CAHs, there are three objectives that would require a ``yes'' or ``no'' 
response during attestation. The associated measures for eligible 
hospitals and CAHs require the provider to conduct a security risk 
analysis, report to four registries to fulfill the public health 
objective and must implement at least five clinical decision support 
interventions. We estimate each of these measures would take 1 minute 
to report.
    Providers would also be required to attest that they are protecting 
electronic health information. 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 6 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 52 minutes to complete, and would 
take an eligible hospital or CAH 6 hours 52 minutes to complete.
    In this proposed rule EPs, eligible hospitals, and CAHs have 
virtually identical burdens. Eligible hospitals and CAHs are required 
to report to one additional registry than EPs are required to report. 
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 6--Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                             Burden estimate    Burden estimate
      Objectives--Eligible        Objectives--Eligible        Measures        per respondent     per respondent
         professionals               hospitals/CAHs                               (EPs)           (hospitals)
----------------------------------------------------------------------------------------------------------------
Protect electronic protected     Protect electronic      Conduct or review  6 hours..........  6 hours.
 health information (ePHI)        protected health        a security risk
 created or maintained by the     information (ePHI)      analysis in
 CEHRT through the                created or maintained   accordance with
 implementation of appropriate    by the CEHRT through    the requirements
 technical, administrative and    the implementation of   under 45 CFR
 physical safeguards.             appropriate             164.308(a)(1),
                                  technical,              including
                                  administrative and      addressing the
                                  physical safeguards.    security (to
                                                          include
                                                          encryption) of
                                                          data stored in
                                                          CEHRT in
                                                          accordance with
                                                          requirements
                                                          under 45 CFR
                                                          164.312(a)(2)(iv
                                                          ) and 45 CFR
                                                          164.306(d)(3),
                                                          implement
                                                          security updates
                                                          as necessary,
                                                          and correct
                                                          identified
                                                          security
                                                          deficiencies as
                                                          part of the
                                                          provider's risk
                                                          management
                                                          process.
Generate and transmit            Generate and transmit   1. EP Measure:     10 minutes.......  10 minutes.
 permissible prescriptions        permissible discharge   More than 80% of
 electronically (eRx.).           prescriptions           all permissible
                                  electronically (eRx).   prescriptions
                                                          written by the
                                                          EP are queried
                                                          for a drug
                                                          formulary and
                                                          transmitted
                                                          electronically
                                                          using CEHRT.

[[Page 16783]]

 
                                 ......................  2. Eligible
                                                          Hospital
                                                          Measure: More
                                                          than 25% of
                                                          hospital
                                                          discharge
                                                          medication
                                                          orders for
                                                          permissible
                                                          prescriptions
                                                          (for new and
                                                          changed
                                                          prescriptions)
                                                          are queried for
                                                          a drug formulary
                                                          and transmitted
                                                          electronically
                                                          using CEHRT.
Implement clinical decision      Implement clinical      Measure 1: The     1 minute.........  1 minute.
 support (CDS) interventions      decision support        EP, eligible
 focused on improving             (CDS) interventions     hospital and CAH
 performance on high-priority     focused on improving    must implement
 health conditions.               performance on high-    five clinical
                                  priority health         decision support
                                  conditions.             interventions
                                                          related to four
                                                          or more CQMs at
                                                          a relevant point
                                                          in patient care
                                                          for the entire
                                                          EHR reporting
                                                          period. Absent
                                                          four CQMs
                                                          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.
Use computerized provider order  Use computerized        Measure 1: More    10 minutes.......  10 minutes.
 entry (CPOE) for medication,     provider order entry    than 80 percent
 laboratory, and diagnostic       (CPOE) for              of medication
 imaging orders directly          medication,             orders created
 entered by any licensed          laboratory, and         by the EP or
 healthcare professional,         diagnostic imaging      authorized
 credentialed medical             orders directly         providers of the
 assistant, or a medical staff    entered by any          eligible
 member credentialed to and       licensed healthcare     hospital's or
 performing the equivalent        professional,           CAH's inpatient
 duties of a credentialed         credentialed medical    or emergency
 medical assistant; who can       assistant, or a         department (POS
 enter orders into the medical    medical staff member    21 or 23) during
 record per state, local, and     credentialed to and     the EHR
 professional guidelines.         performing the          reporting period
                                  equivalent duties of    are recorded
                                  a credentialed          using
                                  medical assistant;      computerized
                                  who can enter orders    provider order
                                  into the medical        entry..
                                  record per state,
                                  local, and
                                  professional
                                  guidelines.
                                 ......................  Measure 2: More
                                                          than 60 percent
                                                          of laboratory
                                                          orders created
                                                          by the EP or
                                                          authorized
                                                          providers of the
                                                          eligible
                                                          hospital's or
                                                          CAH's inpatient
                                                          or emergency
                                                          department (POS
                                                          21 or 23) during
                                                          the EHR
                                                          reporting period
                                                          are recorded
                                                          using
                                                          computerized
                                                          provider order
                                                          entry
                                 ......................  Measure 3: More
                                                          than 60 percent
                                                          of diagnostic
                                                          imaging 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
                                                          computerized
                                                          provider order
                                                          entry.
The EP provides access for       The eligible hospital   Measure 1: For     10 minutes.......  10 minutes.
 patients to view online,         or CAH provides         more than 80
 download, and transmit their     access for patients     percent of all
 health information, or           to view online,         unique patients
 retrieve their health            download, and           seen by the EP
 information through an API,      transmit their health   or discharged
 within 24 hours of its           information, or         from the
 availability.                    retrieve their health   eligible
                                  information through     hospital or CAH
                                  an API, within 24       inpatient or
                                  hours of its            emergency
                                  availability.           department (POS
                                                          21 or 23):
                                 ......................  (1) The patient
                                                          (or the patient
                                                          authorized
                                                          representative)
                                                          is provided
                                                          access to view
                                                          online,
                                                          download, and
                                                          transmit his or
                                                          her health
                                                          information
                                                          within 24 hours
                                                          of its
                                                          availability to
                                                          the provider; or
                                 ......................  (2) The patient
                                                          (or the patient
                                                          authorized
                                                          representative)
                                                          is provided
                                                          access to an ONC-
                                                          certified API
                                                          that can be used
                                                          by third-party
                                                          applications or
                                                          devices to
                                                          provide patients
                                                          (or patient
                                                          authorized
                                                          representatives)
                                                          access to their
                                                          health
                                                          information,
                                                          within 24 hours
                                                          of its
                                                          availability to
                                                          the provider

[[Page 16784]]

 
                                 ......................  Measure 2: The
                                                          EP, eligible
                                                          hospital or CAH
                                                          must use
                                                          clinically
                                                          relevant
                                                          information from
                                                          CEHRT to
                                                          identify patient-
                                                          specific
                                                          educational
                                                          resources and
                                                          provide
                                                          electronic
                                                          access to those
                                                          materials to
                                                          more than 35
                                                          percent of
                                                          unique patients
                                                          seen by the EP
                                                          or discharged
                                                          from the
                                                          eligible
                                                          hospital or CAH
                                                          inpatient or
                                                          emergency
                                                          department (POS
                                                          21 or 23) during
                                                          the EHR
                                                          reporting
                                                          period.
Use communications functions of  Use communications      Measure 1: During  10 minutes.......  10 minutes.
 certified EHR technology to      functions of            the EHR
 engage with patients or their    certified EHR           reporting
 authorized representatives       technology to engage    period, more
 about the patient's care.        with patients or        than 25 percent
                                  their authorized        of all unique
                                  representatives about   patients seen by
                                  the patient's care      the EP or
                                                          discharged from
                                                          the eligible
                                                          hospital or CAH
                                                          inpatient or
                                                          emergency
                                                          department (POS
                                                          21 or 23)
                                                          actively engage
                                                          with the
                                                          electronic
                                                          health record
                                                          made accessible
                                                          by the provider.
                                                          An EP may meet
                                                          the measure by
                                                          either--.
                                 ......................  (1) More than 25
                                                          percent of all
                                                          unique patients
                                                          (or patient-
                                                          authorized
                                                          representatives)
                                                          seen by the EP
                                                          or discharged
                                                          from the
                                                          eligible
                                                          hospital or CAH
                                                          during the EHR
                                                          reporting period
                                                          view, download
                                                          or transmit to a
                                                          third party
                                                          their health
                                                          information; or
                                 ......................  (2) More than 25
                                                          percent of all
                                                          unique patients
                                                          (or patient-
                                                          authorized
                                                          representatives)
                                                          seen by the EP
                                                          or discharged
                                                          from the
                                                          eligible
                                                          hospital or CAH
                                                          inpatient or
                                                          emergency
                                                          department (POS
                                                          21 or 23) during
                                                          the EHR
                                                          reporting period
                                                          access their
                                                          health
                                                          information
                                                          through the use
                                                          of an ONC-
                                                          certified API
                                                          that can be used
                                                          by third-party
                                                          applications or
                                                          devices.
                                 ......................  Measure 2: During
                                                          the EHR
                                                          reporting
                                                          period, for more
                                                          than 35 percent
                                                          of all unique
                                                          patients seen by
                                                          the EP or
                                                          discharged from
                                                          the eligible
                                                          hospital or CAH
                                                          during the EHR
                                                          reporting
                                                          period, a secure
                                                          message was sent
                                                          using the
                                                          electronic
                                                          messaging
                                                          function of
                                                          CEHRT to the
                                                          patient (or
                                                          their authorized
                                                          representatives)
                                                          , or in response
                                                          to a secure
                                                          message sent by
                                                          the patient.
                                 ......................  Measure 3:
                                                          Patient-
                                                          generated health
                                                          data or data
                                                          from a non-
                                                          clinical setting
                                                          is incorporated
                                                          into the
                                                          certified EHR
                                                          technology for
                                                          more than 15
                                                          percent of all
                                                          unique patients
                                                          seen by the EP
                                                          or discharged by
                                                          the eligible
                                                          hospital or CAH
                                                          during the EHR
                                                          reporting
                                                          period.
The EP provides a summary of     The eligible hospital   Measure 1: For     10 minutes.......  10 minutes.
 care record when transitioning   or CAH provides a       more than 50
 or referring their patient to    summary of care         percent of
 another setting of care,         record when             transitions of
 retrieves a summary of care      transitioning or        care and
 record upon the first patient    referring their         referrals, the
 encounter with a new patient,    patient to another      EP, eligible
 and incorporates summary of      setting of care,        hospital or CAH
 care information from other      retrieves a summary     that transitions
 providers into their EHR using   of care record upon     or refers their
 the functions of certified EHR   the first patient       patient to
 technology.                      encounter with a new    another setting
                                  patient, and            of care or
                                  incorporates summary    provider of
                                  of care information     care--(1)
                                  from other providers    creates a
                                  into their EHR using    summary of care
                                  the functions of        record using
                                  certified EHR           CEHRT; and (2)
                                  technology.             electronically
                                                          exchanges the
                                                          summary of care
                                                          record.
                                 ......................  Measure 2: For
                                                          more than 40
                                                          percent of
                                                          transitions or
                                                          referrals
                                                          received and
                                                          patient
                                                          encounters in
                                                          which the
                                                          provider has
                                                          never before
                                                          encountered the
                                                          patient, the EP,
                                                          eligible
                                                          hospital or CAH
                                                          incorporates
                                                          into the
                                                          patient's record
                                                          in their EHR an
                                                          electronic
                                                          summary of care
                                                          document from a
                                                          source other
                                                          than the
                                                          provider's EHR
                                                          system.

[[Page 16785]]

 
                                 ......................  Measure 3: For
                                                          more than 80
                                                          percent of
                                                          transitions or
                                                          referrals
                                                          received and
                                                          patient
                                                          encounters in
                                                          which the
                                                          provider has
                                                          never before
                                                          encountered the
                                                          patient, the EP,
                                                          eligible
                                                          hospital, or CAH
                                                          performs
                                                          clinical
                                                          information
                                                          reconciliation.
                                                          The provider
                                                          would choose at
                                                          least two of the
                                                          following three
                                                          clinical
                                                          information sets
                                                          on which to
                                                          perform
                                                          reconciliations:
                                 ......................  Medication.
                                                          Review of the
                                                          patient's
                                                          medication,
                                                          including the
                                                          name, dosage,
                                                          frequency, and
                                                          route of each
                                                          medication.
                                 ......................  Medication
                                                          allergy. Review
                                                          of the patient's
                                                          known allergic
                                                          medications.
                                 ......................  Current Problem
                                                          list. Review of
                                                          the patient's
                                                          current and
                                                          active
                                                          diagnoses.
The EP is in active engagement   The eligible hospital   Providers must     1 minute.........  1 minute.
 with a PHA or CDR to submit      or CAH is in active     report data on
 electronic public health data    engagement with a PHA   an ongoing basis
 in a meaningful way using        or CDR to submit        to established
 certified EHR technology,        electronic public       public health
 except where prohibited, and     health data in a        registries.
 in accordance with applicable    meaningful way using
 law and practice.                certified EHR
                                  technology, except
                                  where prohibited, and
                                  in accordance with
                                  applicable law and
                                  practice.
                                 ......................  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).
                                 ......................  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).
                                 ......................  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.
                                 ......................  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.
                                 ......................  Measure 5:
                                                          Clinical Data
                                                          Registry
                                                          Reporting: The
                                                          EP, eligible
                                                          hospital, or CAH
                                                          is in active
                                                          engagement to
                                                          submit data to a
                                                          clinical data
                                                          registry.
                                 ......................  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
                                 ......................  EP Objective:
                                                          report to 3 of
                                                          the following
                                                          registries:
                                                         Immunization.....
                                                         Syndromic
                                                          Surveillance.
                                                         Case Reporting...
                                                         Public Health....
                                                         Clinical Data....
                                 ......................  EPs may choose to
                                                          report to more
                                                          than one public
                                                          health registry
                                                          to meet the
                                                          number of
                                                          measures
                                                          required to meet
                                                          the objective.
                                 ......................  EPs may choose to
                                                          report to more
                                                          than one
                                                          clinical data
                                                          registry to meet
                                                          the number of
                                                          measures
                                                          required to meet
                                                          the objective.

[[Page 16786]]

 
                                 ......................  EH/CAH Objective:
                                                          report to 4 of
                                                          the following
                                                          registries:
                                                         Immunization.....
                                                         Syndromic
                                                          Surveillance.
                                                         Case Reporting...
                                                         Public Health....
                                                         Clinical Data....
                                                         Electronic
                                                          Reportable
                                                          Laboratory
                                                          Results..
                                 ......................  Eligible
                                                          hospitals and
                                                          CAHs may choose
                                                          to report to
                                                          more than one
                                                          public health
                                                          registry to meet
                                                          the number of
                                                          measures
                                                          required to meet
                                                          the objective.
                                 ......................  Eligible
                                                          hospitals and
                                                          CAHs may choose
                                                          to report to
                                                          more than one
                                                          clinical data
                                                          registry to meet
                                                          the number of
                                                          measures
                                                          required to meet
                                                          the objective.
                                --------------------------------------------------------------------------------
    Criteria Burden Time to      ......................  .................  6 hours 52         6 hours 52
     Attest and Report Clinical                                              minutes.           minutes.
     Quality Measures.
                                                                           -------------------------------------
        Total--Criteria Burden.  ......................  .................  6 hours 52         6 hours 52
                                                                             minutes.           minutes.
----------------------------------------------------------------------------------------------------------------

    In this proposed rule, we estimate that it would take no longer 
than 6 hours and 52 minutes for an EP to satisfy each of the applicable 
objectives and associated measures. The total burden hours for an EP to 
attest to the criteria previously specified would be 6 hours 52 
minutes. We estimate that there could be approximately 609,100 non-
hospital-based Medicare and Medicaid EPs in 2017.
    We estimate the burden for the approximately 13,635 MA EPs in the 
MAO burden section. We estimate the total burden associated with these 
requirements for an EP would be 6 hours 52 minutes. The total estimated 
annual cost burden for all EPs to attest to EHR technology and 
meaningful use objectives would be $385,834,395 (506,400 x 6 hours 52 
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 core meaningful use objectives and associated measures, and 
would electronically submit the clinical quality measures. We estimate 
that it would take no longer, than 6 hours and 52 minutes to attest 
that during the EHR reporting period, they used the certified EHR 
technology, specify the EHR technology used and satisfied each of the 
applicable objectives and associated measures. We estimate that there 
are about 4,900 eligible hospitals and CAHs (3,397 acute care 
hospitals, 1,395 CAHs, 97 children's hospitals, and 11 cancer 
hospitals) that may attest to the aforementioned criteria in FY 2017. 
We estimate the total burden associated with these requirements for an 
eligible hospital and CAH would be 6 hours 52 minutes. The total 
estimated annual cost burden for all eligible hospitals and CAHs to 
attest to EHR technology, meaningful use core set and menu set 
criteria, and electronically submit the clinical quality measures would 
be $2,135,204 (4,908 eligible hospitals and CAHs x $63.46 (6 hours 52 
minutes x $63.46 (mean hourly rate for lawyers based on May 2013 BLS) 
data)).

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 in Stage 3, 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 together if the certified EHR technology is 
required to be used at its facilities, whereas under FFS, each EP 
likely must make the determination on an individual basis. We estimate 
that, on average, it 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 
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, we believe it would cost the 
participating qualifying MA organizations approximately $426,050 
annually to make the attestations ([10,226 hours x $25.00] + [3,408 
hours x $50.00]).

C. ICR Regarding State Reporting Requirements (Sec.  495.316 and Sec.  
495.352)

    We are proposing to revise 42 CFR 495 regarding state reporting 
requirements to CMS. With respect to the annual reporting requirements 
in Sec.  495.316 and the quarterly reporting requirements in Sec.  
495.352, we do not believe that the proposed amendments to these 
reporting requirements would increase the burden on states beyond what 
was previously finalized under OMB control number 0938-1158 following 
the Stage 2 final rule. The

[[Page 16787]]

deadlines we propose or are considering would be consistent with our 
past practice, and the changes we propose or consider to the data 
elements to be reported on would be either reduced or similar in 
burden. Similarly, we do not expect the proposed amendments regarding 
the 90-day EHR reporting period for first time meaningful users would 
impose a burden on states because those amendments would generally 
maintain the current policy.
    However, we are proposing to revise Sec.  495.316 to include a new 
quarterly reporting requirement. Under the proposed amendment, states 
would report quarterly to CMS regarding the EPs and Medicaid eligible 
hospitals that have successfully demonstrated meaningful use for each 
payment year. We need this information to ensure that those EPs who are 
meaningful EHR users in the Medicaid EHR Incentive Program are 
appropriately exempted from the Medicare payment adjustment. We cannot 
accurately exempt these providers using the current data received from 
states. We expect that it would take a state 20 hours each year to 
submit this report on a quarterly basis. We believe that the state 
employee reporting the information could be equivalent to a GS 12, step 
1 (2015 unadjusted for locality rate), with an hourly rate of 
approximately $30.00/hour. This amount is then reduced by the 90 
percent federal contribution for administrative services for Medicaid 
under the EHR Incentive Programs, this equates to approximately $3.00/
hour. Therefore, for all state Medicaid agencies to report four times 
per year at 20 hours per report the estimated cost is $13,460 (4560 
hours x $3.00/hour).

                                                 Table 7--Estimated Annual Information Collection Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Burden per                     Hourly labor
               Reg section                  OMB Control      Number of       Number of       response      Total annual       cost of     Total cost ($)
                                                No.         respondents      responses        (hours)     burden (hours)   reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   495.x--Objectives/Measures (EPs).       0938-1158         609,100         609,100            6.86       4,178,426           92.25     385,834,395
Sec.   495.6--Objectives/Measures              0938-1158           4,900           4,900            6.86          33,614           63.46       2,135,204
 (hospitals/CAHs).......................
Sec.   495.210--Gather information for         0938-1158          13,635          13,635            0.75          10,226           25.00         255,650
 attestation (MA EPs)...................
Sec.   495.210--Attestation on behalf of       0938-1158          13,635          13,635            0.25         3408.75           50.00         170,400
 MA EPs.................................
Sec.   495.316--Quarterly Reporting.....       0938-1158              56             224              20            4480            3.00          13,440
                                                         -----------------------------------------------------------------------------------------------
    Totals..............................  ..............         627,635         627,635  ..............       4,225,674  ..............     388,408,189
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
All non-whole numbers in this table are rounded to 2 decimal places.
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 7.

    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 final rule; or
    2. Submit your comments to the Office of Information and Regulatory 
Affairs, Office of Management and Budget, Attention: CMS Desk Officer, 
[CMS-3310-P], Fax: (202) 395-6974; or Email: 
<a href="/cdn-cgi/l/email-protection#c08f8992819fb3b5a2ada9b3b3a9afae80afada2eea5afb0eea7afb6"><span class="__cf_email__" data-cfemail="410e0813001e3234232c283232282e2f012e2c236f242e316f262e37">[email protected]</span></a>.

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this 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. This proposed rule specifies 
applicable criteria for demonstrating Stage 3 of meaningful use.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This proposed rule is anticipated to have an annual effect on the 
economy of $100 million or more, making it an economically significant 
rule under the Executive Order and a major rule under the Congressional 
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis 
(RIA) that presents the estimated costs and benefits of this proposed 
rule.
    As noted in section I.A.2. of this proposed rule, this proposed 
rule is one of two coordinated rules related to the

[[Page 16788]]

meaningful use of certified EHR technology. The other is ONC's 2015 
Edition Health Information Technology (Health IT) Certification 
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, 
and ONC Health IT Certification Program Modifications proposed 
elsewhere in this issue of the Federal Register. This analysis focuses 
on the impact associated with Stage 3 requirements for meaningful use, 
the changes in quality measures that would take effect beginning in 
2017, and other changes being proposed for the Medicare and Medicaid 
EHR Incentive Programs.
    As we discussed in the Stage 2 final rule (77 FR 54163 through 
54291), a number of factors would affect the adoption of EHR systems 
and demonstration of meaningful use. In this proposed rule, we continue 
to believe that a number of factors would affect the adoption of EHR 
systems and demonstration of meaningful use. Readers should understand 
that these forecasts are also subject to substantial uncertainty since 
demonstration of meaningful use will depend not only on the standards 
and requirements for 2017 and for eligible hospitals and EPs, but on 
future rulemakings issued by the HHS.
    We further stated in the 2012 Stage 2 final rule (77 FR 54135 
through 54136), the statute provides Medicare and Medicaid incentive 
payments for the meaningful use of certified EHR technology. 
Additionally, the Medicaid program also provides incentives for the 
adoption, implementation, and upgrade of certified EHR technology. 
Beginning in 2015, payment adjustments are incorporated into the 
Medicare EHR Incentive Program for providers unable to demonstrate 
meaningful use. The absolute and relative strength of these is unclear. 
For example, a provider with relatively small Medicare billings will be 
less disadvantaged by payment adjustments than one with relatively 
large Medicare billings. Another uncertainty arises because there are 
likely to be ``bandwagon'' effects as the number of providers using 
EHRs rises, thereby inducing more participation in the incentives 
program, as well as greater adoption by entities (for example, clinical 
laboratories) that are not eligible for incentives or subject to 
payment adjustments, but do business with EHR adopters. It is 
impossible to predict exactly if and when such effects may take hold.
    An uncertainty arises because under current law, physicians are 
scheduled for a large payment reduction in April 2015 under the 
sustainable growth rate (SGR) formula, which determines Medicare 
physician payment updates. A large payment reduction could cause major 
changes in physician behavior, enrollee care, and other Medicare 
provider payments, but the specific nature of these changes is 
uncertain. Under current law, the remaining EHR incentives for Medicaid 
or the Medicaid payment adjustments will exert only a minor influence 
on physician behavior relative to this large physician payment 
reduction. However, the Congress has legislatively avoided a large 
physician payment reduction for each year since 2002.
    All of these factors taken together make it impossible in this 
proposed rule to predict with precision the timing or rates of adoption 
and meaningful use. However, new data is currently available regarding 
rates of adoption or costs of implementation since the publication of 
our Stage 1 and Stage 2 final rules. We have included the new data in 
our estimates, although even these forecasts are still fairly 
uncertain.
    Overall, in this proposed rule, we expect spending under the EHR 
incentive program for transfer payments to Medicare and Medicaid 
providers between 2017 and 2020 to be $3.7 billion (this estimate 
includes net payment adjustments for Medicare providers who do not 
achieve meaningful use in the amount of $0.8 billion). We have also 
estimated ``per entity'' costs for EPs, eligible hospitals, and CAHs 
for implementation/maintenance and reporting requirement costs, not all 
costs. We believe many adopting entities may achieve dollar savings at 
least equal to their total costs, and that there may be additional 
benefits to society. We also believe that implementation costs are 
significant for each participating entity because providers who were 
like to qualify as meaningful users of EHRs were likely to purchase 
certified EHR technology. However, we believe that providers who have 
already purchased certified EHR technology and participated in Stage 1 
or Stage 2 of meaningful use will experience significantly lower costs 
for participation in the program. We continue to believe that the 
short-term costs to demonstrate meaningful use of certified EHR 
technology may be outweighed by the long-term benefits, including 
practice efficiencies and improvements in medical outcomes. Although 
both cost and benefit estimates are highly uncertain, the RIA that we 
have prepared presents the estimated costs and benefits of this 
proposed rule.

C. Anticipated Effects

    The objective of the remainder of this proposed RIA is to summarize 
the costs and benefits of the HITECH Act incentive program for the 
Medicare FFS, Medicaid, and MA programs. We also provide assumptions 
and a narrative addressing the potential costs to the health care 
industry for implementation of this technology.
1. Overall Effects
a. EHR Technology Development and Certification Costs
    We note that the costs incurred by IT developers for EHR technology 
development and certification to the 2015 Edition certification 
criteria for health IT are also in part attributable to the 
requirements for the use of CEHRT established in this proposed rule for 
Stage 3 of the EHR Incentive Programs. Therefore, to the extent that 
providers' implementation and adoption costs are attributable to this 
proposed rule, health IT developers' preparation and development costs 
would also be attributable as these categories of activities may be 
directly or indirectly incentivized by the requirements to demonstrate 
meaningful use. However, even if this Stage 3 proposed rule were not 
finalized, other CMS programs (for example PQRS and IQR) do require or 
promote certification to ONC's criteria--or a professional organization 
or other such entity could require or promote certification to ONC's 
critieria.\13\ As noted previously, this analysis focuses on the impact 
associated with Stage 3 requirements for meaningful use for providers; 
while the development and certification costs are addressed in the the 
2015 Edition proposed rule published elsewhere in this issues of the 
Federal Register.
---------------------------------------------------------------------------

    \13\ In this case, the provider implementation and adoption 
costs discussed in this CMS RIA would instead be attributable to 
ONC's rulemaking.
---------------------------------------------------------------------------

b. Regulatory Flexibility Analysis and Small Entities
    The Regulatory Flexibility Act (RFA) requires agencies to prepare 
an Initial Regulatory Flexibility Analysis to describe and analyze the 
impact of the proposed rule on small entities unless the Secretary can 
certify that the regulation will not have a significant impact on a 
substantial number of small entities. In the health care 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.

[[Page 16789]]

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 would be economically 
significant. Accordingly, this RIA section, in conjunction with the 
remainder of the preamble, constitutes the required Initial Regulatory 
Flexibility Analysis (IRFA). We believe that the adoption and 
meaningful use of EHRs will have an impact on virtually every EP and 
eligible hospital, as well as CAHs and some EPs and hospitals 
affiliated with MA organizations. While the program is voluntary, in 
the first 5 years it carries substantial positive incentives that make 
it attractive to virtually all eligible entities. Furthermore, entities 
that do not demonstrate meaningful use of EHR technology for an 
applicable reporting period will be subject to significant Medicare 
payment reductions beginning in 2015. These Medicare payment 
adjustments are expected to motivate EPs, eligible hospitals, and CAHs 
to adopt and meaningfully use certified EHR technology.
    For some EPs, CAHs, and eligible hospitals the EHR technology 
currently implemented could be upgraded to meet the criteria for 
certified EHR technology as defined for this program. These costs may 
be minimal, involving no more than a software upgrade. ``Home-grown'' 
EHR systems that might exist may also require an upgrade to meet the 
certification requirements. We believe many currently used non-
certified EHR systems will require significant changes to achieve 
certification and that EPs, CAHs, and eligible hospitals will have to 
make process changes to achieve meaningful use.
    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. 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. The costs for implementation and 
complying with the criteria of meaningful use could lead to higher 
operational expenses. However, we believe that the combination of 
payment incentives and long-term overall gains in efficiency 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) 
will demonstrate the actual costs incurred by providers participating 
in the EHR Incentive Programs.
(2) Conclusion
    As discussed later in this analysis, we believe that there are many 
positive effects of adopting EHR on health care providers. We believe 
that the net effect on some individual providers may be positive. 
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 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. This proposed rule would 
affect the operations of a substantial number of small rural hospitals 
because they may be subject to adjusted Medicare payments in 2015 if 
they fail to adopt certified EHR technology by the applicable reporting 
period. As stated previously, we have determined that this proposed 
rule would create a significant impact on a substantial number of small 
entities, and have prepared a Regulatory Flexibility Analysis as 
required by the RFA and, for small rural hospitals, section 1102(b) of 
the Act. Furthermore, any impacts that would arise from the 
implementation of certified EHR technology in a rural eligible hospital 
would be positive, with respect to the streamlining of care and the 
ease of sharing information with other EPs to avoid delays, 
duplication, or errors. However, the Secretary retains the 
discretionary statutory authority to make case-by-case exceptions for 
significant hardships, and has already established certain categories 
where case-by-case applications may be made such as barriers to 
internet connectivity that impact health information exchange.
c. Unfunded Mandates Reform Act
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates will require spending in any 1 year 
$100 million in 1995 dollars, updated annually for inflation. In 2014, 
that threshold is approximately $141 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

[[Page 16790]]

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.
    The investments needed to meet the meaningful use standards and 
obtain incentive funding are voluntary, and hence not ``mandates'' 
within the meaning of the statute. However, the potential reductions in 
Medicare reimbursement beginning with FY 2015 would have a negative 
impact on providers that fail to meaningfully use certified EHR 
technology for the applicable reporting period. We note that we have no 
discretion as to the amount of those potential payment reductions. 
Private sector EPs that voluntarily choose not to participate in the 
program may anticipate potential costs in the aggregate that may exceed 
$141 million. However, because EPs may choose for various reasons not 
to participate in the program, we do not have firm data for the 
percentage of participation within the private sector. This RIA, taken 
together with the remainder of the preamble, constitutes the analysis 
required by UMRA.
d. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on state and local governments, 
preempts state law, or otherwise has federalism implications. This 
proposed rule will not have a substantial direct effect on state or 
local governments, preempt state law, or otherwise have a federalism 
implication. Importantly, state Medicaid agencies are receiving 100 
percent match from the federal government for incentives paid and a 90-
percent match for expenses associated with administering the program. 
As previously stated, we believe that state administrative costs are 
minimal. We note that this proposed rule does add a new business 
requirement for states, because of the existing systems that would need 
to be modified to track and report on the new meaningful use 
requirements for provider attestations. We are providing 90-percent FFP 
to states for modifying their existing EHR Incentive Program systems. 
We believe the federal share of the 90-percent match will protect the 
states from burdensome financial outlays and as noted previously, 
states offer the Medicaid EHR incentive program at their option.
2. Effects on EPs, Eligible Hospitals, and CAHs
a. Background and Assumptions
    The principal costs of this proposed rule are the additional 
expenditures that will be undertaken by eligible entities in order to 
obtain the Medicare and Medicaid incentive payments to adopt, implement 
or upgrade and/or demonstrate meaningful use of certified EHR 
technology, and to avoid the Medicare payment adjustments that will 
ensue if they fail to do so. The estimates for the provisions affecting 
Medicare and Medicaid EPs, eligible hospitals, and CAHs are somewhat 
uncertain for several reasons: (1) The program is voluntary although 
payment adjustments will be imposed on Medicare providers beginning in 
2015 if they are unable to demonstrate meaningful use for the 
applicable reporting period; (2) the criteria for the demonstration of 
meaningful use of certified EHR technology has been finalized for Stage 
1 and Stage 2 and is being proposed for Stage 3, but may change over 
time; and (3) the impact of the financial incentives and payment 
adjustments on the rate of adoption of certified EHR technology by EPs, 
eligible hospitals, and CAHs is difficult to predict based on the 
information we have currently collected. The net costs and savings 
shown for this program represent a possible scenario and actual impacts 
could differ substantially.
    Based on input from a number of internal and external sources, we 
estimated the numbers of EPs and eligible hospitals, including CAHs 
under Medicare, Medicaid, and MA and used them throughout the analysis.
    <bullet> About 675,500 Medicare FFS EPs in 2017 (some of whom will 
also be Medicaid EPs).
    <bullet> About 60,600 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physicians assistants) could be 
eligible to receive the Medicaid incentive payments in 2017.
    <bullet> 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)
    <bullet> All eligible hospitals, except for children's and cancer 
hospitals, may qualify and apply for both Medicare and Medicaid 
incentive payments.
    <bullet> About 16 MA organizations
b. Industry Costs and Adoption Rates
    In the Stage 2 final rule (77 FR 54136 through 54146), we estimated 
the impact on health care providers using information from four 
studies. In the absence of any more recent estimates that we are aware 
of, in this proposed rule, we continue to use the same estimates cited 
in the Stage 2 final rule. We continue to believe that these estimates 
are reasonably reflective of EHR costs. However, we note, we are unable 
to delineate all costs due to the great variability in characteristics 
among the entities that are affected by the proposed rule; the 
variability includes, but is not limited to, the size of the practice, 
extent of use of electronic systems, type of system used, number of 
staff using the EHR system and the cost for maintaining and/or 
upgrading systems. Based on these studies and current average costs for 
available certified EHR technology products, we continue to estimate 
for EPs that the average adopt/implement/upgrade cost is $54,000 per 
physician FTE, while annual maintenance costs average $10,000 per 
physician FTE.
    For all eligible hospitals, we continue to estimate the range is 
from $1 million to $100 million. Although reports vary widely, we 
continue to anticipate that the average will be $5 million to achieve 
meaningful use, because providers who will like to qualify as 
meaningful users of EHRs will need to purchase certified EHRs. We 
further acknowledge ``certified EHRs'' may differ in many important 
respects from the EHRs currently in use and may differ in the 
functionalities they contain. We continue to estimate $1 million for 
maintenance, upgrades, and training each year. Both of these estimates 
are based on average figures provided in the 2008 CBO report. However, 
as noted previously, we are unable to delineate all costs due to the 
great variability in characteristics among the entities that are 
affected by the proposed rule; the variability includes, but is not 
limited to, the size of the hospital, extent of use of electronic 
systems, type of system used, number of staff using the EHR system and 
the cost for maintaining and/or upgrading systems.
    Industry costs are important, in part, because EHR adoption rates 
will be a function of these industry costs and the extent to which the 
costs of ``certified EHRs'' are higher than the total value of EHR 
incentive payments available to EPs and eligible hospitals (as well as 
adjustments, in the case of the Medicare

[[Page 16791]]

EHR incentive program) and any perceived benefits including societal 
benefits. Because of the uncertainties surrounding industry cost 
estimates, we have made various assumptions about adoption rates in the 
following analysis in order to estimate the budgetary impact on the 
Medicare and Medicaid programs.
c. Costs of EHR Adoption for EPs
    Since the publication of the Stage 1 final rule, there has been 
little data published regarding the cost of EHR adoption and 
implementation. A 2011 study (http://content.healthaffairs.org/content/30/3/481.abstract) estimated costs of implementation for a five-
physician practice to be $162,000, with $85,500 in maintenance expenses 
in the first year. In the absence of additional data regarding the cost 
of adoption and implementation costs for certified EHR technology, we 
proposed to continue to estimate for EPs that the average adopt/
implement/upgrade cost is $54,000 per physician FTE, while annual 
maintenance costs average $10,000 per physician FTE, based on the cost 
estimate of the Stage 1 final rule. However, as noted previously, we 
are unable to delineate all costs due to the great variability that are 
affected by but not limited to the size of the practice, extent of use 
of electronic systems, type of system used, number of staff using the 
EHR system, and the cost for maintaining and/or upgrading systems.
d. Costs of EHR Adoption for Eligible Hospitals
    According to the American Hospital Association 2008 Survey, the 
range in yearly information technology spending among hospitals ranged 
from $36,000 to over $32 million. EHR system costs specifically were 
reported by other experts to run as high as $20 million to $100 million 
(77 FR 54139). We note that recently we have seen about 96 percent of 
eligible hospitals have received at least one incentive payment under 
either the Medicare or Medicaid programs. However, as noted previously, 
we are unable to delineate all costs due to the great variability that 
are affected by but not limited to the size of the eligible hospital, 
extent of use of electronic systems, type of system used, number of 
staff using the EHR system, and the cost for maintaining and/or 
upgrading systems.
3. Medicare Incentive Program Costs
    The estimates for the HITECH Act provisions are based on the 
economic assumptions underlying the President's FY 2016 Budget. Under 
the statute, Medicare incentive payments for certified EHR technology 
are excluded from the determination of MA capitation benchmarks. We 
continue to expect a negligible impact on benefit payments to hospitals 
and EPs from Medicare and Medicaid because of the implementation of EHR 
technology.
    As noted at the beginning of this analysis, it is difficult to 
predict the actual impacts of the HITECH Act with great certainty. We 
believe the assumptions and methods described herein are reasonable for 
estimating the financial impact of the provisions on the Medicare and 
Medicaid programs, but acknowledge the wide range of possible outcomes.
a. Medicare Eligible Professionals (EPs)
    We began making EHR Incentive payments in 2011. Medicare payments 
are to be paid for the successful demonstration on meaningful use 
through CY 2016. Due to the payment lag, some payments may be issued in 
CY 2017. To avoid the Medicare payment adjustment beginning in 2015, 
EPs need to successfully demonstrate meaningful use regardless of 
whether they earn an incentive payment. We estimated the percentage of 
the remaining EPs who would be meaningful users each calendar year. 
Table 8 shows the results of these calculations.

                 Table 8--Medicare EPS Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
                                                                           Calendar year
                                                 ---------------------------------------------------------------
                                                       2017            2018            2019            2020
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare                 675.5           683.3           691.1           698.8
 (thousands)....................................
Non-Hospital-based Medicare EPs (thousands).....           609.1           616.1           623.1           630.1
Percent of EPs who are Meaningful Users.........              70              73              75              78
Meaningful Users (thousands)....................           426.4           446.7           467.3           488.3
----------------------------------------------------------------------------------------------------------------

    Our estimates of the incentive payment costs and payment adjustment 
savings are presented in Table 9. They reflect actual historical data 
and our assumptions about the proportion of EPs who will demonstrate 
meaningful use of certified EHR technology. Estimated costs are 
expected to decrease in 2017 through 2020 due to a smaller number of 
new EPs that would achieve meaningful use and the cessation of the 
incentive payment program. Payment adjustment receipts represent the 
estimated amount of money collected due to the payment adjustments for 
those not achieving meaningful use. Estimated net costs for the 
Medicare EP portion of the HITECH Act are also shown in Table 9.

   Table 9--Estimated Costs (+) and Savings (-) for Medicare EPS Demonstrating Meaningful Use of Certified EHR
                                                   Technology
                                                  [In Billions]
----------------------------------------------------------------------------------------------------------------
                                                                      Payment
                   Fiscal Year                       Incentive      adjustment        Benefit        Net total
                                                     payments        receipts        payments
----------------------------------------------------------------------------------------------------------------
2017............................................            $0.6           -$0.2              --            $0.3
2018............................................              --            -0.2              --            -0.2
2019............................................              --            -0.2              --            -0.2
2020............................................              --            -0.1              --            -0.1
----------------------------------------------------------------------------------------------------------------


[[Page 16792]]

b. Medicare Eligible Hospitals and CAHs
    In brief, the estimates of hospital adoption were developed by 
calculating projected incentive payments and then making assumptions 
about how rapidly hospitals would adopt meaningful use.
    Specifically, the first step in preparing estimates of Medicare 
program costs for eligible hospitals was to determine how many eligible 
hospitals already received payments under the EHR Incentive program and 
for what years those payments were received. In order to do this, we 
used the most recent available data that listed the recipients of 
incentive payments, and the year and payment amount. This information 
pertained to eligible hospitals receiving payments through September 
2014.
    We assume that all eligible hospitals that receive a payment in the 
first year will receive payments in future years. We also assume the 
eligible hospitals that have not yet received any incentive payments 
will eventually achieve meaningful use (either to receive incentive 
payments or to avoid payment adjustments). We assume that all eligible 
hospitals would achieve meaningful use by 2018. No new incentive 
payments would be paid after 2016. However, some incentive payments 
originating in 2016 would be paid in 2017.
    The average incentive payment for each eligible hospital was $1.5 
million in the first year. In later years, the amount of the incentive 
payments drops according to the schedule allowed in law. The average 
incentive payment for CAHs received in the first year was about 
$950,000. The average incentive payment received in the second year was 
about $332,500. The average incentive payment received in the third 
year was about $475,000. These average amounts were used for these 
incentive payments in the future. The third year average was also used 
for the fourth year. These assumptions about the number of hospitals 
achieving meaningful use in a particular year and the average amount of 
an incentive payment allows us to calculate the total amount of 
incentive payments to be made and the amount of payment adjustments for 
those hospitals who have not achieved meaningful use. The payment 
incentives available to hospitals under the Medicare and Medicaid EHR 
Incentive Programs are included in our regulations at 42 CFR part 495. 
We further estimate that there are 16 MA organizations that might be 
eligible to participate in the incentive program. Those plans have 32 
eligible hospitals. The costs for the MA program have been included in 
the overall Medicare estimates.
    The estimated payments to eligible hospitals were calculated based 
on the hospitals' qualifying status and individual incentive amounts 
under the statutory formula. Similarly, the estimated payment 
adjustments for non-qualifying hospitals were based on the market 
basket reductions and Medicare revenues. The estimated savings in 
Medicare eligible hospital benefit expenditures resulting from the use 
of hospital certified EHR systems were discussed earlier in this 
section. We assumed no future growth in the total number of hospitals 
in the U.S. because growth in acute care hospitals has been minimal in 
recent years. The results are shown in Table 10.

  Table 10--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
                                            Certified EHR Technology
                                                  [In billions]
----------------------------------------------------------------------------------------------------------------
                                                                      Payment
                   Fiscal year                       Incentive      adjustment        Benefit        Net total
                                                     payments        receipts        payments
----------------------------------------------------------------------------------------------------------------
2017............................................            $1.6           (\1\)           (\1\)            $1.6
2018............................................             0.0           (\1\)           (\1\)           (\1\)
2019............................................             0.0             0.0           (\1\)           (\1\)
2020............................................             0.0             0.0           (\1\)           (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million. All numbers are projections.

4. Medicaid Incentive Program Costs
    Under section, 4201 of the HITECH Act, states and territories can 
voluntarily participate in the Medicaid EHR Incentive Program. However, 
as of the writing of this proposed rule, all states already 
participate. The payment incentives available to EPs and eligible 
hospitals under the Medicaid EHR Incentive Program are included in our 
regulations at 42 CFR part 495. The federal costs for Medicaid 
incentive payments to providers who can demonstrate meaningful use of 
EHR technology were estimated similarly to the estimates for Medicare 
eligible hospitals and EPs. Table 11 shows our estimates for the net 
Medicaid costs for eligible hospitals and EPs.

                      Table 11--Estimated Federal Costs (+) and Savings (-) Under Medicaid
                                                 [In $billions]
----------------------------------------------------------------------------------------------------------------
                                                        Incentive payments
                                                 --------------------------------     Benefit
                   Fiscal year                                       Eligible        payments        Net total
                                                     Hospitals     professionals
----------------------------------------------------------------------------------------------------------------
2017............................................             0.4             0.8           (\1\)             1.2
2018............................................             0.1             0.5           (\1\)             0.6
2019............................................               0             0.3           (\1\)             0.3
2020............................................             0.0             0.2           (\1\)             0.2
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.

a. Medicaid EPs

[[Page 16793]]



    Table 12--Assumed Number of Nonhospital Based Medicaid EPS Who Would Be Meaningful Users of Certified EHR
                                                   Technology
                                        [Population figures in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                 Calendar year
                                                             ---------------------------------------------------
                                                                  2017         2018         2019         2020
----------------------------------------------------------------------------------------------------------------
A...................................  EPs who meet the              101.3        102.3        103.3        104.4
                                       Medicaid patient
                                       volume threshold.
B...................................  Medicaid only Eps.....         60.6         61.7         62.9         64.0
                                      Total Medicaid EPs (A         161.8        164.0        166.2        168.4
                                       + B).
                                      Percent of EPs                44.7%        30.9%        20.7%        14.3%
                                       receiving incentive
                                       payment during year.
                                      Number of EPs                  72.4         50.7         34.5         24.0
                                       receiving incentive
                                       payment during year.
                                      Percent of EPs who            67.9%        74.7%        78.0%        81.1%
                                       have ever received
                                       incentive payment.
                                      Number of EPs who have        109.9        122.5        129.6        136.6
                                       ever received
                                       incentive payment.
----------------------------------------------------------------------------------------------------------------

    It should be noted that since the Medicaid EHR Incentive Program 
provides that a Medicaid EP can receive an incentive payment in his or 
her first year because he or she has demonstrated a meaningful use or 
because he or she has adopted, implemented, or upgraded certified EHR 
technology, these participation rates include not only meaningful users 
but eligible providers implementing certified EHR technology as well.
b. Medicaid Hospitals
    Medicaid incentive payments to most eligible hospitals were 
estimated using the same methodology as described previously for 
Medicare eligible hospitals and shown in Table 10. Many eligible 
hospitals may qualify to receive both the Medicare and Medicaid 
incentive payment. We assume that all eligible hospitals would achieve 
meaningful use by 2016. However, many of these eligible hospitals would 
have already received the maximum amount of incentive payments. Table 
13 shows our assumptions about the remaining incentive payments to be 
paid.

   Table 13--Estimated Percentage of Hospitals That Could Be Paid for
         Meaningful Use and Estimated Percentage Payable in Year
------------------------------------------------------------------------
                                            Percent of
                                           hospitals who    Percent of
               Fiscal year                are meaningful     hospitals
                                               users        being paid
------------------------------------------------------------------------
2017....................................           100.0            13.5
2018....................................           100.0             5.2
2019....................................           100.0             1.5
2020....................................           100.0             0.0
------------------------------------------------------------------------

    As stated previously, the estimated eligible hospital incentive 
payments were calculated based on the eligible hospitals' qualifying 
status and individual incentive amounts payable under the statutory 
formula. The average Medicaid incentive payment in the first year was 
$1 million. The estimated savings in Medicaid benefit expenditures 
resulting from the use of certified EHR technology are discussed in 
section V.C.4. of this proposed rule. Since we use Medicare data and 
little data existed for children's hospitals, we estimated the Medicaid 
incentives payable to children's hospitals as an add-on to the base 
estimate, using data on the number of children's hospitals compared to 
non-children's hospitals.
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 et 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 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. As participation and 
adoption increases, there will be more opportunities to capture and 
report on cost savings and benefits.

[[Page 16794]]

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 rule are even harder to quantify because they 
represent, in many cases, adding functionality to existing systems and 
reaping the network externalities created by larger numbers of 
providers participating in information exchange.
    In the Stage 2 final rule at 77 FR 54144, 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, health IT and safety 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.'' However, data relating specifically to 
the EHR Incentive Programs is limited at this time.
7. Summary
    In this proposed rule, the total cost to the Medicare and Medicaid 
programs between 2017 and 2020 is estimated to be $3.7 billion in 
transfers. As discussed in section V.C.4. of this proposed rule, we do 
not estimate total costs to the provider industry, but rather provide a 
possible per EP and per eligible hospital outlay for implementation and 
maintenance.

  Table 14--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
                                   Hitech EHR Incentive Program (Fiscal Year)
                                                  [In billions]
----------------------------------------------------------------------------------------------------------------
                                         Medicare eligible               Medicaid eligible
           Fiscal year           ----------------------------------------------------------------      Total
                                     Hospitals     Professionals     Hospitals     Professionals
----------------------------------------------------------------------------------------------------------------
2017............................            $1.6            $0.3            $0.4            $0.8            $3.1
2018............................             0.0            -0.2             0.1             0.5             0.4
2019............................             0.0            -0.2             0.0             0.3             0.1
2020............................             0.0            -0.1             0.0             0.2             0.1
    Total.......................             1.6            -0.2             0.5             1.8             3.7
----------------------------------------------------------------------------------------------------------------

D. Alternatives Considered

    As stated in the Stage 1 final rule (75 FR 44546), HHS has no 
discretion to change the incentive payments or payment adjustment 
reductions specified in the statute for providers that adopt or fail to 
adopt a certified EHR and demonstrate meaningful use of certified EHR 
technology. However, we have discretion around how best to meet the 
HITECH Act requirements for meaningful use for FY 2017 and subsequent 
years, which we have exercised in this proposed rule. Additionally, we 
have used our discretion to appropriately propose the timing of 
registration, attestation and payment requirements to allow EPs and 
eligible organizations as much time as possible in coordination with 
the anticipated certification of EHR technology to obtain and 
meaningfully use certified EHRs. We recognize that there may be 
additional costs that result from various discretionary policy choices 
by providers. However, those costs cannot be estimated and are not 
captured in this analysis.

E. Accounting Statement and Table

    Whenever a rule is considered a significant rule under Executive 
Order 12866, we are required to develop an accounting statement 
indicating the classification of the expenditures associated with the 
provisions of this proposed rule. Monetary annualized benefits and non-
budgetary costs are presented as discounted flows using 3 percent and 7 
percent factors in the following Table 15. We are not able to 
explicitly define the universe of those additional costs, nor specify 
what the high or low range might be to implement EHR technology in this 
proposed rule. We note that federal annualized monetized transfers 
represent the net total of annual incentive payments in the Medicare 
and Medicaid EHR Incentive programs less

[[Page 16795]]

the reductions in Medicare payments to providers failing to demonstrate 
meaningful use as a result of the related Medicare payment adjustments.
    Expected qualitative benefits include improved quality of care, 
better health outcomes, reduced errors and the like. Private industry 
costs would include the impact of EHR activities such as temporary 
reduced staff productivity related to learning how to use the EHR, the 
need for additional staff to work with HIT issues, and administrative 
costs related to reporting.

         Table 15--Accounting Statement: Classification of Estimated Expenditures CYs 2017 Through 2020
                                                  [In millions]
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                    CATEGORY
----------------------------------------------------------------------------------------------------------------
                                                                             BENEFITS
----------------------------------------------------------------------------------------------------------------
Qualitative.....................................     Expected qualitative benefits include improved quality of
                                                    care, better health outcomes, reduced errors and the like.
                                                 ---------------------------------------------------------------
                                                                               COSTS
                                                 ---------------------------------------------------------------
                                                     Year dollar       Estimates   Unit discount  Period covered
                                                                   (in millions)            rate
                                                 ---------------------------------------------------------------
                                                  ..............      Primary     ..............
                                                                     Estimate
                                                 ---------------------------------------------------------------
Annualized Monetized Costs to Private Industry              2017          $478.1              7%         CY 2017
 Associated with Reporting Requirements.........                          $478.4              3%
----------------------------------------------------------------------------------------------------------------
Qualitative--Other private industry costs
 associated with the adoption of EHR technology.  These costs would include the impact of EHR activities such as
                                                   reduced staff productivity related to learning how to use the
                                                  EHR technology, the need for additional staff to work with HIT
                                                      issues, and administrative costs related to reporting.
----------------------------------------------------------------------------------------------------------------
                                                                             TRANSFERS
                                                 ---------------------------------------------------------------
                                                     Year dollar       Estimates   Unit discount  Period covered
                                                                   (in millions)            rate
                                                 ---------------------------------------------------------------
Federal Annualized Monetized....................            2017        $1,000.4              7%   CYs 2017-2020
                                                                          $954.8              3%
----------------------------------------------------------------------------------------------------------------
From Whom To Whom?..............................             Federal Government to Medicare[dash] and
                                                        Medicaid[dash]eligible professionals and hospitals.
----------------------------------------------------------------------------------------------------------------

F. Conclusion

    The previous analysis, together with the remainder of this 
preamble, provides an RIA. We believe there are many positive effects 
of adopting EHR on health care providers. We believe there are benefits 
that can be obtained by eligible hospitals and EPs, including: 
Reductions in medical recordkeeping costs, reductions in repeat tests, 
decreases in length of stay, and reduced errors. Health IT can enable 
providers to deliver health care more efficiently. For example, EHRs 
can reduce the duplication of diagnostic tests, prompt providers to 
prescribe cost-effective generic medications, remind patients about 
preventive care, reduce unnecessary office visits, and assist in 
managing complex care. We also believe that internal savings will 
likely come through the reductions in the cost of providing care. We 
believe that the net effect on individual providers may be positive 
over time in many cases. Accordingly, we believe that the object of the 
Regulatory Flexibility Analysis to minimize burden on small entities 
are met by this proposed rule. We invite public comments on the 
analysis and request any additional data that would help us determine 
more accurately the impact on the EPs and eligible hospitals affected 
by the proposed rule.
    In accordance with the provisions of Executive Order 12866, 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 amend 42 CFR part 495 as set forth 
below:

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. Adding the definition for ``Application-program interface (API)''.
0
B. Revising the definition of ``Certified electronic health record 
technology''.
0
C. Amending the definition of ``EHR reporting period'' by--
0
i. Redesignating paragraphs (1)(i), (1)(ii), (1)(iii) introductory 
text, (1)(iii)(A), (1)(iii)(B), (1)(iii)(C), (1)(iii)(D), and (1)(iv) 
as paragraphs (1)(i)(A), (1)(i)(B), (1)(i)(C) introductory text, 
(1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3), (1)(1)(C)(4), and (1)(i)(D), 
respectively.
0
ii. Adding new paragraph (1)(i) introductory text.

[[Page 16796]]

0
iii. Adding a new paragraph (1)(ii).
0
iv. Redesignating paragraphs (2)(i), (2)(ii), (2)(iii) introductory 
text, (2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and (2)(iii)(D), as 
paragraphs (2)(i)(A), (2)(i)(B), (2)(i)(C) introductory text and 
(2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and (2)(i)(C)(4), 
respectively.
0
v. Adding new paragraph (2)(i) introductory text.
0
vi. Adding a new paragraph (2)(ii).
0
D. Amending the definition of ``EHR reporting period for a payment 
adjustment year'' by:
0
i. Redesignating paragraphs (1)(i)(A), (1)(i)(B), (1)(ii), (1)(iii)(A), 
and (1)(iii)(B) as paragraphs (1)(i)(A)(1), (1)(i)(A)(2), (1)(i)(B), 
(1)(i)(C)(1) and (1)(i)(C)(2), respectively.
0
ii. In newly redesignated paragraph (1)(i)(A)(1), by removing the 
cross-reference ``paragraphs (1)(i)(B), (ii), and (iii)'' and adding in 
its place the cross-reference ``paragraphs (1)(i)(A)(2), (1)(i)(B), and 
(1)(i)(C)''.
0
iii. In newly redesignated paragraph (1)(i)(A)(2), by removing the 
cross-reference ``paragraphs (1)(iii) or (iv)'' and adding in its place 
the cross-reference ``paragraph (1)(i)(C)''.
0
iv. Adding new paragraph (1)(i) introductory text.
0
v. Adding a new paragraph (1)(ii).
0
vi. Redesignating paragraphs (2)(i)(A), (2)(i)(B), (2)(ii), 
(2)(iii)(A), and (2)(iii)(B) as paragraphs (2)(i)(A)(1), (2)(i)(A)(2), 
(2)(i)(B), (2)(i)(C)(1) and (2)(i)(C)(2), respectively.
0
vii. In newly redesignated paragraph (2)(i)(A)(1), by removing the 
cross-reference ``paragraphs (2)(i)(B), (ii), and (iii)'' and adding in 
its place the cross-reference ``paragraphs (2)(i)(A)(2), (2)(i)(B), and 
(2)(i)(C)''.
0
viii. In newly redesignated paragraph (2)(i)(A)(2), by removing the 
cross-reference ``paragraph (2)(iii)'' and adding in its place the 
cross-reference ``paragraph (2)(i)(C)''.
0
ix. Adding new paragraph (2)(i) introductory text.
0
x. Adding new paragraph (2)(ii).
0
xi. Redesignating paragraphs (3)(i) and (3)(ii) as paragraphs (3)(i)(A) 
and (3)(i)(B).
0
xii. In newly redesignated paragraph (3)(i)(A), by removing the cross-
reference ``paragraph (3)(ii)'' and adding in its place the cross-
reference ``paragraph (3)(i)(B)''.
0
xiii. Adding new paragraph (3)(i) introductory text.
0
xiv. Adding new paragraph (3)(ii).
0
E. In the paragraph (1) of the definition of ``Meaningful EHR User'' by 
removing the reference ``under Sec.  495.6'' and adding in its place 
the reference to ``under Sec.  495.6 or 495.7''.
    The additions read as follows:


Sec.  495.4  Definitions.

* * * * *
    Application-program interface (API) means a set of programming 
protocols established for multiple purposes. APIs may be enabled by a 
provider or provider organization to provide the patient with access to 
their health information through a third-party application with more 
flexibility than often found in many current ``patient portals.''
    Certified electronic health record technology (CEHRT) means the 
following:
    (1) For any Federal fiscal year (FY) or calendar year (CY) before 
2018, EHR technology (which could include multiple technologies) 
certified under the ONC Health IT Certification Program that--
    (i) Meets the--
    (A) 2014 Edition Base EHR definition (as defined at 45 CFR 
170.102); or
    (B) 2015 Edition Base EHR definition (as defined at 45 CFR 
170.102); or
    (ii) Has been certified to the following certification criteria:
    (A)(1) CPOE at--
    (i) 45 CFR 170.314(a)(1), (18), (19) or (20); or
    (ii) 45 CFR 170.315(a)(1), (2) or (3);
    (2)(i) Record demographics at 45 CFR 170.314(a)(3); or
    (ii) 45 CFR 170.315(a)(5).
    (3)(i) Problem list at 45 CFR 170.314(a)(5); or
    (ii) 45 CFR 170.315(a)(7).
    (4)(i) Medication list at 45 CFR 170.314(a)(6); or (ii) 45 CFR 
170.315(a)(8).
    (5)(i) Medication allergy list 45 CFR 170.314(a)(7); or (ii) 45 CFR 
170.315(a)(9);
    (6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or (ii) 
45 CFR 170.315(a)(10).
    (7) Health information exchange at transitions of care at one of 
the following:
    (i) 45 CFR 170.314(b)(1) and (2).
    (ii) 45 CFR 170.314(b)(1), (b)(2), and (h)(1).
    (iii) 45 CFR 170.314(b)(1), (b)(2), and (b)(8).
    (iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and (h)(1).
    (v) 45 CFR 170.314(b)(8) and (h)(1).
    (vi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(h)(2).
    (vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(h)(2).
    (viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(h)(2).
    (ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(h)(2).
    (x) 45 CFR 170.314(b)(8), (h)(1), and 170.315(h)(2).
    (xi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(b)(1).
    (xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(b)(1).
    (xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(b)(1).
    (xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and 
170.315(b)(1).
    (xv) 45 CFR 170.314(b)(8), (h)(1), and 170.315(b)(1).
    (xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(1).
    (xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1), 
and 170.315(h)(2).
    (xviii) 45 CFR 170.314(h)(1) and 170.315(b)(1).
    (xix) 45 CFR 170.315(b)(1) and (h)(1).
    (xx) 45 CFR 170.315(b)(1) and (h)(2).
    (xxi) 45 CFR 170.315(b)(1), (h)(1), and (h)(2).
    (B) Clinical quality measures at 45 CFR 170.314(c)(1) or 
170.315(c)(1).
    (C) The 2014 Edition or 2015 Edition certification criteria that 
are necessary to be a Meaningful EHR User (as defined in this section), 
including the following:
    (1) The applicable automated numerator recording and automated 
measure calculation certification criteria that support attestation as 
a Meaningful EHR User at 45 CFR 170.315(g)(1) and (2) and 45 CFR 
170.314(g)(1) and (2).
    (2) Clinical quality measure certification criteria that support 
the calculation and reporting of clinical quality measures at 45 CFR 
170.314(c)(2) and (c)(3) or 45 CFR 170.315(c)(2) and (c)(3).
    (2) For 2018 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition 
(as defined at 45 CFR 170.102) and has been certified to the 2015 
Edition health IT certification criteria that--
    (i)(A) Include the capabilities to record 45 CFR 170.315(a)(14); or
    (B) Create and incorporate family health history 45 CFR 
170.315(a)(15).
    (ii) Include the capabilities that support patient health 
information capture at 45 CFR 170.315(a)(19); and
    (iii) Are necessary to be a Meaningful EHR User (as defined in this 
section), including the following:
    (A) The applicable automated numerator recording and automated 
measure calculation certification criteria that support attestation as 
a Meaningful EHR User at 45 CFR 170.315(g)(1) and (2).
    (B) Clinical quality measure certification criteria that support 
the calculation and reporting of clinical quality measures under the 
2015 Edition certification criteria 45 CFR 170.315(c)(2) and (c)(3).
* * * * *

[[Page 16797]]

    EHR reporting period. * * *
    (1) * * *
    (i) The following are applicable before CY 2017.
* * * * *
    (ii) The following are applicable beginning in CY 2017 under the 
Medicaid EHR Incentive Program:
    (A) For the payment year in which the EP is first demonstrating he 
or she is a meaningful EHR user, any continuous 90-day period within 
the calendar year.
    (B) For the subsequent payment years following the payment year in 
which the EP first successfully demonstrates he or she is a meaningful 
EHR user, the calendar year.
    (2) * * *
    (i) The following are applicable before CY 2017:
* * * * *
    (ii) The following are applicable beginning in CY 2017 under the 
Medicaid EHR Incentive Program:
    (A) For the payment year in which the eligible hospital or CAH is 
first demonstrating it is a meaningful EHR user, any continuous 90-day 
period within the calendar year.
    (B) For the subsequent payment years following the payment year in 
which the eligible hospital or CAH first successfully demonstrates it 
is a meaningful EHR user, the calendar year.
    EHR reporting period for a payment adjustment year. * * *
    (1) * * *
    (i) The following are applicable before CY 2017:
* * * * *
    (ii) The following are applicable beginning in CY 2017:
    (A) Except as provided under paragraph (1)(ii)(B) of this 
definition, the calendar year that is 2 years before the payment 
adjustment year.
    (B) If an EP is demonstrating under the Medicaid EHR Incentive 
Program that he or she is a meaningful EHR user for the first time in 
the calendar year that is 2 years before the payment adjustment year, 
then the continuous 90-day period that is the EHR reporting period for 
the Medicaid incentive payment within such (2 years prior) calendar 
year.
    (2) * * *
    (i) The following are applicable before CY 2017:
* * * * *
    (ii) The following are applicable beginning in CY 2017:
    (A) Except as provided in paragraph (2)(ii)(B) of this definition, 
the calendar year that is 2 years before the payment adjustment year.
    (B) If an eligible hospital is demonstrating under the Medicaid EHR 
Incentive Program 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 the continuous 90-day period that is the EHR reporting 
period for the Medicaid incentive payment within such (2 years prior) 
calendar year.
    (3) * * *
    (i) The following are applicable before CY 2017:
* * * * *
    (ii) The following are applicable beginning in CY 2017:
    (A) Except as provided in paragraph (3)(ii)(B) of this definition, 
the calendar year that begins on the first day of the second quarter of 
the Federal fiscal year that is the payment adjustment year.
    (B) If a CAH is demonstrating under the Medicaid EHR Incentive 
Program that it is a meaningful EHR user for the first time in the 
calendar year that begins on the first day of the second quarter of the 
Federal fiscal year that is the payment adjustment year, then any 
continuous 90-day period within such calendar year.
* * * * *
0
3. Section 495.6 is amended by revising the section heading and adding 
introductory text to read as follows:


Sec.  495.6  Meaningful use objectives and measures for EPs, eligible 
hospitals, and CAHs before 2018.

    The following criteria are applicable before 2018:
* * * * *
0
4. Section 495.7 is added to read as follows:


Sec.  495.7  Stage 3 meaningful use objectives and measures for EPs, 
eligible hospitals, and CAHs for 2018 and subsequent years.

    The following criteria are optional for EPs, eligible hospitals, 
and CAHs in 2017 as outlined at Sec.  495.8(a)(2)(i)(E)(3) and 
(b)(2)(E)(3) and applicable for all EPs, eligible hospitals, and CAHs 
for 2018 and subsequent years:
    (a) Stage 3 criteria for EPs.
    (1) General rule regarding Stage 3 criteria for meaningful use for 
EPs. Except as specified in paragraphs (a)(2) through (a)(3) of this 
section, EPs must meet all objectives and associated measures of the 
Stage 3 criteria specified in paragraph (d) of this section to meet the 
definition of a meaningful EHR user.
    (2) Selection of measures for specified objectives in paragraph (d) 
of this section. An EP may meet the criteria for 2 out of the 3 
measures associated with an objective, rather than meeting the criteria 
for all 3 of the measures, if the EP meets all of the following 
requirements:
    (i) Must ensure that the objective in paragraph (d) of this section 
includes an option to meet 2 out of the 3 associated measures.
    (ii) Meets the threshold for 2 out of the 3 measures for that 
objective.
    (iii) Attests to all 3 of the measures for that objective
    (3) Exclusion for nonapplicable objectives and measures.
    (i) An EP may exclude a particular objective that includes an 
option for exclusion contained in paragraph (d) of this section, if the 
EP meets all of the following requirements:
    (A) Meets the criteria in the applicable objective that would 
permit the exclusion.
    (B) Attests to the exclusion.
    (ii) An EP may exclude a measure within an objective which allows 
for a provider to meet the threshold for 2 of the 3 measures, as 
outlined in paragraph (a)(2) of this section, in the following manner:
    (A)(1) Meets the criteria in the applicable measure or measures 
that would permit the exlusion; and
    (2) Attests to the exclusion or exclusions.
    (B)(1) Meets the threshold; and
    (2) Attests to any remaining measure or measures.
    (4) Exception for Medicaid EPs who adopt, implement or upgrade in 
their first payment year. For Medicaid EPs who adopt, implement or 
upgrade its certified EHR technology in their first payment year, the 
meaningful use objectives and associated measures of the Stage 3 
criteria specified in paragraph (d) of this section, apply beginning 
with the second payment year, and do not apply to the first payment 
year.
    (b) Stage 3 criteria for eligible hospitals and CAHs.
    (1) General rule regarding Stage 3 criteria for meaningful use for 
eligible hospitals or CAHs. Except as specified in paragraphs (b)(2) 
through (b)(3) of this section, eligible hospitals and CAHs must meet 
all objectives and associated measures of the Stage 3 criteria 
specified in paragraph (d) of this section to meet the definition of a 
meaningful EHR user.
    (2) Selection of measures for specified objectives in paragraph (d) 
of this section. An eligible hospital or CAH may meet the criteria for 
2 out of the 3 measures associated with an objective, rather than 
meeting the criteria for all 3 of the measures, if the eligible 
hospital or CAH meets all of the following requirements:
    (i) Must ensure that the objective in paragraph (d) of this section 
includes an option to meet 2 out of the 3 associated measures.

[[Page 16798]]

    (ii) Meets the threshold for 2 out of the 3 measures for that 
objective.
    (iii) Attests to all 3 of the measures for that objective.
    (3) Exclusion for nonapplicable objectives and measures.
    (i) An eligible hospital or CAH may exclude a particular objective 
that includes an option for exclusion contained in paragraph (d) of 
this section, if the eligible hospital or CAH meets all of the 
following requirements:
    (A) Meets the criteria in the applicable objective that would 
permit the exclusion.
    (B) Attests to the exclusion.
    (ii) An eligible hospital or CAH may exclude a measure within an 
objective which allows for a provider to meet the threshold for 2 of 
the 3 measures, as outlined in paragraph (b)(2) of this section, in the 
following manner:
    (A)(1) Meets the criteria in the applicable measure or measures 
that would permit the exclusion; and
    (2) Attests to the exclusion or exclusions.
    (B)(1) Meets the threshold; and
    (2) Attests to any remaining measure or measures.
    (4) Exception for Medicaid eligible hospitals or CAHs that adopt, 
implement or upgrade in their first payment year. For Medicaid eligible 
hospitals or CAHs who adopt, implement or upgrade certified EHR 
technology in their first payment year, the meaningful use objectives 
and associated measures of the Stage 3 criteria specified in paragraph 
(d) of this section apply beginning with the second payment year, and 
do not apply to the first payment year.
    (c) Objectives and associated measures in paragraph (d) of this 
section that rely on measures that count unique patients or actions.
    (1) If a measure (or associated objective) in paragraph (d) of this 
section references paragraph (c) 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 (c) of this section, then the measure must be calculated by 
reviewing all patient records, not just those maintained using 
certified EHR technology.
    (d) Stage 3 objectives and measures for EPs, eligible hospitals, 
and CAHs.
    (1) Protect patient health information.
    (i) EP protect patient health information.
    (A) Objective. Protect electronic protected health information 
(ePHI) created or maintained by the certified EHR technology (CEHRT) 
through the implementation of appropriate technical, administrative, 
and physical safeguards.
    (B) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), including:
    (1) Addressing the security (including encryption) of data stored 
in CEHRT in accordance with requirements under 45 CFR 164.312(a)(2)(iv) 
and 45 CFR 164.306(d)(3),
    (2) Implement security updates as necessary, and
    (3) Correct identified security deficiencies as part of the EP's 
risk management process.
    (ii) Eligible hospital/CAH protect patient health information.
    (A) Objective. Protect electronic protected health information 
(ePHI) created or maintained by the certified EHR technology (CEHRT) 
through the implementation of appropriate technical, administrative, 
and physical safeguards.
    (B) Measure. Conduct or review a security risk analysis in 
accordance with the requirements under 45 CFR 164.308(a)(1), 
including--
    (1) Addressing the security (including encryption) of data stored 
in CEHRT in accordance with requirements under 45 CFR 164.312(a)(2)(iv) 
and 45 CFR 164.306(d)(3);
    (2) Implement security updates as necessary; and
    (3) Correct identified security deficiencies as part of the 
eligible hospital's or CAH's risk management process.
    (2) Electronic prescribing.
    (i) EP electronic prescribing.
    (A) Objective. Generate and transmit permissible prescriptions 
electronically (eRx).
    (B) Measure. Subject to paragraph (c) of this section, more than 80 
percent of all permissible prescriptions written by the EP are queried 
for a drug formulary and transmitted electronically using certified EHR 
technology (CEHRT).
    (C) Exclusions in accordance with paragraph (a)(3) of this section.
    (1) Any EP who writes fewer than 100 permissible prescriptions 
during the EHR reporting period; or
    (2) Any EP who does not have a pharmacy within its organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his/her EHR 
reporting period.
    (ii) Eligible hospital/CAH electronic prescribing.
    (A) Objective. Generate and transmit permissible discharge 
prescriptions electronically (eRx).
    (B) Measure. Subject to paragraph (c) of this section, more than 25 
percent of hospital discharge medication orders for permissible 
prescriptions (for new and changed prescriptions) are queried for a 
drug formulary and transmitted electronically using certified EHR 
technology (CEHRT).
    (C) Exclusions in accordance with paragraph (b)(3) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and there are no pharmacies 
that accept electronic prescriptions within 10 miles at the start of 
the eligible hospital's or CAH's EHR reporting period.
    (3) Clinical decision support.
    (i) EP clinical decision support.
    (A) Objective. Implement clinical decision support (CDS) 
interventions focused on improving performance on high-priority health 
conditions.
    (B) Measures.
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures (CQMs) at a relevant point in 
patient care for the entire EHR reporting period. Absent four clinical 
quality measures related to an EP's scope of practice or patient 
population, the clinical decision support interventions must be related 
to high-priority health conditions; and
    (2) The EP has enabled and implemented the functionality for drug-
drug and drug-allergy interaction checks for the entire EHR reporting 
period.
    (C) Exclusion in accordance with paragraph (a)(3) of this section 
for paragraph (d)(3)(i)(B)(2) of this section. An EP who writes fewer 
than 100 medication orders during the EHR reporting period.
    (ii) Eligible hospital/CAH clinical decision support.
    (A) Objective. Implement clinical decision support (CDS) 
interventions focused on improving performance on high-priority health 
conditions.
    (B) 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 (CQMs) related to an eligible hospital or CAH's 
patient population, the clinical decision support interventions must be 
related to high-priority health conditions; and
    (2) The eligible hospital or CAH has enabled and implemented the 
functionality for drug-drug and drug-

[[Page 16799]]

allergy interaction checks for the entire EHR reporting period.
    (4) Computerized provider order entry (CPOE).
    (i) EP CPOE.
    (A) Objective. Use computerized provider order entry (CPOE) for 
medication, laboratory, and diagnostic imaging orders directly entered 
by any licensed healthcare professional, credentialed medical 
assistant, or a medical staff member credentialed to and performing the 
equivalent duties of a credentialed medical assistant; who can enter 
orders into the medical record per state, local, and professional 
guidelines.
    (B) Measures. Subject to paragraph (c) of this section--
    (1) More than 80 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry;
    (2) More than 60 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry; and
    (3) More than 60 percent of diagnostic imaging orders created by 
the EP during the EHR reporting period are recorded using computerized 
provider order entry.
    (C) Exclusions in accordance with paragraph (a)(3) of this section.
    (1) For the measure specified in paragraph (d)(4)(i)(B)(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 (d)(4)(i)(B)(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 (d)(4)(i)(B)(3) of this 
section, any EP who writes fewer than 100 diagnostic imaging orders 
during the EHR reporting period.
    (ii) Eligible hospital and CAH CPOE.
    (A) Objective. Use computerized provider order entry (CPOE) for 
medication, laboratory, and diagnostic imaging orders directly entered 
by any licensed healthcare professional, credentialed medical 
assistant, or a medical staff member credentialed to and performing the 
equivalent duties of a credentialed medical assistant; who can enter 
orders into the medical record per state, local, and professional 
guidelines.
    (B) Measures. Subject to paragraph (c) of this section, more than--
    (1) Eighty 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) Sixty percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry; and
    (3) Sixty percent of diagnostic imaging 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.
    (5) Patient electronic access to health information.
    (i) EP patient electronic access to health information.
    (A) Objective. The EP provides access for patients to view online, 
download, and transmit their health information, or retrieve their 
health information through an application-program interface (API), 
within 24 hours of its availability.
    (B) Measures. EPs must meet the following two measures:
    (1) For more than 80 percent of all unique patients seen by the 
EP)--
    (i) The patient (or patient authorized representatives) is provided 
access to view online, download, and transmit their health information 
within 24 hours of its availability to the provider; or
    (ii) The patient (or patient authorized representatives) is 
provided access to an ONC-certified application-program interface (API) 
that can be used by third-party applications or devices to provide 
patients (or patient authorized representatives) access to their health 
information, within 24 hours of its availability to the provider.
    (2) The EP must use clinically relevant information from CEHRT to 
identify patient-specific educational resources and provide electronic 
access to those materials to more than 35 percent of unique patients 
seen by the EP during the EHR reporting period.
    (C) Exclusions in accordance with paragraph (a)(3) of this section.
    (1) Any EP who has no office visits during the reporting period may 
exclude from the measures specified in paragraphs (d)(7)(i)(B)(1) and 
(B)(2) of this section.
    (2) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude from the measures specified in paragraphs 
(d)(7)(i)(B)(1) and (2) of this section.
    (ii) Eligible hospital and CAH patient electronic access to health 
information.
    (A) Objective. The eligible hospital or CAH provides access for 
patients to view online, download, and transmit their health 
information, or retrieve their health information through an 
application-program interface (API), within 24 hours of its 
availability.
    (B) Measures. Eligible hospitals and CAHs must meet the following 
two measures:
    (1) For more than 80 percent of all unique patients discharged from 
the eligible hospital or CAH inpatient or emergency department (POS 21 
or 23)--
    (i) The patient (or patient authorized representatives) is provided 
access to view online, download, and transmit their health information 
within 24 hours of its availability to the provider; or
    (ii) The patient (or patient authorized representatives) is 
provided access to an ONC-certified application-program interface (API) 
that can be used by third-party applications or devices to provide 
patients (or patient authorized representatives) access to their health 
information, within 24 hours of its availability to the provider.
    (2) The eligible hospital or CAH must use clinically relevant 
information from CEHRT to identify patient-specific educational 
resources and provide electronic access to those materials to more than 
35 percent of unique patients discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    (C) Exclusion in accordance with paragraph (b)(3) 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 the 
measures specified in paragraphs (d)(7)(ii)(B)(1) and (2) of this 
section.
    (6) Coordination of care through patient engagement.
    (i) EP coordination of care through patient engagement.
    (A) Objective. Use communications functions of certified EHR 
technology to engage with patients or their authorized representatives 
about the patient's care.
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must satisfy 2 out of the 3 following measures in paragraphs 
(d)(5)(i)(B)(1), (2), and (3) of this section except those measures for 
which an EP qualifies for

[[Page 16800]]

an exclusion under paragraph (a)(3) of this section.
    (1) During the EHR reporting period, more than 25 percent of all 
unique patients seen by the EP actively engage with the electronic 
health record made accessible by the provider. An EP may meet measure 
specified in paragraph (d)(5)(i)(B)(1) of this paragraph by either--
    (i) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP during the EHR reporting 
period view, download or transmit to a third party their health 
information; or
    (ii) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP during the EHR reporting 
period access their health information through the use of an ONC-
certified API that can be used by third-party applications or devices.
    (2) For more than 35 percent of all unique patients seen by the EP 
during the EHR reporting period, a secure message was sent using the 
electronic messaging function of CEHRT to the patient (or their 
authorized representatives), or in response to a secure message sent by 
the patient.
    (3) Patient generated health data or data from a nonclinical 
setting is incorporated into the certified EHR technology for more than 
15 percent of all unique patients seen by the EP during the EHR 
reporting period.
    (C) Exclusions in accordance with paragraph (a)(3) of this section.
    (1) Any EP who has no office visits during the reporting period may 
exclude from the measures specified in paragraphs (d)(5)(i)(B)(1), 
(B)(2) and (B)(3) of this section.
    (2) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period may exclude from the measures specified in paragraphs 
(d)(5)(i)(B)(1), (B)(2) and (B)(3) of this section.
    (ii) Eligible hospital and CAH coordination of care through patient 
engagement.
    (A) Objective. Use communications functions of certified EHR 
technology to engage with patients or their authorized representatives 
about the patient's care.
    (B) Measures. In accordance with paragraph (b)(2) of this section, 
an eligible hospital or CAH must satisfy 2 of the 3 following measures 
in paragraph (d)(5)(ii)(B)(1), (2), and (3) of this section, except 
those measures for which an eligible hospital or CAH qualifies for an 
exclusion under paragraph (b)(3) of this section.
    (1) During the EHR reporting period, more than 25 percent of all 
unique patients discharged from the eligible hospital or CAH inpatient 
or emergency department (POS 21 or 23) actively engage with the 
electronic health record made accessible by the provider. An eligible 
hospital or CAH may meet the measure specified in paragraph 
(d)(5)(ii)(B)(1) of this section by having--
    (i) More than 25 percent of all unique patients (or patient-
authorized representatives) discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period view, download or transmit to a third party their 
health information; or
    (ii) More than 25 percent of all unique patients (or patient-
authorized representatives) discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period access their health information through the use of an 
ONC-certified API that can be used by third-party applications or 
devices.
    (2) For more than 35 percent of all unique patients discharged from 
the eligible hospital or CAH inpatient or emergency department (POS 21 
or 23) during the EHR reporting period, a secure message was sent using 
the electronic messaging function of CEHRT to the patient (or their 
authorized representatives), or in response to a secure message sent by 
the patient.
    (3) Patient generated health data or data from a non-clinical 
setting is incorporated into the certified EHR technology for more than 
15 percent of unique patients discharged from the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period.
    (C) Exclusions under paragraph (b)(3) of this section.
    (1) Any eligible hospital or CAH operating in a location that does 
not have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measures specified in pargraphs (d)(5)(ii)(B)(1), (B)(2), and (B)(3) of 
this section.
    (7) Health information exchange.
    (i) EP health information exchange.
    (A) Objective. The EP provides a summary of care record when 
transitioning or referring their patient to another setting of care, 
retrieves a summary of care record upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other providers into their EHR using the functions of certified EHR 
technology.
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must attest to all 3 measures, but must meet the threshold for 2 
of the 3 measures in paragraph (d)(6)(i)(B)(1), (2), and (3), in order 
to meet the objective. Subject to paragraph (c) of this section--
    (1) Measure 1. For more than 50 percent of transitions of care and 
referrals, the EP that transitions or refers their patient to another 
setting of care or provider of care--
    (i) Creates a summary of care record using CEHRT; and
    (ii) Electronically exchanges the summary of care record.
    (2) Measure 2. For more than 40 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the EP incorporates into the patient's EHR an 
electronic summary of care document from a source other than the 
provider's EHR system.
    (3) Measure 3. For more than 80 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the EP performs clinical information 
reconciliation. The EP must implement clinical information 
reconciliation for the following three clinical information sets:
    (i) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (ii) Medication allergy. Review of the patient's known allergic 
medications.
    (iii) Current problem list. Review of the patient's current and 
active diagnoses.
    (C) Exclusions in accordance with paragraph (a)(3) of this section. 
An EP must be excluded when any of the following occur:
    (1) An EP neither transfers a patient to another setting nor refers 
a patient to another provider during the EHR reporting period must be 
excluded from paragraph (d)(6)(i)(B)(1) of this section.
    (2) Any EP for whom the total of transitions or referrals recieved 
and patient encounters in which the provider has never before 
encountered the patient, is fewer than 100 during the EHR reporting 
period may be excluded from paragraphs (d)(6)(i)(B)(2) and 
(d)(6)(i)(B)(3) of this section.
    (3) Any EP that conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units

[[Page 16801]]

with 4Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period may 
exclude from the measures specified in paragraphs (d)(6)(i)(B)(1), 
(B)(2) and (B)(3) of this section.
    (ii) Eligible hospitals and CAHs health information exchange.
    (A) Objective. The eligible hospital or CAH provides a summary of 
care record when transitioning or referring their patient to another 
setting of care, retrieves a summary of care record upon the first 
patient encounter with a their new patient, and incorporates summary of 
care information from other providers into EHR using the functions of 
certified EHR technology.
    (B) Measures. In accordance with paragraph (b)(2) of this section, 
an eligible hospital or CAH must attest to all three measures, but must 
meet the threshold for 2 of the 3 measures in paragraph 
(d)(6)(ii)(B)(1), (2), and (3). Subject to paragraph (c) of this 
section--
    (1) Measure 1. For more than 50 percent of transitions of care and 
referrals, the eligible hospital or CAH that transitions or refers its 
patient to another setting of care or provider of care--
    (i) Creates a summary of care record using CEHRT; and
    (ii) Electronically exchanges the summary of care record.
    (2) Measure 2. For more than 40 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the eligible hospital or CAH incorporates into 
the patient's EHR an electronic summary of care document from a source 
other than the provider's EHR system.
    (3) Measure 3. For more than 80 percent of transitions or referrals 
received and patient encounters in which the provider has never before 
encountered the patient, the eligible hospital or CAH performs a 
clinical information reconciliation. The provider must implement 
clinical information reconciliation for the following three clinical 
information sets:
    (i) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (ii) Medication allergy. Review of the patient's known allergic 
medications.
    (iii) Current problem list. Review of the patient's current and 
active diagnoses.
    (C) Exclusions in accordance with paragraph (b)(3) of this section.
    (1) Any eligible hospital or CAH for whom the total of transitions 
or referrals recieved and patient encounters in which the provider has 
never before encountered the patient, is fewer than 100 during the EHR 
reporting period may be excluded from paragraphs (d)(6)(i)(B)(2) and 
(d)(6)(i)(B)(3) of this section.
    (2) Any eligible hospital or CAH operating in a location that does 
not have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period may exclude from the 
measures specified in paragraphs (d)(6)(ii)(B)(1), (2) and (3) of this 
section.
    (8) Public Health and Clinical Data Registry Reporting.
    (i) EP Public Health and Clinical Data Registry: Reporting 
objective.
    (A) Objective. The EP 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.
    (B) Measures. In order to meet the objective under paragraph 
(d)(8)(i)(A) of this section, an EP must choose from measures 1 through 
5 (paragraphs (d)(8)(i)(B)(1) through (d)(8)(i)(B)(5) of this section) 
and must successfully attest to any combination of three measures. 
These measures may be met by any combination, including meeting measure 
specified in paragraph (d)(8)(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 (a)(3) 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 
(d)(8)(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 their 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 its EHR 
reporting period.
    (iii) Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data 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 (d)(8)(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 the EP's 
jurisdiction.
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic syndromic surveillance 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 syndromic surveillance data at the start 
of the EHR reporting period.
    (3) Any EP meeting one or more of the following criteria may be 
excluded from the case reporting measure at paragraph (d)(8)(i)(B)(3) 
of this section if the EP:
    (i) 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.
    (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 EP meeting at least one of the following criteria may be 
excluded from the public health registry reporting measure specified in 
paragraph (d)(8)(i)(B)(4) of this section if the EP:

[[Page 16802]]

    (i) Does not diagnose or directly treat any disease or condition 
associated with a public health registry in the EP's 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 beginning 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 (d)(8)(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 their 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 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 beginning of the EHR reporting 
period.
    (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 (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.
    (B) Measures. In order to meet the objective under paragraph 
(d)(8)(ii)(A) of this section, an eligible hospital or CAH must choose 
from measures 1 through 6 (as described in paragraphs (d)(8)(ii)(B)(1) 
through (d)(8)(ii)(B)(6) of this section) and must successfully attest 
to any combination of four measures. These measures may be met by any 
combination, including meeting the measure specified in paragraph 
(d)(8)(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 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 (b)(3) of this section.
    (1) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from to the immunization registry 
reporting measure specified in paragraph (d)(8)(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 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 (d)(8)(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 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 at the start 
of the EHR reporting period.
    (3) Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the case reporting measure 
specified in paragraph (d)(8)(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 their 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 their 
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 (d)(8)(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 its 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 beginning 
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 (d)(8)(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 for which no clinical data registry 
is

[[Page 16803]]

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)(8)(ii)(B)(6) of this section if the eligible hospital or CAH:
    (i) Does not perform or order laboratory tests that are reportable 
in its 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 
at the start of the EHR reporting period.
0
5. Section 495.8 is amended as follows:
0
A. In paragraph (a) introductory text, by removing the cross-reference 
``under Sec.  495.6 of this subpart'' and adding in its place the 
cross-reference ``under Sec.  495.6 or Sec.  495.7''.
0
B. In paragraph (a)(1)(i)(B), by removing the cross-reference ``under 
Sec.  495.6(d) and Sec.  495.6(e) of this subpart'' and adding in its 
place the cross-reference ``under Sec.  495.6 or Sec.  495.7''.
0
C. In paragraph (a)(1)(iii), by removing the cross-reference ``in Sec.  
495.6 and Sec.  495.8 of this subpart'' and adding in its place the 
cross-reference ``in Sec.  495.6 or Sec.  495.7 and Sec.  495.8''.
0
D. In paragraph (a)(2)(i)(B), by removing the cross-reference ``under 
Sec.  495.6'' and adding in its place the cross-reference ``under Sec.  
495.6 or Sec.  495.7''.
0
E. Adding paragraph (a)(2)(i)(E).
0
F. In paragraph (a)(2)(iv), by removing the cross-reference ``in Sec.  
495.6 and Sec.  495.8 of this subpart'' and adding in its place the 
cross-reference ``in Sec.  495.6 or Sec.  495.7 and Sec.  495.8''.
0
G. In paragraph (b)(1)(i)(B), by removing the cross-reference ``under 
Sec.  495.6(f) and Sec.  495.6(g)'' and adding in its place the cross-
reference ``under Sec.  495.6 or Sec.  495.7''.
0
H. Redesignating paragraph (b)(1)(iv) and paragraph (b)(1)(iii).
0
I. In newly redesignated paragraph (b)(1)(iii), by removing the cross-
reference ``in Sec.  495.6 and Sec.  495.8 of this subpart'' and adding 
in its place the cross-reference ``in Sec.  495.6 or Sec.  495.7 and 
Sec.  495.8''.
0
J. In paragraph (b)(2)(i)(B), by removing the cross-reference ``under 
Sec.  495.6'' and adding in its place the cross-reference ``under Sec.  
495.6 or Sec.  495.7''.
0
K. Adding paragraph (b)(2)(i)(E).
    The additions read as follows:


Sec.  495.8  Demonstration of meaningful use criteria.

    (a) * * *
    (2) * * *
    (i) * * *
    (E) For 2017 only, an EP may attest to the following:
    (1) Stage 1 objectives and measures outlined at Sec.  495.6 if the 
EP has never before demonstrated meaningful use, or if the EP 
previously demonstrated meaningful use for the first time in 2015 or 
2016.
    (2) Stage 2 objectives and measures outlined at Sec.  495.6 if the 
EP previously demonstrated meaningful use for any year prior to 2017.
    (3) Stage 3 objectives and measures outlined at Sec.  495.7 if the 
EP has never before demonstrated meaningful use or if the EP has 
demonstrated meaningful use for any year prior to 2017.
* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (E) For 2017 only, an eligible hospital or CAH may attest to the 
following:
    (1) Stage 1 objectives and measures outlined at Sec.  495.6 if the 
eligible hospital or CAH has never before demonstrated meaningful use, 
or if the eligible hospital or CAH previously demonstrated meaningful 
use for the first time in 2015 or 2016.
    (2) Stage 2 objectives and measures outlined at Sec.  495.6 if the 
eligible hospital or CAH previously demonstrated meaningful use for any 
year prior to 2017.
    (3) Stage 3 objectives and measures outlined at Sec.  495.7 if the 
eligible hospital or CAH has never before demonstrated meaningful use 
or if the eligible hospital or CAH has demonstrated meaningful use for 
any year prior to 2017.
* * * * *
0
6. Section 495.316 is amended by revising paragraph (c) introductory 
text and adding paragraphs (d)(2)(iii), (f), (g), and (h) to read as 
follows:


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

* * * * *
    (c) Subject to Sec.  495.332 and Sec.  495.352, the State is 
required to submit to CMS annual reports, in the manner prescribed by 
CMS, on the following:
* * * * *
    (d) * * *
    (2) * * *
    (iii) Subject to Sec.  495.332, the State may propose a revised 
definition for Stage 3 of meaningful use of certified EHR technology, 
subject to CMS prior approval, but only with respect to the public 
health and clinical data registry reporting objective described in 
Sec.  495.7(d)(8).
* * * * *
    (f) Each State must submit to CMS the annual report described in 
paragraph (c) of this section within 45 days of the end of the second 
quarter of the Federal fiscal year.
    (g) The State must, on a quarterly basis and in the manner 
prescribed by CMS, submit a report(s) on the following:
    (1) The State and payment year to which the quarterly report 
pertains.
    (2) Subject to paragraph (h)(2) of this section, provider-level 
attestation data for each EP and eligible hospital that attests to 
demonstrating meaningful use for each payment year beginning with 2013.
    (h)(1) Subject to paragraph (h)(2) of this section, the quarterly 
report described in paragraph (g) of this section must include the 
following for each EP and eligible hospital:
    (i) The payment year number.
    (ii) The provider's National Provider Identifier or CCN, as 
appropriate.
    (iii) Attestation submission date.
    (iv) The state qualification.
    (v) The state qualification date, which is the beginning date of 
the provider's EHR reporting period for which it demonstrated 
meaningful use.
    (vi) The State disqualification, if applicable.
    (vii) The State disqualification date, which is the beginning date 
of the provider's EHR reporting period to which the provider attested 
but for which it did not demonstrate meaningful use, if applicable.
    (2) The quarterly report described in paragraph (g) of this section 
is not required to include information on EPs who are eligible for the 
Medicaid EHR incentive program on the basis of being a nurse 
practitioner, certified nurse-midwife or physician assistant.
0
7. Section 495.352 is revised to read as follows:


Sec.  495.352  Reporting requirements.

    (a) Each State must submit to HHS on a quarterly basis a progress 
report, in the

[[Page 16804]]

manner prescribed by HHS, documenting specific implementation and 
oversight activities performed during the quarter, including progress 
in implementing the State's approved Medicaid HIT plan.
    (b) The quarterly progress reports must include, but need not be 
limited to providing, updates on the following:
    (1) State system implementation dates.
    (2) Provider outreach.
    (3) Auditing.
    (4) State-specific State Medicaid HIT Plan tasks.
    (5) State staffing levels and changes.
    (6) The number and type of providers that qualified for an 
incentive payment on the basis of having adopted, implemented or 
upgraded certified EHR technology and the amounts of incentive 
payments.
    (7) The number and type of providers that qualified for an 
incentive payment on the basis of having demonstrated that they are 
meaningful users of certified EHR technology and the amounts of 
incentive payments.

    Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: March 18, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-06685 Filed 3-20-15; 3:00 pm]
 BILLING CODE 4120-01-P


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