[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62762-62955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25595]



[[Page 62761]]

Vol. 80

Friday,

No. 200

October 16, 2015

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 412 and 495





Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program--Stage 3 and Modifications to Meaningful Use in 2015 Through 
2017; Final Rule

  Federal Register / Vol. 80 , No. 200 / Friday, October 16, 2015 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 412 and 495

[CMS-3310-FC and CMS-3311-FC]
RINs 0938-AS26 and 0938-AS58


Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 
Through 2017

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

ACTION: Final rules with comment period.

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SUMMARY: This final rule with comment period specifies the requirements 
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 the Medicare EHR Incentive Program. 
In addition, it changes the Medicare and Medicaid EHR Incentive 
Programs reporting period in 2015 to a 90-day period aligned with the 
calendar year. This final rule with comment period also removes 
reporting requirements on measures that have become redundant, 
duplicative, or topped out from the Medicare and Medicaid EHR Incentive 
Programs. In addition, this final rule with comment period establishes 
the requirements for Stage 3 of the program as optional in 2017 and 
required for all participants beginning in 2018. The final rule with 
comment period continues to encourage the electronic submission of 
clinical quality measure (CQM) data, establishes requirements to 
transition the program to a single stage, and aligns reporting for 
providers in the Medicare and Medicaid EHR Incentive Programs.

DATES: Effective Date: These regulations are effective on December 15, 
2015.
    Comment Date: To be assured consideration, comments on sections 
II.B.1.b.(3).(iii), II.B.1.b.(4).(a), II.B.2.b, II.D.1.e, and II.G.2 of 
preamble to this final rule with comment period; paragraphs 
(1)(ii)(C)(3), (1)(iii), (2)(ii)(C)(3) and 2(iii) of the definition of 
an EHR reporting period at Sec.  495.4; and paragraphs (2)(ii)(C)(2) 
and (2)(iii) of the definition of an EHR reporting period for a payment 
adjustment year at Sec.  495.4 must be received at one of the addresses 
provided in the ADDRESSES section no later than 5 p.m. EST on December 
15, 2015.

ADDRESSES: In commenting, please refer to file code CMS-3310 & 3311-FC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may (and we encourage you to) submit 
electronic comments on this regulation to http://www.regulations.gov. 
Follow the instructions under the ``submit a comment'' tab.
    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 & 3311-FC, P.O. Box 
8013, Baltimore, MD 21244-1850.
    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 via 
express or overnight mail to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-3310 &3311-FC, Mail Stop C4-26-05, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments before the close of the comment period 
to either of the following addresses:
    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, 
please call the telephone number (410) 786-9994 in advance to schedule 
your arrival with one of our staff members.
    Comments 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, we refer readers to 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.
Elise Sweeney Anthony (ONC), (202) 475-2485, Certification definition.

SUPPLEMENTARY INFORMATION:

Electronic Access

    Inspection of Public Comments: All public 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 public 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.
    This Federal Register document is also available from the Federal 
Register online database through Federal Digital System (FDsys), a 
service of the U.S. Government Printing Office. This database can be 
accessed via the Internet at: http://www.gpo.gov/fdsys.

Acronyms

API Application Programming Interface
ARRA American Recovery and Reinvestment Act of 2009
ACO Accountable Care Organization
AIU Adopt, Implement, Upgrade (certified EHR Technology)
CAH Critical Access Hospital
CCD Continuity of Care Document
CCDA C-CDA, Consolidated Clinical Document Architecture
CCDS Common Clinical Data Set
CCN CMS Certification Number
CDC Centers for Disease Control & Prevention
CDR Clinical Data Registry
CDS Clinical Decision Support
CEHRT Certified Electronic Health Record Technology
CFR Code of Federal Regulations
CHIP Children's Health Insurance Program
CHIPRA Children's Health Insurance Program Reauthorization Act of 
2009
CMS Centers for Medicare & Medicaid Services
CPCI Comprehensive Primary Care Initiative

[[Page 62763]]

CPOE Computerized Physician Order Entry
CQM Clinical Quality Measure
CY Calendar Year
DEC Data Element Catalog
eCQM Electronic Clinical Quality Measure
EHR Electronic Health Record
ELR Electronic Reportable Lab
EP Eligible Professional
ePHI Electronic Protected Health Information
eRx Electronic Prescribing
FACA Federal Advisory Committee Act
FAQ Frequently asked question
FCC Federal Communications Commission
FFP Federal Financial Participation
FFS Fee-for-Service
FQHC Federally Qualified Health Center
FY Fiscal Year
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIE Health Information Exchange
HIT Health Information Technology
HIPAA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical 
Health Act
HMO Health Maintenance Organization
ICR Information Collection Requirement
IFC Interim Final Rule with Comment Period
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
IT Information Technology
MA Medicare Advantage
MACRA Medicare Access and CHIP Reauthorization Act of 2015
MIPS Merit-Based Incentive Payment System
MITA Medicaid Information Technology Architecture
NPI National Provider Identifier
NPPES National Plan and Provider Enumeration System
NwHIN Nationwide Health Information Network
NQF National Quality Forum
ONC Office of the National Coordinator for Health Information 
Technology
OTC Over the counter
PFS Physician Fee Schedule
PHA Public Health Agency
PHSA Public Health Service Act
POS Place of Service
PQRS Physician Quality Reporting System
PHI Protected Health Information
QA Quality Assurance
QRDA Quality Reporting Data Architecture
SMHP State Medicaid Health Information Technology Plan
SRA Security Risk Assessment
ToC Transitions of Care
VDT View, Download, and Transmit

Table of Contents

I. Executive Summary and Background
    A. Executive Summary
    1. Purpose of Regulatory Action
    a. Need for Regulatory Action
    b. Legal Authority for the Regulatory Action
    2. Summary of Major Provisions
    a. Considerations in Defining Meaningful Use
    b. Meaningful Use Requirements, Objectives, and Measures for 
2015 Through 2017
    (1) EHR Reporting Period
    (2) Objectives and Measures
    c. Meaningful Use Requirements, Objectives, and Measures for 
Stage 3 in 2017 and Subsequent Years
    (1) EHR Reporting Period
    (2) Objectives and Measures
    d. Certified EHR Technology Requirements for the EHR Incentive 
Programs
    e. Clinical Quality Measurement
    f. Demonstration of Meaningful Use
    g. Payment Adjustments and Hardship Exceptions
    h. Modifications to the Medicaid EHR Incentive Program
    3. Summary of Costs and Benefits
    B. Overview of the Regulatory History
II. Provisions of the Proposed Regulations and Analysis of and 
Responses to Public Comments
    A. Introduction
    B. Meaningful Use Requirements, Objectives, and Measures
    1. Definitions Across the Medicare Fee-for-Service, Medicare 
Advantage, and Medicaid Programs
    a. Uniform Definitions
    b. Definitions for 2015 Through 2017 and Subsequent Years
    (1) Stages of Meaningful Use
    (2) Meaningful EHR User
    (3) EHR Reporting Period
    (i) Calendar Year Reporting
    (ii) EHR Reporting Period in 2015 Through 2017
    (iii) EHR Reporting Period in 2017 and Subsequent Years
    (4) Considerations in Defining Meaningful Use
    (a) Considerations in Review and Analysis of the Objectives and 
Measures for Meaningful Use
    (i) Topped Out Measures and Objectives
    (ii) Electronic Versus Paper-Based Objectives and Measures
    (iii) Advanced EHR Functions
    (b) Considerations in Defining the Objectives and Measures of 
Meaningful Use for 2015 Through 2017
    (i) Changes to Objectives and Measures for 2015 Through 2017
    (ii) Structural Requirements of Meaningful Use in 2015 Through 
2017
    (iii) Alternate Exclusions and Specifications for Stage 1 
Providers for Meaningful Use
    (iv) Changes to Patient Engagement Requirements for 2015 Through 
2017
    (c) Considerations in Defining the Objectives and Measures of 
Meaningful Use Stage 3
    (d) Flexibility Within Meaningful Use Objectives and Measures
    (e) EPs Practicing in Multiple Practices Locations
    (f) Denominators
    (g) Patient Authorized Representatives
    (h) Discussion of the Relationship of the Requirements of the 
EHR Incentive Programs to CEHRT
    (i) Discussion of the Relationship Between a Stage 3 Objective 
and the Associated Measure
    2. Meaningful Use Objectives and Measures
    a. Meaningful Use Objectives and Measures for 2015, 2016, and 
2017
    Objective 1: Protect Patient Health Information
    Objective 2: Clinical Decision Support
    Objective 3: Computerized Provider Order Entry
    Objective 4: Electronic Prescribing
    Objective 5: Health Information Exchange
    Objective 6: Patient Specific Education
    Objective 7: Medication Reconciliation
    Objective 8: Patient Electronic Access
    Objective 9: Secure Electronic Messaging EP Only
    Objective 10: Public Health and Clinical Data Registry Reporting
    b. Objectives and Measures for Stage 3 of the EHR Incentive 
Programs
    Objective 1: Protect Patient Health Information
    Objective 2: Electronic Prescribing
    Objective 3: Clinical Decision Support
    Objective 4: Computerized Provider Order Entry
    Objective 5: Patient Electronic Access to Health Information
    Objective 6: Coordination of Care Through Patient Engagement
    Objective 7: Health Information Exchange
    Objective 8: Public Health and Clinical Data Registry Reporting
    3. Certified EHR Technology (CEHRT) Requirements
    a. CEHRT Definition for the EHR Incentive Programs
    b. Defining CEHRT for 2015 Through 2017
    c. Defining CEHRT for 2018 and Subsequent Years
    d. Final Definition of CEHRT
    C. Clinical Quality Measurement
    1. Clinical Quality Measure (CQM) Requirements for Meaningful 
Use in 2015 and 2016
    2. Clinical Quality Measure (CQM) Requirements for Meaningful 
Use in 2017 and Subsequent Years
    a. Clinical Quality Measure Reporting Requirements for EPs
    b. CQM Reporting Requirements for Eligible Hospitals and 
Critical Access Hospitals
    c. Quality Reporting Data Architecture Category III (QRDA-III) 
Option for Eligible Hospitals and CAHs
    3. CQM Reporting Period Beginning in 2017
    a. CQM Reporting Period for EPs
    b. CQM Reporting Period for Eligible Hospitals and CAHs
    c. Reporting Flexibility EPs, Eligible Hospitals, CAHs 2017
    4. Reporting Methods for CQMs
    5. CQM Specification and Changes to the Annual Update
    6. Certified EHR Technology Requirements for CQMs
    7. Electronic Reporting of CQMs
    D. Demonstration of Meaningful Use and Other Issues
    1. Demonstration of Meaningful Use
    a. Common Methods of Demonstration in Medicare and Medicaid
    b. Methods for Demonstration of the Criteria for Meaningful Use 
in 2015 Through 2017

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    c. Attestation Deadlines for the EHR Incentive Programs in 2015 
Through 2017
    d. New Participant Attestation Deadlines for Meaningful Use in 
2015 and 2016 to Avoid a Payment Adjustment
    e. Methods for Demonstration of the Stage 3 Criteria of 
Meaningful Use for 2017 and Subsequent Years
    (1) Meaningful Use Objectives and Measures in 2017 and CEHRT 
Flexibility in 2017
    (2) Stage and CEHRT Flexibility in 2017
    (3) CQM Flexibility in 2017
    2. Alternate Method of Demonstration for Certain Medicaid 
Providers Beginning in 2015
    3. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    4. Hospital-Based Eligible Professionals
    5. Interaction With Other Programs
    E. Payment Adjustments and Hardship Exceptions
    1. Statutory Basis for Payment Adjustments and Hardship 
Exceptions
    a. Statutory Basis for Payment Adjustments and Hardship 
Exceptions for Eligible Professionals (EPs)
    b. Statutory Basis for Payment Adjustments and Hardship 
Exceptions for Eligible Hospitals
    c. Statutory Basis for Payment Adjustments and Hardship 
Exceptions for CAHs
    2. EHR Reporting Period for a Payment Adjustment Year
    a. Changes to the EHR Reporting Period for a Payment Adjustment 
Year for EPs
    b. Changes to the EHR Reporting Period for a Payment Adjustment 
Year for Eligible Hospitals
    c. Changes to the EHR Reporting Period for a Payment Adjustment 
Year for CAHs
    3. Hardship Exceptions
    4. Administrative Review Process of Certain Electronic Health 
Record Incentive Program Determinations
    F. Medicare Advantage Organization Incentive Payments
    G. The Medicaid EHR Incentive Program
    1. State Flexibility for Meaningful Use
    2. EHR Reporting Period and EHR Reporting Period for a Payment 
Adjustment Year for First Time Meaningful EHR Users in Medicaid
    3. Reporting Requirements
    a. State Reporting on Program Activities
    b. State Reporting on Meaningful EHR Users
    4. Clinical Quality Measurement for the Medicaid Program
    J Pages
III. Collection of Information Requirements
    A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  
495.24)
    B. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  
495.20 Through Sec.  495.60)
    C. ICRs Regarding Qualifying MA Organizations (Sec.  495.210)
    D. ICR Regarding State Reporting Requirements (Sec.  495.316 and 
Sec.  495.352)
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    1. Overall Effects
    a. EHR Technology Development and Certification Costs--Stage 3
    b. Regulatory Flexibility Analysis and Small Entities
    (1) Small Entities
    (2) Conclusion
    c. Small Rural Hospitals--Modifications
    d. Unfunded Mandates Reform Act
    e. Federalism
    2. Effects on EPs, Eligible Hospitals, and CAHs
    a. Background and Assumptions
    (1) EHR Incentive Programs in 2015 Through 2017
    (2) Stage 3
    b. Industry Costs and Adoption Rates
    (1) Modifications
    (a.) Medicare Eligible Professionals (EPs)
    (b.) Medicare Eligible Hospitals and CAHs
    (c.) Medicaid Only EPs
    (d.) Medicaid Only Hospitals
    (2) Stage 3
    c. Costs of EHR Adoption for EPs
    d. Costs of EHR Adoption for Eligible Hospitals
    3. Medicare and Medicaid Incentive Program Costs for Stage 3
    a. Medicare Program Costs for Stage 3
    (1) Medicare Eligible Professionals (EPs)
    (2). Medicare Eligible Hospitals and CAHs
    b. Medicaid Incentive Program Costs for Stage 3
    (1). Medicaid EPs
    (2). Medicaid Hospitals
    4. Benefits for all EPs and all Eligible Hospitals
    5. Benefits to Society
    6. Summary
    D. Alternatives Considered for Stage 3
    E. Accounting Statement and Table
    (1) EHR Incentive Programs in 2015 Through 2017
    (2) Stage 3
VI. Response to Comments
Regulations Text

I. Executive Summary and Background

A. Executive Summary

1. Purpose of Regulatory Action
a. Need for Regulatory Action
    This final rule with comment period addresses the proposals made in 
two separate CMS notices of proposed rulemaking (NPRM); the March 30, 
2015 ``Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program Stage 3'' NPRM (80 FR 16731 through 16804) (hereafter 
referred to as the ``Stage 3 proposed rule'') and the April 9, 2015 
``Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program--Modifications to Meaningful Use in 2015 through 2017'' NPRM 
(80 FR 20346 through 20399) (hereafter referred to as the ``EHR 
Incentive Programs in 2015 through 2017 proposed rule''). However, the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10) was enacted on April 16, 2015, after publication of the 
proposed EHR rule. Section 101(b)(1)(A) of MACRA amended section 
1848(a)(7)(A) of the Act to sunset the meaningful use payment 
adjustment for EPs at the end of CY 2018. Section 101(c) of MACRA added 
section 1848(q) of the Act requiring the establishment of a Merit-Based 
Incentive Payment System (MIPS), which would incorporate meaningful 
use. In light of the passage of MACRA, this final rule with comment 
period also allows for a 60-day public comment period on certain 
provisions noted in the SUPPLEMENTARY INFORMATION section above in part 
to support the transition to MIPS. The comments received during the 
comment period may be considered as we prepare for future rulemaking to 
implement MIPS, which in general is expected to be more broadly focused 
on quality and care delivery.
    The enactment of MACRA has altered the EHR Incentive Programs such 
that the existing Medicare payment adjustment for EPs under 
1848(a)(7)(A) of the Act will end in CY 2018 and be incorporated under 
MIPS beginning in CY 2019. It is our intent to issue a notice of 
proposed rulemaking for MIPS by mid-2016. This final rule with comment 
period synchronizes reporting under the EHR Incentive Programs to end 
the separate stages of meaningful use, which we believe will prepare 
Medicare EPs for the transition to MIPS.
    In the Stage 3 and the EHR Incentive Program in 2015 through 2017 
proposed rules, and in this final rule with comment period, we have 
responded to public input and comments by providing for flexibility 
that may assist EPs in preparing for the transition to MIPS. This final 
rule with comment period establishes a number of key final policies in 
response to these concerns: A simplification of program requirements, 
an introduction of flexibility within certain objectives, an option to 
participate in Stage 3 in 2017 but not required until 2018, and an 
overall focus on interoperability. We have focused on leveraging health 
IT to support providers and reduce burdensome requirements within an 
evolving environment. In light of public interest and in recognition 
that this is an ongoing and continuous process, we are providing a 60-
day public comment period on the final policies for the Stage 3 
objectives and measures and the EHR reporting period for Stage 3 in 
2017 and subsequent years. Public comments received may be considered 
as we plan for the incorporation of meaningful use into MIPS, and any 
policies developed would be addressed in future rulemaking.

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    The Stage 3 proposed rule (80 FR 16733 through 16735) described the 
final stage of the program, which would incorporate portions of the 
prior stages into Stage 3 requirements, while altering other 
requirements in response to CMS's progress toward policy goals, the 
widespread adoption of technology and clinical standards among 
providers, and high performance on certain objectives among providers. 
These proposed changes included simplifying and reducing the number of 
measures, and focusing the Medicare and Medicaid EHR Incentive Programs 
on the advanced use of EHR technology. In addition, the proposals set a 
path for providers to move toward aligned reporting on a single set of 
requirements, with the goal of moving all participants in the Medicare 
and Medicaid EHR Incentive Programs to a single set of requirements in 
2018. The incorporation of the requirements into one stage for all 
providers is intended to respond to stakeholder concerns by creating 
simplicity in the program by focusing on the success of certain 
measures that are part of the meaningful use program to date, and 
setting a long- term, sustainable foundation based on key advanced use 
objectives for the Medicare and Medicaid EHR Incentive Programs.
    In the EHR Incentive Programs for 2015 through 2017 proposed rule 
(80 FR 20346 through 20399), we proposed to make similar modifications 
to Stage 1 and Stage 2 of the Medicare and Medicaid EHR Incentive 
Programs in order to reduce reporting burden, to eliminate redundant 
and duplicative reporting, and to better align the objectives and 
measures of meaningful use with the proposed Stage 3 requirements, 
which would be optional in 2017 and required beginning in 2018.
    In this final rule with comment period, we are finalizing the 
requirements for the EHR Incentive Programs for 2015 through 2017 and 
for 2018 and subsequent years. We note that our intent in finalizing 
the Stage 3 proposed rule along with the changes for 2015 through 2017 
while continuing to solicit comments on certain provisions is 
multifold; we are creating consistency in the policies for the current 
program in 2015 through 2017 and for 2018 and subsequent years; and we 
have established a clear vision of how current participation will 
assist in meeting our long-term delivery system reform goals. We 
believe this sustained consistency in policy will support the planning 
and development for MIPS and the future use of EHR across a multitude 
of healthcare providers.
    We are also finalizing changes to the EHR reporting period, 
timelines, and structure of the Medicare and Medicaid EHR Incentive 
Programs for 2015 through 2017 to better align EHR reporting periods 
for providers; support a flexible, clear framework to reduce provider 
burden; and support future sustainability of the Medicare and Medicaid 
EHR Incentive Programs. Overall, the requirements of the program 
finalized in this rule for 2015 through 2017 seek to support near-term 
goals for delivery system reform and lay a foundation for our broader 
efforts to pursue 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, CAHs, 
and Medicare Advantage (MA) organizations to promote the adoption and 
meaningful use of CEHRT. Sections 1848(o), 1853(l) and (m), 1886(n), 
and 1814(l) of the Act provide the statutory basis for the Medicare 
incentive payments made to meaningful EHR users. These statutory 
provisions govern EPs, MA organizations (for certain qualifying EPs and 
hospitals that meaningfully use CEHRT), subsection (d) hospitals and 
CAHs, respectively. Sections 1848(a)(7), 1853(l) and (m), 
1886(b)(3)(B), and 1814(l) of the Act also establish downward payment 
adjustments, beginning with calendar or fiscal year (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. Considerations in Defining Meaningful Use
    The Stage 1 final rule established 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 goal: The exchange of essential health 
data among health care providers and patients to improve care 
coordination. We also finalized a set of clinical quality measures 
(CQMs) that all providers participating in any stage of the program are 
required 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 readers to the Stage 2 final rule at 77 FR 
53967 through 54162.)
    In the March 30, 2015 Federal Register, we published a proposed 
rule titled ``Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program Stage 3'' (80 FR 16731 through 16804) hereafter 
referred to as the ``Stage 3 proposed rule''. In the April 15, 2015 
Federal Register, we published a proposed rule titled ``Medicare and 
Medicaid Programs; Electronic Health Record Incentive Program--
Modifications to Meaningful Use in 2015 through 2017'' (80 FR 20346 
through 20399) hereafter referred to as the ``EHR Incentive Programs in 
2015 through 2017 proposed rule''. In this final rule, we are 
finalizing both the Stage 3 proposed rule and the EHR Incentive 
Programs in 2015 through 2017 proposed rule to build on the groundwork 
established in Stage 1 and Stage 2and continue our Stage 2 goal of 
increasing interoperable health data sharing among providers. In 
addition, this final rule also focuses on the advanced use of EHR 
technology to promote improved patient outcomes and health information 
exchange. We are also finalizing proposals 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.
    One significant change we proposed in the Stage 3 proposed rule (80 
FR 16734) included establishing a single set of objectives and measures 
(tailored to EPs or eligible hospitals/CAHs) to meet the definition of 
meaningful use for Stage 3 in 2017 and subsequent years. In the EHR 
Incentive Program in 2015 through 2017 proposed rule (80 FR 20351), we 
additionally proposed a

[[Page 62766]]

transitional period in 2015 through 2017 that would help move providers 
along a participation continuum toward the long term goals proposed 
under the Stage 3 proposed rule. In this final rule, we are adopting 
this transition toward a new, streamlined set of requirements, 
including an optional year for any provider who chooses to attest to 
the objectives and measures for Stage 3 for an EHR reporting period in 
2017. We are additionally finalizing the objectives and measures that 
will be required for all eligible providers--regardless of prior 
participation in the Medicare and Medicaid EHR Incentive Programs--for 
an EHR reporting period in 2018 and subsequent years.
    In the Stage 3 proposed rule (80 FR 16741), we outlined our 
proposed approach and method for measure selection that removed topped 
out, redundant, and duplicative measures from reporting requirements 
and focused on only those measures that represent the most advanced use 
of the functions and standards supported by CEHRT. In the EHR Incentive 
Program in 2015 through 2017 proposed rule (80 FR 20352), we proposed 
adopting this approach as applicable to the current objectives and 
measures in use for Stage 1 and Stage 2 of the program and aligning the 
current objectives and measures with those identified for long-term use 
in the Stage 3 proposed rule. In this final rule, we adopt the approach 
for the Stage 3 objectives and measures, as well as the similar 
approach for the objectives and measures of the EHR Incentive Program 
in 2015 through 2017.
b. Meaningful Use Requirements, Objectives, and Measures for 2015 
Through 2017
(1) EHR Reporting Period
    In this final rule, we adopt changes to the EHR reporting period 
for the Medicare and Medicaid EHR Incentive Programs in 2015, 2016, and 
2017 and finalize the changes that align reporting periods to the 
calendar year. We also finalize the proposal to adopt a 90-day 
reporting period for all providers in 2015 and new participants in 
2016, and based on public comment we are finalizing a 90-day reporting 
period for new participants in 2017.
(2) Objectives and Measures
    In the Stage 3 proposed rule (80 FR 16741), we outlined our method 
and approach for identifying the objectives and measures retained for 
Stage 3 of meaningful use beginning in 2017. We also identified those 
objectives and measures that are now redundant, duplicative, or topped 
out, and therefore will no longer be required for the successful 
demonstration of meaningful use for Stage 3. For further discussion of 
this approach, we refer readers to section II.B.1.b.(4).(a) of this 
final rule with comment period.
    In this final rule, we are adopting the proposed approach from the 
EHR Incentive Program in 2015 through 2017 proposed rule to use a 
similar method to identify the objectives and measures from Stages 1 
and 2 of meaningful use that we believe should no longer be required 
for a provider to demonstrate meaningful use in 2015 through 2017 
because these measures have been identified as redundant, duplicative, 
or topped out. We are also finalizing changes to remove the menu and 
core structure of Stage 1 and Stage 2 and reduce the overall number of 
objectives to which a provider must attest. In addition, we are 
finalizing changes to individual objectives and measures for Stage 2 of 
meaningful use as follows:
     Changing the threshold for two measures requiring patient 
action (the second measure for the Stage 2 Objective for Patient 
Electronic Access and the measure for the Stage 2 Objective for Secure 
Electronic Messaging).
     Consolidating all public health reporting objectives into 
one objective with measure options similar to the structure of the 
Stage 3 Public Health Reporting Objective (80 FR 16762 through 16767).
     Changing the eligible hospital electronic prescribing 
objective from a menu objective to a required objective with an 
exclusion available for eligible hospitals and CAHs in 2015 and 2016.
    We are additionally finalizing the proposal to maintain the 
existing definitions for the objectives and measures, including the 
numerator and denominator calculations, the proposal to maintain 
certain measure specifications for 2015, and the proposal to allow 
exclusions for certain measures in 2015 and 2016 in order to facilitate 
the transition for providers already engaged in the workflows, data 
capture, and measure calculation for meaningful use for an EHR 
reporting period in 2015 and 2016.For further discussion of this 
approach, we refer readers to section II.B.1.b.(4).(b).of this final 
rule.
c. Meaningful Use Requirements, Objectives, and Measures for Stage 3 in 
2017 and Subsequent Years
(1) EHR Reporting Period
    In this final rule, we are adopting changes to the EHR reporting 
period for 2017, 2018, and subsequent years based on the Stage 3 
proposed rule (80 FR 16739) and public comments received. We are 
finalizing the proposal for full calendar year reporting for providers 
beginning in 2018 with a limited exception for Medicaid providers in 
their first year of demonstrating meaningful use. We are also 
finalizing an optional 90-day reporting period for providers 
demonstrating the Stage 3 requirements for an EHR reporting period in 
2017. For further discussion, we refer readers to section II.B.1.b.(3) 
of this final rule.
(2) Objectives and Measures
    The methodology outlined in the Stage 3 proposed rule at 80 FR 
16741 for the selection of objectives and measures for the Medicare and 
Medicaid EHR Incentive Programs for Stage 3 in 2017 and subsequent 
years included the following:
     Review attestation data for Stages 1 and 2 of meaningful 
use;
     Conduct listening sessions and interviews with providers, 
EHR system developers, regional extension centers, and health care 
provider associations; and
     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 and Prevention 
(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 and consideration of public comment 
received, we are finalizing a set of 8 objectives with associated 
measures designed to meet the following policy goals:
     Align with national health care quality improvement 
efforts;
     Promote interoperability and health information exchange; 
and
     Focus on the 3-part aim of reducing cost, improving 
access, and improving quality.
    We intend for Stage 3 to be the final 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.

[[Page 62767]]

Measures in the Stage 1 and Stage 2 final rules that included paper-
based workflows, chart abstraction, or other manual actions have been 
removed or transitioned to an electronic format utilizing EHR 
functionality for Stage 3. In addition, we are finalizing the removal 
of topped out measures, or measures that are no longer useful in 
gauging performance, because these less advanced measures are now 
achieving widespread adoption.
d. Certified EHR Technology Requirements for the EHR Incentive Programs
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20374), we proposed no changes to the individual certification 
requirements for the objectives and measures of meaningful use for an 
EHR reporting period in 2015 through 2017 using EHR technology 
certified to the 2014 Edition certification criteria. In the Stage 3 
proposed rule (80 FR 16767), we proposed that providers use EHR 
technology certified to the 2015 Edition certification criteria for an 
EHR reporting period in 2018. In this rule, we are finalizing that 
providers may continue to usher technology certified to the 2014 
Edition until EHR technology certified to the 2015 Edition is required 
with an EHR reporting period beginning in 2018. In the Stage 3 proposed 
rule, we also noted our intent to allow providers to upgrade to 
technology certified to the 2015 Edition as soon as such technology is 
available if they determine that the EHR technology certified to the 
2015 Edition would support and meet the requirements of the EHR 
Incentive Programs in 2015 through 2017. We are finalizing that 
providers may use EHR technology certified to the 2014 Edition for an 
EHR reporting period in 2015; EHR technology certified to either the 
2014 Edition, the 2015 Edition, or a combination of the two in 2016 and 
2017; and EHR technology certified to the 2015 Edition for an EHR 
reporting period in 2018 and subsequent years.
    We are also finalizing a definition of CEHRT within 42 CFR 495.4 
that includes the functions and standards outlined for the 
certification of health information technology to the 2014 and 2015 
Edition certification criteria for use in the Medicare and Medicaid EHR 
Incentive Programs. For further discussion of the definition and use of 
CEHRT, we direct readers to section II.B.3 of this final rule.
e. Clinical Quality Measurement
    EPs, eligible hospitals, and CAHs must report CQMs in order to meet 
the requirements of the Medicare and Medicaid EHR Incentive Programs. 
We are committed to continuing to promote the electronic capture, 
calculation, and reporting of key clinical data through the use of 
CEHRT. We are also focused on improving alignment of reporting 
requirements for CMS programs that leverage EHR technology for clinical 
quality reporting and quality measurement to streamline reporting 
mechanisms for providers and increase quality data integrity.
    This final 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 order to facilitate continuous quality 
improvement, we noted in the Stage 3 proposed rule our intent to 
implement changes to quality reporting requirements in conjunction with 
the quality reporting programs through the annual Medicare payment 
rules, such as the Physician Fee Schedule (PFS) and the Inpatient 
Prospective Payment Systems (IPPS) rules. In the Stage 3 proposed rule, 
we proposed 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 final rule.)
    We did not propose changes to the CQM selection or reporting scheme 
(9 or 16 CQMs across at least 3 domains) from the CQM requirements 
previously established for all providers seeking to demonstrate 
meaningful use in the Medicare and Medicaid EHR Incentive Programs 
defined in earlier rulemaking (see 77 FR 54049 through 54089). In the 
EHR Incentive Programs in 2015 through 2017 proposed rule, for an EHR 
reporting period in 2015, and for providers demonstrating meaningful 
use for the first time in 2016 or 2017, we proposed that providers 
may--
     Attest to any continuous 90-day period of CQM data during 
the calendar year through the Medicare EHR Incentive Program 
registration and attestation site; or
     Electronically report CQM data using the established 
methods for electronic reporting.
    We are finalizing these reporting periods for CQM reporting for 
2015 and 2016. We are finalizing that for 2017, providers beyond their 
first year of meaningful use may attest to one full calendar year of 
CQM data or they may electronically report their CQM data using the 
established methods for electronic reporting outlined in section II.C. 
of this final rule. In addition, we are finalizing that for an EHR 
reporting period in 2018, all providers are required to submit CQM data 
for the Medicare EHR Incentive Program using these established methods 
for electronic reporting. We refer readers to section II.C. of this 
final rule for further information on clinical quality measurement.
f. Demonstration of Meaningful Use
    We are finalizing our proposal to continue our common method for 
meaningful use in both the Medicare and Medicaid EHR Incentive Programs 
of attestation as the method for demonstrating that an EP, eligible 
hospital, or CAH has met the requirements of the Medicare and Medicaid 
EHR Incentive Programs. We are additionally finalizing changes to the 
attestation deadlines to accommodate the change to reporting based on 
the calendar year for eligible hospitals and CAHs beginning with an EHR 
reporting period in 2015, as well as the proposed change to a 90-day 
EHR reporting period for all providers in 2015. We are also finalizing 
changes to the attestation deadlines for new meaningful EHR users in 
2015 and 2016 to avoid the Medicare payment adjustments in 2016 and 
2017. Finally, we are adopting the alternate attestation method 
proposed in the EHR Incentive Program in 2015 through 2017 proposed 
rule for certain Medicaid providers to demonstrate meaningful use in 
2015 and subsequent years to avoid Medicare payment adjustments. For 
further discussion, we refer readers to section II.D of this final 
rule.
g. Payment Adjustments and Hardship Exceptions
    The HITECH statute requires Medicare payment adjustments beginning 
in 2015. In this final rule, we are maintaining the payment adjustment 
policies for EPs, eligible hospitals, and CAHs as 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, the payment adjustment year, and the attestation deadlines 
to avoid the payment adjustment. For the discussion of payment 
adjustments and hardship exceptions, we refer readers to section II.E 
of this final rule with comment period.

[[Page 62768]]

h. 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. In this final rule with 
comment period, we finalize 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 (80 FR 16779).
    We will 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 are also finalizing 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.
    The provisions included in this final rule with comment period will 
apply for the Medicaid EHR Incentive Program, including the changes to 
the EHR reporting period in 2015 and 2016, and the objectives and 
measures required to demonstrate meaningful use in 2015 through 2017. 
We will continue to allow states flexibility under the Medicaid EHR 
Incentive Program for the public health reporting objective. 
Specifically, for meaningful use in 2015 through 2017 and for Stage 3, 
we will continue the policy stated in the Stage 2 final rule (77 FR 
53979) to allow states to specify the means of transmission of the data 
or otherwise change the public health measure (as long as it does not 
require EHR functionality above and beyond that which is included in 
the certification requirements specified under the 2014 Edition 
certification criteria). We refer readers to section II.G of this final 
rule with comment period for further information on the Medicaid EHR 
Incentive Programs.
3. Summary of Costs and Benefits
    Upon finalization, the provisions in this final rule with comment 
period 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 
with comment period.
    Based on prior rulemaking, we expect spending under the EHR 
Incentive Programs for transfer payments to Medicare and Medicaid 
providers between 2015 and 2017 to be $14.2 billion; however, the 
policies in this final rule with comment period do not change estimates 
over the current period.
    Our analysis of impacts for the policies in this final rule with 
comment period relate to the reduction in cost associated with provider 
reporting burden estimates for 2015 through 2017 as affected by the 
adopted changes to the current program. The estimates also relate to 
the transfer payments for incentives for Medicaid providers and 
reductions in payments for Medicare providers through payment 
adjustments for 2018 and subsequent years. For 2015 through 2017, we 
estimate the reduction in the reporting burden for providers 
demonstrating meaningful use in a calendar year as 1.45 to 1.9 hours 
per EP respondent and 2.62 hours per eligible hospital or CAH 
respondent. We estimate the total annual cost savings related to this 
reduction at $52,547,132 for a low estimate and $68,617,864 for a high 
estimate. We expect spending under the EHR Incentive Programs for 
transfer payments to Medicare and Medicaid providers between 2017 and 
2020 to be $3.7 billion (this estimate includes net payment adjustments 
in the amount of $0.8 billion for Medicare providers who do not achieve 
meaningful use).
    In this final rule with comment period, 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 HIT.
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). 
Accordingly, we have prepared a regulatory impact analysis that to the 
best of our ability presents the costs and benefits of the final rule 
with comment period.

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, 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 the Stage 1 final rule, we also detailed that the 
Medicare and Medicaid EHR Incentive Programs would consist of three 
different stages of meaningful use requirements.
    In the September 4, 2012 Federal Register (77 FR 53967 through 
54162), we published a final rule (``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program-Stage 2; Final Rule,'' or 
``Stage 2 final rule'') that specified the Stage 2 criteria that EPs, 
eligible hospitals, and CAHs would have to meet in order to qualify for 
incentive payments. In addition, the Stage 2 final rule finalized 
payment adjustments and other program participation requirements under 
Medicare for covered professional and hospital services provided by 
EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use 
of CEHRT, 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 the 
Office of the National Coordinator for Health Information Technology 
(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.

[[Page 62769]]

The December 7, 2012 IFC also revised the Medicare and Medicaid EHR 
Incentive Programs by--
     Adding an alternative measure for the Stage 2 meaningful 
use objective for hospitals to provide structured electronic laboratory 
results to ambulatory providers;
     Correcting the regulation text for the measures associated 
with the objective for hospitals to provide patients the ability to 
view online, download, and transmit information about a hospital 
admission; and
     Making the case number threshold exemption for CQM 
reporting applicable for eligible hospitals and CAHs beginning with FY 
2013.
    The December 7, 2012 IFC also provided notice of our intention to 
issue technical corrections to the electronic specifications for CQMs 
released on October 25, 2012.
    In the September 4, 2014 Federal Register (79 FR 52910 through 
52933), CMS and ONC published a final rule titled ``Medicare and 
Medicaid Programs; Modifications to the Medicare and Medicaid 
Electronic Health Record (EHR) Incentive Program for 2014 and Other 
Changes to the EHR Incentive Program; and Health Information 
Technology: Revisions to the Certified EHR Technology Definition and 
EHR Certification Changes Related to Standards; Final Rule'' (``2014 
CEHRT Flexibility final rule''). Due to issues related to availability 
delays for EHR technology certified to the 2014 Edition, the 2014 CEHRT 
Flexibility final rule included policies allowing EPs, eligible 
hospitals, and CAHs that could not fully implement EHR technology 
certified to the 2014 Edition for an EHR reporting period in 2014 to 
continue to use one of the following options for reporting periods in 
CY 2014 and FY 2014, respectively--
     EHR technology certified to the 2011 Edition; or
     A combination of EHR technology certified to the 2011 
Edition and EHR technology certified to the 2014 Edition for the EHR 
reporting periods.
    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 titled ``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.
    In the March 30, 2015 Federal Register, we published a proposed 
rule titled ``Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program Stage 3'' (80 FR 16731 through 16804). In the Stage 3 
proposed rule, we specified the proposed meaningful use criteria that 
EPs, eligible hospitals, and critical access hospitals must meet in 
order to demonstrate meaningful use of CEHRT for Stage 3 of the 
Medicare and Medicaid EHR Incentive Programs. The proposed rule also 
specified the proposed requirements for electronic submission of CQMs 
and created a single set of meaningful use requirements for Stage 3 
that would be optional for providers in 2017 and required for all 
providers beginning in 2018. Finally, the Stage 3 proposed rule would 
also change the EHR reporting period so that all providers would report 
under a calendar year timeline.
    In the April 15, 2015 Federal Register, we published a proposed 
rule titled ``Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Modifications to Meaningful Use in 2015 through 
2017'' (80 FR 20346 through 20399). In the proposed rule, we proposed 
to change the EHR reporting period in 2015 to a 90-day period aligned 
with the calendar year and to align the EHR reporting period in 2016 
with the calendar year. In addition, in the proposed rule, we proposed 
to modify the patient action measures in the Stage 2 objectives related 
to patient engagement. Finally, we proposed to streamline the program 
by removing reporting requirements on measures that have become 
redundant, duplicative, or topped out through advancements in EHR 
function and provider performance for Stage 1 and Stage 2 of the 
Medicare and Medicaid EHR Incentive Programs.
    For Stage 1 and Stage 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 parts 170. CMS and ONC have worked 
together to align the Stage 3 proposed rule and the ONC 2015 Edition 
proposed rule (80 FR 16731 through 16804 and 80 FR 16804 through 
16921), and again are working together to align the final rules.
    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 and Analysis of and 
Responses to Public Comments

A. Introduction

    When the Medicare and Medicaid EHR Incentive Programs began in 
2011, the requirements for the objectives and measures of meaningful 
use were designed to begin a process of health care delivery system 
transformation aligning with foundational goals defined in the Health 
Information Technology for Economic and Clinical Health Act (HITECH) 
Act. The HITECH Act 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); 
requiring the use of EHR technology, which defines both the functions 
that should be available within the EHR and the purpose to which those 
functions should be applied (see section 1848(o)(4) of the Act); and 
defining key foundational principles of meaningful use to support the 
improvement of care and care coordination, and the use of EHR 
technology to submit information on clinical quality measures and other 
measures (see section 1848(o)(2)(A) of the Act).
    In 2015, we published two notices of proposed rulemaking in 2015 
relating to the EHR Incentive programs to address near term goals in 
2015 through 2017 and long-term goals for Stage 3 in 2017 and 
subsequent years.
    In the March 30, 2015 Stage 3 proposed rule (80 FR 16734), we 
proposed the requirements for the Medicare and Medicaid EHR Incentive 
Programs for 2017 and subsequent years to build a long-term sustainable 
program

[[Page 62770]]

focused on the advanced use of CEHRT to support clinical effectiveness, 
health information exchange, and quality improvement. We proposed a 
total of eight objectives that focus on supporting advanced clinical 
processes, promoting interoperability and health information exchange, 
continuing progress in electronic public health reporting, and 
expanding the scope and methods for provider and patient engagement.
    In the April 15, 2015 EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20347), we proposed modifications to Stage 1 and 
Stage 2 to reflect this long-term vision and to be responsive to the 
changing environment and stakeholder concern over program complexity 
and redundant reporting requirements. The proposed rule included a 
reduced set of objectives and measures based on the Stage 2 objectives 
and measures that align with the policies for Stage 3. The proposed 
rule also proposed removing measures that had become topped out, 
redundant or duplicative, and easing requirements around measures 
requiring providers to be accountable for patient action. We proposed 
the modifications to address stakeholder concerns and to continue to 
support the overall goal of the widespread adoption and meaningful use 
of CEHRT in efforts to transform our health care delivery system and 
improve health care quality.
    Comment: Many commenters supported the policies proposed in the EHR 
Incentive Programs in 2015 through 2017 proposed rule. A few commenters 
stated that the proposed rule was a more accurate reflection of what 
caregivers are able to provide to patients and the tools they have 
available to do so. Additionally, they stated that the proposals 
reflected what patients are willing to provide to the caregivers.
    A few commenters indicated that CMS should update the measures and 
requirements to ensure they are appropriately aligned and would improve 
a provider's ability to successfully demonstrate meaningful use. A 
commenter stated that we should first receive provider input before 
adding or suggesting any changes to the requirements.
    Response: We appreciate the supportive comments and reiterate that 
our goals include reducing the reporting burden, eliminating redundant 
and duplicative reporting, and better aligning the objectives and 
measures of meaningful use for 2015 through 2017 with the Stage 3 
requirements.
    We proposed revisions to the requirements according to provider and 
stakeholder feedback received through correspondence, public forums, 
and listening sessions. Additionally, we proposed these changes through 
a notice of proposed rulemaking and accepted comments from the public 
during the comment periods for both proposed rules. We believe that 
providers helped to shape the requirements for meaningful use in part 
through those processes.
    Comment: A few commenters stated that the proposal for the EHR 
Incentive Programs in 2015 through 2017 proposed rule imposes 
unreasonable financial constraints and reporting burdens. Other 
commenters stated the EHR Incentive Program in 2015 through 2017 
proposed rule moves the program backward instead of forward. Another 
commenter stated that there are administrative burdens that providers 
face daily that distract from patient care or force implementation of 
alternative workflows or processes that do not relate to real-world 
care or improved quality and that the EHR Incentive Programs add to 
that burden.
    Response: We understand cost and burden are factors for health care 
providers. As previously noted in the EHR Incentive Programs in 2015 
through 2017 proposed rule (80 FR 20386), the regulatory impact 
analysis outlines the reduction in the reporting burden for providers 
demonstrating meaningful use in 2015 and estimates the total annual 
cost savings. We believe the modifications to Stage 1 and Stage 2 in 
the EHR Incentive Programs in 2015 through 2017 proposed rule represent 
forward progress for the program by better aligning reporting periods 
for providers; supporting a flexible, clear framework to reduce 
provider burden; and ensuring future sustainability of the Medicare and 
Medicaid EHR Incentive Programs. We understand the competing demands on 
a provider's time. However, as we have stated previously in the Stage 3 
proposed rule (80 FR 16735), we believe the efficiencies to be gained 
by the HIT user will provide a long-term benefit for providers and 
outweigh the short-term concern over revisions to workflows, staff 
training, and other administrative needs.
    Comment: A commenter on the EHR Incentive Programs in 2015 through 
2017 proposed rule stated that new measures should not be added and 
changes should either eliminate measures or reduce the measurement 
thresholds.
    Response: We did not propose to add new measures to the EHR 
Incentive Programs in 2015 through 2017. We proposed to require that 
all providers attest to a reduced set of objectives and measures 
beginning in 2015. The reduced set of objectives and measures are based 
on the existing Stage 1 and Stage 2 objectives and measures already 
required for the EHR Incentive Programs.
    Additionally, we proposed to remove measures that we believe are 
redundant, duplicative, or topped out based on provider performance.
    Comment: Many commenters on the Stage 3 proposed rule supported the 
proposals in the Stage 3 proposed rule to establish a single set of 
objectives and measures, align the Medicare and Medicaid EHR Incentive 
Programs timeline and requirements for clinical quality measure 
reporting with other CMS quality reporting programs that use CEHRT, and 
have optional Stage 3 participation in 2017.
    Response: We appreciate the supportive comments and reiterate that 
our priority is to improve the efficiency, effectiveness, and 
flexibility of the EHR Incentive Programs by simplifying the reporting 
requirements and reducing the complexity of the program.
    Comment: Several commenters on the Stage 3 proposed rule believed 
that the proposals made in the Stage 3 proposed rule would be 
burdensome, more time-consuming, and do little to improve patient care. 
Some commenters attributed the increased burden to increased measure 
thresholds.
    Response: We recognize clinical workflows and maintaining 
documentation may require modifications upon implementation of the 
requirements for Stage 3. However, the changes were proposed in 
response to stakeholder concerns and designed to reduce burdens 
associated with the number of program requirements, the multiple stages 
of program participation, and the timing of EHR reporting periods.
    Patient-focused care is very important to us, and we have proposed 
to maintain measures specific to patient engagement and that support a 
patient's access to their health information. The measures promote 
increased communication between providers and their patients, while 
placing focus on a patient's involvement in their care.
    As noted in the Stage 3 proposed rule, (80 FR 16734), Stage 3 is 
intended to align the timeline and requirements for clinical quality 
measure reporting in the Medicare and Medicaid EHR Incentive Programs 
with other CMS quality reporting programs that use CEHRT. This 
alignment is meant to reduce provider burden associated with reporting 
on multiple CMS programs and enhance CMS operational efficiency.

[[Page 62771]]

    In addition, we understand that the increase in thresholds proposed 
in the Stage 3 rule may increase the work required to achieve an 
individual measure. However, we noted that part of our decision making 
process in the overall reduction of the number of objectives in the 
program was to reduce the burden on providers for those measures by 
allowing them to focus on advanced use objectives that support clinical 
effectiveness, patient safety, patient engagement, and care 
coordination. We believe providers should prioritize their efforts to 
strive to achieve high performance on these important measures. In 
addition, as noted in the proposed rule (80 FR 16740), the statute 
specifically requires the Secretary to seek to improve the use of EHRs 
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). Therefore, for these reasons, we intend to continue to use 
measure thresholds that may increase over time and to incorporate 
advanced use functions of CEHRT into meaningful use objectives and 
measures.
    Comment: A commenter on the EHR Incentive Programs in 2015 through 
2017 proposed rule suggested that with Stage 3 in place, the Physician 
Quality Reporting System (PQRS) program and the Hospital Inpatient 
Quality Reporting (IQR) Program should be eliminated in 2018.
    Response: We cannot eliminate the PQRS and Hospital IQR Programs 
because they are required by statute (see sections 1848(a)(8) and 
1886(b)(3)(B)(viii) of the Act, respectively). Furthermore, although 
PQRS payment adjustments sunset after 2018 in accordance with section 
101(b)(2)(A) of MACRA, certain provisions and processes under PQRS will 
continue to apply for purposes of MIPS. MIPS is also required by 
statute (see section 1848(q) of the Act, as added by section 101(c) of 
MACRA). One of the focal points for Stage 3, however, is alignment with 
other quality programs such as the Hospital IQR Program and PQRS, not 
replacement of them.
    Comment: A few commenters relayed concerns regarding financial 
issues related to costs associated with Stage 3 implementation, 
upgrading, installing, testing, and maintenance of EHRs that are 
outside of normal operating practices. A commenter stated maintenance 
of EHRs requires many expenses that surpass what is considered 
reasonable.
    Response: We understand cost is a factor for health care providers. 
Our goal with Stage 3 is to simplify reporting requirements, reduce 
program complexity, and focus on the advanced use of EHR technology to 
promote improved patient outcomes and health information exchange to 
minimize burdens placed on providers.
    The Stage 3 objectives and measures were designed to focus on the 
three-part aim of better health, better care, and lower costs. We 
believe that the costs associated with EHR adoption and continued 
maintenance are outweighed by the long-term benefits a provider may 
experience from meaningfully using CEHRT, including practice 
efficiencies and improvements in medical outcomes. For example, EHR 
supported processes such as drug-drug and drug-allergy interaction and 
clinical decision support, as well as electronic prescribing and 
computerized provider order entry for medication orders, can all work 
in tandem to support a provider's efforts to effectively and safely 
prescribe and administer medications and reduce costs and risks 
associated with adverse events. In addition, while there may be a cost 
associated with HIT supported patient engagement as compared to not 
engaging with patients, the use of HIT allows providers to leverage 
economies of scale and engage with a large number and wide range of 
patients in ways not otherwise possible. Patient education and patient 
engagement in many forms support improved care and reduced cost of care 
as patients who are engaged with their health care have better outcomes 
and cost savings for their care.\1\ The use of CEHRT, while 
representing a capital investment in procurement and maintenance, can 
result in improved care and long term cost reduction and we believe 
these investments provide a strong return on investment for both 
providers and patients in our healthcare system.
---------------------------------------------------------------------------

    \1\ Recent research cites an 8 percent cost of care reduction in 
the first year and 20 percent in subsequent years attributable to 
patient engagement.
    Hibbard, Judith H and Jessica Greene. ``What The Evidence Shows 
About Patient Activation: Better Health Outcomes And Care 
Experiences; Fewer Data On Costs'' Health Affairs: February 2013 
32:207-214.
---------------------------------------------------------------------------

    Comment: A commenter on the Stage 3 proposed rule recommended that 
CMS eliminate measures that focus on data entry in favor of measures 
that focus on interoperability. Some commenters stated the Medicare and 
Medicaid EHR Incentive Programs do little to establish or promote 
interoperability among providers, between providers and consumers, or 
among participants in the health information ecosystem. Some commenters 
stated that many of the Stage 3 requirements depend on interoperability 
of EHR systems, which has not yet been realized except within health 
systems sharing the same software. These limited networks contribute to 
a decrease in patient access to care, choice, and timely availability 
of specialists, thus thwarting many of the overall objectives intended 
by the Medicare and Medicaid EHR Incentive Programs and creating a 
challenge for providers. Some commenters stated interoperability must 
expand in order for Stage 3 of the EHR Incentive Programs to generate 
the significant quality, safety, efficiency, coordination, and public 
health outcomes needed. Those commenters suggested that one approach to 
this challenge would be for CMS and ONC to establish an 
interoperability benchmark first, and then measure its progress.
    Response: We disagree that the Medicare and Medicaid EHR Incentive 
Programs do little to establish or promote interoperability. As stated 
in the Stage 3 proposed rule (80 FR 16734), the Stage 3 measures and 
objectives are designed to promote interoperability with a focus on the 
advanced use of EHR technology, the use of electronic standards, and 
the interoperable exchange of health information between systems. The 
program leverages the ONC HIT Certification Program and the associated 
editions of certification criteria to ensure that eligible providers 
possess health IT that conforms with standards and the requirements for 
the capture and exchange of certain data in a structured format. This 
improves interoperability by ensuring that data within one system can 
be received and used by the recipient system. Various objectives within 
the Stage 3 proposed rule aim to increase interoperability through--
     Provider to provider exchange through the transmission of 
an electronic summary of care document;
     Provider to patient exchange through the provision of 
electronic access to view, download, or transmit health information; 
and
     Provider to public health agency exchange through the 
public health reporting objectives.
    Research supports our belief that the policies established in the 
EHR Incentive Programs, the ONC HIT Certification Program, and the 
related effort to support provider participation at a state and 
national level have had a significant impact on the development of 
health information exchange infrastructure in the United States. For 
EHR reporting periods in 2014, more than 3,700 eligible hospitals and 
CAHs

[[Page 62772]]

and more than 232,000 EPs received incentive payments under the EHR 
Incentive Programs for meaningful use of CEHRT, which included 
exchanging health information electronically with other providers and 
with their patients. In addition, research shows a significant shift 
since the program began in 2011. Hospital electronic health information 
exchange (HIE) with other hospitals or ambulatory care providers 
outside their organization increased by 85 percent from 2008 to 2014 
and increased by 23 percent since 2013.\2\
---------------------------------------------------------------------------

    \2\ http://www.healthit.gov/sites/default/files/data-brief/ONC_DataBrief24_HIE_Final.pdf.
---------------------------------------------------------------------------

    The Stage 3 proposed rule focuses less on data capture and entry 
and more on interoperable health data sharing by including additional 
functions and requirements for the transmission and consumption of 
standardized health data through electronic exchange. The proposed 
Stage 3 objectives can essentially be broken into 2 categories:
     Category 1 objectives that support clinical effectiveness 
and patient safety, and
     Category 2 objectives that support health information 
exchange.

For Category 2, four of the eight proposed objectives are clearly 
focused on the electronic exchange of health information through 
interoperable systems: Patient Electronic Access, Coordination of Care 
through Patient Engagement, Health Information Exchange, and Public 
Health and Clinical Data Registry Reporting. Each of these objectives 
involves the capture of structured data using a standard and the 
transmission of that data in a standardized format that can be sent, 
received, and incorporated electronically. These objectives build on 
the transmission standards established in prior rules by incorporating 
receipt standards and consumption requirements for HIE. We also 
proposed to expand the technology functions that may be used for 
transmission including a wider range of options, such as application-
program interface (API) functionality.
    In addition, two of the three objectives that fall into the first 
category (for example, computerized provider order entry and electronic 
prescribing) may also be categorized as objectives that support the 
interoperable exchange of health information through the process of 
creating and transmitting prescriptions, medication orders, laboratory 
order, and diagnostic imaging orders using standards established by 
CEHRT for that purpose.
    We believe this continued emphasis on requiring standards in the 
technology and the use of these standards in clinical settings will 
continue to support and promote interoperability. Furthermore, we 
believe the expansion of the requirements around data transmission will 
continue to drive use and the ongoing development and strengthening of 
an interoperable HIE infrastructure.
    We also received numerous comments on the EHR Incentive Programs in 
2015 through 2017 and Stage 3 proposed rules during the public comment 
periods that were either unrelated to the Medicare and Medicaid EHR 
Incentive Programs or outside the scope of the proposed rules. These 
comments included considerations for future rulemaking activities, 
requests for new incentives for various provider types that are not 
currently eligible to participate, requests to create a sliding scale 
for payment adjustments, and support or recommendations for ONC's 2015 
Edition proposals. We thank all the commenters for their suggestions 
and feedback on the Medicare and Medicaid EHR Incentive Programs. 
However, comments unrelated to the proposals fall outside the scope of 
the proposed rule and are not addressed in this final rule with comment 
period.

B. Meaningful Use Requirements, Objectives, and Measures

1. Definitions Across the Medicare Fee-for-Service, Medicare Advantage, 
and Medicaid Programs
a. Uniform Definitions
    We proposed changes to the uniform definitions in part 495 subpart 
A of the regulations, in both the Stage 3 proposed rule (80 FR 16736 
through 16737) and the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20351 through 20352). We proposed to maintain 
these definitions, unless specifically stated otherwise in the proposed 
rule. We proposed moving to a single set of criteria for meaningful 
use, which we herein call Stage 3, in order to eliminate the varying 
stages of the Medicare and Medicaid EHR Incentive Programs. We proposed 
that a modified version of Stage 1 and Stage 2 would be applicable for 
2015 through 2017. We proposed that the Stage 3 definition of 
meaningful use would be optional for providers in 2017 and mandatory 
for all providers beginning in 2018. To support these changes, we 
proposed revising the uniform definitions under 42 CFR 495.4 for ``EHR 
reporting period'' and ``EHR reporting period for a payment adjustment 
year,'' as discussed in sections II.B.1.b.(3) and section II.E.2.2 of 
this final rule with comment period.
b. Definitions for 2015 Through 2017, and 2017 and Subsequent Years
    In the Stage 3 proposed rule (80 FR 16737), we sought to streamline 
the criteria for meaningful use. We intended to do this by--
     Creating a single stage of meaningful use objectives and 
measures (herein called Stage 3) that would be optional for all 
providers in 2017 and mandatory for all providers in 2018;
     Allowing providers flexible options for 2017;
     Changing the EHR reporting period to a full calendar year 
for all providers; and
     Aligning with other CMS quality reporting programs using 
CEHRT, such as PQRS and Hospital IQR, for clinical quality measurement.
    In the EHR Incentive Program in 2015 through 2017 proposed rule (80 
FR 20352), we proposed changes to a number of definitions previously 
finalized for the EHR Incentive Programs in the Stage 1 and Stage 2 
final rules in order to modify the program in response to the changing 
HIT environment and related stakeholder concerns. These changes address 
the following:
     An overall simplification of the program aligned to the 
overarching goals of sustainability, as discussed in the Stage 3 
proposed rule (80 FR 16737) and in section II.B.1.b.(1) and (4) of this 
final rule with comment period, and a related change to requirements 
necessary to accommodate these changes, outlined in sections 
II.B.1.b.(2). and (3). of this final rule with comment period.
     Moving all providers to an EHR reporting period aligned 
with the calendar year, as outlined in section II.B.1.b.(3).A. of this 
final rule with comment period.
     Allowing flexibility for providers in 2015 to accommodate 
the proposed changes, as outlined in section II.B.1.b. of this final 
rule with comment period.
     Removing requirements for objectives and measures that are 
redundant or duplicative or that have ``topped out,'' as described in 
the Stage 3 proposed rule (80 FR 16741 through 16742) and outlined in 
section II.B.1.b.(4).(a). of this final rule with comment period.
     Restructuring the remaining measures and objectives to 
streamline requirements for 2015 through 2017 and to accommodate the 
changes for an EHR reporting period in 2015, as outlined in section 
II.B.1.b.(2). and (3). and II.B.1.b.(4).(b). of this final rule with 
comment period.
     Refocusing the existing program so that it is building 
toward advanced use

[[Page 62773]]

of EHR technology, aligned with the Stage 3 proposed rule (80 FR 16741) 
through maintaining the objectives and measures outlined in section 
II.B.2 of this final rule with comment period.
(1) Stages of Meaningful Use
    In the phased approach to meaningful use, we finalized the criteria 
for meaningful use through incremental rulemaking that covered Stage 1 
and Stage 2 of the Medicare and Medicaid EHR Incentive Programs. (For 
further explanation of the criteria we finalized in Stage 1 and Stage 
2, we refer readers to 75 FR 44314 through 44588, 77 FR 53968 through 
54162, and 79 FR 52910 through 52933.)
    In the Stage 3 proposed rule (80 FR 16737 through 16739), we 
proposed to set a new foundation for this evolving program by proposing 
a number of changes to the Medicare and Medicaid EHR Incentive 
Programs. First, we proposed a definition of meaningful use that would 
apply beginning in 2017. This definition, although herein 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 Stage 1 and Stage 2. Beginning with 2018, we proposed to 
require all EPs, eligible hospitals, and CAHs, regardless of their 
prior participation in the Medicare and Medicaid EHR Incentive 
Programs, to satisfy the requirements, objectives, and measures of 
Stage 3. However, for 2017, we proposed that Stage 3 would be optional 
for providers. This proposed option would allow a provider to meet to 
Stage 3 in 2017 or to remain at Stage 2 or Stage 1, depending on their 
prior participation.
    Furthermore, we proposed that Stage 3 would adopt a simplified 
reporting structure on a focused set of objectives and associated 
measures to replace all criteria under Stage 1 and Stage 2. 
Specifically, we proposed 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.
    In the EHR Incentive Program in 2015 through 2017 proposed rule (80 
FR 20352), we proposed to further reduce complexity in the program and 
to realign the current program to work toward this overall shift to a 
single set of objectives and measures in Stage 3 in 2018. We proposed 
to require that all providers attest to a single set of objectives and 
measures beginning with an EHR reporting period in 2015 instead of 
waiting until Stage 3 in 2018. Because this change may occur after 
providers have already begun their work toward meeting meaningful use 
in 2015, we proposed accommodations within individual objectives for 
providers in different stages of participation. These accommodations 
include retaining the different specifications between Stage 1 and 
Stage 2 and allowing special exclusions for certain objectives or 
measures for EPs previously scheduled to participate in Stage 1 for an 
EHR reporting period in 2015.
    We proposed all providers would be required to attest to certain 
objectives and measures finalized in the Stage 2 final rule that would 
align with those objectives and measures proposed for Stage 3 of 
meaningful use. In effect, this would create a new progression using 
the existing objectives and measures where providers attest to a 
modified version of Stage 2 with accommodations for Stage 1 providers 
(equivalent to a reduced version of Stage 3) in 2015; a modified 
version of Stage 2 in 2016 (equivalent to a reduced version of Stage 
3); either a modified version of Stage 2 (equivalent to a reduced 
version of Stage 3) or the full version of Stage 3 outlined in the 
Stage 3 proposed rule in 2017; and the full version of Stage 3 outlined 
in the Stage 3 proposed rule beginning in 2018 (80 FR 16738).
    We sought comment on whether or not we should implement only the 
modifications proposed in the rule from 2015 through 2017 (80 FR 20351 
through 20353) and begin Stage 3 in 2018 without an option year in 
2017, or if we should allow providers the option to demonstrate Stage 3 
beginning in 2017 as discussed in the Stage 3 proposed rule (80 FR 
16738).
    Comment: Several commenters supported the option of moving to Stage 
3 or remaining in Modified Stage 2 in 2017 in the EHR Incentive Program 
in 2015 through 2017 proposed rule. Many commenters believed that 
having the option to attest to Stage 3 in 2017 would allow vendor 
development and upgrades to be spread over a longer period of time. 
Other providers supported the option for providers to attest to either 
Stage 1, Stage 2, or Stage 3 in calendar year 2017.
    Numerous commenters on the EHR Incentive Program in 2015 through 
2017 proposed rule supported the proposal to move all providers to 
Stage 3 in 2018. They stated it is very complicated to keep track of 
all providers and their various programs, stages, and years, and that 
the proposed approach would ease the burden associated with reporting 
different stages of meaningful use. Numerous commenters on the Stage 3 
proposed rule supported the proposal to move all providers to Stage 3 
in 2018.
    Response: We appreciate the number of commenters who supported the 
proposal for optional Stage 3 participation in 2017. We believe the 
option to attest to Stage 3 in 2017 offers flexibility for those 
providers ready to move forward to Stage 3 requirements, while allowing 
additional time for providers who may need to update, implement, and 
optimize the technology certified to the 2015 Edition. We believe 
vendors, developers, and providers will have an appropriate amount of 
time between the publication date of the final rule with comment period 
and 2018 to transition to Stage 3.
    We thank commenters for their support of the proposal to move all 
providers to Stage 3 in 2018. As noted in the EHR Incentive Programs in 
2015 through 2017 proposed rule, the proposal was based in part on 
comments received in earlier rulemaking that relayed 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.
    Comment: We received multiple comments on the Stage 3 proposed rule 
opposing the proposal to move all providers to Stage 3 in 2018. 
Commenters indicated this proposal changes CMS' prior plan to permit 
providers who had not spent 2 years in either Stage 1 or Stage 2 to 
remain in that stage for a second year before transitioning to Stage 3. 
A commenter suggested that CMS consider extending Stage 1 and Stage 2 
requirements for 2015 through 2017 to also include 2018. A few 
commenters stated providers should remain in each stage of meaningful 
use for 3 years to allow sufficient time to update, implement, and 
optimize the new technology. Some commenters requested that CMS delay 
Stage 3 to 2019 or later based on a lack of data related to experience 
for Stage 2.
    Response: We appreciate the feedback from commenters. We recognize 
that our proposals would modify our earlier approach of allowing 
providers to remain in Stage 1 and Stage 2 for 2 years prior to 
transitioning to Stage 3. In the EHR Incentive Program in 2015 through 
2017 proposed rule (80 FR 20352), we proposed to reduce the complexity 
of the program by proposing to require providers to attest to a single 
set of objectives and measures starting in 2015. We proposed alternate 
exclusions and specifications for 2015 to accommodate Stage 1 providers 
working toward demonstration of meaningful use in 2015. Therefore, the 
combination of

[[Page 62774]]

Stage 1 and Stage 2 objectives and measures into a single stage 
(Modified Stage 2) beginning in 2015 effectively removes the ``Stage'' 
designation. Under our proposal, providers would have the option to 
meet the single set of objectives and measures for Modified Stage 2 for 
up to 3 years (2015 through 2017) prior to moving to Stage 3. We are 
therefore removing the requirement that providers remain in each Stage 
for a set number of years because we believe our proposal to streamline 
the objectives and measures reduces the complexity of the program.
    We proposed to align the objectives and measures of meaningful use 
for 2015 through 2017 with the Stage 3 objectives and measures in part 
because we believe this will provide a smoother transition for 
providers to Stage 3. Additionally, we believe that interoperability 
and EHR functionalities will continue to advance prior to 2018, when 
Stage 3 would be required of all eligible providers, which should 
increase providers' success in meeting the program requirements. 
Multiple providers have expressed their support for the option to 
attest to Stage 3 in 2017, indicating confidence in the transition. 
Therefore, we are maintaining the timeframe for implementation of Stage 
3.
    Comment: Some commenters believed that Stage 3, like its 
predecessors, takes a ``one size fits all'' approach with requirements 
that may not be applicable to all eligible participants.
    Response: We disagree that Stage 3 is a ``one size fits all'' 
approach. We believe our proposal for Stage 3 allows flexibility within 
the objectives to allow providers to focus on implementations that 
support their practice. For example, we proposed to incorporate 
flexibility for the Stage 3 objectives of Coordination of Care through 
Patient Engagement, Health Information Exchange, and Public Health 
Reporting so that providers can choose the measures most relevant to 
their unique practice setting.
    Comment: A few commenters on the EHR Incentive Program in 2015 
through 2017 proposed rule expressed concern that providers entering 
the program in 2015 or 2016 and those experiencing financial 
constraints would have difficulty moving to Stage 3 in 2018.
    Response: As previously noted, we proposed to align the objectives 
and measures of meaningful use for 2015 through 2017 with the Stage 3 
objectives and measures. We believe that the modified Stage 2 we 
proposed for 2015 through 2017 will provide a smoother transition for 
providers to Stage 3, including new participants in the program. For 
example, new participants who would otherwise have been in Stage 1 will 
be able to take advantage of the alternate exclusions and 
specifications of these Modified Stage 2 requirements. We understand 
cost is a factor for health care providers. However, as noted in prior 
rules, we believe the benefits of EHR adoption outweigh the potential 
costs (for more information, see the Stage 2 final rule at 77 FR 
53971).
    Comment: A commenter on the Stage 3 proposed rule requested clarity 
on the expectations for the 90-day ``gap'' hospitals will have from 
October 1 through December 31, 2016, and whether hospitals need to 
demonstrate meaningful use during that timeframe.
    Response: In the Stage 3 proposed rule (80 FR 16739 through 16740), 
we noted a possible reporting gap from October 1 through December 31, 
2016 as a result of our proposal to align the EHR reporting period for 
eligible hospitals and CAHs with the calendar year beginning in 2017. 
After the Stage 3 proposed rule was published, we published the EHR 
Incentive Program in 2015 through 2017 proposed rule, in which we 
proposed this alignment with the calendar year would begin earlier, in 
2015, eliminating the potential for a gap in the fourth quarter of CY 
2016.
    Comment: Some commenters on the EHR Incentive Program in 2015 
through 2017 proposed rule opposed having an option to attest to Stage 
3 in 2017, stating that keeping providers at the same stage allows 
performance to remain at the same level, thereby making it easier to 
track and measure. Additional commenters stated the option does not 
support CMS efforts to streamline the EHR Incentive Programs.
    A few commenters were concerned that many providers will have 
difficulty attesting to Stage 3 in 2017 if other collaborating partners 
are not operating with the same CEHRT.
    A few commenters indicated that a provider electing to attest to a 
later stage was a rarity in previous years when given an option.
    Response: We thank commenters for their feedback. First, we note 
that providers have not been given an option to move forward in their 
Stage progression in the past, and that CMS has in fact received 
multiple requests to allow providers to do so in past years. Second, we 
understand the challenges faced by providers who are not ready or able 
to move to Stage 3 in 2017. However, as other comments have shown, 
several stakeholders are supportive of the option for 2017 and, because 
it is an option and not a requirement for 2017, providers would not be 
required to meet Stage 3 requirements in 2017 if they were not ready to 
do so. Finally, the meaningful use objectives and measures proposed for 
2015 through 2017 align with the objectives and measures proposed for 
Stage 3. Therefore, we believe many providers may seek to work toward 
meeting Stage 3 in 2017. If they find they are unable to meet the Stage 
3 requirements, they would be able to successfully attest to Modified 
Stage 2 in 2017. Additionally, there is no requirement nor any 
technological limitation on providers to only collaborate with other 
providers with EHR technology certified to the same Edition of 
certification criteria. In fact, many of the certification criteria are 
similar between the 2014 Edition and the 2015 Edition. Therefore, we 
believe the transition to Stage 3 will be less complex and the program 
will be more streamlined moving forward. We believe offering the option 
of a transitional year in 2017 would enable providers to weigh the 
risks and benefits of moving to Stage 3 and decide for themselves what 
is most appropriate based on their individual circumstances.
    Comment: Regarding the EHR Incentive Program in 2015 through 2017 
proposed rule, other commenters stated that the timeline in the 
proposed rule represents an aggressive deadline for health IT vendors 
and developers supporting customers who might choose to begin Stage 3 
in 2017. A few commenters stated removal of the option to participate 
in Stage 3 in 2017 would give EHR vendors and developers an additional 
12 months to deploy EHR Technology certified to the 2015 Edition.
    Response: We recognize stakeholder concerns and the potential 
burden that these changes may have on vendor upgrades in relation to 
timing for system changes. We believe that some vendors, developers, 
and providers will be able to make the necessary system changes in time 
to implement Stage 3 in 2017. We encourage discussion between vendors, 
developers, and providers on the feasibility to upgrade to EHR 
technology certified to the 2015 Edition and attest to Stage 3 in 2017. 
However, we remind commenters that this upgrade is optional in 2017 and 
for those providers who choose to attest to Modified Stage 2 and not to 
Stage 3, EHR technology certified to the 2015 Edition would not be 
required until 2018. In addition, providers may also choose to upgrade 
some modules as early as 2016 if the CEHRT is available.
    Comment: The majority of commenters on the Stage 3 proposed rule 
supported the option of

[[Page 62775]]

participating in Stage 3 in 2017 and of using technology certified to 
either the 2014 or 2015 Edition in 2017 and believed this would provide 
relief to the industry. Some commented they would support this 
flexibility in all future years where changes to CEHRT will be required 
and noted transitioning to technology certified to a new Edition can be 
complex and can require more resources and time than anticipated. Other 
commenters suggested that providing an optional year to transition to 
technology certified to a new Edition allows the time necessary to help 
ensure a safe transition for patients and a smoother transition for 
providers. Other commenters were also appreciative of CMS' response to 
their concerns as reflected in the Stage 3 proposed rule.
    Some commenters on the EHR Incentive Program in 2015 through 2017 
proposed rule indicated that in the case of unanticipated challenges or 
delays with the adoption and implementation of the technology certified 
to the 2015 Edition, CMS should preemptively detail alternative 
scenarios to avoid future rule changes.
    However, other commenters stated that 2017 is not a realistic start 
date for Stage 3 due to the expected timing of the final rule; 
necessary upgrades to technology; transitional processes after 
deployment such as training, workflow, and validation of reporting; and 
full year reporting requirements. A commenter suggested there would be 
only 12-15 months from the publication date of the final rule (assuming 
publication in late 2015) until technology certified to the2015 Edition 
would need to be available from vendors and developers and implemented 
by organizations with necessary staff training completed for new 
workflows. Some commenters indicated EHR vendors and developers need on 
average 18 months to develop, test, market, and implement new 
functionality, while providers need lead time to re-work their 
processes and systems to new or revised requirements. Other commenters 
indicated concern about the timeline of transitioning to Stage 3 in 
2017 and 2018, stating that 18 months is the minimum length of time 
needed between the final rules and the start of any stage of the EHR 
Incentive Program. Furthermore, as the change requires a technology 
upgrade, and given the likely timing for the publication of the final 
rules, the proposed Stage 3 timetable will not allow for a full 18-
month timeline before the beginning of Stage 3 as an option in 2017.
    Some commenters on the EHR Incentive Program in 2015 through 2017 
proposed rule indicated that in case of unanticipated challenges or 
delays with the adoption and implementation of the technology certified 
to the 2015 Edition, CMS should proactively detail alternative 
scenarios to avoid future rule changes.
    Response: We appreciate the commenters' feedback and seek to 
explain a few points related to the proposed option for providers to 
participate in Stage 3 in 2017. First we note that providers may 
upgrade to EHR technology certified to the 2015 Edition when it becomes 
available. We note that CMS will allow a provider to successfully 
attest in 2015, 2016, or 2017 with technology certified to either the 
2014 Edition, the 2015 Edition, or a combination of the two as long, as 
the technology possessed can support the objectives and measures to 
which they plan to attest. Therefore, providers may adopt technology 
certified to the 2015 Edition prior to 2017, either in a modular 
approach or in total, and may still choose to attest to Modified Stage 
2 and wait to begin Stage 3 until 2018.
    Providers who are seeking to demonstrate Stage 3 in 2017 cannot do 
so without the support of certain functions that are only available for 
certification as part of the 2015 Edition certification criteria. This 
means that for 2017 a provider must have at least a combination of EHR 
technology certified to the 2014 Edition and the 2015 Edition in order 
to support participation in Stage 3. However, as Stage 3 is optional, 
providers are not required to upgrade to technology certified to the 
2015 Edition until 2018.
    As discussed further in section II.B.3 of this final rule with 
comment period, this means providers have flexibility to use EHR 
technology certified to either the 2014 or 2015 Edition (or a 
combination of CEHRT modules certified to different Editions). We 
proposed the flexibility to allow providers to move forward with 
upgrading their EHR technology at their own speed and to optionally 
attest to Stage 3 in 2017 if they are able to do so.
    In total, these proposals allow for a staggered upgrade timeline 
for developers and providers of more than 24 months between the date of 
the publication of this final rule with comment period and 2018, when 
providers must begin using EHR technology certified to the 2015 
Edition.
    Because of this more than 24 month lead time for development, we do 
not anticipate significant challenges or delays in the adoption and 
implementation of the 2015 Edition CEHRT. We will continue to monitor 
and assess providers' progress towards adoption and implementation as 
EHR technology certified to the 2015 Edition becomes available.
    Comment: Some commenters on the Stage 3 proposed rule noted the 
previous transitional difficulties for Stage 2 and recommended removing 
the option to demonstrate Stage 3 in 2017 and only require the Modified 
Stage 2 in 2017. These commenters suggested keeping the required start 
of Stage 3 at 2018, but allowing a 90-day or calendar year quarter EHR 
reporting period for the first year of Stage 3in 2018.
    Response: We disagree with the recommendation to remove the option 
of demonstrating Stage 3 in 2017. Although recognizing that not all 
providers will have the necessary technology to move to Stage 3 in 
2017, many commenters supported allowing this option for those 
providers who are able to do so and we wish to maintain this proposed 
flexibility for providers. We address the suggestion for a 90-day EHR 
reporting period for Stage 3 in further detail in section 
II.B.1.b.(3).(iii) of this final rule with comment period.
    After consideration of the public comments received, we are 
finalizing our approach to the timing of the stages of meaningful use 
as proposed in the EHR Incentive Program in 2015 through 2017 proposed 
rule and the Stage 3 proposed rule. We are finalizing that all EPs, 
eligible hospitals, and CAHs must attest to the Modified version of 
Stage 2 beginning with an EHR reporting period in 2015, with alternate 
exclusions and specifications for certain providers, as discussed 
further in section II.B.1.b.(4).(b).(iii). of this final rule with 
comment period. We finalize as proposed the option for all EPs, 
eligible hospitals, and CAHs to attest to Stage 3 for an EHR reporting 
period in 2017 and the requirement for all providers to attest to Stage 
3 beginning with an EHR reporting period in 2018.

[[Page 62776]]



                                                 Table 1--Stage of Meaningful Use Criteria by First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Stage of meaningful use
First year demonstrating meaningful --------------------------------------------------------------------------------------------------------------------
                use                                                                                                                   2019 and  future
                                              2015                    2016                    2017                   2018                  years
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011...............................  Modified Stage 2......  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2012...............................  Modified Stage 2......  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2013...............................  Modified Stage 2......  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2014...............................  Modified Stage 2......  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2015...............................  Modified Stage 2......  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2016...............................  NA....................  Modified Stage 2......  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2017...............................  NA....................  NA....................  Modified Stage 2 or    Stage 3..............  Stage 3.
                                                                                      Stage 3.
2018...............................  NA....................  NA....................  NA...................  Stage 3..............  Stage 3.
2019 and future years..............  NA....................  NA....................  NA...................  NA...................  Stage 3.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We are adopting these provisions under the definition of a 
``Meaningful EHR user'' at Sec.  495.4 as noted in section II.B.1.b.(2) 
of this final rule with comment period and as noted in further detail 
in section II.B.2.a. and II.B.2.bof this final rule with comment 
period.
(2) Meaningful EHR User
    In the Stage 3 proposed rule (80 FR 16737), we proposed 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.
    In the EHR Incentive Program in 2015 through 2017proposed rule (80 
FR 20353), we additionally proposed to redesignate some of the 
numbering of the regulation text under part 495 to more clearly 
identify which sections of the regulation apply to specific years of 
the program. The redesignated numerical references for the regulation 
text are as follows:

------------------------------------------------------------------------
      Current section designation         Proposed section redesignation
------------------------------------------------------------------------
Sec.   495.6--Objectives and Measures..  Sec.   495.20--Objectives and
                                          Measures Prior to 2015.
                                         Sec.   495.22--Objectives and
                                          Measures Beginning in 2015.
Sec.   495.7 *--Stage 3 Objectives and   Sec.   495.24--Stage 3
 Measures.                                Objectives and Measures.
Sec.   495. 8--Demonstration of          Sec.   495.40--Demonstration of
 Meaningful Use.                          Meaningful Use.
Sec.   495.10--Participation             Sec.   495.60--Participation
 Requirements.                            Requirements.
------------------------------------------------------------------------
* Indicates a new section that was proposed in the Stage 3 proposed
  rule. We indicated that all proposed changes in part 495 would be
  reconciled through this final rule with comment period.

    We received no comments specific to these proposals, and therefore, 
are finalizing them without modification.
(3) EHR Reporting Period
    In both the EHR Incentive Program in 2015 through 2017 and Stage 3 
proposed rules (80 FR 16739 and 80 FR 20353), we proposed changes to 
the EHR reporting period in order to accomplish the following:
     Simplify reporting for providers, especially groups and 
diverse systems.
     Support further alignment with CMS quality reporting 
programs using certified health IT such as Hospital IQR and PQRS.
     Simplify HHS system requirements for data capture.
     Provide for greater flexibility in developing, 
implementing, stress testing, and conducting Quality Assurance (QA) of 
systems before deployment.
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20353), we proposed changes to the uniform definition of an 
``EHR reporting period'' in Sec.  495.4 beginning in 2015. We proposed 
similar changes to the definition of an ``EHR reporting period for a 
payment adjustment year'' in Sec.  495.4 beginning in 2015, as 
discussed in section II.E.2of this final rule with comment period. We 
proposed changes to the attestation deadlines for purposes of the 
incentive payments and payment adjustments as discussed in section II.D 
of this final rule with comment period.
(i) Calendar Year Reporting
    In the EHR Incentive Program 2015 through 2017 proposed rule (80 FR 
20354), beginning in 2015, we proposed to change the definition of 
``EHR reporting period'' at Sec.  495.4 for EPs, eligible hospitals, 
and CAHs such that the EHR reporting period would begin and end in 
relation to a calendar year. We proposed all providers (EPs, eligible 
hospitals, and CAHs) would be required to complete an EHR reporting 
period within January 1 and December 31 of the calendar year in order 
to fulfill the requirements of the EHR Incentive Programs. We proposed 
that for 2015 only, eligible hospitals and CAHs may begin an EHR 
reporting period as early as October 1, 2014 and must end by December 
31, 2015. Beginning with 2016, the EHR reporting period must be 
completed within January 1 and December 31 of a calendar year.
    For the payment adjustments under Medicare, we proposed changes to 
the EHR reporting periods applicable for payment adjustment years in 
the EHR Incentive Program 2015 through 2017 proposed rule at 80 FR 
20379.
    Comment: The majority of commenters for the EHR Incentive Program 
in 2015 through 2017 proposed rule supported the move to calendar year 
reporting for all providers and

[[Page 62777]]

believed this would simplify the reporting, monitoring, and attestation 
for hospitals. Other commenters stated aligning the reporting period 
would ease provider reporting burden for larger organizations that will 
not have to track their providers through different stages. Another 
commenter stated that this not only allows those health IT vendors and 
developers who service both outpatient and inpatient clients to be 
better aligned in their deployment and support, but also permits them 
to better harmonize technology implementation and program reporting. 
Other commenters stated that calendar year reporting, combined with the 
new ``Active Engagement'' options for public health and clinical data 
registry reporting (see section II.B.2.a.x of this final rule with 
comment period), will permit them to onboard, test, and deploy 
participants in a timely manner based upon the ability to meet their 
own internal resource constraints, while ensuring all participants can 
meet their meaningful use objectives.
    Response: We thank the commenters for support of this proposal. As 
we stated in the EHR Incentive Program in 2015 through 2017 proposed 
rule (80 FR 20353), the movement of all providers to calendar year 
reporting supports program alignment and simplifies reporting 
requirements among provider types.
    Comment: A commenter stated the move to reporting on the calendar 
year would eliminate the 3-month gap that currently exists between the 
end of the hospital EHR reporting period and the end of the EPEHR 
reporting period. This could cause issues, especially among 
organizations that share resources to support build, testing, and 
report validation for eligible hospitals, CAHs, and EPs. Other 
commenters stated aligning all providers to a calendar year would 
diminish their time to troubleshoot unexpected issues with final 
reports and validate the accuracy of data or lead to an increased risk 
in data entry errors in order to meet the February deadline for 
attestation for both EPs, eligible hospitals, and CAHs.
    Response: We understand the concerns stated by stakeholders over 
the changes proposed for the EHR reporting periods. Because this final 
rule with comment period maintains the existing definitions for the 
objectives and measures, including the numerator and denominator 
calculations and measure thresholds for 2015, we believe vendors, 
developers, and providers will have minimal issues in the upgrades and 
testing for 2015. Likewise, the requirements for 2015 through 2017 use 
the existing measure specifications and EHR technology requirements 
with minimal changes. Finally, the hospital attestation period is 
currently October 1 through the end of November of a given year, while 
the new attestation period was proposed as January 1 through the end of 
February. The attestation window would still be the same amount of 
time, and with the single period providers (especially those 
organizations that support both EPs and hospitals) can plan for testing 
and data validation for all settings in advance of the required 
deadline for attestation.
    Comment: A few commenters on the EHR Incentive Program in 2015 
through 2017 proposed rule stated that hospitals should be able to 
choose whether to report on a fiscal or calendar year basis in 2015 and 
2016. Some commenters indicated that the proposed change to calendar 
year reporting would delay incentive payments for at least 3 months and 
cause financial and budgeting challenges. Additionally, some of the 
commenters stated hospitals have already made reporting plans and 
fiscal projections for these years.
    Response: We disagree with the commenters' recommendation to allow 
hospitals to choose a fiscal or calendar year EHR reporting period in 
2015 and 2016. Allowing hospitals this option would be inconsistent 
with the goal of program simplification and alignment. We agree that 
for most eligible hospitals and CAHs, this change would shift the 
incentive payment by one quarter within the same federal fiscal year. 
However, these are incentive payments and not reimbursements and, as 
noted in the EHR Incentive Program in 2015 through 2017 proposed rule 
(80 FR 20376), we believe the potential negative impact of this change 
would be minimal and outweighed by the opportunity to capitalize on 
efficiencies created by aligning the EHR reporting periods across EPs, 
eligible hospitals, and CAHs.
    Comment: A commenter stated this alignment would further stress the 
CMS reporting system because the systems currently struggle to handle 
the surge of activity that occurs with the staggered reporting periods. 
The commenter suggested we improve the capacity of the attestation 
systems to ease the burden of the reporting process.
    Response: We understand the commenter's concerns. However, 
historical evidence has shown that the vast majority of the more than 
200,000 EPs have attested during the open attestation window from the 
beginning of January through the end of February and have done so 
successfully each year. In addition, consistent with past experience, 
the expectation and planning for the CMS systems in 2015 was that the 
majority of providers would be attesting during this time, as most 
would have been required to attest for a full year EHR reporting 
period. The addition of fewer than 5,000 attestations by eligible 
hospitals and CAHs during this time will not significantly impact the 
load on the system. We do recommend that providers try to attest in 
January and not wait until the end of February to allow adequate time 
to address any issues that may arise, such as issues related to the 
accuracy of their attestation or their contact and banking information. 
CMS will also monitor readiness and attestation progress throughout the 
period and work to mitigate any risk that should arise.
    After consideration of the public comments received, we are 
finalizing the proposal in the EHR Incentive Programs in 2015 through 
2017 proposed rule (80 FR 20348) to align the EHR reporting period for 
eligible hospitals and CAHs with the calendar year beginning in 2015. 
For 2015 only, eligible hospitals and CAHs may begin an EHR reporting 
period as early as October 1, 2014 and must end by December 31, 2015. 
Beginning with 2016, the EHR reporting period must be completed within 
January 1 and December 31 of the calendar year. We made corresponding 
revisions to the definition of an ``EHR Reporting Period'' at Sec.  
495.4. For the payment adjustments under Medicare, we discuss the 
duration and timing of the EHR reporting period in relation to the 
payment adjustment year in section II.E.2 of this final rule with 
comment period.
(ii) EHR Reporting Period in 2015 Through 2017
    In the EHR Incentive Program in 2015 through 2017 proposed rule (80 
FR 20354), we proposed to allow a 90-day EHR reporting period in 2015 
for all providers to accommodate implementation of the other changes 
proposed in that rule. For 2015 only, we proposed to change the 
definition of ``EHR reporting period'' at Sec.  495.4 for EPs, eligible 
hospitals, and CAHs such that the EHR reporting period in 2015 would be 
any continuous 90-day period within the calendar year. We proposed that 
for an EHR reporting period in 2015, EPs may select an EHR reporting 
period of any continuous 90-day period from January 1, 2015 through 
December 31, 2015; eligible hospitals and CAHs may select an EHR 
reporting period of any continuous 90-day period from October 1, 2014 
through December 31, 2015.

[[Page 62778]]

    We proposed that in 2016, for EPs, eligible hospitals, and CAHs 
that have not successfully demonstrated meaningful use in a prior year, 
the EHR reporting period would be any continuous 90-day period between 
January 1, 2016 and December 31, 2016. However, for all returning 
participants that have successfully demonstrated meaningful use in a 
prior year, the EHR reporting period would be a full calendar year from 
January 1, 2016 through December 31, 2016.
    For the payment adjustments under Medicare, we proposed changes to 
the EHR reporting periods applicable for payment adjustment years in 
the EHR Incentive Programs in 2015 through 2017 proposed rule at (80 FR 
20379).
    Comment: All comments received on the EHR Incentive Program in 2015 
through 2017 proposed rule overwhelmingly supported the 90-day EHR 
reporting period in 2015. Many commenters stated the 90-day EHR 
reporting period would be beneficial for small and rural providers and 
provide the time needed to implement the required changes for the next 
stage of meaningful use. Other commenters stated that this is essential 
due to vendors and developers struggling to keep their systems up-to-
date with all the changes and new requirements.
    We also received numerous comments on the Stage 3 proposed rule 
strongly supporting the proposal for a 90-day EHR reporting period for 
all providers in 2015. Some commenters noted that the reduction to a 
90-day EHR reporting period would assist providers transitioning from 
Stage 1 to Stage 2 without compromising patient care. Another commenter 
stated changing to any continuous 90 days (as opposed to calendar 
quarters) allows for needed flexibility in the event of unforeseen 
circumstances that could otherwise impede reporting within the 
originally planned timeframe.
    Response: As stated in the EHR Incentive Program in 2015 through 
2017 proposed rule (80 FR 20348), this 90-day EHR reporting period in 
2015 would allow providers additional time to address any remaining 
issues with the implementation of EHR technology certified to the 2014 
Edition and to accommodate the proposed changes to the objectives and 
measures of meaningful use for 2015. We also proposed an EHR reporting 
period of any continuous 90 days not tied to a specific calendar 
quarter in 2015.
    Comment: A commenter on the EHR Incentive Program in 2015 through 
2017 proposed rule suggested that the 90-day EHR reporting period was 
too short. Another commenter stated that he or she believes the 
modification to the EHR reporting period would present a real and 
material risk to patients and that patients should have the benefit of 
a full year EHR reporting period. However, some commenters stated that 
if a provider can demonstrate meaningful use for 90 days, that provider 
must have the technology and workflows in place for meaningful use and 
therefore should not be required to submit a full year of data to 
confirm they are in compliance.
    Response: We agree that a full year EHR reporting period is the 
most effective way to ensure that all actions related to patient safety 
that leverage CEHRT are fully enabled for the duration of the year. 
This is one of the primary considerations of our continued push for 
full year reporting whenever feasible, in addition to promoting greater 
alignment with other CMS quality reporting programs. However, we stated 
in the EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 
20348) that a 90-day EHR reporting period would allow providers 
additional time to address any remaining issues related to 
implementation of technology certified to the 2014 Edition. A 90-day 
EHR reporting period is necessary in order to accommodate the proposed 
changes to the program that reduce the overall burden on providers to 
allow greater focus on the objectives and measures that promote patient 
safety, support clinical effectiveness, and drive toward advanced use 
of health IT. Despite the allowance for a 90-day EHR reporting period, 
we believe it is essential to maintain the processes and the workflows 
supporting and promoting patient safety enabled and fully implemented 
throughout the year. The EHR reporting period alone should not dictate 
a provider's commitment to patient safety.
    In response to commenters who suggest that, in the future, 
demonstrating meaningful use for a 90-day period should serve as 
confirmation of a full year of compliance with program requirements, we 
note that if a provider does have the necessary workflows and processes 
in place for a full year there is no valid reason that provider should 
not demonstrate meaningful use for a full year. If extreme 
circumstances outside of the provider's control prohibit a full year of 
meaningful use, the provider may file for a hardship exception from the 
Medicare payment adjustments.
    Comment: A commenter in the EHR Incentive Programs in 2015 through 
2017 proposed rule requested quarterly reporting, stating that it is 
far more efficient and that eligible hospitals and EPs are now familiar 
with reporting quarters and can plan accordingly. Another commenter 
requested the option to choose either a 90-day consecutive reporting 
period or a calendar quarter. Another commenter suggested a 60-day 
reporting period for 2015.
    Response: We understand that some commenters may favor quarterly 
reporting due to the ease of planning based on a calendar quarter and 
to the prior requirement finalized in the Stage 2 final rule for EHR 
reporting periods in 2014 (77 FR 53974). However, an EHR reporting 
period of any continuous 90 days would still allow for providers to 
select and report on a quarter in the calendar year if they so choose. 
We disagree with the appropriateness of a 60-day EHR reporting period, 
and further note that a shorter EHR reporting period is not easier to 
meet than a longer period if the provider is fully engaged in the 
workflows and has the functions fully enabled. Statistically, a larger 
number of patient encounters allow providers a wider margin to meet the 
overall threshold. As the majority of providers would already have been 
meaningfully using their CEHRT and then attesting based on a full year 
EHR reporting period, or for a minimum of a 90-day EHR reporting 
period, these workflows should be implemented and functioning for at 
least that length of time. Therefore, the necessity for a shorter EHR 
reporting period as dictated by the need to accommodate the changes in 
this final rule with comment period is limited in scope to 90 days.
    Comment: A commenter stated that their group practice has already 
gathered data for some EPs for quarters 1 and 2 and have new EPs for 
whom they would like to be able to report for quarter 4. The commenter 
requested organizations be allowed to use a different EHR reporting 
period for each EP.
    Response: Each EP is required to individually meet the requirements 
of meaningful use regardless of their affiliation with a group 
practice. Therefore, each EP may use a separate EHR reporting period to 
demonstrate meaningful use and in 2015, that EHR reporting period may 
be any continuous 90-day period in the calendar year selected by each 
individual EP.
    Comment: A few commenters from the EHR Incentive Programs in 2015 
through 2017 proposed rule stated CMS previously requiring a full year 
of reporting and then subsequently removing that requirement dilutes 
the message to providers and sets an expectation that goals do not need 
to be met.

[[Page 62779]]

    Response: We note that this perception is of concern and is not 
reflective of our policy goals for the program. As we stated in the EHR 
Incentive Programs in 2015 through 2017 proposed rule (80 FR 20348), 
the 90-day EHR reporting period is intended only to accommodate the 
changes to the EHR Incentive Programs in 2015 through 2017, which are 
in turn intended to drive toward the long-term goals outlined in the 
Stage 3 proposed rule.
    Comment: A commenter requested CMS acknowledge the challenges 
associated with reporting on a full calendar year for EPs newly 
employed by a health system during the course of a program year, 
switching EHRs, system downtime, cyber-attacks, and office relocation.
    A few commenters strongly recommended in the EHR Incentive Program 
in 2015 through 2017 proposed rule that CMS retain the 90-day 
attestation option for providers who change employers during the year. 
Furthermore, the commenters further stated they do not believe an 
organization can sufficiently rely upon the actions of a previous 
employer to complete the necessary validation, analysis, and 
implementation of an EHR that would satisfy CMS audit requirements. If 
a previous employer's data is found to be faulty, the current 
organization is put at risk for the data reported.
    Response: We understand the commenters' concerns and note that EPs 
may consider applying for a hardship exception from the reduction to 
Medicare PFS payments based on extreme and uncontrollable 
circumstances. Specifically, in the case of issues related to CEHRT, 
situations involving technology upgrades, switching products during the 
year, or the decertification of a product may be reason for a provider 
to apply for a hardship.
    EPs who are switching employment or practicing in multiple 
locations during an EHR reporting period may apply for a hardship 
exception that would be reviewed on a case-by-case basis. However, we 
disagree that CMS should take into account the business practices of 
individual EPs in establishing the requirements for the entirety of the 
program. It is incumbent on the individual EP to establish their own 
contractual or business arrangements for the purposes of attesting for 
the Medicare and Medicaid EHR Incentive Programs.
    Comment: A commenter suggested the EHR reporting period should be 
at least 90 days or 3 calendar months. The commenter suggested this 
would allow a provider to create a monthly report within their EHR 
system using their dashboard, regardless of the number of days in any 
given month, as long as they capture at least 90 days or 3 calendar 
months. As an example, the commenter suggested that an EP or 
administrator can run a report for October through December that would 
provide 92 days of data, or February through April that would provide 
89 days of data.
    Response: We thank the commenter for their suggestion and 
respectfully disagree. The EHR reporting period must be at least 90 
continuous days in order to ensure that all providers are meeting at 
least the same minimum requirement. While a provider may choose a 
period longer than 90 days, they may not choose a period that is less, 
so the use of the designated months is not adequate. Furthermore, a 90-
day period need not be tied to the beginning or end of a month. 
Therefore, the use of 90 days is the most appropriate for this policy 
as it allows flexibility for providers to choose any continuous 90-day 
period, or any 3-monthperiod of at least 90 days, or any calendar year 
quarter of at least 90 days, without adding additional complexity. As 
proposed in the EHR Incentive Programs in 2015 through 2017 proposed 
rule (80 FR 20348), the EHR reporting period would be any continuous 90 
days for all providers in 2015. This change allows for greater 
flexibility in the reporting requirements.
    Comment: A few commenters stated they believed the statute does not 
obligate CMS to require a year for reporting and believed the full year 
reporting requirement will discourage EPs from participation and 
increases risk of non-success.
    Response: We agree that the statute allows discretion to specify 
the EHR reporting period and does not require a full year. As mentioned 
in our Stage 2 final rule (77 FR 53974), the more robust data set 
provided by a full year EHR reporting period offers more opportunity 
for alignment of programs, such as PQRS, than the data set provided by 
a shorter EHR reporting period, especially when compared across several 
years. We believe the full reporting year will yield data necessary to 
sustain and further progress the program. Furthermore, we believe, as 
previously noted, that the actions and workflows that support the 
requirements of the EHR Incentive Programs are intended to be in effect 
continuously, not enabled and implemented for only 90 days. Finally, we 
believe in the importance of alignment with and support of quality 
measurement and quality improvement initiatives like Accountable Care 
Organizations (ACOs) and the Comprehensive Primary Care Initiative 
(CPCI) as well as the value based purchasing programs that require full 
year reporting for the efficacy of data on clinical processes and 
patient outcomes. Thus, our policy has been to allow a 90-day reporting 
period only in circumstances where a shorter reporting period is 
warranted to allow providers to implement program changes or to begin 
participation in the program.
    Comment: Several commenters recommended the reporting period should 
be 90 days for 2016 and subsequent years, as this would greatly reduce 
the reporting burden. A few commenters stated that a full year of 
reporting in 2016 is unreasonable. Multiple commenters stated that a 
full year reporting period for all participants in 2016 does not 
adequately account for a number of real life scenarios that could cause 
issues with meeting the requirements, such as environmental setbacks, 
infrastructure problems, vendor-related difficulties, and human 
resource issues. Some commenters strongly recommended CMS retain the 
90-day EHR reporting period for first-time attesters in the program in 
future years.
    Response: We decline to extend the 90-day EHR reporting period to 
2016 for all returning participants because we disagree that full year 
reporting is unreasonable. In 2012 and 2013, thousands of returning 
providers successfully attested to program requirements for an EHR 
reporting period of one full year. In addition, as noted previously, 
hardship exceptions may be available for providers experiencing extreme 
and uncontrollable circumstances. However, as proposed in the EHR 
Incentive Programs in 2015 through 2017 proposed rule (80 FR 20348), 
all providers demonstrating meaningful use for the first time may use 
an EHR reporting period of any continuous 90 days in 2016, which has 
been the policy in past years, to support these providers beginning 
implementation of the program.
    After consideration of the public comments received, we are 
finalizing a 90-day EHR reporting period in 2015 for all providers as 
proposed. Eligible professionals may select an EHR reporting period of 
any continuous 90-day period from January 1, 2015 through December 31, 
2015; eligible hospitals and CAHs may select an EHR reporting period of 
any continuous 90-day period from October 1, 2014 through December 31, 
2015. We are finalizing a 90-day

[[Page 62780]]

EHR reporting period in CY 2016 for EPs, eligible hospitals, and CAHs 
that have not successfully demonstrated meaningful use in a prior year. 
For all providers who have successfully demonstrated meaningful use in 
a prior year, we are finalizing an EHR reporting period of the full CY 
2016. We have made corresponding revisions to the definition of ``EHR 
reporting period'' under Sec.  495.4. For the payment adjustments under 
Medicare, we discuss the duration and timing of the EHR reporting 
period in relation to the payment adjustment year in section II.E.2 of 
this final rule with comment period.
(iii) EHR Reporting Period in 2017 and Subsequent Years
    In the Stage 3 proposed rule (80 FR 16739), we proposed that 
beginning in 2017, and for all EPs, eligible hospitals, and CAHs, the 
EHR reporting period would be one full calendar year. We proposed 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. For 
that exception, we proposed 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 noted that the EHR incentive payments under Medicare fee-for-service 
(FFS) and MA(sections1848(o), 1886(n), 1814(l)(3), 1853(l) and(m) of 
the Act) will end before 2017. We stated that under these proposals, 
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.
    These proposals would allow for a single EHR reporting period of a 
full calendar year for all providers across all settings. We proposed 
corresponding revisions to the definition of ``EHR reporting period'' 
under Sec.  495.4. For the payment adjustments under Medicare, we 
proposed changes to the EHR reporting periods applicable for payment 
adjustment years in the Stage 3 proposed rule (80 FR 16774 through 
16777).
    Comment: Several commenters supported the proposal 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. A commenter 
appreciated the effort to standardize reporting timelines to other CMS 
quality programs. Other commenters stated that longer reporting periods 
would facilitate public health reporting, as Public Health Agencies 
(PHAs) have more time to work with providers and their EHR vendors and 
developers to submit data to meet their public health measures. A few 
commenters indicated annual reporting has the benefit of yielding 
valuable data that may not necessarily be captured with a short 90-day 
reporting period.
    Response: We appreciate the support of these comments. We believe 
full year reporting will allow for the collection of more comparable 
data and increase alignment across quality reporting programs, where 
measure data is typically collected over a calendar year period. The 
more robust data set provided by a full year EHR reporting period 
offers more opportunity for alignment than the data set provided by a 
shorter EHR reporting period, especially when compared across several 
years.
    Comment: We received many comments opposing the full year reporting 
period, indicating that it is very challenging and may add 
administrative burdens. Commenters also indicated the following areas 
of concerns that could impact the ability to demonstrate a full year of 
meaningful use:
     EPs change in place of service (POS).
     EPs joining a practice in the middle of the year.
     Ongoing software updates (for example, ICD-10).
     Difficulty in getting data from previous places of 
employment.
     Not enough time for the vendors and developers to make 
software updates.
     Timing of the data submission.
    Other commenters stated full year reporting does not allow 
sufficient time for these practices to identify shortcomings in their 
adherence to meaningful use and implement corrective actions before the 
next reporting period.
    Response: First, we understand the commenters' concerns and note 
that providers may consider applying for a hardship exception from the 
Medicare payment adjustments based on extreme circumstances outside the 
provider's control that contribute to their inability to meet the 
requirements of the EHR Incentive Programs. Second, we note that the 
thresholds of the measures themselves are designed to provide leeway 
for providers to adjust workflows and implementation as necessary 
during the EHR reporting period. With the exception of maintaining drug 
interaction and drug allergy clinical decision supports for the 
duration of the EHR reporting period, no measure has a threshold of 100 
percent. We believe that system downtime could be expected in some 
cases for software or system maintenance, but providers may still meet 
meaningful use if they meet the threshold for each measure and are 
using the required CEHRT Edition for the EHR reporting period. Third, 
as noted previously, if a provider is fully implementing the 
requirements of the program, the workflows and implementation of the 
technology would not be limited to only 90 days, and thus a longer EHR 
reporting period should be feasible.
    Comment: A commenter recommended shortening the reporting period 
from 12 months to 3 months and that CMS should consider an 
``incentive'' for providers who report on a 6-month period or even a 
12-month period. Another commenter similarly suggested reopening 
incentive payments for the program including providing additional 
monies for new participants successfully demonstrating meaningful use 
for a full year under the Stage 3 requirements.
    Response: While we appreciate the commenter's suggestion of 
additional incentives for providers, we do not have discretion to alter 
the timing and duration of the incentive payments under Medicare and 
Medicaid that are established by statute.
    Comment: Some commenters also stated that the yearly reporting 
period also introduces problems for quality reporting and that vendors 
and developers have insufficient time to update and test the products, 
especially for new quality measures that will not be finalized under 
the Medicare PFS until November 1 of the previous year. Other 
commenters stated that vendors and developers are unlikely to be able 
to implement the changes made in the Medicare PFS final rule in time to 
deliver updated products prior to the January 1, 2018 Stage 3 deadline, 
and these conflicting deadlines will continue to be a problem that will 
impact future program years.
    Response: We note that CMS quality reporting programs for EPs (for 
example, PQRS and Value-Based Payment Modifier) have a full year 
reporting or performance period and that the CQMs used for those 
programs require a full year of data. CMS quality reporting programs 
are working in partnership with the EHR developer and vendor community 
to streamline the annual update process to ensure the integrity of data 
and the effectiveness of eCQM specifications. (For further information,

[[Page 62781]]

we refer readers to section II.C of this final rule with comment 
period.)
    Comment: A number of commenters requested a 90-day reporting period 
for providers in the first year of Stage 3 especially for any providers 
seeking to demonstrate the Stage 3 objectives and measures in the 
optional year in 2017. Some of these commenters indicated that they 
agree with the need for full year reporting, but believe that it is 
appropriate to allow a 90-day EHR reporting period when providers move 
to a new stage in order to mitigate issues with workflows, ensure the 
effective implementation of new technologies, and integrate new 
processes into clinical operations.
    Response: We disagree that a 90-day EHR reporting period is 
appropriate for all providers moving to Stage 3, as we believe the lead 
time required for participation in 2018 is sufficient. In addition, the 
optional year in 2017 allows providers to work toward the Stage 3 
measures and test workflows prior to their required implementation in 
2018. However, we agree that the allowance of a 90-day EHR reporting 
period may be appropriate for providers attesting to the objectives and 
measures of Stage 3 in 2017. A 90-day EHR reporting period in this case 
would recognize the shorter time period from development of the 
technology to implementation for use in 2017 and a shorter time period 
for the necessary testing and implementation of workflows and new 
technologies. A 90-day EHR reporting period in 2017 would allow for 
further flexibility in the installation and implementation of the 
overall upgrade to technology certified to the 2015 Edition by 
spreading out the demand over a greater period of time. In addition, a 
90-day EHR reporting period in 2017 for Stage 3 providers would provide 
a benefit by easing the transition for those providers who choose to 
move to Stage 3 early and will potentially make that choice more 
accessible for a greater number of providers. Therefore, we agree that 
allowing a 90-day EHR reporting period for Stage 3 providers in 2017 
would support the transition to a new technology, the adoption of 
technology and clinical workflows, and the overall progress toward 
program goals.
    After consideration of the public comments received, we are 
finalizing our proposal to require a full CY EHR reporting period for 
all providers (with a limited exception for new meaningful EHR users 
under Medicaid) beginning in CY 2017, with a modification for providers 
attesting to Stage 3 of meaningful use in 2017. For EPs, eligible 
hospitals, and CAHs that choose to meet Stage 3 in 2017, the EHR 
reporting period is any continuous 90-day period within CY 2017. For 
all other providers, the EHR reporting period is the full CY 2017. 
Beginning in CY 2018, for all EPs, eligible hospitals, and CAHs 
(including those attesting to Stage 3 for the first time), the EHR 
reporting period is the full CY.
    We finalize our proposal 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 for 2017 and subsequent years.
    We revised the definition of ``EHR reporting period'' under Sec.  
495.4 to reflect these final policies. As we noted previously and in 
the Stage 3 proposed rule (80 FR 16739), the incentive payments under 
FFS and MA (sections1848(o), 1886(n), 1814(l)(3), 1853(l) and (m) of 
the Act) will end before 2017. Thus the final policies for the EHR 
reporting period we adopt here would apply only for EPs and eligible 
hospitals that seek to qualify for an incentive payment under Medicaid. 
For the payment adjustments under Medicare, we discuss the duration and 
timing of the EHR reporting period for a payment adjustment year in 
section II.E.2 of this final rule with comment period.
(4) Considerations in Defining Meaningful Use
(a) Considerations in Review and Analysis of the Objectives and 
Measures for Meaningful Use
    In the Stage 3 proposed rule (80 FR 16740), we noted that for the 
Stage 1 and Stage 2 final rules, the requirements of the EHR Incentive 
Programs included the concept of a core and a menu set of objectives 
that a provider needed to meet as part of demonstrating meaningful use 
of CEHRT. In Stage 2, we also combined some of the objectives of Stage 
1 and incorporated them into objectives for Stage 2. 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.
    However, since the Stage 2 final rule publication, we have reviewed 
program performance from both a qualitative and quantitative 
perspective including analyzing performance rates; reviewing the 
adoption and use of CEHRT; and considering information gained by 
engaging with providers through listening sessions, correspondence, and 
open forums like the HIT Policy Committee. The data supported the 
following key points for consideration:
     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).
     Providers in different specialties and settings 
implemented CEHRT and met objectives in different ways.
     Providers express support for reducing the reporting 
burden on measures that have ``topped out.''
     Providers expressed support for advanced functionality 
that would offer value to providers and patients.
     Providers expressed support for flexibility regarding how 
objectives are implemented in their practice settings.
     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 beginning of the Medicare and Medicaid EHR Incentive 
Programs in 2011, stakeholder associations and providers have requested 
that we consider changes to the number of objectives and measures 
required to meet the program requirements, including the recommendation 
to allow a provider to fail any two objectives, thus making all 
objectives ``menu'' objectives. We noted in the Stage 3 proposed rule 
(80 FR 16740) that we decline to follow these recommendations for 
several 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). Second, there are certain 
objectives and measures that capture policies specifically required by 
the statute as core goals of meaningful use of CEHRT, such as 
electronic prescribing for EPs, HIE, and clinical quality measurement 
(see sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act). Furthermore, 
the statute requires that the CEHRT providers must 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--
     Provide clinical decision support;
     Support physician order entry;
     Capture and query information relevant to health care 
quality; and
     Exchange electronic health information with, and integrate 
such

[[Page 62782]]

information from, other sources (see section 1848(o)(4) of the Act).
    We analyzed the objectives and measures 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 through 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.
    We proposed (as discussed in sections II.B.1.b.(3) and II.C of this 
final rule with comment period) to reduce provider burden and simplify 
the program by aligning EHR reporting periods and CQM reporting. Our 
proposals for Stage 3 would continue the precedent of focusing on the 
advanced use of CEHRT and 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.
(i) Topped Out Measures and Objectives
    In the Stage 3 proposed rule (80 FR 16741 through 16742), we 
proposed 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 proposed to apply the following two criteria, which 
are similar to the criteria used in the Hospital Inpatient Quality 
Reporting (IQR) and Hospital Value Based Purchasing (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.
    Comment: A large number of commenters on the Stage 3 proposed rule 
are in support of the removal of reporting requirements for measures 
that have achieved high rates of compliance. Some commenters wrote that 
this would greatly reduce the reporting burden for EPs and eligible 
hospitals.
    Response: We thank the commenters for their support of this 
proposal. As we stated in the Stage 3 proposed rule (80 FR 16741), the 
removal of topped out measures is intended in part to focus on 
reduction of the reporting burden on providers for measures already 
achieving widespread adoption.
    Comment: A few commenters stated they do not believe that 
performance rates alone provide a valid reason to consider a measure 
topped out. High performance rates on some measures among reporting EPs 
may be partly attributable to intensified improvement efforts motivated 
by the reporting opportunities. Furthermore, classifying any given 
measure as having a high performance rate when the Stage 2 reporting 
rate is less than 10 percent of all EPs is premature.
    Response: Performance rates are only one factor considered in the 
decision to discontinue use of a measure in the Medicare and Medicare 
EHR Incentive Programs. Similarly, measure performance among hospitals 
(whether a measure is ``topped out'') is one of several criteria 
considered when determining whether to remove Hospital IQR Program 
measures (79 FR 50203). Multiple factors beyond performance are 
included in the determination of whether a measure should be considered 
for removal from reporting requirements.
    For the 2014 EHR reporting period, more than 1,800 eligible 
hospitals and CAHs and 60,000 EPs attested for their performance on the 
Stage 2 objectives and measures. However, we did not limit our analysis 
to only Stage 2 providers. Instead, we looked at performance rates 
across the longevity of the program for providers in all levels of 
participation. Most of the measures identified are at exceptionally 
high performance among first time participants in Stage 1 as well, with 
little or no variation as compared to providers in 3 or more years of 
participation. For the Medicare and Medicaid EHR Incentive Programs, we 
additionally looked at measures that represent static data capture 
measures and measures for which the action is now automated by the EHR 
technology, as opposed to active measures that use the structure data 
to inform a clinical decision, provide patient specific education, or 
are used in care coordination. Once the performance on a static measure 
exceeds the point at which reasonable differentiation can be made among 
providers using CEHRT, we believe that the active use of the data 
elements is more beneficial for both provider and patient than the 
continued requirement to measure the capture of these elements.
    For further information on the performance rates for new 
participants, as well as quartile performance rates for individual 
measures, we direct readers to the CMS EHR Incentive Program Web site 
data and reports page.
    Comment: A commenter cautioned against removing measures that may 
appear to be topped out but are clinically significant or focused on 
patient safety. Another commenter suggested that CMS consider both the 
pediatric population, as well as the adult population before they 
determine that a measure is topped out.
    Response: As we stated in the Stage 3 proposed rule (80 FR 16741) 
and in the previous responses to comments, we believe it is appropriate 
to remove some measures which have reached widespread adoption. 
However, we agree that the analysis of these measures and their 
identification as topped out should take into account other factors 
such as clinical significance and patient safety. In the proposed rule 
we specifically discussed reviewing the provider performance on 
measures identified as redundant and duplicative measures, as this 
impacts the statistical likelihood that the functions of measures and 
the processes behind them would continue even without a requirement to 
report the results (80 FR 16742). For example, electronic prescribing 
for EPs may be considered topped out if only the performance 
percentiles are considered. However, we proposed to maintain this 
measure because it relates to clinical effectiveness and patient safety 
and is foundational to the program (80 FR 16747).
    For the commenter mentioning pediatric versus adult populations, 
the EHR Incentive Programs do not include a separate set of meaningful 
use objectives and measures for adult populations versus pediatric 
populations. Nor does CMS collect individual patient data through the 
EHR Incentive Programs. While certain measures may include 
specifications related to age, CMS only collects summary-level data in 
the form of numerators and denominators. Therefore we are not able to 
compare performance on these measures for different patient 
populations. However, we would note that the measures we proposed to 
remove had significantly high performance, with providers in all 
specialties performing well above the required thresholds.

[[Page 62783]]

    Comment: Another commenter is concerned that by suddenly 
eliminating measures, CMS may be creating uncertainty and inadvertently 
sending the message that sustained performance is no longer necessary. 
The commenter believes it is important that EPs be given proper notice 
of the agency's plans for eliminating measures.
    Some commenters stated removing the measures may lead to EHR 
vendors and developers not providing metrics on the measures in reports 
that are used for benchmarking and internal quality improvement work. 
These commenters recommended that providers should continue to be 
required to report on all topped out measures without a threshold, 
where the measure would be to attest that the provider is recording the 
information.
    Response: We notified the public of our intent to remove measures 
from the program through notice of proposed rulemaking and requested 
public comment on these changes in both the Stage 3 proposed rule and 
the EHR Incentive Programs in 2015 through 2017 proposed rule. In 
addition, as noted in the Stage 3 proposed rule (80 FR 16741), 
evaluation of measures and performance is common practice for CMS 
programs to ensure ongoing program effectiveness.
    We disagree that threshold measures should be replaced with ``check 
box'' measures for each of the topped out measures as this would 
provide no value for measurement and is counter to the effort to reduce 
the reporting burden on providers. Providers who wish to independently 
measure the capture of a particular data element should work with their 
EHR developer and vendor to ensure they are receiving the most 
appropriate analytics for their practice and patient population--just 
as they would with any data element they wished to track that was not 
already required by the Medicare and Medicaid EHR Incentive Programs.
    Comment: A few commenters stated the impact of reducing the 
reporting burden for meaningful use is minimal and that the burden of 
meeting the requirements of the EHR Incentive Programs lies in bridging 
clinical workflow and best practices, patient safety, technology, and 
program understanding.
    Response: While we agree that the objectives and measures required 
in the program are directly correlated with clinical workflows, 
technology, program understanding, and patient safety, we are 
responding to concerns stated by a wide range and significant number of 
stakeholders, including the burden of reporting requirements and 
complexity within the program.
    After consideration of the public comments received, we are 
finalizing as proposed our approach for evaluating whether objectives 
and measures are ``topped out,'' and if so, whether a particular 
objective or measure should be considered for removal from the EHR 
Incentive Programs.
(ii) Electronic Versus Paper-Based Objectives and Measures
    In Stage 1 and Stage 2, we require or allow providers the option to 
include paper-based formats for certain objectives and measures, 
including the provision of a non-electronic summary of care document 
for a transition or referral, at Sec.  495.6(j)(14)(i) for EPs and for 
eligible hospitals and CAHs atSec.  495.6(l)(11)(i), and the provision 
of paper-based patient education materials, at Sec.  495.6(j)(12)(i) 
for EPs and Sec.  495.6(l)(9)(i) for eligible hospitals and CAHs. 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. We proposed to discontinue this 
policy for Stage 3; paper-based formats would not be required or 
allowed for the purposes of the objectives and measures for Stage 3 of 
meaningful use.
    This does not imply that we do not support the continued use of 
paper-based materials in a practice setting. 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.
    Comment: Many commenters on the Stage 3 proposed rule stated they 
enthusiastically support this requirement. Requiring or even allowing 
paper-based methods, such as faxing of summaries of care at transitions 
or referrals, may be hindering some providers from adopting digital 
technologies (for example, direct addresses) that support the 
overarching goal of meaningful use, which is to use technology to 
improve patient outcomes.
    Response: We appreciate your feedback in support of eliminating 
paper-based methods of reporting in order to be a meaningful user in 
Stage 3 and we agree that limiting the focus of the program to only 
health IT solutions may encourage adoption as well as spurring further 
innovation among IT developers. As stated in the Stage 3 proposed rule 
(80 FR 16742) our goal is to focus on advanced use of EHRs. While we do 
not in any way seek to limit the methods by which a provider may engage 
with a patient or share information, we do not believe that requiring 
providers to measure paper-based actions is consistent with the long-
term goals of the program. We believe that the requirements and focus 
of the program should be exclusively on leveraging HIT to support 
clinical effectiveness and patient safety, HIE, and quality 
improvement.
    Comment: Many commenters requested that we keep paper-based 
measures in place, stating that CMS should not encourage electronic 
processes exclusively until consumers are ready to accept them.
    Response: As noted in the Stage 3 proposed rule (80 FR 16742), our 
policy to no longer require or allow providers to record and report 
paper-based actions 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. Our proposal would simply no longer require or 
allow providers to manually count and report on these paper-based 
exchanges.
    Comment: Another commenter stated this proposal to eliminate paper-
based formats will cause extreme hardship for providers who serve 
geriatric populations and will negatively impact the quality of care 
their elderly patients will receive. Many geriatric patients and their 
caretakers do not have access to internet or computers and do not have 
any other means of receiving electronic health information.
    Response: 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. However, we proposed this method would no longer be required 
or allowed for manual measurement in order to meet the requirements of 
the Medicare and Medicaid EHR Incentive Programs.
    Comment: A commenter stated there must be a focus on standards to 
ensure that EHRs are collecting the appropriate and relevant clinical 
data. If printed, the electronic versions of visit summaries should be 
presented in a clinically relevant manner. In addition, because the 
commercial payer community is not

[[Page 62784]]

impacted by the requirements of the EHR Incentive Programs, many 
providers continue to prefer a paper-based information format, with 
electronic formats limited to practice management software. A commenter 
also stated that if the EHR systems do not adequately populate 
necessary information, paper-based formats are necessary to track 
actions and measure calculations.
    Response: We respectfully disagree. Paper-based formats are not 
necessary to populate information that CEHRT systems capture. CEHRT 
stores data in a structured format that allows patient information to 
be easily retrieved and transferred. The removal of paper-based actions 
is intended to support the discontinuation of manual paper-based 
calculation and chart abstraction. If a provider's EHR is not 
accurately capturing and allowing for the retrieval and transfer of 
data, the provider should work with their EHR developer to correct the 
error. The provider should also ensure that all staff entering 
information into the EHR have the necessary training to input patient 
data, just as staff were previously trained to input data correctly 
into a paper record or administrative or billing system. We believe 
this will also eliminate redundancy for providers in clinical and 
administrative processes. As noted in the Stage 3 proposed rule, we 
consider redundant objectives and measures to include those where a 
viable health IT-based solution may replace paper-based actions (80 FR 
16741).
    After consideration of the public comments, we are finalizing our 
proposal that paper-based formats will not be required or allowed for 
the purposes of the objectives and measures for Stage 3 of meaningful 
use.
(iii) Advanced EHR Functions
    In the Stage 3 proposed rule (80 FR 16742), we proposed 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 noted 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. We stated that it was our intent that 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 (C-CDA) 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 received the following comments on this proposal and our 
response follows.
    Comment: Many commenters applauded this proposal noting that it 
made no sense to require providers to track the capture of data when 
providers were also tracking the use of that exact same data in other 
objectives and measures. Providers specifically noted that items such 
as vital signs and smoking status were not only used in multiple other 
objectives (for example, they must be included in a summary of care 
document), but that they are also included in CQMs which allow 
providers more insight into the clinical relevance of the data.
    Some commenters objected to removing duplicative data capture from 
the program--specifically citing the measures for patient demographics, 
structured lab results, vital signs, advance directives, and smoking 
status--because they believe the measures should continue to be 
independently captured. One commenter requested clarification on how 
Stage 2 measures like family health history and electronic progress 
reports are incorporated into Stage 3. A commenter suggested that there 
needs to be more clarity with respect to how those measures which are 
duplicative of more advanced processes are still required for use and 
potentially tracked through other means, such as in the common clinical 
data set (CCDS).
    Response: As stated previously in this final rule with comment 
period, we note that we sought to identify the objectives and measures 
which measure only the capture data in a structured format without any 
additional requirement on the use of that data within the measure. We 
also note that this was an important factor in reviewing those measures 
which were identified as potentially topped out (section 
II.B.2.b.(4)(a)(i)). In other words, most measures selected for removal 
were both topped out and also redundant or paper-based (as discussed 
previously in section II.B.2.b.(4)(a)(ii)), or duplicative of more 
advanced use objectives. We understand some providers may still find 
value in independently setting goals for data capture of structured 
data elements; however, we believe it is appropriate to no longer 
require reporting to CMS on these redundant or duplicative measures. We 
believe this will allow providers to focus on the use of the technology 
and the use of the data to support care coordination and quality 
improvement rather than monitoring the simple capture of that data for 
a measure which has already reached high capture rates.
    We note that family health history is still a required data field 
within the definition of CEHRT at Sec.  495.4. This means it will still 
be part of CEHRT available for provider use. This measure in particular 
was identified as having high performance, but also representing a 
significant burden for counting and measurement purposes. According to 
provider recommendations, family health history should not be recorded 
in an EHR in episodic fashion but should allow for linear capture as 
structured data that can be leveraged by more advanced functions, such 
as the Patient Specific Education measure under the Patient Electronic 
Access objective. Electronic notes are similar use cases within the 
CEHRT, as are the standards for advance directives and smoking status. 
In addition, the requirements for the fields within an electronic 
summary of care document, the C-CDA, include structured data elements 
such as demographics, medication list, medication allergy list, vital 
signs, and structure lab results, among others, which are required as 
part of the electronic summary of care document C-CDA a provider must 
send in conjunction with a transition of care or referral in support of 
effective care coordination. For further information, we refer readers 
to the ONC 2015 Edition Certification Criteria final rule published 
elsewhere in this Federal Register.
    Comment: A commenter on the Stage 3 proposed rule stated that 
although it is implied, it does not appear to be clearly stated that 
vocabularies and standards associated with the topped out, redundant, 
or duplicative measures are still required for use.
    Response: We did not propose to remove the required use of 
standards associated with structured data capture within the CEHRT. 
CEHRT must still include the functions and capabilities that are part 
of the overall definition of requirements for CEHRT for the Medicare 
and Medicaid EHR Incentive Programs, including LOINC standards, HL7 
standards, and SNOMED standards, among others, as established in the 
ONC certification criteria for CEHRT. These structured data elements 
must also be

[[Page 62785]]

part of the C-CDA in an electronic exchange and the information 
provided to a patient through the view, download, and transmit 
functions of CEHRT. For further information, we refer readers to the 
ONC 2015 Edition Certification Criteria final rule published elsewhere 
in this Federal Register.
    After consideration of the public comments received, we are 
finalizing our proposed approach for analyzing the objectives and 
measures to identify and maintain and promote the advanced use of 
health IT for Stage 3 of meaningful use.
(b) Considerations in Defining the Objectives and Measures of 
Meaningful Use for 2015 Through 2017
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20354), we stated that we analyzed the existing objectives and 
measures of meaningful use to consider if they should be modified for 
the program beginning in 2015. Using the approach outlined in the Stage 
3 proposed rule, we looked at the set of potential objectives and 
measures for inclusion in the program for 2017 and subsequent years and 
sought to determine if they were redundant, duplicative, or had reached 
a performance level considered to be topped out. We also considered the 
functions and standards included the technology certified to the 2014 
Edition when determining if a measure is redundant or duplicative and 
adding a review of isolated performance rates for providers in the 
first year of meaningful use in addition to reviewing quartile 
performance rates for topped out measures.
    Our analysis of the objectives and measures of meaningful use Stage 
1 and Stage 2 identified a number of measures that met the criteria as 
either redundant, duplicative, or topped out, with new participants 
consistently performing at a statistically comparable rate to returning 
participants. Table 2 identifies the current objectives and measures 
that met the criteria. Therefore, we proposed (80 FR 20355) to no 
longer require providers to attest to these objectives and measures as 
currently codified in the CFR under Sec.  495.6 in order to meet 
program requirements beginning in 2015.

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

    We noted that many of these objectives and measures include actions 
that may be valuable to providers and patients, such as providing a 
clinical summary to a patient after an office visit. We encouraged 
providers to continue to conduct these activities as best suits their 
practice and the preferences of their patient population. The removal 
of these measures is in no way intended as a withdrawal of an 
endorsement for these best practices or to discourage providers from 
conducting and tracking these activities for their own quality 
improvement goals. Instead, we would no longer require providers to 
calculate and attest to the results of these measures in order to 
demonstrate meaningful use beginning in 2015.
    Comment: The majority of commenters for the EHR Incentive Programs 
in 2015 through 2017 proposed rule were in support of removing the 
objectives and measures that are considered redundant, duplicative, or 
``topped out,'' including patient reminders, recording vital signs, 
smoking status, structured lab results, patient lists, imaging results, 
family health history, and demographics. Some commenters stated they 
agree that many of the measures no longer provided enough value to 
remain part of the program. Limiting the number of objectives to those 
that can truly impact the biggest issues facing healthcare technology 
is an appropriate and much needed direction.
    Other commenters stated they believe this will have the effect of 
simplifying the EHR Incentive Programs and easing

[[Page 62786]]

the administrative burdens associated with the attestation process. 
Other commenters support the idea of encouraging providers to continue 
to conduct these activities if it suits their practice and the 
preferences of their patient population--but not be required to attest 
to these measures in order to meet the requirements of the program.
    Response: As we stated in the EHR Incentive Programs in 2015 
through 2017 proposed rule (80 FR 16741), we proposed the removal of 
these 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.
    Comment: Some commenters on the EHR Incentive Programs in 2015 
through 2017 proposed rule indicated some objectives still require some 
of the same structured data elements scheduled to be retired and some 
may still be of value to an organization in meeting other initiatives 
or regulatory requirements and are, therefore, worth retaining. A 
commenter disagreed with removal of the vital signs measure, as other 
measures may not fully capture vital sign information on all patients 
and keeping the measure incentivizes providers not only to collect 
these important data points but also to ensure that vital signs data is 
input into the EHR. Another commenter stated that not providing 
clinical summaries could have the adverse effect of decreasing patient 
engagement, especially if patients are not using patient portals. Some 
commenters indicated exempting laboratory data is especially damaging 
to the creation of EHRs because structured laboratory data provides the 
best opportunity to load results automatically into an EHR, given the 
degree of coding and structure, and prevents duplicate ordering. Other 
commenters are concerned that an EHR will not allow providers to create 
their own patient lists so they can assess which of their patients may 
require additional clinical attention. Another commenter was opposed to 
the removal of electronic notes, stating when providers must 
continually find the paper chart in order to know what is going on with 
the patient, it slows them down and they do not get optimal value out 
of an EHR.
    Some commenters opposed the removal of specific objectives or 
measures, such as the imaging results measure, stating it should be 
retained as a menu set choice or as an alternate choice to implementing 
reporting for a second public health measure in addition to 
immunization reporting. Other commenters are concerned with the removal 
of the family history measure because this data can be a strong 
indicator for preventative services. A few commenters are concerned 
with the removal of the record demographics measure and stated, if 
removed, adherence may drop and reporting will be less useful.
    Response: We agree that functions and standards related to measures 
that are no longer required for the EHR Incentive Programs could still 
hold value for some providers and organizations. As stated in the EHR 
Incentive Programs in 2015 through 2017 proposed rule (80 FR 20355), we 
encourage providers to continue to use the information as best suits 
their practice and the preferences of their patient population. The 
removal of these measures from the EHR Incentive Programs is not 
intended as a withdrawal of an endorsement of the use of the standards, 
the capture of the data, the implementation of best practices, or to 
discourage providers from conducting and tracking the information for 
their own quality improvement goals. Additionally, the data standards 
and functions will remain part of CEHRT for provider use. As part of 
our effort to reduce complexity, reduce reporting burden, and 
streamline the EHR Incentive Programs, we proposed to remove the core 
and menu structure established in previous rules. We do not believe the 
continuation of an optional menu objective for simple data capture 
provides better support for the standard than the support provided by 
requiring the inclusion of the standard in CEHRT and the use of that 
data within a more advanced objective.
    As noted previously, we support the continued use of structured 
data within a certified EHR to support advanced clinical processes, 
care coordination, and quality improvement. The capture of this data in 
a structured format allows the provider to use the data for these 
processes and supports the efficacy of quality measurement and quality 
improvement. The removal of the requirement to count simple data 
capture allows providers to shift the focus of their use of technology 
to support effective use of the data.
    Comment: A commenter on the EHR Incentive Programs in 2015 through 
2017 proposed rule requested CMS clarify further the reasons why 
objectives and measures were removed.
    Response: As we noted in the Stage 3 proposed rule (80 FR 16741 
through 16742), we reviewed performance data submitted by providers 
through attestation to determine topped out measures. We applied the 
following criteria to determine topped out measures: (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. We then compared the 
identified measures to other meaningful use objectives that use the 
data in a more advanced function. We also proposed to remove measures 
that are paper-based for the reasons stated previously. We encourage 
commenters to review the performance data on our Web site under EHR 
Incentive Programs Objective and Measure Performance Report for 
additional information.\3\
---------------------------------------------------------------------------

    \3\ CMS EHR Incentive Programs Data and Reports at www.CMS.gov/EHR Incentive Programs.
---------------------------------------------------------------------------

    After consideration of the public comments received, we are 
finalizing, as proposed, the list of objectives and measures in Table 2 
identified as redundant, duplicative, or topped out and will no longer 
require these objectives and measures for meaningful use beginning with 
an EHR reporting period in 2015. The removal of these measures is 
reflected in the final objectives and measures adopted in the 
regulation text at Sec.  495.22.
(i) Changes to Objectives and Measures for 2015 Through 2017
    In the EHR Incentive Programs in 2015 through 2017 proposed rule, 
we noted that in order to implement the proposed changes to the program 
to align with long-term goals; there are a number of changes that must 
be made to other requirements of meaningful use (80 FR 20355). These 
changes fall into the following two major categories--
     Changes to streamline the structure in 2015 through 2017 
to align with the proposed structure for Stage 3 of meaningful use in 
2017 and subsequent years; and
     Changes to accommodate this shift to allow providers to 
demonstrate meaningful use for an EHR reporting period in 2015.
    We recognized and considered the stakeholder and provider 
representatives' concerns in implementing the patient engagement 
objectives requiring patient action (see the Stage 2 final rule at 77 
FR 54046 under the Health Outcomes Policy Priority ``Engage patients 
and families in their care''), which include barriers to successful 
implementation of the required health IT or CEHRT functions necessary 
to support the measures. We proposed changes to these objectives to 
allow providers to focus on improvements without jeopardizing

[[Page 62787]]

their ability to successfully fulfill the requirements of the EHR 
Incentive Programs.
(ii) Structural Requirements of Meaningful Use in 2015 Through 2017
    In the EHR Incentive Programs in 2015 through 2017 proposed rule, 
we proposed to eliminate the distinction between core and menu 
objectives and purported that all retained objectives would be required 
for the program. We note that for Stage 1 providers, this means three 
current menu objectives would now be required; and for Stage 2 eligible 
hospitals and CAHs, one current menu objective would now be a required 
objective (80 FR 20356). These objectives are as follows:

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

    Furthermore, we stated that the objectives and measures retained in 
each case for all providers would be the Stage 2 objectives and 
measures and proposed to establish alternate exclusions and 
specifications to mitigate any additional burden on providers for an 
EHR reporting period in 2015 (80 FR 20356).
    For the public health reporting objectives and measures, we 
proposed to consolidate the different Stage 2 core and menu objectives 
into a single objective with multiple measure options. We proposed this 
approach for the Stage 3 public health reporting objective because we 
believe it allows for greater flexibility for providers and supports 
continued efforts to engage providers and public health agencies in the 
essential data capture and information exchange that supports quality 
improvement, emergency response, and population health management 
initiatives. For further discussion of the rationale for the Stage 3 
objective, we direct readers to 80 FR 16731 through 16804. For the 
consolidated public health reporting objective in the EHR Incentive 
Programs in 2015 through 2017 proposed rule (80 FR 20366), we proposed 
that EPs report on any combination of two of the five available 
options, while eligible hospitals and CAHs report on any combination of 
three of the six available options. If a provider is scheduled to 
attest to Stage 1 of meaningful use in 2015, we proposed to allow EPs 
to report on only one of the five available options outlined and the 
eligible hospitals or CAHs to report on any combination of two of the 
six available options for an EHR reporting period in 2015 (80 FR 
20366).
    Therefore, we proposed that the structure of meaningful use for 
2015 through 2017 would be nine required objectives for EPs using the 
Stage 2 objectives for EPs, with alternate exclusions and 
specifications for Stage 1 providers in 2015. We proposed that the 
structure of meaningful use for 2015 through 2017 would be eight 
required objectives for eligible hospitals and CAHs, with alternate 
exclusions and specifications for Stage 1 providers and some stage 2 
providers in 2015. In addition, EPs would be required to report on a 
total of two measures from the public health reporting objective or 
meet the criteria for exclusion from up to five measures; eligible 
hospitals and CAHs would be required to report on a total of three 
measures from the public health reporting objective or meet the 
criteria for exclusion from up to six measures.

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

We received public comment on this proposal and our response follows.
    Comment: Many commenters on the EHR Incentive Programs in 2015 
through 2017 proposed rule relayed their support of program 
consolidation with transition to a single stage, as well as the removal 
of core and menu objectives and measures.
    Other commenters believe that such changes will make it much easier 
for all providers to attest, for providers to know what Stage they are 
in, and for CMS to track providers who are in different reporting 
years. Some commenters stated that the transition to a single stage of 
meaningful use would drastically reduce the administrative burden, 
provide simplicity that will benefit EHR developers and users, and 
facilitate meeting interoperability goals. Other commenters stated that 
by reducing the amount of effort that a participant has to exert--
especially for measures that are already a matter of clinical routine--
participants will have an experience that is significantly less 
intrusive.
    Response: We appreciate the commenters' feedback and support for 
our proposal to transition to a single stage of meaningful use. In this 
final rule with comment period, we are making changes to the 
requirements for Stage 1 and Stage 2 for 2015 through 2017 to align 
with the approach for Stage 3 in 2018 and subsequent years. This 
includes a simplified structure and focus on objectives and measures 
with sustainable growth potential aligned to the programs' foundational 
goals prior to the full implementation of Stage 3 in 2018.
    Comment: Some commenters on the EHR Incentive Programs in 2015 
through 2017 proposed rule stated that eliminating the core and menu 
structure does not mean that choice should be

[[Page 62788]]

eliminated from the structure of reporting. Other commenters requested 
that the original core and menu structure be kept in the program.
    Response: The proposed removal of the core and menu structure is 
part of our focus to simplify the reporting requirements and decrease 
complexity in response to stakeholder feedback. We proposed this change 
to refocus program requirements on those objectives and measures that 
represent advanced use of CEHRT.
    We disagree that the commenters' suggestion to retain a core and 
menu structure offers value to supporting program goals or to promoting 
flexibility in a meaningful way. Retaining a menu of objectives that 
includes topped out, redundant, or duplicative measures for the sole 
purpose of allowing providers to continue to choose among them is 
counter-productive to efforts to reduce program complexity and ease the 
reporting burden on providers. It also offers no benefit to CMS to 
continue to require reporting on measures that no longer represent a 
statistical value for measurement or a means of differentiating 
provider performance. The only other method by which a menu could be 
implemented would be to make formerly required objectives optional. As 
stated in the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20386), we do not believe that approach supports program goals 
or meets our statutory duty to require more stringent measures of 
meaningful use over time.
    Furthermore, we believe the objectives that we proposed to retain 
represent the functions that any provider should apply to leverage HIT 
in support of improved outcomes for their patients. We believe that the 
existing exclusions for each measure are adequate to allow flexibility 
for providers. Additionally, we have proposed to include alternate 
exclusions and specifications for Stage 1 providers in 2015 to allow 
them to continue the workflows they have already established for 2015 
and give them time to move forward with the more advanced measures.
    After consideration of public comments received, we are finalizing 
the changes to the structure as proposed.
(iii) Alternate Exclusions and Specifications for Stage 1 Providers for 
Meaningful Use
    We proposed (80 FR 20357) several alternate exclusions and 
specifications for providers scheduled to demonstrate Stage 1 of 
meaningful use in 2015 that would allow these providers to continue to 
demonstrate meaningful use, despite the proposals to use only the Stage 
2 objectives and measures identified for meaningful use in 2015 through 
2017. These provisions fall into the following two major categories:
     Maintaining the specifications for objectives and measures 
that have a lower threshold or other measure differences between Stage 
1 and Stage 2;
     Establishing exclusion for Stage 2 measures that do not 
have an equivalent Stage 1 measure associated with any Stage 1 
objective, or where the provider did not plan to attest to the menu 
objective that would now be otherwise required.
    For the first category, we proposed that for an EHR reporting 
period in 2015, providers scheduled to demonstrate Stage 1 of 
meaningful use may attest based on the specifications associated with 
the Stage 1 measure. We noted that for an EHR reporting period 
beginning in 2016, we proposed that all providers must attest to the 
specifications (including the measure thresholds) associated with the 
Stage 2 measure. For the second category, we proposed the alternate 
exclusions outlined for providers would only apply for an EHR reporting 
period in 2015. For an EHR reporting period in 2016, we proposed that 
all providers, including those who would otherwise be scheduled for 
Stage 1 in 2016, would be required to meet the Stage 2 specifications 
with no alternate exclusions.
    The proposed alternate exclusions and specifications for certain 
objectives and measures of meaningful use for an EHR reporting period 
in 2015 are defined for each objective and measure in the description 
of each objective and measure in the EHR Incentive Programs in 2015 
through 2017 proposed rule(80 FR 20358 through 20374).
    Comment: Many commenters were supportive of allowing alternate 
exclusions for Stage 1 providers in 2015.Some stated that if the 
proposal to shift to a single set of measures for 2015 were adopted, 
providers who were planning to attest to Stage 1 in 2015 in accordance 
with the current policies would certainly require accommodations. Other 
commenters stated that these exclusions should also be considered 
optional for Stage 1 providers who want to move to Stage 2 immediately. 
Many commenters stated that it would benefit the provider if they were 
able to indicate the Stage that they were scheduled to demonstrate for 
2015 in the attestation system.
    Response: We thank you for your support of our proposal to 
establish alternate exclusions and specifications to ease the 
transition to a single stage of meaningful use. We proposed to 
accommodate eligible providers previously scheduled to demonstrate 
Stage 1 in 2015 by allowing alternate exclusions and specifications for 
certain objectives or measures. Providers scheduled to be in Stage 1 
may opt to use the alternate exclusions and specifications, but they 
are not required to use them. The Medicare and Medicaid EHR Incentive 
Programs registration and attestation system will automatically 
identify those providers who are eligible for alternate exclusions and 
specifications. Upon attestation, these providers will be offered the 
option to attest to the Stage 2 objective and measure and the option to 
attest to the alternate specification or claim the alternate exclusion 
if available. The provider may independently select the option 
available to them for each measure for which an alternate specification 
or exclusion may apply.
    Comment: A commenter requested clarification on how providers 
should document that they did not intend to attest to a menu objective 
or clarification that this is not something that will be/should be 
audited.
    Response: We understand that intent or lack thereof may be 
difficult for a provider to document and will not require documentation 
that a provider did not plan to attest to a menu objective for the 
provider to claim the alternate exclusion.
    Comment: A number of commenters strongly recommended that CMS keep 
the alternate specifications and exclusions proposed for 2015 available 
for providers meant to be in Stage 1 in 2016 and 2017 to allow more 
recent participants the same progression through the stages of the EHR 
Incentive Programs as those who entered the program earlier. Other 
commenters suggested that while the Stage 2 objectives are achievable 
with prior planning by 2017, retaining the alternate exclusions 
alternate in 2016 would allow providers to obtain and effectively 
implement any necessary software required to meet certain Stage 2 
measures that they may not currently have in place. These commenters 
noted that for some objectives and measures, the need to obtain and 
implement CEHRT that they do not already possess would require time to 
ensure privacy and security protocols and patient safety measures are 
effectively implemented. Commenters noted this is especially true with 
the functions, clinical workflows, and staff training that would be 
required to effectively implement electronic prescribing and 
computerized provider order entry, which may present

[[Page 62789]]

a significant risk to patient safety if the technology is implemented 
incorrectly in order to meet an expedited timeline.
    Response: We understand the commenters' concerns that meeting the 
Modified Stage 2 requirements may be challenging for some providers for 
those objectives and measures that would require the implementation of 
additional CEHRT modules they did not previously possess because they 
were not scheduled to be in Stage 2 or because they did not intend to 
attest to the menu objective. In general, the timing to implement these 
new technologies would not necessary be prohibitive for a provider to 
successfully participate in 2016; however, as some commenters mentioned 
there are patient safety risks associated with the effective 
implementation of the technology and the supportive workflows which are 
of concern for certain objectives. To accommodate these concerns, we 
will allow providers who would otherwise be scheduled for Stage 1 in 
2016 to claim the alternate exclusions for the Modified Stage 2 
objectives and measures that would require the effective implementation 
of CEHRT modules for an EHR reporting period in 2016 that the provider 
does not currently possess. Specifically, we believe this includes 
measures 2 and 3 (lab and radiology orders) of the Computerized 
Provider Order Entry Objective for EPs, eligible hospitals, and CAHs, 
as well as the Electronic Prescribing Objective for eligible hospitals 
and CAHs. However, we do not believe this extension should include the 
Health Information Exchange Objective for a number of reasons. First, 
we have already proposed additional flexibility for that objective in 
2015 through 2017 regarding the CEHRT requirement for the transmission 
of an electronic summary of care document. Second, we believe the 
threshold of 10 percent associated with the Health Information Exchange 
Objective and measure is achievable within a calendar year. Finally, we 
believe that the ability of all providers to successfully exchange 
health information electronically is enhanced by greater participation 
among providers as a whole. We also do not believe that providers who 
otherwise would be scheduled for Stage 1 in 2016 should be allowed to 
use for an EHR reporting period in 2016 the alternate specifications 
that we proposed for 2015, as these are only applicable for measures 
that already have both a Stage 1 and Stage 2 equivalent and are 
supported by measures using the same CEHRT functions and standards. We 
direct readers to each objective in section II.B.2.a of this final rule 
with comment period for a full discussion of the details pertaining to 
the requirements for the alternate exclusions and specifications for 
the applicable objectives and measures.
    After consideration of the public comments, we finalize the 
structure of the objectives and measures for the EHR Incentive Programs 
in 2015 through 2017 as proposed. In addition, we are finalizing as 
proposed the proposal for alternate exclusions and specifications for 
certain providers in 2015. We finalize that providers that were 
scheduled to demonstrate Stage 1 in 2015 or2016 (for certain exclusions 
only) may choose the alternate exclusions and specifications where 
applicable or may attest to the modified Stage 2 objectives and 
measures. We finalize that EPs, eligible hospitals and CAHs that were 
scheduled to be in Stage 1 in 2016 may claim an alternate exclusion for 
an EHR reporting period in 2016 for the Computerized Provider Order 
Entry Objective Measures 2 and 3 (lab and radiology orders) or choose 
the modified Stage 2 objective and measures. We finalize that eligible 
hospitals and CAHs that were scheduled to be in Stage 1 in 2016 may 
claim an alternate exclusion for an EHR reporting period in 2016 for 
the Electronic Prescribing Objective or choose the modified Stage 2 
Objective. For further detail, we direct readers to the individual 
objectives and measures for the EHR Incentive Programs in 2015 through 
2017 in section II.B.2.a of this final rule with comment period. We 
refer readers to Table 1 in the EHR Incentive Programs in 2015 through 
2017 proposed rule (80 FR 20352) for an illustration of our policy on 
the prior progression of stages and whether a provider is scheduled to 
be in Stage 1 in 2015 or 2016.
(iv) Changes to Patient Engagement Requirements for 2015 Through 2017
    As discussed in the EHR Incentive Program for 2015 through 2017 
proposed rule (80 FR 20357), we proposed to make changes to two 
objectives that have measures related to patient engagement. We 
proposed to remove the threshold requirement for these two measures 
that count patient action in order for the provider to meet the 
measure. While we support patient engagement and believe that providers 
have a role in influencing patient behavior and supporting improved 
health literacy among their patients, data analysis on the measures 
supports concerns expressed by providers that significant barriers 
exist that heavily impact a provider's ability to meet the patient 
action measures. Therefore, we proposed to remove the thresholds for 
these two measures in order to allow for further maturity of the 
technology, greater saturation in the market, and increased awareness 
among patient population. We believe this allows for the necessary time 
for providers to work toward patient education and the availability of 
these resources, as well as allowing the industry as a whole time to 
develop a stronger infrastructure supporting patient engagement.
    There are two objectives for EPs and one objective for eligible 
hospitals and CAHs that specifically contain measures requiring a 
provider to track patient action. We proposed to modify these measures 
as follows:
     Patient Action to View, Download, or Transmit (VDT) Health 
Information
    ++ Remove the 5 percent threshold for Measure 2 from the EP Stage 2 
Patient Electronic Access (VDT) objective. Instead require that at 
least 1 patient seen by the provider during the EHR reporting period 
views, downloads, or transmits his or her health information to a third 
party.
    ++ Remove the 5 percent threshold for Measure 2 from the eligible 
hospital and CAH Stage 2 Patient Electronic Access (VDT) objective. 
Instead require that at least 1 patient discharged from the hospital 
during the EHR reporting period views, downloads, or transmits his or 
her health information to a third party.
     Secure Electronic Messaging Using CEHRT
    ++ Convert the measure for the Stage 2 EP Secure Electronic 
Messaging objective from the 5 percent threshold to a yes/no 
attestation to the statement: ``The capability for patients to send and 
receive a secure electronic message was enabled during the EHR 
reporting period''.
    These changes are reflected in the discussion of these objectives 
in section II.B.2.a of this final rule with comment period. We note 
that these changes are intended to allow providers to work toward 
meaningful patient engagement through HIT using the methods best suited 
to their practice and their patient population. Furthermore, we note 
that beginning in 2018 (and optionally in 2017); providers are required 
to meet an objective exclusively focused on patient engagement that has 
an expanded set of measures and increased thresholds. (For further 
information on that proposed objective, we direct readers to 80 FR 
16755 through 16758.)

[[Page 62790]]

(c) Considerations in Defining the Objectives and Measures of 
Meaningful Use Stage 3
    After analysis of the existing Stage 1 and Stage 2 objectives and 
measures as described in section II.B.1.b.(4)(a) and review of the 
recommendations of the HIT Policy Committee and the foundational goals 
and requirements under the HITECH Act, we identified in the Stage 3 
proposed rule (80 FR 16743) eight key policy areas that 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.\4\ These 
eight policy areas provide the basis for the proposed objectives and 
measures for Stage 3. They are included in Table 4 as follows:
---------------------------------------------------------------------------

    \4\ 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 the EHR
                                          Incentive Program and
                                          Certified EHR Technology.*
                                         Recommended by HIT Policy
                                          Committee.
Electronic Prescribing (eRx)...........  Foundational to the EHR
                                          Incentive Program 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 the EHR
                                          Incentive Program 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.

    In the Stage 3 proposed rule (80 FR 16743), we proposed that 
providers must successfully attest to these eight objectives and the 
associated measures (or meet the exclusion criteria for the applicable 
measure) to meet the requirements of Stage 3 in the Medicare and 
Medicaid EHR Incentive Programs. These objectives and measures include 
advanced EHR functions, use a wide range of structured standards in 
CEHRT, employ increased thresholds over similar Stage 1 and Stage 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.
    Comment: Many commenters supported the approach for identifying the 
key priorities for the EHR Incentive Programs over the long term. 
Commenters' opinions on the top priorities varied, with some supporting 
greater patient engagement, some supporting a stronger shift towards 
outcomes-based quality measurement and quality improvement, and others 
encouraging continued support of interoperability and health 
information exchange infrastructure. Several commenters agreed with the 
specific selection of high priority goals identified by CMS. Other 
commenters noted that the priority goals are too broad and not specific 
enough to outcomes and chronic disease management or that many may not 
be universally relevant across all patient populations. Commenters also 
submitted comments on specific objectives or noted that across the 
board the measures associated with these objectives are not measuring 
improvements in patient outcomes.
    Several commenters appreciated the removal of the core and menu 
structure of the objectives, while establishing a single set of 
objectives and measures in Stage 3, and believed it would reduce the 
program's complexity.
    Response: We thank the commenters for their input both on our 
selection process and on the eight key policy areas we identified as 
well as on the structure of Stage 3. We agree with commenters who note 
that a wide range of high priority health conditions, as well as 
specific specialties and characteristics of unique patient populations, 
are not explicitly recognized in our proposals or identified in the 
eight key policy areas. We note that we sought to establish a broad 
spectrum of key policy areas, which may include many varied projects, 
initiatives, and outcomes-based impact goals within their scope. The 
eight key policy areas here identified are intentionally broad in scope 
because, as noted in the proposed rule, we are seeking to align with 
overarching national health care improvement and delivery system reform 
goals and establish methods by which HIT can be leveraged by individual 
providers to support their efforts toward these key policy goals in 
their unique implementation.
    In response to commenters who specifically cited a need to focus on 
outcomes and quality improvement based on outcomes measurement, we 
agree with this assessment. We note that the goal of the EHR Incentive 
Program is largely to spur the development and adoption of health HIT 
solutions that support these broader goals. We believe that technology 
itself cannot improve care coordination or patient outcomes, but the 
use of that technology can be a tool for providers to work toward these 
key policy areas. HIT can provide efficiencies in administrative 
processes which support clinical effectiveness, leveraging automated 
patient safety checks, supporting clinical decision making, enabling 
wider access to health information for patients, and allowing for 
dynamic communication between providers. That is why we proposed a set 
of priorities for Stage 3 that focus on these concepts. However, it is 
also the reason behind our efforts to align the EHR Incentive Program 
with the National Quality Strategy and with CMS quality measurement and 
quality improvement programs like PQRS, CPCI, Pioneer ACOs and Hospital 
IQR and HVBP programs. We welcome continued input from providers and 
stakeholder groups as we continue our efforts to support and promote 
patient-centered delivery system reform.
    We note that public comments received on specific objectives and 
responses to comments for these objectives are included in the 
discussion of each objective and its

[[Page 62791]]

associated measures in section II.B.2.b of this final rule with comment 
period.
    After consideration of the comments received, we are finalizing our 
approach for setting the eight key policy areas for Stage 3 as 
proposed. We address the individual objectives and measures in section 
II.B.2.b of this final rule with comment period.
(d) Flexibility Within Meaningful Use Objectives and Measures
    We proposed to incorporate flexibility within certain objectives 
for Stage 3 for providers to choose the measures most relevant to their 
unique practice setting. As a result, 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:
     Coordination of Care through Patient Engagement--Providers 
must attest to the numerators and denominators of all three measures, 
but must only meet the thresholds for two of three measures.
     Health Information Exchange--Providers must attest to the 
numerators and denominators of all three measures, but must only meet 
the thresholds for two of three measures.
     Public Health Reporting--EPs must report on three measures 
and eligible hospitals and CAHs must report on four measures.
    For the objectives that allow providers to meet the thresholds for 
two of three measures (for example, the Coordination of Care through 
Patient Engagement objective and the Health Information Exchange 
objective), we proposed that if a provider claims an exclusion for a 
measure the provider must meet the thresholds of the remaining two 
measures to meet the 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 still meet the objective.
    Comment: We received comments supporting the flexibility proposed 
within certain objectives for Stage 3. Several commenters requested 
also allowing flexibility within other objectives not included in our 
proposal such as Computerized Provider Order Entry (CPOE) and CDS in 
order to accommodate specialties who may have low numbers of orders or 
who have limited applicable CQMs to pair with a CDS. We also received 
recommendations to change our approach toward flexibility including 
allowing providers to attest to only 2 of the 3 measures for which they 
meet the threshold to meet the objective, allowing providers to attest 
to all 3 measures and meet only 1 threshold to meet the objective, and 
variations on those concepts.
    Response: We thank the commenters and note that we did not propose 
flexibility for other objectives such as CPOE and CDS because we 
believe there are already accommodations within these objectives for 
specialists. For CPOE these are in the form of exclusions and for CDS 
providers may elect to focus their selection on high priority health 
conditions within their specialty if they do not believe they have 
adequate CQM pairings to implement. We thank those commenters who 
provided recommendations on the number of measures required for 
attestation and for the thresholds. We note that our intent to require 
attestation to all three is to ensure that the functions for all 
measures are available for provider use and to provide CMS with 
valuable data on performance from all providers on these measures.
    After consideration of the public comments received, we are 
finalizing our proposal to provide flexibility within certain measures 
as proposed.
(e) EPs Practicing in Multiple Practices/Locations
    For Stage 3, we proposed to maintain the policy from the Stage 2 
final rule (77 FR 53981) that 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. 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.
    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. We stated that 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.
     The EP could access CEHRT remotely using computing devices 
at the practice/location.
    We proposed to maintain these definitions for Stage 3.
    Comment: We received a number of comments requesting clarification 
for providers practicing in certain settings as to how they should 
calculate the percentage of their patient encounters occurring in a 
location equipped with CEHRT. Specifically, a commenter requested 
guidance on how to calculate the percentage for providers who practice 
in a long-term care facility but for whom these patient encounters 
represent less than 50 percent of their total. Another commenter 
requested clarification on how the calculation works with regards to a 
hardship exception from a payment adjustment.
    Response: Our policy is the same across practice settings: To be a 
meaningful EHR user, an EP must have 50 percent or more of his or her 
outpatient encounters during the EHR reporting period at a practice/
location or practices/locations equipped with CEHRT. Thus, EPs who 
practice in long-term care settings must track their outpatient 
encounters across their practice settings during the EHR reporting 
period and meet the 50 percent threshold. EPs who practice in multiple 
locations and lack control over the availability of CEHRT may consider 
applying for a hardship exception.
    After consideration of the public comments received, we are 
finalizing our proposal to maintain this policy as finalized in the 
Stage 2 final rule at (77 FR 53981).
(f) Denominators
    In the Stage 3 proposed rule (80 FR 16744), we note that the 
objectives for Stage 3 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 (77 FR 53982 for EPs 
and 77 FR 53983 for eligible hospitals and CAHs).
    For EPs, the references used to define the scope of the potential 
denominators for measures include the following:
     Unique patients seen by the EP during the EHR reporting 
period.

[[Page 62792]]

     Office visits.
     All medication, laboratory, and diagnostic imaging orders 
created during the reporting period.
     Transitions of care and referrals including:
    ++ When the EP is the recipient of the transition or referral, 
first encounters with a new patient and encounters with existing 
patients where a summary of care record (of any type) is provided to 
the receiving EP.
    ++ When the EP is the initiator of the transition or referral, 
transitions and referrals ordered by the EP.
    For the purposes of distinguishing settings of care in determining 
the movement of a patient, we proposed 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 also proposed 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 eligible hospitals and CAHs, the references used to define the 
scope of the potential denominators for measures include the following:
     Unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department during the EHR reporting 
period.
     All medication, laboratory, and diagnostic imaging orders 
created during the reporting period.
     Transitions of care and referrals including:
    ++ When the hospital is the recipient of a transition or referral, 
all admissions to the inpatient and emergency departments.
    ++ When the hospital is the initiator of the transition or 
referral, all discharges from the inpatient department, and after 
admissions to the emergency department when follow-up care is ordered 
by authorized providers of the hospital.
    We proposed 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 proposed 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. We stated that all 
discharges from an inpatient setting are considered a transition of 
care. We also proposed 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 to the receiving provider.
    Comment: We received a few comments noting that we inadvertently 
left out the hospital denominator termed ``inpatient bed days,'' which 
was discussed in the Stage 2 final rule.
    Response: We thank the commenters for their assistance and note 
that this was not an oversight but a deliberate omission. In the Stage 
2 final rule, we stated that while inpatient bed days was a potential 
useful inclusion in defining discharge calculations, it was not in use 
for any objective or measure (77 FR 53984). As the denominators are 
specific to the language used in the objectives and measures, we did 
not include inpatient bed days in our proposal.
    Comment: Multiple commenters requested clarification on when 
patients whose records are not maintained in CEHRT may be excluded from 
the denominator for a measure.
    Response: Each objective includes a specific designation regarding 
whether the denominator or denominators for the associated measures may 
be limited to only those records maintain in the CEHRT. We direct 
readers to the definition of each objective in Sec.  495.22 for 2015 
through 2017 and Sec.  495.24 for Stage 3, respectively.
    Comment: Several commenters offered suggestions on an approach for 
calculation for the numerators related to any measure or objective 
using the ``unique patient'' denominator (for example, patient specific 
education). These commenters requested clarification for measures which 
are based on actions for unique patients and if they may occur before, 
during, or after the reporting period. Some commenters specifically 
mentioned FAQ 8231 \5\ which specified the timing required to measure 
actions for the numerator for measures which do not explicitly state 
the timing in the numerator. The FAQ stated these actions may occur 
before, during or after the EHR reporting period if the EHR reporting 
period is less than one full year, but could not be counted if they 
occurred prior to the beginning of the year or after the end of the 
year. Commenters noted that prior interpretation used by many 
developers contradicted this guidance and interpreted the lack of a 
time distinction in the numerator to mean that the action could occur 
at any point and was not constrained to the EHR reporting period or 
even the calendar or fiscal year. Commenters requested that CMS allow a 
continuation of the prior interpretation until 2015 Edition technology 
is required in order to not force developers to change systems to a 
different calculation.
---------------------------------------------------------------------------

    \5\ FAQ #8231 https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/FAQ.html Frequently Asked 
Questions: EHR Incentive Programs.
---------------------------------------------------------------------------

    Response: We note that we do not agree with an interpretation of 
the unique patient denominator that allows for an action in previous 
reporting years to count in the numerator for a measure (such as the 
patient specific education objective and measure) in perpetuity. We 
believe that this not only skews the accuracy of the measure, it also 
is counter to the intention of establishing a benchmark of performance 
in each reporting period. We require these actions because we believe 
they should be regularly performed as part of a provider's meaningful 
use of CEHRT. In addition, this method of measurement suggested would 
cause drastic variations between providers over time based on their 
specialty, patient population, and frequency of repeat visits. We do, 
however, understand the desire to minimize the need for developers to 
change EHR technology already certified to the 2014 Edition or to 
require recertification. We address the issue of specification on 
timing directly in the applicable objectives in section II.B.2.a of 
this final rule with comment period.
    Comment: One commenter requested the removal of the qualifying 
language regarding encounters with a new patient for the denominator 
for transitions and referrals for an EP. The commenter expressed 
concern that it was burdensome to include all new patients as a 
referral and that in many cases there was no referring provider 
initiating the first encounter with the patient.
    Response: We appreciate the commenter's concern, but note that 
these denominators and definitions are for the purposes of defining the 
objectives and measures for the Medicare and Medicaid EHR Incentive 
Programs and that for the objectives where this language is included, 
we believe it is appropriate to include all new patients. Specifically, 
this denominator is used in objectives that relate to reconciling 
important patient health information including

[[Page 62793]]

medications the patient may be taking and any medication allergies the 
patient may have. We believe that it is essential that a provider 
include all new patient encounters (even those where there is no 
referring provider) in these important objectives that impact patient 
safety. Furthermore, we note that these definitions in the Stage 3 
proposed rule at 80 FR 16744 are continuations of the Stage 2 
definitions previously finalized for the Medicare and Medicaid EHR 
Incentive Programs in the Stage 2 final rule at 77 FR 53984.
    After consideration of the public comments received, we are 
finalizing these denominators and the related explanations of terms as 
proposed.
(g) Patient Authorized Representatives
    In the Stage 3 proposed rule at 80 FR 16745 we proposed the 
inclusion of patient-authorized representatives in the numerators of 
the Coordination of Care through Patient Engagement objective and the 
Patient Electronic Access objective as equivalent to the inclusion of 
the patient. 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. 
Furthermore, we 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.
    Comment: Commenters were supportive of the inclusion of a patient-
authorized representative in the Stage 3 objectives and measures 
related to patient electronic access and patient engagement. A 
commenter expressed approval of our proposal to include the patient-
authorized representative in the meaningful use numerators as 
equivalent to the patient, believing this will encourage physicians to 
treat the authorized representative in the same fashion as the patient. 
The commenter noted that this is particularly important for providers 
serving patient populations where a large percent have cognitive 
limitations or dementia and the role of the caregiver or authorized 
representative is critical. Another commenter noted that many patients 
trust and rely on their representatives to help them navigate the 
health care system, coordinate their care, and comply with treatment 
plans. Inclusion of patient-authorized representatives recognizes the 
importance of these individuals in the care and treatment of many 
patients. A number of commenters also noted that this would prove a 
substantial benefit to providers caring for parents of young children 
and working to engage the parent using these tools in relation to the 
child who is their patient.
    Response: We thank the commenters for their support and insight 
into how this policy supports the overall goals to expand the concept 
of patient engagement and support the communication continuum between 
provider and patient with the clear focus on patient-centered care.
    After consideration of the public comments received, we are 
finalizing this policy as proposed. We direct readers to the individual 
objectives and measures outlined in section II.B.2.b of this final rule 
with comment period for further discussion of this provision within the 
applicable objectives and measures.
(h) Discussion of the Relationship of the Requirements of the EHR 
Incentive Programs to CEHRT
    We proposed to continue our policy of linking each 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 HIT 
Certification Program to meet the objectives and associated measures 
for Stage 3.
    We received no comments specific to this proposal and are 
finalizing as proposed. We direct readers to the individual objectives 
and measures outline in section II.B.2.b of this final rule with 
comment period for further discussion of this provision within the 
applicable objectives and measures and to section II.B.3 of this final 
rule with comment period for discussion of the definition of CEHRT for 
the Medicare and Medicaid EHR Incentive Programs.
(i) Discussion of the Relationship Between a Stage 3 Objective and the 
Associated Measure
    We proposed to continue our Stage 1 and Stage 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 in Stage 
3.
    We received no comments specific to this proposal and are 
finalizing as proposed. We direct readers to the individual objectives 
and measures outlined in section II.B.2.b of this final with comment 
period rule for further discussion of this provision within the 
applicable objectives and measures.
2. Meaningful Use Objectives and Measures
a. Meaningful Use Objectives and Measures for 2015, 2016, and 2017
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20358), we proposed the following objectives and measures for 
EPs, eligible hospitals, and CAHs to demonstrate meaningful use for an 
EHR reporting period in 2015 through 2017. We noted that there are nine 
proposed objectives for EPs plus one consolidated public health 
reporting objective, and eight proposed objectives for eligible 
hospitals and CAHs plus one consolidated public health reporting 
objective. We proposed these objectives would be mandatory for all 
providers for an EHR reporting period beginning in 2016 and proposed to 
allow alternate exclusions and specifications for some providers in 
2015 depending on their prior participation.

Objective 1: Protect Patient Health Information

    In the EHR Incentive Programs in 2015 through 2017 proposed rule, 
we proposed at 80 FR 20358 to retain, with certain modifications, the 
Stage 2 objective and measure for Protect Electronic Health Information 
for meaningful use in 2015 through 2017. In the Stage 2 final rule (77 
FR 54002 through 54003), we discussed the benefits of safeguarding 
ePHI, as doing so is essential to all other aspects of meaningful use. 
Unintended and/or unlawful disclosures of ePHI could diminish 
consumers' confidence in EHRs and health information exchange. Ensuring 
that ePHI is adequately protected and secured would assist in 
addressing the unique risks and challenges that EHRs may present.
    We note that we were inconsistent with our naming of this objective 
calling it ``protect patient health information'' and alternately 
``protect electronic health information''. The former matches the Stage 
3 Objective (section II.B.2.b.i) while the latter is what we called it 
in our Stage 2 final rule.
    Proposed Objective: Protect electronic health information created 
or maintained by the CEHRT through the implementation of appropriate 
technical capabilities.
    Proposed Measure: Conduct or review a security risk analysis in 
accordance with the requirements in 45 CFR 164.308(a)(1), including 
addressing the security (to include encryption) of ePHI created or 
maintained in CEHRT in accordance with requirements under 45 CFR 
164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security

[[Page 62794]]

updates as necessary and correct identified security deficiencies as 
part of the EP, eligible hospital, or CAH's risk management process.
    A review must be conducted for each EHR reporting period and any 
security updates and deficiencies that are identified should be 
included in the provider's risk management process and implemented or 
corrected as dictated by that process.
    The HHS Office for Civil Rights (OCR) has issued guidance on 
conducting a security risk analysis in accordance with the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA) Security 
Rule (http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). Other free tools and resources available to 
assist providers include a Security Risk Assessment (SRA) Tool 
developed by ONC and OCR http://www.healthit.gov/providers-professionals/security-risk-assessment-tool.
    The scope of the security risk analysis for purposes of this 
meaningful use measure applies to ePHI created or maintained in CEHRT. 
However, we noted that other ePHI may be subject to the HIPAA rules, 
and we refer providers to those rules for additional security 
requirements.
    Comment: The vast majority of commenters expressed support for the 
inclusion of this objective. These commenters recognized the importance 
of protecting patient health information and agreed that this 
protection should consist of administrative, technical, and physical 
safeguards. A commenter stated that the measure is onerous for small 
practices because the elements of what constitutes a risk analysis are 
not necessarily clear. A commenter suggested an exclusion for small 
practices.
    Another commenter noted that larger healthcare networks have a 
dedicated IT staff; small practices do not, making it difficult and 
costly to meet the standards of an annual security risk analysis and 
implementing security changes.
    Response: We appreciate the commenters' support for the continued 
inclusion of this objective and measure.
    We disagree that the elements of what constitutes a security risk 
analysis are not clear. In the proposed rule, we identified the 
specific requirements in the CFR and provided links to free tools and 
resources available to assist providers, including an SRA Tool 
developed by ONC and OCR. We decline to consider exclusions, including 
for small practices, as we believe it is of utmost importance for all 
providers to protect ePHI.
    We maintain that a focus on protection of electronic personal 
health information is necessary for all providers due to the number of 
breaches reported to HHS involving lost or stolen devices.
    Comment: A commenter believes that these requirements are actually 
redundant with existing expectations for security risk assessment under 
HIPAA Security Rule compliance. The current HIPAA Security Rule 
requirement to conduct or review a security risk assessment is 
comprehensive and clearly requires providers to comply with all of its 
provisions. Thus, it seems unnecessary and overly burdensome to require 
attestation under the Medicare and Medicaid EHR Incentive Programs.
    Response: As we have stated previously, this objective and measure 
are only relevant for meaningful use and this program, and are not 
intended to supersede what is separately required under HIPAA and other 
rulemaking. We do believe it is crucial that all EPs, eligible 
hospitals, and CAHs evaluate the impact CEHRT has on their compliance 
with HIPAA and the protection of health information in general.
    Comment: A commenter requested clarification that only one risk 
assessment is required by their organization per year. The commenters 
noted that their organization has multiple groups of EPs with multiple 
90-day reporting periods in a year.
    Several commenters suggested that we incorporate the language from 
one of our frequently asked questions (FAQs) into the final rule--that 
the security risk assessment ``may be completed outside of the EHR 
reporting period timeframe but must take place no earlier than the 
start of the EHR reporting year and no later than the provider 
attestation date.''
    Many commenters suggested that we update our frequently asked 
questions that relate to security risk assessments.
    Response: As noted in the Stage 3 proposed rule (80 FR 16746) (in 
which we proposed to maintain this Stage 2 objective even into Stage 3 
with clarification on the timing for the requirements),the existing 
policy is that an analysis or review must be conducted annually for 
each EHR reporting period. We note that the security risk assessment is 
not an ``episodic'' item related only to a snapshot in time, but should 
cover the entirety of the year for which the analysis or review is 
conducted. Therefore, it is acceptable for the security risk analysis 
to be conducted outside the EHR reporting period if the reporting 
period is less than one full year. However, the analysis or review must 
be conducted within the same calendar year as the EHR reporting period, 
and if the provider attests prior to the end of the calendar year, it 
must be conducted prior to the date of attestation. An organization may 
conduct one security risk analysis or review which is applicable to all 
EPs within the organization, provided it is within the same calendar 
year and prior to any EP attestation for that calendar year. However, 
each EP is individually responsible for their own attestation and for 
independently meeting the objective. Therefore, it is incumbent on each 
individual EP to ensure that any security risk analysis or review 
conducted for the group is relevant to and fully inclusive of any 
unique implementation or use of CEHRT relevant to their individual 
practice.
    We intend to update our FAQs to reflect policy changes and 
clarifications that flow from this final rule with comment period. 
Prior versions of FAQs and those related to past program years will be 
archived and maintained for public access on our Web site at 
www.cms.gov/EHRIncentivePrograms.
    Comment: A commenter stated that the scope of the risk assessment 
in the proposed rule appears to be limited to ePHI created or 
maintained via CEHRT. The commenter questioned whether this scope is 
more limited than in prior meaningful use requirements.
    Response: The scope of the security risk analysis for the Medicare 
and Medicaid EHR Incentive Programs relates to ePHI created or 
maintained using CEHRT. We did not propose to change the scope of this 
objective and measure from the Stage 2 requirements.
    Comment: Several commenters requested a national educational 
campaign sponsored by the federal government to help physicians ensure 
that they are adequately equipped to protect electronic patient 
information.
    Response: We will continue to work with OCR and ONC on educational 
efforts related to protecting electronic health information. We agree 
that this will require ongoing education and outreach.
    After consideration of public comments received, we are finalizing 
this objective and measure as proposed with a minor modification to 
adopt the title ``Protect Patient Health Information'' for EPs, 
eligible hospitals and CAHs as follows:
Objective 1: Protect Patient Health Information
    Objective: Protect electronic health information created or 
maintained by

[[Page 62795]]

the CEHRT through the implementation of appropriate technical 
capabilities.
    Measure: Conduct or review a security risk analysis in accordance 
with the requirements in 45 CFR 164.308(a)(1), including addressing the 
security (to include encryption) of ePHI created or maintained by CEHRT 
in accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 
CFR 164.306(d)(3), and implement security updates as necessary and 
correct identified security deficiencies as part of the EP, eligible 
hospital, or CAH's risk management process.
    We are adopting Objective 1: Protect Patient Health Information at 
Sec.  495.22(e)(1)(i) for EPs and Sec.  495.22(e)(1)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measure, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 2: Clinical Decision Support
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20358), we proposed to retain the Stage 2 objective and measures 
for Clinical Decision Support (CDS) for meaningful use in 2015 through 
2017 such that CDS would be used to improve performance on high-
priority health conditions. This is a consolidated objective, which 
incorporates the Stage 1 objective to implement drug-drug and drug-
allergy interaction checks. It would be left to the provider's clinical 
discretion to select the most appropriate CDS interventions for his or 
her patient population.
    Proposed Objective: Use clinical decision support to improve 
performance on high-priority health conditions.
    We proposed that CDS interventions selected should be related to 
four or more of the CQMs on which providers would be expected to 
report. The goal of the proposed CDS objective is for providers to 
implement improvements in clinical performance for high-priority health 
conditions that would result in improved patient outcomes.
    Proposed Measure: In order for EPs, eligible hospitals, and CAHs to 
meet the objective they must satisfy both of the following measures:
     Measure 1: Implement five clinical decision support 
interventions related to four or more clinical quality measures at a 
relevant point in patient care for the entire EHR reporting period. 
Absent four clinical quality measures related to an EP, eligible 
hospital, or CAH's scope of practice or patient population, the 
clinical decision support interventions must be related to high-
priority health conditions.
     Measure 2: The EP, eligible hospital or CAH has enabled 
and implemented the functionality for drug-drug and drug allergy 
interaction checks for the entire EHR reporting period.
    For the first measure, we suggested that one of the five clinical 
decision support interventions be related to improving healthcare 
efficiency.
    Exclusion: For the second measure, any EP who writes fewer than 100 
medication orders during the EHR reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    For an EHR reporting period in 2015 only, we proposed that an EP, 
eligible hospital or CAH who is scheduled to participate in Stage 1 in 
2015 may satisfy the following Stage 1 measure instead of the Stage 2 
measure 1 as follows:
     Proposed Alternate Objective and Measure (For Measure 1): 
Objective: Implement one clinical decision support rule relevant to 
specialty or high clinical priority, or high priority hospital 
condition, along with the ability to track compliance with that rule. 
Measure: Implement one clinical decision support rule.
    Comment: Many commenters expressed support of the Clinical Decision 
Support Objective in its entirety. Several noted that the inclusion of 
this objective in the EHR Incentive Program in 2015 through 2017 
requirements ensures the continued implementation of these important 
supports for providers. In addition, commenters agree that it is best 
for CDS interventions to be implemented at the point in patient care 
that best enhances clinical decision making before taking an action on 
behalf of a patient. Some noted appreciation for the continued 
requirement for drug-drug and drug-allergy interaction checking. They 
also believe that it is a significant benefit to patient care.
    A commenter was supportive of the flexibility provided by CMS and 
ONC in the use of homegrown alerts and for nurturing a supportive 
environment for those providers developing their own homegrown alerts 
and not deterring this type of innovation with overly onerous measure 
definitions or certification requirements. Many commenters expressed 
that the use of CDS will have a positive impact on the quality, safety, 
and efficiency of care. They also supported the proposed objective and 
measures to use CDS to improve performance on high-priority health 
conditions.
    Response: We greatly appreciate and thank commenters' support for 
this objective.
    Comment: A few commenters expressed concern about the work and 
strain and the substantial cost involved in implementing, training, 
maintenance, and updating of the tools to meet the clinical decision 
support requirements.
    A commenter expressed concerned that the requirement for every EP 
to have five CDS elements pertaining to his or her scope of work may be 
overly burdensome for large organizations with highly specialized EPs 
where there may be circumstances necessary to build CDS tools that 
would only be useful for a few individuals.
    Additionally, a commenter stated there is a struggle to interpret 
whether or not each of our implemented features meet ONC's referential 
link and source attribute requirements.
    Response: We recognize commenters' concerns regarding 
implementation of the necessary tools to meet the CDS requirements. The 
companion ONC standards and certification criteria final rule for the 
2014 Edition certification (77 FR 54163 through 54292) as well as the 
2015 Edition certification criteria in the 2015 Edition final rule 
published elsewhere in this Federal Register, provide further 
information regarding the standards for CDS within CEHRT. With each 
incremental phase of meaningful use, CDS systems progress in their 
level of sophistication and ability to support patient care. It is our 
expectation that, at a minimum, providers will select CDS interventions 
to drive improvements in the delivery of care for the high-priority 
health conditions relevant to their patient population. Continuous 
quality improvement requires an iterative process in the implementation 
and evaluation of selected CDS interventions that will allow for 
ongoing learning and development. In this final rule with comment 
period, we will consider a broad range of CDS interventions that 
improve both clinical performance and the efficient use of healthcare 
resources, and as noted in the Stage 2 final rule (77 FR 53995 through 
53996), we believe sufficient CDS options exist to support providers' 
implementation of five total. Given the wide range of CDS interventions 
currently available and the continuing development of new technologies, 
we do not believe that any

[[Page 62796]]

EP, eligible hospital, or CAH would be unable to identify and implement 
five CDS interventions, as previously described. Therefore, we did not 
establish an exclusion for the first measure of this objective based on 
specialty in the Stage 2 final rule and we did not propose to change 
that policy.
    Comment: A commenter suggested we eliminate the drug-drug and drug-
allergy interaction checks as a topped out measure.
    Other commenters requested the removal of the language requiring 
participants to have CDS enabled for ``the entire reporting period,'' 
as it is challenging for participants to meet. A commenter suggested 
that we change the requirement to provide that CDS be enabled within 
the first 45 days of the reporting period and remain enabled throughout 
the reporting period.
    Another commenter believes that the level of interaction checks 
should be determined by the organizational directives, as well as the 
discretion of the clinical team.
    Response: We noted our belief that automated drug-drug and drug-
allergy checks provide important information to advise the provider's 
decisions in prescribing drugs to a patient. Because this functionality 
provides important CDS that focuses on patient health and safety, we 
proposed to continue to include the use of this functionality within 
CEHRT as part of the objective for using CDS and maintain our belief 
that this function should be enabled, as previously finalized, for the 
duration of the EHR reporting period. We note that the provider has 
discretion to implement the CDS for drug-drug and drug-allergy checks 
in a manner that is most appropriate for their organization and 
clinical needs.
    Comment: A commenter requested clarification on the exclusion and 
for similar exclusions that include the language ``fewer than 100 
(medication orders, office visits, etc.).'' Commenters requested 
further clarification that the 100 would be over the course of the full 
year and requested confirmation that providers using a shorter 
reporting period should pro-rate this total for that reporting period.
    Response: The policy is fewer than 100 during the EHR reporting 
period and this language is used consistently in both Stage 1 and Stage 
2 objectives and measures that include a similar exclusion. There is no 
distinction based on the length of the EHR reporting period and no 
option to pro-rate.
    Comment: Commenters additionally expressed concern about the 
requirement to track compliance with CDS and recommended that we allow 
them to retain the freedom to use whatever forms of CDS make sense for 
their practice including the timing of the interventions. A commenter 
stated that tracking compliance puts increased emphasis on pop-up type 
support over other types where tracking compliance does not necessarily 
happen easily and noted that provider responses to some types of CDS 
(like creating order sets for different conditions and providing health 
maintenance suggestions) are not easily tracked, and not within their 
certified system.
    Some commenters requested that CDS should be enabled to address 
conditions relevant to the EP's scope of practice. Others stated that 
children's hospitals or specialty providers should have the same level 
of choice that is available to adult hospitals and general 
practitioners, while others requested the removal of the link to CQMs 
completed. Still others requested that the five CDS interventions be 
related either to CQMs or to other metrics included in a nationally 
recognized quality improvement registry or a qualified clinical 
database registry.
    One commenter on the EHR Incentive Programs for 2015 through 2017 
proposed rule specifically requested clarification whether an example 
used in the Stage 3 proposed rule (for example, the appropriate use 
criteria for imaging services example at 80 FR 16750) could also be 
used to satisfy the CDS objective for the EHR Incentive Programs in 
2015 through 2017.
    Response: We appreciate the comments and note that in Stage 1, we 
allowed providers significant leeway in determining the CDS 
interventions most relevant to their scope of practice. In Stage 2 and 
later, we are continuing to provide the flexibility for providers to 
identify high-priority health conditions that are most appropriate for 
CDS. We expect that providers will implement many CDS interventions, 
and providers are free to choose interventions in any domain that is a 
priority to the EP, eligible hospital, or CAH.
    We also agree with the commenter that providers should be allowed 
the flexibility to determine the most appropriate CDS intervention and 
timing of the CDS. The CDS measure for EPs, eligible hospitals, and 
CAHs allows this flexibility by allowing the implementation at a 
relevant point in patient care that refers to 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. Further, 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. We believe that the 
examples outlined in the Stage 3 proposed rule and further discussed in 
the Stage 3 objective in section II.B.2.b.iii of this final rule with 
comment period are applicable for CDS in general and would apply for 
the EHR Incentive Programs in 2015 through 2017. We refer readers to 
the CDS objective description in the Stage 3 proposed rule for further 
information (80 FR 16749 through 16750).
    After consideration of the public comments received, we are 
finalizing the objective, measures, exclusions, and alternate objective 
and measure as proposed for EPs, eligible hospitals, and CAHs as 
follows:
Objective 2: Clinical Decision Support
    Objective: Use clinical decision support to improve performance on 
high-priority health conditions.
    Measure 1: Implement five clinical decision support interventions 
related to four or more clinical quality measures at a relevant point 
in patient care for the entire EHR reporting period. Absent four 
clinical quality measures related to an EP, eligible hospital, or CAH's 
scope of practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions.
    Measure 2: The EP, eligible hospital or CAH has enabled and 
implemented the functionality for drug-drug and drug allergy 
interaction checks for the entire EHR reporting period.
    Exclusions: For the second measure, any EP who writes fewer than 
100 medication orders during the EHR reporting period.
    Alternate Objective and Measure: For an EHR reporting period in 
2015 only, an EP, eligible hospital or CAH who is scheduled to 
participate in Stage 1 in 2015 may satisfy the following in place of 
Measure 1:
     Objective: Implement one clinical decision support rule 
relevant to specialty or high clinical priority, or high priority 
hospital condition, along with the ability to track compliance with 
that rule.
     Measure: Implement one clinical decision support rule.
    We are adopting Objective 2: Clinical Decision Support at Sec.  
495.22(e)(2)(i) for EPs and Sec.  495.22(e)(2)(ii) for eligible

[[Page 62797]]

hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 3: Computerized Provider Order Entry
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20359),we proposed to retain the Stage 2 objective and measures 
for CPOE for meaningful use in 2015 through 2017, with modifications 
proposed for alternate exclusions and specifications for Stage 1 
providers for an EHR reporting period in 2015.
    Proposed Objective: Use computerized provider order entry for 
medication, laboratory, and radiology orders directly entered by any 
licensed healthcare professional that can enter orders into the medical 
record per state, local, and professional guidelines.
    We define CPOE as entailing the provider's use of computer 
assistance to directly enter medical orders (for example, medications, 
consultations with other providers, laboratory services, imaging 
studies, and other auxiliary services) from a computer or mobile 
device. The order is then documented or captured in a digital, 
structured, and computable format for use in improving the safety and 
efficiency of the ordering process. CPOE improves quality and safety by 
allowing clinical decision support at the point of the order, and 
therefore, influences the initial order decision. CPOE improves safety 
and efficiency by automating aspects of the ordering process to reduce 
the possibility of communication and other errors.
    Proposed Measures: In Stage 2 of meaningful use, we adopted three 
measures for this objective:
     Measure 1: More than 60 percent of medication orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry.
     Measure 2: More than 30 percent of laboratory orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry.
     Measure 3: More than 30 percent of radiology orders 
created by the EP or by authorized providers of the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) during the 
EHR reporting period are recorded using computerized provider order 
entry.
    We proposed to retain the three distinct measures of the Stage 2 
objective to calculate a separate percentage threshold for all three 
types of orders: Medication, laboratory, and radiology. We proposed to 
retain exclusionary criteria for those providers who so infrequently 
issue an order type that it is not practical to implement CPOE for that 
order type. To calculate the percentage, CMS and ONC have worked 
together to define the following for this objective:
 Proposed Measure 1: Medication Orders
    Denominator: Number of medication orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 60 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 medication orders 
during the EHR reporting period.
 Proposed Measure 2: Laboratory Orders
    Denominator: Number of laboratory orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 30 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 laboratory orders 
during the EHR reporting period.
 Proposed Measure 3: Radiology Orders
    Denominator: Number of radiology orders created by the EP or 
authorized providers in the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
    Numerator: The number of orders in the denominator recorded using 
CPOE.
    Threshold: The resulting percentage must be more than 30 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who writes fewer than 100 radiology orders during 
the EHR reporting period.
    An EP, through a combination of meeting the thresholds and 
exclusions (or both), must satisfy all three measures for this 
objective. A hospital must meet the thresholds for all three measures.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed alternate exclusions and alternate specifications for 
this objective and measures for Stage 1 providers in 2015.
    Proposed Alternate Measure 1: More than 30 percent of all unique 
patients with at least one medication in their medication list seen by 
the EP or admitted to the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period 
have at least one medication order entered using CPOE; or more than 30 
percent of medication orders created by the EP during the EHR reporting 
period, or created by the authorized providers of the eligible hospital 
or CAH for patients admitted to their inpatient or emergency 
departments (POS 21 or 23) during the EHR reporting period, are 
recorded using computerized provider order entry.
    Proposed Alternate Exclusion for Measure 2: Provider may claim an 
exclusion for measure 2 (laboratory orders) of the Stage 2 CPOE 
objective for an EHR reporting period in 2015.
    Proposed Alternate Exclusion for Measure 3: Provider may claim an 
exclusion for measure 3 (radiology orders) of the Stage 2 CPOE 
objective for an EHR reporting period in 2015.
    Comment: A number of commenters supported the inclusion of the 
objective into the proposed rule; some supported the thresholds and 
agreed with the alternative specifications and exclusions. A few 
commenters stated the thresholds for all three measures are 
realistically achievable if scribes and clinical staff with proper 
orders are allowed to perform CPOE. A few commenters appreciated the 
clarification around who may enter orders using CPOE for purposes of 
this objective. Another commenter believed that the use of CPOE in 
conjunction with the Clinical Decision Support for interaction checking 
greatly benefits patient safety initiatives and reduces medication 
errors.

[[Page 62798]]

    Response: We appreciate the many comments of overall support for 
the CPOE objective, thresholds and alternate specifications and 
exclusions. We believe our explanation in the proposed rule at 80 FR 
20359 of which staff may enter orders using CPOE for purposes of this 
objective will alleviate some of the burden associated with providers' 
confusion. This explanation was in response to feedback from 
stakeholders requesting further information.
    Comment: A commenter opposed the objective indicating although 
there are exclusions for providers who write less than 100 orders per 
EHR reporting period for any of the measures, it still may be a high 
bar for providers new to the program or who have just completed their 
first year. Other commenters believe that Stage 1 participants would 
have difficulty meeting the objective. Another commenter requested 
lower thresholds related to CEHRT issues.
    Response: Under our proposals for 2015, new participants in the 
program or those scheduled to demonstrate Stage 1 in 2015 may attest to 
an alternate measure 1, which is the equivalent of the current Stage 1 
measure. Additionally, we proposed alternate exclusions for these 
providers for the measures for laboratory and radiology orders 
(measures 2 and 3) under CPOE. We believe the alternate specifications 
and exclusions provide ample flexibility for meeting the requirements 
in 2015.
    Comment: A few commenters stated that the definition of 
credentialed user is difficult to isolate and varies from state to 
state. Another commenter stated the physician using an EHR should be 
able to dictate who enters orders on their behalf.
    Other commenters stated they disagreed with the requirement that 
only credentialed staff may enter orders for CPOE, as not all medical 
assistants are required to be credentialed to practice. They further 
suggested that if a standard for medical assistant CPOE is required, 
then the standard should be that the medical assistant must be 
appropriately trained for CEHRT use (including CPOE) by the employer or 
CEHRT vendor in order to be counted.
    Other commenters recommended that we allow medical assistants who 
were hired and handling the paper-based equivalent of CPOE prior to the 
Stage 2 final rules (September 2012), and still with the same employing 
organization (as of September 2012), to be referred to as ``Veteran 
Medical Assistants'' and be permitted to enter CPOE.
    Another commenter proposed that the rule be revised to allow orders 
placed by licensed healthcare providers, medical interns, and certified 
medical assistants in the numerator of the measure.
    A commenter requested clarification as to whether CEHRT entries 
completed by scribes are eligible for CPOE. Another commenter inquired 
as to whether orders entered by non-physician staff through the means 
of standing orders are eligible as CPOE. A commenter requested 
clarification on whether phone orders from physicians can be considered 
CPOE if they are entered at the time of the call by a licensed 
healthcare professional that is authorized to enter orders based on the 
state regulations.
    Response: In the Stage 2 final rule (77 FR 53986) and in subsequent 
guidance in FAQ 9058,\6\ we explained for Stage 2 that a licensed 
health care provider or a medical staff person who is a credentialed 
medical assistant or is credentialed to and performs the duties 
equivalent to a credentialed medical assistant may enter orders. We 
maintain our position that medical staff must have at least a certain 
level of medical training in order to execute the related CDS for a 
CPOE order entry. We defer to the provider to determine the proper 
credentialing, training, and duties of the medical staff entering the 
orders as long as they fit within the guidelines we have proscribed. We 
believe that interns who have completed their medical training and are 
working toward appropriate licensure would fit within this definition. 
We maintain our position that, in general, scribes are not included as 
medical staff that may enter orders for purposes of the CPOE objective. 
However, we note that this policy is not specific to a job title but to 
the appropriate medical training, knowledge, and experience.
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    \6\ CMS.gov Frequently Asked Questions #9058 [EHR Incentive 
Programs] https://questions.cms.gov/faq.php?id=5005&faqId=9058.
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    Further, we note that we did not propose to change our prior policy 
on allowing providers to exclude standing orders as finalized in the 
Stage 2 final rule at 77 FR 53986.
    Finally, we believe that a circumstance involving tele-health or 
remote communication may be included in the numerator as long as the 
order entry otherwise meets the requirements of the objective and 
measures.
    Comment: A commenter stated that CPOE does not help ensure patient 
safety or encourage continuity of care, which is the premise of the 
program. They stated ``reputable labs'' are not equipped to accept 
online orders. The commenter also indicated that interoperability 
issues are also a concern with meeting this measure. They stated that 
many specialists practice in private office settings and many do not 
share the same EHR system as hospitals, laboratories, and imaging 
facilities.
    Response: We respectfully disagree with the commenter's feedback. 
As noted in the proposed rule, we believe CPOE improves quality and 
safety. For example, a CPOE for medications may trigger a clinical 
decision support checking for potential medication allergies or drug 
interactions at the point of the order and therefore, influences the 
appropriateness of initial order decision. In addition, we maintain our 
position that CPOE improves safety and efficiency by automating aspects 
of the ordering process to reduce the possibility of communication and 
other errors. However, we note that the inclusion of the order into the 
patient's electronic record allows for the exchange of that information 
electronically, while paper-based order entry systems do not.
    Comment: A commenter requested clarification on the definition of 
``exclusionary criteria.''
    Response: Exclusionary criteria are merely the exclusions listed 
for each of the measures. We specifically stated that we proposed to 
retain exclusionary criteria for those providers who so infrequently 
issue an order type that it is not practical to implement CPOE for that 
order type.
    Comment: A commenter requested a combined measure for CPOE rather 
than the requirement that the measures be broken down by lab, meds, and 
imaging and stated that a 60 percent overall threshold for all orders, 
regardless of type, would be less burdensome to report.
    Response: We respectfully disagree. As stated in the Stage 2 final 
rule (77 FR 53987), we believe providers implement CPOE for packages of 
order types which are handled similarly and so we do not believe it is 
appropriate to measure CPOE universally for all order types in one 
process. We also expressed concerns in the Stage 2 proposed rule about 
the possibility that an EP, eligible hospital, or CAH could create a 
test environment to issue the one order and not roll out the capability 
widely or at all. For these reasons, we finalized percentage thresholds 
for all three types of order medications, laboratory, and radiology, 
rather than one consolidated measure.
    Comment: A commenter recommended that we clarify in the preamble of 
the final rule that EPs can exclude ``protocol'' or ``standing orders'' 
from the denominators of the measures under the CPOE objective, as this

[[Page 62799]]

explanation was provided in the preamble of the proposed rule for Stage 
3, but not in the 2015 through 2017 proposed rule.
    Response: We did not propose changes to our policy on ``protocol'' 
or ``standing orders'' from Stage 2. We reiterate from the Stage 2 
final rule that 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. Note this 
does not require providers to exclude this category of orders from 
their numerator and denominator (77 FR 53986).
    Comment: A commenter requested clarification defining what 
constitutes an ``order'' (for example, whether an order is equivalent 
to a single transaction or if each order code in the single transaction 
represents an individual) order. The commenter also inquired whether a 
laboratory panel/profile test is counted as one order.
    Response: Each order that is associated with a specific code would 
count as one order. Multiple tests ordered at the same time count 
individually if they fall under a different order code. For example, a 
laboratory panel, which consists of one order code but multiple tests, 
would only count as one order for the purposes of CPOE. If those tests 
were ordered individually with each having its own order code, each 
test would count as an order.
    Comment: Several commenters requested that for CPOE measure 2 lab 
orders, we modify the exclusion criteria to include circumstances where 
there are no receiving centers for electronic radiology orders or lab 
orders in case there are no local or regional imaging centers that are 
set up to receive or transmit CPOE. Another commenter believed there 
should be an additional exclusion for measure 2 to address instances in 
which the lab does not want to connect electronically due to the low 
number of lab orders submitted by the physician. One commenter stated 
CPOE measures are not relevant or valuable for physician office or 
outpatient settings and should be limited only to inpatient settings 
such as hospitals.
    Some commenters stated that the CPOE objective should be considered 
topped out.
    Response: We respectfully disagree with the commenters. CPOE is the 
entry of the order into the patient's EHR that uses a specific function 
of CEHRT. CPOE does not otherwise specify how the order is filled or 
otherwise carried out. Therefore, whether the ordering of laboratory or 
radiology services using CPOE in fact results in the order being 
transmitted electronically to the laboratory or radiology center 
conducting the test does not affect a provider's performance on the 
CPOE measures. CPOE is a step in a process that takes place in both 
hospital and ambulatory settings, and we continue to believe it is 
relevant to both settings.
    Additionally, we note that when we analyzed attestation data from 
2011 through 2013, provider performance on the CPOE measures is high, 
but high performance is not the only consideration in determining 
whether to retain an objective or measure in the program. We also 
review provider performance across varying levels of participation, the 
variance between provider types at different quartiles, stakeholder 
feedback on the potential value add of the objective and measure, and 
other similar considerations. Based on these factors, we believe the 
CPOE objective should be maintained in the program as it promotes 
patient safety and clinical efficiency. In addition, we believe there 
is room for significant improvement on measure performance.
    Comment: A commenter suggested replacing ``radiology orders'' with 
``imaging orders'' to better align with the Stage 3 objective.
    Response: We appreciate the feedback and suggestion. In the 
proposed rule, we sought to make changes to the requirements for Stage 
1 and Stage 2 of meaningful use for 2015 through 2017 to align with the 
approach for Stage 3. However, as stated in the proposed rule, we also 
sought to avoid proposing new requirements that would require changes 
to the existing technology certified to the 2014 Edition certification 
criteria, and therefore, retained the three measures of the current 
Stage 2 objective (medication, laboratory, and radiology) as finalized 
in Stage 2 (77 FR 53987)
    Comment: A commenter specifically requested an exclusion for 
providers who are using a 90-day reporting period of less than 25 
medication orders for the 90-day reporting period.
    Response: We decline to change the exclusion criteria. The policy 
is fewer than 100 orders during the EHR reporting period and this 
language is used consistently in both Stage 1 and Stage 2 objectives 
and measures that include a similar exclusion. There is not a 
distinction based on the length of the EHR reporting period.
    After consideration of public comments received, we are finalizing 
the alternate exclusions and specifications with the following 
modifications based on the final policy we adopted in section 
II.B.1.b.(4)(b)(iii) of this final rule with comment period. We note 
that providers who would otherwise have been scheduled for Stage 1 in 
2016 may be required to implement technology functions for certain 
Stage 2 measures if they do not already have these functions in place 
because there is no Stage 1 equivalent to the Stage 2 measure. In 
certain cases, the improper implementation of these functions could 
represent a patient safety issue and therefore we are finalizing an 
alternate exclusion in 2016 in order to allow sufficient time for 
implementation in these circumstances. The Stage 2 CPOE objective 
measure for lab orders and the measure for radiology orders both 
require functions that a provider who was expecting to be in Stage 1 in 
2016 may not be able to safely implement in time for an EHR reporting 
period in 2016. Therefore a provider may elect to exclude from these 
two measures for an EHR reporting period in 2016 if they were 
previously scheduled to be in Stage 1 in 2016.
    We are finalizing the objective, measures, exclusions and alternate 
specifications and exclusions for EPs, eligible hospitals, and CAHs as 
follows:
Objective 3: Computerized Provider Order Entry
    Objective: Use computerized provider order entry for medication, 
laboratory, and radiology orders directly entered by any licensed 
healthcare professional that can enter orders into the medical record 
per state, local, and professional guidelines.
    Measure 1: More than 60 percent of medication orders created by the 
EP or by authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry.
     Denominator: Number of medication orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 60 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.

[[Page 62800]]

     Exclusion: Any EP who writes fewer than 100 medication 
orders during the EHR reporting period.
    Measure 2: More than 30 percent of laboratory orders created by the 
EP or by authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry.
     Denominator: Number of laboratory orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 30 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
     Exclusion: Any EP who writes fewer than 100 laboratory 
orders during the EHR reporting period.
    Measure 3: More than 30 percent of radiology orders created by the 
EP or by authorized providers of the eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry.
     Denominator: Number of radiology orders created by the EP 
or authorized providers in the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 30 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
     Exclusion: Any EP who writes fewer than 100 radiology 
orders during the EHR reporting period.
Alternate Exclusions and Specifications
     Alternate Measure 1: For Stage 1 providers in 2015, more 
than 30 percent of all unique patients with at least one medication in 
their medication list seen by the EP or admitted to the eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period have at least one medication order 
entered using CPOE; or more than 30 percent of medication orders 
created by the EP during the EHR reporting period, or created by the 
authorized providers of the eligible hospital or CAH for patients 
admitted to their inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period, are recorded using computerized 
provider order entry.
    Alternate Exclusion for Measure 2: Providers scheduled to be in 
Stage 1 in 2015 may claim an exclusion for measure 2 (laboratory 
orders) of the Stage 2 CPOE objective for an EHR reporting period in 
2015; and, providers scheduled to be in Stage 1 in 2016 may claim an 
exclusion for measure 2 (laboratory orders) of the Stage 2 CPOE 
objective for an EHR reporting period in 2016.
    Alternate Exclusion for Measure 3: Providers scheduled to be in 
Stage 1 in 2015may claim an exclusion for measure 3 (radiology orders) 
of the Stage 2 CPOE objective for an EHR reporting period in 2015; and, 
providers scheduled to be in Stage 1 in 2016 may claim an exclusion for 
measure 3 (radiology orders) of the Stage 2 CPOE objective for an EHR 
reporting period in 2016.
    We are adopting the Objective 3: Computerized Provider Order Entry 
at Sec.  495.22(e)(3)(i) for EPs and Sec.  495.22(e)(3)(ii) for 
eligible hospitals and CAHs. We further specify that in order to meet 
this objective and measures, an EP, eligible hospital, or CAH must use 
the capabilities and standards of as defined for as defined CEHRT at 
Sec.  495.4. We direct readers to section II.B.3 of this final rule 
with comment period for a discussion of the definition of CEHRT and a 
table referencing the capabilities and standards that must be used for 
each measure.
Objective 4: Electronic Prescribing
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20360),we proposed to retain the Stage 2 objective and measure 
for Electronic Prescribing (eRx) for EPs, as well as for eligible 
hospitals and CAHs, for meaningful use in 2015 through 2017. We note 
that the Stage 2 objective for eligible hospitals and CAHs is currently 
a menu objective, but we proposed the objective would be required for 
2015 through 2017, with an exception for Stage 1 eligible hospitals and 
CAHs for an EHR reporting period in 2015.
    (A) Proposed EP Objective: Generate and transmit permissible 
prescriptions electronically (eRx).
    As noted in the Stage 2 final rule at 77 FR 54035, the use of 
electronic prescribing has several advantages over having the patient 
carry the prescription or the provider directly faxing handwritten or 
typewritten prescriptions to the pharmacy. These advantages include: 
Providing decision support to promote safety and quality in the form of 
adverse interactions and other treatment possibilities; efficiency of 
the health care system by alerting the EP to generic alternatives or to 
alternatives favored by the patient's insurance plan that are equally 
effective; reduction of communication errors; and automatic comparisons 
of the medication order to others the pharmacy or third parties have 
received for the patient. We proposed to maintain these policies in the 
EHR Incentive Programs in 2015 through 2017 proposed rule (80 FR 
20361).
    Proposed EP Measure: More than 50 percent of all permissible 
prescriptions, or all prescriptions, written by the EP are queried for 
a drug formulary and transmitted electronically using CEHRT.
    We proposed to retain the exclusion introduced for Stage 2 that 
would allow EPs to exclude this objective if no pharmacies within 10 
miles of an EP's practice location at the start of his/her EHR 
reporting period accept electronic prescriptions.
    We also proposed to retain the exclusion for EPs who write fewer 
than 100 permissible prescriptions during the EHR reporting period.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of prescriptions written for drugs requiring a 
prescription in order to be dispensed other than controlled substances 
during the EHR reporting period; or Number of prescriptions written for 
drugs requiring a prescription in order to be dispensed during the EHR 
reporting period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP to meet this measure.
    Exclusions: Any EP who:
     Writes fewer than 100 permissible prescriptions during the 
EHR reporting period; or
     Does not have a pharmacy within his or her organization 
and there are no pharmacies that accept electronic prescriptions within 
10 miles of the EP's practice location at the start of his or her EHR 
reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that for an EHR reporting period in 2015, EPs scheduled 
to demonstrate Stage 1 of meaningful use may attest to the 
specifications and threshold associated with the Stage 1 measure. We 
note that for an EHR

[[Page 62801]]

reporting period beginning in 2016, all EPs must meet the 
specifications and threshold for the retained Stage 2 measure in order 
to successfully demonstrate meaningful use.
    Proposed Alternate EP Measure: More than 40 percent of all 
permissible prescriptions written by the EP are transmitted 
electronically using CEHRT.
    We proposed no alternate exclusions for this EP objective.
    Comment: We received a number of comments in support of this 
objective including commenters who stated that clinicians support 
electronic prescribing if it is efficient and does not interfere with 
workflows. Of those who supported the objective, most believe that 
electronic prescribing has clear patient and provider benefits, 
specifically with helping to reduce prescription errors. Some 
commenters also supported the proposal to continue to exclude over-the-
counter medications from the definition of prescription for the 
purposes of the electronic prescribing objective. Commenters 
specifically stated support, noting that the use of electronic 
prescribing will reduce the number of prescription drug related adverse 
events, deter the creation of fraudulent prescriptions, and decrease 
the opportunity for prescription drug misuse and abuse. Finally, a 
commenter noted that the inclusion of the drug formulary query will 
support CMS' efforts to reduce the financial burden to the patient.
    Response: We thank the commenters for their insight and support of 
this objective.
    Comment: One topic of concern expressed by commenters was how 
controlled substances would be addressed in this final rule with 
comment period given that there are certain state restrictions on how 
providers can prescribe controlled substances. Commenters stated that 
in the past, previous mandates stated that prescriptions for controlled 
substances were required have to be written, not electronically 
prescribed. Many commenters indicated they believe the inclusion of 
controlled substances should remain optional and depend on whether or 
not the state allows the electronic prescription submission of these 
types of drugs. However, other commenters noted that many states now 
allow controlled substances to be electronically prescribed either for 
all prescriptions or for certain circumstances and types of drugs. 
These commenters noted that controlled substances should be included 
where feasible, as the inclusion would reduce the paper-based 
prescription process often used for such prescriptions, as long as the 
inclusion of these prescriptions are permissible under in accordance 
with state law.
    Response: We appreciate the feedback on the inclusion of controlled 
substances and agree that at present this should remain an option for 
providers, but not be required. As the commenters note, many states 
have varying policies regarding controlled substances and may address 
different schedules, dosages, or types of prescriptions differently. 
Given these developments with states easing some of the prior 
restrictions on electronically prescribing controlled substances, we 
believe it is no longer necessary to categorically exclude controlled 
substances from the term ``permissible prescriptions.'' Therefore the 
continued inclusion of the term ``controlled substances'' in the 
denominator may no longer be an accurate description to allow for 
providers seeking to include these prescriptions in the circumstances 
where they may be included. We will define a permissible prescription 
as all drugs meeting our current Stage 2 definition of a prescription 
(77 FR 53989) with a modification to allow the inclusion of controlled 
substances where feasible and allowed by law as proposed in Stage 3 (80 
FR 16747) in the denominator of the measure. We will no longer 
distinguishing between prescriptions for controlled substances and all 
other prescriptions, and instead will refer only to permissible 
prescriptions (consistent with the definition for Stage 3 at Section 
II.B.2.b.ii). Therefore, we are changing the measure for this objective 
to remove the term controlled substances from the denominator and 
instead changing the denominator to read ``permissible prescriptions''. 
We note this is only a change in wording and does not change the 
substance of our current policy for Stage 2--which providers have the 
option, but are not required, to include prescriptions for controlled 
substances in the measure--which we will maintain for 2015 through 
2017. For the purposes of this objective, we are adopting that 
prescriptions for controlled substances may be included in the 
definition of permissible prescriptions where the electronic 
prescription of a specific medication or schedule of medications is 
permissible under state and federal law.
    Comment: A number of providers commented on the inclusion of the 
query for the drug formulary, noting that this process takes time, 
interrupts provider workflows, is burdensome for providers to conduct 
for patients who are uninsured, and often requires additional paperwork 
or manual processing in order to comply with the requirement that each 
prescription must complete a query in order to count in the numerator. 
Some providers noted a gap in the CEHRT function for this measure.
    Response: If no formulary is available for a prescription, the 
provider may still count the patient in the numerator for the measure. 
However, we understand that the formulary query may prove burdensome in 
some instances, especially when it requires additional action beyond 
the automated function in CEHRT. We believe that the query of a 
formulary can provide a benefit, and our long-term vision is the 
progress toward fully automated queries using universal standards in 
real time. In order to balance the potential benefit of this function 
with the current burden on providers, we provide the following guidance 
on how providers may count the query of a formulary. Providers may 
count a patient in the numerator where no formulary exists to conduct a 
query, providers may also limit their effort to query a formulary to 
simply using the function available to them in their CEHRT with no 
further action required. This means that if a query using the function 
of their CEHRT is not possible or shows no result, a provider is not 
required to conduct any further manual or paper-based action in order 
to complete the query, and the provider may count the prescription in 
the numerator.
    After consideration of the public comments received, we are 
finalizing changes to the language to continue to allow providers the 
option to include or exclude controlled substances in the denominator 
where such medications can be electronically prescribed. We are 
finalizing that these prescriptions may be included in the definition 
of ``permissible prescriptions'' at the providers discretion where 
allowable by law. We are modifying the measure language to maintain 
``permissible prescriptions'' and remove the ``or all prescriptions'' 
language and changing the denominator to read ``Number of permissible 
prescriptions written for drugs requiring a prescription in order to be 
dispensed during the EHR reporting period'' in accordance with this 
change. We are finalizing the alternate specifications for providers 
scheduled to demonstrate Stage 1 of meaningful for an EHR reporting 
period in 2015 as proposed.
    We are finalizing the objective, measure, exclusions and alternate 
specifications for EPs as follows:

[[Page 62802]]

Objective 4: Electronic Prescribing
    EP Objective: Generate and transmit permissible prescriptions 
electronically (eRx).
    Measure: More than 50 percent of permissible prescriptions written 
by the EP are queried for a drug formulary and transmitted 
electronically using CEHRT.
     Denominator: Number of permissible prescriptions written 
during the EHR reporting period for drugs requiring a prescription in 
order to be dispensed.
     Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
     Exclusions: Any EP who:
    [cir] Writes fewer than 100 permissible prescriptions during the 
EHR reporting period; or
    [cir] Does not have a pharmacy within his or her organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his or her EHR 
reporting period
    Alternate Specifications: Alternate EP Measure: For Stage 1 
providers in 2015, more than 40 percent of all permissible 
prescriptions written by the EP are transmitted electronically using 
CEHRT.
    We are adopting Objective 4: Electronic Prescribing at Sec.  
495.22(e)(4)(i) for EPs. We further specify that in order to meet this 
objective and measure, an EPm must use the capabilities and standards 
of as defined for as defined CEHRT at Sec.  495.4. We direct readers to 
section II.B.3 of this final rule with comment period for a discussion 
of the definition of CEHRT and a table referencing the capabilities and 
standards that must be used for each measure.
    (B) Proposed Eligible Hospital/CAH Objective: Generate and transmit 
permissible discharge prescriptions electronically (eRx).
    In the Stage 2 final rule at 77 FR 54035, we describe how the use 
of electronic prescribing has several advantages over having the 
patient carry the prescription to the pharmacy or directly faxing a 
handwritten or typewritten prescription to the pharmacy. When the 
hospital generates the prescription electronically, CEHRT can provide 
support for a number of purposes, such as: Promoting safety and quality 
in the form of decision support around adverse interactions and other 
treatment possibilities; increasing the efficiency of the health care 
system by alerting the EP to generic alternatives or to alternatives 
favored by the patient's insurance plan that are equally effective; and 
reducing communication errors by allows the pharmacy or a third party 
to automatically compare the medication order to others they have 
received for the patient. This allows for many of the same decision 
support functions enabled at the generation of the prescription, but 
with access to potentially greater information. For this reason, we 
continue to support the use of electronic prescribing for discharge 
prescriptions in a hospital setting (80 FR 20361).
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of 
hospital discharge medication orders for permissible prescriptions (for 
new, changed, and refilled prescriptions) are queried for a drug 
formulary and transmitted electronically using CEHRT.
    We proposed to retain the exclusion that would allow a hospital to 
exclude this objective if there is no internal pharmacy that can accept 
electronic prescriptions and is not located within 10 miles of any 
pharmacy that accepts electronic prescriptions at the start of their 
EHR reporting period.
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of new, changed, or refill prescriptions 
written for drugs requiring a prescription in order to be dispensed 
other than controlled substances for patients discharged during the EHR 
reporting period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted 
electronically.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an eligible hospital or CAH to meet this measure.
    Exclusion: Any eligible hospital or CAH that does not have an 
internal pharmacy that can accept electronic prescriptions and is not 
located within 10 miles of any pharmacy that accepts electronic 
prescriptions at the start of their EHR reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that eligible hospitals and CAHs scheduled to report on 
Stage 1 objectives for an EHR reporting period in 2015 may claim an 
exclusion for the Stage 2 eRx measure as there is not an equivalent 
Stage 1 measure defined at 42 CFR 495.6. We further proposed that 
eligible hospitals and CAHs scheduled to report Stage 2 objectives for 
an EHR reporting period in 2015 that were not intending to attest to 
the eRx menu objective and measure may also claim an exclusion.
    Proposed Alternate Eligible Hospital/CAH Exclusion: Provider may 
claim an exclusion for the eRx objective and measure for an EHR 
reporting period in 2015 if they were either scheduled to demonstrate 
Stage 1, which does not have an equivalent measure, or if they are 
scheduled to demonstrate Stage 2 but did not intend to select the Stage 
2 eRx menu objective for an EHR reporting period in 2015.
    We proposed no alternate specifications for this eligible hospital 
and CAH objective.
    Comment: Commenters were divided in terms of opposition to or 
support of the proposed objective for eligible hospitals and CAHs. 
Those in support expressed agreement with the concept of the 
requirement that discharge prescriptions be transmitted electronically, 
citing improvements in patient safety and reducing medication errors. 
Those in opposition predominantly cited concern over their ability to 
adopt the necessary technology by 2016.
    A commenter noted that electronic prescribing would cause 
medication errors because the hospital often makes numerous changes to 
a patient's prescription at the time of discharge, and incorrect 
prescriptions (with the wrong medication or dosage) written on paper 
can simply be torn up rather than requiring a new prescription to be 
sent and causing confusion for the patient. Other commenters also 
stated similar scenarios related to current workflows, which would need 
to be changed in order to comply with electronic prescribing 
requirements.
    Response: We thank the commenters for their input and consideration 
of this proposal. We agree that the successful implementation of 
electronic prescribing for eligible hospitals and CAHs would require 
changes to technology implementation and workflows. However, we believe 
the opportunity for efficiencies and improvements in patient safety 
outweigh these concerns. We will finalize the proposed objective and 
measure for eligible hospitals and CAHs. However, we will maintain the 
alternate exclusion through 2016 in order to allow adequate time to 
update systems and workflows to support successful and safe 
implementation.
    Comment: A number of commenters on the hospital measure also noted 
concerns over the formulary and controlled substances. As commenters on 
the EP objective noted, there are

[[Page 62803]]

currently challenges involved in effectively completing a query of a 
drug formulary universally which may cause an additional burden on 
providers. Commenters also noted that the ability to include or exclude 
controlled substances should be continued but made more flexible to 
reflect the changes regarding the allowance and feasibility of 
electronic prescribing for these medications. Some commenters noted 
this would be especially important for eligible hospitals and CAHs 
serving patients in a wide geographic region which may overlap multiple 
jurisdictions. These commenters noted that a change around the language 
to make it more flexible would allow them to include prescriptions for 
controlled substance based on an organizational policy that addressed 
any potential discrepancies. Other commenters requested clarification 
on the approach for internal pharmacies and drugs dispensed on site.
    Finally, other commenters provided feedback on the request for 
comment regarding refill prescriptions and continued medications and 
whether the measure language should be modified to only mention ``new 
prescriptions'' or ``new or changed prescriptions'' rather than the 
proposed continuation of including new, changed, and refilled 
prescriptions. The vast majority of commenters did not support 
including refilled prescriptions noting that these prescriptions should 
be included and monitored by the original prescriber. Commenters were 
divided on whether to include or exclude changed prescriptions. Some 
noting, again, that changed prescriptions should be monitored by the 
original prescriber while others noted that the change constitutes 
accountability for the prescription by the eligible hospital.
    Response: We agree these concerns are applicable for both the EP 
and the eligible hospital/CAH measures. The guidance we provided above 
regarding how providers may count the query of a formulary for the EP 
measure is also applicable for the eligible hospital/CAH measure. For 
controlled substances, based on public comment received we are 
finalizing similar changes to the denominator for the eligible hospital 
objective as were adopted for the EP objective to allow for the 
inclusion or exclusion of these prescriptions at provider discretion 
where allowable by law. We further note that prescriptions from 
internal pharmacies and drugs dispensed on site may be excluded from 
the denominator. Finally, we thank the commenters for their insight and 
will exclude refill prescriptions but maintain other prescription 
types. We agree with the rationale stated by commenters; however we 
note that many EHRs may be programmed to automatically include these 
prescriptions and a change in the definition could cause unintended 
negative consequences for EHR system developers and providers if the 
change required significant modifications to the software. Therefore we 
will modify the measure language to remove the requirement for refill 
prescriptions, but we will allow providers discretion over including or 
excluding these prescriptions rather than requiring providers to 
exclude them.
    After consideration of the public comments received, we are 
modifying our proposal and finalizing changes to the language to 
continue to allow providers the option to include or exclude controlled 
substances in the denominator where such medications can be 
electronically prescribed. We are finalizing that these prescriptions 
may be included in the definition of ``permissible prescriptions'' at 
the providers discretion where allowable by law. We are modifying the 
denominator to read ``Number of permissible new, changed, or refill 
prescriptions written for drugs requiring a prescription in order to be 
dispensed for patients discharged during the EHR reporting period'' in 
accordance with this change.
    Finally, we proposed that some of the Stage 2 objectives and 
measures do not have an equivalent Stage 1 measure and so for 2015 we 
proposed to allow providers to exclude from these measures. However, 
the eligible hospital electronic prescribing objective was included in 
this policy for both Stage 1 providers and Stage 2 providers in 2015 
because it was previously a menu measure so many Stage 2 providers may 
not be able to meet the measure in 2015 if they had not prepared to do 
so. As noted in section II.B.1.b.(4)(c)(iii), based on public comment 
we determined to also allow alternate exclusions in 2016 for certain 
measures. We determined this to be necessary because, for certain 
measures providers may not have the specific CEHRT function required to 
support the measure if they were not prepared to attest to that measure 
in 2015. These providers may not be able to successfully obtain and 
fully and safely implement the technology in time to succeed at the 
measure for an EHR reporting period in 2016. In the case of electronic 
prescribing, accelerating the implementation of the technology in a 
short time frame could present a patient safety risk, and so therefore 
for the eligible hospital objective we are finalizing an alternate 
exclusion in 2016 for eligible hospitals scheduled for Stage 1 or Stage 
2 in 2016. We believe this change will provide the time necessary to 
safely implement the technology for eligible hospitals and CAHs. 
Therefore, we are finalizing the alternate exclusion for providers 
scheduled to demonstrate meaningful for an EHR reporting period in 
2015with an extension of the exclusion into 2016.
    We are finalizing the objective, measure, exclusions, and alternate 
exclusion for eligible hospitals and CAHs as follows:
Objective 4: Electronic Prescribing
    Eligible Hospital/CAH Objective: Generate and transmit permissible 
discharge prescriptions electronically (eRx).
    Measure: More than 10 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.
     Denominator: Number of new or changed permissible 
prescriptions written for drugs requiring a prescription in order to be 
dispensed for patients discharged during the EHR reporting period.
     Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted 
electronically.
     Threshold: The resulting percentage must be more than 10 
percent in order for an eligible hospital or CAH to meet this measure.
     Exclusions: Any eligible hospital or CAH that does not 
have an internal pharmacy that can accept electronic prescriptions and 
is not located within 10 miles of any pharmacy that accepts electronic 
prescriptions at the start of their EHR reporting period.
    Alternate Exclusion: Alternate Eligible Hospital/CAH Exclusion: The 
eligible hospital or CAH may claim an exclusion for the eRx objective 
and measure if for an EHR reporting period in 2015 if they were either 
scheduled to demonstrate Stage 1, which does not have an equivalent 
measure, or if they are scheduled to demonstrate Stage 2 but did not 
intend to select the Stage 2 eRx objective for an EHR reporting period 
in 2015; and, the eligible hospital or CAH may claim an exclusion for 
the eRx objective and measure for an EHR reporting period in 2016 if 
they were either scheduled to demonstrate Stage 1 in 2016 or if they 
are scheduled to demonstrate Stage 2 but did not intend to select the 
Stage 2 eRx objective for an EHR reporting period in 2016.
    We are adopting the Objective 4: Electronic Prescribing at Sec.  
495.22(e)(4)(ii) for eligible hospitals

[[Page 62804]]

and CAHs. We further specify that in order to meet this objective and 
measure, an eligible hospital or CAH must use the capabilities and 
standards of as defined for as defined CEHRT at Sec.  495.4. We direct 
readers to section II.B.3 of this final rule with comment period for a 
discussion of the definition of CEHRT and a table referencing the 
capabilities and standards that must be used for each measure.
Objective 5: Health Information Exchange
    For Objective 5: Summary of Care (here retitled to Health 
Information Exchange), we proposed to retain only the second measure of 
the existing Stage 2 Summary of Care objective for meaningful use in 
2015 through 2017 (80 FR 20361) and directed readers to the full 
description in the Stage 2 final rule at 77 FR 54013 through 54021.
    Proposed Objective: The EP, eligible hospital or CAH who 
transitions their patient to another setting of care or provider of 
care or refers their patient to another provider of care provides a 
summary care record for each transition of care or referral.
    Proposed Measure: The EP, eligible hospital or CAH that transitions 
or refers their patient to another setting of care or provider of care 
that--(1) Uses CEHRT to create a summary of care record; and (2) 
electronically transmits such summary to a receiving provider for more 
than 10 percent of transitions of care and referrals.
    We proposed to retain an updated version of the second measure of 
the Stage 2 Summary of Care objective with modifications based on 
guidance provided through CMS responses to frequently asked questions 
we have received since the publication of the Stage 2 final rule. We 
proposed to retain this measure for electronic transmittal because we 
believe that the electronic exchange of health information between 
providers would encourage the sharing of the patient care summary from 
one provider to another and important information that the patient may 
not have been able to provide. This can significantly improve the 
quality and safety of referral care and reduce unnecessary and 
redundant testing. Use of common standards in creating the summary of 
care record can significantly reduce the cost and complexity of 
interfaces between different systems and promote widespread exchange 
and interoperability.
    The proposed updates to this measure reflect stakeholder input 
regarding operational challenges in meeting this measure, and seek to 
increase flexibility for providers while continuing to drive 
interoperability across care settings and encouraging further 
innovation. Previously, the measure specified the manner in which the 
summary of care must be electronically transmitted stating: Providers 
must either--(1) Electronically transmit the summary of care using 
CEHRT to a recipient; or (2) where the recipient receives the summary 
of care record via exchange facilitated by an organization that is a 
Nationwide Health Information Network (NwHIN) Exchange participant or 
in a manner that is consistent with the governance mechanism ONC 
establishes for the nationwide health information network. We proposed 
to update this measure to state simply that a provider would be 
required to create the summary of care record using CEHRT and transmit 
the summary of care record electronically.
    To calculate the percentage of the measure, CMS and ONC have worked 
together to define the following for this objective:
    Denominator: Number of transitions of care and referrals during the 
EHR reporting period for which the EP's 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 CEHRT and 
exchanged electronically.
    Threshold: The percentage must be more than 10 percent in order for 
an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who transfers a patient to another setting or 
refers a patient to another provider less than 100 times during the EHR 
reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that providers scheduled to demonstrate Stage 1 of 
meaningful use for an EHR reporting period in 2015 may claim an 
exclusion for Measure 2 of the Stage 2 Summary of Care core objective 
because there is not an equivalent Stage 1 measure.
    Proposed Alternate Exclusion: Provider may claim an exclusion for 
the measure of the Stage 2 Summary of Care objective, which requires 
the electronic transmission of a summary of care document if, for an 
EHR reporting period in 2015, they were scheduled to demonstrate Stage 
1, which does not have an equivalent measure.
    We proposed no alternate specifications for this objective.
    Comment: Many commenters supported our efforts towards 
interoperability and continuity of care. Commenters' general opposition 
to our original Stage 2 efforts included concerns about building the 
direct tool into existing systems being difficult and expensive, as 
well as the lack of receiving facilities capable of direct exchange. 
Commenters provided a number of general recommendations, including 
suggestions for keeping data private, allowing providers more freedom 
regarding which information is included in the summary of care 
documents, and permitting more alternative technologies to meet the 
measure. In addition, many commenters expressed the need for a more 
coordinated effort towards data integration on a national scale, such 
as a centralized data registry and national standards for interaction 
and interfacing with data through CEHRT.
    Response: We appreciate the comments provided and the wide range of 
subjects raised in the comments. We agree with the general sentiment 
that a continued push for improved infrastructure, flexibility, and 
interoperability among data systems is necessary and appreciate the 
continued efforts of providers to play a role in this ongoing effort to 
modernize health care information systems and promote better care 
coordination through electronic health information exchange.
    Comment: Some commenters expressed a general confusion that there 
was not a list of the required data elements for the C-CDA in the 
proposed rule. Some commenters expressed an assumption that because we 
did not restate the previously finalized list, we are allowing 
providers to determine the data and information to include in the 
summary of care document. Other commenters noted that in the numerator 
discussion for the summary of care, the problem list, medication list 
and medication allergy list requirement is not reflected, but in 
subsequent text in the proposed rule the required inclusion of these 
data elements is clearly identified. These commenters suggest 
clarification of this point.
    Finally, some commenters asked if the omission was intentional and 
if we intended that the data elements would still be available for 
providers to use discretion on a case-by-case basis. Other commenters 
did not express confusion about the requirement, but did not that some 
flexibility would be welcome as their trading partners are often 
overwhelmed by the amount of unnecessary information they receive, 
especially in relation to extensive

[[Page 62805]]

laboratory test results. The commenters suggested that allowing 
individual providers some flexibility to determine what is important 
and relevant to send to the next provider in care would allow receiving 
providers to process and use the information more effectively.
    Response: First, we note that we did not intend to cause this 
confusion. As stated in the EHR Incentive Program in 2015 through 2017 
proposed rule at (80 FR 20361) we proposed to maintain the second 
measure of the Stage 2 Summary of Care Objective with certain 
modifications. For efficiency and to reduce the overall length of the 
proposed rule, we focused our discussion on the proposed modifications 
and referenced the full description of the measure in the Stage 2 final 
rule at 77 FR 54013 through 54021. The only modifications that we 
intended to make were those that we expressly discussed, and unless we 
indicated otherwise, our intention was to maintain the existing Stage 2 
policies for the measure. This includes maintaining the requirements 
for the data elements included in the summary of care document at 77 FR 
54016 as follows:
    ``All summary of care documents used to meet this objective must 
include the following information if the provider knows it:
     Patient name.
     Referring or transitioning provider's name and office 
contact information (EP only).
     Procedures.
     Encounter diagnosis
     Immunizations.
     Laboratory test results.
     Vital signs (height, weight, blood pressure, BMI).
     Smoking status.
     Functional status, including activities of daily living, 
cognitive and disability status.
     Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
     Care plan field, including goals and instructions.
     Care team including the primary care provider of record 
and any additional known care team members beyond the referring or 
transitioning provider and the receiving provider.
     Discharge instructions (Hospital Only)
     Reason for referral (EP only)
    In circumstances where there is no information available to 
populate one or more of the fields listed previously, either because 
the EP, eligible hospital, or CAH can be excluded from recording such 
information (for example, vital signs) or because there is no 
information to record (for example, laboratory tests), the EP, eligible 
hospital, or CAH may leave the field(s) blank and still meet the 
objective and its associated measure.
    In addition, all summary of care documents used to meet this 
objective must include the following in order to be considered a 
summary of care document for this objective:
     Current problem list (providers may also include 
historical problems at their discretion),
     Current medication list, and
     Current medication allergy list.
    An EP or hospital must verify these three fields for current 
problem list, current medication list, and current medication allergy 
list are not blank and include the most recent information known by the 
EP or hospital as of the time of generating the summary of care 
document.''
    We intend to maintain this policy of the required data elements for 
the C-CDA as previously finalized. However, we do understand provider 
concern over the ability to exercise some discretion over the amount of 
data transmitted, and as noted in the Stage 3 proposed rule (80 FR 
16760) we recognize there may be reasons to apply a policy of 
determining clinical relevance for the amount of data in the lab 
results field and clinical notes field which should be included in the 
summary of care document. Specifically, it may be beneficial for a 
provider to limit the lab results transmitted in the record of an 
extended hospital stay to those which best represent the patient status 
upon admission, any outliers or abnormal results, and the patient 
status upon discharge. Further, we note that this is only one example 
and other definitions of clinical relevance for lab results may apply 
in other clinical settings and for other situations. We are therefore 
adopting a similar policy for this measure as the one outlined for 
Stage 3; however, we are limiting this policy to lab results. We are 
therefore requiring that a provider must have the ability to send all 
laboratory test results in the summary of care document, but that a 
provider may work with their system developer to establish clinically 
relevant parameters based on their specialty, patient population, or 
for certain transitions and referrals which allow for clinical 
relevance to determine the most appropriate results for given 
transition or referral. We further note that a provider who limits the 
results in a summary of care document must send the full results upon 
the request of the receiving provider or upon the request by the 
patient. For discussion of this proposal in relation to the Stage 3 
objective in this final rule with comment period we direct readers to 
section II.B.2.b.vii.
    Comment: Many commenters supported the modified objective removing 
the 50 percent measure for providing a summary of care record by any 
means, as well as the measure's widening of the pathways acceptable for 
transmitting Summary of Care records. These commenters noted that the 
relaxation of requirements for manual transmission will allow them to 
better tailor the contents of the summary of care document to the 
transport mechanism and will, in fact, encourage the electronic 
adoption because of the ease of obtaining a full range of information 
on a patient as compared to non-electronic transport mechanisms.
    Response: As noted previously, the general movement away from 
requiring reporting on paper-based measures is intended to allow 
providers to focus efforts on the use of CEHRT to support health 
information exchange. We agree that limiting the EHR Incentive Program 
objectives and measures exclusively to electronic transmissions while 
simultaneously expanding the options by which such exchange may occur 
will allow developers, providers, and the industry as a whole to focus 
on the support of HIE infrastructure while supporting innovation in 
interoperable health IT development.
    Comment: Many commenters expressed opposition to the objective 
noting a lack of participation by EPs to whom the referrals are made. A 
large number of commenters believe that they should not be penalized 
for other EPs inability to receive electronic delivery, something over 
which they state they have no control. In addition, some primary care 
doctors believe they are unfairly being held responsible for 
communicating with specialists who can claim an exclusion for referring 
less than 100 times. Many commenters requested that we reduce the 
threshold or change the measure to a yes/no attestation due to the lack 
of control over other EPs and eligible hospitals/CAHs without receiving 
capabilities. Many recommendations about the denominator varied, with 
some suggesting that the denominator referrals should exclude providers 
who are not EPs, eligible hospitals, or CAHs under the EHR Incentive 
Programs or should exclude patients who do not choose a specific 
provider for their recommended referral service. Commenters also 
requested various exclusions, including exclusions for transitions to 
pediatric providers, referrals to therapists, and for those in areas 
where there are not enough EPs

[[Page 62806]]

participating in Stage 2. Commenters requested clarifications on the 
measure regarding what constitutes ``transfer of care'' and what 
defines electronic transmissions.
    Response: We appreciate the commenters' concern about a lack of 
participation by EPs to whom the referrals are made and note that this 
is one reason behind the relatively low 10 percent threshold for this 
measure. We also note that in the proposed rule, we expressed a concern 
that a key factor influencing successful HIE is the active 
participation of a large number of providers in the process. We note 
that those providers who did participate in electronic exchange through 
Stage 2 in 2014 performed reasonably well on the measure, but through 
letters and public comment expressed a need for wider participation 
among providers to ensure a significant number of trading partners are 
available for electronic exchange. This is a driving influence behind 
our continued support of this measure and the move to require all 
providers to participate in this objective and measure beginning in 
2016.The definition of a transition of care for this objective was 
finalized in the Stage 2 final rule where we outline the denominators 
for the various objectives and measures (77 FR 53984). We subsequently 
further defined (80 FR 16759) a transition of care for electronic 
exchange as one where the referring provider is under a different 
billing identity within the Medicare and Medicaid EHR Incentive 
Programs than the receiving provider and where the providers do not 
share access to the EHR. In cases where the providers do share access 
to the EHR, a transition or referral may still count toward the measure 
if the referring providers creates the summary of care document using 
CEHRT and sends the summary of care document electronically. If a 
provider chooses to include such transitions to providers where access 
to the EHR is shared, they must do so universally for all patient and 
all transitions or referrals.
    Comment: Some commenters requested an extension of the alternate 
exclusion for Stage 1 providers into 2016 rather than only making this 
allowance for 2015.
    Response: We do not believe that extending the alternate exclusion 
into 2016 serves the goals of the program to promote interoperability, 
an expanded HIT infrastructure, and the use of HIT to support care 
coordination. As noted previously, one of the biggest concerns 
expressed by providers seeking to engage in HIE is the need to increase 
overall participation to ensure an adequate pool of trading partners 
exists within the industry. We believe that requiring all participating 
providers to exchange health information electronically when 
transitioning or referring a patient to a new setting of care, but 
maintaining the reasonably low threshold at 10 percent, represents a 
reasonable balance between promoting participation and setting an 
achievable goal for providers.
    We acknowledge that in some cases we have decided to extend the 
alternate exclusion for 2015 into 2016 where a provider may not have 
the appropriate CEHRT functions in place for a measure. However, we 
have limited those instances to those cases where rushed implementation 
of the function could present a risk to patient safety. We do not 
believe this objective and measure pose such a risk, and further 
maintain our assertion from the Stage 3 proposed rule (80 FR 16739) 
that overall success on in health information exchange is enhanced by 
increased participation.
    Comment: Many commenters supported the modified objective and the 
flexibility proposed around the pathways acceptable for transmitting 
Summary of Care records. Some commenters noted this change will 
facilitate queried exchange and encourage providers to push information 
to an HIE. Another commenter believes that this update will enhance the 
growth and utilization of the electronic exchange of information while 
upholding the same security standards as DIRECT or NwHIN.
    Some commenters requested that we initiate the mandatory reporting 
of direct address directories to a central repository so that 
established standards will help providers meet future requirements in 
Stage 3.
    Response: The intent behind the expansion of the potential 
transport mechanism proposed is to drive interoperability across care 
settings and encourage further innovation in electronic health 
information exchange and care coordination. We agree that the retention 
of the document standards for health information exchange will help to 
support interoperability, while allowing providers a wider range of 
options for the electronic transport mechanism. This will also mitigate 
difficulties for providers whose most common referrals may be to other 
caregivers who are not using a Direct transport mechanism. We note that 
CEHRT is required to be able to receive a C-CDA, but that the potential 
to use a wider range of transport mechanisms will allow for greater 
diversity of information exchange.
    While we encourage the use of query-based exchange for many use 
cases, we note that to count in the numerator the sending provider must 
reasonable certainty of receipt of the summary of care document. This 
means that a ``push'' to an HIE which might be queried by the recipient 
is insufficient. Instead, r the referring provider must confirmation 
that a query was made to count the action toward the measure. We 
further specify that the exchange must comply with the privacy and 
security protocols for ePHI under HIPAA.
    We thank the commenters for the suggestion around the concept of an 
information exchange address repository. We agree that a potential 
model which might allow for easier access to health information 
exchange contact information could be a positive step toward supporting 
interoperability and an improved care continuum. We refer readers to 
section II.D.3 of this final rule with comment period for further 
discussion of the collection of direct addresses or health information 
exchange information for potential inclusion in a nationwide healthcare 
provider directory. After consideration of public comments received, we 
are finalizing this objective, measure, exclusion, and alternate 
exclusion as proposed for EPs, eligible hospitals, and CAHs as follows:
Objective 5: Health Information Exchange
    Objective: The EP, eligible hospital or CAH who transitions their 
patient to another setting of care or provider of care or refers their 
patient to another provider of care provides a summary care record for 
each transition of care or referral.
    Measure: The EP, eligible hospital or CAH that transitions or 
refers their patient to another setting of care or provider of care 
must--(1) Use CEHRT to create a summary of care record; and (2) 
electronically transmit such summary to a receiving provider for more 
than 10 percent of transitions of care and referrals.
    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 CEHRT and 
exchanged electronically.
    Threshold: The percentage must be more than 10 percent in order for 
an EP,

[[Page 62807]]

eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who transfers a patient to another setting or 
refers a patient to another provider less than 100 times during the EHR 
reporting period.
    Alternate Exclusion:
    Alternate Exclusion: Provider may claim an exclusion for the Stage 
2 measure that requires the electronic transmission of a summary of 
care document if for an EHR reporting period in 2015, they were 
scheduled to demonstrate Stage 1, which does not have an equivalent 
measure.
    We are adopting Objective 5: Health Information Exchange at Sec.  
495.22(e)(5)(i) for EPs and Sec.  495.22(e)(5)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 6: Patient-Specific Education
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20362), we proposed to retain the Stage 2 objective and measure 
for Patient-Specific Education for meaningful use for 2015 through 
2017.
    Proposed Objective: Use clinically relevant information from CEHRT 
to identify patient-specific education resources and provide those 
resources to the patient.
    In the Stage 2 proposed rule (77 FR 54011), we explained that 
providing clinically relevant education resources to patients is a 
priority for the meaningful use of CEHRT. While CEHRT must be used to 
identify patient-specific education resources, these resources or 
materials do not have to be maintained within or generated by the 
CEHRT. We are aware that there are many electronic resources available 
for patient education materials, such as through the National Library 
of Medicine's MedlinePlus (http://www.nlm.nih.gov/medlineplus), that 
can be queried via CEHRT (that is, specific patient characteristics are 
linked to specific consumer health content). The EP or hospital should 
use CEHRT in a manner in which the technology suggests patient-specific 
educational resources based on the information created or maintained in 
the CEHRT. CEHRT is certified to use the patient's problem list, 
medication list, or laboratory test results to identify the patient-
specific educational resources. The EP or eligible hospital may use 
these elements or additional elements within CEHRT to identify 
educational resources specific to patients' needs. The EP or hospital 
can then provide these educational resources to patients in a useful 
format for the patient (such as electronic copy, printed copy, 
electronic link to source materials, through a patient portal or PHR).
    Proposed EP Measure: Patient-specific education resources 
identified by CEHRT are provided to patients for more than 10 percent 
of all unique patients with office visits seen by the EP during the EHR 
reporting period.
    We proposed to retain the exclusion for EPs who have no office 
visits in order to accommodate such EPs.
    The resources would have to be those identified by CEHRT. If 
resources are not identified by CEHRT and provided to the patient, then 
it would not be counted in the numerator. We do not intend through this 
requirement to limit the education resources provided to patients to 
only those identified by CEHRT. The education resources would need to 
be provided prior to the calculation and subsequent attestation to 
meaningful use.
    To calculate the percentage for EPs, CMS, and ONC have worked 
together to define the following for this objective:
    Denominator: Number of unique patients with office visits seen by 
the EP during the EHR reporting period.
    Numerator: Number of patients in the denominator who were provided 
patient-specific education resources identified by the CEHRT.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an EP to meet this measure.
    Exclusion: Any EP who has no office visits during the EHR reporting 
period.
    Proposed Eligible Hospital/CAH Measure: More than 10 percent of all 
unique patients admitted to the eligible hospital's or CAH's inpatient 
or emergency department (POS 21 or 23) are provided patient-specific 
education resources identified by CEHRT.
    To calculate the percentage for hospitals, CMS and ONC have worked 
together to define the following for this objective:
    Denominator: Number of unique patients admitted to the eligible 
hospital or CAH inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period.
    Numerator: Number of patients in the denominator who are 
subsequently provided patient-specific education resources identified 
by CEHRT.
    Threshold: The resulting percentage must be more than 10 percent in 
order for an eligible hospital or CAH to meet this measure.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    While the Patient-Specific Education objective is designated as an 
optional menu objective in Stage 1, the same objective is a mandatory 
core objective in Stage 2. We expect that not all Stage 1 scheduled 
providers were planning to choose this menu objective when attesting in 
an EHR reporting period in 2015. Therefore, we proposed that any 
provider scheduled to demonstrate Stage 1 of meaningful use for an EHR 
reporting period in 2015 who was not intending to attest to the Stage 1 
Patient-Specific Education menu objective, may claim an exclusion to 
the measure. We note that for an EHR reporting period beginning in 
2016, all providers must attest to the objective and measure and meet 
the Stage 2 specifications and threshold in order to successfully 
demonstrate meaningful use.
    Proposed Alternate Exclusion: Providers may claim an exclusion for 
the measure of the Stage 2 Patient-Specific Education objective if for 
an EHR reporting period in 2015 they were scheduled to demonstrate 
Stage 1 but did not intend to select the Stage 1 Patient Specific 
Education menu objective.
    We proposed no alternate specifications for this objective.
    Comment: The vast majority of commenters expressed support for the 
inclusion of the Patient-Specific Education objective in the EHR 
Incentive Programs for 2015 through 2017 proposed rule. They recognized 
the importance of supplying patients with materials about their 
conditions and summaries about their visits.
    Response: We thank the commenters for their support of this 
objective.
    Comment: Those who opposed the objective believe that the inclusion 
of the objective in the EHR Incentive Programs for 2015 through 2017 
proposed rule increased administrative burden on providers. Some 
commenters opposed to the objective believe that physicians should have 
flexibility regarding the sources and types of materials they can 
provide to their patients, rather than being limited to those 
identified by CEHRT.
    Response: We appreciate the insight from providers and note that 
the intent of the objective is to promote wider availability of 
patient-specific education leveraging the function of CEHRT, as noted 
in the similar, electronic-only

[[Page 62808]]

Stage 3 proposed measure. We note that this should in no way limit the 
provider's selection of patient-specific education materials or 
provision of paper-based education materials for patients if the 
provider deems such an action beneficial and of use to the patient. We 
are simply not requiring providers to count and report any such 
provision that falls outside the definition for the EHR Incentive 
Programs for 2015 through 2017 as described in this objective and 
measure.
    Comment: Multiple commenters requested clarification of the 
timeframe in which the information should be shared with the patient. 
Commenters specifically requested additional clarity on FAQ 8231 \7\ 
released by CMS, stating the actions taken would need to fall within 
the reporting year, even if they fall outside of the reporting period. 
For the patient education measure of this objective, some commenters 
believe requiring the action to occur during the reporting period 
promotes wasted resources and functions from the provider. Specialty 
providers who are providing long-term care for a patient would need to 
send out patient education for what would amount to the same problem 
each year. This education could have been provided in a previous year 
to the patient, and the FAQ is stating the patient be provided the 
education again in order to count for the numerator in the current 
reporting year. Commenters further noted that many specialist EPs 
provide education at the beginning of an engagement with a patient 
appropriate to their condition with the intent that it be applicable to 
the entire duration of the treatment of the patient's condition. 
Commenters expressed concern that the policy would require the provider 
to either provide repetitive education or identify additional 
educational opportunities in order to count the action in the 
numerator. The commenters state that allowing for any prior action to 
count would reduce the unnecessary burden placed on physicians, and the 
waste of resources to provide the patient with repetitive information.
---------------------------------------------------------------------------

    \7\ FAQ #8231: CMS Frequently Asked Questions: EHR Incentive 
Programs https://questions.cms.gov/faq.php?faqId=8231.
---------------------------------------------------------------------------

    Response: As discussed in section II.B.1.b.(4), some measures in 
the Stage 2 final rule did not include a specification on the timing 
when an action must occur for inclusion in the numerator. The Stage 2 
patient-specific education objective did not contain language stating 
that the provision of patient-specific education must occur within the 
office visit or during the hospital stay. For EPs the measure states 
only that the patient had an office visit during the EHR reporting 
period and was provided patient-specific education. This could refer to 
materials provided during an office visit or at another point in time.
    However, we disagree with the recommendation to allow any action to 
count in perpetuity. We note that this measure refers to a single 
action for each unique patient seen during the EHR reporting period. 
This means that if a provider meets the minimum action, even for those 
patients who have multiple office visits within an EHR reporting 
period, the provider would be providing educational information a 
single time each year for only just over 10 percent of their patients. 
We strongly disagree that this represents an unreasonable burden or 
that this action should not be required to continue on an annual basis. 
We disagree with the commenter's suggestion that patient specific 
education is not useful or relevant for a patient for each year in 
which they receive medical care. We further disagree with the examples 
provided for specialists or other providers providing long-term care or 
working with a patient to manage a chronic disease that a single 
provision of patient specific education should be counted for the 
numerator in perpetuity. Research shows that continued patient 
engagement and education positively impacts patient outcomes, 
especially for patients with a chronic disease and patients who may 
experience health disparities.\8\ In addition, as a patient ages, or as 
their health condition changes, their needs for education about their 
care may also change.
---------------------------------------------------------------------------

    \8\ ``Patient Education and Empowerment Can Improve Health 
Outcomes for Diabetes'' NY Presbyterian DSME study August 2014: 
http://www.nyp.org/news/hospital/2014-education-diabetes.html.
    Keolling,Todd M., MD; Monica L. Johnson, RN; Robert J. Cody, MD; 
Keith D. Aaronson, MD, MS: ``Discharge Education Improves Clinical 
Outcomes in Patients with Chronic Heart Failure'' Heart Failure: AHA 
Journals: http://circ.ahajournals.org/content/111/2/179.full.
---------------------------------------------------------------------------

    Therefore, as indicated in FAQ 8231, we believe that while the 
patient-specific education resources may be provided outside of the EHR 
reporting period, this action must occur no earlier than the start of 
the same year as the EHR reporting period if the EHR reporting period 
is less than one full calendar year and no later than the date of 
attestation. For the eligible hospital and CAH measure, the numerator 
includes the qualifier ``subsequently'' which indicates the patient-
specific education resources must be provided after the patient's 
admission to the hospital, and consistent with FAQ 8231, no later than 
the date of attestation. As noted in section II.B.1.b.(4)(b), some EHRs 
may have previously been designed and certified to calculate this 
measure based on a prior assumption, and for that reason we will not 
require this method of calculation until the EHR reporting period in 
2017 in order to allow sufficient time for the calculation to be 
updated in systems.
    Comment: Other commenters were concerned that the exclusion for 
providers who were scheduled for Stage 1 but ``did not intend to select 
the Stage 1 Patient Education menu objective'' is vague and will lead 
to audit problems.
    Response: We refer readers to the discussion of intent in section 
II.B.1.b.(4).(b)(iii) of this final rule with comment period where we 
acknowledge that it may be difficult for a provider to document intent 
and will not require such documentation.
    Comment: Multiple commenters recommended that we add the Patient-
Specific Education objective to the list of topped-out measures. 
Another group of commenters recommended that we provide an alternate 
measure for eligible hospitals/CAHs/EPs that were scheduled to be in 
Stage 1 in 2015 and desired to select patient education as a menu 
objective utilizing the current Stage 1 measure definition. Others 
recommended we require that providers have multi-lingual and low-
literacy patient portals.
    Response: We respectfully disagree that the measure is topped out 
and believe there is value in continued measurement especially in light 
of the inclusion of the similar electronic measure within Stage 3. We 
also disagree with the recommendation to include an alternate 
specification for the measure in addition to the alternate exclusion. 
While the policy would allow some providers to attest, it adds an 
additional level of complexity and makes no accommodation for those 
providers in 2015 who have not been engaged in the measure at all, as 
they did not intend to attest to that menu selection. Finally, we 
appreciate the recommendation on the inclusion of multi-lingual and 
low-literacy patient portals to provide and support patient education 
for a wider range of patients. We note that it is a priority of CMS and 
ONC to continue to foster interoperability between assistive 
technologies, portals such as those recommended by the commenters, 
applications leveraging multi-media supports, and other accessible 
tools and CEHRT. Unfortunately, while we strongly encourage adoption of 
these resources and support the development

[[Page 62809]]

of standards and testing, we believe the requirement of these tools for 
all providers in the Medicare and Medicaid EHR Incentive Programs is 
premature based on the current availability of such interoperable 
resources in the EHR marketplace.
    Comment: Some commenters requested clarification if the transitive 
effect described in FAQ 7735 and FAQ 9686 applies for the patient-
specific education objective as well. These commenters note that if 
patient-specific education is provided via a patient portal, it is very 
difficult to measure as attributable to a specific provider within a 
group practice or even across settings if providers are sharing an EHR.
    Response: FAQ7735 and FAQ 9686 refer to the Patient Electronic 
Access Objective measures 2 and the Secure Electronic Messaging 
Objective respectively,\9\ and allow for a single action by a patient 
to count in the numerator for multiple providers under certain 
circumstances if each of the providers has the patient in their 
denominator for that EHR reporting period. In each case, this policy is 
intended to facilitate calculation in circumstances where accurate 
calculation and attribution of the action to a single provider may be 
impossible. This is not inherently the case with the patient-specific 
education objective which is why this objective is not included in 
either FAQ. The Stage 2 Patient-specific Education Objective (80 FR 
20362) does not limit the measure to education provided via a patient 
portal and therefore a universal policy allowing the ``transitive 
effect'' would not be appropriate. For example, if a provider gives a 
patient a paper-based educational resource during their office visit, 
that instance is only attributable to that provider and should not be 
counted in the numerator for other providers within the group practice. 
However, if the resource is provided electronically and such 
attribution is impossible, it may be counted in the numerator for any 
provider within the group sharing the CEHRT who has contributed 
information to the patient's record, if that provider also has the 
patient in their denominator for the EHR reporting period. We recognize 
that this may result in a process of manual calculation if both 
electronic and paper-based resources are used. While we are seeking to 
avoid manual calculation and paper-based actions, we must also balance 
avoiding unintended negative consequences which may result from 
changing the specifications for this measure for providers who are 
currently using paper-based methods. For information on the fully 
electronic Patient-specific Education measure included in the Stage 3 
proposed rule, we direct readers to section II.B.2.b.vi of this final 
rule with comment period.
---------------------------------------------------------------------------

    \9\ CMS.gov Frequently Asked Questions: EHR Incentive Programs 
FAQ 7735: https://questions.cms.gov/faq.php?id=5005&faqId=7735 and 
FAQ 9686: https://questions.cms.gov/faq.php?id=5005&faqId=9686.
---------------------------------------------------------------------------

    After consideration of public comments received, we are finalizing 
the objective, measures, exclusions, and alternate exclusion as 
proposed for EPs, eligible hospitals and CAHs.
    The final objective is as follows:
Objective 6: Patient-Specific Education
    Objective: Use clinically relevant information from CEHRT to 
identify patient-specific education resources and provide those 
resources to the patient.
    EP Measure: Patient-specific education resources identified by 
CEHRT are provided to patients for more than 10 percent of all unique 
patients with office visits seen by the EP during the EHR reporting 
period.
     Denominator: Number of unique patients with office visits 
seen by the EP during the EHR reporting period.
     Numerator: Number of patients in the denominator who were 
provided patient-specific education resources identified by the CEHRT.
     Threshold: The resulting percentage must be more than 10 
percent in order for an EP to meet this measure.
     Exclusion: Any EP who has no office visits during the EHR 
reporting period.
    Eligible Hospital/CAH Measure: More than 10 percent of all unique 
patients admitted to the eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
provided patient-specific education resources identified by CEHRT.
     Denominator: Number of unique patients admitted to the 
eligible hospital or CAH inpatient or emergency departments (POS 21 or 
23) during the EHR reporting period.
     Numerator: Number of patients in the denominator who are 
subsequently provided patient-specific education resources identified 
by CEHRT.
     Threshold: The resulting percentage must be more than 10 
percent in order for an eligible hospital or CAH to meet this measure.
    Alternate Exclusion:
    Alternate Exclusion: Providers may claim an exclusion for the 
measure of the Stage 2 Patient-Specific Education objective if for an 
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 
but did not intend to select the Stage 1 Patient Specific Education 
menu objective.
    We are adopting Objective 6: Patient-Specific Education at Sec.  
495.22(e)(6)(i) for EPs and Sec.  495.22(e)(6)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 7: Medication Reconciliation
    In the EHR Incentive Programs for 2015 through 2017 proposed rule 
(80 FR 20363), we proposed to retain the Stage 2 objective and measure 
for Medication Reconciliation for meaningful use in 2015 through 2017. 
Medication reconciliation allows providers to confirm that the 
information they have on the patient's medication is accurate. This not 
only assists the provider in his or her direct patient care, it also 
improves the accuracy of information they provide to others through 
health information exchange.
    Proposed Objective: The EP, eligible hospital, or CAH who receives 
a patient from another setting of care or provider of care or believes 
an encounter is relevant should perform medication reconciliation.
    In the Stage 2 proposed rule at 77 FR 54012 through 54013, we noted 
that when conducting medication reconciliation during a transition of 
care, the EP, eligible hospital, or CAH that receives the patient into 
their care should conduct the medication reconciliation. We reiterated 
that the measure of this objective does not dictate what information 
must be included in medication reconciliation, as information included 
in the process is appropriately determined by the provider and patient. 
We defined medication reconciliation as the process of identifying the 
most accurate list of all medications that the patient is taking, 
including name, dosage, frequency, and route, by comparing the medical 
record to an external list of medications obtained from a patient, 
hospital or other provider. In the EHR Incentive Programs in 2015 
through 2017 proposed rule (80 FR 20363), we proposed to maintain these 
definitions without modification.
    Proposed Measure: The EP, eligible hospital or CAH performs 
medication reconciliation for more than 50 percent of transitions of 
care in which the

[[Page 62810]]

patient is transitioned into the care of the EP or admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    To calculate the percentage, CMS and ONC have worked together to 
define the following for this objective:
    Denominator: Number of transitions of care during the EHR reporting 
period for which the EP or eligible hospital's or CAH's inpatient or 
emergency department (POS 21 or 23) was the receiving party of the 
transition.
    Numerator: The number of transitions of care in the denominator 
where medication reconciliation was performed.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP, eligible hospital or CAH to meet this measure.
    Exclusion: Any EP who was not the recipient of any transitions of 
care during the EHR reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that any provider scheduled to demonstrate Stage 1 of 
meaningful use for an EHR reporting period in 2015 who was not 
intending to attest to the Stage 1 Medication Reconciliation menu 
objective, may claim an exclusion to the measure.
    Proposed Alternate Exclusion: Provider may claim an exclusion for 
the measure of the Stage 2 Medication Reconciliation objective if for 
an EHR reporting period in 2015 they were scheduled to demonstrate 
Stage 1 but did not intend to select the Stage 1 Medication 
Reconciliation menu objective.
    We proposed no alternate specifications for this objective.
    Comment: One commenter requested clarification of whether CMS 
intends to limit the denominator of this proposed measure to 
transitions of care, or if certain referrals would also continue to be 
included as was the case prior to this rulemaking. Another commenter 
stated that they believe their CEHRT incorrectly includes encounters in 
the denominator where no actual transition of care is occurring or 
where the encounter is not a face-to-face encounter with the patient.
    Many commenters provided recommendations for additional exclusions 
for the objective including exclusions for providers who do not have 
office visits; and providers who have fewer than 10 or 100 transitions 
of care rather than limiting the exclusion to providers who not the 
recipient of any transition or referral. Another commenter believes 
that medication reconciliation is out of scope for his practice while 
others requested excluding referrals for reading certain tests or 
imaging services. Commenters also requested that we revise the measure 
to allow an exclusion for providers with fewer than 100 transitions or 
referral received electronically or to limit the denominator to only 
those transitions or referrals where an electronic summary of care 
document was received.
    Finally, one commenter stated a belief that the requirements for 
medication reconciliation objective depend upon the interoperability of 
EHR systems and may pose a significant burden to providers.
    Response: We reiterate that in the EHR Incentive Program for 2015 
through 2017 (80 FR 20363), we proposed to maintain the denominators 
finalized through rulemaking in the Stage 2 final rule (77 FR 54012 
through 54013 and 53982 through 53984), including the current 
definition of a transition of care for inclusion in the denominator of 
this measure. We note that the denominator includes when the provider 
is the recipient of the transition or referral, first encounters with a 
new patient and encounters with existing patients where a summary of 
care record (of any type) is provided to the receiving provider (77 FR 
53984).
    In addition, for those EPs who note that they have no office 
visits, or face-to-face encounters, and therefore should not have to 
include patient encounters for these services (such as only reading an 
EKG); we refer readers to the description in the Stage 2 final rule (77 
FR 53982) which notes that a provider may choose to include these 
encounters in the denominator or to exclude them. However, if the 
provider chooses to include or exclude these encounters they must apply 
the policy universally across all such encounters and across all 
applicable measures. A provider should consider how the policy will 
affect their ability to meet all applicable measures, and then work 
with their EHR vendor to ensure that the calculation of denominators 
and numerators matches the provider's decision.
    In terms of additional or expanded exclusions or concerns over 
scope of practice, we note that we did not propose any such changes and 
disagree that any such changes are necessary or beneficial. We believe 
medication reconciliation is an important part of maintaining a 
patient's record, that it is integral to patient safety, and that 
maintaining an accurate list of medications may be relevant to any 
provider's plan of care for a patient.
    In addition, robust health information exchange is of great 
assistance to medication reconciliation, but an electronic summary of 
care document is not required for medication reconciliation. Nor is 
electronic HIE the only way EHRs can assist with medication 
reconciliation. Medication reconciliation may take many forms, from 
automated inclusion of ePHI to review of paper records, to discussion 
with the patient upon intake or during consultation with the provider. 
Going back to Stage 1 we have noted that medication reconciliation may 
become more automated as technology progresses, but may never reach a 
point of full automation as these other methods continue to offer 
value--especially conversation with the patient which may remain an 
important part of that process (75 FR 44362). Furthermore, while the 
measure does involve health information exchange, we see no value in 
limiting the medication reconciliation measure to only those patients 
for whom a record is received electronically. We believe that it is 
appropriate and important to conduct medication reconciliation for each 
patient regardless of the method that reconciliation may require. 
Therefore, while we believe that medication reconciliation will become 
easier as health information exchange capability increases and that 
robust health information exchange supports medication reconciliation, 
it is not a prerequisite to performing medication reconciliation. 
Further, we believe the continued inclusion of a broad requirement for 
medication reconciliation will encourage developers and providers to 
continue to focus on how HIT can be designed and leveraged to better 
support provider medication reconciliation workflows through innovative 
new tools and resources.
    Comment: A commenter recommended that we require medication 
reconciliation when a provider receives a Summary of Care that is not a 
duplicate document and only reconcile if there are changes to the 
medication list. Another commenter requested that automated results 
should only be counted if there are medications in the queried document 
so it is possible to ``compare the medical record to an external list 
of medications obtained from a patient, hospital, or other provider.''
    Response: We note that we discuss the denominator for a transition 
of care in section II.B.1.b.(4)(f) of this final rule with comment 
period and that in the EHR Incentive Programs in 2015 through 2017 
proposed rule at (80 FR

[[Page 62811]]

20363) we proposed to maintain the definition for this objective from 
the Stage 2 final rule when the EP is the recipient of the transition 
or referral, first encounters with a new patient and encounters with 
existing patients where a summary of care record (of any type) is 
provided to the receiving EP (77 FR 53984). We note that the 
reconciliation occurs with the transition or referral, not with the 
receipt of the summary of care document. Therefore, if a provider 
receives duplicate summaries for a single referral such an action must 
only be counted once. In addition, the action of reviewing the 
medication list to determine if there are changes or confirm that there 
are no changes would meet the requirements of the objective to count as 
an action in the numerator.
    Comment: Commenters requested that CMS define what a ``new'' 
patient is for the purposes of the definition of a transition or 
referral. For example, one commenter noted that in their billing 
practices they define a patient as ``new'' if they have not been seen 
in 2 years. The commenter noted that using this definition in the 
denominator would include a greater number of relevant patient 
encounters than our current definition which uses patients who were 
never before seen by the provider. The commenter suggested this 
definition would ensure that these patients records were also updated 
which would be a significant benefit.
    Response: In the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20363) as in the Stage 2 final rule (77 FR 54013), 
we consider a patient to be a new patient if he or she has never before 
been seen by the provider. We agree that the commenter's definition of 
``new patient'' may capture a wider range of patients for whom 
medication reconciliation would be relevant and beneficial. While we 
will not change the denominator for this existing objective, a provider 
may use an expanded definition which includes a greater number of 
patients for whom the action may be relevant within their practice. We 
intend that our description of a new patient is a baseline that a 
provider must meet; however, if that requirement is met the provider 
may include further actions or addition encounters relevant to their 
practice and patient population, so long as the approach is applied 
universally across all such encounters, all settings and for the 
duration of the EHR reporting period.
    Comment: A commenter requested clarification of whether the 
denominator of medication reconciliation includes first encounters with 
all new patients (in other words, ``encounters in which the provider 
has never before encountered the patient'' as specified in the Stage 3 
proposal) or only those new patients that are accompanied by a summary 
of care record.
    Response: For providers who are on the receiving end of a 
transition of care or referral, the denominator includes first 
encounters with a new patient and encounters with existing patients 
where a summary of care record (of any type) is provided to the 
receiving provider.
    Comment: A commenter requested clarification of whether CMS intends 
to limit the denominator of this proposed measure to transitions of 
care, or if certain referrals would also continue to be included as was 
the case prior to this rulemaking.
    Response: For the purposes of this measure, we continue to maintain 
the definition of a transition of care as the movement of a patient 
from one setting of care (for example, a hospital, ambulatory primary 
care practice, ambulatory specialty care practice, long-term care, home 
health, rehabilitation facility) to another. Referrals are cases where 
one provider refers a patient to another, but the referring provider 
maintains his or her care of the patient as well. Thus, the denominator 
includes both transitions of care and referrals in which the provider 
was the transferring or referring provider.
    Comment: The proposal to allow exclusion for this measure if a 
provider was scheduled for Stage 1 but ``did not intend to select the 
Stage 1 Medication Reconciliation menu objective'' is vague and will 
lead to audit problems. It should just be clearly stated that this is 
exclusion for Stage 1 EPs.
    Response: As explained in section II.B.1.b.(4)(b)(iii) of this 
final rule with comment period where we acknowledge that it may be 
difficult for a provider to document intent and will not require such 
documentation.
    Comment: While the commenter agrees that medication reconciliation 
is a critical patient care requirement when patients move from one 
setting of care to another, they encourage us to specify that 
transitions from physicians who furnish services in POS 22 code should 
not be considered ``transitions of care'' for purposes of this 
objective and measure.
    Response: We note that we make no distinction between settings nor 
do we reference any POS code for the party transitioning the patient. 
We consider a transition as the movement of a patient from one care 
setting to another. We reference POS in this objective only with regard 
to the inclusion of patients admitted to either the Inpatient or 
Emergency Department (POS 21 and 23) in the denominator. We see no 
reason that patients referred from a provider billing under a POS 22 
should not be included in the definition of a transition or referral.
    After considerations of public comments received, we are finalizing 
as proposed the objective, measure, exclusion and alternate exclusions 
for EPs, eligible hospitals, and CAHs as follows:
Objective 7: Medication Reconciliation
    Objective: The EP, eligible hospital or CAH that receives a patient 
from another setting of care or provider of care or believes an 
encounter is relevant performs medication reconciliation.
    Measure: The EP, eligible hospital or CAH performs medication 
reconciliation for more than 50 percent of transitions of care in which 
the patient is transitioned into the care of the EP or admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
     Denominator: Number of transitions of care during the EHR 
reporting period for which the EP or eligible hospital's or CAH's 
inpatient or emergency department (POS 21 or 23) was the receiving 
party of the transition.
     Numerator: The number of transitions of care in the 
denominator where medication reconciliation was performed.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP, eligible hospital or CAH to meet this 
measure.
     Exclusion: Any EP who was not the recipient of any 
transitions of care during the EHR reporting period.
    Alternate Exclusion:
    Alternate Exclusion: Provider may claim an exclusion for the 
measure of the Stage 2 Medication Reconciliation objective if for an 
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1 
but did not intend to select the Stage 1 Medication Reconciliation menu 
objective.
    We are adopting Objective 7: Medication Reconciliation at Sec.  
495.22(e)(7)(i) for EPs and Sec.  495.22(e)(7)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.

[[Page 62812]]

Objective 8: Patient Electronic Access
    We proposed to retain the Stage 2 objective for Patient Electronic 
Access for meaningful use in 2015 through 2017. We proposed to retain 
the first measure of the Stage 2 objective without modification. We 
proposed to retain the second measure for the Stage 2 objective with 
modification to the measure threshold.
    Proposed EP Objective: Provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    Proposed Eligible Hospital/CAH Objective: Provide patients the 
ability to view online, download, and transmit their health information 
within 36 hours of hospital discharge.
    In the Stage 2 proposed rule, we stated that the goal of this 
objective was to allow patients easy access to their health information 
as soon as possible, so that they can make informed decisions regarding 
their care or share their most recent clinical information with other 
health care providers and personal caregivers as they see fit.
    The ability to have this information online means it is always 
retrievable by the patient, while the download function ensures that 
the patient can take the information with them when secure internet 
access is not available. The patient must be able to access this 
information on demand, such as through a patient portal or PHR. We note 
that while a covered entity may be able to fully satisfy a patient's 
request for information through VDT, the measure does not replace the 
covered entity's responsibilities to meet the broader requirements 
under HIPAA to provide an individual, upon request, with access to PHI 
in a designated record set. Providers should also be aware that while 
meaningful use is limited to the capabilities of CEHRT to provide 
online access there may be patients who cannot access their EHRs 
electronically because of their disability, or who require assistive 
technology to do so. Additionally, other health information may not be 
accessible. Finally, we noted that providers who are covered by civil 
rights laws, including the Americans with Disabilities Act, Section 504 
of the Rehabilitation Act of 1973, or Section 1577 of the Affordable 
Care Act, must provide individuals with disabilities equal access to 
information and appropriate auxiliary aids and services as provided in 
the applicable statutes and regulations. For a useful reference of how 
to meet these obligations, we suggest covered providers reference the 
Department of Justice's Effective Communications guidance at http://www.ada.gov/effective-comm.htm.
    Proposed EP Measures:
     EP Measure 1: More than 50 percent of all unique patients 
seen by the EP during the EHR reporting period are provided timely 
(within 4 business days after the information is available to the EP) 
online access to their health information subject to the EP's 
discretion to withhold certain information.
     EP Measure 2: At least one patient seen by the EP during 
the EHR reporting period (or their authorized representatives) views, 
downloads, or transmits his or her health information to a third party.
    In order to meet this objective, the following information must be 
made available to patients electronically within 4 business days of the 
information being made available to the EP:
    ++ Patient name.
    ++ Provider's name and office contact information.
    ++ Current and past problem list.
    ++ Procedures.
    ++ Laboratory test results.
    ++ Current medication list and medication history.
    ++ Current medication allergy list and medication allergy history.
    ++ Vital signs (height, weight, blood pressure, BMI, growth 
charts).
    ++ Smoking status.
    ++ Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
    ++ Care plan field(s), including goals and instructions.
    ++ Any known care team members including the primary care provider 
(PCP) of record.
    To calculate the percentage of the first measure for providing 
patient with timely online access to health information, CMS and ONC 
have worked together to define the following for this objective:
     Proposed EP Measure 1: More than 50 percent of all unique 
patients seen by the EP during the EHR reporting period are provided 
timely (within 4 business days after the information is available to 
the EP) online access to their health information subject to the EP's 
discretion to withhold certain information.
    Denominator: Number of unique patients seen by the EP during the 
EHR reporting period.
    Numerator: The number of patients in the denominator who have 
timely (within 4 business days after the information is available to 
the EP) online access to their health information.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an EP to meet this measure.
     Proposed EP Measure 2: At least one patient seen by the EP 
during the EHR reporting period (or his or her authorized 
representatives) views, downloads, or transmits his or her health 
information to a third party.
     Proposed Exclusions: Any EP who--
    (a) Neither orders nor creates any of the information listed for 
inclusion as part of the measures; or
    (b) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units 
with 4Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period.
    Proposed Eligible Hospital/CAH Measures:
     Eligible Hospital/CAH Measure 1: More than 50 percent of 
all patients who are discharged from the inpatient or emergency 
department (POS 21 or 23) of an eligible hospital or CAH have their 
information available online within 36 hours of discharge.
     Eligible Hospital/CAH Measure 2: At least 1 patient who is 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH (or his or her authorized representative) 
views, downloads or transmits to a third party his or her information 
during the EHR reporting period.
    The following information must be available to satisfy the 
objective and measure:
    ++ Patient name.
    ++ Admit and discharge date and location.
    ++ Reason for hospitalization.
    ++ Care team including the attending of record as well as other 
providers of care.
    ++ Procedures performed during admission.
    ++ Current and past problem list.
    ++ Vital signs at discharge.
    ++ Laboratory test results (available at time of discharge).
    ++ Summary of care record for transitions of care or referrals to 
another provider.
    ++ Care plan field(s), including goals and instructions.
    ++ Discharge instructions for patient.
    ++ Demographics maintained by hospital (sex, race, ethnicity, date 
of birth, preferred language).
    ++ Smoking status.
    To calculate the percentage of the first measure for providing 
patients timely

[[Page 62813]]

access to discharge information, CMS and ONC have worked together to 
define the following for this objective:
     Proposed Eligible Hospital/CAH Measure 1: More than 50 
percent of all patients who are discharged from the inpatient or 
emergency department (POS 21 or 23) of an eligible hospital or CAH have 
their information available online within 36 hours of discharge.
    Denominator: Number of unique patients discharged from an eligible 
hospital's or CAH's inpatient or emergency department (POS 21 or 23) 
during the EHR reporting period.
    Numerator: The number of patients in the denominator whose 
information is available online within 36 hours of discharge.
    Threshold: The resulting percentage must be more than 50 percent in 
order for an eligible hospital or CAH to meet this measure.
     Proposed Eligible Hospital/CAH Measure 2: At least 1 
patient who is discharged from the inpatient or emergency department 
(POS 21 or 23) of an eligible hospital or CAH (or his or her authorized 
representative) views, downloads or transmits to a third party his or 
her information during the EHR reporting period.
     Proposed Exclusion: Any eligible hospital or CAH that is 
located in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that providers scheduled to demonstrate Stage 1 of 
meaningful use for an EHR reporting period in 2015 may additionally 
claim an exclusion for the second measure of the Stage 2 Patient 
Electronic Access objective because there is not an equivalent Stage 1 
measure defined at 42 CFR 495.6.
    Proposed Alternate Exclusion Measure 2: Providers may claim an 
exclusion for the second measure if for an EHR reporting period in 2015 
they were scheduled to demonstrate Stage 1, which does not have an 
equivalent measure.
    We proposed no alternate specifications for this objective.
    Comment: Many commenters appreciate the proposed modifications to 
the objective's measures that rely on patient's actions. Many 
respondents believe the flexibility provided in the modifications will 
provide more time for both providers and patients to become more 
comfortable accessing and using patient portals, and will not penalize 
providers for failing to meet thresholds based on patient actions they 
cannot control.
    Response: We thank the commenters for their feedback concerning 
this proposed change in the EHR Incentive Programs in 2015 through 
2017.
    Comment: A number of commenters opposed our proposal to modify the 
second measure requiring that patients taking action to view, download, 
or transmit their health information. These commenters stated concern 
that the change will have a negative effect on patients access to their 
health record because it will allow providers to stop investing in the 
workflows, training, and patient education needed to support patient 
access.
    Other commenters urged CMS to ``preserve the existing thresholds 
for patient online access and secure, messaging'' stating that 
requiring that only one patient has access is not meaningful enough. 
These commenters included statements advocating for patients to have 
the ability to access their EHR and that we should not reduce the 
threshold to let providers off the hook.
    Response: We appreciate the commenters' advocacy for patients and 
agree that patient electronic access to health information is essential 
to improving the quality of care. However, we disagree that reducing 
the patient action measure will negatively impact the workflows, 
training, and patient education for patient access because the patient 
access measure is still fully in place: That is, measure 1 which 
requires providers to ensure that more than 50 percent of patients are 
provided access to their health information. This measure requires that 
providers ensure that patients have all the information they need to 
access their record, even for patients who may choose to opt out, so a 
provider cannot stop doing the workflows, training, and patient 
education for patient access and still meet the requirements of 
meaningful use for measure one of this objective.
    For the commenters who state that one patient having access is not 
meaningful enough, we believe these commenters may have misunderstood 
which measure we proposed to modify. As noted, we proposed no changes 
to the first measure under the Patient Electronic Access objective 
which is required for all providers in Stage 1 and Stage 2, in Medicare 
and Medicaid, and for both EPs, eligible hospitals, and CAHs. For this 
measure, each provider must demonstrate that more than 50 percent of 
their unique patients during the EHR reporting period have access to 
view, download, and transmit their health information. In the proposed 
rule, we proposed only to modify the second measure (which measures the 
patient's action, not the provider) from a threshold of 5 percent to at 
least one patient.
    Comment: While some commenters supported EP Measure 1 as proposed, 
many more were concerned with patients' general ability to access their 
health information. A portion of respondents in disagreement with 
Measure 1 were concerned the 50 percent threshold will be unattainable 
because their patient population is elderly, ill, low-income, and/or 
located in remote, rural areas. These patients do not have access to 
computers, Internet and/or email and are concerned with having their 
health information online. Several others believe Measure 1 is 
unnecessary, as patients must use the access provided in order for an 
EP, eligible hospital or CAH to meet Measure 2 of this objective. A 
number of commenters also disagreed with the requirement for the 
provision of new information within 36 hours for eligible hospitals and 
CAHs (four business days for EPs) stating that it was either too long a 
time for patients to wait or too short a time for providers to respond.
    Response: We have proposed no changes to the first measure and 
reiterate our intent to maintain the first measure as previously 
finalized in the Stage 2 final rule. We note that providing access to 
patients to view, download, and transmit their information is a top 
priority for patient engagement, patient-centered care, and care 
coordination. We note that in the EHR Incentive Programs, the 
specifications for the measure allow the provision of access to take 
many forms and do not require a provider to obtain an email address 
from the patient. We understand that many CEHRT products may be 
designed in that fashion, but it is not by the program.
    If a provider's CEHRT does require a patient email address, but the 
patient does not have or refuses to provide an email address or elects 
to ``opt out'' of participation, that is not prohibited by the EHR 
Incentive Program requirements nor does it allow the provider to 
exclude that patient from the denominator. Instead, the provider may 
still meet the measure by providing that patient all of the necessary 
information required for the patient to subsequently access their 
information, obtain access through a patient-authorized representative, 
or otherwise opt-back-in without further follow up action required by 
the provider. We note

[[Page 62814]]

that we have proposed no changes to the timeframe for provision of new 
information and maintain that 36 hours (for eligible hospitals and 
CAHs) and 4 business days (for EPs) is a reasonable time limit because 
it allows for immediate access (if feasible) and a reasonable amount of 
time for providers to review any information necessary before it is 
made available to the patient.
    Comment: A commenter noted that the patient access measure 1 needs 
clarification as to when it must occur in relation to the EHR reporting 
period. The commenter further stated that once a patient has been 
provided access there is no need to provide additional access unless 
the patient originally opted out of receiving electronic access. The 
commenter further noted that active, ongoing access that preceded the 
EHR reporting period should always count in the numerator for a patient 
seen during the EHR reporting period. The commenter also states that 
when a patient opts out of electronic access, as long as the patient 
was properly educated on the portal and how to gain access, there 
should be no need to count access again.
    Further commenters referenced EHR Incentive Programs FAQ 8231 \10\ 
and recommended that we clarify measure one and measure 2, and 
suggested that all measure with a denominator referencing unique 
patient should allow a provider to count actions from any time period 
before the reporting period or reporting year to count in the 
numerator.
---------------------------------------------------------------------------

    \10\ FAQ 8231. www.cms.gov/ehrincentiveprograms CMS Frequently 
Asked Questions: EHR Incentive Programs (archived).
---------------------------------------------------------------------------

    Response: We believe the confusion on this issue for the first 
measure may relate to the ways in which different EHRs are set up to 
initiate access for a patient the first time. The measure does not 
address the enrollment process or how the initiation process to ``turn 
on'' access for a patient within an EHR system should function. The 
measure is addressing the health information itself. To count in the 
numerator, this health information needs to be made available to each 
patient for view, download, and transmit within 4 business days of its 
availability to the provider for each and every time that information 
is generated whether the patient has been ``enrolled'' for three months 
or for three years. We note that a patient needs to be seen by the EP 
during the EHR reporting period or be discharged from the hospital 
inpatient or emergency department during the EHR reporting period in 
order to be included in the denominator.
    For example, if a provider's CEHRT uses an enrollment process to 
issue a user ID to the patient, a provider does not need to create a 
new user ID for a patient each time the patient has an office visit. 
That initial enrollment can occur any time as it is not governed by the 
measure. What the measure addresses is the health information that 
results from care (e.g. from an office visit or a hospital admission). 
The measure timeline for making any health information available resets 
to 36 hours for an eligible hospital or CAH and 4 business days for an 
EP each time new information is available to which the patient should 
be provided access. Therefore, although a provider does not need to 
enroll a unique patient a second time if the patient has a second 
office visit during the EHR reporting period, the provider must 
continue to update the information accessible to the patient each time 
new information is available. In addition, if the provider fails to 
provide access to a patient upon an initial visit during the EHR 
reporting period, but provides access on a subsequent visit, the 
patient cannot be counted in the numerator because the patient did not 
have timely online access to health information related to the first 
visit. Similarly, the patient cannot be included in the numerator if 
access is provided on the first visit, but the provider fails to update 
the information within the time period required after the second visit. 
In short, a patient who has multiple encounters during the EHR 
reporting period, or even in subsequent EHR reporting periods in future 
years, needs to have access to the information related to their care 
for each encounter where they are seen by the EP or discharged from the 
eligible hospital or CAH's inpatient or emergency department.
    In relation to the suggestion that the second measure should be 
allowed to be calculated including any action in any time period before 
the EHR reporting period to count in the numerator, we strongly 
disagree. We do not believe a single instance of a patient accessing 
their record should be counted in perpetuity for the measure. The 
calculation may include actions taken before, during, or after the EHR 
reporting period if the period is less than one full year; however, 
consistent with FAQ 8231, these actions must be taken no earlier than 
the start of the same year as the EHR reporting period and no later 
than the date of attestation. We understand, as discussed in section 
II.B.1.b.(4), that some certified EHRs may not calculate the numerator 
in this fashion and therefore we will allow providers to use an 
alternate calculation for an EHR reporting period in 2015 and 2016 if 
that calculation is a part of their CEHRT to allow sufficient time to 
upgrade the calculation prior to providers attesting to data for an EHR 
reporting period in 2017.
    Comment: Those commenters in support of the changes to measure 2 of 
this objective supported our incorporation of stakeholder and 
participant feedback into the modifications of this measure. Supporting 
commenters agreed with the proposed patient engagement threshold 
reduction, stating that it is currently unattainable for their practice 
due to a patient population that is elderly, ill, low-income, and/or 
located in remote, rural areas. For these sites, commenters believe 
lowering the threshold will permit them flexibility in working with 
their vendors and developing new approaches to increase their patient 
engagement.
    Response: We thank the commenters for their contribution. We 
believe that continued efforts to raise awareness and provide access 
through a wider range of electronic means (such as the inclusion of 
APIs in the Stage 3 measure) will help to expand the adoption of this 
technology over time.
    Comment: The majority of commenters concerned about the 
modifications of Measure 2 believe lowering the patient engagement 
threshold is counter-productive for improving patient outcomes and 
moving the meaningful use program forward. Commenters worry the new 
threshold is much too low to incentivize providers to encourage patient 
access to the electronic health records that are central to the 
overarching goal of meaningful use.
    Some commenters disagreed with the modifications to Measure 2 and 
are concerned with the large jump to meet the proposed Stage 3 
meaningful use VDT requirement in 2018. Several commenters believe that 
the reduction of the patient engagement threshold will slow momentum of 
this measure leaving providers ill-prepared for the future of 
meaningful use. Many commenters believed that lowering the requirement 
to only one patient viewing, downloading, or transmitting their health 
information is counterproductive to improving patient outcomes 
nationally. Engaging patients by using technology is a critical path to 
move the healthcare system forward and demonstrate the core value of 
meaningful use. Several commenters recommended a phased approach for 
the threshold for the measure, increasing over time to the proposed

[[Page 62815]]

Stage 3 level. They recommended a phased approach that recognizes the 
challenges that some providers are encountering as they try to get 
their patient population more engaged with viewing, downloading or 
transmitting their information to a third party. They believe that a 
higher measure threshold will be easier to achieve as the technology 
becomes even more user-friendly and patients begin to see the value in 
becoming more involved in their own care and taking these actions. 
Overall, they believe a phased-in approach for the patient electronic 
access objective would be an appropriate and balanced step forward.
    Response: We agree that providers have a role in promoting 
behavioral change among patients in regard to engaging with their 
health information and increasing health literacy and that provider 
influence may be a factor. However, as noted in the EHR Incentive 
Programs in 2015 through 2017 proposed rule (80 FR 20357), statistical 
analysis of measure performance shows a wide variance, and further 
analysis in comparison to the first measure does not show a correlation 
between provider action and patient response.\11\ Through our analysis 
we found that neither high nor low performance on the first measure nor 
an overall increase or decrease in the number of patients who have 
access to their data, had a strong or moderate correlation to 
performance on patient action either for high performers or low 
performers. This suggests that other external factors currently impact 
performance on the objective. This may include a lag in the adoption of 
technologies by patients, patient self-selection, or other unknown 
factors related to the IT environment and the patients themselves. We 
believe that continued efforts to raise awareness and provide access 
through a wider range of electronic means (such as the inclusion of 
APIs in the Stage 3 measure) will help to expand the adoption of this 
technology over time, and we maintain that providers should be 
supported in that effort rather than having additional burden added for 
factors outside their control.
---------------------------------------------------------------------------

    \11\ EHR Incentive Programs Performance Data: Program Data and 
Reports: www.cms.gov/EHRIncentivePrograms Programs.
---------------------------------------------------------------------------

    We wish to reiterate that we understand the concerns voiced by 
providers regarding patient populations that are unable to engage in 
their health care information electronically due to various factors, 
which include income, age, technological capabilities, or 
comprehension. We agree with the phased approach recommended by the 
commenters who noted that it provides additional time for the adoption 
of technology by patients, but also maintains the importance of the 
measure. We believe this approach will allow providers to set a 
progressive goal with incremental increases in performance through 
2018. We believe this approach is in line with our policy to build from 
basic to advanced use and to increase measure thresholds over time and 
that it will also maintain the incentive for providers to focus on 
methods and approaches to increase patient engagement. Therefore, we 
are finalizing a change from our proposal for 2015 through 2017 to 
build toward the Stage 3 measure threshold required in 2018. We are 
setting the measure threshold at 1 patient for 2015 and 2016 and 5 
percent in 2017 to work toward the increased threshold for Stage 3 in 
2018 (see also section II.B.2.b.(vi) for the Stage 3 objective).
    After consideration of public comment received, we are finalizing 
the objective and the alternate exclusion to Measure 2 as proposed for 
EPs, eligible hospitals and CAHs.
    We are finalizing Measure 1 with modifications to improve the 
clarity of the measure language based on stakeholder feedback and 
Measure 2 with modifications to the thresholds and to specify the 
timing of the action for EPs to match the eligible hospital and CAH 
measure. We are maintaining our prior policy for the information that 
must be provided to the patient for the objective as proposed.
    We are adopting the objective as follows:
Objective 8: Patient Electronic Access
    EP Objective: Provide patients the ability to view online, 
download, and transmit their health information within 4 business days 
of the information being available to the EP.
    EP Measure 1: More than 50 percent of all unique patients seen by 
the EP during the EHR reporting period are provided timely access to 
view online, download, and transmit to a third party their health 
information subject to the EP's discretion to withhold certain 
information.
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator who 
have access to view online, download and transmit their health 
information within 4 business days after the information is available 
to the EP.
     Threshold: The resulting percentage must be more than 50 
percent in order for an EP to meet this measure.
    EP Measure 2: For an EHR reporting period in 2015 and 2016, at 
least one patient seen by the EP during the EHR reporting period (or 
patient-authorized representative) views, downloads or transmits to a 
third party his or her health information during the EHR reporting 
period.
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator (or 
patient-authorized representative) who view, download, or transmit to a 
third party their health information.
     Threshold: The numerator and denominator must be reported, 
and the numerator must be equal to or greater than 1.
     Exclusions: Any EP who--
    [cir] Neither orders nor creates any of the information listed for 
inclusion as part of the measures; or
    [cir] 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.
    For an EHR reporting period in 2017, more than 5 percent of unique 
patients seen by the EP during the EHR reporting period (or his or her 
authorized representatives) view, download or transmit to a third party 
their health information during the EHR reporting period.
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator who 
view, download, or transmit to a third party their health information.
     Threshold: The resulting percentage must be greater than 5 
percent.
     Exclusions: Any EP who--
    [cir] Neither orders nor creates any of the information listed for 
inclusion as part of the measures; or
    [cir] 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.
    Eligible Hospital/CAH Objective: Provide patients the ability to 
view online, download, and transmit their health information within 36 
hours of hospital discharge.
    Eligible Hospital/CAH Measure 1: More than 50 percent of all unique 
patients who are discharged from the

[[Page 62816]]

inpatient or emergency department (POS 21 or 23) of an eligible 
hospital or CAH are provided timely access to view online, download and 
transmit to a third party their health information.
     Denominator: Number of unique patients discharged from an 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23) during the EHR reporting period.
     Numerator: The number of patients in the denominator who 
are have access to view, download, and transmit their health 
information within 36 hours after the information is available to the 
eligible hospital or CAH.
     Threshold: The resulting percentage must be more than 50 
percent in order for an eligible hospital or CAH to meet this measure.
    Eligible Hospital/CAH Measure 2: For an EHR reporting period in 
2015 and 2016, at least 1 patient who is discharged from the inpatient 
or emergency department (POS 21 or 23) of an eligible hospital or CAH 
(or patient-authorized representative) views, downloads or transmits to 
a third party his or her health information during the EHR reporting 
period.
     Denominator: Number of unique patients discharged from the 
inpatient or emergency department (POS 21 or 23) of the eligible 
hospital or CAH during the EHR reporting period.
     Numerator: The number of patients (or patient-authorized 
representative) in the denominator who view, download, or transmit to a 
third party their health information.
     Threshold: The numerator and denominator must be reported 
and the numerator must be equal to or greater than 1.
     Exclusion: Any eligible hospital or CAH that is located in 
a county that does not have 50 percent or more of its housing units 
with 4Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period.
    For an EHR reporting period in 2017, more than 5 percent of unique 
patients discharged from the inpatient or emergency department (POS 21 
or 23) of an eligible hospital or CAH (or patient-authorized 
representative) view, download or transmit to a third party their 
health information during the EHR reporting period.
     Denominator: Number of unique patients discharged from the 
inpatient or emergency department (POS 21 or 23) of the eligible 
hospital or CAH during the EHR reporting period.
     Numerator: The number of patients (or patient-authorized 
representative) in the denominator who view, download, or transmit to a 
third party their health information.
     Threshold: The resulting percentage must be greater than 5 
percent.
     Exclusion: Any eligible hospital or CAH that is located in 
a county that does not have 50 percent or more of its housing units 
with 4Mbps broadband availability according to the latest information 
available from the FCC on the first day of the EHR reporting period.
    Alternate Exclusion: Providers may claim an exclusion for the 
second measure if for an EHR reporting period in 2015 they were 
scheduled to demonstrate Stage 1, which does not have an equivalent 
measure.
    We are adopting Objective 8: Patient Electronic Access at Sec.  
495.22(e)(8)(i) for EPs and Sec.  495.22(e)(8)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 9: Secure Electronic Messaging (EP Only)
    We proposed to retain the EP Stage 2 objective for secure 
electronic messaging with modifications to the measure for meaningful 
use in 2015 through 2017.
    Proposed Objective: Use secure electronic messaging to communicate 
with patients on relevant health information.
    Proposed Measure: The capability for patients to send and receive a 
secure electronic message with the provider was fully enabled during 
the EHR reporting period.
    We proposed to retain the exclusion for EPs who have no office 
visits and for those EPs who lack the infrastructure required for 
secure electronic messaging due to being located in areas with limited 
broadband availability as identified by the Federal Communications 
Commission (FCC).
    Exclusion: Any EP who has no office visits during the EHR reporting 
period, or any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period.
Proposed Alternate Exclusions and Specifications for Stage 1 Providers 
for Meaningful Use in 2015
    We proposed that an EP scheduled to demonstrate Stage 1 of 
meaningful use for an EHR reporting period in 2015 may claim an 
exclusion for the secure electronic messaging objective measure as 
there is not an equivalent Stage 1 objective or measure defined at 42 
CFR 495.6.
     Alternate Exclusion: An EP may claim an exclusion for the 
measure if for an EHR reporting period in 2015 they were scheduled to 
demonstrate Stage 1, which does not have an equivalent measure.
    We proposed no alternate specifications for this objective and 
there is no equivalent objective for eligible hospitals and CAHs in the 
Stage 2 objectives and measures for meaningful use.
    Comment: Some commenters expressed their general support for secure 
messaging, stating their appreciation for the convenience and ease with 
messaging their EPs electronically. Numerous commenters also agreed 
with exclusions for EPs with no office visits during the EHR reporting 
period and recommended a higher number than zero. A commenter expressed 
support for the alternate exclusion and requested the extension of this 
exclusion beyond 2015.
    Commenters expressing general opposition to secure messaging cited 
their patients' reluctance to sign up for the portal due to data breach 
fears, lack of internet familiarity, and overall lack of access. Other 
commenters also recommended continuing the reduced requirement in the 
future.
    Response: We thank the commenters for their insight. We believe 
that given the proposed changes to the measure, the current exclusions 
are adequate and that the proposed alternate exclusion does not need to 
be extended beyond 2015.
    Comment: Many commenters disagreed with the proposal to lower the 
threshold, with some believing that it takes momentum away from patient 
engagement. Some commenters conflated the proposals and stated the same 
concerned opposition for secure messaging as for the patient action 
measure discussed in section II.B.2.a.(viii) stating that ``one 
patient'' for secure messaging is not meaningful enough.
    Response: We appreciate the commenters' advocacy for patients and 
applaud their efforts to promote patient engagement and raise awareness 
about the need for accessibility of health

[[Page 62817]]

information. We agree with the intent behind the policy and support the 
policy goal of promoting enhanced patient and provider engagement, and 
leveraging HIT solutions to enhance patient and provider 
communications. We direct readers to the proposed measure we included 
for the Stage 3 Objective for Coordination of Care through Patient 
Engagement in section II.B.2.b.vi of this final rule with comment 
period. We would like to highlight some key differences between the 
Stage 3 proposed objective and the current objective, which are the 
result of lessons learned through feedback over the past few years from 
providers about their efforts to implement the requirements of the EHR 
Incentive Program. We believe this will help to illustrate why we 
proposed to reduce the threshold for this Secure Messaging objective 
and how we are seeking to maintain the policy of moving patient 
engagement forward.
    As noted in the Stage 3 proposed rule (80 FR 16756) and for the 
Stage 3 objective in section II.B.2.b.vi of this final rule with 
comment period, we included proposals for bi-directional communication 
and communications among and between the patient and multiple providers 
in a care team. We also expanded the potential role of patient-
authorized representatives, and we sought to adopt a wider range of 
communications methods that could support and promote patient-centered 
care coordination. We proposed this objective because we believe that 
leveraging health IT to support care team communications in which a 
patient is actively engaged can lead to better care coordination and 
better outcomes for the patient. However, the current Stage 2 secure 
messaging objective as finalized in the 2012 Stage 2 final rule (77 FR 
54031) does not include this flexibility of form, method and 
participation. It includes only patient-initiated communication rather 
than provider driven engagement, and it does not promote a wide range 
of use cases. Comments received indicate that this is a significant 
shortfall in the language of the current measure supporting the 
identified health care delivery system reform goal. In addition, 
commenters note that these factors and other environmental or patient 
related factors create a significant burden on providers and negatively 
impact a provider's ability to meet the measure. This means that 
providers are investing a large amount of resources to achieve a 
measure that is flawed, does not adequately meet the intended health 
goal, and provides only a limited value.
    We believe that the measure should be modified to better serve as a 
foundation for a more dynamic use of HIT for patient engagement. For 
this reason, we proposed to continue support of the function and to 
adopt a more dynamic measure for Stage 3 that will help drive adoption 
and innovation to support the long-term goals of leveraging HIT for 
patient engagement.
    Comment: General recommendations from commenters included 
encouraging greater definition around secure messaging, allowing for 
texting/voicemail/other options, adding more exclusions, and taking 
into consideration patients' preferences for communication with their 
EPs. Some commenters requested clarification on what we consider 
``fully enabled'' when it comes to secure messaging.
    In addition, some commenters opposed lowering the threshold believe 
that removing the current thresholds will not help or encourage 
providers to prepare for upcoming Stage 3 thresholds. These commenters 
recommended that we consider an incrementally phased-in approach 
towards measure thresholds to balance the challenges providers face in 
promoting patient engagement. These commenters suggested beginning with 
simple enabled functions as proposed and increasing the threshold 
incrementally year over year to work toward the proposed Stage 3 
threshold of 35 percent rather than having a static low threshold and a 
sudden jump to a higher level in Stage 3.
    Still other commenters requested expanding the definition of secure 
messaging in the current objective to reflect the options and methods 
proposed for the Stage 3 objective. These commenters requested that 
provider initiated messaging should be the action that counts toward 
the numerator for the current objective and that communications with a 
patient-authorized representative on the patient's behalf should also 
count toward the measure.
    Response: Fully enabled means the function is fully installed, any 
security measures are fully enabled, and the function is readily 
available for patient use. We note that we have proposed no changes to 
the definition of secure messaging for this measure or to any of the 
exclusions apart from the proposed alternate exclusion for Stage 1 
providers in 2015. We proposed to remove the Stage 2 threshold of 5 
percent and instead require that the capability for patients to send 
and receive a secure electronic message is fully enabled during the EHR 
reporting period (80 FR 20365). However, we agree with commenters' 
recommendations for a phased in approach over the period of 2015 
through 2017 to the Stage 3 threshold in 2018, as it will allow 
providers to work incrementally toward a high goal and is consistent 
with our past policy in the program to establish incremental change 
from basic to advanced use and increased thresholds over time. We will 
therefore finalize ``fully enabled'' for 2015, at least one patient for 
2016, and a threshold of 5 percent for 2017 to build toward the Stage 3 
threshold addressed in section II.B.2.b.6 of this final rule with 
comment period.
    We cannot fully adopt the Stage 3 specifications as the commenters 
recommend because some parts, such as communications among care team 
members, would not be supported by EHR technology certified to the 2014 
Edition certification criteria. However, we agree that it makes sense 
to focus the measure on provider action rather than on patient action 
and to allow provider initiated actions to be included in the 
numerator. As noted previously, we believe that a measure that more 
accurately reflects the policy goal for delivery system reform should 
include these provider initiated actions and we also agree with the 
inclusion of interactions involving a patient-authorized representative 
as this is an important factor for many patients in coordinating care. 
We will therefore modify the current objective to include provider 
initiated communications and communications with a patient-authorized 
representative in the numerator. We note that this change also means 
that a patient-initiated message would only count toward the numerator 
if the provider responded to the patient as that is part of measuring 
the provider action rather than the patient action for this measure. As 
this measurement would not be required until 2016 and then at a level 
of only 1 patient, we believe it is reasonable to make this change in 
the counting methodology in the current objective.
    Comment: Some commenters stated a belief that the unique patient 
measures, including secure messaging, should be able to pull data from 
any time period before the reporting period and reporting year in order 
to qualify in the numerator. These commenters noted that this 
clarification would reduce the unnecessary burden placed on physicians, 
and the waste of resources to provide the patient with the same 
information they have already been provided.
    Response: We do not believe a single instance of a patient sending 
a secure message should be counted in

[[Page 62818]]

perpetuity for the measure. The calculation may include actions taken 
before, during, or after the EHR reporting period if the period is less 
than one full year; however, consistent with FAQ 8231, these actions 
must be taken no earlier than the start of the same year as the EHR 
reporting period and no later than the date of attestation. We 
understand, as discussed in section II.B.1.b.(4)(f), that some 
certified EHRs may not calculate the numerator in this fashion; 
however, as we are also changing the threshold for the measure so that 
significant measurement will not be required until 2016 and then at a 
required level of only 1 patient, we believe that changing this 
calculation will not drastically impact EHR developers and providers.
    After consideration of the comments received, we are finalizing as 
proposed the objective, exclusion, and alternate exclusion as proposed. 
We are finalizing the measure with the modifications to the thresholds. 
We are adopting the objective as follows:
Objective 9: Secure Electronic Messaging (EP Only)
    EP Objective: Use secure electronic messaging to communicate with 
patients on relevant health information.
    EP Measure: For an EHR reporting period in 2015, the capability for 
patients to send and receive a secure electronic message with the EP 
was fully enabled during the EHR reporting period.
    For an EHR reporting period in 2016, for at least 1 patient 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 the 
patient-authorized representative), or in response to a secure message 
sent by the patient (or the patient-authorized representative) during 
the EHR reporting period.
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator for 
whom a secure electronic message is sent to the patient (or patient-
authorized representative), or in response to a secure message sent by 
the patient (or patient-authorized representative).
     Threshold: The numerator and denominator must be reported, 
and the numerator must be equal to or greater than 1.
    For an EHR reporting period in 2017, for more than 5 percent of 
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 the patient-authorized representative), or in 
response to a secure message sent by the patient (or the patient-
authorized representative) during the EHR reporting period.
     Denominator: Number of unique patients seen by the EP 
during the EHR reporting period.
     Numerator: The number of patients in the denominator for 
whom a secure electronic message is sent to the patient (or patient-
authorized representative), or in response to a secure message sent by 
the patient (or patient-authorized representative).
     Threshold: The resulting percentage must be more than 5 
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, or any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the FCC on the first day of the EHR 
reporting period.
    Alternate Exclusion:
    Alternate Exclusion: An EP may claim an exclusion for the measure 
if for an EHR reporting period in 2015 they were scheduled to 
demonstrate Stage 1, which does not have an equivalent measure.
    We are adopting Objective 9: Secure Electronic Messaging at Sec.  
495.22(e)(9)(i) for EPs. We further specify that in order to meet this 
objective and measures, an EP must use the capabilities and standards 
of as defined for as defined CEHRT at Sec.  495.4. We direct readers to 
section II.B.3 of this final rule with comment period for a discussion 
of the definition of CEHRT and a table referencing the capabilities and 
standards that must be used for each measure.
Objective 10: Public Health and Clinical Data Registry Reporting
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 80 
FR 20366,we proposed to adopt a modified version of the consolidated 
Public Health and Clinical Data Registry Reporting objective proposed 
in the Stage 3 proposed rule for all providers to demonstrate 
meaningful use for an EHR reporting period in 2015 through 2017.
    Proposed Objective: The EP, eligible hospital or CAH is in active 
engagement with a Public Health Agency (PHA) or clinical data registry 
(CDR) to submit electronic public health data in a meaningful way using 
CEHRT, except where prohibited and in accordance with applicable law 
and practice.
    In the EHR Incentive Programs for 2015 through 2017 proposed rule 
80 FR 20366, we highlighted our intention to align with the Stage 3 
proposed rule and remove the prior ongoing submission requirement and 
replace it with an ``active engagement'' requirement. We reiterated our 
definition of ``active engagement'' as defined in the Stage 3 proposed 
rule at (80 FR 16739 and 16740) and noted our proposal to adopt the 
same definition for the Modified Stage 2 objective proposed for 2015 
through 2017 as we believe this change is more aligned with the process 
providers undertake to report to a clinical registry or public health 
agency.
    At (80 FR 20366), we proposed that ``active engagement'' may be 
demonstrated by any of the following options:
    Proposed 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.
    Proposed 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.
    Proposed 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 noted that the change in definition is intended to better 
capture the activities a provider may conduct in order to engage with a 
PHA or CDR, and that any prior action taken to meet the non-
consolidated public health reporting objectives of meaningful use 
Stages 1 and 2 would count toward

[[Page 62819]]

meeting the active engagement requirement of this objective.
    Comment: Many commenters expressed concern regarding whether 
provider and developers would have adequate time to implement a new 
active engagement requirement in place of the ongoing submission 
requirement in time to successfully attest for an EHR reporting period 
in 2015.
    Response: We note that while the active engagement options included 
in the EHR Incentive Program for 2015 to 2017 replace the ``ongoing 
submission'' requirement included in the Stage 2 final rule, they 
should not be considered mutually exclusive. We note that for providers 
who have already planned for and/or acted toward meeting any of the 
Stage 1 or Stage 2 public health reporting objectives, those actions 
would count toward meeting the active engagement options.
    For clarification on the rationale behind this change, we note that 
over the past few years, we have received feedback on the Stage 1 and 
Stage 2 public health reporting objectives through letters, public 
forums, and individual inquiries from both providers/provider 
representatives and from public health agencies. The common trend in 
these communications is that the difference between the Stage 1 and 
Stage 2 requirements and the ``ongoing submission'' structure for the 
Stage 2 objectives created confusion around both the actions required 
and the timing of those actions for providers. The active engagement 
requirement clarifies what is expected of a provider who seeks to meet 
the measures within this objective and more accurately describes the 
actions necessary to meet each option within the structure. This does 
not mean that actions a provider has already taken in an attempt to 
meet the ``ongoing submission'' requirement would not be acceptable 
under the new objective. Any action which would be acceptable under the 
Stage 1 and Stage 2 public health reporting objectives would fit within 
the definition of the ``active engagement'' options. In addition, 
because of the similarity between the substantive requirements of the 
``ongoing submission'' requirement and the ``active engagement'' 
requirement options included in this final rule with comment period, we 
do not believe that significant time will be needed to implement the 
updated requirement.
    For example, in Stage 2 a provider could register their intent to 
submit data to successfully meet a measure in one of the public health 
reporting objectives. Our proposal in the EHR Incentive Programs for 
2015 through 2017 proposed rule includes the exact same requirement 
under ``Active Engagement Option 1: Completed Registration to Submit 
Data.''
    We also believe that the flexibility within the active engagement 
options enables a provider additional time to determine the option that 
is best suited to their practice. For example, in Active Engagement 
Option 1, we also proposed that a provider would be required to 
register to submit data to the PHA within 60 days of the beginning of 
the EHR reporting period and not on the first day of the EHR reporting 
period. We believe that this 60-day timeframe will benefit providers 
who seek to determine whether Option 1 best captures their reporting 
status, or whether Option 2 or Option 3 are more appropriate. We 
further note that this requirement would allow a provider to begin 
their registration prior to the start of their EHR reporting period if 
such were necessary, so long as the action was completed within 60 days 
of the start of the EHR reporting period.
    Comment: Commenters requested clarification on whether a provider 
needed to register each year under the active engagement option 1. 
Commenters noted that requiring registration each year would result in 
duplicative registrations. Commenters also requested clarity on whether 
registration is required for each measure. A commenter noted that they 
recommend that clarity be provided regarding whether registration is 
required for measures that the provider has not registered for 
previously (for example, measures not included in Stage 2).
    Response: As we have noted elsewhere in this final rule with 
comment period, under the proposed active engagement requirement, 
providers would only need to register once with a public health agency 
or a clinical data registry and could register before the reporting 
period begins. In addition, we note that previous registrations with a 
public health agency or clinical data registry that occurred in a 
previous stages of meaningful use could count toward Active Engagement 
Option 1 for any of the EHR reporting periods in 2015, 2016, or 2017. 
We clarify that providers must register with a PHA or CDR for each 
measure they intend to use to meet meaningful use. Further, we also 
clarify that to meet Active Engagement Option 1, registration with the 
applicable PHA or CDR is required where a provider seeks to meet 
meaningful use using a measure they have not successfully attested to 
in a previous EHR reporting period.
    Comment: Commenters also requested clarification regarding whether 
a provider can successfully attest to meaningful use using proof of 
active engagement collected by their organization, or whether a 
provider must demonstrate that they independently engaged with the PHA 
or CDR.
    Response: Providers can demonstrate meaningful use by using 
communications and information provided by a PHA or CDR to the provider 
directly. A provider also may demonstrate meaningful use by using 
communications and information provided by a PHA or CDR to the practice 
or organization of the provider as long as the provider shares the same 
CEHRT as the practice or organization.
    Comment: Some comments requested clarification of the definition of 
production under Active Engagement Option 3.
    Response: To meet any of the measures using Active Engagement--
Option 3 (production), we proposed that a provider only may 
successfully attest to meaningful use when the receiving PHA or CDR 
moves the provider into a production phase. We recognize that live data 
may be sent during the Testing and Validation phase of Active 
Engagement: Option 2, but-in such a case the data received in Option 2 
is insufficient for purposes of meeting Option 3 unless the PHA and CDR 
is actively accepting the production data from the provider for purpose 
of reporting.
    Proposed Measures: We proposed a total of six possible measures for 
this objective. For meaningful use in 2015 through 2017, EPs would be 
required to choose from Measures 1 through 5, and would be required to 
successfully attest to any combination of two measures. For meaningful 
use in 2015 through 2017, eligible hospitals, and CAHs would be 
required to choose from Measures 1 through 6, and would be required to 
successfully attest to any combination of three measures. In 2015 only 
for providers scheduled to be in Stage 1, EPs would be required to 
choose from Measures 1 through 5, but would be permitted to 
successfully attest to one measure; and eligible hospitals and CAHs 
would be required to choose from Measures 1 through 6, but would be 
permitted to successfully attest to any combination of two measures. 
The proposed measures are as shown in Table 5. We proposed that 
measures 4 and 5 for Public Health Registry Reporting and Clinical Data 
Registry Reporting may be counted more than once if more than one 
Public

[[Page 62820]]

Health Registry or Clinical Data Registry is available.

   Table 5--Measures for Objective 8: Public Health and Clinical Data
                      Registry Reporting Objective
------------------------------------------------------------------------
                                                        Maximum times
                                  Maximum times       measure can count
           Measure              measure can count     towards objective
                                towards objective       for eligible
                                     for EP            hospital or CAH
------------------------------------------------------------------------
Measure 1--Immunization                          1                     1
 Registry Reporting.........
Measure 2--Syndromic                             1                     1
 Surveillance Reporting.....
Measure 3--Case Reporting...                     1                     1
Measure 4--Public Health                         2                     3
 Registry Reporting *.......
Measure 5--Clinical Data                         2                     3
 Registry Reporting **......
Measure 6--Electronic                          N/A                     1
 Reportable 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 proposed that an exclusion for a measure does not count 
toward the total of two measures. Instead, in order to meet this 
objective an EP would need to meet two of the total number of measures 
available to them. If the EP qualifies for multiple exclusions and the 
remaining number of measures available to the EP is less than two, the 
EP can meet the objective by meeting the one remaining measure 
available to them and claiming the applicable exclusions. If no 
measures remain available, the EP can meet the objective by claiming 
applicable exclusions for all measures. An EP who is scheduled to be in 
Stage 1 in 2015 must report at least one measure unless they can 
exclude from all available measures. Available measures include ones 
for which the EP does not qualify for an exclusion.
    For eligible hospitals and CAHs, we proposed that an exclusion for 
a measure does not count toward the total of three measures. Instead, 
in order to meet this objective, an eligible hospital or CAH would need 
to meet three of the total number of measures available to them. If the 
eligible hospital or CAH qualifies for multiple exclusions and the 
total number of remaining measures available to the eligible hospital 
or CAH is less than three, the eligible hospital, or CAH can meet the 
objective by meeting all of the remaining measures available to them 
and claiming the applicable exclusions. If no measures remain 
available, the eligible hospital or CAH can meet the objective by 
claiming applicable exclusions for all measures. An eligible hospital 
or CAH that is scheduled to be in Stage 1 in 2015 must report at least 
two measures unless they can--either;--(1) Exclude from all but one 
available measure and report that one measure; or (2) can exclude from 
all available measures. Available measures include ones for which the 
eligible hospital or CAH does not qualify for an exclusion.
    We note that we proposed 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 also proposed 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.
    Comment: Commenters requested clarification regarding the number of 
measures that a provider would be required to meet for the EHR 
reporting periods covered by the EHR Incentive Program in 2015 through 
2017 requirements.
    Response: In the EHR Incentive Program for 2015 through 2017 
proposed rule (80 FR 20356), we proposed that for providers scheduled 
to attest to Stage 1 in 2015, EPs would be required to successfully 
attest to one measure and eligible hospitals and CAHs would be required 
to successfully attest to any combination of two measures. We also 
proposed that for providers scheduled to attest to Stage 2 in 2015 and 
for all providers in 2016 and 2017, EPs would be required to 
successfully attest to any combination of two measures and eligible 
hospitals and CAHs would be required to successfully attest to any 
combination of three measures. Finally, we proposed that EPs may select 
from measures 1 through 5 while eligible hospitals and CAHs may select 
from measures 1 through 6.
    To calculate the measures:
     Proposed 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 proposed that to successfully meet the requirements of this 
measure, bi-directional data exchange between the provider's CEHRT 
system and the immunization registry/IIS is required.
    Exclusion: Any EP, eligible hospital, or CAH meeting one or more of 
the following criteria may be excluded from the immunization registry 
reporting measure if the EP, eligible hospital, or CAH--
    ++ Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the EHR reporting period;
    ++ Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    ++ Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data from the EP, eligible hospital, or CAH at the start 
of the EHR reporting period.
    Comment: For Measure 1--Immunization Registry Reporting, the vast 
majority of commenters noted that the addition of bi-directionality 
during the EHR Incentive Program 2015 through 2017 period would be 
burdensome to accomplish. A commenter noted that bi-directional 
capability is newly proposed for Stage 3 and as part of the 2015 
Edition proposed rule, and is not currently part of the

[[Page 62821]]

Stage 2 or 2014 Edition rule requirements. The commenter noted that 
adding in this requirement would require significant development and 
implementation effort and that most states are not yet able to engage 
in this functionality.
    Response: We appreciate commenters' concerns regarding the addition 
of a bi-directionality requirement for the EHR reporting periods 
covered by the modified Stage 2 requirements. We agree with commenters 
that additional time may be needed for both public health agencies and 
providers to adopt the necessary technology to support bi-directional 
functionality. Therefore, we are not finalizing the bi-directionality 
proposal in the EHR Incentive Programs for 2015 through 2017.
     Proposed 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 where the jurisdiction accepts syndromic data 
from such settings and the standards are clearly defined for EPs, or an 
emergency or urgent care department for eligible hospitals and CAHs 
(POS 23).
    Exclusion for EPs: Any EP meeting one or more of the following 
criteria may be excluded from the syndromic surveillance reporting 
measure if the EP--
    ++ Does not treat or diagnose or directly treat any disease or 
condition associated with a syndromic surveillance system in his or her 
jurisdiction;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from EPs in 
the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs at 
the start of the EHR reporting period.
    Exclusion for eligible hospitals/CAHs: Any eligible hospital or CAH 
meeting one or more of the following criteria may be excluded from the 
syndromic surveillance reporting measure if the eligible hospital or 
CAH--
    ++ Does not have an emergency or urgent care department;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data from 
eligible hospitals or CAHs in the specific standards required to meet 
the CEHRT definition at the start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from eligible 
hospitals or CAHs at the start of the EHR reporting period.
    Comment: For Measure 2--Syndromic Surveillance Reporting, many 
commenters noted that jurisdictions are not able to receive ambulatory 
syndromic surveillance data and that, the standards for ambulatory 
syndromic surveillance in 2014 CEHRT for reporting are vague. A comment 
noted that few PHAs appear to be able to accept non-emergency or non-
urgent care ambulatory syndromic surveillance data electronically. 
These commenters recommended that the syndromic surveillance measure 
should be removed from the objective.
    Response: We disagree with commenters who suggest that the 
syndromic surveillance measure should be removed from the EHR Incentive 
Programs for 2015 through 2017. While some jurisdictions are not 
currently accepting syndromic surveillance data from ambulatory care 
providers, there are other providers who have been able to report in 
their jurisdictions and who have successfully attested to this measure. 
We believe that removing the syndromic surveillance measure as an 
option would negatively impact such providers. We also believe that 
maintaining this measure for 2015 through 2017 allows additional 
providers to choose this measure in the future. We remind commenters 
that syndromic surveillance reporting is one option available to 
providers. If this option is not suitable for the provider, additional 
options are available and exclusions for this measure are also 
available. We are modifying the proposed EP exclusion which states 
``does not treat or diagnose or directly treat any disease or condition 
associated with a syndromic surveillance system in his or her 
jurisdiction'' to better indicate that the registry may or may not 
allow the EP to report based on their category rather than on whether 
they treat or diagnose specific diseases or condition for syndromic 
surveillance reporting. For eligible hospitals and CAHs, almost all 
jurisdictions currently accept syndromic surveillance data. Finally, we 
note that some eligible professionals are already submitting syndromic 
surveillance data which is allowable under Stage 2. Therefore, we are 
adopting a modification that allows all eligible professionals to 
submit syndromic surveillance data for an EHR reporting period in 2015 
through 2017.
     Proposed 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.
    Proposed Exclusions: Any EP, eligible hospital, or CAH meeting one 
or more of the following criteria may be excluded from the case 
reporting measure if the EP, eligible hospital, or CAH--
    ++ Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data at the 
start of the EHR reporting period.
    Comment: Some commenters noted that case reporting is not mature 
enough to be included in meaningful use for 2015, 2016, or 2017. A 
commenter noted that the majority of eligible providers operate in 
jurisdictions where PHAs are not able to receive electronic case 
reporting data and have not developed the infrastructure to support 
such reporting. The commenters noted that the 2015 Edition proposed 
rule does not include certification criteria on case reporting. These 
commenters recommended removing this measure from the objective for 
2015 through 2017.
    Response: We appreciate commenter concerns regarding the readiness 
of standards and functionality for case reporting and believe that 
technology may not yet be sufficiently mature. Based on public comment 
received, it is clear that many public health jurisdictions have not 
yet built the infrastructure to receive electronic case reports, and 
while a few public health jurisdictions have infrastructure to accept 
case reports, many of these are not able to accept case reports in a 
standard format. Building new infrastructure to support electronic case 
reporting across multiple public health jurisdictions and to support 
certification may not be feasible for EHR Incentive Program reporting 
periods in 2015, 2016, and 2017. We continue to believe that case 
reporting is a core component of public health reporting and to health 
improvement around the country and, as noted elsewhere, are maintaining 
this measure for Stage 3. However, for purposes of the EHR Incentive 
Program for 2015 through 2017, we believe

[[Page 62822]]

additional time is needed across the HIT landscape to develop the 
technology and infrastructure to support case reporting and we are not 
finalizing this measure as proposed.
    If a provider chooses to participate in Stage 3 in 2017, they must 
meet the requirements defined for the Stage 3 Public Health and 
Clinical Data Registry Reporting objective which may include the case 
reporting measure defined for the Stage 3 objectives discussed in 
section II.B.2.b.viii of this final rule with comment period.
     Proposed 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.
    As noted in the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20368), in the Stage 2 final rule, we were 
purposefully general in our use of the term ``specialized registry'' 
(other than a cancer registry) for the Stage 2 Specialized Registry 
Reporting Objective to encompass both registry reporting to public 
health agencies and clinical data registries in order to prevent 
inadvertent exclusion of certain registries through an attempt to be 
more specific (77 FR 54030). In response to insight gained from the 
industry through listening sessions, public forums, and responses to a 
Federal Register notice soliciting public comments on the proposed 
information collections to develop a centralized repository on public 
health readiness to support meaningful use (79 FR 7461); we proposed to 
carry forward the concept behind this broad category from Stage 2, but 
also proposed 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 in the EHR 
Incentive Programs in 2015 through 2017 proposed rule (80 FR 20367). We 
proposed 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 
proposed 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).
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20367), we reiterated 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.
    We further noted that ONC adopted standards for ambulatory cancer 
case reporting in its 2014 Edition final rule (see Sec.  170.314(f)(6)) 
and CMS provided EPs the option to select the cancer case reporting 
menu objective in the Stage 2 final rule (77 FR 54029 through 54030). 
We included cancer registry reporting as a separate objective from 
specialized registry reporting because it was more mature in its 
development than other registry types, not because other reporting was 
intended to be excluded from meaningful use. In the EHR Incentive 
Program in 2015 through 2017 proposed rule (80 FR 20369), we proposed 
that EPs would have the option of counting cancer case reporting under 
the public health registry reporting measure, but that cancer case 
reporting is not an option for eligible hospitals and CAHs, because 
hospitals have traditionally diagnosed and treated cancers (or both) 
and have the infrastructure needed to report cancer cases.
    Proposed Exclusions: Any EP, eligible hospital, or CAH meeting at 
least one of the following criteria may be excluded from the public 
health registry reporting measure if the EP, eligible hospital, or 
CAH--
    ++ Does not diagnose or directly treat any disease or condition 
associated with a public health registry in their jurisdiction during 
the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the EHR 
reporting period; or
    ++ Operates in a jurisdiction where no public health registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions at the beginning 
of the EHR reporting period.
    Comment: Some commenters noted that for Measure 4--Public Health 
Registry Reporting, public health registries that would fall within 
this measure would need additional time to implement the applicable 
standards identified in the 2015 Edition rule, which would be 
applicable to providers seeking to attest to meaningful use in 2015, 
2016, or 2017. Commenters specifically noted that the certification 
requirements for public health registries are not identified in the 
2014 Edition rule and that the technology and infrastructure to support 
such registries is not yet mature.
    Many commenters recommended changing this measure and the clinical 
data registry reporting measure back to the prior Stage 2 requirements 
for the specialized registry reporting objective for 2015 through 2017 
instead of splitting that objective into two measures as proposed. 
Commenters noted that if the language in the Stage 2 specialized 
registry reporting objective were changed to include the ``Active 
engagement'' definition, it would provide a wide range of options which 
offers a value for providers and especially for certain EP specialties 
who may otherwise be excluding from all available measures. In 
addition, commenters note that maintaining the existing specialized 
registry reporting objective would provide continuity for providers and 
not inadvertently penalize providers who had selected to report to a 
registry under the specialized registry reporting objective which may 
not qualify under the definition of a public health registry or a 
clinical data registry from the proposed rule.
    Response: We appreciate commenters concerns regarding the public 
health registry reporting measure proposed. We agree that the standards 
for public health registry reporting are part of the 2015 Edition rule 
and are not currently part of 2014 Edition Rule that providers are 
required to use in 2015 and may use in 2016 and 2017. We understand 
commenter concerns that requiring public health registry reporting 
could present a challenge for developers and for public health 
jurisdictions seeking to support such reporting. Furthermore, we agree 
that our proposal to split the Specialized Registry Reporting objective 
into two measures may inadvertently cause some providers to no longer 
use their current reporting option to meet the measure. We are 
therefore not finalizing our proposal to split specialized registry 
reporting into two measures as proposed.
    Instead, we will maintain for 2015 through 2017 a unified 
specialized registry reporting measure which adopts the change from 
``ongoing submission'' to ``active engagement''. We believe that this 
will allow providers flexibility to continue in the direction they may 
have already planned for reporting while still allowing for a wide 
range of reporting options in the future. We further note that we have 
previously supported the

[[Page 62823]]

inclusion of a variety of registries under the specialized registry 
measure, including Prescription Drug Monitoring Program reporting and 
electronic case reporting. We agree that a variety of registries may be 
considered specialized registries, which allows providers the 
flexibility to report using a registry that is most helpful to their 
patients. Therefore, we will continue to allow these registries to be 
considered specialized registries for purposes of reporting the EHR 
Reporting period in 2015, 2016, and 2017. However, we will modify the 
exclusion not only to reflect the change from public health registry to 
specialized registry but also to allow an exclusion if the provider 
does not collect the data relevant to a specialized registry within 
their jurisdiction.
    We are also finalizing our proposed policy to incorporate cancer 
case reporting into the measure for EPs only. Therefore, EPs who were 
previously planning to attest to the cancer case reporting objective, 
may count that action toward the Specialized Registry Reporting 
measure. We believe this change is necessary to support continued 
provider reporting to cancer case registries. However, we note that EPs 
who did not intend to attest to the cancer case reporting menu 
objective are not required to engage in or exclude from cancer case 
reporting in order to meet the specialized registry reporting measure. 
We further note that providers may use electronic submission methods 
beyond the functions of CEHRT to meet the requirements for the 
Specialized Registry Reporting measure. Finally, we are adopting our 
proposal that providers may count the measure more than one time if 
they report to multiple specialized registries as proposed. For the 
Stage 3 public health registry reporting measure within the Public 
Health and Clinical Data Registry Reporting Objective, we direct 
readers to section II.B.2.b.viii of this final rule with comment 
period.
     Proposed 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 
proposed 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 proposed 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 \[1]\. We 
proposed 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.
    We proposed that any EP, eligible hospital, or CAH may report to 
more than 1 clinical data registry to meet the total number of required 
measures for this objective. ONC would consider the adoption of 
standards and implementation guides in future rulemaking. Should these 
subsequently be finalized, they may then be adopted as part of the 
CEHRT definition as it relates to meeting the clinical data registry 
reporting measure through future rulemaking for the EHR Incentive 
Programs.
    Exclusion: Any EP, eligible hospital, or CAH meeting at least one 
of the following criteria may be excluded from the clinical data 
registry reporting measure if the EP, eligible hospital, or CAH--
    ++ Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the EHR reporting period;
    ++ Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period; or
    ++ Operates in a jurisdiction where no clinical data registry for 
which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions at the beginning 
of the EHR reporting period.
    Comment: Some commenters noted that for Measure 5--Clinical Data 
Registry Reporting, the potential registries will need additional time 
to implement the applicable standards in the 2015 Edition rule. Other 
commenters disagreed with our proposal to split the Specialized 
Registry Reporting Objective into two measures for reporting in 2015 
through 2017 citing unintended negative consequences on providers who 
have planned for and acted toward meeting the prior requirements, 
especially on the short term in 2015 and 2016. These commenters 
recommended retaining the prior specifications for the objective 
instead of adopting two new measures.
    Response: We agree that the standards for clinical data registry 
reporting are not currently part of the 2014 CEHRT definition 
requirements and understand commenter concerns that without clarity on 
the functionality needed to support this measure, it would be difficult 
for providers to implement. As noted in relation to the proposed public 
health reporting measure, we also agree with commenters who state that 
there would potentially be unintended negative consequences for 
providers in 2015 and 2016 especially if we adopt the proposal to split 
the Specialized Registry Reporting Objective into two separate measures 
As noted previously, we are not adopting this policy for the public 
health reporting measure, and we are also therefore not adopting the 
policy for a separate clinical data registry reporting measure. We are 
therefore not adopting this measure as proposed.
    As noted previously, we are not finalizing our proposal to split 
the measure from the Stage 2 Specialized Registry Reporting Objective 
(77 FR 54030) into two measures. Therefore, we are not finalizing the 
clinical data registry reporting measure for 2015, 2016, and for 2017 
for those providers who are not demonstrating Stage 3. If a provider 
chooses to participate in Stage 3 in 2017, they must meet the 
requirements defined for the Stage 3 Public Health and Clinical Data 
Registry Reporting objective as discussed in section II.B.2.b.viii of 
this final rule with comment period.
     Proposed 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 
(ELR) results. We proposed this measure for eligible hospitals and CAHs 
only.
    Exclusion: Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure if the eligible hospital or CAH--

[[Page 62824]]

    ++ Does not perform or order laboratory tests that are reportable 
in their jurisdiction during the EHR reporting period;
    ++ Operates in a jurisdiction for which no public health agency is 
capable of accepting the specific ELR standards required to meet the 
CEHRT definition at the start of the EHR reporting period; or
    ++ Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic reportable laboratory results 
from eligible hospitals or CAHs at the start of the EHR reporting 
period.
    Comment: For Measure 6--ELR, commenters agreed with the 
continuation of this measure but requested that it also be included as 
an option for EPs that maintain in-house laboratories.
    Response: We thank commenters for their support of this measure. 
However, we do not agree that this measure should be extended to EPs. 
We note that in-house laboratories of EPs do not perform the types of 
tests that are reportable to public health jurisdictions. For example, 
many in-house laboratories focus on tests such as rapid strep tests 
that test for strep throat. The rapid strep tests are not reportable to 
public health agencies.
    After consideration of public comments received, for EHR reporting 
periods in 2015 through 2017, we are finalizing the objective with a 
modification to the name to state Public Health Reporting Objective and 
to remove the reference to clinical data registries. We are finalizing 
the measures with modifications. For Measure 1, we remove the 
requirement for bi-directional data exchange and note that providers 
will not be required to receive a full immunization history and will 
not be required to display an immunization forecast from an 
Immunization Information System (IIS) to meet the measure. Providers 
will only need to electronically submit immunization data to the 
appropriate public health jurisdiction's IIS. For Measure 2, we are 
adopting a modification to the final policy to allow all EPs to submit 
syndromic surveillance data and to modify the exclusions to reflect 
that different categories of providers may or may not be able to report 
based on the requirements of the registry. For Measure 3, we are not 
finalizing the proposed case reporting measure. For Measure 4, we are 
not finalizing our proposal to split specialized registry reporting 
into two distinct measures. Instead, we will maintain a unified 
specification for specialized registry reporting which adopts the 
change from ``ongoing submission'' to ``active engagement'' and 
includes reporting for eligible hospitals and CAHs for 2015 through 
2017. We include cancer case reporting as an option for EPs only under 
the adopted specialized registry reporting measure. We are 
redesignating this measure as ``Measure 3''. For Measure 5, we are not 
finalizing the proposed clinical data registry reporting measure. For 
Measure 6, we are finalizing the measure language as proposed and 
redesignating the measure as ``Measure 4''.
    For the explanation of terms, we are finalizing the definition of 
active engagement with the additional clarification provided through 
response to public comment. We are finalizing that EPs must meet at 
least 2 measures with a modification to reference the selection from 
measures 1 through 3 (rather than 1 through 5). Similarly, we are 
finalizing that eligible hospitals and CAHs must meet at least 3 
measures from measures 1 through 4 (rather than 1 through 6). We are 
also finalizing the alternate specification that in 2015 Stage 1 EPs 
may meet one measure to meet the threshold and Stage 1 eligible 
hospitals and CAHs may meet two measures to meet the threshold.
    For EPs, we are finalizing that an exclusion for a measure does not 
count toward the total of two measures. Instead, in order to meet this 
objective an EP would need to meet two of the total number of measures 
available to them. If the EP qualifies for multiple exclusions and the 
remaining number of measures available to the EP is less than two, the 
EP can meet the objective by meeting the one remaining measure 
available to them and claiming the applicable exclusions. If no 
measures remain available, the EP can meet the objective by claiming 
applicable exclusions for all measures. An EP who is scheduled to be in 
Stage 1 in 2015 must report at least one measure unless they can 
exclude from all available measures. Available measures include ones 
for which the EP does not qualify for an exclusion.
    For eligible hospitals and CAHs, we are finalizing that an 
exclusion for a measure does not count toward the total of three 
measures. Instead, in order to meet this objective an eligible hospital 
or CAH would need to meet three of the total number of measures 
available to them. If the eligible hospital or CAH qualifies for 
multiple exclusions and the total number of remaining measures 
available to the eligible hospital or CAH is less than three, the 
eligible hospital or CAH can meet the objective by meeting all of the 
remaining measures available to them and claiming the applicable 
exclusions. If no measures remain available, the eligible hospital or 
CAH can meet the objective by claiming applicable exclusions for all 
measures. An eligible hospital or CAH that is scheduled to be in Stage 
1 in 2015 must report at least two measures unless they can either--(1) 
Exclude from all but one available measure and report that one measure; 
or (2) can exclude from all available measures. Available measures 
include ones for which the eligible hospital or CAH does not qualify 
for an exclusion.
    Finally, we note that a provider may report to more than one 
specialized registry and may count specialized registry reporting more 
than once to meet the required number of measures for the objective.
    We are adopting the final objective, measures, exclusions, and 
alternate specification as follows:
Objective 10: Public Health Reporting
    Objective: The EP, eligible hospital or CAH is in active engagement 
with a public health agency to submit electronic public health data 
from CEHRT 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.
    Exclusion: Any EP, eligible hospital, or CAH meeting one or more of 
the following criteria may be excluded from the immunization registry 
reporting measure if the EP, eligible hospital, or CAH--
     Does not administer any immunizations to any of the 
populations for which data is collected by its jurisdiction's 
immunization registry or immunization information system during the EHR 
reporting period;
     Operates in a jurisdiction for which no immunization 
registry or immunization information system is capable of accepting the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period; or
     Operates in a jurisdiction where no immunization registry 
or immunization information system has declared readiness to receive 
immunization data from the EP, eligible hospital, or CAH 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.

[[Page 62825]]

    Exclusion for EPs: Any EP meeting one or more of the following 
criteria may be excluded from the syndromic surveillance reporting 
measure if the EP--
     Is not in a category of providers from which ambulatory 
syndromic surveillance data is collected by their jurisdiction's 
syndromic surveillance system;
     Operates in a jurisdiction for which no public health 
agency is capable of receiving electronic syndromic surveillance data 
from EPs in the specific standards required to meet the CEHRT 
definition at the start of the EHR reporting period; or
     Operates in a jurisdiction where no public health agency 
has declared readiness to receive syndromic surveillance data from EPs 
at the start of the EHR reporting period.
    Exclusion for eligible hospitals/CAHs: Any eligible hospital or CAH 
meeting one or more of the following criteria may be excluded from the 
syndromic surveillance reporting measure if the eligible hospital or 
CAH--
     Does not have an emergency or urgent care department;
     Operates in a jurisdiction for which no public health 
agency is capable of receiving electronic syndromic surveillance data 
from eligible hospitals or CAHs in the specific standards required to 
meet the CEHRT definition at the start of the EHR reporting period; or
     Operates in a jurisdiction where no public health agency 
has declared readiness to receive syndromic surveillance data from 
eligible hospitals or CAHs at the start of the EHR reporting period.
    Measure 3--Specialized Registry Reporting--The EP, eligible 
hospital, or CAH is in active engagement to submit data to a 
specialized registry.
    Exclusions: Any EP, eligible hospital, or CAH meeting at least one 
of the following criteria may be excluded from the specialized registry 
reporting measure if the EP, eligible hospital, or CAH--
     Does not diagnose or treat any disease or condition 
associated with or collect relevant data that is required by a 
specialized registry in their jurisdiction during the EHR reporting 
period;
     Operates in a jurisdiction for which no specialized 
registry is capable of accepting electronic registry transactions in 
the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period; or
     Operates in a jurisdiction where no specialized 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 4--Electronic Reportable Laboratory Result Reporting: The 
eligible hospital or CAH is in active engagement with a public health 
agency to submit electronic reportable laboratory (ELR) results.
    Exclusion: Any eligible hospital or CAH meeting one or more of the 
following criteria may be excluded from the electronic reportable 
laboratory result reporting measure if the eligible hospital or CAH--
     Does not perform or order laboratory tests that are 
reportable in their jurisdiction during the EHR reporting period;
     Operates in a jurisdiction for which no public health 
agency is capable of accepting the specific ELR standards required to 
meet the CEHRT definition at the start of the EHR reporting period; or
     Operates in a jurisdiction where no public health agency 
has declared readiness to receive electronic reportable laboratory 
results from eligible hospitals or CAHs at the start of the EHR 
reporting period.
    Alternate Specification: An EP scheduled to be in Stage 1 in 2015 
may meet 1 measure and an eligible hospital or CAH scheduled to be in 
Stage 1 in 2015 may meet two measures.

  Table 6--Public Health Reporting Objective Measures for EPS, Eligible
                Hospitals, and CAHs in 2015 Through 2017
------------------------------------------------------------------------
                                                          Maximum times
                                                           measure can
    Measure number and name      Measure specification    count towards
                                                          the objective
------------------------------------------------------------------------
Measure 1--Immunization         The EP, eligible        1.
 Registry Reporting.             hospital, or CAH is
                                 in active engagement
                                 with a public health
                                 agency to submit
                                 immunization data.
Measure 2--Syndromic            The EP, eligible        1.
 Surveillance Reporting.         hospital or CAH is in
                                 active engagement
                                 with a public health
                                 agency to submit
                                 syndromic
                                 surveillance data.
Measure 3--Specialized          The EP, eligible        2 for EP, 3 for
 Registry Reporting.             hospital, or CAH is     eligible
                                 in active engagement    hospital/CAH.
                                 with a public health
                                 agency to submit data
                                 to a specialized
                                 registry.
Measure 4--Electronic           The eligible hospital   N/A.
 Reportable Laboratory Results   or CAH is in active
 Reporting.                      engagement with a
                                 public health agency
                                 to submit ELR results.
------------------------------------------------------------------------

    We are adopting Objective 10: Public Health Reporting at Sec.  
495.22(e)(10)(i) for EPs and Sec.  495.22(e)(10)(ii) for eligible 
hospitals and CAHs. We further specify that providers must use the 
functions and standards as defined for CEHRT at Sec.  495.4 where 
applicable; however, as noted for measure 3, providers may use 
functions beyond those established in CEHRT in accordance with state 
and local law. We direct readers to section II.B.3. of this final rule 
with comment period for a discussion of the definition of CEHRT and a 
table referencing the capabilities and standards that must be used for 
each measure.

[[Page 62826]]



  Table 7--Eligible Professional (EP) Objectives and Measures for 2015
                              Through 2017
------------------------------------------------------------------------
                                                    Alternate exclusions
  Objectives for 2015, 2016       Measures for             and/or
          and 2017             providers in 2015,    specifications for
                                  2016 and 2017       certain providers
------------------------------------------------------------------------
Objective 1: Protect Patient  Measure: Conduct or   NONE.
 Health Information.           review a security
                               risk analysis in
                               accordance with the
                               requirements in 45
                               CFR 164.308(a)(1),
                               including
                               addressing the
                               security (to
                               include encryption)
                               of ePHI created or
                               maintained by
                               Certified EHR
                               Technology in
                               accordance with
                               requirements in 45
                               CFR
                               164.312(a)(2)(iv)
                               and 45 CFR
                               164.306(d)(3), and
                               implement security
                               updates as
                               necessary and
                               correct identified
                               security
                               deficiencies as
                               part of the EP's
                               risk management
                               process.
Objective 2: Clinical          Measure 1:   If for an EHR
 Decision Support.             Implement five        reporting period in
                               clinical decision     2015, the provider
                               support               is scheduled to
                               interventions         demonstrate Stage
                               related to four or    1:
                               more clinical        Alternate Objective
                               quality measures at   and Measure 1:
                               a relevant point in  Objective: Implement
                               patient care for      one clinical
                               the entire EHR        decision support
                               reporting period.     rule relevant to
                               Absent four           specialty or high
                               clinical quality      clinical priority,
                               measures related to   along with the
                               an EPs scope of       ability to track
                               practice or patient   compliance with
                               population, the       that rule.
                               clinical decision    Measure: Implement
                               support               one clinical
                               interventions must    decision support
                               be related to high-   rule.
                               priority health
                               conditions.
                               Measure 2:
                               The EP has enabled
                               and implemented the
                               functionality for
                               drug-drug and drug-
                               allergy interaction
                               checks for the
                               entire EHR
                               reporting period.
Objective 3: Computerized      Measure 1:    Alternate
 Provider Order Entry CPOE.    More than 60          Measure 1: For
                               percent of            Stage 1 providers
                               medication orders     in 2015 only, more
                               created by the EP     than 30 percent of
                               during the EHR        all unique patients
                               reporting period      with at least one
                               are recorded using    medication in their
                               computerized          medication list
                               provider order        seen by the EP
                               entry.                during the EHR
                               Measure 2:    reporting period
                               More than 30          have at least one
                               percent of            medication order
                               laboratory orders     entered using CPOE;
                               created by the EP     or more than 30
                               during the EHR        percent of
                               reporting period      medication orders
                               are recorded using    created by the EP
                               computerized          during the EHR
                               provider order        reporting period
                               entry.                during the EHR
                               Measure 3:    reporting period,
                               More than 30          are recorded using
                               percent of            computerized
                               radiology orders      provider order
                               created by the EP     entry.
                               during the EHR        Alternate
                               reporting period      Exclusion for
                               are recorded using    Measure 2:
                               computerized          Providers scheduled
                               provider order        to be in Stage 1 in
                               entry.                2015 may claim an
                                                     exclusion for
                                                     measure 2
                                                     (laboratory orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2015;
                                                     and, providers
                                                     scheduled to be in
                                                     Stage 1 in 2016 may
                                                     claim an exclusion
                                                     for measure 2
                                                     (laboratory orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2016.
                                                     Alternate
                                                     Exclusion for
                                                     Measure 3:
                                                     Providers scheduled
                                                     to be in Stage 1 in
                                                     2015 may claim an
                                                     exclusion for
                                                     measure 3
                                                     (radiology orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2015;
                                                     and, providers
                                                     scheduled to be in
                                                     Stage 1 in 2016 may
                                                     claim an exclusion
                                                     for measure 3
                                                     (radiology orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2016.
Objective 4: Electronic       EP Measure: More      Alternate EP
 Prescribing.                  than 50 percent of    Measure: For Stage
                               all permissible       1 providers in 2015
                               prescriptions         only, More than 40
                               written by the EP     percent of all
                               are queried for a     permissible
                               drug formulary and    prescriptions
                               transmitted           written by the EP
                               electronically        are transmitted
                               using CEHRT.          electronically
                                                     using CEHRT.
Objective 5: Health           Measure: The EP that  Alternate Exclusion:
 Information Exchange.         transitions or        Provider may claim
                               refers their          an exclusion for
                               patient to another    the measure of the
                               setting of care or    Stage 2 Summary of
                               provider of care      Care objective,
                               (1) uses CEHRT to     which requires the
                               create a summary of   electronic
                               care record; and      transmission of a
                               (2) electronically    summary of care
                               transmits such        document if for an
                               summary to a          EHR reporting
                               receiving provider    period in 2015 they
                               for more than 10      were scheduled to
                               percent of            demonstrate Stage
                               transitions of care   1, which does not
                               and referrals.        have an equivalent
                                                     measure.
Objective 6: Patient-         EP Measure: Patient-  Alternate Exclusion:
 Specific Education.           specific education    Provider may claim
                               resources             an exclusion for
                               identified by CEHRT   the measure of the
                               are provided to       Stage 2 Patient-
                               patients for more     Specific Education
                               than 10 percent of    objective if for an
                               all unique patients   EHR reporting
                               with office visits    period in 2015 they
                               seen by the EP        were scheduled to
                               during the EHR        demonstrate Stage 1
                               reporting period.     but did not intend
                                                     to select the Stage
                                                     1 Patient-Specific
                                                     Education menu
                                                     objective.
Objective 7: Medication       Measure: The EP,      Alternate Exclusion:
 Reconciliation.               performs medication   Provider may claim
                               reconciliation for    an exclusion for
                               more than 50          the measure of the
                               percent of            Stage 2 Medication
                               transitions of care   Reconciliation
                               in which the          objective if for an
                               patient is            EHR reporting
                               transitioned into     period in 2015 they
                               the care of the EP.   were scheduled to
                                                     demonstrate Stage 1
                                                     but did not intend
                                                     to select the Stage
                                                     1 Medication
                                                     Reconciliation menu
                                                     objective.

[[Page 62827]]

 
Objective 8: Patient           EP Measure   Alternate Exclusion
 Electronic Access (VDT).      1: More than 50       Measure 2:
                               percent of all        Providers may claim
                               unique patients       an exclusion for
                               seen by the EP        the second measure
                               during the EHR        if for an EHR
                               reporting period      reporting period in
                               are provided timely   2015 they were
                               access to view        scheduled to
                               online, download,     demonstrate Stage
                               and transmit to a     1, which does not
                               third party their     have an equivalent
                               health information    measure.
                               subject to the EP's
                               discretion to
                               withhold certain
                               information.
                               EP Measure
                               2: For 2015 and
                               2016: At least 1
                               patient seen by the
                               EP during the EHR
                               reporting period
                               (or patient-
                               authorized
                               representative)
                               views, downloads or
                               transmits his or
                               her health
                               information to a
                               third party during
                               the EHR reporting
                               period.
                              For 2017: More than
                               5 percent of unique
                               patients seen by
                               the EP during the
                               EHR reporting
                               period (or patient-
                               authorized
                               representative)
                               views, downloads or
                               transmits their
                               health information
                               to a third party
                               during the EHR
                               reporting period.
Objective 9: Secure           Measure: For 2015:    Alternate Exclusion:
 Messaging.                    For an EHR            An EP may claim an
                               reporting period in   exclusion for the
                               2015, the             measure if for an
                               capability for        EHR reporting
                               patients to send      period in 2015 they
                               and receive a         were scheduled to
                               secure electronic     demonstrate Stage
                               message with the EP   1, which does not
                               was fully enabled.    have an equivalent
                              For 2016: For at       measure.
                               least 1 patient
                               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 patient-
                               authorized
                               representative), or
                               in response to a
                               secure message sent
                               by the patient (or
                               patient-authorized
                               representative)
                               during the EHR
                               reporting period.
                              For 2017: For more
                               than 5 percent of
                               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 the
                               patient-authorized
                               representative), or
                               in response to a
                               secure message sent
                               by the patient (or
                               the patient-
                               authorized
                               representative)
                               during the EHR
                               reporting period.
Objective 10: Public Health.   Measure 1--  Stage 1 EPs in 2015
                               Immunization          must meet at least
                               Registry Reporting:   1 measure in 2015,
                               The EP is in active   Stage 2 EPs must
                               engagement with a     meet at least 2
                               public health         measures in 2015,
                               agency to submit      and all EPs must
                               immunization data.    meet at least 2
                               Measure 2--   measures in 2016
                               Syndromic             and 2017.
                               Surveillance
                               Reporting: The EP
                               is in active
                               engagement with a
                               public health
                               agency to submit
                               syndromic
                               surveillance data.
                              Measure 3--
                               Specialized
                               Registry Reporting:
                               The EP is in active
                               engagement to
                               submit data to a
                               specialized
                               registry.
------------------------------------------------------------------------


   Table 8--Eligible Hospital and CAH Objectives and Measures for 2015
                              Through 2017
------------------------------------------------------------------------
                                                    Alternate exclusions
  Objectives for 2015, 2016       Measures for             and/or
          and 2017             providers in 2015,    specifications for
                                  2016 and 2017       certain providers
------------------------------------------------------------------------
Objective 1: Protect Patient  Measure: Conduct or   NONE.
 Health Information.           review a security
                               risk analysis in
                               accordance with the
                               requirements in 45
                               CFR 164.308(a)(1),
                               including
                               addressing the
                               security (to
                               include encryption)
                               of ePHI created or
                               maintained in CEHRT
                               in accordance with
                               requirements in 45
                               CFR
                               164.312(a)(2)(iv)
                               and 45 CFR
                               164.306(d)(3), and
                               implement security
                               updates as
                               necessary and
                               correct identified
                               security
                               deficiencies as
                               part of the
                               eligible hospital
                               or CAHs risk
                               management process.

[[Page 62828]]

 
Objective 2: Clinical          Measure 1:   If for an EHR
 Decision Support.             Implement five        reporting period in
                               clinical decision     2015, the provider
                               support               is scheduled to
                               interventions         demonstrate Stage
                               related to four or    1:
                               more clinical        Alternate Objective
                               quality measures at   and Measure 1:
                               a relevant point in  Objective: Implement
                               patient care for      one clinical
                               the entire EHR        decision support
                               reporting period.     rule relevant to
                               Absent four           specialty or high
                               clinical quality      clinical priority,
                               measures related to   along with the
                               an eligible           ability to track
                               hospital or CAH's     compliance with
                               scope of practice     that rule.
                               or patient           Measure: Implement
                               population, the       one clinical
                               clinical decision     decision support
                               support               rule.
                               interventions must
                               be related to high-
                               priority health
                               conditions.
                               Measure 2:
                               The eligible
                               hospital or CAH has
                               enabled and
                               implemented the
                               functionality for
                               drug-drug and drug-
                               allergy interaction
                               checks for the
                               entire EHR
                               reporting period.
Objective 3: Computerized      Measure 1:    Alternate
 Provider Order Entry CPOE.    More than 60          Measure 1: For
                               percent of            Stage 1 providers
                               medication orders     in 2015 only, more
                               created by            than 30 percent of
                               authorized            all unique patients
                               providers of the      with at least one
                               eligible hospital's   medication in their
                               or CAH's inpatient    medication list
                               or emergency          seen by the EP
                               department (POS 21    during the EHR
                               or 23) during the     reporting period
                               EHR reporting         have at least one
                               period are recorded   medication order
                               using computerized    entered using CPOE;
                               provider order        or more than 30
                               entry.                percent of
                               Measure 2:    medication orders
                               More than 30          created by the EP
                               percent of            during the EHR
                               laboratory orders     reporting period
                               created by            during the EHR
                               authorized            reporting period,
                               providers of the      are recorded using
                               eligible hospital's   computerized
                               or CAH's inpatient    provider order
                               or emergency          entry.
                               department (POS 21    Alternate
                               or 23) during the     Exclusion for
                               EHR reporting         Measure 2:
                               period are recorded   Providers scheduled
                               using computerized    to be in Stage 1 in
                               provider order        2015 may claim an
                               entry.                exclusion for
                               Measure 3:    measure 2
                               More than 30          (laboratory orders)
                               percent of            of the Stage 2 CPOE
                               radiology orders      objective for an
                               created by            EHR reporting
                               authorized            period in 2015;
                               providers of the      and, providers
                               eligible hospital's   scheduled to be in
                               or CAH's inpatient    Stage 1 in 2016 may
                               or emergency          claim an exclusion
                               department (POS 21    for measure 2
                               or 23) during the     (laboratory orders)
                               EHR reporting         of the Stage 2 CPOE
                               period are recorded   objective for an
                               using computerized    EHR reporting
                               provider order        period in 2016.
                               entry.                Alternate
                                                     Exclusion for
                                                     Measure 3:
                                                     Providers scheduled
                                                     to be in Stage 1 in
                                                     2015may claim an
                                                     exclusion for
                                                     measure 3
                                                     (radiology orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2015;
                                                     and, providers
                                                     scheduled to be in
                                                     Stage 1 in 2016 may
                                                     claim an exclusion
                                                     for measure 3
                                                     (radiology orders)
                                                     of the Stage 2 CPOE
                                                     objective for an
                                                     EHR reporting
                                                     period in 2016.
Objective 4: Electronic       Eligible Hospital/    Alternate EH
 Prescribing.                  CAH Measure: More     Exclusion: The
                               than 10 percent of    eligible hospital
                               hospital discharge    or CAH may claim an
                               medication orders     exclusion for the
                               for permissible       eRx objective and
                               prescriptions (for    measure if for an
                               new and changed       EHR reporting
                               prescriptions) are    period in 2015 if
                               queried for a drug    they were either
                               formulary and         scheduled to
                               transmitted           demonstrate Stage
                               electronically        1, which does not
                               using CEHRT.          have an equivalent
                                                     measure, or if they
                                                     are scheduled to
                                                     demonstrate Stage 2
                                                     but did not intend
                                                     to select the Stage
                                                     2 eRx objective for
                                                     an EHR reporting
                                                     period in 2015;
                                                     and, the eligible
                                                     hospital or CAH may
                                                     claim an exclusion
                                                     for the eRx
                                                     objective and
                                                     measure if for an
                                                     EHR reporting
                                                     period in 2016 if
                                                     they were either
                                                     scheduled to
                                                     demonstrate Stage 1
                                                     in 2015 or 2016, or
                                                     if they are
                                                     scheduled to
                                                     demonstrate Stage 2
                                                     but did not intend
                                                     to select the Stage
                                                     2 eRx objective for
                                                     an EHR reporting
                                                     period in 2015.
Objective 5: Health           Measure: The          Alternate Exclusion:
 Information Exchange.         eligible hospital     Provider may claim
                               or CAH that           an exclusion for
                               transitions or        the measure of the
                               refers their          Stage 2 Summary of
                               patient to another    Care objective,
                               setting of care or    which requires the
                               provider of care      electronic
                               (1) uses CEHRT to     transmission of a
                               create a summary of   summary of care
                               care record; and      document if for an
                               (2) electronically    EHR reporting
                               transmits such        period in 2015 they
                               summary to a          were scheduled to
                               receiving provider    demonstrate Stage
                               for more than 10      1, which does not
                               percent of            have an equivalent
                               transitions of care   measure.
                               and referrals.
Objective 6: Patient-         Eligible Hospital/    Alternate Exclusion:
 Specific Education.           CAH Measure: More     Provider may claim
                               than 10 percent of    an exclusion for
                               all unique patients   the measure of the
                               admitted to the       Stage 2 Patient-
                               eligible hospital's   Specific Education
                               or CAH's inpatient    objective if for an
                               or emergency          EHR reporting
                               department (POS 21    period in 2015 they
                               or 23) are provided   were scheduled to
                               patient-specific      demonstrate Stage 1
                               education resources   but did not intend
                               identified by CEHRT.  to select the Stage
                                                     1 Patient-Specific
                                                     Education menu
                                                     objective.

[[Page 62829]]

 
Objective 7: Medication       Measure: The          Alternate Exclusion:
 Reconciliation.               eligible hospital     Provider may claim
                               or CAH performs       an exclusion for
                               medication            the measure of the
                               reconciliation for    Stage 2 Medication
                               more than 50          Reconciliation
                               percent of            objective if for an
                               transitions of care   EHR reporting
                               in which the          period in 2015 they
                               patient is admitted   were scheduled to
                               to the eligible       demonstrate Stage 1
                               hospital's or CAH's   but did not intend
                               inpatient or          to select the Stage
                               emergency             1 Medication
                               department (POS 21    Reconciliation menu
                               or 23).               objective.
Objective 8: Patient           Eligible     Alternate Exclusion
 Electronic Access (VDT).      Hospital/CAH          Measure 2: Provider
                               Measure 1: More       may claim an
                               than 50 percent of    exclusion for the
                               all unique patients   second measure if
                               who are discharged    for an EHR
                               from the inpatient    reporting period in
                               or emergency          2015 they were
                               department (POS 21    scheduled to
                               or 23) of an          demonstrate Stage
                               eligible hospital     1, which does not
                               or CAH are provided   have an equivalent
                               timely access to      measure.
                               view online,
                               download and
                               transmit their
                               health information
                               to a third party
                               their health
                               information.
                               Eligible
                               Hospital/CAH
                               Measure 2: For 2015
                               and 2016: At least
                               1 patient who is
                               discharged from the
                               inpatient or
                               emergency
                               department (POS 21
                               or 23) of an
                               eligible hospital
                               or CAH (or patient-
                               authorized
                               representative)
                               views, downloads,
                               or transmits to a
                               third party his or
                               her health
                               information during
                               the EHR reporting
                               period.
                              For 2017: More than
                               5 percent of unique
                               patients discharged
                               from the inpatient
                               or emergency
                               department (POS 21
                               or 23) of an
                               eligible hospital
                               or CAH (or patient-
                               authorized
                               representative)
                               view, download, or
                               transmit to a third
                               party their health
                               information during
                               the EHR reporting
                               period.
Objective 9: Secure           Not applicable for    Not applicable for
 Messaging.                    eligible hospitals    eligible hospitals
                               and CAHs.             and CAHs.
Objective 10: Public Health.   Measure 1--  Stage 1 eligible
                               Immunization          hospitals and CAHs
                               Registry Reporting:   must meet at least
                               The eligible          2 measures in 2015,
                               hospital or CAH is    Stage 2 eligible
                               in active             hospitals and CAHs
                               engagement with a     must meet at least
                               public health         3 measures in 2015,
                               agency to submit      all eligible
                               immunization data.    hospitals and CAHs
                               Measure 2--   must meet at least
                               Syndromic             3 measures in 2016
                               Surveillance          and 2017.
                               Reporting: The
                               eligible hospital
                               or CAH is in active
                               engagement with a
                               public health
                               agency to submit
                               syndromic
                               surveillance data.
                               Measure 3--
                               Specialized
                               Registry Reporting:
                               The eligible
                               hospital, or CAH is
                               in active
                               engagement to
                               submit data to a
                               specialized
                               registry.
                               Measure 4--
                               Electronic
                               Reportable
                               Laboratory Result
                               Reporting: The
                               eligible hospital
                               or CAH is in active
                               engagement with a
                               public health
                               agency to submit
                               ELR results.
------------------------------------------------------------------------

b. Objectives and Measures for Stage 3 of the EHR Incentive Programs
Objective 1: Protect Patient Health Information
    In the Stage 3 proposed rule at 80 FR 16745 through 16747, we noted 
that, consistent with HIPAA and its implementing regulations and both 
the Stage 1 and Stage 2 final rules (75 FR 44368 through 44369 and 77 
FR 54002 through 54003), protecting electronic protected health 
information (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 the Stage 3 proposed rule, we noted that 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

[[Page 62830]]

alleviate provider confusion and simplify the EHR Incentive Program, we 
proposed maintaining the previously finalized Stage 2 objective on 
protecting ePHI. However, we proposed 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 CEHRT through the implementation of 
appropriate technical, administrative, and physical safeguards.
    For the proposed Stage 3 objective, we added language to the 
security requirements for the implementation of appropriate technical, 
administrative, and physical safeguards. We proposed 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.
    Comment: Most commenters supported the inclusion of this objective 
and many appreciate the addition of ``administrative and physical 
safeguards'' to the objective because it aligns with HIPAA. Most 
commenters appreciated our clarification of the timing and content of 
the security risk assessments. Several commenters appreciated the 
clarification that the requirements of this measure are narrower than 
what is required by HIPAA.
    Some commenters noted in their support of the objective that it is 
essential for privacy protection and consumer confidence in EHRs as 
electronic personal health information is vulnerable to unauthorized 
access, theft, tampering, and corruption. Several commenters noted the 
rise in data breaches and the importance of this objective in keeping 
health information well secured.
    A commenter suggested triggers to remind providers to conduct the 
security risk assessment. Many commenters supported the requirement 
that providers conduct a security risk analysis upon installation or 
upgrade of CEHRT.
    Response: We appreciate the support for this measure. As we stated 
in our proposal, we included administrative and physical safeguards 
because an entity would require them in addition to technical 
safeguards to implement security measures to reduce the risks and 
vulnerabilities identified. Technical safeguards alone are not enough 
to ensure the confidentiality, integrity, and availability of ePHI.
    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.
    As noted in the proposed rule, 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, 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 explained that the requirement of the 
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 the 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.
    In the Stage 3 proposed rule at 80 FR 16746 through 16747, we 
further proposed that the timing or review of the security risk 
analysis to satisfy this proposed measure must be as follows:
     EPs, eligible hospitals, and CAHs must conduct the 
security risk analysis upon installation of CEHRT or upon upgrade to a 
new Edition. The initial security risk analysis and testing may occur 
prior to the beginning of the first EHR reporting period using that 
Edition of CEHRT.
     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.
    Comment: A commenter suggested that ``mandatory consequential 
insurance'' be required of all parties involved in data handling, 
storage, and dissemination.
    Response: We thank the commenter for their suggestion and we will 
share the suggestion with other programs and agencies, which deal 
directly with the business requirements established under the HIPAA 
security rules.
    Comment: Several commenters stated that inclusion of this objective 
was superfluous and redundant, as it is already required by HIPAA. 
Another suggested that we accept compliance with the HIPAA Security 
Rule as fulfillment of this objective. A commenter noted that it is 
confusing when there are requirements from more than one oversight 
agency. They noted that protecting patient health information is in the 
purview of the OCR.
    Response: We disagree. In fact, in our audits of providers who 
attested to the requirements of the EHR Incentive Program, this 
objective and measure are failed more frequently than any other 
requirement. We have included this objective in all Stages because of 
the importance of protecting patients' ePHI. Although OCR does oversee 
the implementation of the HIPAA Security Rule and the protection of 
patient health information, we believe it is important and necessary 
for a provider to attest to the specific actions required to protect 
ePHI created or maintained by CEHRT in order to meet the EHR Incentive 
Program requirements.
    Comment: Several commenters stated that the proposed measure is 
``too comprehensive'' and would be very difficult, time consuming, and 
expensive.
    Many commenters requested clarification about the requirement to 
perform a security risk analysis when CEHRT is upgraded or patched. 
Others noted that requiring a security risk

[[Page 62831]]

analysis whenever software is updated is particularly burdensome.
    A commenter recommended changing the requirement of ``conduct or 
review a security risk analysis'' to ``conduct and review a security 
risk analysis,'' to ensure both the behavior and the review of a 
security risk analysis will be completed. Several commenters requested 
further clarification of the timing for completion of the security risk 
assessment.
    Response: We disagree with the concept that the objective as 
proposed is too comprehensive. We believe that the proposed addition of 
administrative and technical safeguards to this measure enables 
providers to implement risk management security measures to reduce the 
risks and vulnerabilities identified. 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.
    The proposed requirement is to perform the security risk analysis 
upon installation of CEHRT or upon upgrade to a new Edition. Thus, it 
would be required when a provider upgraded from EHR technology 
certified to the 2014 Edition to EHR technology certified to the 2015 
Edition as established by ONC. We note that the second part of the 
requirement states a review must be conducted at least on an annual 
basis, and additional review may be required if additional 
implementation changes are subsequently made that were not included and 
planned for in the initial review.
    We note that a security risk analysis is not a discrete item in 
time, but a comprehensive analysis covering the full period of time for 
which it is applicable; and the annual review of such an analysis is 
similarly comprehensive. In other words, the analysis and review are 
not merely episodic but should cover a span of the entire year, 
including a review planning for future system changes within the year 
or a review of prior system changes within the year. Therefore, we 
believe the commenters' concerns may be a semantic misunderstanding of 
the nature of an analysis and annual review. We proposed to maintain 
the previously finalized Stage 2 objective on protecting ePHI, which 
includes the statement ``conduct or review'' for both the EHR Incentive 
Programs in 2015 through 2017 and for Stage 3.
    We note that for the proposed objective and measure, the measure 
must be completed in the same calendar year as the EHR reporting 
period. If the EHR reporting period is 90 days, it must be completed in 
the same calendar year. This may occur either before or during the EHR 
reporting period; or, if it occurs after the EHR reporting period, it 
must occur before the provider attests or before the end of the 
calendar year, whichever date comes first. Again, we reiterate that the 
security risk analysis and review should not be an episodic ``snap-
shot'' in time, but rather include an analysis and review of the 
protection of ePHI for the full year no matter at what point in time 
that analysis or review are conducted within the year. In short, the 
analysis should cover retrospectively from the beginning of the year to 
the point of the analysis and prospectively from the point of the 
analysis to the end of the year.
    Comment: A commenter noted that the measure only addresses 
compliance and risk and should also address usability. They suggested 
that the analysis of security should look at how the data is used and 
if patients can readily access the data.
    Response: We note that other objectives in the EHR Incentive 
Program, as well as other certification requirements around the 
technology, include functions related to patient access to health data 
as well as the sharing of health data with patients and other 
providers. Inherent in these objectives is the requirement to use 
certification criteria in the action or process of information sharing. 
Therefore, these actions and functions are part of the CEHRT and ePHI 
protections, which should be included in the provider's security risk 
analysis and review. We note that providers should employ a security 
risk analysis that is most appropriate to their own organization, which 
may include several resources for strategies and methods for securing 
ePHI. Completing a security risk analysis requires a time investment, 
and may necessitate the involvement of security, HIT, or system IT 
staff or support teams at your facility. The 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 ONC provides guidance and an 
SRA tool created in conjunction with OCR on its Web site at: http://www.healthit.gov/providers-professionals/security-risk-assessment-tool.
    Comment: Commenters questioned if the SRA Tool is only for 
providers and professionals in small and medium sized practices asking 
for further information on the definitions of small, medium, and large 
practices. Another commenter requested the identification of additional 
guidance for solo or small group practices.
    Several commenters recommended that CMS collaborate with the OCR to 
develop more robust guidance on conducting security risk assessments 
and understanding and implementing encryption. A commenter suggested a 
national education campaign to help ensure that they are adequately 
equipped to protect ePHI.
    Response: We decline to define practice size in this final rule 
with comment period. Instructions for the SRA tool notes its usefulness 
to small and medium practices because it was intended to provide 
support to organizations, which often have more limited staff and 
organizational knowledge on ePHI than larger organizations. However, 
the SRA Tool information is applicable to and may be useful for 
organizations of any size.
    In the Stage 3 proposed rule (80 FR 16747), we did note that OCR 
provides broad scale guidance on security risk analysis requirements 
and that other tools and resources are available to assist providers in 
the process. In addition, CMS and ONC will continue to work to provide 
tools and resources, tip sheets, and to respond to FAQs from providers 
and developers on the privacy and security requirements.
    Comment: A commenter requested clarification of the term 
``correcting identified security deficiencies'' as not all risks can be 
corrected. Commenters requested information on identity proofing, 
authentication, and authorization. Another commenter requested more 
than a passing mention of encryption.
    Response: At minimum, providers should be able to show a plan for 
correcting or mitigating deficiencies and that steps are being taken to 
implement that plan. Our discussion of this measure as it relates to 45 
CFR 164.308(a)(1) is only relevant for purposes of the EHR Incentive 
Program requirements and is not intended to supersede or satisfy the 
broader, separate requirements under the HIPAA Security Rule and other 
rulemaking. For information on identity proofing, authentication, 
authorization, and encryption, we refer readers to the OCR Web site, 
www.hhs.gov/ocr.
    As noted in the Stage 1 final rule (75 FR 44314 at 44368), while 
this objective is intended to support compliance with

[[Page 62832]]

the HIPAA Privacy and Security Rules, we maintain that meaningful use 
is not the appropriate regulatory tool to ensure compliance with the 
HIPAA Privacy and Security Rules. In addition, as noted in the Stage 2 
final rule, the scope of the security risk analysis for purposes of 
this meaningful use measure applies only to data created or maintained 
by CEHRT and does not apply to data centers that are not part of CEHRT 
(77 FR 53968 at 54003).
    After consideration of the comments received on this objective and 
measure, we are finalizing the objective as proposed and finalizing the 
measure with a modification to replace the word ``stored'' with the 
phrase ``created or maintained.'' We are adopting this change to 
correct a discrepancy between the text of the objective and the measure 
as well as between the measure (the objective reads ``created and 
maintained'') and to better reflect the HIPAA security rules. We are 
finalizing the objective and measure as follows:
Objective 1: Protect Patient Health Information
    Objective: Protect electronic protected health information (ePHI) 
created or maintained by the CEHRT through the implementation of 
appropriate technical, administrative, and physical safeguards.
    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 created or maintained by 
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.
    We are adopting Objective 1: Protect Patient Health Information at 
Sec.  495.24(d)(1)(i) for EPs and Sec.  495.24(d)(1)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 2: Electronic Prescribing
    In the Stage 3 proposed rule (80 FR 16747 through16749), we 
proposed to maintain the objective and measure finalized in the Stage 2 
final rule (77 FR 53989 through 53990) for electronic prescribing for 
EPs, with minor changes. We also proposed to maintain the previous 
Stage 2 menu objective for eligible hospitals and CAHs as a required 
objective for Stage 3 with an increased threshold.
    Proposed Objective: EPs must generate and transmit permissible 
prescriptions electronically, and eligible hospitals and CAHs must 
generate and transmit permissible discharge prescriptions 
electronically (eRx).
    We proposed 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 proposed 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 permitted 
to be electronically prescribed. We proposed 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 prescriptions, they must do so uniformly across all patients and 
across all allowable schedules for the duration of the EHR reporting 
period. We proposed to continue to exclude over- the-counter (OTC) 
medicines from the definition of a prescription, although we encouraged 
public comments on 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. For Stage 3, we proposed 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 (1) 
Prescribes the drug; (2) transmits it to a pharmacy independent of the 
provider's organization; and (3) 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 HIT Certification Program 
criteria.
    Comment: Some commenters recommended that OTC medications should be 
excluded in the definition of prescription, as they are not typically 
prescribed electronically.
    Response: We thank commenters for their input and agree that OTC 
medications should continue to be excluded from the definition.
    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.
    We proposed 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 proposed 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

[[Page 62833]]

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.
    We proposed to limit this measure for Stage 3 to only new and 
changed prescriptions and invited 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.
    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.
    In the proposed rule, we recognized that not every patient will 
have a formulary that is relevant to 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.
    Comment: A few commenters were in support of the e-prescribing 
objective because it is an important priority in quality reporting 
efforts.
    Response: We appreciate the support and note as we have previously 
stated, transmitting the prescription electronically promotes 
efficiency and patient safety through reduced communication errors.
    Comment: Many commenters expressed concerns about requiring e-
prescribing for hospitals where the objective was previously a menu 
option. Some noted that the shift from optional to required, combined 
with an increased threshold for Stage 3, makes the objective difficult 
to achieve for eligible hospitals and CAHs.
    Response: We thank the commenters for sharing their concerns. 
However, we believe the potential benefits of electronic prescribing 
are substantial. 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, which works in 
conjunction with clinical decision support interventions enabled at the 
generation of the prescription. In addition, we note that, as required 
by the HITECH Act, e-prescribing has been a required part of the EHR 
Incentive Programs for EPs since 2011. As noted in the Stage 3 proposed 
rule, eligible hospital and CAH performance on electronic prescribing 
in 2014 was well over the threshold. We believe that the continued 
expansion of the infrastructure and 3 years to transition toward 
incremental increases via the objective in place for 2015 through 2017 
will support hospitals in succeeding on this measure.
    Comment: Some commenters requested exclusions for eRx because they 
have less than 100 office visits (in concurrence with previous 
requirements) or have an average low census. Others simply stated that 
they could not meet the measure.
    Response: We note that we proposed 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 proposed 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. For eligible 
hospitals and CAHs in Stage 3, there is an exclusion if they do 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 do not agree with 
setting an exclusion based on office visits, as the denominator for the 
measure is based not on office visits but on permissible prescriptions.
    Comment: Several commenters stated that the threshold of over 80 
percent for EPs is too high. Commenters cited this high threshold as a 
potential patient safety risk for providers switching products, since 
systems issues could occur from inappropriately expediting 
implementation in order to meet the high threshold.
    Some of these commenters expressed that if the provider is required 
to query a drug formulary, the provider cannot be expected to meet the 
80 percent threshold. Further commenters discussed the disconnect 
between the various options for formulary queries and discussed the 
ongoing evolution of standards specifically referencing the following 
issues:
     Formulary queries where no formulary exists may generate 
errors on some systems;
     Formulary queries of formularies with access restrictions, 
either technological restrictions or proprietary restrictions limit the 
ability to query even where such a formulary is available;
     Static formularies are often not fully electronic, are not 
a format that can be queried, or are updated infrequently so they 
provide limited benefit;
     Real time formulary query standards are split with as many 
as three primary options available in the industry.
    Despite these concerns, many commenters noted that they agree with 
the concept of an automated, real-time formulary query. Commenters 
stated that they believe it provides a value for patients when the 
query is feasible and successful.
    Response: As we noted in the proposed rule (80 FR 16747), our 
analysis of the attestation data indicates the majority of EPs have 
already been exceeding this threshold; however, we note that each year 
a small but significant portion of EPs may struggle to meet this 
measure if they are engaged in a transition from one EHR product to 
another or in a full upgrade of CEHRT to a new Edition. For many 
functions, the potential risk to patient safety during these 
transitions may be easily mitigated; however, because the appropriate 
management of prescribed medications can be critical for both acute and 
chronic patient care, the risk for electronic prescribing during 
transitions may be significant. We are therefore finalizing a threshold 
of 60 percent rather than the 80 percent proposed. We agree with the 
provider commenter concerns regarding the drug

[[Page 62834]]

formulary query and reiterate that the long-term goal is to move toward 
real-time automated queries using a unified standard. For the short 
term, as noted for the electronic prescribing objective and measure for 
2015 through 2017 in section II.B.2.a(iv), we believe that the query 
function should be maintained. However, providers are only required to 
meet this part of the measure to the extent that such a query is 
automated by their CEHRT and to the extent that a query is available 
and can be automatically queried by the provider. This means that if a 
query using the function of their CEHRT is not possible or shows no 
result, a provider is not required to conduct any further manual or 
paper-based action in order to complete the query, and the provider may 
count the prescription in the numerator.
    Comment: Commenters noted that controlled substances should be 
included where feasible, as the inclusion would reduce the paper based 
prescription process often used for such prescriptions, as long as the 
inclusion of these prescriptions were permissible in accordance with 
state law. Commenters noted that the ability to electronically 
prescribe controlled substances 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.
    Response: We agree with commenters that the eventual progression 
toward universal inclusion of controlled substances in electronic 
prescribing is a desired goal. However, as stated previously we believe 
that at present this should remain an option for providers, but not be 
required. As many states have now have eased some of the prior 
restrictions on electronically prescribing controlled substances, we 
believe it is no longer necessary to categorically exclude controlled 
substances from the term ``permissible prescriptions.'' Therefore we 
will define a permissible prescription as all drugs meeting our current 
definition of a prescription as the authorization by a provider to 
dispense a drug that would not be dispensed without such authorization 
and we will no longer distinguishing between prescriptions for 
controlled substances and all other prescriptions. Instead will refer 
only to permissible prescriptions consistent with the proposed 
definition for Stage 3 (80 FR 16747) as all drugs meeting the 
definition of prescription not listed as a controlled substance in 
Schedules II-V \12\ (77 FR 53989) with a modification to allow for 
inclusion of scheduled drugs where such drugs are permissible to be 
electronically prescribed. Therefore the continued inclusion of the 
term ``controlled substances'' in the denominator may no longer be an 
accurate description to allow for providers seeking to include these 
prescriptions in the circumstances where they may be included. We are 
modifying the denominator to remove this language. Again, we note this 
is only a change in wording and does not change the substance of our 
current policy that providers have the option, but are not required, to 
include prescriptions for controlled substances in the measure for 
Stage 3. For the EHR Incentive Programs in 2015 through 2017, we note 
that the inclusion of controlled substances under permissible 
prescriptions is optional under the Electronic Prescribing Objective 
(see section II.B.2.a.iv). For Stage 3, while we intended to maintain 
this option, based on public comment received and the progress of 
states toward acceptance of electronic prescribing of controlled 
substances we are modifying this policy that the inclusion of 
controlled substances should be required where it is feasible to 
electronically prescribe the drug and where allowable by law. We 
believe the reduced threshold of 60 percent will help to mitigate the 
additional effort to meet this requirement and that the benefit 
outweighs this increased burden.
---------------------------------------------------------------------------

    \12\ (DEA Web site at http://www.deadiversion.usdoj.gov/schedules/index.html.
---------------------------------------------------------------------------

    Therefore, we are changing the measure for this objective to remove 
the language regarding controlled substances. Instead, we are adopting 
that under ``permissible prescriptions'' for the Stage 3 objective 
providers must may include electronic prescriptions of controlled 
substances in the measure where creation of an electronic prescription 
for the medication is feasible using CEHRT and where allowed by law for 
the duration of the EHR reporting period.
    After consideration of the comments received, we are adopting the 
objective and exclusion for electronic prescribing as proposed. We will 
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 are finalizing changes to the language to continue 
to allow providers the option to include or exclude controlled 
substances in the denominator where such medications can be 
electronically prescribed. We are finalizing that these prescriptions 
may be included in the definition of ``permissible prescriptions'' at 
the provider's discretion where allowable by law.
    We will not include OTC medicines in the definition of a 
prescription for this objective. We are maintaining the different 
workflow scenarios that are possible as discussed in the Stage 2 final 
rule at (77 FR 53989). We are maintaining this policy for Stage 3 for 
EPs and extending it to eligible hospitals and CAHs.
    For EPs, eligible hospitals and CAHs we are finalizing the 
objective as follows:
Objective 2: Electronic Prescribing
    Objective: EPs must generate and transmit permissible prescriptions 
electronically, and eligible hospitals and CAHs must generate and 
transmit permissible discharge prescriptions electronically (eRx).
    EP Measure: More than 60 percent of all permissible prescriptions 
written by the EP are queried for a drug formulary and transmitted 
electronically using CEHRT.
     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 60 
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.
    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.
     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.

[[Page 62835]]

     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 are adopting Objective 2: Electronic Prescribing at Sec.  
495.24(d)(2)(i) for EPs and Sec.  495.24(d)(2)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 3: Clinical Decision Support
    Clinical decision support at the relevant point of care is an area 
of HIT in which significant evidence exists for substantial positive 
impact on the quality, safety, and efficiency of care delivery. For 
Stage 3 of the EHR Incentive Programs, we proposed 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 offered 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).\13\ We continue to encourage innovative efforts to use CDS 
to improve care quality, efficiency, and outcomes. Health IT 
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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    \13\ FDASIA Health IT report available on the FDA Web site at: 
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf.
---------------------------------------------------------------------------

    Proposed Objective: Implement clinical decision support (CDS) 
interventions focused on improving performance on high-priority health 
conditions.
    We proposed to retain both measures of the Stage 2 objective for 
Stage 3 and that these additional options stated previously on the 
actions, functions, and interventions may constitute CDS for purposes 
of the EHR Incentive Programs and would meet the measure requirements 
outlined in the proposed measures.
    Comment: Most commenters agreed that clinical decision support 
should be included as an objective in Stage 3, and many expressed 
appreciation for the consistency between the existing Stage 2 objective 
and Stage 3. Some commended CMS' emphasis on clinical decision support 
tools in the proposed rule. Others were also pleased that CMS is 
aligning this objective with the HHS National Quality Strategy goals by 
emphasizing preventive care, chronic condition management, and heart 
disease and hypertension as areas of focus for quality improvement. A 
commenter acknowledged the value of CDS available in EHR technology in 
improving patient safety and care quality, and believes that this 
requirement has become obsolete as an attestation measure. Others 
similarly suggest that this measure is ``topped out'' because most 
participants in the Medicare and Medicaid EHR Incentive Program have 
many more than 5 CDS implemented in their EHRs, but they believed that 
CDS is a statutory requirement.
    Response: We appreciate the support for this objective. As we 
stated in the proposed rule, 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. We believe these factors outweigh the 
potential reporting burden in place for providers who have 
significantly more than 5 CDS interventions in place for whom the 
measurement may no longer be required.
    Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy 
both measures in order to meet the objective:
    Measure 1: Implement 5 clinical decision support interventions 
related to four or more CQMs at a relevant point in patient care for 
the entire EHR reporting period. Absent 4 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.
    Where possible, we recommend providers implement CDS interventions 
that relate to care quality improvement goals and a related outcome 
measure CQM. However, for specialty hospitals and certain EPs, if there 
are no CQMs that 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.
    Comment: Many commenters supported Measure 1period), with a 
significant number supporting CMS for acknowledgement of the wide 
variety of innovative clinical decision tools that can be used. Some 
acknowledged ``alarm fatigue'' and the subsequent ignoring of alerts, 
so they appreciated the alternatives to pop-up alerts. As an 
alternative to alerts, one provider suggested that information display 
as

[[Page 62836]]

links for condition-specific order sets, diagnostic support, and 
contextually relevant reference information, which seem to be more 
user-friendly support tools. A commenter stated that the multiple tools 
available to meet the requirements of CDS may be difficult and there 
could be substantial costs associated with the tools.
    Other commenters requested clarification of the types of resources 
that will count towards meeting the requirements of the EHR Incentive 
Programs related to CDS. Specifically, commenters asked about the 
InfoButton standard, and the requirement that RCERHT enable users to 
review the attributes of CDS resources.
    Response: Our examples are intended to illustrate that CDS 
encompasses a variety of workflow-optimized information tools. The 
examples are meant to be illustrative and not a requirement to utilize 
all of the options.
    We proposed to embrace a broad definition of CDS, including (but 
not limited to) resources such as: Computerized alerts and reminders 
for providers and patients, clinical guidelines, condition-specific 
order sets, documentation templates, focused patient data reports and 
summaries, and contextually relevant reference information. We posted a 
tip sheet and guidance on the CMS Web site, www.cms.hhs.gov/ehrincentive, which includes several examples of CDS and information on 
the general intent of this requirement, and referencing best practices 
for using CDS to improve care. The guidance also clarifies that CDS 
need not necessarily be presented during a patient encounter, or be 
limited to interventions targeted at physicians, and is not limited to 
interruptive alerts or reminders. CDS is often an integrated part of 
the provider's EHR system, but may also present in a variety of other 
mechanisms, including but not limited to: pharmacy systems, patients' 
personal health records (PHRs), or Patient portals provided by the 
practice.
    The InfoButton standard can be used to provide hyperlinks to 
information, such as clinical guidelines or patient data summaries, at 
the relevant point in the care continuum and therefore represents one 
type of CDS that EPs, eligible hospitals, and CAHs may use to meet the 
EHR Incentive Programs CDS requirements. There are also likely to be 
cases where it makes sense for a CDS resource to display certain 
attributes at the time of presentation, or for a resource to include an 
InfoButton linking to additional information with CDS attributes. The 
potential workflows and implementations of these resources within a CDS 
is varied and should be tailored to best meet the provider's needs. 
However, please note that in this example, the use of the InfoButton 
would not count as a separate or additional CDS intervention, but 
rather would be a supporting part of the one CDS of which it is a part.
    Comment: For Measure 1, many commenters appreciated the 
strengthened connection of CQMs to CDS. However, some commenters 
recommended removing the requirement to link CDS to CQMs in favor of 
high-priority safety and quality improvement objectives. A commenter 
clarified that eliminating the link would enable them to meet their 
system quality improvement goals and would remove the measurement 
burden of tracking links between CDS and CQMs. Some commenters noted a 
lack of CQMs for some provider types and referenced pediatricians. 
Another stated that if the EHR developer limits the number of CQMs that 
are included in the CEHRT, it may limit a providers' ability to 
implement CDS. A commenter inquired about changes to CQMs that could 
relate to selected CDS. Another recommended that CDS interventions be 
grandfathered in for a year after a CQM change.
    Many commenters requested clarification of ``high-priority health 
conditions.'' A commenter suggested that ``high-priority health 
conditions'' be replaced with ``conditions relevant to the EP's scope 
of practice''. Another suggested that the CDS be related to 4 or more 
CQMS or high-priority health conditions. Yet another commenter stated 
that the high priority health conditions are not related to many of the 
specialties, including surgery, pediatrics, or medical subspecialties. 
They recommended that we allow providers to link to clinical guidelines 
relevant to their practice or a clinical registry that can provide 
real-time specialty-specific data on their scope of practice if there 
are not four relevant CQMs. A commenter urged us to include 
immunization forecasting as a measure of CDS. Another commenter 
requested that we consider behavioral health as an additional priority 
area. A commenter does not believe CDS interventions are applicable to 
providers servicing elderly patient populations, specifically those in 
nursing homes with cognitive deficit since their mental functions are 
limited and life expectancy short.
    Response: For providers linking CDS to CQM selections, we proposed 
that providers are allowed the flexibility to implement CDS 
interventions that are related to any of the CQMs that are finalized 
for the EHR Incentive Program. They are not limited to the CQMs they 
choose to report and we note that we have a recommended set of CQMs for 
EPs, which includes both a set for adult population and for pediatric 
populations, which may serve as a guide.\14\ As we stated when we 
finalized this measure for Stage 2 of the EHR Incentive Programs (77 FR 
53996), it is our expectation that, at a minimum, providers will select 
CDS interventions to drive improvements in the delivery of care for the 
high-priority health conditions relevant to their patient population. 
CQMs may be changed on an annual basis through the PFS or IPPS 
rulemaking. As CQMs are still required as part of a provider's 
demonstration of meaningful use, providers should modify their CDS 
selections if CQMs change over time.
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    \14\ EHR Incentive Programs Recommended Core Set Adult and 
Pediatric Clinical Quality Measure Tables available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2014_ClinicalQualityMeasures.html.
---------------------------------------------------------------------------

    Providers who are not able to identify CQMs that apply to their 
scope of practice or patient population may implement CDS interventions 
that they believe are related to high-priority health conditions 
relevant to their patient population and will be effective in improving 
the quality, safety or efficiency of patient care. These high priority 
conditions must be determined prior to the start of the EHR reporting 
period in order to implement the appropriate CDS to allow for improved 
performance. We proposed to require a minimum number of CDS 
interventions, and providers must determine whether a greater number of 
CDS interventions are appropriate for their patient populations.
    Comment: A commenter recommended an exclusion for physicians who 
face challenges implementing 5 CDS interventions. Another requested 
that only 3 CDS interventions be required. A commenter recommended an 
exclusion for highly specialized EPs and a reduction in the number of 
interventions required for each individual EP.
    Response: We believe that CDS at the point of care is an area of 
health IT in which significant evidence exists for its substantial 
positive impact on the quality, safety, and efficiency of care 
delivery. Therefore, we did not propose exclusion for this measure. In 
addition, we proposed to offer considerable flexibility in the 
selection of the CDS interventions.
    Comment: A commenter questioned if all the CDS tools suggested are 
required. Another commenter recommended that HHS support research that 
would help

[[Page 62837]]

providers identify the most valuable CDS interventions and the most 
effective placement of such interventions in provider workflows.
    Response: We offered a list of workflow optimized information tools 
to illustrate some examples in the Stage 3 proposed rule (80 FR 16749). 
It is not meant to be list of required tools, nor is it an exhaustive 
list of all the options available. Also in the Stage 3 proposed rule 
(80 FR 16750), CMS and ONC have provided examples of CDS interventions 
as well as program models such as Million Hearts, which may offer 
suggestions to providers and raise awareness of the possibilities 
available. CMS and ONC will consider providing further guidance as to 
CDS options, CDS and CQM pairings, and industry research on various CDS 
implementations.
    Comment: A commenter requested a clarification on the relationship 
between the functions that are included in the definition of CEHRT and 
the actions that are required for the EHR Incentives Programs. Some 
commenters expressed concern that EPs and eligible hospitals and CAHs 
might be limited only to CDS that ONC had certified. Several commenters 
also expressed concern that the CDS requirements for the EHR Incentive 
Program objectives do not match the standards for certification and 
question if the certification requirements for health IT would limit 
the types or utility of CDS a provider might use to meet the Clinical 
Decision Support Objective.
    Response: CMS does not certify CDS functions or resources, but 
instead defines that a provider must use CDS resources and that those 
resources must meet the ONC certification criteria to meet the 
definition of CEHRT. The EHR Incentive Programs do not otherwise 
restrict a provider's ability to choose any CDS option or resource to 
meet their unique needs. For the certification criteria for CDS, the 
ONC 2015 Edition proposed rule (80 FR 16804 through 16921) proposed the 
functionalities that health IT developers would build into their ``CDS 
module'' to meet the certification criteria. These ``CDS modules'' are 
what meet the CEHRT definition for the EHR Incentive Programs. However, 
while the certification rule specifies that the ``CDS module'' that is 
certified to the CDS standard must have certain capabilities to provide 
or enable CDS for provider use, it does not certify the supports or 
resources themselves. This means that the ONC health IT certification 
criteria are designed to ensure that the ``CDS module'' implemented by 
EPs and eligible hospitals and CAHs will enable them to meet the CDS 
Objective requirements without limiting the potential use and 
innovation of a wide range of options for providers.
    Comment: Several commenters recommended removing the ``entire EHR 
reporting period'' from the measure specifications to limit unnecessary 
measurement burden. Another commenter was concerned that the 
requirement for CDS interventions to be in place for the entire 
reporting year would make it impossible for EPs, eligible hospitals, 
and CAHs to change CEHRT mid-year and remain eligible.
    Response: We disagree. We believe that having providers implement 
improvements in clinical performance for high-priority health 
conditions will result in improved patient outcomes and believe CDS 
should be in place for the entire EHR reporting period. We note that we 
understand reasonable downtime as may be expected with any health IT 
systems to ensure security or fix any issues which arise is acceptable. 
We intend for the implementation of 5 five CDS interventions to be a 
minimum. We do not intend to limit the number of interventions that may 
be implemented if an organization chooses to implement more than 5 
five. The same interventions do not have to be implemented for the 
entire EHR reporting period as long as the threshold of 5 is maintained 
for the duration of the EHR reporting period. For example, if a 
provider identifies quality improvement goals that change the quality 
improvement and CDS implementation plan over the course of the year, 
they may make these changes as long as the total number of CDS 
interventions implemented at any given time during the EHR reporting 
period is 5 or more. In fact, we expect that EPs, eligible hospitals, 
and CAHs will regularly update and adjust their portfolios of CDS 
interventions--fine-tuning them to evolving patient population needs 
and in response to each intervention's observed impact on the related 
CQM(s).
    Comment: Many commenters were concerned about the documentation 
required for audit to demonstrate that a specific CDS is implemented 
for the duration of the reporting period. Another commenter suggested 
reducing the audit burden while several commenters suggested a 
clarification be added to reduce the audit burden by only requiring 
documentation showing the CEHRT has the functionality.
    Several commenters requested clarification in the area of audit 
readiness and guidance related to expectations for the use of specific 
CDS at the individual level. They requested that we to consider 
identifying this objective as an organizational or group objective 
rather than a specific eligible professional objective and allow the 
organization's efforts to meet the requirements for each provider 
practicing in that organization.
    Response: We disagree with the suggestion to allow CDS attestations 
at a group level. While certain CDS may support providers in a wide 
range of specialties, others may be designed for particular patient 
populations or specialties and the selection of CQMs may also be 
related to the priorities for an individual provider. For example, the 
Million Hearts campaign may provide CDS models for many providers, but 
may not be relevant for certain specialties. Providers should be 
selecting and implementing CDS within their practice based on their 
priorities to promote quality improvement and positive outcomes for 
patients, not to avoid a potential audit failure. Furthermore, we note 
that we will provide guidance to the auditors to support their 
understanding of the wide scope of CDS interventions available to 
providers.
    Comment: Most commenters supported the second measure related to 
drug-drug and drug-allergy interaction checks. A commenter suggested 
clarifying that the use of the word ``enabled'' signifies that the 
provider is actively using the functionality as opposed to just having 
the functionality available. Another appreciated the inclusion of this 
measure because it is a huge benefit to patient care.
    However, a commenter recommended that we allow exclusions from the 
drug-drug and drug-allergy interaction checks if the EP is a low-volume 
prescriber.
    Response: We appreciate the support for this measure. We meant by 
``enabled'' that the provider should be actively using the function for 
the duration of the EHR reporting period at the relevant point in care. 
For the second measure, we did propose an exclusion for any EP who 
writes fewer than 100 medication orders during the EHR reporting 
period.
    Comment: Several commenters stated that for the second measure they 
believe it is burdensome to require eligible hospitals, CAHs, and EPs 
to enable and implement the functionality for drug-drug and drug-
allergy interaction checks for the entire EHR reporting period.
    Response: We believe that this measure is an important component of 
the EHR Incentive Programs and offers the opportunity for positive 
impact on quality, efficiency of care delivery, and especially patient 
safety. We believe that the functionality for drug-drug and drug-
allergy interaction checks should

[[Page 62838]]

be enabled and implemented for the duration of the EHR reporting period 
with the exception of limited unavoidable downtime if a system issue 
should arise.
    After consideration of the public comments received, we are 
finalizing the objective, measures and exclusion as proposed for EPs, 
eligible hospitals and CAHs as follows:
Objective 3: Clinical Decision Support
    Objective: Implement clinical decision support (CDS) interventions 
focused on improving performance on high-priority health conditions.
    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 are adopting Objective 3:Clinical Decision Support at Sec.  
495.24(d)(3)(i) for EPs and Sec.  495.24(d)(3)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
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 proposed 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 proposed 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. However, we proposed to expand the third measure 
of the objective to include diagnostic imaging. This change was 
intended to address the needs of specialists and allow for a wider 
variety of clinical orders relevant to particular specialists to be 
included for purposes of measurement.
    For Stage 3, we proposed 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 proposed 
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 addressed the needs of specialists and allowed 
for a wider variety of clinical orders relevant to particular 
specialists to be included for purposes of measurement.
    We further proposed 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 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 noted 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 deferred 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--
     Organizational workflows;
     Appropriate credentialing of the staff member by an 
organization other than the employing organization;
     Analysis of duties performed by the staff member in 
question; and
     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 
continued 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 proposed 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 proposed 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 CEHRT, but does not include paper orders entered initially into 
the patient record or orders entered into technology not compliant with 
the CEHRT definition and then transferred into the CEHRT at a later 
time.

[[Page 62839]]

    In addition, we proposed to maintain for Stage 3 that ``protocol'' 
or ``standing'' orders may but are not required to be excluded from 
this objective.
    We proposed 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 proposed 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 proposed 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 received public comment on our proposals and our response 
follows.
    Comment: The majority of commenters supported the inclusion of this 
objective. Some of the commenters appreciated the consistency with the 
previous Stage 2 objective. A commenter requested that we clarify that 
there are no changes to the objective or to the definition of terms 
except for ``diagnostic imaging.''
    Response: We appreciate the support for the objective. We proposed 
to maintain the Stage 2 CPOE policies except that the third measure 
would be expanded from radiology orders to diagnostic imaging orders 
and the thresholds for the measures would be increased.
    Comment: Commenters requested clarification of ``medical staff 
member credentialed to perform the equivalent duties of a credentialed 
medical assistant'' and requested clarification on a number of 
potential roles including an in-house phlebotomist, an ophthalmological 
assistant, a medical student in residency, and other health care 
professionals. Other commenters requested clarification on the phrase 
``under the direct supervision or active engagement of a licensed 
healthcare professional.''
    Response: As noted in the Stage 3 proposed rule (80 FR 16751), we 
require that the person entering the orders be a licensed health care 
professional or credentialed medical assistant (or staff member 
credentialed to the equivalency and performing the duties equivalent to 
a medical assistant). 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.
    However, the descriptive phrase ``direct supervision or active 
engagement'' was not meant to capture a hierarchical organizational or 
contractual arrangement, but rather to signify that any required 
assistance and direction to assess and act upon a CDS and ensure the 
order is accurately entered should be provided in real time.
    Comment: A commenter disagreed that only ``certified'' medical 
assistants are capable of entering orders and requested clarification 
on the specific certification required. Another commenter stated that 
in Massachusetts, medical assistants are not required to be 
credentialed in order to practice and there is no local credentialing 
body for medical assistants. The commenter suggested that if a standard 
for medical assistant CPOE is required, then the standard should be 
that the medical assistant must be appropriately trained for CEHRT use 
(including CPOE) by the employer or CEHRT vendor in order to be 
counted.
    Response: We thank the commenter for their feedback and suggestion. 
We believe there may be some confusion related to the term ``Certified 
Medical, Assistant'' which is not used by CMS in our proposed rules or 
guidance with reference to the credentialed medical assistant or the 
credentialed medical staff equivalent of a medical assistant. We 
reiterate that CMS does not require any specific or general 
``certification'' and note that credentialing may take many forms 
including, but not limited to, the appropriate degree from a health 
training and education program from which the medical staff 
matriculated.
    We note that a simple search online returns dozens of medical 
assistant training and credentialing programs as well as local industry 
associations for Medical Assistants offering resources on training in 
the Commonwealth of Massachusetts. We note that any such program which 
met a provider's requirements for their practice would also be an 
example of an acceptable credentialing for the purposes of this 
objective.
    We disagree that the training on the use of CEHRT is adequate for 
the purposes of entering an order under CPOE and executing any relevant 
action related to a CDS. We believe CPOE and CDS duties should be 
considered clinical in nature, not clerical. Therefore, CPOE and CDS 
duties, as noted, should be viewed in the same category as any other 
clinical task, which may only be performed by a qualified medical or 
clinical staff.
    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 or 
CAH 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 or 
CAH 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 or CAH inpatient or emergency department (POS 21 or 23) during 
the EHR reporting period are recorded using computerized provider order 
entry.
    We proposed 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 proposed 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.
    We proposed 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.
    Finally, we sought public comment 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.
    Comment: A few commenters supported not requiring providers to 
limit the measure of this objective to patients whose records are 
maintained using CEHRT.
    Response: We believe that the majority of providers will store 
their patient records in CEHRT by the beginning of Stage 3. However, as 
noted previously, a certain percentage of charts may still be 
maintained outside of CEHRT (such as workers compensation or other 
special contracts).
    After consideration of public comments received, we maintain the 
distinction between measures that include only those patients whose 
records are maintained using CEHRT

[[Page 62840]]

and measures that include all patients. Providers may continue to limit 
the denominator to those patients whose records are maintained using 
CEHRT for measures with a denominator other than unique patients seen 
by the EP during the EHR reporting period or unique patients admitted 
to the eligible hospital or CAH inpatient or emergency department 
during the EHR reporting period.
    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 or CAH 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 or CAH 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 or CAH 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 further sought public 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 sought 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.
    Comment: A few commenters noted potential barriers for cost of a 
system if the provider conducts very few orders of a specific type. 
Many providers noted they believe that CPOE saves money and delivers 
process improvement benefits in a relatively short and easily 
measureable cycle and so saw a strong benefit from the objective.
    Many commenters noted that the change from radiology orders to 
diagnostic imaging orders increases relevance for specialty hospitals. 
A few commenters requested clarification around the inclusion of 
diagnostic imaging and how this is different from Stage 2.
    Some commenters stated that the increase in thresholds, especially 
for laboratory and radiology orders, were appropriate and they would be 
able to meet them. Some commenters supported the increased thresholds 
noting that our inclusion of this objective provided additional 
pressure on their organization to work toward a higher goal and 
maximize the potential benefits CPOE offers. However, some commenters 
noted that the 80 percent threshold could present a problem for 
providers who are transitioning between certified EHR technologies 
within a reporting period. These commenters noted that for CPOE 
medication orders, and the related CDS interventions for drug-drug and 
medication-allergies, it is extremely important to allow adequate time 
for product and process implementation to ensure patient safety and 
minimize the risk of serious adverse events.
    Response: In relation to the potential costs associated, we believe 
the proposed exclusions would allow providers with significantly low 
numbers of a certain type or types of orders to exclude the related 
measure and therefore avoid any unnecessary expenditure. We believe 
CPOE continues to represent an opportunity for providers to leverage 
technology to capture these orders to reduce error and maximize 
efficiencies within their practice.
    We appreciate the support for the inclusion of diagnostic imaging 
for measure 3. We proposed the expansion for diagnostic imaging to 
include other imaging tests such as ultrasound, magnetic resonance, and 
computed tomography in addition to traditional radiology orders which 
were the limit of the scope of the Stage 2 objective at 80 FR 16750. We 
believe 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, benchmarking, and process 
improvement initiatives within healthcare organizations.
    Finally, we thank those commenters who supported the increased 
thresholds for Stage 3. We have reconsidered the increase for the 
medication orders measure and are in agreement with commenters who 
suggested this potential measure should not be raised to this level in 
order to avoid inadvertently encouraging rushed implementation if a 
provider is switching between products or implementing an upgrade to 
the technology. As we explained in our discussion regarding the 
threshold of the Electronic Prescribing Objective for Stage 3, we 
believe the appropriate management of medications can be critical for 
both acute and chronic patient care, and therefore the risk associated 
with CPOE for medication orders during transitions may be significant. 
Therefore we will maintain the Stage 2 threshold for that measure only 
which also aligns the three measures at the same level.
    After consideration of the public comments received, at we are 
finalizing the objective and the measures for CPOE for laboratory 
orders and CPOE for diagnostic imaging orders and the exclusions for 
all measures as proposed. We are finalizing the measure for CPOE for 
medication orders with a modified threshold. We are adopting the 
objective for EPs, eligible hospitals and CAHs as follows:
Objective 4: Computerized Provider Order Entry
    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.
    Measure 1: More than 60 percent of medication orders created by the 
EP or

[[Page 62841]]

authorized providers of the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
recorded using computerized provider order entry;
     Denominator: Number of medication orders created by the EP 
or authorized providers in the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period.
     Numerator: The number of orders in the denominator 
recorded using CPOE.
     Threshold: The resulting percentage must be more than 60 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
     Exclusion: Any EP who writes fewer than 100 medication 
orders during the EHR reporting period.
    Measure 2: More than 60 percent of laboratory orders created by the 
EP or authorized providers of the eligible hospital or CAH inpatient or 
emergency department (POS 21 or 23) during the EHR reporting period are 
recorded using computerized provider order entry; and
     Denominator: Number of laboratory orders created by the EP 
or authorized providers in the eligible hospital or CAH 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.
    Measure 3: More than 60 percent of diagnostic imaging orders 
created by the EP or authorized providers of the eligible hospital or 
CAH inpatient or emergency department (POS 21 or 23) during the EHR 
reporting period are recorded using computerized provider order entry.
     Denominator: Number of diagnostic imaging orders created 
by the EP or authorized providers in the eligible hospital or CAH 
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 are adopting Objective 4: Computerized Provider Order Entry at 
Sec.  495.24(d)(4)(i) for EPs and Sec.  495.24(d)(4)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 5: Patient Electronic Access to Health Information
    In the Stage 3 proposed rule (80 FR 16752), we 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 that the second is 
to engage in patient-centered communication for care planning and care 
coordination. While these two goals are intricately linked, we noted 
that we see them as two distinct priorities requiring different foci 
and measures of success. For the first goal, we proposed 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 
CEHRT to support increasing patient access to important health 
information. For the second goal, we proposed 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 CEHRT.
    In the Stage 3 Patient Electronic Access Objective, we proposed 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. We also proposed to no longer 
require or allow paper-based methods to be included in the measures (80 
FR 16753) and to expand the options through which providers may engage 
with patients under the EHR Incentive Programs. Specifically, we 
proposed an additional functionality, known as application programming 
interfaces (APIs), which would allow providers to enable new 
functionalities to support data access and patient exchange.
    We sought comment on what additional requirements might be needed 
to ensure that for the API-- (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 information, and to important information about their care, is a 
high priority for the EHR Incentive Programs.
    We noted 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. We also stated that to ``provide access'' means that the 
patient has all the tools and information they need to gain access to 
their health information including, but not limited to, 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. We further stated that 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.
    Further, we noted that this objective is a requirement for 
meaningful use and it 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.
    We received the following comments and our response follows:

[[Page 62842]]

    Comment: We received a number of comments requesting further 
clarification of the proposal to incorporate API functionality into an 
objective for patient electronic access. We received comments 
requesting clarification around how we envision the relationship 
between an API and the existing view, download, and transmit 
functionalities as well how a patient or provider might leverage an 
enabled API over multiple use cases. Commenters also requested 
clarification on if the API would replace their patient portal or be a 
part of it or an additional Web site. Some commenters expressed concern 
about supporting a second patient portal.
    Response: We thank the commenters and offer the following 
explanation of our intent for the use of an API within the patient 
electronic access objective as one of the potential functions through 
which a patient may obtain access to their health information.
    First, we do not consider the API to be a ``second'' patient portal 
and that the current trend to use a patient portal to meet the view, 
download and transmit functions, while prevalent and acceptable, is not 
the only way a provider might meet the current objective. We recognize 
the value in these systems and support the implementation of patient 
portals to allow patients to engage with their health care providers 
for both clinical and administrative information.
    However, at a basic level, the EHR Incentive Program currently 
requires only that providers give their patients access to their health 
information to be able to do three activities: View their information, 
download their information, and transmit their information. This is a 
nuanced but important distinction between the existing Stage 2 
requirement and the current systems, which are used to meet it. This 
distinction is important, as not only do we not require a ``patient 
portal'' format for VDT, we also do not advocate such a limit on 
innovation in software or systems designed to allow patients to access 
and engage with their health information. We believe that the efficacy 
of the health IT environment now and the potential for future 
innovation, relies on the establishment of clear standards and 
functionality requirements paired with the flexibility to develop 
differentiated technical specifications, functions, and user interface 
design that meet those requirements.
    This proposed Stage 3 objective for Patient Electronic Access is 
not a ``patient portal'' versus ``API'' requirement or a requirement to 
support two patient portals. Instead, this proposed objective is 
supporting four basic actions that a patient should be able to take:
     View their health information;
     Download their health information;
     Transmit their health information to a third party; and
     Access their health information through an API.
    We also believe that these actions may be supported by a wide range 
of system solutions, which may overlap in terms of the software 
function used to do an action or multiple actions. This intent to allow 
for innovation and change within the scope of health IT development is 
part of a broader goal to lay the foundation for health care systems to 
support the patient and provider.
    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 is often found in 
many current ``patient portals.''
    From the provider perspective, an API could complement a specific 
provider ``branded'' patient portal or could also potentially make one 
unnecessary if patients were able to use software applications designed 
to interact with an API that could support their ability to view, 
download, and transmit their health information to a third party.
    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 the patient. Patients could collect 
their health information from multiple providers and potentially 
incorporate all of their health information into a single portal, 
application, program, or other software. Such a solution may be offered 
on a state, local, or regional basis, for instance, through a health 
information exchange, or through another commercial vendor. 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. For this 
reason, we proposed the inclusion of patient-authorized representatives 
within the measures.
    Comment: Commenters requested clarification on the function of the 
API itself, the standards in place, the potential process for 
determining the possible applications, which may leverage the API, and 
how to successfully provide patients access to their information 
through an API.
    Response: For the provider to implement an API under our proposal, 
the provider would need to fully enable the API functionality such that 
any application chosen by a patient would enable the patient to gain 
access to their individual health information provided that the 
application is configured to meet the technical specifications of the 
API. Providers may not prohibit patients from using any application, 
including third-party applications, which meet the technical 
specifications of the API, including the security requirements of the 
API. Providers are expected to provide patients with detailed 
instructions on how to authenticate their access through the API and 
provide the patient with supplemental information on available 
applications that leverage the API. We believe there are multiple paths 
by which a provider organization may provide this information to the 
patient, just as the current information for access is provided through 
a variety of means depending on the circumstances.
    Additionally, similar to how providers support patient access to 
VDT capabilities, we expect that providers will continue to have 
identity verification processes to ensure that a patient using an 
application, which is leveraging the API, is provided access to their 
health information.
    We proposed 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. The certification 
criteria proposed by ONC would establish API criteria, which would 
allow patients, through an application of their choice (including 
third-party applications), to pull certain components of their unique 
health data directly from the provider's CEHRT. This could also 
potentially allow a patient to pull such information from multiple 
providers engaged in their care. For further discussion on the 
technical requirements for APIs, we direct readers to the 2015 Edition 
proposed rule (80 FR 16840 through 16850).
    Comment: A number of commenters expressed concern over the privacy 
and security of patient information through the use of an API. 
Commenters noted a number of issues including--(1) How the application 
would or would not be governed by HIPAA; (2) what verification 
mechanisms would be required to be included by the provider, the EHR 
system, and the patient in order to allow the enabled API to function 
with the patient selected application; (3) what standards would be 
required for the API, the application, and any

[[Page 62843]]

provider verification process for enrolling patients; and (4) general 
concern over the security of having an enabled API for an EHR.
    Response: It is recognized that APIs and VDT provide access to 
sensitive health care material and security and privacy of patients' 
ePHI is of utmost importance. As has been seen in other industries 
where system interoperability has enabled considerable benefits for the 
consumer, security technology is constantly evolving to meet the 
changing environment. Thus, detailed monitoring, penetration testing, 
audits, and key management are all necessities. In addition, this 
changing environment requires similarly nimble guidelines and standards 
for privacy and security protocols. The EHR Incentive Program includes 
an Objective to Protect Patient Health Information (see also section 
II.B.2.b.1 of this final rule with comment period). This objective 
includes a measure requiring providers to conduct or review a security 
risk analysis in accordance with HIPAA requirements to ensure the 
protection of patient ePHI created or maintained by CEHRT. This 
requirement to conduct and review a security risk analysis would 
include the certified API enabled as a part of the provider's CEHRT. 
This analysis must also be done in compliance with HIPAA Security 
Rules, which would likewise be applicable to the provider actions 
related to the provision of access to the patient's health information. 
Beyond this baseline, we believe that evidence in similar technological 
transitions illustrates the need for a balanced and responsive approach 
to privacy and security. As noted previously, we encourage providers to 
innovate around enrollment structures for patients to provide 
accountability for privacy and security standards; we encourage 
developers to incorporate security best practices in their design; and 
we encourage patients to employ sound practices just as they would with 
their online banking or other online activities regarding personal 
information.
    Comment: Many commenters expressed concerns about successfully 
meeting the objective because their patient population is elderly, ill, 
low-income, and/or located in remote, rural areas. These patients do 
not have access to computers, Internet and/or email and are concerned 
with having their health information online. A commenter specifically 
requested that clinics with high elderly populations, especially those 
in rural areas, be exempt from meeting these patient electronic access 
requirements. Another commenter recommended keeping the VDT threshold 
to Stage 2 levels.
    Several comments also included concerns about patients not using or 
accessing patient portals, which make it difficult for providers and 
hospitals to meet patient electronic access requirements. Eligible 
providers and hospitals do not want to be penalized if patients choose 
not to use the patient portal or send them secure messages. A commenter 
recommended that compliance with access occur when the patient has been 
given documentation on how to sign up for the patient portal, and that 
a patient's decision to opt-out be counted as compliance. The same 
commenter also recommended that the denominator for compliance with the 
portal usage measure be counted as the total number of patients in the 
portal, not the total number of qualified patients discharged in that 
period.
    Many commenters supported the inclusion of patient-authorized 
representatives within this objective noting that this change is 
essential for patient care and provides greater flexibility for 
providers. These commenters noted specific patient populations, such as 
disabled persons, elderly patients, and newborn patients or young 
children where the more comprehensive inclusion of non-physician 
caregivers, family members, and other patient-authorized 
representatives within the measure more accurately captures the 
inclusiveness of these interactions and the role that health IT can 
provide in supporting communications with patients and their 
caregivers.
    Response: We note that this proposed objective is entirely focused 
on the provision of access to patients or their authorized 
representatives and does not require the provider to be accountable for 
the patient using that access. Additionally, the numerator is 
calculated based on the provision of access by the provider, not based 
on whether a patient possesses or can obtain technology for their own 
use. The provision of access by the provider is the entirety of the 
measurement and any subsequent barriers to access which are outside the 
providers control do not affect the numerator calculation. In other 
words, for this measure the provider must ensure the patient has been 
provided the information they would need to gain access whether or not 
the patient has the technology they need to gain access.
    We believe that the overall focus of this objective on the 
provision of access allows providers the flexibility to work with 
patients with a wide range of backgrounds and IT adoption. We further 
believe that it prevents any negative unintended consequences of 
assumptions which may be placed on patients to use or not use various 
technologies. We believe that no patient should be excluded from access 
to their health care information for any reason, especially reasons 
which would allow for a blanket exclusion of any patient based on a 
demographic factor. We note that we proposed to maintain our current 
policy, which applies to the Stage 2 Patient Electronic Access 
Objective, which requires that access be provided, even for those who 
choose to opt-out via providing them the information and resources they 
would need to opt back in. We further thank those commenters for their 
support of the expansion of the concept of access for patient-
authorized representatives and note that this inclusion is designed to 
recognize the existing relationships and expand the access to 
information for family members and other caregivers who may serve as 
patient-authorized representatives. Patient-authorized representatives 
encompass both ``personal representatives'' as defined by HIPAA, as 
well as those authorized or designated by an individual.
    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.
    We proposed 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. We proposed that all three 
functionalities (view, download, and transmit) or an API must be 
present and accessible to meet the measure. We further proposed that 
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

[[Page 62844]]

164.524(c) of the HIPAA Privacy Rule. However, we proposed that 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.

To calculate the percentage, CMS and ONC worked together to define the 
following for the proposed 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.
    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: 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.
    Proposed Measure 2: To calculate the percentage, CMS and ONC 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.
    We proposed that both measures for this objective must be met using 
CEHRT.
    Comment: A number of commenters expressed concern about the 
timeframe of 24 hours for the availability, stating that it was either 
too long for patients to wait or too short a time for providers to 
adequately review the information provided for accuracy and compliance 
with any concerns over disclosure of information, such as sensitive 
test results, mental health issues, or information which must be 
withheld in order to comply with state or local law.
    Response: We appreciate this assessment and recognize that such a 
review may be required in certain cases where the disclosure or non-
disclosure cannot simply be automated. We recognize that provider's 
workflows, especially for EPs in small practices, may be impacted in 
these instances where such a need arises. Therefore, we are instead 
finalizing that information must be included for access within 48 hours 
for EPs and are retaining the current 36 hours for eligible hospitals 
and CAHs. We note that this would allow for immediate availability for 
most patients where the provision of information can be automated and 
will provide adequate time for review processes for sensitive 
information by providers as necessary.
    Comment: A number of commenters expressed skepticism about the 
maturity and security of API technology for patient electronic access, 
and noted that the ONC API certification process is not fully 
functional yet. In response to our request for comment regarding 
expansion of the patient engagement measures to include the use of 
application programming interfaces (APIs) in addition to, or in place 
of, a patient portal, one commenter referenced the JASON report and the 
Argonaut Project \15\ and expressed strong support the use of APIs to 
enhance interoperability, increase patient engagement, and ease the 
burden of EHR end users with respect to programming, updating, and 
maintenance. Some commenters expressed concern about the potential cost 
associated with API implementation.
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    \15\ JASON Report: http://www.healthit.gov/sites/default/files/ptp13-700hhs_white.pdfArgonaut Project: http://hl7.org/implement/standards/fhir/2015Jan/argonauts.html.
---------------------------------------------------------------------------

    Response: As noted, referencing the JASON report and Argonaut 
Project, the use of APIs in the health care industry represents an 
opportunity for both patients and providers to leverage technology to 
support the free flow of information in a dynamic and secure manner. 
This technology is already in widespread use in other industries with 
similar implementation challenges, such as finance, and the social IT 
environment includes the use of APIs in simple every day interactions. 
Some low-cost and even free API functions already exist in the health 
IT industry, and we expect third-party application developers to 
continue to create low-cost solutions that leverage APIs as part of 
their business models.
    Further, we encourage health IT system developers to leverage the 
existing API platforms and applications as this would allow developers 
to immediately begin offering providers no-cost, or low-cost solutions 
to implement and enable an API as part of their current systems even 
prior to the implementation of Stage 3 in 2018.
    In terms of cost, as we have stated in the past with the view, 
download, and transmit functions, we do not believe it would be 
appropriate for EPs and hospitals or CAHs to charge patients a fee for 
accessing their information using an API or VDT. We believe the 
economies of scale provided by enabling an API render the cost of use 
by an individual patient minimal and we do not believe that providing 
free access to patients represents a burden to the provider.
    However, we recognize that the potential usage of APIs extends 
beyond

[[Page 62845]]

the individual patient to other provider organizations, non-physician 
care settings, home health care, and many other uses. We recognize that 
under very high usage, it may be expensive to support APIs, and in 
those circumstances, providers may want to consider the feasibility of 
cost sharing arrangements with outside organizations or businesses, 
which frequently leverage the enabled API to support care coordination.
    Comment: A few comments focused on Measure 2, the requirement to 
provide CEHRT-generated patient educational materials to patients. A 
commenter discussed how low patient adoption of portals/APIs makes it 
difficult to provide more than 35 percent of patients with electronic 
educational materials. Another commenter requested that--(1) the 
denominator be patients who have office visits rather than patients who 
are seen by an EP; and (2) providers who have less than 100 office 
visits during the EHR reporting period be excluded. Lastly, a commenter 
opposed only using CEHRT-generated patient educational materials and 
thought additional materials printed in-office by providers should be 
acceptable.
    Response: We disagree that this measure threshold should be reduced 
or limited to office visits or that providers should be required or 
allowed to continue to count paper-based actions toward this measure. 
We believe that the provision of access to patient-specific education 
following a similar model as the provision of access to a patient's 
record will allow providers the opportunity to leverage a wide range of 
resources for patients and include this information in concert with the 
patient's electronic health record. We believe that as the technology 
continues to evolve providers will perform well beyond the threshold 
and expect that innovative options will progress apace with this 
progress. We by no means intend to discourage providers from also using 
paper-based or other methods of providing patients with education about 
their health and their care. We are simply no longer requiring or 
allowing paper-based actions to be counted because the EHR Incentive 
Programs focuses on leveraging health IT to support patient engagement.
    We are therefore finalizing Measure 2 as proposed for the method of 
delivery and with a modification to specify that for the numerator of 
for measure 2 for each year, the action must occur within the same 
calendar year as the EHR reporting period, but may occur before, 
during, or after the EHR reporting period if the EHR reporting period 
for the provider is less than a full calendar year. We note that the 
action must occur prior to the provider submitting their attestation if 
they attest prior to the end of the calendar year. For measure 1, we 
refer readers to the discussion on the Alternate Proposals for the 
measure immediately following.
    Alternate Proposals:
    For measure 1, we sought 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. 
Measure 1 as proposed 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 sought 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.
    We welcomed public comment on these proposals. We received the 
following comments and our response follows:
    Comment: The majority of commenters who discussed APIs recommended 
that the use of APIs be optional (for example, no requirement for both 
APIs and patient portals); most opposed making APIs mandatory. A few 
comments specifically noted that patient portals are already in place 
and it would be counterproductive and financially wasteful to force 
investment in APIs. Others also expressed skepticism about the maturity 
and security of API technology for patient electronic access, and noted 
that the ONC API certification process is not fully functional yet. 
Commenters noted that EPs, eligible hospitals, and CAHs have worked 
very hard to establish patient portals, and have encouraged patients to 
use them and that this effort has required an extraordinary effort in 
time and financial commitment. The commenters further stated that it 
would not make financial, strategic, or technical sense to abandon 
patient portals. They also stated that many patients who have begun to 
engage with their health record would not be willing to change their 
approach to obtaining their patient data, and while they may

[[Page 62846]]

eventually eagerly accept and use alternatives, it will take time to 
transition them. Commenters requested maximum flexibility for this 
measure, noting that the stated goal of providing such flexibility 
means that the best alternative is to allow providers to choose whether 
to have a portal or an API, or both, but not to require both. Requiring 
APIs as a substitute for patient portals represents an overhaul of 
existing, expensive, and time-consuming technology. CMS should not 
require such an overhaul.
    Response: As noted previously, we disagree that the API 
functionality cannot be implemented successfully by 2018 as the 
technology is already in widespread use in other industries and API 
functions already exist in the health IT industry. Within the Objective 
for Patient Electronic Access, we see the potential and need for 
multiple use cases, which leverage a wide range of systems design, from 
the traditional patient portal to leveraged APIs, which allow providers 
and patients to expand information sharing among systems. Examples of 
these use cases could include a patient with a chronic condition 
seeking to combine records from multiple providers, home health care 
providers accessing records from multiple patients in real time, 
patients accessing a wide range of health information and scheduling 
appointments with or requesting refills from a single provider on a 
dedicated site, and many more. While we understand the commenters' 
concern about adding new technology in light of the investment already 
made in existing technology, we believe that patient access should not 
be limited to a single function, action or use case when multiple 
viable options are available to support a wider range of potential use. 
We believe that the investments that have been made in existing patient 
portals--serve a positive and necessary function, and those who 
invested in such portals should not abandon that investment. In 
addition, as noted previously, we believe that there are existing API 
options that can be leveraged to provide low-cost health IT solutions 
that diversify the technology pathways and expand the capacity of 
providers and patients to share health information. We believe these 
functions are compatible and complementary of each other and that the 
appropriate requirement is the inclusion of both concepts by 
supporting, all four possible actions for patients access (that is, 
view, download, transmit, and access data through an API).
    After consideration of public comments received, we are finalizing 
the objective with a modification based on the change to the 24 hour 
requirement proposed as well as to better represent the functions of 
CEHRT use. For Measure 1 we are finalizing Alternate A which includes 
the requirement that providers offer all four functionalities (view, 
download, transmit, and access through API) to their patients. We 
further specify that any patient health information must be made 
available to the patient within 48 hours of its availability to the 
provider for an EP and 36 hours of its availability to the provider for 
an eligible hospital or CAH. For measure two, we are finalizing measure 
a modification to the numerator to specify the timing of the action in 
relation to the EHR reporting period.
Objective 5: Patient Electronic Access to Health Information
    Objective: The EP, eligible hospital or CAH provides patients (or 
patient-authorized representative) with timely electronic access to 
their health information and patient-specific education.
    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 the patient-authorized representative) is 
provided timely access to view online, download, and transmit his or 
her health information; and
    (2) The provider ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the API in the provider's CEHRT.
     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 (or 
patient-authorized representative) who are provided timely access to 
health information to view online, download, and transmit to a third 
party and to access using an application of their choice that is 
configured meet the technical specifications of the API in the 
provider's CEHRT.
     Threshold: The resulting percentage must be more than 80 
percent in order for a provider to meet this measure.
    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.
     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 
during the EHR reporting period.
     Threshold: The resulting percentage must be more than 35 
percent in order for a provider to meet this measure.
    Exclusions: A provider may exclude the measures if one of the 
following apply:
     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.
    We are adopting Objective 5: Patient Electronic Access at Sec.  
495.24(d)(5)(i) for EPs and Sec.  495.24(d)(5)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 6: Coordination of Care Through Patient Engagement
    For Stage 3, as previously noted, we proposed to incorporate the 
Stage 2

[[Page 62847]]

objectives related to providing patients with access to health 
information into a new Stage 3 objective entitled, ``Patient Electronic 
Access'' (see section II.B.2.b.v). For this objective 6 entitled 
``Coordination of Care through Patient Engagement,'' we proposed 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 CEHRT.
    Proposed Objective: Use communications functions of CEHRT to engage 
with patients or their authorized representatives about the patient's 
care.
    The Stage 3 proposed rule focused 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. Similar to the Patient Electronic Access 
Objective, we also proposed to expand the options through which 
providers may engage with patients under the Medicare and Medicaid EHR 
Incentive Programs including the use of APIs. 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 patient. We proposed the Coordination of Care through 
Patient Engagement 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 proposed 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.
    We proposed three measures for this objective, which are discussed 
below. We proposed 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.
    Comment: Commenters supported the concept of patient engagement and 
promoting communication among provider and patients. Also, commenters 
supported the changes we proposed to expand the technologies and 
methods by which providers and patients can leverage technology to 
support communication and care coordination. Commenters also commended 
us for the provision allowing providers to attest to all three measures 
but only meet the threshold for 2 of the 3 in order to pass the 
measure. Comments stated that this would allow us to collect meaningful 
data but not penalize providers for variation in their patient 
populations or other factors that might impact their performance.
    Response: We thank the commenters for their support of the 
objective and our approach to provide flexibility while continuing to 
encourage a wide range of use cases for patient engagement. We agree 
that the open communication between provider and patient is a 
fundamental factor in patient-centered care and effective care 
coordination. This was a driver behind our proposal for this objective 
to improve and enhance the channels of communication through supporting 
health IT solutions.
    Comment: Some commenters disagreed with our approach and stated 
that we should not enforce provider and patient communication through 
the use of health IT. Commenters claimed that elderly populations, 
economically disadvantaged populations, patients living in rural areas, 
and patients with disabilities may not want to use technology to engage 
with their provider and this makes the requirement unfair to providers 
serving these patient populations.
    Response: First, we disagree that any universal demographic factor 
would prohibit a patient from using or leveraging technology to 
communicate with a provider. ONC's research found that there were no 
significant differences in use of online medical records by age, race/
ethnicity, education or setting.\16\ We note that assistive 
technologies, telemedicine technologies, and affordable mobile 
technologies already exist in the marketplace to serve a wide range of 
individuals coming from a wide range of backgrounds and we believe that 
health IT communications technologies will find similar utilization. 
Second, we recognize that technology supported communication may not be 
adopted by each patient, which is why we did not propose requiring that 
a provider ensure all patients actually take action and engage in this 
manner. However, we note that we do not believe that potential 
challenges to online or electronic communications are in any way more 
significant that the existing challenges to communication posed by the 
current limited channels available. Nor do we note a causal 
relationship or correlation between communications challenges and a 
diminished need or interest in communicating with one's provider. 
Therefore, we are aiming to support a wide range of communication 
channels, technologies, and approaches to support many use cases.
---------------------------------------------------------------------------

    \16\ ONC Data Brief June 2015 healthit.gov.
---------------------------------------------------------------------------

    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 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.
    Proposed 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 ONC-certified API.

[[Page 62848]]

    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 \17\ on the first day of the 
EHR reporting period may exclude from the measure.
---------------------------------------------------------------------------

    \17\ www.broadbandmap.gov.
---------------------------------------------------------------------------

     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.
    For measure 1, for the API option, we proposed that providers must 
attest that they have enabled an ONC-certified API and that at least 
one application, which leverages the API, is available to patients (or 
the patient-authorized representatives) to retrieve health information 
from the provider's CEHRT. We also stated that we recognize that there 
may be inherent challenges in measuring patient access to CEHRT through 
third-party applications that utilize an ONC-certified API, and we 
solicited comment on the nature of those challenges and what solutions 
can be put in place to overcome them. We also solicited 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.
    Comment: Similar to the objective in general, a large number of 
commenters opposed this measure stating providers should not be held 
accountable for patient action. However, those commenters in support of 
the measure concept recommended that it be measured as a combination of 
use cases rather than independently for each function. These commenters 
approved the inclusion of the API function noting that it offers 
greater flexibility for patients, but stated that providers should not 
be required to meet separate thresholds for patient use of the 
different functions. They stated that the use of APIs is currently 
self-selective among patient populations, which skew the provider's 
ability to push their use universally. Additionally, they noted issues 
related to independently counting the usage of a function. For example, 
an API may not be designed to recognize individual instances of use 
separately over time; it may not independently recognize an action 
which might also meet the view, download, or transmit actions; or it 
may prohibit providers who wish to switch to an API assisted VDT system 
from being able to also meet a separate VDT threshold. However, both 
commenters in support of the measure and opposed to the measure 
suggested a lower threshold in order to ensure that providers can meet 
the requirements by 2018. Some commenters suggested an approach where 
the threshold increases over time to allow providers to work toward 
incrementally increased levels. Commenters noted that this would allow 
providers more time to innovate workflows and methods to overcome 
barriers to patient engagement.
    Response: As noted previously, we disagree that providers have no 
role in influencing patient engagement. In this new measure for Stage 
3, we are seeking to enhance a provider's ability to influence patient 
engagement by providing a wider range of technologies and methods for a 
patient's use. We agree with the commenters' recommendation against 
independent thresholds for the functions within the objective and 
reiterate our view that there are four actions a patient might take:
    1. View their information.
    2. Download their information.
    3. Transmit their information to a third party.
    4. Access their information through an API.
    We further agree that these actions may overlap and that a provider 
should be able to count any and all actions in the single numerator. 
Therefore, we believe it is a reasonable modification to change the 
first measure to state that a provider may meet a combined threshold of 
for VDT and API actions or if their technology functions overlap then 
any and view, download, transmit, or API actions taken by the patient 
using CEHRT would count toward the threshold.
    We do agree that the threshold should represent a goal, but that we 
should seek to set a goal that will be attainable for providers who 
make the effort to achieve this measure. As noted in section 
II.B.1.b.(4)(b)(iv) of this final rule with comment period, we adopted 
a phased approach for the two measures related to patient action for 
reporting in 2015 through 2017 (Objective 8--Patient Electronic Access 
measure 2 and the Objective 9--Secure Electronic Messaging.) This 
phased approach includes a 5 percent threshold in 2017, and we believe 
it is appropriate to adopt a 5 percent threshold for measures 1 of this 
objective also (Objective 6--Coordination of Care through Patient 
Engagement) for an EHR reporting period in 2017. We believe that the 
primary barrier to performance on the measure is the lag in the 
adoption of technology by patients as well as the influence of self-
selective participation. We further believe that these influences can 
be mitigated by providing additional time for the technologies to 
mature as noted in our rationale for adoption of the phased approach. 
Therefore, it is appropriate for the 5 percent threshold in 2017 to 
apply for all applicable measures based on the timeline established.
    We believe that 10 percent is a reasonable threshold for providers 
participating in 2018 as compared to the proposed 25 percent threshold, 
and should be attainable by providers. In addition, we will continue to 
monitor performance on the measure to determine if any further 
adjustment is needed prior to 2018 and to potentially set another 
incremental increase toward the proposed 25 percent threshold in a 
subsequent year.
    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).
    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.

[[Page 62849]]

    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.
    For measure 2, we proposed that ``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 further proposed to include in the measure numerator situations 
where providers communicate with other care team members using the 
secure messaging function of CEHRT, 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 sought 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. In addition, we sought 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 specified 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. We 
noted 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 noted that if such a message is excluded, all 
subsequent actions related to that message would not count toward the 
numerator.
    Comment: Commenters overwhelmingly supported our approach to the 
redesigned secure electronic messaging objective for Stage 3. 
Specifically, commenters noted that this more dynamic, multi-
directional objective is a better approach for meeting the underlying 
goal of effective provider-patient communication than our prior Stage 2 
objective.
    Specifically, commenters also supported the ability for providers 
to select to focus on this measure rather than on measure 1 as for some 
specialists, the ability to quickly and effectively communicate with a 
patient and other care team members is paramount. These commenters 
noted that for their patients, the information they provide through VDT 
is often duplicative of that provided by the patient's primary care 
provider. However, they note they often receive request for 
clarification around specific results or recommendations so the ability 
to provide that support through secure messaging with the patient and 
other care team members is a significant benefit.
    Some commenters opposed the measure in general, again highlighting 
that providers should not be held accountable for patient action. Still 
others disagreed with the requirement that a provider must respond to a 
patient-initiated communication in order for such an action to count in 
the numerator.
    Again, commenters both opposed to and in support of the measure 
suggested a lower threshold to ensure the measure is attainable for 
providers who make the effort to engage in this action. Finally, some 
commenters requested clarity about what the content of the message 
needs to be to count toward the numerator.
    Response: We appreciate the support and agree with the commenters' 
assessment that the Stage 2 objective did not fully meet the intended 
goal of secure messaging. We agree that this proposed objective 
supports a wider range of use and a more effective method of 
communication for providers and patients.
    We disagree that this proposed measure holds providers accountable 
for patient action, as the Stage 3 proposed measure specifically puts 
the control over communications in the hands of the provider. For this 
measure, we proposed to include provider-initiated communications, 
provider-to-provider communications if the patient is included, and 
allows the provider to count any patient-initiated communication if the 
provider responds to the patient (80 FR 16757). We disagree that the 
provider should not be required to respond to the patient in order to 
meet the measure, the goal of the measure is to promote provider-
patient communication where the action driving the communication rests 
with provider initiated communication. We note that this does not 
require the provider to respond to every message received if no 
response is necessary. In addition, the denominator is not based on the 
number of messages received from the patient nor are patient-initiated 
messages required to meet the measure. Therefore we believe that it is 
reasonable to only allow providers to count messages in the numerator 
when the provider participates in the communication, in this case by 
responding to the patient.
    Again, we do agree that the threshold should represent a goal, but 
that we should seek to set a goal that will be attainable for providers 
who make the effort to achieve this measure. As discussed for Measure 
1, we adopted a phased approach for the two measures related to patient 
action for reporting in 2015 through 2017 (Objective 8--Patient 
Electronic Access measure 2 and the Objective 9--Secure Electronic 
Messaging.) This phased approach includes a 5 percent threshold in 2017 
and we believe it is appropriate to adopt a 5 percent threshold for 
measures 2 of this objective (Stage 3 Objective 6--Coordination of Care 
through Patient Engagement) for an EHR reporting period in 2017. In 
this case, it is not the barrier of patient action which is a potential 
risk factor, as the measure itself has been changed, but instead the 
adoption of new CEHRT and implementing the related workflows which 
would be required for providers participating in Stage 3 in 2017. We 
also believe a 25 percent threshold would be an attainable goal for 
providers in 2018 because the measure focuses on provider-initiated 
action and offers multiple paths for success; while the reduction from 
35 percent reduces the risk of failure for those providers who may 
require additional time to implement the functions and workflows within 
their practice. As stated in the Stage 3 proposed rule (80 FR 16757), 
the types of communications which cannot count toward the measure are 
communications dealing exclusively with billing, appointment 
scheduling, or other administrative processes.

[[Page 62850]]

    Proposed Measure 3: Patient-generated health data or data from a 
non-clinical setting is incorporated into the CEHRT 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.
    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 CEHRT 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.
    For measure 3, we noted 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 proposed that a non-clinical setting 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 and where the care 
provider does not have shared access to the EP, eligible hospital, or 
CAH's CEHRT. 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 noted this last item and referred 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 sought 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 representative, 
advance directives, medical device data, home health monitoring data, 
and fitness monitor data.
    We also sought 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 sought comment on 
whether this measure should be divided into two distinct measures--for 
example, (1) patient-generated health data, or data generated 
predominantly through patient self-monitoring rather than by a 
provider; and (2) 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 sought 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 sought further 
comment on whether eligible hospitals and CAHs should then choose one 
of the remaining two measures or be required to attest to both. We 
received the following comments and our response follows:
    Comment: Commenters were supportive of the concept of the measure 
with a specific emphasis on the ability to incorporate this type of 
data into a patient record. Commenters felt this measure specifically 
supports chronic disease management and care coordination. Commenters 
recommended that the denominator be limited to two or more visits in a 
year, which would make the measure more relevant for hospitals and CAHs 
as well as some types of specialists. Commenters recommended against 
splitting the measure into two parts and noted that the threshold 
proposed is too high for a measure that is entirely new.
    A number of commenters opposed the measure, expressed concern over 
the efficacy of data originating from a source other than a clinician, 
stated that patient generated data is not relevant to their practice, 
or stated that all data is patient generated so the measure is useless.
    Most commenters requested further information on what types of data 
would count toward the measure. Some commenters asked if provider 
questionnaires sent via secure message might count while others asked 
if patient self-assessment screenings done in the physician's office 
may count. Some commenters questioned whether a patient that provided 
information on family health history may count toward the measure if 
the information were provided outside an office visit via an electronic 
means. Finally, commenters requested an episodic designation for the 
measure to identify when the inclusion of such information must occur 
and if the inclusion must be repetitive for each EHR reporting period.
    Response: We thank the commenters for their input. We agree with 
the recommendation to maintain a single measure as we believe this best 
represents the goal of the policy to support the use of CEHRT to 
incorporate many kinds of data into a comprehensive record for each 
patient. We are declining the recommended changes to limit the 
denominator as we believe a wider range is more suitable. However, we 
agree with the recommendation to reduce the required threshold for this 
new measure and function to promote adoption with an attainable goal. 
We are therefore reducing the threshold to 5 percent for the measure. 
For the purposes of this measure, we note our intent as stated in the 
Stage 3 proposed rule (80 FR 16757) that the types of data that would 
satisfy the measure are broad. It may include, but is not limited to, 
social service data, data generated by a patient or a patient's 
authorized representative, 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 emphasized that these represent several examples of the 
data types that could be covered under this measure. We note that 
providers in non-clinical settings may include, but are not limited to, 
care

[[Page 62851]]

providers such as nutritionists, physical therapists, occupational 
therapists, psychologists, and home health care providers. Other key 
providers in the care team such as behavioral health care providers, 
may also be included, and we encourage providers to consider ways in 
which this measure can incorporate this essential information from the 
broader care team. We also note, as stated in the Stage 3 proposed 
rule, while the scope of data covered by this proposed measure is 
broad, it may not include data related to billing, payment, or other 
insurance information (80 FR 16757).
    We also disagree with the suggestion that the data may be 
information the patient provides to the EP, eligible hospital or CAH on 
location during the office visit or hospital stay as such data does not 
meet the intent of the measure to support care coordination and patient 
engagement in a wide range of settings outside the provider's immediate 
scope of practice. However, we agree that if a patient separately 
provides clinical information including family health history and the 
information noted previously through other means, that such information 
may count toward the numerator if it is incorporated into the patient 
record using the adopted specifications for CEHRT for the measure.
    With regard to the efficacy of the data, we do not specify the 
manner in which providers are required to incorporate the data. 
Providers may work with their EHR developers to establish the methods 
and processes which work best for their practice and needs. We note 
that in cases where the data provided can be easily incorporated in a 
structured format or into an existing field within the EHR (such as a 
C-CDA or care team member reported vital signs or patient reported 
family health history and demographic information) the provider may 
elect to do so. Alternately, a provider may maintain an isolation 
between the data and the patient record and instead include the data by 
other means such as attachments, links, and text references again as 
best meets their needs. We believe there may be a wide range of 
potential methods by which a provider may ensure the data is relevant 
for their needs and that provenance and purpose are identified.
    Finally, we note that measure 3 includes longitudinal measurement 
within the EHR reporting period, rather than purely episodic 
measurement. This means that for more than 5 percent of unique patients 
during the EHR reporting period, this information must be included. If 
information is obtained and incorporated for a patient following their 
first visit during the EHR reporting period, the provider may count the 
patient in the numerator even if no further information is provided 
after a subsequent visit.
    After consideration of public comments received, we are finalizing 
the objective with a modification to remove the reference to 
communications functions due to the adoption of the use of an API 
(which is broader than a communication function). We are finalizing the 
exclusions as proposed and the measures with the modifications for the 
threshold as previously discussed. We are finalizing that providers 
must attest to all three measures and must meet the thresholds for at 
least two measures to meet the objective. We are adopting finalizing 
the objective and measures as follows:
Objective 6: Coordination of Care Through Patient Engagement
    Objective: Use CEHRT to engage with patients or their authorized 
representatives about the patient's care.
    Measure 1: During the EHR reporting period, more than 10 percent of 
all unique patients (or their authorized representatives) 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 and either:
    (1) View, download or transmit to a third party their health 
information; or
    (2) access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (3) a combination of (1) and (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 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 during the EHR reporting period and the number of unique 
patients (or their authorized representatives) in the denominator who 
have accessed their health information through the use of an API during 
the EHR reporting period.
     Threshold for 2017: The resulting percentage must be more 
than 5 percent.
     Threshold for 2018 and Subsequent Years: The resulting 
percentage must be more than 10 percent.
    Measure 2: For 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) during the EHR reporting period, a 
secure message was sent using the electronic messaging function of 
CEHRT to the patient (or the patient-authorized representative), or in 
response to a secure message sent by the patient or their authorized 
representative. For an EHR reporting period in 2017, the threshold for 
this measure is 5 percent rather than 25 percent.
     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 (or patient-
authorized representative) or in response to a secure message sent by 
the patient (or patient-authorized representative), during the EHR 
reporting period.
     Threshold in 2017: The resulting percentage must be more 
than 5 percent in order for an EP, eligible hospital, or CAH to meet 
this measure
     Threshold in 2018 and Subsequent Years: The resulting 
percentage must be more than 25 percent in order for an EP, eligible 
hospital, or CAH to meet this measure.
    Measure 3: Patient generated health data or data from a nonclinical 
setting is incorporated into the CEHRT for more than 5 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.
     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 CEHRT into the patient 
record during the EHR reporting period.
     Threshold: The resulting percentage must be more than 5 
percent in order for an EP, eligible hospital, or CAH to meet this 
measure.
    Exclusions: A provider may exclude the measures if one of the 
following apply:
     An EP may exclude from the measure if they have no office 
visits during the EHR reporting period.

[[Page 62852]]

     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 are adopting Objective 6: Coordination of Care Through Patient 
Engagement at Sec.  495.24(d)(6)(i) for EPs and Sec.  495.24(d)(6)(ii) 
for eligible hospitals and CAHs. We further specify that in order to 
meet this objective and measures, an EP, eligible hospital, or CAH must 
use the capabilities and standards of as defined for as defined CEHRT 
at Sec.  495.4. We direct readers to section II.B.3 of this final rule 
with comment period for a discussion of the definition of CEHRT and a 
table referencing the capabilities and standards that must be used for 
each measure.
Objective 7: Health Information Exchange
    In the Stage 3 proposed rule 80 FR 16758, we stated that 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. We noted that 
the purpose of the proposed objective is to ensure a summary of care 
record is transmitted or captured electronically and incorporated into 
the EHR for patients seeking care among different providers in the care 
continuum, and to encourage reconciliation of health information for 
the patient. We further stated that the proposed 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 CEHRT.
    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. For additional information, see section II.B.1.b.(4).(f) of 
this final rule with comment period. Referrals are cases where one 
provider refers a patient to another provider, but the referring 
provider also continues to provide care to the patient. We also 
recognized 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, in the Stage 3 proposed rule at 80 FR 16759 for the 
purposes of distinguishing settings of care in determining the movement 
of a patient, we explained that for a transition or referral, it must 
take place between providers which have, at minimum, different billing 
identities within the EHR Incentive Programs, such as different 
National Provider Identifiers (NPI) or hospital CMS Certification 
Numbers (CCN) to count toward this objective.
    Please note that a ``referral'' as defined here only applies to the 
EHR Incentive Programs and is not applicable to other federal 
regulations.
    We stated in the Stage 2 final 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 noted 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 proposed to revise 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 
noted 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 creates and 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 proposed that providers must attest to the 
numerator and denominator for all three measures,

[[Page 62853]]

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:
     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 
medication allergies.
     Current Problem list. Review of the patient's current and 
active diagnoses.
    For the first measure, we maintained 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 required 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 information in order to 
meet the objective, if the provider knows it:
     Patient name.
     Referring or transitioning provider's name and office 
contact information (EP only).
     Procedures.
     Encounter diagnosis.
     Immunizations.
     Laboratory test results.
     Vital signs (height, weight, blood pressure, BMI).
     Smoking status.
     Functional status, including activities of daily living, 
cognitive and disability status.
     Demographic information (preferred language, sex, race, 
ethnicity, date of birth).
     Care plan field, including goals and instructions.
     Care team including the primary care provider of record 
and any additional known care team members beyond the referring or 
transitioning provider and the receiving provider.
     Discharge instructions (Eligible hospitals and CAHs Only).
     Reason for referral (EP only).
    For the 2015 Edition proposed rule, ONC proposed a set of criteria 
called the Common Clinical Data Set that 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 proposed that summary 
of care documents used to meet the Stage 3 Health Information Exchange 
objective must include the requirements and specifications included in 
the CCDS specified by ONC for certification to the 2015 Edition 
proposed rule.
    In the Stage 3 proposed rule (80 FR 16760), we stated that the CCDS 
may include additional fields beyond those initially required for Stage 
2 of meaningful use as new standards are 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. As 
we noted in the Stage 3 proposed rule at 80 FR 16760, we believe 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. 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. For further information on the CCDS 
standards, please see ONC's 2015 Edition final rule, published 
elsewhere in this issue of the Federal Register. 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:
     Current problem list (Providers may also include 
historical problems at their discretion).
     Current medication list.
     Current medication allergy list.
    We defined allergy in the proposed rule as an exaggerated immune 
response or reaction to substances that are generally not harmful (80 
FR 16760). 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 proposed 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, eligible hospital, or CAH as of the time of generating 
the summary of care document.
    In the Stage 3 proposed rule 80 FR 176760, we encouraged 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, we noted comments from stakeholders and through public 
forums and correspondence on the potential of allowing only clinically 
relevant

[[Page 62854]]

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 stated our belief 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 noted 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 proposed to defer to provider 
discretion on the circumstances and cases in which 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. In the Stage 3 proposed rule 80 FR 16760 we 
further specified our proposal 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, to state that 
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 noted that this proposal 
would apply for lab results, clinical notes, problem lists, and the 
care plan within the summary of care document.
    For the second measure, we proposed to address the other end of the 
transition of care continuum. In the Stage 2 final rule, we limited the 
action required by providers to sending an electronic transmission of a 
summary of care document (77 FR 54017 through 54018). 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 proposed a measure for the provider as 
the recipient of a transition or referral requiring him or her 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 was 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 
proposed that what constitutes ``unavailable'' and, therefore, may be 
excluded from the denominator, will be that a provider--
     Requested an electronic summary of care record to be sent 
and did not receive an electronic summary of care document; and
     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 sought 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 2two, 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 sought 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 proposed that a provider 
may use a wide range of health IT systems 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 also proposed that the receipt of the 
summary of care document may be passive (provider is sent the C-CDA and 
incorporates it) or active (provider requests a direct transfer of the 
C-CDA or provider queries an HIE for the C-CDA). 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). In the Stage 2 final rule, a governance 
mechanism option was included in the second measure for the summary of 
care objective at 77 FR 54020. In the Stage 3 proposed rule 80 FR 
16762,we again sought comment on a health information exchange 
governance mechanism. Specifically we sought 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 sought 
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 sought 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 HIE objective.
    For the third measure, we proposed 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. Clinical information such 
as medication allergies and problems 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 specified 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 reiterated 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 proposed to define clinical information

[[Page 62855]]

reconciliation as the process of creating the most accurate patient-
specific information in one or more of the specified categories using 
the clinical information reconciliation capability of 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 referred providers to the 
standards and certification criteria for clinical information 
reconciliation proposed in ONC's 2015 Edition proposed rule at 80 FR 
16831 through 16833.
    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 recognized that workflows to reconcile clinical information vary 
widely across providers and settings of care, and we requested 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 solicited comment on the 
following:
     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 requiring manual reconciliation imposes significant 
workflow burden. We also sought 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.
     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 CPOE objective?
     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?
     What additional exclusions, if any, should be considered 
for this measure?
    We also encouraged 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 explained that 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 solicited 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 solicited 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 proposed 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.
    Measure 1: To calculate the percentage of the first measure, CMS 
and ONC 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 or CAH 
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 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 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 or CAH 
inpatient or emergency department (POS 21 or 23) was the recipient of 
the transition or referral or has never before encountered the patient.

[[Page 62856]]

    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 received the following comments and our response follows:
    Comment: Many commenters supported our proposal for the HIE 
Objective applauding the focus on interoperability stating the move 
toward a true ability to share all patient health records in real time, 
regardless of EHR system in use, is much needed and very valuable to 
both providers and patients. This would almost certainly allow better 
management of care, less duplication of tests and reduction of other 
waste elements in the system, thus reducing costs. Other commenters 
noted support of the use of CEHRT to transmit a summary of care record 
during transitions of care and acknowledges the value of incorporating 
a patient's summary of care record received from another provider to 
facilitate clinical information reconciliation and care delivery.
    Some commenters specifically mentioned that people with cancer 
often receive fragmented and uncoordinated care because their 
treatments frequently require multiple clinicians including surgeons, 
oncologists, primary care physicians, and other specialists. These 
commenters noted that providing coordinated care requires access to all 
of a patient's data by all of his or her providers, an essential 
function that EHRs can provide.
    Still others expressed conceptual support for the proposed 
objective as the measures rationally seeks to organize the care of the 
patient on the care continuum and takes the next step in closing the 
transitions of care loop by incorporating outside medical information 
and promoting the reconciliation of medical data from transitioning 
patients. These commenters expressed a belief that the efforts to 
improve communication between providers for the same patient promotes 
better care decisions and care coordination. The ability to communicate 
information electronically decreases the chance of errors, missing 
information, or misunderstandings due to lack of standardization. 
Finally many commenters noted that the ability to send and receive data 
from other providers throughout the care continuum is imperative to 
transforming healthcare and improving patient care.
    Response: We thank the commenters for their support and agree that 
this objective should be a top priority for delivery system reform to 
promote the real-time interoperable exchange of health information and 
facilitate care coordination. We also appreciate the insight on how 
electronic exchange can support care management through reducing errors 
and duplicate testing. We believe the benefits of effective health 
information exchange are extensive for both providers and patients and 
for this reason we have maintained health information exchange as a key 
goal of the EHR Incentive Programs.
    Comment: The majority of commenters believe the thresholds for 
health information exchange (HIE) are too high for EPs. They pointed to 
various interoperability challenges, which make it difficult to meet 
the requirements and generally state that we are holding providers 
accountable for industry or national issues surrounding 
interoperability that are beyond their control.
    Many commenters stated that there are not enough providers and 
practices that can electronically receive transition of care documents 
because many (especially those in rural areas) do not have the 
capabilities needed to meet the HIE requirements (for example, Direct 
technologies, HIE access). Other commenters stated a lack of trading 
partners, including health care providers who are not subject to these 
regulations) as one of the main obstacles to meeting the Stage 3 HIE 
requirements. Several commenters requested that providers only be 
required to engage eligible professionals and eligible hospitals who 
are also working toward meeting the requirements of the EHR Incentive 
Programs, and that there should be exclusions based on the capabilities 
of surrounding practices or a lack of trading partners. Other 
commenters indicated statewide and regional health information 
exchanges are at varying levels of development and vary widely in their 
capabilities and sophistication. Other commenters stated the HIE 
technology and interoperability capabilities are not mature enough to 
meet these HIE requirements and will lead to provider failure or 
providers being held responsible for criteria they cannot control and 
standards they cannot meet.
    Another commenter stated there are no national or regional data 
repositories in place for direct email addresses to be shared which has 
made it extremely challenging for providers to comply with this 
objective and measure, even if the provider has the capability to 
generate and transmit a C-CDA.
    Response: We disagree and believe that this threshold is a 
reasonable and achievable goal for providers for an EHR reporting 
period in 2018. We understand the challenges providers and other 
stakeholders describe and recognize that the transition to 
interoperable health information exchange requires a paradigm shift 
across the health care industry. We believe the work providers are 
already engaged in and the HIE objectives and measures from Stage 2 are 
helping to actualize this change. As described in the Stage 3 proposed 
rule (80 FR 16739), we believe that electronic exchange is more likely 
to succeed as a higher volume of providers are actively engaged in the 
sending and receiving of electronic health information. Further, we 
note that we have proposed more flexibility in the transport mechanism 
in order to support the exchange of a standardized file in a wide range 
of transactions. Therefore, we believe that the requirement of this 
objective is a challenging goal, but a challenge that can and should be 
achieved.
    We disagree that there should be additional exclusions for this 
objective. As stated previously, we believe that the increased 
participation in the EHR Incentive Programs will help to support the 
overall ability for providers to electronically exchange health 
information. Further, we note that performance for providers in rural 
areas on the Stage 2 objective does not differ from the overall 
performance on the

[[Page 62857]]

measure.\18\ We also note that, as stated in the proposed rule, we 
define a transition of care or referral as a transition or referral to 
another provider of care that is recognized as a different billing 
entity for the EHR Incentive Programs (NPI, CCN). The inclusion or 
exclusion of additional provider types and transitions or referrals is 
at the discretion of the provider as best meets their practice needs as 
long as the inclusion or exclusion policy is applied universally for 
the duration of the EHR reporting period.
---------------------------------------------------------------------------

    \18\ ONC Data Brief June 2015 healthit.gov.
---------------------------------------------------------------------------

    We intend to support policies that mitigate the impact that a lack 
of trading partners or a lack of transport mechanisms have on 
providers. As we note throughout this final rule with comment period, 
we are seeking to increase participation among EHR Incentive Program 
participants and expand the methods by which providers may exchange 
information. These policies are aimed at ensuring that a lack of 
trading partners will not continue to be a significant hurdle for 
providers as the widespread adoption of certified EHRs continues and 
new flexible innovations for transport are supported.
    In addition, CMS and ONC share a mutual understanding of the issue 
relating to importance of provider access to health information 
exchange contact information and agree that a method to facilitate this 
access would support interoperable health information exchange. We are 
committed to exploring potential models and opportunities to enable 
providers to more readily share their own electronic exchange contact 
information and access the contact information of potential trading 
partners. It is our intent to populate the National Plan and Provider 
Enumeration System (NPPES) with direct addresses and/or electronic 
service endpoints of EHR Incentive Program participants as a means of 
creating a health care provider directory resource. For more 
information, we direct readers to section II.D.3 of this final rule 
with comment period.
    Comment: Many commenters requested a clearer definitions for the 
denominators relating to the measures including:
     Transitions of care for providers with a shared EHR
     Patient-reported referrals and patient self-referrals
     New patients and patient encounters in which the provider 
has never before encountered the patient
    Commenters further went on to express support for the option to 
include providers with a shared EHR and support for the ability to 
include patient-self referrals as an option, and asked specific 
questions relating to how these items impact any variation in the 
denominators between the measures.
    Response: We refer commenters to the Stage 2 final rule at 77 FR 
53982 through 53983 as well as section II.B.1.b.(4).(f) of this final 
rule with comment period for further explanation of the definition of 
transitions of care and the definition of transition or referral, which 
has not been modified from Stage 2.
    For our policy regarding transitions or referrals among providers 
with a shared EHR, in the Stage 3 proposed rule, we proposed that 
providers may count a transition of care or referral as long as the 
receiving provider would at least be considered a different provider if 
attesting for the EHR Incentive Programs (individual NPI or CCN level) 
in the denominator if they do so universally across all settings. They 
may also count these transitions with providers who share a certified 
EHR if they do so universally across all settings and for all such 
transitions. However, for any action to count in the numerator of a 
measure within this objective, the provider may not simply deem the 
shared access to the record sufficient, they would instead need to 
complete the required action associated with each measure. We maintain 
that this option to include or not include such transitions is entirely 
at the provider's discretion, but the policy must be applied 
universally for all transitions or referrals related to the denominator 
for Measure 1 and Measure 2. We believe that these transitions and 
referrals should not be excluded from Measure 3, as clinical 
information reconciliation may include actions beyond the electronic 
exchange of a patient record. We further clarify that the use of the 
reference to a billing identity within the program is intended to 
establish the baseline that if a provider chooses to included exchanges 
with providers with a shared EHR they may do so as long as the 
recipient would be considered a different provider in the EHR Incentive 
Programs (e.g., by the EPs NPI or the eligible hospital or CAH CCN). 
Some examples which would be included under this policy would be one EP 
sending to another EP in the same group practice, an eligible hospital 
sending to an EP in an ambulatory setting which shares the hospital 
EHR, or a provider sending to a non-EP practitioner who may have shared 
access to the EHR but whose patient encounters are not included under 
the referring EPs supervision. Some examples which would be excluded 
under the policy are an EP in one setting referring a patient to 
another setting for a different service but where the same EP is the 
provider, an eligible hospital referring a patient from one clinical 
setting within the hospital to another (where they attest with the same 
CCN), and an EP sending to a non-EP practitioner who is under direct 
supervision and whose patient encounters may be included in the EPs 
attestation.
    We note that in the Stage 3 proposed rule (80 FR 16759) we stated 
that we believe a provider should count a referral in the denominator 
in the case of patient-self referrals if the patient subsequently 
identifies the provider from whom they received care. We further stated 
that 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. However, we have reconsidered this requirement based on 
feedback from commenters who note that variations in timing and 
provider specialty might impact the feasibility and value proposition 
for a provider to count patient self-referrals in this manner. For 
example, if a primary care provider is notified of a self-referral to a 
specialist months after the resulting visit with the specialist has 
occurred, the receipt and incorporation (Measure 2) and reconciliation 
(Measure 3) of the summary of care record by the primary care provider 
from the specialist is important for the patient's continued care by 
the primary care provider. In this scenario, it may not make sense for 
Measure 1 to be required. Under measure 1 as proposed, the primary care 
provider would be required to send a summary of care record to the 
specialist. If the specialist has already seen the patient and no 
follow-up or continued treatment is needed, we believe the referring 
provider is best suited to determine whether the summary of care record 
should still be sent. We note that there are further examples of such 
instances which provide further complications for feasibility of this 
requirement as proposed. We are, therefore, modifying our initial 
proposal so that patient self-referrals may be included, but are not 
required, for measure 1. The provider should determine in what cases 
they would include or not include patient-self referrals and apply that 
policy across all such referrals for the duration of the reporting 
period. We note that providers

[[Page 62858]]

should seek to receive or retrieve a summary of care document from the 
other provider of care and should seek to reconcile clinical 
information once the provider is identified in the same manner they 
would for any other transition or referral for measures 2 and 3.
    For the definition of new patient and never before seen by the 
provider, we stated that we use the same definition of ``new patient'' 
as described in Objective 7 Medication Reconciliation for the EHR 
Incentive Programs in 2015 through 2017 in section II.B.2.a.v of this 
final rule with comment period.
    Comment: Some commenters opposed the option to allow providers to 
only meet the threshold for 2 of 3 objectives, suggesting this would 
result in slower adoption of true interoperability between providers as 
they pursue different goals of the EHR Incentive Programs. These 
commenters stated that providers need to align on common goals to 
successfully reach interoperability. Other commenters praised this 
flexibility stating that it would allow them to set internal goals and 
a continuous improvement process and still be able to meet program 
requirements if they sought to make adjustments to workflows.
    Response: We appreciate the insights from the commenters and agree 
that the allowance to meet two of three thresholds represents a more 
flexible option for providers. We believe that rather than hinder 
participation, this flexibility will allow providers to innovate and 
expand their uses of HIE as best meets their organizational needs.
    Comment: Many commenters supported our proposal allowing providers 
to limit the transmission of certain data elements based on clinical 
relevance. Others commended the approach of requiring the ability to 
send all data elements while allowing flexibility for providers to make 
the determination of relevance as best fits their practice and patient 
population.
    Some commenters further suggested that providers be able to limit 
the C-CDA itself or not be required to send the full C-CDS on all 
transitions of care. Many commenters addressed the C-CDS itself stating 
that they support renaming the clinical data sets from ``Common MU Data 
Set'' to a new term, as the data sets are relevant beyond the EHR 
Incentive Programs. Some noted that CCDS is close to C-CDA however 
commenters were split on if that was a problem or a benefit.
    Some commenters opposed the changes to the required data set in the 
CCDS stating that the additional data fields that are incorporated into 
the proposed Stage 3 CCDS would involve significant effort to implement 
and transition the data elements necessary to support the standard 
summary of care record.
    Other commenters noted agreement with the expansion of captured 
data elements and recommended we maintain capture of this information 
in a format supported by the C-CDA data structure, but that they should 
not be mandatory to be populated on the C-CDA in order to meet the 
numerator of sending an electronic summary of care. These commenters 
supported continuing to require that the current problem list, 
medication list, and medication allergy must be populated within the C-
CDA.
    Response: We thank the commenters and note that our proposal to 
allow for provider discretion over clinical relevance stemmed largely 
from the input from providers on how best to address issues with this 
measure. We also agree that it is essential to maintain the ability to 
send a full set of all available lab results and clinical notes. We 
reiterate that while the provider generally has the discretion to 
define the relevant clinical notes or relevant laboratory results, 
providers must be able to provide all clinical notes and/or laboratory 
results through an electronic transmission of a summary of care 
document. Furthermore, providers must send all clinical notes and/or 
all laboratory results if that level of detail is subsequently 
requested by a provider receiving a transition of care or referral, or 
if that level of detail is requested by the patient who is 
transitioning to another setting of care.
    We disagree with the suggestion that the C-CDA not be required and 
that any electronic transmission of patient health information may be 
accepted for attestation. Furthermore, we disagree with suggestions 
that the C-CDA should not include all required elements of the ONC 
defined CCDS for purposes of CEHRT. We note that both the CCDS and C-
CDA support the interoperable exchange of data elements for provider 
use. Without standards, the data from one system cannot readily be 
translated into usable data in another system.
    However, we clarify that not all elements of the CCDS are required 
to include data if no such data is available or known to the provider. 
The only three fields which must include data are the current problem 
list, medication list, and medication allergy list, which must at least 
include a reference that no such data is known or available. This is an 
important patient safety element finalized in the Stage 2 final rule 
which we maintain for Stage 3.
    Comment: Some commenters noted the importance of the availability 
of certain information in care delivery, including sexual orientation & 
gender identity, disparities, behavior health, and UDI data. Some 
commenters specifically highlighted the importance of capturing UDI 
data for improved care and better reporting of adverse events as well 
as allowing for the ability to provide more effective corrective and 
preventative action in response to device recalls and alerts.
    Response: We thank commenters for their comments and for their 
support of UDI within the program. We note that ONC's 2015 Edition 
final rule, published elsewhere in this issue of the Federal Register, 
includes UDIs for a patient's implantable devices in the CCDS and the 
corresponding implantable device list certification criterion in the 
Base EHR definition. We believe that incorporating UDIs, beginning with 
UDIs for implantable devices, in certified EHR technology will be 
integral to patient care, as this information can help those within a 
patient's care team to accurately identify the patient's devices (and 
associated clinically relevant information, such as a device's latex 
content or MRI safety) and thus be better informed and better able to 
care for the needs of the patient. We refer readers to the 2015 Edition 
final rule for further discussion of this criteria.
    Certain other types of information, while not required within the 
CCDS, have associated standards and capabilities for data capture that 
are included in certification criteria that compose the Base EHR 
definition. As such, while these types of information are not required 
within the CCDS, the ability to capture this information is required 
under the definition of CEHRT. This distinction means the provider 
would have the data element available for use within their certified 
EHR and would have the ability to capture the data in a structured 
format as appropriate for their individual practice and patient 
population. For example, the Base EHR definition included in the 2015 
Edition final rule provides for the capture of demographic data within 
certified EHR technology, including the capture of more granular data 
on race and ethnicity and of data that extends beyond a more limited 
understanding of clinical care data--such as the collection of social, 
psychological, and behavioral health information. The ability to 
capture this information in CEHRT supports provider efforts to provide 
improved, patient-centered care and reduce health disparities.

[[Page 62859]]

    The 2015 Edition proposed rule also included a criterion to record 
a patient's sexual orientation and gender identity (SO/GI) in a 
structured way with standardized data. Where the patient chooses to 
disclose this information, the inclusion of this information can help 
those within the patient's care team to have more information on the 
patient that can aid in identifying interventions and treatments most 
helpful to the particular patient. Additionally, sexual orientation and 
gender identity can be relevant to individual treatment decisions; for 
example, transgender men who were assigned female at birth should be 
offered a cervical exam, as appropriate. In the final rule, ONC is 
requiring that Health IT modules enable a user to record, change, and 
access SO/GI to be certified to the 2015 Edition ``demographics'' 
certification criterion. By doing so, SO/GI is now included in the 2015 
Edition Base EHR definition, which is a part of the definition of CEHRT 
(see section II.B.3). We note that certification does not require that 
a provider collect this information; it requires only that their CEHRT 
enable the provider to do so. CMS and ONC believe including SO/GI in 
the ``demographics'' criterion represents a crucial step forward to 
improving care for LGBT communities.
    We also note that we received comments specific to the composition 
of the CCDS and addressing the C-CDA, which are out of scope for this 
rule. We refer readers to the 2015 Edition final rule included 
elsewhere in this Federal Register for further information on the CCDS 
and the C-CDA, as well as for further information on provisions related 
to data collection, including the collection of sexual orientation and 
gender identity data and behavioral, social, and psychological data.
    Comment: For Measure 1, many commenters expressed similar concerns 
with the first measure as with HIE as a whole citing interoperability 
barriers and the lack of providers and other trading partners available 
to electronically exchange data. Commenters also considered the 
threshold of 50% to be too high and too far a leap from the 10% 
requirement in Stage 2. Additionally, commenters opposed removing the 
exclusion qualifier which allowed providers to exclude the measure if 
they conduct fewer than 100 referrals or transitions of care during the 
EHR reporting period. A few commenters believe measure 1 is valuable 
driver of interoperability within health care, but acknowledged that 
refinements/adjustments need to be made.
    Response: We reiterate that CMS and ONC are committed to working 
with the industry to support and promote an expanded HIE infrastructure 
to facilitate health IT facilitated care coordination. We believe 
expanding the flexibility for the use of a wide variety of transport 
mechanisms, encouraging wider provider participation and continuing to 
support the use of standards for structured data in certified EHR 
technology will help to mitigate these concerns. We do not believe the 
threshold is too high given the past performance, the expansion of 
options, and the expressed need for higher overall participation. We do 
however note that the change to the exclusion may be problematic for 
providers with very few transitions in an EHR reporting period and are 
therefore maintaining the exclusion at 100 transitions and referrals as 
finalized in the Stage 2 final rule for an electronic summary of care 
and consistent with measures 2 and 3.
    Comment: Some commenters requested clarification if any electronic 
means could include transmission via pdf or electronic fax, or the 
conversion of a C-CDA document into one of these formats. Commenters 
also suggested that any electronic means is not a rigorous enough 
definition to ensure the security of patient information in 
transmission.
    Many commenters strongly supported the expansion of the available 
methods by which secure electronic exchange could occur. Some strongly 
encouraged us to continue to require summary of care record exchange in 
a manner that is consistent with a governance mechanism ONC establishes 
for the nationwide health information network. These commenters noted 
that transmission of a summary of care record could be accomplished in 
various ways and requested that CMS and ONC should provide resources 
outside the regulations to support and clarify these requirements for 
developers and providers.
    Other commenters specifically supported the requirement for the 
transmission of electronic summary of care document in a manner that is 
consistent with the governance mechanism ONC establishes for the 
nationwide health information network and believe that allowing any 
other transmission method will increase the cost and complexity of 
receiving and incorporating data into the EHR.
    Response: We note that the intent for flexibility around sending 
via any electronic means (so long as the provider is using the 
standards established for certified health IT under the ONC 
certification program for the creation of the electronic summary of 
care document) is to promote and facilitate a wide range of options and 
also to specifically facilitate the receipt of a summary of care 
document electronically. In the past, in response to inquiries by 
providers we developed an FAQ which stated that an electronic summary 
of care document may be converted from a C-CDA to another format (e.g. 
SOAP, secure email, electronic fax, and etc.) by a third party 
intermediary, and that such a transition may still be counted in the 
numerator if the third party can confirm for the sending provider that 
the summary of care was ultimately received by the next provider of 
care.\19\ However, for Stage 3 we do not intend to continue to allow 
this policy, as it does not drive toward the overall goal of the HIE 
Objective that providers send, receive or retrieve, and incorporate an 
electronic summary of care document for each transition or referral. 
This means the initiating provider must send a C-CDA document that the 
receiving provider would be capable of electronically incorporating as 
a C-CDA on the receiving end. In other words, if a provider sends a C-
CDA and the receiving provider converts the C-CDA into a pdf or a fax 
or some other format, the sending provider may still count the 
transition or referral in the numerator. If the sending provider 
converts the file to a format the receiving provider could not 
electronically receive and incorporate as a C-CDA, the initiating 
provider may not count the transition in their numerator. We further 
note that for measure 1, a provider must have confirmation of receipt 
or that a query of the summary of care record has occurred in order to 
count the action in the numerator.
---------------------------------------------------------------------------

    \19\ FAQ #10660 https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/FAQ.html Frequently Asked 
Questions: EHR Incentive Programs.
---------------------------------------------------------------------------

    We further note that the security of the transmission is of 
paramount importance to CMS. We, therefore, remind providers and 
emphasize that any transmission method chosen by a provider must comply 
with the privacy and security protocols for ePHI outlined in HIPAA.
    We requested comment from providers on how the governance mechanism 
could be considered for purposes of the objectives and measures in 
Stage 3 and we thank commenters for their comments. We will continue to 
consider these comments as we work with ONC to address governance as it 
relates to health information exchange, and look forward to continuing 
to work with stakeholders in this area.

[[Page 62860]]

    Comment: For Measure 2, some commenters acknowledged the potential 
benefit of this measure with the understanding that various challenges 
would need to be overcome first. Commenters felt the 40 percent 
threshold was too high, particularly for a new measure. They also 
expressed concerns with the administrative burden, workflow and time 
management challenges, and technological barriers involved in reviewing 
and incorporating data from other providers.
    Response: We respectfully disagree that the threshold for the 
measure is too high, as the ability to retrieve, receive and 
incorporate an electronic summary of care document for transitions or 
referrals as defined by the measure is entirely within the provider's 
control. For example, in our proposal we allow providers to exclude a 
patient from the denominator where a reasonable due diligence reveals 
that no electronic record is available for the patient. This reduces 
the burden on providers to incorporate the record for only those 
patients for whom an electronic record is available after their effort 
to receive, request, or query for an electronic summary of care is 
successful. We believe there may be many variations in how providers 
accomplish this measure and believe those workflows and processes are 
best left to provider discretion.
    Comment: Some commenters expressed that it would be unreasonable to 
include patients never before seen by the provider. These commenters 
noted that, for example, emergency department workflows are simply 
incompatible with requirements to try to identify outside sources of 
summary of care records for walk-in patients. They further noted that 
the infrastructure for doing this does not exist in most areas and is 
not likely to exist for several years to come.
    Other commenters requested we add the word ``electronically'' to 
the measure language so that the measure reads ``For 40 percent of 
transitions or referrals received electronically''. Other commenters 
noted that a provider may have the capacity to query an HIE in their 
CEHRT, but is unable to do so because there is no HIE in their area or 
their organization is still in the process of on-boarding with a 
potential HIE network. These commenters expressed concern that the 
denominator calculation would not allow them to exclude patients for 
whom they were unable to query in this instance. Others expressed a 
similar concern over the understanding of an HIE noting that many do 
not require the provider to possess additional functionality, but 
instead allow a provider to query for a document and receive that 
document via direct transport from the HIE.
    Response: We disagree with the commenters that it is unreasonable 
to include new patients and note that the example provided about the 
ability of a hospital to find information on a patient presenting at 
the emergency department is exactly the type of process that is 
supported by health IT rather than hindered by it.
    We also decline to add the qualifier to the measure to specify only 
counting existing electronic transitions or referrals in the 
requirement to receive, request or query for an electronic summary of 
care record. If we were to change the measure to read ``received 
electronically'' it eliminates any further follow up to request or 
query for an electronic record when an electronic record was not 
already received with the transition or referral. This change would 
fundamentally alter the measure and render it meaningless.
    The proposed measure denominator already allows providers to 
exclude patients for whom no electronic document is available after a 
reasonable effort is made, such as a request to the referring provider 
and a query of any HIE or service. As stated in the proposed rule, for 
the purposes of defining the cases in the denominator, we proposed that 
what constitutes ``unavailable'' and, therefore, may be excluded from 
the denominator, will be that a provider--
     Requested an electronic summary of care record to be sent 
and did not receive an electronic summary of care document; and
     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.
    However, we do agree with commenters and are adopting a change to 
state that the reference to HIE functionality within the denominator 
calculation should be revised to reflect whether or not there is an HIE 
from which the provider is able to query and receive a C-CDA using 
their CEHRT. We are therefore adding an additional qualifier to the 
statement to include that the HIE functionality supporting a query for 
a summary of care document is not currently operational in the 
provider's geographic region or EHR network. Therefore, for the 
purposes of defining the cases in the denominator, we are modifying our 
proposal to state that what constitutes, ``unavailable'' and therefore 
may be excluded from the denominator,--is as follows:
     The provider requested an electronic summary of care 
record to be sent and did not receive an electronic summary of care 
document; and
     The provider either:
    1. Queried at least one external source via HIE functionality and 
did not locate a summary of care for the patient, or
    2. Confirmed that HIE functionality supporting query for summary of 
care documents was not operational in the provider's geographic region 
and not available within the provider's EHR network as of the start of 
the EHR reporting period.
    Comment: Finally, commenters requested information on what the term 
``incorporated'' means in the numerator. Some expressed concerns over 
the integrity of the information if they are forced to incorporate it 
into their EHR.
    Response: We do not define incorporate, as it may vary among 
recipient providers based on the providers HIE workflows, their patient 
population, and based on the referring provider. The record may be 
included as an attachment, as a link within the EHR, as imported 
structured data, or the provider may conduct a reconciliation of the 
clinical information within the record to incorporate this information 
into the patient record within their EHR. We note that a record cannot 
be considered to be incorporated if it is discarded without the 
reconciliation of clinical information or if it is stored in a manner 
that is not accessible for provider use within the EHR.
    Comment: Many commenters supported Measure 3 and clinical 
information reconciliation with some stating that the measure should be 
required rather than an option within the objective. Others stated that 
all three types of information should be required for all care 
transitions because reconciliation of medications, medication 
allergies, and current problems is consistent with the requirement to 
provide the safest care. Many commenters also agreed with the threshold 
for the measure of more than 80 percent, with some stating that we 
should simply require all patients for this measure instead.
    Some commenters discussed the administrative burden, various 
workflow challenges involved in reviewing, and incorporating data from 
other providers including the amount of time required to review inbound 
summary of care reports. Other commenters discussed how the CCDS are 
not helpful because they contain too much unnecessary and redundant 
information as well as the risk associated with receiving summary of 
care information that has not been

[[Page 62861]]

reviewed by a provider in a timely manner.
    Other commenters stated that not all new patient referrals require 
comprehensive data reconciliation. For example a dermatologist 
evaluating a simple skin lesion or an orthopedist evaluating a painful 
joint may not need to perform in depth reconciliation to provide 
quality care.
    In addition, many commenters discussed the means of measurement for 
medications, problems, and allergies such as if duplicate records 
needed to be reconciled or if data that is verified as requiring no 
further update would also count toward the measure. Several commenters 
requested clarification on whether the reconciliation should be 
automated or manual. Some requested we offer both options to allow 
providers to choose the means that best fits their practice, and many 
commenters had concerns about the liability associated with automated 
reconciliation.
    Response: We appreciate the support for the measure; however, we 
did not propose that this measure should be required for the objective 
but rather that providers must meet the threshold for two of three 
measures based on the needs of their practice. We believe that many 
providers may conduct some form of reconciliation in conjunction with 
measure 2, or that providers in certain specialties may elect to 
conduct reconciliation of clinical information even beyond our 
requirement at all patient encounters. We understand from previous 
listening sessions and feedback from stakeholders that the summary of 
care documents sometimes contain an overwhelming amount of information. 
For this reason, we allow provider discretion to define the relevant 
clinical notes and/or laboratory results to send in the summary of care 
document, although we maintain that providers must still have the CEHRT 
functionality to include and send all labs or clinical notes. We 
believe this will provide the efficiency sought by stakeholders in 
their feedback.
    We note that this measure builds on the existing Medication 
Reconciliation Objective for the EHR Incentive Programs in 2015 through 
2017 (see section II.B.2.a.v). We agree that this process may include 
both automated and manual reconciliation to allow the receiving 
provider to work with both the electronic data provided with any 
necessary review, and to work directly with the patient to reconcile 
their health information. We further note that the point of 
reconciliation is to assist in maintaining the most relevant, complete, 
and up to date information for a given patient. If no update is 
necessary, the process of reconciliation may consist of simply 
verifying that fact or reviewing a record received on referral and 
determining that such information is merely duplicative of existing 
information in the patient record. Both such examples would count 
toward the measure if the provider established their reconciliation 
process to include such verification.
    Comment: Commenters requested clarification on whether data can be 
reconciled by non-credentialed staff or by credentialed staff only. 
Commenters were split on their opinions of whether reconciliation 
should be conducted by only credentialed medical staff like CPOE or by 
any staff trained to work with the EHR and enter patient information. 
Some recommended allowing auto reconciliation of data as long as it is 
reviewed by credentialed staff or provider. Other commenters stated 
that non-credentialed staff should be able to reconcile the data, then 
have it reviewed by credentialed staff.
    Response: We require the person entering the order in CPOE to be 
credentialed medical staff because of the need to review, assess, and 
potentially act on a CDS based on the order entered. For further 
discussion, we direct readers to the CPOE objective in section 
II.B.2.a. of this final rule with comment period. In most cases, 
clinical information reconciliation may not require the same level of 
medical training and knowledge and a non-clinical staff person trained 
to accurately and completely enter patient information may be fully 
qualified to conduct this task. However, in some instances, further 
medical knowledge and training may be required, such as if a medication 
reconciliation triggers a CDS drug-drug intervention. We therefore 
agree with commenters that non-medical staff may conduct reconciliation 
under the direction of the provider so long as the provider or other 
credentialed medical staff is responsible and accountable for review of 
the information and for the assessment of and action on any relevant 
CDS.
    Comment: A few commenters supported the inclusion of electronic 
alerts to the EP, when their patient is seen in the emergency 
department or admitted and/or discharged from the hospital. Other 
commenters stated that the standard is too vague and the technology too 
immature for required use at this time and that CMS should allow 
providers to choose if they wish to participate in this action for the 
near future.
    Response: We decline to finalize an inclusion of electronic alerts 
at this time. We will continue to review the development of the 
technology and standard for potential inclusion in the future.
    After consideration of public comments received, we are finalizing 
the objective with a minor modification to the language to clarify 
receiving or retrieving a summary of care through query as discussed 
for measure 2. We are finalizing the measures and exclusions as 
proposed for EPs, eligible hospitals and CAHs. We are finalizing that 
providers must attest to all three measures and must meet the 
thresholds for at least two measures to meet the objective. The final 
objective and measures are as follows:
Objective 7: Health Information Exchange
    Objective: The EP, eligible hospital, or CAH provides a summary of 
care record when transitioning or referring their patient to another 
setting of care, receives or retrieves a summary of care record upon 
the receipt of a transition or referral or 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 
CEHRT.
    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.
     Denominator: Number of transitions of care and referrals 
during the EHR reporting period for which the EP or eligible hospital 
or CAH 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: A provider may exclude from the measure if any 
of the following apply:
    [cir] Any EP who transfers a patient to another setting or refers a 
patient to another provider less than 100 times during the EHR 
reporting period.
    [cir] 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

[[Page 62862]]

latest information available from the FCC on the first day of the EHR 
reporting period may exclude the measures.
    [cir] 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: 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.
     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: A provider may exclude from the measure if any 
of the following apply:
    [cir] 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.
    [cir] 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.
    [cir] 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: 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:
    (1) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication.
    (2) Medication allergy. Review of the patient's known medication 
allergies.
    (3) Current Problem list. Review of the patient's current and 
active diagnoses.
     Denominator: Number of transitions of care or referrals 
during the EHR reporting period for which the EP or eligible hospital 
or CAH 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.
    We are adopting Objective 7: Health Information Exchange at Sec.  
495.24(d)(7)(i) for EPs and Sec.  495.24(d)(7)(ii) for eligible 
hospitals and CAHs. We further specify that in order to meet this 
objective and measures, an EP, eligible hospital, or CAH must use the 
capabilities and standards of as defined for as defined CEHRT at Sec.  
495.4. We direct readers to section II.B.3 of this final rule with 
comment period for a discussion of the definition of CEHRT and a table 
referencing the capabilities and standards that must be used for each 
measure.
Objective 8: Public Health and Clinical Data Registry Reporting
    In the Stage 3 proposed rule (80 FR 16763) we proposed this 
objective to build on the requirements set forth in the Stage 2 final 
rule (77 FR 54021 through 54026). We proposed this objective to include 
improvements to the Stage 2 measures, support innovation that has 
occurred since the Stage 2 final rule was released, and add flexibility 
in the options that an eligible provider has to successfully report.
    We further noted that this objective places increased focus on the 
importance of the ongoing lines of communication that should exist 
between providers and public health agencies or as further discussed 
later in this section, between providers and clinical data registries. 
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 
public health agencies and clinical data registries, as well as 
strengthen the capture and transmission of such health information 
within the care continuum.
    For Stage 3, we proposed changes to the Stage 1 and Stage 2 public 
health and specialty registry objectives to consolidate the prior 
objectives and measures into a single objective in alignment with 
efforts to streamline the program and support flexibility for 
providers. We proposed to include a new measure for electronic case 
reporting to reflect the diverse ways that providers can electronically 
exchange data with public health agencies. In addition, we used 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 known in the 
health care industry to designate a broader range of registry types. We 
further explained 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 public health agency or clinical data registry to 
submit electronic public health data in a meaningful way using 
certified EHR technology, except where prohibited, and in accordance 
with applicable law and practice.
    For Stage 3, we proposed 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 public 
health agency or clinical data registry 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

[[Page 62863]]

ongoing submission requirement does not accurately capture the nature 
of communication between providers and a public health agency or 
clinical data registry, and does not consider the many steps necessary 
to arrange for registry submission to a public health agency or 
clinical data registry. 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 clinical data registry or to 
a public health agency.
    For purposes of meeting this new objective, EPs, eligible hospitals 
and CAHs would be required to demonstrate that ``active engagement'' 
with a public health agency or clinical data registry has occurred. 
Active engagement means that the provider is in the process of moving 
towards sending ``production data'' to a public health agency or 
clinical data registry, or is sending production data to a public 
health agency or clinical data registry. We noted that the term 
``production data'' refers to data generated through clinical processes 
involving patient care and it is 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 proposed 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 
public health agency or, where applicable, the clinical data registry 
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 public 
health agency or clinical data registry to begin testing and 
validation. This option allows providers to meet the measure when the 
public health agency or the clinical data registry 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 public health agency or, where applicable, the 
clinical data registry 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 
public health agency or clinical data registry.
    We also proposed to provide support to providers seeking to meet 
the requirements of this objective by creating a centralized repository 
of national, state, and local public health agency and clinical data 
registry readiness. In the Stage 2 final rule (77 FR 54021), we noted 
the benefits of developing a centralized repository where a public 
health agency could post readiness updates regarding their ability to 
accept electronic data using specifications prescribed by ONC for the 
public health objectives. In accordance with the Paperwork Reduction 
Act of 1995, we also published 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 
proposed 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 public 
health agencies and clinical data registries at the state, local, and 
national level. We received the following comments and our responses 
follow:
    Comment: Some commenters expressed concern regarding the active 
engagement requirement included in the proposed rule. Commenters noted 
that the description of active engagement is vague. Commenters also 
noted that additional time, beyond the 2018 requirement year, would be 
needed to ensure that providers could change their current framework to 
meet the new active engagement requirement. Other commenters requested 
clarification on the definition of production in Option 3. Other 
commenters noted that during the production phase, issues may arise 
that need resolution and that, similar to the testing and validation 
phases, processes are needed to ensure proper resolution. A commenter 
proposed adding a 30-day allowance to the active engagement option 3 
(production) to align with the 30-day allowance included in active 
engagement option 2 (testing and validation).
    Response: We thank the commenters for their input and note the 
following clarifications of intent and purpose for the change from 
``ongoing submission'' to ``active engagement.'' We received feedback 
from a variety of stakeholders that the ``ongoing submission'' 
structure created confusion. This feedback highlighted that providers 
are unsure of how ongoing submission could be achieved and whether 
periodic, continuous, or episodic reporting was generally required. We 
found that the wide variation among potential provider reporting 
scenarios and submission processes contributed to the difficulty in 
defining ``ongoing submission'' in a fair and universally applicable 
manner. Therefore our change to ``active engagement'' is intended to 
more clearly identify the progression of the requirement as well as 
providing a basis for defining the actions required by the provider in 
each step of the process. In a sense, the active engagement options are 
a clarification of the more basic concept of reporting which is that 
the provider is taking action and in communication with a public health 
agency in order to register, test and submit data in a progression 
which results in the provider successfully reporting relevant data to 
the public health agency.
    The active engagement requirement clarifies what is expected of a 
provider who seeks to meet the measures within this objective and 
renames the requirement to better describe the provider's role in 
meeting each option within the structure. There is an intentional 
similarity between some of the broad descriptions of the Stage 2 
``ongoing reporting'' and the requirements for the ``active 
engagement'' options. This is both to provide continuity and to define 
a more comprehensive progression for providers in meeting the measure. 
For example, in the Stage 2 rule (77 FR 54021), we generally stated 
that a provider could register their intent to submit data to 
successfully meet a measure in the public health objective. This 
concept is defined with additional guidance in the Stage 3 proposed 
rule as Active Engagement Option 1: Completed Registration to Submit 
Data.
    For the commenters discussing the submission of production data as 
defined in Action Engagement Option 3: Production, we note that under 
this option a provider only may successfully attest to meaningful use 
when the receiving public health agency or clinical data registry moves 
the provider into a production phase. We recognize that live data may 
be sent during the Testing and Validation phase of Option 2, but the 
data received in Option 2 is not sufficient for purposes of meeting 
Option 3 unless the public health agency and clinical data registry is

[[Page 62864]]

actively accepting the production data from the provider for purpose of 
reporting. We agree with commenters who noted that issues may arise 
that require provider action. In such a case, we require providers to 
respond to issues in the same manner as described in Option 2. For 
example, a provider in the production phase would not be able to 
successfully attest to Option 3 if there were issues in production 
where the provider fails to respond to an issue within 30 days on two 
occasions.
    Comment: Some commenters sought clarification on whether a provider 
who has already registered with a public health agency or clinical data 
registry during a previous reporting period would have to register 
again in order to meet the active engagement requirement. Commenters 
noted that a registration requirement in such circumstances would be 
duplicative.
    Response: As we have noted in the proposed rule, under the active 
engagement requirement, providers would only need to register once with 
a public health agency or a clinical data registry and could register 
before the reporting period begins. In addition, we note that previous 
registrations with a public health agency or clinical data registry 
that occurred in a previous stage of meaningful use could count toward 
option 1 of the active engagement requirement for purposes of attesting 
to Stage 3. We clarify that providers must register with a public 
health agency or clinical data registry for each measure they intend to 
use to meet meaningful use. Further, we also clarify that to meet 
option 1 of the active engagement requirement, registration with the 
applicable public health agency or clinical data registry is required 
where a provider seeks to meet meaningful use using a measure they have 
not successfully attested to in a previous EHR reporting period.
    Comment: Commenters requested clarification regarding whether a 
provider can successfully attest to meaningful use using proof of 
active engagement collected by their organization, or whether a 
provider must demonstrate that he or she independently engaged with the 
public health agency or clinical data registry.
    Response: The EHR Incentive Programs are based on individual 
providers meeting the objectives and measures of meaningful use. 
Therefore an individual provider can only meet an objective or measure 
if they are engaged in the activity which is used to meet the measure. 
This means a provider can demonstrate meaningful use by using 
communications and information provided by a public health agency or 
clinical data registry to the provider directly for individual 
reporting. Or, a provider also may demonstrate meaningful use by using 
communications and information provided by a public health agency or 
clinical data registry to the practice or organization of the provider 
if the organization reports at the group level as long as the provider 
is contributing to the data reported by the group. If the provider does 
not contribute to the data, they must claim the exclusion if applicable 
and/or meet another public health reporting measure. For example, a 
provider who does not administer immunizations should claim the 
exclusion even if their organization submits immunization reporting at 
the group level.
    Comment: Commenters also expressed support for the proposed 
centralized repository of public health agencies and clinical data 
registry readiness. Commenters noted that the repository would help 
developers and providers consider available registry options and 
provide advance notice of the status of registries. Though the 
repository received many positive comments, some commenters noted that 
variability in the readiness of public health agencies presented an 
additional challenge for providers who seek to prepare for and meet the 
measures.
    Response: In response to comments received and the concern that 
providers need advance readiness notification from public health 
agencies and clinical data registries to prepare and plan before the 
EHR reporting period begins, we are broadening the exclusions that 
could apply to providers seeking to meet the objective. The exclusion 
will allow providers more time to prepare their processes to align with 
what data public health jurisdictions are ready to accept. 
Specifically, we will not finalize the proposed requirement that public 
health agency and clinical data registries declare readiness on the 
first day of the EHR reporting period. We are instead finalizing a 
modified exclusion that if public health agencies have not declared 6 
months before the start of the EHR reporting period whether the 
registry they are offering will be ready on January 1 of the upcoming 
year for use by providers seeking to meet EHR reporting periods in that 
upcoming year, a provider can claim an exclusion. We believe that 
modifying the exclusion to request public health agency or clinical 
data registry to declare their readiness 6 months ahead of the first 
day of the EHR reporting period would allow providers adequate notice 
of public health agency and clinical data registry plans to accept data 
at the beginning of an EHR reporting period.
    Proposed Measures: We proposed 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 proposed measures are 
as shown in Table 9. As noted, we proposed that 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.

   Table 9--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 **...........................

[[Page 62865]]

 
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 proposed 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 proposed 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 also proposed 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 also proposed 
allowing 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 explained that 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.
    Proposed 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).
    In the Stage 3 proposed rule (80 FR 16764), we noted that the 
immunization registry reporting measure remains a priority 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 proposed that to successfully meet the requirements of this 
measure, bi-directional 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 bi-directionally with providers, and that 
the number of states and localities able to support bi-directional 
exchange continues to increase. In the 2015 Edition proposed rule, ONC 
proposed to adopt a bi-directional 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 bi-directional immunization data exchange. We welcomed 
comment on this proposal.
    Proposed 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.
    Comment: Many comments supported the concept of bi-directional 
messaging, but some commenters requested additional background on what 
bi-directionality means for purpose of the measure. Many commenters 
expressed concern about elements of the bi-directional components of 
immunization registry reporting, and around jurisdictional variation 
and the lack of public health readiness to implement bi-directional 
data exchange. Many commenters expressed concern about public health 
readiness for bi-directional data exchange, especially during the EHR 
Incentive Program reporting periods of 2015 through 2017. A commenter 
expressed concern that immunization registries are not fully prepared 
to support bi-directional interfaces. Many commenters also expressed 
concern around accepting the immunization history and forecast from

[[Page 62866]]

an IIS when the EHR may already perform that functionality and may have 
better information to perform the forecasting algorithm. A commenter 
expressed concern that the forecast info interface could conflict with 
their system's existing health maintenance functionality.
    Response: Bi-directionality, as noted in the applicable 
implementation guide Version 2.5.1: Implementation Guide for 
Immunization Messaging, Release 1.5 (October 2014) (``Release 1.5''), 
provides that certified health IT must be able to receive and display a 
consolidated immunization history and forecast in addition to sending 
the immunization record. Some comments noted that certified EHR 
technology may already perform the forecast and may have better 
information to perform the forecasting algorithm. For clarification, we 
note that the provider's technology certified in accordance with the 
ONC Health IT Certification Program may layer additional information 
and recommendations on top of the forecast received from the 
immunization registry. The requirements of CEHRT serve only as a 
baseline upon which additional capabilities may be built.
    Regarding the bi-directionality requirement, we note that we have 
modified the requirements of bi-directionality for the EHR Incentive 
Program for 2015 through 2017 (see section II.B.2.a.x). However, for 
Stage 3, we believe that the bi-directionality requirement should 
remain. We believe that by the time Stage 3 begins, the bi-directional 
components of immunization registry reporting will be ready. At the 
time of publication of this final rule with comment period, more than 
half of public health jurisdictions can support bi-directional 
messaging and the remaining public health jurisdictions are on their 
way to supporting the bi-directional capability. Therefore, we are 
finalizing this measure, with the modification that a provider's health 
IT system may layer additional information on the immunization history, 
forecast, and still successfully meet this measure.
    Proposed 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).
    In the Stage 3 proposed rule (80 FR 16764), we noted that this 
measure remains a policy priority because electronic syndromic 
surveillance is valuable for early detection of outbreaks, as well as 
monitoring disease and condition trends. We distinguished between EPs 
and eligible hospitals or CAHs reporting locations because, as 
discussed in the Stage 2 final rule, few public health agencies 
appeared to have the ability to accept non-emergency or non-urgent care 
ambulatory syndromic surveillance data electronically (77 FR 53979). We 
continued to observe differences in the infrastructure and current 
environments for supporting electronic syndromic surveillance data 
submission to public health agencies between eligible hospitals or CAHs 
and EPs. Because eligible hospitals and CAHs send syndromic 
surveillance data using different methods as compared to EPs, we 
defined slightly different exclusions for each setting as described 
later in this section.
    Proposed 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.
    Proposed 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.
    Comment: Many commenters noted that many jurisdictions are not able 
to receive ambulatory syndromic surveillance data and that the 
standards for reporting are vague. A commenter expressed concern that 
requiring a provider's system to be certified to the ambulatory 
standard does not provide value to the industry. Another commenter 
noted that for the few jurisdictions accepting syndromic surveillance 
data from ambulatory practices, the data that these jurisdictions are 
accepting are not data that is commonly considered syndromic 
surveillance data. A commenter noted that if data is being requested or 
collected for use cases beyond the standard syndromic surveillance 
definition, the requested or collected data should be used to report to 
proposed Measure 4: Public Health Reporting, not this measure.
    Response: We agree that few jurisdictions accept syndromic 
surveillance from non-urgent care eligible professionals and that at 
times the data that is collected may not be considered traditional 
syndromic surveillance data. For the EHR Incentive Programs in 2015 
through 2017, we continue to offer syndromic surveillance as an option 
for ambulatory care providers as a few jurisdictions are already 
accepting such data. Because syndromic surveillance reporting is more 
appropriate for urgent care settings and eligible hospitals/CAHs, we 
remove this measure for eligible professionals for Stage 3 with the 
exception of providers who are practicing in urgent care settings. For 
CAHs and eligible hospitals, we adopt this measure as proposed. We 
further note that as any provider for whom reporting is not possible, 
an exclusion is already available; therefore, the additional setting 
restriction within the measure language is duplicative and may cause 
confusion for providers who practice in multiple settings where the 
measure may have different relevance. We are therefore modifying the 
measure language and the exclusion to help clarify the measure for 
those reporting on the measure and the exclusion options for those who 
are not reporting on the measure.
    Proposed 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 proposed new reporting option was not part of Stage 2. The 
collection of electronic case reporting data greatly improves reporting 
efficiencies between providers and the public health agency. Public 
health agencies collect ``reportable, conditions'', as defined by the 
state, territorial, and local public health agencies, 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,

[[Page 62867]]

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 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 public health agencies and providers and can 
include structured questions or data fields to prompt the provider to 
supply additional required or care-relevant information.
    Proposed 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.
    Comment: For Measure 3, commenters overwhelmingly supported the 
need for electronic case reporting. Many comments expressed concern 
with the standards referenced and the immaturity to perform these 
functions, especially the ability of public health jurisdictions to 
accept data during the EHR Incentive program for 2015 through 2017. 
Some commenters noted their support for case reporting, including its 
potential impact on patient outcomes and the use of data elements for 
reporting. Another commenter supported the measure, but noted the 
importance of ensuring high quality data and sufficient funding for 
public health agencies to accept data transmissions.
    Response: We note that we did not finalize the case reporting 
option for the EHR Incentive Program in 2015 through 2017 to allow 
additional time for the development of the technology and 
infrastructure to support the measure. We also, as described elsewhere 
in this final rule with comment period and as noted in the Stage 2 
final rule, we did allow case reporting to continue to count under the 
specialized registry measure. For Stage 3, we do believe that case 
reporting should remain. However, to allow EPs, EHR vendors, and other 
entities adequate time to prepare for this new measure in Stage 3, this 
measure will not begin requiring electronic case reporting until 2018. 
By the 2018 year of Stage 3, we believe that the standards will be 
mature and that jurisdictions will be able to accept these types of 
data. Therefore, we finalize this measure as proposed to begin in 2018.
    Proposed Measure 4--Public Health Registry Reporting: The EP, 
eligible hospital, or CAH is in active engagement with a public health 
agency to submit data to public health registries.
    In the Stage 2 final rule, we were purposefully general in our use 
of the term ``specialized registry'' (other than a cancer registry) to 
encompass both registry reporting to public health agencies and 
clinical data registries in order to prevent inadvertent exclusion of 
certain registries through an attempt to be more specific (77 FR 
54030). In response to insight gained from the industry through 
listening sessions, public forums, and responses to the February 2014 
Public Health Reporting Request for Information, we proposed to carry 
forward the concept behind this broad category from Stage 2, but also 
proposed 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 proposed to 
define a ``public health registry'' as a registry that is administered 
by, or on behalf of, a local, state, territorial, or national public 
health agency and which collects data for public health purposes. While 
immunization registries are a type of public health registry, we 
proposed 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 reiterated 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 noted 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 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 proposed 
that EPs would have the option of counting cancer case reporting under 
the public health registry reporting measure. We noted 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.
    Proposed 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.

[[Page 62868]]

    Comment: Many commenters noted their support for public health 
registries. Commenters appreciated the flexibility and additional means 
to meet the measure, which they noted, aids specialists. Nearly all 
commenters expressed specific support for the Centralized Readiness 
Repository noting that it is essential for providers to determine if 
they can attest to the measure if they should take an exclusion. 
Commenters also noted the specific content that should be available 
within the Centralized Readiness Repository.
    Response: We appreciate the overall support for this measure. We 
agree that this measure offers flexibility for specialists and as other 
public health registry standards mature, additional options will be 
available. We also appreciate the support for the Centralized Readiness 
Repository and will make note of the specific requirements made by 
commenters, including the requirement for national as well as local and 
state public health registries.
    Comment: Some commenters noted that there were no public health 
registries available for their specialty or that their state may not be 
ready to receive data for the registries appropriate for them. 
Commenters were concerned that they would not be able to meet this 
measure because of a lack of public health registries available to 
them.
    Response: We appreciate the comments. We note that providers may 
exclude from the public health registry as noted in the exclusions if 
there are no public health registries available. Providers can still 
meet the overall objective by choosing other measures or excluding out 
of other measures.
    Comment: Many commenters noted that public health would not be 
providing data back as part of the public health registries.
    Response: We appreciate the comments on the bi-directional 
component of public health registries. We encourage associations to 
work with their public health colleagues to maximize the use of data 
flowing into, and out of, public health registries.
    Comment: Many commenters expressed concern that under the proposal, 
specialized registries included in the Stage 2 final rule would not be 
available as a measure option for eligible providers seeking to attest 
to Stage 3. A commenter noted that the addition of specific standards 
for reporting to public health registries and clinical data registries 
is a change from the specialized registry objective in Stage 2 and may 
pose a problem for states that already designated specialized 
registries in Stage 2. Another commenter expressed concern that without 
a special provision in place in Stage 3, some of the existing 
specialized registries would not meet the requirements for Stage 3.
    Response: We understand the concerns raised by these providers. The 
specialized registry provision included in the Stage 2 final rule was 
developed to provide additional flexibility to providers to choose a 
registry best suited for their practice. Many public health 
jurisdictions began to accept electronic case reporting and 
prescription drug monitoring during previous stages of meaningful use 
and these reporting options were considered specialized registries. We 
want to continue to encourage those providers who have already started 
down the path of reporting to a specialized registry as part of their 
participation in Stage 2. Therefore, we will allow such specialized 
registries to be counted for purposes of reporting to this objective in 
Stage 3 under the public health registry reporting measure for Stage 3 
in 2017, 2018 and subsequent years in the following manner: A provider 
may count a specialized registry if the provider achieved the phase of 
active engagement defined under Active Engagement Option 3: Production, 
including production data submission with the specialized registry in a 
prior year under the applicable requirements of the EHR Incentive 
Programs in 2015 through 2017. We do note that reporting to specialized 
registries does not require certification under the ONC Health IT 
Certification Program or adherence to specific implementation guides 
for reporting in 2015 through 2017, and we direct readers to section 
aII.B.2.b.x for further information on the Specialized Registry 
Reporting measure for 2015 through 2017.
    However we note that providers would not be able to count 
production reporting to a specialized registry under the Public Health 
Reporting Objective for 2015 through 2017, if there are standards and 
requirements referenced in the ONC 2015 Edition regulations for Public 
Health and Clinical Data Registry Stage 3 Measures:
     Example 1, EPs would not receive credit for cancer 
reporting under the Specialized Registry measure in Stage 3; rather the 
EPs would need to be in active engagement with the public health agency 
under the Public Health Registry Measure to submit cancer case data to 
the PHA using the standards mandated in the 2015 Edition Certification 
Criteria.
     Example 2, EPs would not receive credit for case reporting 
under the Specialized Registry measure in Stage 3 for production data 
submission that started in Modified Stage 2; rather the EPs would need 
to be in active engagement with the public health agency under the Case 
Reporting Measure using the standards mandated in the 2015 Edition 
Certification Criteria.
    In future years, as standards are developed and referenced in 
future ONC regulations, CMS may require further specialized registries 
to meet these future requirements under the ONC Health IT Certification 
Program.
    Proposed 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, in 
the Stage 3 proposed rule (80 FR 16766) we proposed 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 proposed 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.\20\ We proposed 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 public health agencies 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.
---------------------------------------------------------------------------

    \20\ https://download.ama-assn.org/resources/doc/cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.
---------------------------------------------------------------------------

    In the Stage 3 proposed rule, we reiterated that any EP, eligible 
hospital,

[[Page 62869]]

or CAH may report to more than one clinical data registry to meet the 
total number of required measures for this objective. We further noted 
that ONC will consider the adoption of standards and implementation 
guides in future rulemaking and should these 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.
    Proposed 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.
    Comment: Many commenters noted their support for clinical data 
registries. Commenters appreciated the flexibility and additional means 
to meet the measure, which they noted aids specialists. Nearly all 
commenters expressed specific support for the Centralized Readiness 
Repository noting that it is essential for providers to determine if 
they can attest to the measure of if they should take an exclusion. 
Commenters also noted the specific content that should be available 
within the Centralized Readiness Repository.
    Response: We appreciate the overall support for this measure. We 
agree that this measure offers flexibility for specialists and as other 
clinical data registry standards mature, additional options will be 
available. We also appreciate the support for the Centralized Readiness 
Repository and will make note of the specific requirements made by 
commenters, including the requirement for national as well as local and 
state public health registries.
    Comment: A commenter noted that since an increasing number of 
clinical data registries are national in scope and are essentially 
``borderless,'' it is unclear how CMS would define a provider's 
``jurisdiction.''
    Response: Our definition of jurisdiction here is general, and the 
scope may be local, state, regional or at the national level. The 
definition will be dependent on the type of registry to which the 
provider is reporting. A registry that is ``borderless'' would be 
considered a registry at the national level and would be included for 
purposes of this measure.
    Comment: Some commenters noted that there were no clinical data 
registries available for the specialty or that their state may not be 
ready to receive data for the registries appropriate for them. 
Commenters were concerned that they would not be able to meet this 
measure because of a lack of clinical data registries available to 
them.
    Response: We appreciate the comments. We note that providers may 
exclude from the clinical data registry as noted in the exclusions; if 
there are no clinical data registries available, providers can exclude 
from this measure. Providers can still meet the overall objective by 
choosing other measures or excluding out of other measures.
    Comment: Many comments noted that organizations hosting clinical 
data registries would not be providing data back as part of the 
measure.
    Response: We appreciate the comments on the bi-directional 
component of clinical data registries. We encourage all stakeholders to 
work with their clinical data registry colleagues to maximize the use 
of data flowing into, and out of, clinical data registries.
    Comment: Many commenters noted that better exclusion criteria 
should exist for providers in jurisdictions with limited options for 
reporting and in cases where registries are not able to receive data. A 
commenter suggested that CMS consider allowing exclusions for providers 
in states where electronic reporting is not possible. Other commenters 
noted that specialists and other providers who do not perform specific 
types of reporting should have better ways to exclude out of the 
applicable measures. Another commenter noted that for orthopedic 
surgeons, there are few clinical data registry reporting options.
    Response: We believe that the measure and associated exclusions 
that we have proposed provide a variety of options for providers to 
successfully attest or as appropriate be excluded from the measure. We 
note that the measure framework allows for multiple ways to achieve 
successful attestation under this objective, and allow for a provider 
to find a reporting option that works for them. For example, the public 
health agency and clinical data registry measure does not limit the 
provider to a predetermined list of reporting options. Rather, these 
two measures allow a provider to consider a broad array of reporting 
options available from public health agencies and clinical data 
registries and allows for reporting options developed in the future to 
be used to meet this measure. Considering the multiple ways and the 
flexibility included in this objective, we do not believe that 
additional exclusions are necessary. We believe that the requirements 
for exclusions under this objective strike the right balance to ensure 
that a provider seeking to exclude from a measure is unable to meet the 
requirements of the measure.
    Proposed 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 public health 
agencies is required for eligible hospitals and CAHs in Stage 2 (77 FR 
54021). We proposed to retain this measure for Stage 3 to promote the 
exchange of laboratory results between eligible hospitals/CAHs and 
public health agencies for improved timeliness, reduction of manual 
data entry errors, and more complete information.
    Proposed 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.
    Comment: For Measure 6, Electronic Reportable Laboratory Result 
Reporting, commenters agreed with the continuation of this measure, but 
requested that it also be included as an option for EPs with in-house 
laboratories.
    Response: We thank commenters for their support of this measure. 
However, we do not agree that this measure should be extended to EPs. 
We note that

[[Page 62870]]

in-house laboratories of EPs do not typically perform the types of 
tests that are reportable to public health jurisdictions. For example, 
many in-house laboratories focus on tests such as rapid strep tests 
that test for strep throat. The rapid strep tests are not reportable to 
public health agencies.
Use of CEHRT for 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 proposed to define it under 
Sec.  495.4 in the proposed rule and use the standards included in the 
2015 Edition proposed rule. 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 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 rulemaking.
    Comment: Many commenters requested clarification of the CEHRT 
specifications for each measure.
    Response: We thank the commenters for these comments and refer 
readers to section II.B.3 for a discussion of the definition of CEHRT 
and a table referencing the certification criteria required for each 
objective and measure for use in 2015 through 2017 and for Stage 3 in 
2017, 2018 and subsequent years.
    After consideration of public comment received, we are finalizing 
the objectives, measures, and exclusions as proposed except for the 
items previously discussed in this section. Specifically we are 
adopting modifications to include the 6 month lead time for the 
declaration of readiness for all exclusions for all 6 measures, to 
clarify the setting specificity for syndromic surveillance reporting, 
and to specify electronic case reporting, We are finalizing a total of 
6 measures for this objective, and EPs would be required to choose from 
measures 1 through 5, and would be required to successfully attest to 
any combination of two 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. We are 
finalizing that providers may attest to measure 4 and measure 5 more 
than once, and that an exclusion to a measure does not count toward the 
total in the manner proposed. The final objective and measures are as 
follows:
Objective 8: Public Health and Clinical Data Registry Reporting
    Objective: The EP, eligible hospital, or CAH is in active 
engagement with a public health agency or clinical data registry to 
submit electronic public health data in a meaningful way using 
certified EHR technology, except where prohibited, and in accordance 
with applicable law and practice.
    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).
    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 as of 6 
months prior to 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 an urgent care setting.
    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) Is not in a category of providers from 
which ambulatory syndromic surveillance data is collected by their 
jurisdiction's syndromic surveillance system; (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 as of 6 months prior to 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 as of 6 months prior to the start of the EHR 
reporting period.
    Measure 3--Electronic Case Reporting: The EP, eligible hospital, or 
CAH is in active engagement with a public health agency to submit case 
reporting of reportable conditions.
    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

[[Page 62871]]

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 as of 6 
months prior to 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.
    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 as of 6 months prior to the start 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.
    Proposed 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 as of 6 
months prior to the start 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.
    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 as of 6 months prior to the start of the EHR reporting 
period.
    We are adopting Objective 8: Public Health and Clinical Data 
Registry Reporting at Sec.  495.24(d)(8)(i) for EPs and Sec.  
495.24(d)(8)(ii) for eligible hospitals and CAHs. We further specify 
that in order to meet this objective and measures, an EP, eligible 
hospital, or CAH must use the capabilities and standards of as defined 
for as defined CEHRT at Sec.  495.4. We direct readers to section 
II.B.3 of this final rule with comment period for a discussion of the 
definition of CEHRT and a table referencing the capabilities and 
standards that must be used for each measure.

   Table 10--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
                                             objective     for eligible
                                              for 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                      2               4
 Reporting*.............................
Measure 5--Clinical Data Registry                      2               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. A specialized registry to which the EP, eligible
  hospital or CAH reported using Active Engagement Option 3: Production
  in a prior year under the EHR Incentive Programs in 2015 through 2017
  public health reporting objective may also count toward the measure in
  2017, 2018 and subsequent years.
** 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.

3. Certified EHR Technology (CEHRT) Requirements
a. CEHRT Definition for the EHR Incentive Programs
    The definition of CEHRT establishes the requirements for EHR 
technology that must be used by providers to meet the meaningful use 
objectives and measures. The Stage 2 final rule requires that CEHRT 
must be used by EPs, eligible hospitals, and CAHs to satisfy their CQM 
reporting requirements in the Medicare and Medicaid EHR Incentive 
Programs. In addition, the CQM data reported to CMS must originate from 
EHR technology that is certified to ``capture and export'' in 
accordance with 45 CFR 170.314(c)(1) and ``electronic submission'' in 
accordance with 45 CFR 170.314(c)(3) (77 FR 54053). Certified EHR 
technology is defined for the Medicare and Medicaid EHR Incentive 
Programs at 42 CFR 495.4 and previously referenced ONC's definition of 
CEHRT in 45 CFR 170.102.

[[Page 62872]]

    In the Stage 3 proposed rule 80 FR 16767, rather than establishing 
a specific CEHRT definition for the EHR Incentive Programs in the ONC 
2015 Edition proposed rule, we instead proposed to define the term 
``Certified EHR Technology'' at Sec.  495.4. This proposed change is 
designed to simplify the overall regulatory relationship between ONC 
and CMS rules for stakeholders and to ensure that relevant CMS policy 
for the Medicare and Medicaid EHR Incentive Programs is clearly defined 
in CMS regulations.
    We also proposed that providers must use EHR technology certified 
at least to the 2014 Edition in 2016 and 2017. We further proposed that 
providers may adopt EHR technology certified to the 2015 Edition prior 
to the beginning of Stage 3 in 2017 or 2018, and that technology could 
be used to satisfy the definition of CEHRT under Sec.  495.4 to 
demonstrate meaningful use (80 FR 16767 through 16768).
    Comment: Some commenters suggested potential changes to the 
certification program. Some commenters suggested the current EHR 
incentive programs mandate the use of certified EHRs that incorporate 
draft standards to support program requirements, including the exchange 
of health information among clinicians and the format of the content 
exchanged. Inconsistency in the implementation of the standards by 
vendors has led to confusion and limited provider success in meeting 
regulatory requirements for information exchange. For example, Stage 2 
of meaningful use established a reliance on the ``direct protocol,'' a 
new standard to support the sharing of information. As a result of 
inconsistent implementation among EHR vendors, the ability to use the 
direct protocol standard to enable information exchange varies. For 
example, providers are required to use the C-CDA standard to send 
patient care summaries in a structured template. However, the C-CDA has 
proved difficult to use and has not met clinical needs to share 
pertinent information to support care. Finally, one commenter stated 
that given the complexity of the objectives proposed under Stage 3, we 
believe meaningful use of EHRs can only be achieved if and when data 
captured in various EHRs and other data systems are interoperable.
    Response: We refer commenters to the ONC 2015 Edition certification 
criteria final rule published elsewhere in this Federal Register for 
the established standards for certified health IT (see also the 2015 
Edition proposed rule at 80 FR 16813 through 16872). We note that in 
the Stage 2 rule we adopted multiple options for HIE transport, and in 
this final rule with comment period, we have further expanded the 
mechanisms by which a provider can send and receive a C-CDA. We 
maintain that the C-CDA standard is required, and that a single C-CDA 
standard serves to support the interoperable exchange of health 
information.
    Comment: Many commenters supported the proposal to allow providers 
to upgrade to the 2015 Edition at their own pace with an allowance for 
early upgrades in 2016 and 2017. Commenters noted that with the modular 
certification process, providers may be able to update parts of systems 
beginning in late 2016 so the allowance for technology certified to a 
combination of Editions is necessary. Most commenters noted that, given 
the timing, it is unlikely that technology certified to the 2015 
Edition will be widely available in time to participate in Stage 3 in 
2017 and expressed support of the flexibility to select a stage in 
2017. Other commenters expressed concern citing the same reasons and 
noted that the time between publication and implementation of the 
requirements of the Stage 3 final rule is too short to require 2015 
Edition and Stage 3 in 2017. Some commenters suggested that 18 months 
is required for the transition and suggested making Stage 3 optional in 
2018 or further delaying Stage 3 to support the upgrade timing.
    Response: We thank the commenters for their input and agree that 
the shift should allow for greater flexibility in the upgrade process 
for developers and providers. We note that we have changed the EHR 
reporting period in 2017 to 90 days for providers who choose to 
participate in Stage 3, which allows a longer time frame between the 
publication of the final rules and implementation of systems capable of 
supporting the Stage 3 objectives and measures. We also note that many 
of the standards required for Stage 3 are similar or the same in 2014 
and 2015 Edition certification criteria. Finally, we reiterate the 
requirement that providers use the 2015 Edition in 2018 to meet the 
requirements for Stage 3 for an EHR reporting period in 2018 and note 
that this timing also allows more than 24 months to the requirement to 
use technology certified to the 2015 Edition for an EHR reporting 
period in 2018.
    Comment: Some commenters expressed support for our decision to move 
the CEHRT definition from the ONC certification criteria rules to the 
EHR Incentive Programs rule. Other commenters expressed concern 
regarding whether moving the CEHRT definition to the Stage 3 rule would 
increase confusion. A commenter noted that the Stage 3 proposed rule 
reference to ``certified EHR technology'' conflicts with use of the 
term ``health information technology'' in the 2015 Edition proposed 
rule.
    Several commenters addressed proposals specific to the Health IT 
Certification Program, the scope and focus of the certification 
criteria and standards for health IT under consideration by the ONC, 
testing of health IT systems presented for certification to ONC, and 
the specifics on how the newly created interoperability standards apply 
to the certification process.
    Response: CMS, in consultation with ONC, believes that placing the 
CEHRT definition in the Stage 3 rule increases the simplicity of the 
rule. We do not believe that moving the CEHRT definition will lead to 
program confusion. Rather, by placing the requirements of the CEHRT 
definition within the rule that it impacts--the Stage 3 rule--we avoid 
confusion regarding the scope of the CEHRT definition (which is limited 
to EHR Incentive Program participants) and the broader scope of the ONC 
Health IT Certification Program (which applies to EHR Incentive Program 
participants and others, and may be used by other HHS programs). We 
believe that placing the CEHRT definition within the Stage 3 rule is 
appropriate and CMS will continue to work closely with ONC on the 
certification requirements that would be needed to support the 
objectives and measures of the EHR Incentive Programs. In addition, we 
are committed to releasing educational materials that will ease the 
transition related to the move of the CEHRT definition and, as 
requested by many commenters, have included a chart that outlines the 
certification criteria that will support providers who intend to attest 
to Stage 3 of meaningful use.
    Regarding references in to ``health IT,'' we do not agree that the 
use of the term ``health IT'' and the use of the term ``certified EHR 
technology'' is evidence of a disconnect between the Stage 3 and the 
ONC Health IT Certification Program. Rather, certified EHR technology 
is one type of health IT and is mandated required by the HITECH Act as 
part of for purposes of meeting attestation requirements and becoming a 
meaningful user. The ONC Health IT Certification Program and the 
associated 2015 Edition final rule provides certification criteria and 
standards integral to the CEHRT definition for Stage 3, but also is 
designed to address the needs of a broader set of settings that

[[Page 62873]]

use health IT functionality beyond the requirements of the CEHRT 
definition.
    Finally, comments related to the specific certification criteria 
proposed in the 2015 Edition proposed rule are outside the scope of 
this rulemaking. We direct commenters to the 2015 Edition proposed rule 
published on March 30, 2015. (80 FR 16804 through 16921) and the 2015 
Edition final rule published elsewhere in this Federal Register.
    After consideration of public comments received, we are finalizing 
the provision to include a full EHR Incentive Programs specific 
definition of CEHRT at 495.4 as proposed.
b. Defining CEHRT for 2015 Through 2017
    In adopting a CEHRT definition specific for the EHR Incentive 
Programs, we proposed in the EHR Incentive Programs in the Stage 3 
proposed rule 80 FR 16767 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 referred readers to ONC's 
2015 Edition proposed rule for the proposed 2015 Edition Base EHR 
definition and a discussion of the 2014 Edition Base EHR definition. We 
included the Base EHR definition(s) because, as ONC explained in the 
2014 Edition certification final rule (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 Public Health Service Act 
(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 includes additional 
capabilities as proposed by ONC that we agreed 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 to support interoperable health information exchange.
    We also proposed 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. We stated that 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 that meet the 
requirements for the objectives and measures or if they fully upgrade 
during an EHR reporting period.
    Additionally, because ONC proposed, 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 
proposed 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. In the EHR 
Incentive Program in the Stage 3 proposed rule, we noted 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 
explained that 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 sought comments on 
the accuracy of the identified available options. We received the 
following comments and our responses follow:
    Comment: Some commenters expressed concern that there is a 
misalignment between the requirements of the ONC Health IT 
Certification Program and the objectives and measures of Stage 3. 
Specifically, the commenter noted that though the automated numerator 
recording and measure calculation are not required for a module to be 
certified to the 2015 Edition, it is required for Stage 3.
    Response: The automated numerator recording and measure calculation 
are not requirements of modules seeking certification under the 2015 
Edition final rule. However, this does not represent a misalignment 
between the ONC Health IT Certification Program and the EHR Incentive 
Programs. Rather, the two criteria are required for purposes of meeting 
meaningful use, but may not be necessary for other users of the ONC's 
Health IT Certification Program. For example, a non-EHR Incentive 
Program provider using technology certified by the ONC Health IT 
Certification Program to meet requirements of CMS' chronic care 
management program would not need the automated numerator recording and 
measure calculation. ONC has sought to avoid requiring non-EHR 
Incentive Program participants to possess technology with the criteria 
previously stated in this final rule with comment period. Therefore, 
the 2015 Edition proposed and final rule includes the criteria for 
developers who intend to certify their products for use by EHR 
Incentive Program providers, but it does not make such criteria 
requirements for all technology certified under the ONC Health IT 
Certification Program.
    Comment: Some commenters requested clarification on whether 2014 
Edition or 2015 Edition (or both) could be used to attest to meaningful 
use in 2015 through 2017.
    Response: We clarify as follows:
    For EHR reporting periods in 2017:
     A provider who has technology certified to the 2015 
Edition may attest to Stage 3 or to the modified Stage 2 requirements 
identified elsewhere in this rule.
     A provider who has technology certified to a combination 
of 2015 Edition and 2014 Edition may attest to: (1) The modified Stage 
2 requirements; or (2) potentially to the Stage 3 requirements if the 
mix of certified technologies would not prohibit them from meeting the 
Stage 3 measures.
     A provider who has technology certified to the 2014 
Edition only may attest to the modified Stage 2 requirements and may 
not attest to Stage 3.
    For EHR reporting periods in 2018:
     All providers must use technology certified to the 2015 
Edition to meet Stage 3 requirements.
    Comment: Commenters expressed concern that it is unclear whether 
technology that is certified only to the Base EHR definition is 
adequate for purposes of attesting to meaningful use. Another commenter 
suggested that the ``Base certified EHRs'' should be fully capable of 
meeting the needs of an EHR Incentive Program participant, without 
having to--for example--purchase add-ons, interfaces, or pay for 
reporting. Some commenters noted that requiring providers to attest to 
meaningful use using technology certified to the 2015 Edition Base EHR 
definition will result in providers having to possess software that is 
not necessary to that provider achieving meaningful use.
    Response: Technology that is certified only to the Base EHR 
definition would not be adequate for purposes of attesting to 
meaningful use in any EHR reporting

[[Page 62874]]

period. We agree that the components of the Base EHR definition 
proposed in the 2015 Edition proposed rule are integral to attesting to 
meaningful use and include a variety of criteria including, among 
others, criteria related to demographics, CPOE, medication allergy 
lists and data portability. However, the Base EHR definition does not 
include criteria related to items such as public health reporting, 
electronic prescribing, and drug-drug/drug-allergy, checks--which also 
are integral to attest to meaningful use.
    The Base EHR definition is designed to include specific criteria 
that would apply to a broad cross section of developers seeking to 
support provider needs. The Base EHR definition is not designed solely 
for the use of the EHR Incentive Programs. For this reason, a product 
that a provider seeks to use to attest to meaningful use must be 
certified to the Base EHR definition and additional criteria that is 
determined by (a) the requirements of this CEHRT definition and (b) the 
specific objectives and measures the provider intends to use to meet 
meaningful use. Therefore, we do not believe it is appropriate to limit 
the CEHRT definition to the criteria included in ONC's Base EHR 
definition.
    In this final rule with comment period, we have specifically 
identified the privacy and security certification criteria that EHR 
technology must be certified to meet the CEHRT definition for any 
federal fiscal year or calendar year before 2018, when an EP, eligible 
hospital, or CAH is using EHR certified to both the 2014 Edition and 
2015 Edition to meet the definition.
    We proposed provisions in the CEHRT definition for any federal 
fiscal year or calendar year before 2018 that would permit the use of a 
mix of EHR technology certified to 2014 and 2015 editions. This was 
designed to account for providers upgrading from EHR technology 
certified to the 2014 Edition to the 2015 Edition to meet the 
requirements of the CEHRT definition for 2018 and subsequent years 
(i.e., the use of EHR technology only certified to the 2015 Edition). 
In most instances, providers will have certified privacy and security 
capabilities because these capabilities are part of the 2014 Edition 
Base EHR definition. The proposal also took into account that the 
adoption of EHR technology certified to the 2015 Edition would likely 
include most, if not, all relevant privacy and security capabilities. 
For example, EHR technology certified only to the 2015 Edition CPOE-
order medications criterion will also be required to be certified to 
the 2015 Edition versions of all privacy and security criteria included 
in the 2014 Edition Base EHR definition, expect the ``integrity'' 
criterion.
    Our proposal did not, however, account for the unlikely, but 
plausible, scenario where a new entrant to the EHR Incentive Programs 
in 2016 or 2017 was able to meet the CEHRT definition for a federal 
fiscal year or calendar year before 2018 with EHR technology only or 
mostly certified to the 2014 Edition that did not include the requisite 
privacy and security capabilities which are part of the 2014 Base EHR 
definition. Therefore, we have specifically included privacy and 
security certification criteria in the definition to guard against this 
possibility.
    We note that we encourage providers to work closely with their 
developers to determine what compilation of technology certified under 
the ONC Health IT Certification Program would allow the provider to 
successfully attest to meaningful use in an EHR reporting period 
covered under this rule. We also have provided a chart of the 
technology that would be required for a provider seeking to attest to 
an objective or measure (See Table 2, 80 FR 16810 through 16811). In 
addition, we encourage providers to review the Web site of the ONC 
Health IT Certification Program and the Certified Health IT Products 
List (CHPL), which include real time information on what products are 
certified for what functionalities (see www.healthit.gov).
    We note that some commenters expressed concern regarding fraudulent 
statements and claims regarding the technology offered to meet 
meaningful use. We encourage providers to use the CHPL as a resource 
for identifying whether a product is certified and to contact ONC if 
fraudulent activity is suspected.
    After consideration of public comments received, we are finalizing 
and adopting this provision without modification at Sec.  495.4.
c. Defining CEHRT for 2018 and Subsequent Years
    In the Stage 3 proposed rule at 80 FR 16767, we proposed 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 to 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:
     Record or create and incorporate family health history;
     Capture patient health information such as advance 
directives;
     Record numerators and denominators for meaningful use 
objectives with percentage-based measures and calculate the 
percentages;
     Calculate and report clinical quality measures; and
     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, we referred readers to the 2015 Edition 
proposed rule. We noted that 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.
    Comment: We received a variety of comments on these proposals. Some 
commenters agreed that technology certified to the 2015 Edition would 
be developed and could be implemented by providers by 2018. Other 
commenters expressed their concern that requiring providers to attest 
to Stage 3 using 2015 Edition technology in 2018 was not realistic, and 
did not account for the new technology that needed to be developed to 
support the objectives and measures in Stage 3.
    Some commenters requested that providers in 2018 be allowed to use 
technology certified to the 2014 Edition and the 2015 Edition to meet 
Stage 3 requirements. A commenter expressed a concern that requiring 
use of 2015 Edition in 2018 may be problematic for certain providers 
that need radiation oncology EHR products. The commenter requested that 
the 2018 year be a flex year as well as 2017. Another commenter 
suggested that making the 2015 Edition optional in 2017 could create 
confusion and that we should simply adopt a single edition.
    Response: We note that 2017 provides a flex year for providers to 
fully implement their CEHRT. Extending the flex year beyond 2017 would 
slow provider progression to updated technology that better enables 
interoperability, care coordination, and health information exchange. 
We appreciate commenters concerns regarding whether technology 
certified to the 2015 Edition would be ready in 2018. Developers have 
noted that between 18 or 24 months is the necessary to develop and 
implement health IT technology. With the finalization of this final 
rule with

[[Page 62875]]

comment period, developers and providers will have more than 24 months 
to develop and implement 2015 Edition technology required by this final 
rule with comment period.
    Further, we note that many of the requirements of Stage 3 are 
similar to those of Stage 2 and would use the same certification 
criteria with slight updates to vocabulary standards. For those 
criteria that are new to meaningful use in Stage 3 or for which 
significant updates are required, we agree with developers who confirm 
that 18 to 24 months provide enough time to develop and implement 
certified technology for purposes of meaningful use. We refer readers 
to section III.A. Table 2 of the ONC 2015 Edition Certification 
Criteria final rule published elsewhere in this Federal Register for 
further information on the differences between 2014 Edition and 2015 
Edition criteria.
    We further note that 2018 is the required year for the use of 2015 
Edition and for attesting to Stage 3. We proposed and are finalizing in 
this rule a 2017 flex year that allows providers options in the edition 
of CEHRT used and the stage of meaningful use to which the provider 
attests. This flexibility is in place in recognition of the 
implementation needed for technology. However, by 2018, all providers 
will be required to attest to Stage 3 using 2015 Edition technology.
    Comment: Some commenters requested clarification on if a provider 
would be required to be certified to technology needed for measures the 
provider does not intend to use for attestation or if there is a 
specific certification requirement for certain specialties.
    Response: ONC certifies products not by specialty, but by each 
specific functionality. In some cases, intended impatient or ambulatory 
use may be a factor in the product a provider chooses to possess. 
Beyond this distinction, the definition of CEHRT includes the 
requirements specific to each measure which may be independently 
certified and a provider may not be required to obtain and use 
functions for which they do not intend to attest. We recognize that 
there are multiple permutations that could lead to a successful 
attestation under the EHR Incentive Programs. For example, a provider 
may decide to attest to the modified Stage 2 or Stage 3 Public Health 
measure using reporting options other than syndromic surveillance 
reporting. In such a case, the provider would not need to possess 
technology certified to ONC's ``Transmission to Public Health 
Agencies--Syndromic Surveillance Criterion''. In contrast, in Stage 3, 
some objectives require a provider to attest to all three measures but 
only successfully meet the thresholds of two of the three measures. For 
such objectives, a provider would need to possess certified technology 
for all three measures for purposes of attesting. We further note that 
in the case of a provider that meets the exclusions of a measure, the 
provider is not required to possess technology to meet that measure.
    We caution providers to carefully make determinations regarding the 
technology they will need to attest to meaningful use and encourage 
providers to work closely with their developers to ensure that the 
technology they possess will meet their attestation needs. Please refer 
to Tables 11 through 16, which we have developed in conjunction with 
ONC of the technology requirements that support the CEHRT definition 
and each measure in section II.B.3.(d). of this final rule with comment 
period.
    We also note that the CEHRT definition provides a baseline of 
functionality, but a provider may choose to possess technology that 
goes beyond the requirements of this CEHRT definition. We encourage 
providers to review products available to meet their needs and to 
review the Certified Health IT Products List that is available online 
at www.healthit.gov.
    Comment: Some commenters suggested that providers should not be 
required to possess technology that is certified to record or create 
and incorporate family health history.
    Response: We do not agree. Family health history is an integral 
component in the provision of care and the criterion supports the 
intake of such data into a provider's health IT system. As a result, 
care coordination between providers and between providers and patients 
is improved and accessible. The CEHRT definition includes the baseline 
of functionality that we believe is necessary to provide better care, 
advance care coordination, and support interoperability. Requiring a 
provider to have a system that is able to capture family health history 
or other patient information (such as advanced directives) is a 
foundational element of health IT that we will continue to support. For 
this reason, we decline to remove family health history or the 
requirement to capture patient health information from the CEHRT 
definition.
    Comment: A commenter recommended that the ability to automatically 
query an HIE and retrieve a summary of care document be part of the 
definition of CERT. Many current systems rely on an EP to download a 
summary of care document from an external portal and then manually 
upload it into their EHR.
    Response: This was not a separate functionality that we proposed to 
be part of the CEHRT definition, and we do not intend to adopt this 
suggestion as part of the CEHRT definition. However, we did propose 
that to meet the CEHRT definition a provider must have technology 
certified to the ``Transitions of Care'' certification criterion (45 
CFR 170.315(b)(1)). The criterion requires that technology be capable 
of sending and receiving a C-CDA. We believe this will support a 
provider's ability to electronically exchange interoperable health 
information.
    After consideration of public comments received, we are finalizing 
and adopting this provision as proposed at Sec.  495.4.
d. Final Definition of CEHRT
    To facilitate readers identifying the requirements of CEHRT for 
each objective and measure defined in sections II.B.2.a and II.B.2.b of 
this final rule with comment period, ONC and CMS have developed a set 
of tables providing the appropriate certification criteria reference 
under the 2014 Edition and 2015 Edition certification criteria for the 
objectives and measures of meaningful use. These tables are provided 
for references purposes and reflect the definition of CEHRT adopted at 
Sec.  495.4 for each year. We note that providers must also have the 
capabilities defined at Sec.  495.4 for clinical quality measures 
(1)(ii)(B) or (2)(ii)(B), privacy and security (1)(ii)(C) or (2), and 
the certification criteria that are necessary to be a Meaningful EHR 
User (1)(ii)(D) or (2)(ii)(A).

[[Page 62876]]



                                   Table 11--EP Objectives, Measures, and Certification Criteria for 2015 Through 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                         Additional
            Objective                      Measure(s)                    2014 edition                       2015 edition               considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Objective 1: Protect Patient       Measure: Conduct or        The requirements are included in   The requirements are a part of     The requirements are
 Health Information.                review a security risk     the Base EHR Definition.           CEHRT specific to each             a part of CEHRT
                                    analysis in accordance                                        certification criterion.           specific to each
                                    with the requirements in                                                                         certification
                                    45 CFR 164.308(a)(1),                                                                            criterion.
                                    including addressing the
                                    security (to include
                                    encryption) of ePHI
                                    created or maintained in
                                    Certified EHR Technology
                                    in accordance with
                                    requirements in 45 CFR
                                    164.312(a)(2)(iv) and 45
                                    CFR 164.306(d)(3), and
                                    implement security
                                    updates as necessary and
                                    correct identified
                                    security deficiencies as
                                    part of the EP's risk
                                    management process.
Objective 2: Clinical Decision     Measure 1: Implement five  Sec.   170.314(a)(8) (Clinical     Sec.   170.315(a)(9) (Clinical     N/A.
 Support.                           clinical decision          Decision Support).                 Decision Support).
                                    support interventions
                                    related to four or more
                                    clinical quality
                                    measures at a relevant
                                    point in patient care
                                    for the entire EHR
                                    reporting period.
                                   Measure 2: The EP has      Sec.   170.314(a)(2) (Drug-drug,   Sec.   170.315(a)(4) (Drug-drug,   N/A.
                                    enabled and implemented    Drug-Allergy Interaction Checks).  Drug-Allergy Interaction Checks
                                    the functionality for                                         for CPOE).
                                    drug-drug and drug-
                                    allergy interaction
                                    checks for the entire
                                    EHR reporting period.
Objective 3: Computerized          Measure 1: More than 60%   Sec.   170.314(a)(1)               Sec.   170.315(a)(1)               N/A.
 Provider Order Entry CPOE.         of medication orders       (Computerized Provider Order       (Computerized Provider Order
                                    created by the EP during   Entry) or                          Entry--Medications).
                                    the EHR reporting period  Sec.   170.314(a)(18) (Optional--
                                    are recorded using CPOE.   Computerized Provider Order
                                                               Entry--Medications).
                                   Measure 2: More than 30%   Sec.   170.314(a)(1)               Sec.   170.315(a)(2)               N/A.
                                    of laboratory orders       (Computerized Provider Order       (Computerized Provider Order
                                    created by the EP during   Entry) or                          Entry--Laboratory).
                                    the EHR reporting period  Sec.   170.314(a)(19) (Optional--
                                    are recorded using CPOE.   Computerized Provider Order
                                                               Entry--Laboratory).
                                   Measure 3: More than 30%   Sec.   170.314(a)(1)               Sec.   170.315(a)(3)               N/A.
                                    of radiology orders        (Computerized Provider Order       (Computerized Provider Order
                                    created by the EP during   Entry) or                          Entry--Diagnostic Imaging).
                                    the EHR reporting period  Sec.   170.314(a)(20) (Optional--
                                    are recorded using CPOE.   Computerized Provider Order
                                                               Entry--Diagnostic Imaging).
Objective 4: Electronic            Measure: More than 50% of  Sec.   170.314(b)(3) (Electronic   Sec.   170.315(b)(3) (Electronic   EPs may use a
 Prescribing.                       all permissible            Prescribing).                      Prescribing).                      combination of
                                    prescriptions written by  Sec.   170.314(a)(10) (Drug-       Sec.   170.315(a)(10) (Drug-        technologies
                                    the EP are queried for a   Formulary and Preferred Drug       Formulary and Preferred Drug       certified to either
                                    drug formulary and         List Checks).                      List Checks).                      the 2014 Edition or
                                    transmitted                                                                                      2015 Edition.
                                    electronically using
                                    CEHRT.
Objective 5: Health Information    Measure: The EP that       Sec.   170.314(b)(2) (Transitions  Sec.   170.315(b)(1) (Transitions  N/A.
 Exchange.                          transitions or refers      of Care-Create and Transmit        of Care).
                                    their patient to another   Transition of Care/Referral
                                    setting of care or         Summaries) or
                                    provider of care (1)      Sec.   170.314(b)(8) (Optional--
                                    uses CEHRT to create a     Transitions of care).
                                    summary of care record;
                                    and (2) electronically
                                    transmits such summary
                                    to a receiving provider
                                    for more than 10% of
                                    transitions of care and
                                    referrals.
Objective 6: Patient-Specific      Measure: Patient-specific  Sec.   170.314(a)(15) (Patient-    Sec.   170.315(a)(13) (Patient-    N/A.
 Education.                         education resources        Specific Education Resources).     Specific Education Resources).
                                    identified by CEHRT are
                                    provided to patients for
                                    more than 10% of all
                                    unique patients with
                                    office visits seen by
                                    the EP during the EHR
                                    reporting period.
Objective 7: Medication            Measure: The EP performs   Sec.   170.314(b)(4) (Clinical     Sec.   170.315(b)(2) (Clinical     N/A.
 Reconciliation.                    medication                 Information Reconciliation) or     Information Reconciliation and
                                    reconciliation for more   Sec.   170.314(b)(9) (Optional--    Incorporation).
                                    than 50% of transitions    Clinical Information
                                    of care in which the       Reconciliation and
                                    patient is transitioned    Incorporation).
                                    into the care of the EP.
Objective 8: Patient Electronic    Measure 1: More than       Sec.   170.314(e)(1) (View,        Sec.   170.315(e)(1) (View,        N/A.
 Access (VDT).                      50%of all unique           Download, and Transmit to 3rd      Download, and Transmit to 3rd
                                    patients seen by the EP    Party).                            Party).
                                    during the EHR reporting
                                    period are provided
                                    timely access to view
                                    online, download, and
                                    transmit to a third
                                    party their health
                                    information subject to
                                    the EP's discretion to
                                    withhold certain
                                    information.

[[Page 62877]]

 
                                   Measure 2: For 2015 and    Sec.   170.314(e)(1) (View,        Sec.   170.315(e)(1) (View,        N/A.
                                    2016: At least one         Download, and Transmit to 3rd      Download, and Transmit to 3rd
                                    patient seen by the EP     Party).                            Party).
                                    during the EHR reporting
                                    period (or his or her
                                    authorized
                                    representatives) views,
                                    downloads, or transmits
                                    his or her health
                                    information to a third
                                    party, during the EHR
                                    reporting period.
                                   For 2017: More than 5
                                    percent of unique
                                    patients seen by the EP
                                    during the EHR reporting
                                    period (or their
                                    authorized
                                    representatives) views,
                                    downloads, or transmits
                                    their health information
                                    to a third party, during
                                    the EHR reporting period.
Objective 9: Secure Messaging....  Measure: For 2015: During  Sec.   170.314(e)(3) (Secure       Sec.   170.315(e)(2) (Secure       N/A.
                                    the EHR reporting period   Messaging).                        Messaging).
                                    the capability for
                                    patients to send and
                                    receive a secure
                                    electronic message with
                                    the EP was fully enabled.
                                   For 2016: For at least 1
                                    patient 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 the patient-
                                    authorized
                                    representative), or in
                                    response to a secure
                                    message sent by the
                                    patient (or the patient-
                                    authorized
                                    representative) during
                                    the EHR reporting period.
                                   For 2017: For more than 5
                                    percent of 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 the patient-
                                    authorized
                                    representative), or in
                                    response to a secure
                                    message sent by the
                                    patient (or the patient-
                                    authorized
                                    representative) during
                                    the EHR reporting period.
Objective 10: Public Health        Measure 1--Immunization    Sec.   170.314(f)(1)               N/A..............................  N/A.
 Reporting.                         Registry Reporting.        (Immunization Information) and
                                                              Sec.   170.314(f)(2)
                                                               (Transmission to Immunization
                                                               Registries).
                                   Measure 2--Syndromic       Sec.   170.314(f)(3)               Sec.   170.315(f)(2)               N/A.
                                    Surveillance Reporting.    (Transmission to Public Health     (Transmission to Public Health
                                                               Agencies--Syndromic                Agencies--Syndromic
                                                               Surveillance) or                   Surveillance) Urgent Care
                                                              Sec.   170.314(f)(7) (Optional--    Settings Only.
                                                               Ambulatory Setting Only--
                                                               Transmission to Public Health
                                                               Agencies--Syndromic
                                                               Surveillance).
                                   Measure 3--Specialized     Sec.   170.314(f)(5) (Optional--   EPs may choose one or more of the  Certified EHR
                                    Registry Reporting.        Ambulatory Setting Only--Cancer    following:                         technology is not
                                                               Case Information) and             Sec.   170.315(f)(5)                required for
                                                              Sec.   170.314(f)(6) (Optional--    (Transmission to Public Health     specialized
                                                               Ambulatory Setting Only--          Agencies--Electronic Case          registry reporting
                                                               Transmission to Cancer             Reporting).                        for 2015-2017, but
                                                               Registries).                      Sec.   170.315(f)(7) Transmission   EHR technology
                                                                                                  to Public Health Agencies--        certified to the
                                                                                                  Health Care Surveys.               2014 Edition or
                                                                                                 Sec.   170.315(f)(4) Transmission   2015 Edition may be
                                                                                                  to Cancer Registries.              used.
                                                                                                                                    Other non-named
                                                                                                                                     specialized
                                                                                                                                     registries
                                                                                                                                     unsupported by
                                                                                                                                     certification
                                                                                                                                     requirements may
                                                                                                                                     also be chosen.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 62878]]


   Table 12--Eligible Hospital and CAH Objectives, Measures, and Certification Criteria for 2015 through 2017
----------------------------------------------------------------------------------------------------------------
                                                                                                  Additional
            Objective                 Measure(s)         2014 Edition        2015 Edition       considerations
----------------------------------------------------------------------------------------------------------------
Objective 1: Protect Patient      Measure: Conduct    The requirements    The requirements    The requirements
 Health Information.               or review a         are included in     are a part of       are a part of
                                   security risk       the Base EHR        CEHRT specific to   CEHRT specific to
                                   analysis in         Definition.         each                each
                                   accordance with                         certification       certification
                                   the requirements                        criterion.          criterion.
                                   in 45 CFR
                                   164.308(a)(1),
                                   including
                                   addressing the
                                   security (to
                                   include
                                   encryption) of
                                   data stored in
                                   CEHRT in
                                   accordance with
                                   requirements in
                                   45 CFR
                                   164.312(a)(2)(iv)
                                   and 45 CFR
                                   164.306(d)(3),
                                   and implement
                                   security updates
                                   as necessary and
                                   correct
                                   identified
                                   security
                                   deficiencies as
                                   part of the
                                   eligible hospital
                                   or CAH's risk
                                   management
                                   process.
Objective 2: Clinical Decision    Measure 1:          Sec.                Sec.                N/A.
 Support.                          Implement five      170.314(a)(8)       170.315(a)(9)
                                   clinical decision   (Clinical           (Clinical
                                   support             Decision Support).  Decision Support).
                                   interventions
                                   related to four
                                   or more clinical
                                   quality measures
                                   at a relevant
                                   point in patient
                                   care for the
                                   entire EHR
                                   reporting period.
                                  Measure 2: The      Sec.                Sec.                N/A.
                                   eligible hospital   170.314(a)(2)       170.315(a)(4)
                                   or CAH has          (Drug-drug, Drug-   (Drug-drug, Drug-
                                   enabled and         Allergy             Allergy
                                   implemented the     Interaction         Interaction
                                   functionality for   Checks).            Checks for CPOE).
                                   drug-drug and
                                   drug-allergy
                                   interaction
                                   checks for the
                                   entire EHR
                                   reporting period.
Objective 3: Computerized         Measure 1: More     Sec.                Sec.                N/A.
 Provider Order Entry CPOE.        than 60% of         170.314(a)(1)       170.315(a)(1)
                                   medication orders   (Computerized       (Computerized
                                   created by          Provider Order      Provider Order
                                   authorized          Entry) or           Entry--Medication
                                   providers of the   Sec.                 s).
                                   eligible            170.314(a)(18)
                                   hospital's or       (Optional--Comput
                                   CAH's inpatient     erized Provider
                                   or emergency        Order Entry--
                                   department (POS     Medications).
                                   21 or 23) during
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.
                                  Measure 2: More     Sec.                Sec.                N/A.
                                   than 30% of         170.314(a)(1)       170.315(a)(2)
                                   laboratory orders   (Computerized       (Computerized
                                   created by          Provider Order      Provider Order
                                   authorized          Entry) or           Entry--Laboratory
                                   providers of the   Sec.                 ).
                                   eligible            170.314(a)(19)
                                   hospital's or       (Optional--Comput
                                   CAH's inpatient     erized Provider
                                   or emergency        Order Entry--
                                   department (POS     Laboratory).
                                   21 or 23) during
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.
                                  Measure 3: More     Sec.                Sec.                N/A.
                                   than 30% of         170.314(a)(1)       170.315(a)(3)
                                   radiology orders    (Computerized       (Computerized
                                   created by          Provider Order      Provider Order
                                   authorized          Entry) or           Entry--Diagnostic
                                   providers of the   Sec.                 Imaging).
                                   eligible            170.314(a)(20)
                                   hospital's or       (Optional--Comput
                                   CAH's inpatient     erized Provider
                                   or emergency        Order Entry--
                                   department (POS     Diagnostic
                                   21 or 23) during    Imaging).
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.
Objective 4: Electronic           Measure: More than  Sec.                Sec.                Eligible hospitals
 Prescribing.                      10% of hospital     170.314(b)(3)       170.315(b)(3)       and CAHs may use
                                   discharge           (Electronic         (Electronic         a combination of
                                   medication orders   Prescribing).       Prescribing).       technologies
                                   for permissible    Sec.                Sec.                 certified to
                                   prescriptions       170.314(a)(10)      170.315(a)(10)      either the 2014
                                   (for new or         (Drug-Formulary     (Drug-Formulary     Edition or 2015
                                   changed             and Preferred       and Preferred       Edition.
                                   prescriptions)      Drug List Checks).  Drug List Checks).
                                   are queried for a
                                   drug formulary
                                   and transmitted
                                   electronically
                                   using CEHRT.
Objective 5: Health Information   Measure: The        Sec.                Sec.                N/A.
 Exchange.                         eligible hospital   170.314(b)(2)       170.315(b)(1)
                                   or CAH that         (Transitions of     (Transitions of
                                   transitions or      Care-Create and     Care).
                                   refers their        Transmit
                                   patient to          Transition of
                                   another setting     Care/Referral
                                   of care or          Summaries) or
                                   provider of care   Sec.
                                   (1) uses CEHRT to   170.314(b)(8)
                                   create a summary    (Optional--Transi
                                   of care record;     tions of care).
                                   and (2)
                                   electronically
                                   transmits such
                                   summary to a
                                   receiving
                                   provider for more
                                   than 10% of
                                   transitions of
                                   care and
                                   referrals.
Objective 6: Patient-Specific     Measure: More than  Sec.                Sec.                N/A.
 Education.                        10% of all unique   170.314(a)(15)      170.315(a)(13)
                                   patients admitted   (Patient-Specific   (Patient-Specific
                                   to the eligible     Education           Education
                                   hospital's or       Resources).         Resources).
                                   CAH's inpatient
                                   or emergency
                                   department (POS
                                   21 or 23) are
                                   provided patient
                                   specific
                                   education
                                   resources
                                   identified by
                                   CEHRT.
Objective 7: Medication           Measure: The        Sec.                Sec.                N/A.
 Reconciliation.                   eligible hospital   170.314(b)(4)       170.315(b)(2)
                                   or CAH performs     (Clinical           (Clinical
                                   medication          Information         Information
                                   reconciliation      Reconciliation)     Reconciliation
                                   for more than 50%   or                  and
                                   of transitions of  Sec.                 Incorporation).
                                   care in which the   170.314(b)(9)
                                   patient is          (Optional--Clinic
                                   admitted to the     al Information
                                   eligible            Reconciliation
                                   hospital's or       and
                                   CAH's inpatient     Incorporation).
                                   or emergency
                                   department (POS
                                   21 or 23).
Objective 8: Patient Electronic   Measure 1: More     Sec.                Sec.                N/A.
 Access (VDT).                     than 50 percent     170.314(e)(1)       170.315(e)(1)
                                   of all unique       (View, Download,    (View, Download,
                                   patients who are    and Transmit to     and Transmit to
                                   discharged from     3rd Party).         3rd Party).
                                   the inpatient or
                                   emergency
                                   department (POS
                                   21 or 23) of an
                                   eligible hospital
                                   or CAH are
                                   provided timely
                                   access to view
                                   online, download
                                   and transmit
                                   their health
                                   information to a
                                   third party their
                                   health
                                   information.

[[Page 62879]]

 
                                  Measure 2: For      Sec.                Sec.                N/A.
                                   2015 and 2016: At   170.314(e)(1)       170.315(e)(1)
                                   least 1 patient     (View, Download,    (View, Download,
                                   who is discharged   and Transmit to     and Transmit to
                                   from the            3rd Party).         3rd Party).
                                   inpatient or
                                   emergency
                                   department (POS
                                   21 or 23) of an
                                   eligible hospital
                                   or CAH (or his or
                                   her authorized
                                   representative)
                                   views, downloads,
                                   or transmits to a
                                   third party his
                                   or her
                                   information
                                   during the EHR
                                   reporting period.
                                  For 2017: More
                                   than 5 percent of
                                   unique patients
                                   discharged from
                                   the inpatient or
                                   emergency
                                   department (POS
                                   21 or 23) of an
                                   eligible hospital
                                   or CAH (or his or
                                   her authorized
                                   representative)
                                   view, download,
                                   or transmit to a
                                   third party their
                                   information
                                   during the EHR
                                   reporting period.
Objective 9: Secure Messaging...  N/A...............  N/A...............  N/A...............  N/A.
Objective 10: Public Health       Measure 1--         Sec.                N/A...............  N/A.
 Reporting.                        Immunization        170.314(f)(1)
                                   Registry            (Immunization
                                   Reporting.          Information) and
                                                      Sec.
                                                       170.314(f)(2)
                                                       (Transmission to
                                                       Immunization
                                                       Registries).
                                  Measure 2--         Sec.                Sec.                N/A.
                                   Syndromic           170.314(f)(3)       170.315(f)(2)
                                   Surveillance        (Transmission to    (Transmission to
                                   Reporting.          Public Health       Public Health
                                                       Agencies--Syndrom   Agencies--Syndrom
                                                       ic Surveillance).   ic Surveillance).
                                  Measure 3--         N/A...............  Eligible Hospitals/ Certified EHR
                                   Specialized                             CAHs may choose     technology is not
                                   Registry                                one or more of      required for
                                   Reporting.                              the following:      specialized
                                                                          Sec.                 registry
                                                                           170.315(f)(5)       reporting for
                                                                           (Transmission to    2015-2017, but
                                                                           Public Health       EHR technology
                                                                           Agencies--Electro   certified to the
                                                                           nic Case            2014 Edition or
                                                                           Reporting ).        2015 Edition may
                                                                          Sec.                 be used.
                                                                           170.315(f)(6)      Other non-named
                                                                           Transmission to     specialized
                                                                           Public Health       registries
                                                                           Agencies--Antimic   unsupported by
                                                                           robial Use and      certification
                                                                           Resistance          requirements may
                                                                           Reporting.          also be chosen.
                                                                          Sec.
                                                                           170.315(f)(7)
                                                                           Transmission to
                                                                           Public Health
                                                                           Agencies--Health
                                                                           Care Surveys.
                                  Measure 4--         Sec.                Sec.                N/A.
                                   Electronic          170.314(f)(4)       170.315(f)(3)
                                   Reportable          (Inpatient          (Transmission to
                                   Laboratory Result   Setting Only--      Public Health
                                   Reporting.          Transmission of     Agencies--Reporta
                                                       Reportable          ble Laboratory
                                                       Laboratory Tests    Tests and Values/
                                                       and Values/         Results).
                                                       Results.
----------------------------------------------------------------------------------------------------------------


                Table 13--EP Objectives, Measures, and Certification Criteria for Stage 3 in 2017
----------------------------------------------------------------------------------------------------------------
            Objective                 Measure(s)         2014 Edition        2015 Edition        Combinations
----------------------------------------------------------------------------------------------------------------
Objective 1: Protect Electronic   Measure: Conduct    The requirements    The requirements    The requirements
 Health Information.               or review a         are included in     are a part of       are a part of
                                   security risk       the Base EHR        CEHRT specific to   CEHRT specific to
                                   analysis in         Definition.         each                each
                                   accordance with                         certification       certification
                                   the requirements                        criterion.          criterion.
                                   in 45 CFR
                                   164.308(a)(1),
                                   including
                                   addressing the
                                   security (to
                                   include
                                   encryption) of
                                   ePHI data created
                                   or maintained by
                                   CEHRT in
                                   accordance with
                                   requirements in
                                   45 CFR
                                   164.312(a)(2)(iv)
                                   and 45 CFR
                                   164.306(d)(3),
                                   and implement
                                   security updates
                                   as necessary and
                                   correct
                                   identified
                                   security
                                   deficiencies as
                                   part of the
                                   provider's risk
                                   management
                                   process.
Objective 2: Electronic           Measure: More than  Sec.                Sec.                EPs may use a
 Prescribing.                      60% of all          170.314(b)(3)       170.315(b)(3)       combination of
                                   permissible         (Electronic         (Electronic         technologies
                                   prescriptions       Prescribing)        Prescribing).       certified to
                                   written by the EP  Sec.                Sec.                 either the 2014
                                   are queried for a   170.314(a)(10)      170.315(a)(10)      Edition or 2015
                                   drug formulary      (Drug-Formulary     (Drug-Formulary     Edition.
                                   and transmitted     and Preferred       and Preferred
                                   electronically      Drug List Checks).  Drug List checks).
                                   using CEHRT.
Objective 3: Clinical Decision    Measure 1: The EP   Sec.                Sec.                N/A.
 Support.                          must implement      170.314(a)(8)       170.315(a)(9)
                                   five clinical       (Clinical           (Clinical
                                   decision support    Decision Support).  Decision Support).
                                   interventions
                                   related to four
                                   or more CQMs at a
                                   relevant point in
                                   patient care for
                                   the entire EHR
                                   reporting period.

[[Page 62880]]

 
                                  Measure 2: The EP   Sec.                Sec.                N/A.
                                   has enabled and     170.314(a)(2)       170.315(a)(4)
                                   implemented the     (Drug-Drug, Drug-   (Drug-Drug, Drug-
                                   functionality for   Allergy             Allergy
                                   drug--drug and      Interaction         Interaction
                                   drug--allergy       Checks).            Checks for CPOE).
                                   interaction
                                   checks for the
                                   entire EHR
                                   reporting period.
Objective 4: Computerized         Measure 1: More     Sec.                Sec.                N/A.
 Provider Order Entry (CPOE).      than 60% of         170.314(a)(1)       170.315(a)(1)
                                   medication orders   (Computerized       (Computerized
                                   created by the EP   Provider Order      Provider Order
                                   during the EHR      Entry) or           Entry-Medications
                                   reporting period   Sec.                 ).
                                   are recorded        170.314(a)(18)
                                   using CPOE.         (Optional--Comput
                                                       erized Provider
                                                       Order Entry-
                                                       Medications).
                                  Measure 2: More     Sec.                Sec.                N/A.
                                   than 60% of         170.314(a)(1)       170.315(a)(2)
                                   laboratory orders   (Computerized       (Computerized
                                   created by the EP   Provider Order      Provider Order
                                   during the EHR      Entry) or           Entry-Laboratory).
                                   reporting period   Sec.
                                   are recorded        170.314(a)(19)
                                   using CPOE.         (Optional-Compute
                                                       rized Provider
                                                       Order Entry-
                                                       Laboratory).
                                  Measure 3: More     Sec.                Sec.                N/A.
                                   than 60% of         170.314(a)(1)       170.315(a)(3)
                                   diagnostic          (Computerized       (Computerized
                                   imaging orders      Provider Order      Provider Order
                                   created by the EP   Entry) or           Entry-Diagnostic
                                   during the EHR     Sec.                 Imaging).
                                   reporting period    170.314(a)(20)
                                   are recorded        (Optional-Compute
                                   using CPOE.         rized Provider
                                                       Order Entry-
                                                       Diagnostic
                                                       Imaging).
Objective 5: Patient Electronic   Measure 1: For      Sec.                Sec.                EPs may use
 Access.                           more than 80% of    170.314(e)(1)       170.315(e)(1)       technologies
                                   all unique          (View, Download,    (View, Download,    certified to
                                   patients seen by    and Transmit to     and Transmit to     either the 2014
                                   the EP:             3rd Party).         3rd Party).         Edition or 2015
                                  (1) The patient                         Sec.                 Edition VDT
                                   (or the patient                         170.315(g)(7)       certification
                                   authorized                              (Application        criteria (i.e.,
                                   representative)                         Access--Patient     Sec.
                                   is provided                             Selection) *..      170.314(e)(1)
                                   timely access to                       Sec.                or Sec.
                                   view online,                            170.315(g)(8)       170.315(e)(1)) in
                                   download, and                           (Application        2017).
                                   transmit his or                         Access--Data       The 2014 Edition
                                   her health                              Category Request)   does not offer
                                   information; and.                       *.                  ``API''
                                  (2) The EP ensures                      Sec.                 certification
                                   the patient's                           170.315(g)(9)       criteria.
                                   health                                  (Application        Therefore, EPs
                                   information is                          Access--All Data    choosing to
                                   available for the                       Request) *..        attest to the
                                   patient (or                            * The three          Stage 3 measures
                                   patient--authoriz                       criteria combined   in 2017 would
                                   ed                                      are the ``API''     need to possess
                                   representative)                         certification       technology
                                   to access using                         criteria.           certified to Sec.
                                   any application                                               170.315(g)(7),
                                   of their choice                                             Sec.
                                   that is                                                     170.315(g)(8),
                                   configured to                                               and Sec.
                                   meet the                                                    170.315(g)(9).
                                   technical
                                   specifications of
                                   the API in the
                                   provider's CEHRT..
                                  Measure 2: The EP   Sec.                Sec.                N/A.
                                   must use            170.314(a)(15)      170.315(a)(13)
                                   clinically          (Patient-Specific   (Patient-specific
                                   relevant            Education           Education
                                   information from    Resources).         Resources).
                                   CEHRT to identify
                                   patient-specific
                                   educational
                                   resources and
                                   provide
                                   electronic access
                                   to those
                                   materials to more
                                   than 35% of
                                   unique patients
                                   seen by the EP.
Objective 6: Coordination of      Measure 1: For      Sec.                Sec.                EPs may use a
 Care through Patient Engagement.  2017, during the    170.314(e)(1)       170.315(e)(1)       combination of
                                   EHR reporting       (View, Download,    (View, Download,    technologies
                                   period, more than   and Transmit to     and Transmit to     certified to
                                   5% of all unique    3rd Party).         3rd Party).         either the 2014
                                   patients(or                            Sec.                 Edition or 2015
                                   patient-                                170.315(g)(7)       Edition VDT
                                   authorized                              (Application        certification
                                   representative)se                       Access--Patient     criteria (i.e.,
                                   en by the EP                            Selection) *.       Sec.
                                   actively engage                        Sec.                 170.314(e)(1) or
                                   with the EHR made                       170.315(g)(8)      Sec.
                                   accessible by the                       (Application        170.315(e)(1)) in
                                   provider. An EP                         Access--Data        2017).
                                   may meet the                            Category Request)  The 2014 Edition
                                   measure by                              *.                  does not offer
                                   either--                               Sec.                 API certification
                                  (1) view, download                       170.315(g)(9)       criteria.
                                   or transmit to a                        (Application        Therefore, EPs
                                   third party their                       Access--All Data    choosing to
                                   health                                  Request) *.         attest to the
                                   information; or.                       * The three          Stage 3 measures
                                  (2) access their                         criteria combined   in 2017 would
                                   health                                  are the ``API''     need to possess
                                   information                             certification       technology
                                   through the use                         criteria.           certified to Sec.
                                   of an API that                                                170.315(g)(7),
                                   can be used by                                              Sec.
                                   applications                                                170.315(g)(8),
                                   chosen by the                                               and Sec.
                                   patient and                                                 170.315(g)(9).
                                   configured to the
                                   API in the
                                   provider's CEHRT;
                                   or (3) a
                                   combination of
                                   (1) and (2)..
                                  Measure 2: For      Sec.                Sec.                N/A.
                                   2017, more than     170.314(e)(3)       170.315(e)(2)
                                   5% of all unique    (Secure             (Secure
                                   patients seen by    Messaging).         Messaging).
                                   the EP during the
                                   EHR reporting
                                   period, a secure
                                   message was sent
                                   using the
                                   electronic
                                   messaging
                                   function of CEHRT
                                   to the patient
                                   (or the patient-
                                   authorized
                                   representative),
                                   or in response to
                                   a secure message
                                   sent by the
                                   patient (or the
                                   patient-
                                   authorized
                                   representative.

[[Page 62881]]

 
                                  Measure 3:          N/A...............  Sec.                ..................
                                   Patient--generate                       170.315(e)(3)
                                   d health data or                        (Patient Health
                                   data from a non-                        Information
                                   clinical setting                        Capture) *.
                                   is incorporated                        * Supports meeting
                                   into the CEHRT                          the measure, but
                                   for more than 5                         is NOT required
                                   of all unique                           to be used to
                                   patients seen by                        meet the measure.
                                   the EP during the                       The certification
                                   EHR reporting                           criterion is part
                                   period.                                 of the CEHRT
                                                                           definition
                                                                           beginning in 2018.
Objective 7: Health Information   Measure 1: For      Sec.                Sec.                N/A.
 Exchange.                         more than 50% of    170.314(b)(2)       170.315(b)(1)
                                   transitions of      (Transitions of     (Transitions of
                                   care and            Care--Create and    Care).
                                   referrals, the EP   Transmit
                                   that transitions    Transition of
                                   or refers their     Care/Referral
                                   patient to          Summaries) or
                                   another setting    Sec.
                                   of care or          170.314(b)(8)
                                   provider of care--  (Optional--Transi
                                   (1) creates a       tions of Care).
                                   summary of care
                                   record using
                                   CEHRT; and (2)
                                   electronically
                                   exchanges the
                                   summary of care
                                   record.
                                  Measure 2: For      Sec.                Sec.                N/A.
                                   more than 40% of    170.314(b)(1)       170.315(b)(1)
                                   transitions or      (Transitions of     (Transitions of
                                   referrals           Care-Receive,       Care).
                                   received and        Display and
                                   patient             Incorporate
                                   encounters in       Transition of
                                   which the EP has    Care/Referral
                                   never before        Summaries) or
                                   encountered the    Sec.
                                   patient, the EP     170.314(b)(8)
                                   receives or         (Optional--Transi
                                   retrieves and       tions of Care).
                                   incorporates into
                                   the patient's
                                   record an
                                   electronic
                                   summary of care
                                   document.
                                  Measure 3: For      Sec.                Sec.                N/A.
                                   more than 80% of    170.314(b)(4)       170.315(b)(2)
                                   transitions or      (Clinical           (Clinical
                                   referrals           Information         Information
                                   received and        Reconciliation)     Reconciliation
                                   patient             or                  and
                                   encounters in      Sec.                 Incorporation).
                                   which the EP has    170.314(b)(9)
                                   never before        (Optional--Clinic
                                   encountered the     al Information
                                   patient, the EP     Reconciliation
                                   performs clinical   and
                                   information         Incorporation).
                                   reconciliation.
Objective 8: Public Health and    Measure 1:          N/A...............  Sec.                N/A.
 Clinical Data Registry            Immunization                            170.315(f)(1)
 Reporting.                        Registry                                (Transmission to
                                   Reporting.                              Immunization
                                                                           Registries).
Data Registry Reporting.........  Measure 2:          Sec.                Sec.                N/A.
                                   Syndromic           170.314(f)(3)       170.315(f)(2)
                                   Surveillance        (Transmission to    (Transmission to
                                   Reporting.          Public Health       Public Health
                                                       Agencies--Syndrom   Agencies--Syndrom
                                                       ic Surveillance)    ic Surveillance)
                                                       or                  Urgent Care
                                                      Sec.                 Setting Only.
                                                       170.314(f)(7)
                                                       (Optional-Ambulat
                                                       ory Setting Only-
                                                       Transmission to
                                                       Public Health
                                                       Agencies--Syndrom
                                                       ic Surveillance).
                                  Measure 3:          N/A...............  Sec.                N/A.
                                   Electronic Case                         170.315(f)(5)
                                   Reporting.                              (Transmission to
                                                                           Public Health
                                                                           Agencies--Electro
                                                                           nic Case
                                                                           Reporting).
                                  Measure 4: Public   Sec.                EPs may choose one  EPs may choose to
                                   Health Registry     170.314(f)(5)       or more of the      use technologies
                                   Reporting.          (Optional --        following:          certified to
                                                       Ambulatory         Sec.                 either the 2014
                                                       Setting Only--      170.315(f)(4)       Edition or 2015
                                                       Cancer Case         (Transmission to    Edition
                                                       Information) and    Cancer              certification
                                                      Sec.                 Registries).        criteria in 2017.
                                                       170.314(f)(6)      Sec.
                                                       (Optional--Ambula   170.315(f)(7).
                                                       tory Setting Only- (Transmission to
                                                       Transmission to     Public Health
                                                       Cancer              Agencies--Health
                                                       Registries).        Care Surveys).
                                  Measure 5:          N/A...............  No 2015 Edition     N/A.
                                   Clinical Data                           health IT
                                   Registry                                certification
                                   Reporting.                              criteria at this
                                                                           time.
----------------------------------------------------------------------------------------------------------------


[[Page 62882]]


      Table 14--Eligible Hospital/CAH Objectives, Measures, and Certification Criteria for Stage 3 in 2017
----------------------------------------------------------------------------------------------------------------
            Objective                 Measure(s)         2014 Edition        2015 Edition        Combinations
----------------------------------------------------------------------------------------------------------------
Objective 1: Protect Electronic   Measure: Conduct    The requirements    The requirements    The requirements
 Health Information.               or review a         are included in     are a part of       are a part of
                                   security risk       the Base EHR        CEHRT specific to   CEHRT specific to
                                   analysis in         Definition.         each                each
                                   accordance with                         certification       certification
                                   the requirements                        criterion.          criterion.
                                   in 45 CFR
                                   164.308(a)(1),
                                   including
                                   addressing the
                                   security (to
                                   include
                                   encryption) of
                                   ePHI data created
                                   or maintained by
                                   CEHRT in
                                   accordance with
                                   requirements in
                                   45 CFR
                                   164.312(a)(2)(iv)
                                   and 45 CFR
                                   164.306(d)(3),
                                   and implement
                                   security updates
                                   as necessary and
                                   correct
                                   identified
                                   security
                                   deficiencies as
                                   part of the
                                   provider's risk
                                   management
                                   process.
Objective 2: Electronic           Measure: More than  Sec.                Sec.                Eligible Hospitals/
 Prescribing.                      25% of hospital     170.314(b)(3)       170.315(b)(3)       CAHs may use a
                                   discharge           (Electronic         (Electronic         combination of
                                   medication orders   Prescribing).       Prescribing)..      technologies
                                   for permissible    Sec.                Sec.                 certified to
                                   prescriptions       170.314(a)(10)      170.315(a)(10)      either the 2014
                                   (for new and        (Drug-Formulary     (Drug-Formulary     Edition or 2015
                                   changed             and Preferred       and Preferred       Edition.
                                   prescriptions)      Drug List Checks).  Drug List Checks).
                                   are queried for a
                                   drug formulary
                                   and transmitted
                                   electronically
                                   using CEHRT.
Objective 3: Clinical Decision    Measure 1: The      Sec.                Sec.                N/A.
 Support.                          eligible hospital   170.314(a)(8)       170.315(a)(9)
                                   or CAH must         (Clinical           (Clinical
                                   implement five      Decision Support).  Decision Support).
                                   clinical decision
                                   support
                                   interventions
                                   related to four
                                   or more CQMs at a
                                   relevant point in
                                   patient care for
                                   the entire EHR
                                   reporting period.
                                  Measure 2: The      Sec.                Sec.                N/A.
                                   eligible hospital   170.314(a)(2)       170.315(a)(4)
                                   or CAH has          (Drug-Drug, Drug-   (Drug-Drug, Drug-
                                   enabled and         Allergy             Allergy
                                   implemented the     Interaction         Interaction
                                   functionality for   Checks).            Checks for CPOE).
                                   drug[dash]drug
                                   and
                                   drug[dash]allergy
                                   interaction
                                   checks for the
                                   entire EHR
                                   reporting period.
Objective 4: Computerized         Measure 1: More     Sec.                Sec.                N/A
 Provider Order Entry (CPOE).      than 60% of         170.314(a)(1)       170.315(a)(1)
                                   medication orders   (Computerized       (Computerized
                                   created by the      Provider Order      Provider Order
                                   authorized          Entry) or Sec.      Entry--Medication
                                   providers of the    170.314(a)(18)      s).
                                   eligible            (Optional--Comput
                                   hospital's or       erized Provider
                                   CAH's inpatient     Order Entry--
                                   or emergency        Medications).
                                   department (POS
                                   21 or 23) during
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.
                                  Measure 2: More     Sec.                Sec.                N/A.
                                   than 60% of         170.314(a)(1)       170.315(a)(2)
                                   laboratory orders   (Computerized       (Computerized
                                   created by the      Provider Order      Provider Order
                                   authorized          Entry) or Sec.      Entry--Laboratory
                                   providers of the    170.314(a)(19)      ).
                                   eligible            (Optional--Comput
                                   hospital's or       erized Provider
                                   CAH's inpatient     Order Entry--
                                   or emergency        Laboratory).
                                   department (POS
                                   21 or 23) during
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.
                                  Measure 3: More     Sec.                Sec.                N/A.
                                   than 60% of         170.314(a)(1)       170.315(a)(3)
                                   diagnostic          (Computerized       (Computerized
                                   imaging orders      Provider Order      Provider Order
                                   created by the      Entry) or Sec.      Entry--Diagnostic
                                   authorized          170.314(a)(20)      Imaging).
                                   providers of the    (Optional--Comput
                                   eligible            erized Provider
                                   hospital's or       Order Entry--
                                   CAH's inpatient     Diagnostic
                                   or emergency        Imaging).
                                   department (POS
                                   21 or 23) during
                                   the EHR reporting
                                   period are
                                   recorded using
                                   CPOE.

[[Page 62883]]

 
Objective 5: Patient Electronic   Measure 1: For      Sec.                Sec.                Eligible Hospitals/
 Access.                           more than 80% of    170.314(e)(1)       170.315(e)(1)       CAHs may use
                                   all unique          (View, Download,    (View, Download,    technologies
                                   patients            and Transmit to     and Transmit to     certified to
                                   discharged from     3rd Party).         3rd Party).         either the 2014
                                   the eligible                           Sec.                 Edition or 2015
                                   hospital or CAH                         170.315(g)(7)*      Edition VDT
                                   inpatient or                            (Application        certification
                                   emergency                               Access--Patient     criteria (i.e.,
                                   department (POS                         Selection).         Sec.
                                   21 or 23):                             Sec.                 170.314(e)(1) or
                                  (1) The patient                          170.315(g)(8)*      Sec.
                                   (or the patient                         (Application        170.315(e)(1))in
                                   authorized                              Access--Data        2017).
                                   representative)                         Category           The 2014 Edition
                                   is provided                             Request)*.          does not offer
                                   timely access to                       Sec.                 ``API''
                                   view online,                            170.315(g)(9)       certification
                                   download, and                           (Application        criteria.
                                   transmit his or                         Access--All Data   Therefore,
                                   her health                              Request)*.          Eligible
                                   information.; and.                     * The three          Hospitals/CAHs
                                  (2) The provider                         criteria combined   choosing to
                                   ensures the                             are the ``API''     attest to the
                                   patient's health                        certification       Stage 3 measures
                                   information is                          criteria.           in 2017 would
                                   available for the                                           need to possess
                                   patient (or                                                 technology
                                   patient[dash]auth                                           certified to Sec.
                                   orized                                                        170.315(g)(7),
                                   representative)                                             Sec.
                                   to access using                                             170.315(g)(8),
                                   any application                                             and Sec.
                                   of their choice                                             170.315(g)(9).
                                   that is
                                   configured to
                                   meet the
                                   technical
                                   specifications of
                                   the API in the
                                   provider's CEHRT.
                                  Measure 2: The      Sec.                Sec.                N/A.
                                   eligible hospital   170.314(a)(15)      170.315(a)(13)
                                   or CAH must use     (Patient-Specific   (Patient-Specific
                                   clinically          Education           Education
                                   relevant            Resources).         Resources).
                                   information from
                                   CEHRT to identify
                                   patient-specific
                                   educational
                                   resources and
                                   provide
                                   electronic access
                                   to those
                                   materials to more
                                   than 35% of
                                   unique patients
                                   discharged from
                                   the eligible
                                   hospital or CAH
                                   inpatient or
                                   emergency
                                   department (POS
                                   21 or 23) during
                                   the EHR reporting
                                   period.
Objective 6:....................  Measure 1: During   Sec.                Sec.                Eligible Hospitals/
Coordination of Care through       the EHR reporting   170.314(e)(1)       170.315(e)(1)       CAHs may use
 Patient Engagement.               period, more than   (View, Download,    (View, Download,    technologies
                                   10 percent of all   and Transmit to     and Transmit to     certified to
                                   unique patients     3rd Party).         3rd Party).         either the 2014
                                   (or their                              Sec.                 Edition or 2015
                                   authorized                              170.315(g)(7)       Edition VDT
                                   representatives)                        (Application        certification
                                   discharged from                         Access--Patient     criteria (i.e.,
                                   the eligible                            Selection)*.        Sec.
                                   hospital or CAH                        Sec.                 170.314(e)(1) or
                                   inpatient or                            170.315(g)(8)       Sec.
                                   emergency                               (Application        170.315(e)(1)) in
                                   department (POS                         Access--Data        2017.
                                   21 or 23)                               Category           The 2014 Edition
                                   actively engage                         Request)*.          does not offer
                                   with the EHR made                      Sec.                 ``API''
                                   accessible by the                       170.315(g)(9)       certification
                                   provider and                            (Application        criteria.
                                   either:                                 Access--All Data    Therefore,
                                  (1) view, download                       Request)*.          Eligible
                                   or transmit to a                       * The three          Hospitals/CAHs
                                   third party their                       criteria combined   choosing to
                                   health                                  are the ``API''     attest to the
                                   information; or.                        certification       Stage 3 measures
                                  (2) access their                         criteria.           in 2017 would
                                   health                                                      need to possess
                                   information                                                 technology
                                   through the use                                             certified to Sec.
                                   of an API that                                                170.315(g)(7),
                                   can be used by                                              Sec.
                                   applications                                                170.315(g)(8),
                                   chosen by the                                               and Sec.
                                   patient and                                                 170.315(g)(9).
                                   configured to the
                                   API in the
                                   provider's CEHRT;
                                   or.
                                  (3) a combination
                                   of (1) and (2)..
                                  Measure 2: For      Sec.                Sec.                N/A.
                                   more than 25% of    170.314(e)(3)       170.315(e)(2)
                                   all unique          (Secure             (Secure
                                   patients            Messaging).         Messaging).
                                   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-
                                   authorized
                                   representative),
                                   or in response to
                                   a secure message
                                   sent by the
                                   patient (or the
                                   patient-
                                   authorized
                                   representative)
                                   during the EHR
                                   reporting period.

[[Page 62884]]

 
                                  Measure 3:          N/A...............  Sec.                N/A.
                                   Patient[dash]gene                       170.315(e)(3)
                                   rated health data                       (Patient Health
                                   or data from a                          Information
                                   non-clinical                            Capture)*..
                                   setting is                             *Supports meeting
                                   incorporated into                       the measure, but
                                   the CEHRT for                           is NOT required
                                   more than 5% of                         to be used to
                                   all unique                              meet the measure.
                                   patients                                The certification
                                   discharged from                         criterion is part
                                   the eligible                            of the CEHRT
                                   hospital or CAH                         definition
                                   (POS 21 and 23)                         beginning in 2018.
                                   during the EHR
                                   reporting period.
Objective 7: Health Information   Measure 1: For      Sec.                Sec.                N/A.
 Exchange.                         more than 50% of    170.314(b)(2)       170.315(b)(1)
                                   transitions of      (Transitions of     (Transitions of
                                   care and            Care--Create and    Care).
                                   referrals, the      Transmit
                                   eligible hospital   Transition of
                                   or CAH that         Care/Referral
                                   transitions or      Summaries) or
                                   refers their        Sec.
                                   patient to          170.314(b)(8)
                                   another setting     (Optional--Transi
                                   of care or          tions of Care).
                                   provider of care--
                                   (1) creates a
                                   summary of care
                                   record using
                                   CEHRT; and (2)
                                   electronically
                                   exchanges the
                                   summary of care
                                   record
                                  Measure 2: For      Sec.                Sec.                N/A.
                                   more than 40% of    170.314(b)(1)       170.315(b)(1)
                                   transitions or      (Transitions of     (Transitions of
                                   referrals           Care--Receive,      Care).
                                   received and        Display and
                                   patient             Incorporate
                                   encounters in       Transition of
                                   which the           Care/Referral
                                   provider has        Summaries) or
                                   never before        Sec.
                                   encountered the     170.314(b)(8)
                                   patient, the        (Optional--Transi
                                   eligible hospital   tions of Care).
                                   or CAH receives
                                   or retrieves and
                                   incorporates into
                                   the patient's
                                   record in their
                                   EHR an electronic
                                   summary of care
                                   document.
                                  Measure 3: For      Sec.                Sec.                N/A.
                                   more than 80%of     170.314(b)(4)       170.315(b)(2)
                                   transitions or      (Clinical           (Clinical
                                   referrals           Information         Information
                                   received and        Reconciliation)     Reconciliation
                                   patient             or Sec.             and
                                   encounters in       170.314(b)(9)       Incorporation).
                                   which the           (Optional--Clinic
                                   provider has        al Information
                                   never before        Reconciliation
                                   encountered the     and
                                   patient, the        Incorporation).
                                   eligible hospital
                                   or CAH performs
                                   clinical
                                   information
                                   reconciliation.
Objective 8: Public Health and    Measure 1:          N/A...............  Sec.                N/A.
 Clinical Data Registry            Immunization                            170.315(f)(1)
 Reporting.                        Registry                                (Transmission to
                                   Reporting.                              Immunization
                                                                           Registries).
                                  Measure 2:          Sec.                Sec.                N/A.
                                   Syndromic           170.314(f)(3)       170.315(f)(2)
                                   Surveillance        (Transmission to    (Transmission to
                                   Reporting.          Public Health       Public Health
                                                       Agencies--Syndrom   Agencies--Syndrom
                                                       ic Surveillance).   ic Surveillance).
                                  Measure 3:          N/A...............  Sec.                N/A.
                                   Electronic Case                         170.315(f)(5)
                                   Reporting.                              (Transmission to
                                                                           Public Health
                                                                           Agencies--Electro
                                                                           nic Case
                                                                           Reporting).
                                  Measure 4: Public   N/A...............  Eligible Hospitals/ EPs may choose to
                                   Health Registry                         CAHs may choose     use technologies
                                   Reporting.                              one or more of      certified to
                                                                           the following:.     either the 2014
                                                                          Sec.                 Edition or 2015
                                                                           170.315(f)(6)       Edition
                                                                           (Transmission to    certification
                                                                           Public Health       criteria in 2017.
                                                                           Agencies--Antimic
                                                                           robial Use and
                                                                           Resistance)..
                                                                          Sec.
                                                                           170.315(f)(7)
                                                                           (Transmission to
                                                                           Public Health
                                                                           Agencies--Health
                                                                           Care Surveys).
                                  Measure 5:          ..................  No 2015 Edition     N/A.
                                   Clinical Data                           health IT
                                   Registry                                certification
                                   Reporting.                              criteria at this
                                                                           time.

[[Page 62885]]

 
                                  Measure 6:          Sec.                Sec.                N/A.
                                   Electronic          170.314(f)(4)       170.315(f)(3)
                                   Reportable          (Inpatient          (Transmission to
                                   Laboratory Result   Setting Only--      Public Health
                                   Reporting.          Transmission of     Agencies--Reporta
                                                       Reportable          ble Laboratory
                                                       Laboratory Tests    Tests and Values/
                                                       and Values/         Results).
                                                       Results).
----------------------------------------------------------------------------------------------------------------


 Table 15--EP Objectives, Measures, and Certification Criteria for Stage
                     3 in 2018 and Subsequent Years
------------------------------------------------------------------------
           Objective                  Measure(s)          2015 Edition
------------------------------------------------------------------------
Objective 1: Protect            Measure: Conduct or     The requirements
 Electronic Health Information.  review a security       are a part of
                                 risk analysis in        CEHRT specific
                                 accordance with the     to each
                                 requirements in 45      certification
                                 CFR 164.308(a)(1),      criterion.
                                 including addressing
                                 the security (to
                                 include encryption)
                                 of ePHI data created
                                 or maintained by
                                 CEHRT in accordance
                                 with requirements in
                                 45 CFR
                                 164.312(a)(2)(iv) and
                                 45 CFR 164.306(d)(3),
                                 and implement
                                 security updates as
                                 necessary and correct
                                 identified security
                                 deficiencies as part
                                 of the provider's
                                 risk management
                                 process.
Objective 2: Electronic         Measure: More than 60%  Sec.
 Prescribing.                    of all permissible      170.315(b)(3)
                                 prescriptions written   (Electronic
                                 by the EP are queried   Prescribing)
                                 for a drug formulary   Sec.
                                 and transmitted         170.315(a)(10)
                                 electronically using    (Drug-Formulary
                                 CEHRT.                  and Preferred
                                                         Drug List
                                                         checks).
Objective 3: Clinical Decision  Measure 1: The EP must  Sec.
 Support.                        implement five          170.315(a)(9)
                                 clinical decision       (Clinical
                                 support interventions   Decision
                                 related to four or      Support).
                                 more CQMs at a
                                 relevant point in
                                 patient care for the
                                 entire EHR reporting
                                 period.
                                Measure 2: The EP has   Sec.
                                 enabled and             170.315(a)(4)
                                 implemented the         (Drug-Drug,
                                 functionality for       Drug-Allergy
                                 drug[dash]drug and      Interaction
                                 drug[dash]allergy       Checks for
                                 interaction checks      CPOE).
                                 for the entire EHR
                                 reporting period.
Objective 4: Computerized       Measure 1: More than    Sec.
 Provider Order Entry (CPOE).    60% of medication       170.315(a)(1)
                                 orders created by the  (Computerized
                                 EP during the EHR       Provider Order
                                 reporting period are    Entry--Medicati
                                 recorded using CPOE.    ons).
                                Measure 2: More than    Sec.
                                 60% of laboratory       170.315(a)(2)
                                 orders created by the  (Computerized
                                 EP during the EHR       Provider Order
                                 reporting period are    Entry--Laborato
                                 recorded using CPOE.    ry).
                                Measure 3: More than    Sec.
                                 60% of diagnostic       170.315(a)(3)
                                 imaging orders         (Computerized
                                 created by the EP       Provider Order
                                 during the EHR          Entry--Diagnost
                                 reporting period are    ic Imaging).
                                 recorded using CPOE.
Objective 5: Patient            Measure 1: For more     Sec.
 Electronic Access.              than 80% of all         170.315(e)(1)
                                 unique patients seen    (View,
                                 by the EP:              Download, and
                                (1) The patient (or      Transmit to 3rd
                                 the patient             Party)
                                 authorized             Sec.
                                 representative) is      170.315(g)(7)
                                 provided timely        (Application
                                 access to view          Access--Patient
                                 online, download, and   Selection)*
                                 transmit his or her    Sec.
                                 health information;     170.315(g)(8)
                                 and.                    (Application
                                (2) The EP ensures the   Access--Data
                                 patient's health        Category
                                 information is          Request)*
                                 available for the      Sec.
                                 patient (or patient-    170.315(g)(9)
                                 authorized              (Application
                                 representative) to      Access--All
                                 access using any        Data Request)*
                                 application of their   *The three
                                 choice that is          criteria
                                 configured to meet      combined are
                                 the technical           the ``API''
                                 specifications of the   certification
                                 API in the provider's   criteria.
                                 CEHRT.
                                Measure 2: The EP must  Sec.
                                 use clinically          170.315(a)(13)
                                 relevant information    (Patient-
                                 from CEHRT to           specific
                                 identify patient-       Education
                                 specific educational    Resources).
                                 resources and provide
                                 electronic access to
                                 those materials to
                                 more than 35% of
                                 unique patients seen
                                 by the EP.
Objective 6: Coordination of    Measure 1: For 2017,    Sec.
 Care through Patient            during the EHR          170.315(e)(1)
 Engagement.                     reporting period,       (View,
                                 more than 10% of all    Download, and
                                 unique patients(or      Transmit to 3rd
                                 patient-authorized      Party)
                                 representative) seen   Sec.
                                 by the EP actively      170.315(g)(7)
                                 engage with the EHR    (Application
                                 made accessible by      Access--Patient
                                 the provider. An EP     Selection)*
                                 may meet the measure   Sec.
                                 by either--             170.315(g)(8)
                                (1) view, download or    (Application
                                 transmit to a third     Access--Data
                                 party their health      Category
                                 information; or.        Request)*
                                (2) access their        Sec.
                                 health information      170.315(g)(9)
                                 through the use of an   (Application
                                 API that can be used    Access--All
                                 by applications         Data Request)*
                                 chosen by the patient  *The three
                                 and configured to the   criteria
                                 API in the provider's   combined are
                                 CEHRT; or (3) a         the ``API''
                                 combination of (1)      certification
                                 and (2).                criteria.
                                Measure 2: For 2017,    Sec.
                                 more than 25% of all    170.315(e)(2)
                                 unique patients seen    (Secure
                                 by the EP during the    Messaging).
                                 EHR reporting period,
                                 a secure message was
                                 sent using the
                                 electronic messaging
                                 function of CEHRT to
                                 the patient (or the
                                 patient-authorized
                                 representative), or
                                 in response to a
                                 secure message sent
                                 by the patient (or
                                 the patient-
                                 authorized
                                 representative.

[[Page 62886]]

 
                                Measure 3:              Sec.
                                 Patient[dash]generate   170.315(e)(3)
                                 d health data or data   (Patient Health
                                 from a non-clinical     Information
                                 setting is              Capture)*
                                 incorporated into the  *Supports
                                 CEHRT for more than 5   meeting the
                                 of all unique           measure, but is
                                 patients seen by the    NOT required to
                                 EP during the EHR       be used to meet
                                 reporting period.       the measure.
                                                         The
                                                         certification
                                                         criterion is
                                                         part of the
                                                         CEHRT
                                                         definition
                                                         beginning in
                                                         2018.
Objective 7: Health             Measure 1: For more     Sec.
 Information Exchange.           than 50% of             170.315(b)(1)
                                 transitions of care     (Transitions of
                                 and referrals, the EP   Care).
                                 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.
                                Measure 2: For more     Sec.
                                 than 40% of             170.315(b)(1)
                                 transitions or          (Transitions of
                                 referrals received      Care).
                                 and patient
                                 encounters in which
                                 the EP has never
                                 before encountered
                                 the patient, the EP
                                 receives or retrieves
                                 and incorporates into
                                 the patient's record
                                 an electronic summary
                                 of care document.
                                Measure 3: For more     Sec.
                                 than 80% of             170.315(b)(2)
                                 transitions or          (Clinical
                                 referrals received      Information
                                 and patient             Reconciliation
                                 encounters in which     and
                                 the EP has never        Incorporation).
                                 before encountered
                                 the patient, the EP
                                 performs clinical
                                 information
                                 reconciliation.
Public Health and Clinical      Measure 1:              Sec.
 Data Registry Reporting.        Immunization Registry   170.315(f)(1)
                                 Reporting.              (Transmission
                                                         to Immunization
                                                         Registries).
                                Measure 2: Syndromic    Sec.
                                 Surveillance            170.315(f)(2)
                                 Reporting.              (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Syndr
                                                         omic
                                                         Surveillance)
                                                        Urgent Care
                                                         Setting Only.
                                Measure 3: Electronic   Sec.
                                 Case Reporting.         170.315(f)(5)
                                                         (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Elect
                                                         ronic Case
                                                         Reporting ).
                                Measure 4: Public       EPs may choose
                                 Health Registry         one or more of
                                 Reporting.              the following:
                                                        Sec.
                                                         170.315(f)(4)
                                                         (Transmission
                                                         to Cancer
                                                         Registries)
                                                        Sec.
                                                         170.315(f)(7)
                                                        (Transmission to
                                                         Public Health
                                                         Agencies--Healt
                                                         h Care
                                                         Surveys).
                                Measure 5: Clinical     No 2015 Edition
                                 Data Registry           health IT
                                 Reporting.              certification
                                                         criteria at
                                                         this time.
------------------------------------------------------------------------


 Table 16--Eligible Hospital/CAH Objectives, Measures, and Certification
            Criteria for Stage 3 in 2018 and Subsequent Years
------------------------------------------------------------------------
           Objective                  Measure(s)          2015 Edition
------------------------------------------------------------------------
Objective 1: Protect            Measure: Conduct or     The requirements
 Electronic Health Information.  review a security       are a part of
                                 risk analysis in        CEHRT specific
                                 accordance with the     to each
                                 requirements in 45      certification
                                 CFR 164.308(a)(1),      criterion.
                                 including addressing
                                 the security (to
                                 include encryption)
                                 of ePHI data created
                                 or maintained by
                                 CEHRT in accordance
                                 with requirements in
                                 45 CFR
                                 164.312(a)(2)(iv) and
                                 45 CFR 164.306(d)(3),
                                 and implement
                                 security updates as
                                 necessary and correct
                                 identified security
                                 deficiencies as part
                                 of the provider's
                                 risk management
                                 process.
Objective 2: Electronic         Measure: More than 25%  Sec.
 Prescribing.                    of hospital discharge   170.315(b)(3)
                                 medication orders for   (Electronic
                                 permissible             Prescribing).
                                 prescriptions (for     Sec.
                                 new and changed         170.315(a)(10)
                                 prescriptions) are      (Drug-Formulary
                                 queried for a drug      and Preferred
                                 formulary and           Drug List
                                 transmitted             Checks).
                                 electronically using
                                 CEHRT.
Objective 3: Clinical Decision  Measure 1: The          Sec.
 Support.                        eligible hospital or    170.315(a)(9)
                                 CAH must implement      (Clinical
                                 five clinical           Decision
                                 decision support        Support).
                                 interventions related
                                 to four or more CQMs
                                 at a relevant point
                                 in patient care for
                                 the entire EHR
                                 reporting period.
                                Measure 2: The          Sec.
                                 eligible hospital or    170.315(a)(4)
                                 CAH has enabled and     (Drug-Drug,
                                 implemented the         Drug-Allergy
                                 functionality for       Interaction
                                 drug[dash]drug and      Checks for
                                 drug[dash]allergy       CPOE).
                                 interaction checks
                                 for the entire EHR
                                 reporting period.
Objective 4: Computerized       Measure 1: More than    Sec.
 Provider Order Entry (CPOE).    60% of medication       170.315(a)(1)
                                 orders created by the   (Computerized
                                 authorized providers   Provider Order
                                 of the eligible        Entry--Medicatio
                                 hospital's or CAH's     ns).
                                 inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period are recorded
                                 using CPOE.

[[Page 62887]]

 
                                Measure 2: More than    Sec.
                                 60% of laboratory       170.315(a)(2)
                                 orders created by the   (Computerized
                                 authorized providers   Provider Order
                                 of the eligible         Entry--Laborato
                                 hospital's or CAH's     ry).
                                 inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period are recorded
                                 using CPOE.
                                Measure 3: More than    Sec.
                                 60% of diagnostic       170.315(a)(3)
                                 imaging orders          (Computerized
                                 created by the          Provider Order
                                 authorized providers    Entry--Diagnost
                                 of the eligible         ic Imaging).
                                 hospital's or CAH's
                                 inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period are recorded
                                 using CPOE.
Objective 5: Patient            Measure 1: For more     Sec.
 Electronic Access.              than 80% of all         170.315(e)(1)
                                 unique patients         (View,
                                 discharged from the     Download, and
                                 eligible hospital or    Transmit to 3rd
                                 CAH inpatient or        Party)
                                 emergency department   Sec.
                                 (POS 21 or 23):         170.315(g)(7)*
                                (1) The patient (or      (Application
                                 the patient             Access--Patient
                                 authorized              Selection).
                                 representative) is     Sec.
                                 provided timely         170.315(g)(8)*
                                 access to view          (Application
                                 online, download, and   Access--Data
                                 transmit his or her     Category
                                 health information.;    Request)*.
                                 and.                   Sec.
                                (2) The provider         170.315(g)(9)
                                 ensures the patient's   (Application
                                 health information is   Access--All
                                 available for the       Data Request)*
                                 patient (or            *The three
                                 patient[dash]authoriz   criteria
                                 ed representative) to   combined are
                                 access using any        the ``API''
                                 application of their    certification
                                 choice that is          criteria.
                                 configured to meet
                                 the technical
                                 specifications of the
                                 API in the provider's
                                 CEHRT.
                                Measure 2: The          Sec.
                                 eligible hospital or    170.315(a)(13)
                                 CAH must use            (Patient-
                                 clinically relevant     Specific
                                 information from        Education
                                 CEHRT to identify       Resources).
                                 patient-specific
                                 educational resources
                                 and provide
                                 electronic access to
                                 those materials to
                                 more than 35% of
                                 unique patients
                                 discharged from the
                                 eligible hospital or
                                 CAH inpatient or
                                 emergency department
                                 (POS 21 or 23) during
                                 the EHR reporting
                                 period.
Objective 6: Coordination of    Measure 1: During the   Sec.
 Care through Patient            EHR reporting period,   170.315(e)(1)
 Engagement.                     more than 10 percent    (View,
                                 of all unique           Download, and
                                 patients (or their      Transmit to 3rd
                                 authorized              Party)
                                 representatives)       Sec.
                                 discharged from the     170.315(g)(7)
                                 eligible hospital or   (Application
                                 CAH inpatient or        Access--Patient
                                 emergency department    Selection)*.
                                 (POS 21 or 23)         Sec.
                                 actively engage with    170.315(g)(8)
                                 the EHR made            (Application
                                 accessible by the       Access--Data
                                 provider and either:    Category
                                (1) view, download or    Request)*.
                                 transmit to a third    Sec.
                                 party their health      170.315(g)(9)
                                 information; or.        (Application
                                (2) access their         Access--All
                                 health information      Data Request)*
                                 through the use of an  *The three
                                 API that can be used    criteria
                                 by applications         combined are
                                 chosen by the patient   the ``API''
                                 and configured to the   certification
                                 API in the provider's   criteria.
                                 CEHRT; or.
                                (3) a combination of
                                 (1) and (2).
                                Measure 2: For more     Sec.
                                 than 25% of all         170.315(e)(2)
                                 unique patients         (Secure
                                 discharged from the     Messaging).
                                 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-
                                 authorized
                                 representative), or
                                 in response to a
                                 secure message sent
                                 by the patient (or
                                 the patient-
                                 authorized
                                 representative)
                                 during the EHR
                                 reporting period.
                                Measure 3:              Sec.
                                 Patient[dash]generate   170.315(e)(3)
                                 d health data or data   (Patient Health
                                 from a non-clinical     Information
                                 setting is              Capture)*.
                                 incorporated into the  *Supports
                                 CEHRT for more than     meeting the
                                 5% of all unique        measure, but is
                                 patients discharged     NOT required to
                                 from the eligible       be used to meet
                                 hospital or CAH (POS    the measure.
                                 21 and 23) during the   The
                                 EHR reporting period.   certification
                                                         criterion is
                                                         part of the
                                                         CEHRT
                                                         definition
                                                         beginning in
                                                         2018.
Objective 7: Health             Measure 1: For more     Sec.
 Information Exchange.           than 50% of             170.315(b)(1)
                                 transitions of care     (Transitions of
                                 and referrals, the      Care).
                                 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.
                                Measure 2: For more     Sec.
                                 than 40% of             170.315(b)(1)
                                 transitions or          (Transitions of
                                 referrals received      Care).
                                 and patient
                                 encounters in which
                                 the provider has
                                 never before
                                 encountered the
                                 patient, the eligible
                                 hospital or CAH
                                 receives or retrieves
                                 and incorporates into
                                 the patient's record
                                 in their EHR an
                                 electronic summary of
                                 care document.
                                Measure 3: For more     Sec.
                                 than 80% of             170.315(b)(2)
                                 transitions or          (Clinical
                                 referrals received      Information
                                 and patient             Reconciliation
                                 encounters in which     and
                                 the provider has        Incorporation).
                                 never before
                                 encountered the
                                 patient, the eligible
                                 hospital or CAH
                                 performs clinical
                                 information
                                 reconciliation.
Objective 8: Public Health and  Measure 1:              Sec.
 Clinical Data Registry          Immunization Registry   170.315(f)(1)
 Reporting.                      Reporting.              (Transmission
                                                         to Immunization
                                                         Registries).
                                Measure 2: Syndromic    Sec.
                                 Surveillance            170.315(f)(2)
                                 Reporting.              (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Syndr
                                                         omic
                                                         Surveillance).

[[Page 62888]]

 
                                Measure 3: Electronic   Sec.
                                 Case Reporting.         170.315(f)(5)
                                                         (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Elect
                                                         ronic Case
                                                         Reporting).
                                Measure 4: Public       Eligible
                                 Health Registry         Hospitals/CAHs
                                 Reporting.              may choose one
                                                         or more of the
                                                         following:
                                                        Sec.
                                                         170.315(f)(6)
                                                         (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Antim
                                                         icrobial Use
                                                         and
                                                         Resistance).
                                                        Sec.
                                                         170.315(f)(7)
                                                         (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Healt
                                                         h Care
                                                         Surveys).
                                Measure 5: Clinical     No 2015 Edition
                                 Data Registry           health IT
                                 Reporting.              certification
                                                         criteria at
                                                         this time.
                                Measure 6: Electronic   Sec.
                                 Reportable Laboratory   170.315(f)(3)
                                 Result Reporting.       (Transmission
                                                         to Public
                                                         Health
                                                         Agencies--Repor
                                                         table
                                                         Laboratory
                                                         Tests and
                                                         Values/
                                                         Results).
------------------------------------------------------------------------

C. Clinical Quality Measurement

1. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 
2015 and 2016
    Under sections 1848(o)(2)(A), 1886(n)(3)(A), and 1814(l)(3)(A) of 
the Act and 42 CFR 495.4, EPs, eligible hospitals, and CAHs must report 
on CQMs selected by CMS using certified EHR technology, as part of 
being a meaningful EHR user under the Medicare and Medicaid EHR 
Incentive Programs.
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20375 through 20376), we proposed to maintain the existing 
requirements established in earlier rulemaking for the reporting of 
CQMs. We summarized the options for CQM submission for providers in the 
Medicare EHR Incentive Program as follows:
     EP Options for Medicare EHR Incentive Program 
Participation (single program Participation--EHR Incentive Program 
only)
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System
    ++ Option 2: Electronically report CQMs through Physician Quality 
Reporting System (PQRS) Portal
     EP Options for Electronic Reporting for Multiple Programs 
(for example: EHR Incentive Program plus PQRS participation)
    ++ Option 1: Report individual EP's CQMs through PQRS Portal
    ++ Option 2: Report group's CQMs through PQRS Portal
    We note that under option 2, this may include an EP reporting using 
the group reporting option, either electronically using QRDA, or via 
the GPRO Web Interface.
     Eligible hospital and CAH Options for Medicare EHR 
Incentive Program Participation (single program participation--EHR 
Incentive Program only)
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System
    ++ Option 2: Electronically report CQMs through QualityNet Portal
     Eligible hospital and CAH Options for Electronic Reporting 
for Multiple Programs (for example: EHR Incentive Program plus IQR 
participation)
    ++ Electronically report through QualityNet Portal
    For the Medicaid EHR Incentive Program, we stated that states would 
continue to be responsible for determining whether and how electronic 
reporting of CQMs would occur, or if they wish to allow reporting 
through attestation. Any changes that states make to their CQM 
reporting methods must be submitted through the State Medicaid Health 
IT Plan (SMHP) process for our review and approval prior to being 
implemented.
    We proposed to maintain the existing CQM reporting requirements of 
nine CQMs covering at least three NQS domains for EPs and 16 CQMs 
covering at least three NQS domains for eligible hospitals and CAHs (77 
FR 54058 for EPs and 77 FR 54056 for eligible hospitals and CAHs).
    Beginning in 2015, we proposed to change the definition of ``EHR 
reporting period'' in Sec.  495.4 for eligible hospitals and CAHs such 
that the EHR reporting period would begin and end in relation to a 
calendar year. In connection with this proposal, we also proposed that 
in 2015 and for all methods of reporting, eligible hospitals and CAHs 
would be required to complete a reporting period for clinical quality 
measures aligned with the calendar year in order to demonstrate 
meaningful use.
    For 2015 only, we proposed to change the EHR reporting period for 
all EPs, eligible hospitals, and CAHs to any continuous 90-day period 
within the calendar year. In connection with this proposal, we proposed 
a 90-day reporting period in 2015 for clinical quality measures for all 
EPs, eligible hospitals, and CAHs that report clinical quality measures 
by attestation. We proposed that EPs may select any continuous 90-day 
period from January 1, 2015 through December 31, 2015, while eligible 
hospitals and CAHs may select any continuous 90-day period from October 
1, 2014 through December 31, 2015, to report CQMs via attestation using 
the EHR Incentive Program registration and attestation system. We 
proposed that a provider may choose to attest to a CQM reporting period 
of greater than 90 days up to and including 1 full calendar year of 
data.
    We further proposed to continue our existing policy that providers 
in any year of participation for the EHR Incentive Programs for 2015 
through 2017 may instead electronically report CQM data using the 
options previously outlined for electronic reporting either for single 
program participation in the Medicare EHR Incentive Programs, or for 
participation in multiple programs if the requirements of the aligned 
quality program are also met. We noted that EPs seeking to participate 
in multiple programs with a single electronic submission would be 
required to submit a full calendar year of CQM data using

[[Page 62889]]

the 2014 electronic specifications for the CQMs (which are also known 
as eCQMs) for a reporting period in 2015. We also noted that eligible 
hospitals and CAHs seeking to participate in multiple programs with a 
single electronic submission for a reporting period in 2015 would be 
required to submit one calendar quarter of data for 2015 from either Q1 
(January 1, 2015-March 31, 2015), Q2 (April 1, 2015-June 30, 2015), or 
Q3 (July 1, 2015-September 30, 2015) and would require of the use of 
the April 2014 release of the eCQMs. For further information on the 
requirements for eligible hospitals and CAHs electronically submitting 
CQMs for a reporting period in 2015 for the Medicare EHR Incentive 
Program, we referred readers to the FY 2015 IPPS final rule (79 FR 
50319 through 50323).
    We noted that an EHR certified for CQMs under the 2014 Edition 
certification criteria does not need to be recertified each time it is 
updated to a more recent version of the eCQMs.
    Comment: We received many comments in support of maintaining the 
existing CQM reporting requirements and aligning CQM requirements with 
other quality programs where possible, including support of our 
proposal to align reporting for eligible hospitals and CAHs to the 
calendar year. Some commenters expressed concerns over their ability to 
report CQMs, and some commenters requested that CMS expand the number 
of CQMs available to specialists.
    Response: We appreciate the comments in support of our proposals 
and understand the concerns raised by others. CMS continues to evaluate 
the available CQMs for inclusion in the EHR Incentive Programs and will 
consider adding CQMs to the program as they are developed and found to 
be appropriate for inclusion. In the meantime, we understand that there 
are situations in which an EP, eligible hospital or CAH does not have 
data to report on for a particular CQM, and its EHR is not certified to 
additional CQMs or does not have additional CQMs available to report 
on. In these instances, we believe that our policy on allowing zero 
denominators to be reported allow these providers and specialists to 
meet the CQM reporting requirements of the EHR Incentive Programs (see 
the Stage 2 final rule 77 FR 54059 and 54079 and FY 2015 IPPS final 
rule 79 FR 50323).
    Comment: A few commenters suggested that we further align the 
Medicare EHR Incentive Program with PQRS and allow EPs reporting 
through a Qualified Clinical Data Registry (QCDR) to satisfy the CQM 
reporting requirements for meaningful use.
    Response: The QCDR reporting mechanism was introduced for the 
Physician Quality Reporting System (PQRS) beginning in 2014. For 2015, 
a QCDR is a CMS-approved entity that collects medical and clinical 
data, or both, for the purpose of patient and disease tracking to 
foster improvement in the quality of care provided to patients. A QCDR 
is different from a PQRS qualified registry in that it is not limited 
to reporting data on measures within the PQRS measure set or the EHR 
Incentive Program. We appreciate the commenters' suggestion to allow 
CQM reporting for the EHR Incentive Programs through the PQRS QCDR 
option and will consider broadening our policy to accept all QCDR 
submissions in future policy and rulemaking. Currently, EPs can report 
on CQMs through a QCDR and satisfy some of the requirements for the 
Medicare EHR Incentive Program, as well as PQRS requirements, if they 
submit CQMs using certified EHR technology and the approved QRDA-I or 
QRDA-III format (78 FR 74754 through 74755). We note for the Medicare 
EHR Incentive Program, the only CQMs that may be reported through a 
QCDR are those finalized in the Stage 2 final rule (77 FR 54069 through 
54075), and this does not include the non-PQRS measures submitted via 
QCDR.
    Comment: Some commenters suggested that reporting on CQMs could be 
removed as a requirement from the EHR Incentive Program.
    Response: As we noted in the Stage 2 final rule (77 FR 54056 
through 54078), CQM reporting is a statutory requirement for providers 
seeking to be meaningful users of certified EHR technology. In 
addition, as noted in the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20351) and in the Stage 3 proposed rule (80 FR 
16740 through 16741), the use of EHR technology to submit information 
on clinical quality measures is defined in the HITECH Act as a key 
foundational principle and policy of meaningful use (see sections 
1848(o)(2)(A) and 1886(n)(3)(A) of the Act). Additionally, we believe 
CQM reporting is key to the continued efforts to improve the quality of 
care in a patient centered delivery system reform model. We maintain 
our commitment to CQM reporting as part of meaningful use of certified 
EHR technology.
    Comment: Many commenters supported our proposal to allow a 90-day 
reporting period for clinical quality measures for all EPs, eligible 
hospitals, and CAHs that report clinical quality measures by 
attestation. Some commenters additionally suggested that this option 
should be extended to every year of the EHR Incentive Programs. Some 
commenters noted that alignment with other quality programs such as 
PQRS requires full-year reporting even in 2015, and therefore this 
policy does not align with those quality programs. Commenters also 
suggested that there be a 90-day reporting period for PQRS.
    Response: We appreciate the comments in support of our proposal. We 
note that our proposal was for 2015 only, and that we are not extending 
it to 2016 or subsequent years. We also acknowledge that this 90-day 
reporting period does not fully align with other CMS quality programs 
such as PQRS, and that each quality program has its own reporting 
requirements. While we seek to align the CMS quality programs wherever 
possible and as appropriate, we acknowledge that this is one area where 
a provider seeking to satisfy the various requirements of multiple 
programs would need to report data separately to each program, or 
choose to instead report through one of our aligned options.
    After consideration of the public comments, we are finalizing all 
of the proposals discussed previously as proposed. We note that after 
these proposals were published, we published the August 17, 2015 FY 
2016 IPPS final rule (80 FR 49756 through 49761), which includes 
additional final policies for eligible hospitals and CAHs reporting 
CQMs in 2016 for the Medicare EHR Incentive Program.
2. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 
2017 and Subsequent Years
a. Clinical Quality Measure Reporting Requirements for EPs
    In the Stage 3 proposed rule (80 FR 16768), we noted that 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 quality programs affecting EPs. We 
noted 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 proposed to continue the policy of establishing certain CQM 
requirements

[[Page 62890]]

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.
    Comment: Commenters supported the alignment efforts between the 
Medicare EHR Incentive Program and PQRS or other quality programs 
affecting EPs. Most commenters stated that alignment would reduce 
burden on EPs and streamline the quality reporting process. Some 
commenters also appreciated the link between the annual rulemaking 
cycle and updates to the CQMs stating that aligning CQM requirements 
for the EHR Incentive Programs with other quality programs in annual 
rulemaking would require measure developers to revise their CQM 
specifications more frequently, helping to ensure CQMs reflect the 
latest clinical evidence.
    Response: We appreciate the commenters' support of our proposal, 
and agree that aligning the Medicare EHR Incentive Program and PQRS or 
other quality programs affecting EPs would reduce burden on EPs. We 
also agree that annual rulemaking will allow CMS to ensure that CQMs 
used in quality reporting programs are updated regularly.
    Comment: A few commenters suggested that since CQMs are a 
requirement of multiple EP quality programs, they could be removed from 
the EHR Incentive Program requirements because this CQM reporting is 
redundant.
    Response: We appreciate the commenters' suggestion. However, as 
noted previously, CQM reporting for the EHR Incentive Programs is 
required by section 1848(o)(2)(A)(iii) of the Act and an integral part 
of the National Quality Strategy for CMS and HHS as a whole. We further 
note that in the EHR Incentive Programs in 2015 through 2017 proposed 
rule (80 FR 20375) we stated our intent to maintain these CQM policies 
as previously finalized. We further believe that by aligning the CQM 
requirements of the different quality reporting programs, we are 
reducing burden and removing the redundancy of CQM reporting by 
allowing EPs to report once for multiple programs.
    Comment: Some commenters expressed concerns regarding the amount of 
time between the publication of the PFS final rule and when the CQMs 
and policies would go into effect. Many expressed concern over whether 
their EHR vendor would have time to certify and update their system to 
the most recent version of the CQMs.
    Response: We understand the commenters' concerns and note that CQMs 
referenced in the PFS rulemaking are generally updated annually, and 
certain updates are posted in advance of the final rule. We also note 
that re-certification of EHR technology is not required for the CQM 
annual update. Additionally, we have taken steps to align certain 
aspects of the various CMS quality reporting programs that include the 
submission of CQMs.
    Comment: Other commenters expressed concern about the number of 
stakeholders involved in these aligned programs, and stated that it 
would be challenging for EPs to get answers to questions or responses 
from CMS due to the number of stakeholders involved in CQM submissions.
    Response: We understand this concern, and we note that we also 
continue to align CMS help desks, feedback processes, and other 
resources to avoid delays in answering questions. We believe that 
alignment of the CQM requirements along with this coordination effort 
will greatly reduce burden on EPs.
    Comment: While commenters acknowledged the alignment effort to 
address CQM policies in the PFS rule, some also requested further 
clarification in regard to how CQM alignment among the programs would 
work. Specifically, they questioned whether EPs who choose to attest in 
2017 would still be required to report to other quality programs, or 
whether attestation could count for multiple programs.
    Response: We appreciate the question and opportunity to further 
explain this policy, which is a current policy not a new policy. 
Reporting CQMs by attestation under the EHR Incentive Programs is not 
an acceptable method of submission for other CMS quality reporting 
programs because, unlike the EHR Incentive Programs, these other 
programs have not adopted attestation as a reporting mechanism and also 
have additional requirements that relate to the results of the CQM 
calculation. Therefore, reporting CQMs by attestation for the EHR 
Incentive Programs would not count toward CQM reporting for other 
quality programs. EPs who choose to report CQMs for the EHR Incentive 
Programs by attestation in 2017 would need to separately report to 
other quality programs via one of the approved reporting mechanisms for 
the particular program.
    After consideration of the public comments we received, we intend 
to continue our 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. We 
intend to address CQM reporting requirements for the Medicare and 
Medicaid EHR Incentive Programs for EPs in the PFS rulemaking. We 
intend to continue to allow the states to determine form and manner of 
reporting CQMs for their respective state Medicaid EHR Incentive 
Programs subject to CMS approval.
b. CQM Reporting Requirements for Eligible Hospitals and Critical 
Access Hospitals
    In the Stage 3 proposed rule (80 FR 16769), similar to our 
intentions for EPs discussed previously, we noted that 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. We stated that 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. We proposed 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.
    Comment: Commenters supported the alignment efforts between the 
Medicare EHR Incentive Program and Hospital IQR Program. Most 
commenters stated that alignment would reduce burden on eligible 
hospitals and CAHs. Some commenters also appreciated the link between 
the annual rulemaking cycle and updates to the CQMs stating that 
aligning CQM requirements for the EHR Incentive Program with other 
quality programs in annual rulemaking would require measure developers 
to revise their CQM specifications more frequently helping to ensure 
that CQMs reflect the latest clinical evidence.
    Response: We appreciate the commenters' support of our proposal, 
and agree that aligning the Medicare EHR Incentive Program and the 
Hospital IQR Program or other quality programs affecting eligible 
hospitals and CAHs would reduce burdens. We also agree that annual 
rulemaking will allow CMS

[[Page 62891]]

to ensure that CQMs used in quality reporting programs are updated 
regularly.
    Comment: Some commenters expressed concerns regarding the amount of 
time between the publication of the IPPS final rule and when the CQMs 
and policies would go into effect. Many expressed concern over whether 
their EHR vendor would have time to certify and update their system to 
the most recent version of the CQMs, and a few went on to request that 
changes to CQMs and submission requirements not change from one quarter 
reporting period to the next.
    Response: We understand the commenters' concerns and note that CQMs 
referenced in the IPPS rulemaking are generally updated annually, and 
certain updates are posted in advance of the final rule. The 2016 IPPS 
final rule provides flexibility to eligible hospitals and CAHs needing 
to update their EHR systems only for the most recent version of the 
CQMs. No changes to 2014 CEHRT criteria or timelines are being 
finalized in this final rule with comment period.
    Comment: Some commenters expressed concerns related to CMS' ability 
to accept electronically submitted CQMs.
    Response: We understand the commenters' concerns. CMS has worked to 
continually develop and improve its CQM receiving system for the 
purposes of collecting CQMs electronically.
    Comment: Some commenters noted that the Hospital IQR Program is not 
required for CAHs and requested clarification on how the alignment of 
the Medicare EHR Incentive Program and Hospital IQR Program would 
impact CAHs seeking to electronically submit their CQM data.
    Response: We agree that the Hospital IQR Program is not required 
for CAHs. Only subsection (d) hospitals are subject to the requirements 
and payment reductions of the Hospital IQR Program. For the EHR 
Incentive Programs, CAHs may continue to report their CQM data by 
attestation in CY 2016. However, we encourage CAHs to submit their CQMs 
electronically through the QualityNet portal. We believe electronic 
submission of CQMs is an important next step in the meaningful use of 
certified EHR technology, and encourage CAHs to begin submitting CQMs 
electronically in 2016. We further note that in section II.C.4 of this 
final rule with comment period, we finalize our policy to require the 
electronic submission of CQMs starting in 2018 and thus encourage CAHs 
to begin electronically reporting CQMs as soon as feasible.
    After consideration of the public comments we received, we intend 
to continue our 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. We 
intend to address CQM reporting requirements for the Medicare and 
Medicaid EHR Incentive Programs for eligible hospitals and CAHs in the 
IPPS rulemaking. We intend to continue to allow the states to determine 
form and manner of reporting CQMs for their respective state Medicaid 
EHR Incentive Programs subject to CMS approval.
c. Quality Reporting Data Architecture Category III (QRDA-III) Option 
for Eligible Hospitals and CAHs
    In the Stage 3 proposed rule (80 FR 16771), we proposed to remove 
the QRDA-III option for eligible hospitals and CAHs, as we believe the 
CQM calculations, per the QRDA-III, are not advantageous to quality 
improvement in a hospital setting. We noted that as the EHR Incentive 
Programs 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.
    We also proposed that states would continue to have the option, 
subject to our prior approval, to allow or require QRDA-III for CQM 
reporting.
    We received comments regarding these proposals in response to the 
Stage 3 proposed rule, as well as comments regarding the QRDA-III 
option in response to the FY 2016 IPPS/LTCH PPS proposed rule. We 
considered these comments and responded to them in the FY 2016 IPPS/
LTCH PPS final rule, and we finalized our proposal to remove the QRDA-
III as an option for reporting under the Medicare EHR Incentive 
Program. We stated that for 2016 and future years, we are requiring 
QRDA-I for CQM electronic submissions for the Medicare EHR Incentive 
Program. We also noted that states would continue to have the option, 
subject to our prior approval, to allow or require QRDA-III for CQM 
reporting. For more information, we refer readers to the discussion in 
the FY 2016 IPPS/LTCH PPS final rule (80 FR 49759 through 49760).
3. CQM Reporting Period Beginning in 2017
    In the Stage 3 proposed rule (80 FR 16773), we proposed to require 
an EHR reporting period of one 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 (80 FR 16779). We proposed to require the same 
length for the CQM reporting period for EPs, eligible hospitals, and 
CAHs beginning in 2017. We proposed 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.
a. CQM Reporting Period for EPs
    We proposed to require a CQM 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. We proposed these reporting 
periods would apply beginning in CY 2017 for all EPs participating in 
the EHR Incentive Program.
    Comment: Most commenters supported one full calendar year of 
reporting for EPs participating in the EHR Incentive Programs. Some 
commenters stated that they believed this would result in more complete 
and accurate data. A few commenters stated that no exception should be 
granted for Medicaid providers demonstrating meaningful use for the 
first time because this exception would cause confusion. A commenter 
recommended that under this exception, we allow the 90-day reporting 
period for CQMs to be different than the 90-day EHR reporting period.
    Response: We appreciate the comments in support of our proposal, 
and we agree that a full year of reporting would lead to more complete 
data. However, we believe that a 90-day CQM reporting period is 
appropriate for the Medicaid EHR Incentive Program when the EP is 
attesting to meaningful use for the first time. A 90-day CQM reporting 
period would allow Medicaid EPs additional time and flexibility within 
their first year of demonstrating meaningful use to implement certified 
EHR technology and otherwise integrate the meaningful use objectives 
into their practices. We also believe that it 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

[[Page 62892]]

of meaningful use is consistent with our previous policies and 
meaningful use timelines. We agree with the commenter's recommendation 
that we not require the reporting period for CQMs to be the same 90-day 
period as the EHR reporting period under the exception proposed for 
Medicaid. We believe it is appropriate for the CQM reporting period to 
be any continuous 90-day period in the calendar year for providers 
demonstrating meaningful use for the first time under the Medicaid EHR 
Incentive Program. This will give providers flexibility with attesting 
and would not require states to make system changes as there are 90-day 
reporting periods under the current policy.
    Comment: Some commenters opposed the proposal stating that there is 
additional work that needs to be done to assess the feasibility, 
accuracy, and reliability of electronically reported data, while others 
stated that requiring one calendar year of electronically submitted 
data creates additional burden on EPs to collect that data. A few 
commenters suggested a 90-day reporting period for all EPs in 2018 when 
electronic reporting is required.
    Response: We understand the commenters' concerns and note that CMS 
continues to assess electronically reported data for accuracy and 
reliability. If data is determined to be flawed, such data will be 
identified by CMS in order to preserve the integrity of data used for 
differentiating performance. Additionally we note that one calendar 
year of data is required for PQRS and other quality reporting programs 
with which we seek to align the EHR Incentive Program; this alignment 
reduces provider burden by allowing EPs to report once for multiple 
programs. We believe full year reporting is necessary for the efficacy 
of quality measurement and quality improvement planning, and, in fact, 
most CQMs are designed to be collected over a 12-month period, 
including multiple variables to track change over time. As mentioned in 
the Stage 3 proposed rule, we believe full year CQM reporting will 
allow for the collection of more comparable data across CMS quality 
programs, increase alignment across those programs, and 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 (79 FR 16769). While we are 
allowing a 90-day EHR reporting period for EPs who demonstrate Stage 3 
in 2017, we do not believe it is necessary to similarly allow returning 
participants who are participating in Stage 3 to also use a 90-day 
reporting period for CQMs for 2017. The shorter reporting period for 
Stage 3 participants is intended to ease the transition to the new 
Stage 3 objectives and measures and higher thresholds. There is no such 
difference between the CQM requirements for Stage 3 participation in 
2017 versus participation meeting the objectives and measures outline 
for use in 2015 through 2017 in section II.B.2.a of this final rule 
with comment period.
    Note that there is also a 90-day EHR reporting period permitted in 
2017 for EPs participating for the first time in either the Medicare or 
Medicaid EHR Incentive Programs. Consistent with prior program years, 
we are permitting EPs participating for the first time in 2017 to use a 
90-day reporting period for CQMs.
    After considering the public comments we received, we are 
finalizing our proposal to require a CQM reporting period of one full 
calendar year for EPs participating in the Medicare and Medicaid EHR 
Incentive Programs starting in 2017. We are finalizing with 
modification our proposal of a limited exception for EPs demonstrating 
meaningful use for the first time under the Medicaid EHR Incentive 
Program. For these EPs, the reporting period for CQMs would be any 
continuous 90-day period within the CY, with the modification that it 
could be a different 90-day period than their EHR reporting period for 
the incentive payment under Medicaid.
b. CQM Reporting Period for Eligible Hospitals and CAHs
    For eligible hospitals and CAHs in 2017 and subsequent years, in 
the Stage 3 proposed rule (80 FR 16770)we proposed to require a 
reporting period of one 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. We stated that 
more details of the form and manner will be provided in the IPPS 
rulemaking cycle.
    Comment: Most commenters supported one full calendar year of 
reporting for eligible hospitals and CAHs participating in the EHR 
Incentive Programs. Some commenters stated that they believed this 
would result in more complete and accurate data, and others expressed 
support for a consistent reporting period across reporting programs. 
Some commenters opposed the proposal stating that there is additional 
work that needs to be done to assess the feasibility, accuracy, and 
reliability of electronically submitted data. Some commenters opposed 
the proposal stating that it creates additional burden on eligible 
hospitals and CAHs to collect the data, and some went on to suggest 
that CMS continue the validation pilot instead of requiring one full 
year of electronically submitted data in 2018. A few commenters 
suggested a 90-day reporting period for all eligible hospitals and CAHs 
in 2018 when electronic reporting is required. A commenter recommended 
that under the limited exemption for Medicaid eligible hospitals and 
CAHs, we should allow the 90-day reporting period for CQMs to be 
different than the 90-day EHR reporting period.
    Response: We appreciate the comments we received in support of our 
proposal, and agree that accepting one full year of data will result in 
more complete and accurate data. We understand the concerns stated by 
commenters regarding the additional burden and efforts associated with 
collecting this data, but we note that providers would be able to 
submit one full year of data for both the EHR Incentive Program and the 
Hospital IQR Program, thereby reducing provider burden. We further note 
that CMS continues to assess electronically submitted data for accuracy 
and reliability. If data is determined to be flawed, such data will be 
identified by CMS in order to preserve the integrity of data used for 
differentiating performance.
    While we are allowing a 90-day EHR reporting period for eligible 
hospitals and CAHs who demonstrate Stage 3 in 2017, we do not believe 
it is necessary to similarly allow returning participants who are 
participating in Stage 3 to also use a 90-day reporting period for CQMs 
for 2017. The shorter reporting period for Stage 3 participants is 
intended to ease the transition to the new Stage 3 objectives and 
measures and higher thresholds. There is no such difference between the 
CQM requirements for Stage 3 participation in 2017 versus participation 
meeting the objectives and measures outlined for use in 2015 through 
2017 in section II.B.2.a. of this final rule with comment period.
    Note that there is also a 90-day EHR reporting period permitted in 
2017 for eligible hospitals and CAHs participating for the first time 
in either the Medicare or Medicaid EHR Incentive Programs. Consistent 
with prior program years, we are permitting eligible hospitals and CAHs

[[Page 62893]]

participating for the first time in 2017 to use a 90-day reporting 
period for CQMs.
    After consideration of the public comments that we received, we are 
finalizing our proposal to require a reporting period of one full 
calendar year which consists of 4 quarterly data reporting periods 
starting in 2017 for eligible hospitals and CAHs participating in the 
Medicare and Medicaid EHR Incentive Program. We are finalizing with 
modification our proposal of a limited exception for eligible hospitals 
and CAHs demonstrating meaningful use for the first time under the 
Medicaid EHR Incentive Program. For these eligible hospitals and CAHs, 
the reporting period for CQMs would be any continuous 90-day period 
within the CY, with the modification that it could be a different 90-
day period than their EHR reporting period for the incentive payment 
under Medicaid. More details of the form and manner will be provided in 
the IPPS rulemaking cycle.
c. Reporting Flexibility for EPs, Eligible Hospitals, and CAHs in 2017
    We proposed 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 (80 FR 16770). 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.
    Comment: Commenters supported our proposal to allow more 
flexibility in 2017 reporting. Most commenters supported a move toward 
electronic reporting, and also agreed that attestation should remain an 
option for 2017 to provide options to, and reduce burden on EPs, 
eligible hospitals, and CAHs. Some commenters supported our proposal 
but urged CMS to make electronic reporting mandatory in 2018 or move up 
the timeline to require mandatory electronic reporting as soon as 
possible.
    Response: We appreciate the comments in support of our proposal, 
and agree with commenters' statements that flexibility reduces burden 
on EPs, eligible hospitals, and CAHs. We also appreciate commenters' 
support of a move toward electronic reporting, and requiring electronic 
reporting in 2018 or moving up the timeline for mandatory electronic 
reporting. We believe electronic reporting is an important step in 
demonstrating meaningful use of certified EHR technology and note that 
in section II.C.4 of this final rule with comment period, we are 
finalizing our proposal to require electronic reporting in 2018 where 
feasible.
    After consideration of these public comments, we are finalizing 
this policy as proposed.
4. Reporting Methods for CQMs
    In the Stage 3 proposed rule (80 FR 16770), starting in 2017, we 
proposed 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 the Stage 3 proposed rule (80 FR 
16770), we would allow attestation for CQMs in 2017.
    For 2018 and subsequent years, we proposed that providers 
participating in the Medicare EHR Incentive 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 noted 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 proposed 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 proposed 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. We have included Table 17 in this final rule with comment 
period as a summary of our proposals (80 FR 16770).

           Table 17--Proposed eCQM Reporting Timelines for Medicare and Medicaid EHR Incentive Program
----------------------------------------------------------------------------------------------------------------
                                                                               2018 and            2018 and
              Year                     2017 Only           2017 Only       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
                                  Medicaid providers  Medicaid providers   circumstances      Medicaid providers
                                   must refer to       must refer to       rendering them      must refer to
                                   state               state               unable to eReport.  state
                                   requirements for    requirements for   Medicaid providers   requirements for
                                   reporting.          reporting.          must refer to       reporting.
                                                                           state
                                                                           requirements for
                                                                           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.
eCQM Version Required...........  2016 Annual Update  2016 Annual Update  2016 Annual Update  2017 Annual
(CQM electronic specifications                                             or more recent      Update.
 update).                                                                  version.
CEHRT Edition Required..........  2014 Edition Or     2014 Edition Or     2015 Edition......  2015 Edition
                                   2015 Edition.       2015 Edition.
----------------------------------------------------------------------------------------------------------------


[[Page 62894]]

    Comment: Most commenters supported the move to electronic 
reporting; however, they did so with caution. Commenters expressed 
their support, as well as concerns, related to the feasibility of the 
move to electronic reporting of CQMs citing issues with data submission 
and the reliability of CQMs. Some commenters expressed concerns about 
committing to a timeline for implementing electronic reporting of CQMs 
stating that they had concerns about future updates to CQMs and the 
difficulties eligible hospitals face in implementing CQMs currently.
    Response: We appreciate the comments in support of our move to 
electronic reporting, and understand some of the concerns that come 
along with that move. CMS continues to evaluate the accuracy and 
reliability of CQM data received from providers. We believe that it is 
important to set a timeline for requiring electronic reporting and to 
give EPs, eligible hospitals, CAHs and their EHR vendors time to 
prepare for this requirement.
    Comment: A few commenters requested clarification as to which CQM 
version would be accepted via attestation.
    Response: We appreciate the comments and the opportunity to clarify 
our policy. For 2017 reporting, we will accept the 2016 version of the 
CQM specifications for both attested and electronically reported CQMs. 
For 2018 reporting, we will accept the 2017 version of the CQM 
specifications for both attested and electronically reported CQMs. For 
2018, we will additionally accept the 2016 version of the CQM 
specifications for attestation. We note that attestation in 2018 will 
be allowed for 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, and we are therefore 
allowing either the 2016 or 2017 version of the CQM specifications due 
to this exception.
    Comment: A few commenters stated that since attestation to core 
objectives is a manual process, CQM submission should also remain a 
manual process and the two should not be split.
    Response: We believe that electronic reporting is a valuable step 
in demonstrating meaningful use and helps us to reach our goal of 
alignment with other quality reporting programs. In addition, we note 
that the data received via electronic reporting is valuable and 
necessary for quality improvement.
    Comment: A few commenters suggested that CMS should direct states 
on reporting method to prevent too much variation among the state and 
federal programs.
    Response: While we appreciate the commenters' suggestion, we 
believe that, consistent with our policy in previous years for the EHR 
Incentive Programs, the reporting method for CQMs in the Medicaid EHR 
Incentive Program is an operational question that is best left to state 
discretion subject to our approval. Allowing states flexibility with 
respect to the reporting method for CQMs permits states to continue 
using attestation or to pursue other options such as electronic 
reporting. We believe this is appropriate given the varying 
capabilities and policies among states regarding CQM submission.
    We are finalizing our policy as proposed, that in 2017 all 
providers have two options to report CQM data, either through 
attestation or through use of established methods for electronic 
reporting where feasible. Starting in 2018, providers participating in 
the Medicare EHR Incentive 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. We are also finalizing our proposal that for the Medicaid EHR 
Incentive Program states would continue 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. We note that if a state does require such electronic 
reporting, the state is responsible for sharing the details of the 
process with its provider community. We also note that the states would 
establish the method and requirements, subject to our prior approval, 
for the electronic capture and reporting of CQMs from CEHRT.
5. CQM Specification and Changes to the Annual Update
    In the Stage 3 proposed rule (80 FR 16771), we recognized 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. 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 
and providers must regularly implement those updates to stay current 
with the most recent CQM version.
    In the Stage 3 proposed rule (80 FR 16771), we proposed no changes 
to our policy on updating CQM specifications. However, we stated that 
we will 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 received many comments in response to our request for comments. 
However, we note that we did not make any specific proposal in regard 
to the annual update process for CQMs.
    Comment: Many commenters expressed concerns regarding the timing 
and frequency of annual updates. Several stated that EHR vendors need 
more time to update the CQMs in their EHRs and suggested updates should 
be minimal, or that the new specifications for CQMs should be released 
well in advance of their implementation. A few commenters suggested 
that the CQM updates should be more frequent, such as monthly, to 
address changes in clinical guidance and to keep the CQMs relevant.
    Response: We appreciate both perspectives on this subject and note 
that the CQM specifications are posted at least 6 months prior to the 
reporting period. We believe it is important to reflect the most recent 
clinical guidance in CQMs, and therefore seek to find an appropriate 
balance between the timing of the posting of CQM specifications and the 
reporting period for those CQMs.
    Comment: Some commenters suggested that recertification should be 
required with each update to the CQMs.
    Response: At this time, we do not require recertification with the 
annual update, but instead strongly recommend and encourage EHR vendors 
to test their products against CMS verification tools and receiving 
systems.
    Comment: Some commenters suggested that CMS have some flexibility 
in when a CQM can be updated in order to address those situations where 
a CQM required an update mid-year. For example, these commenters 
suggested that CMS be able to update or suspend the use of that CQM at 
any point during the year.
    Response: We appreciate all comments received in regard to the 
annual update process, and will take

[[Page 62895]]

them into consideration for future rulemaking and policy development. 
We note that we did not make any specific proposals in the Stage 3 
proposed rule, and thus are not finalizing any change to our policy at 
this time.
6. Certified EHR Technology Requirements for CQMs
    In the 2014 Edition EHR Certification Criteria Final Rule, ONC 
finalized certain certification criteria to support the meaningful use 
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.
    As stated in the Stage 3 proposed rule (80 FR 16771 through 16772), 
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 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. 
In the Stage 3 proposed rule (80 FR 16771 through 16772), we sought 
comment on a plan to increase the number of CQMs to which an EHR is 
certified.
    Comment: We received many comments in support of a plan to require 
EHR vendors to certify to more than the minimum required CQMs, and 
several comments in support of a plan to have EHR vendors certify to 
all CQMs. Most commenters stated that either approach would reduce 
burden on EPs, eligible hospitals, and CAHs by allowing them to choose 
which measures to report instead of being forced to report on only 
those CQMs to which their EHR is certified. Commenters also stated that 
having more CQMs to choose from would reduce the number of zero 
denominators that are reported to CMS because EPs, eligible hospitals, 
and CAHs would have better access to CQMs for which they have patient 
data. Some commenters also proposed alternative plans such as a 
requirement to have EHRs certify to ``capture and export'' all CQMs, 
but not necessarily to ``calculate and report'' those CQMs, or to have 
all consumers of CQM data, including states, private payers, etc., 
agree on one set of CQMs to be reported.
    A few commenters opposed any plan to require a certain number of 
CQMs to which EHRs must be certified stating that EHR vendors should be 
allowed to choose CQMs based on their provider population or specialty 
product. Some commenters opposed the plan to certify to all CQMs 
because of the burden it would place on EHR vendors, and because it 
would force EHRs to be certified to CQMs that are not relevant to the 
EHR's provider population. Other commenters expressed concern about a 
plan to certify to all CQMs, even in a phased approach, because they 
were unclear about the number and quality of the CQMs to be included in 
future years of the EHR Incentive Program. Lastly, some commenters 
expressed concern about the burden this plan could place on EPs, 
eligible hospitals, and CAHs because of the added effort it would take 
to implement these measures in their provider setting.
    Response: We appreciate all of the comments we received in regard 
to the plans we outline in the proposed rule(s). We note that we did 
not make any proposals to implement these plans, and we will not be 
finalizing any policy regarding a requirement to have EHRs certify to a 
certain number of CQMs. We agree with the majority of commenters that 
EHRs should be required to certify to more than the minimum number of 
CQMs for reporting. However, we are still determining what that number 
should be, and will take these comments into consideration as we 
continue to develop that policy.
7. Electronic Reporting of CQMs
    As previously stated in the Medicare and Medicaid EHR Incentive 
Programs Stage 2 final rule (77 FR 54051 through 54053) and restated in 
the Stage 3 proposed rule (80 FR 16772), CQM data submitted by EPs, 
eligible hospitals, and CAHs are required to be captured, calculated, 
and reported using certified EHR technology. We do not consider the 
manual abstraction of data from a patient's chart 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.
    Comment: We received several comments regarding the manual 
extraction of data from a patient's chart. Specifically, a few 
commenters objected to the loss of opportunity to manually extract data 
from a patient's chart, and a few stated their need to continue 
extracting data from a patient's chart.
    Response: We did not make any proposals on this subject in the 
Stage 3 proposed rule, but noted that we do not consider the manual 
abstraction of data from the EHR to be capturing the data using 
certified EHR technology (80 FR 16772). Explanation of our goal to 
transition from manual abstraction of data to electronic reporting for 
hospital reporting can be found in the Medicare and Medicaid EHR 
Incentive Programs

[[Page 62896]]

Stage 2 final rule (77 FR 54078 through 54079).

D. Demonstration of Meaningful Use and Other Issues

1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
    In the EHR Incentive Programs for 2015 through 2017 and the Stage 3 
proposed rules, we proposed to continue our common method for 
demonstrating meaningful use in both the Medicare and Medicaid EHR 
Incentive Programs (80 FR 20376 and 80 FR 16772). The demonstration 
methods we adopt for Medicare will automatically be available to the 
states for use in their Medicaid programs.
b. Methods for Demonstration of the Criteria for Meaningful Use in 2015 
through 2017
    As mentioned previously in section II.B.1.b.(2). of this final rule 
with comment period, we are redesignating the numbering of certain 
sections of the regulation text under part 495. In prior rules, we 
defined the criteria for the demonstration of meaningful use at Sec.  
495.8, which is redesignated as Sec.  495.40. We defined the criteria 
for the demonstration of meaningful use at Sec.  495.40, including 
references to the objectives and measures as well as the requirement to 
report CQMs. In order to demonstrate meaningful use in 2015 through 
2017, we proposed (80 FR 20374) that the requirements at Sec.  495.40 
include a reference to the objectives and measures for 2015 through 
2017 outlined at Sec.  495.22 which the provider must satisfy (80 FR 
20376).
    We proposed to continue the use of attestation as the method for 
demonstrating that an EP, eligible hospital, or CAH has met the 
objectives and measures of meaningful use. Instead of individual 
Medicare EP attestation through the CMS Registration and Attestation 
System, we also proposed to continue the existing optional batch file 
process for attestation. Further, we proposed changes to the deadlines 
for EPs, eligible hospitals, and CAHs to demonstrate meaningful use in 
2015 and 2016; as well as specific changes to the deadlines for 
providers to demonstrate meaningful use for the first time in 2015 and 
2016 in order to avoid a payment adjustment in the subsequent year.
    Comment: A number of commenters requested additional support for 
providers seeking to attest for an EHR reporting period in 2015 given 
the proposed changes for the program in 2015.
    Response: We understand the need to provide information for 
providers as quickly as possible and will work to create educational 
guides, FAQs, tip sheets, and other tools to support providers seeking 
to meet the requirements of the EHR Incentive Program for an EHR 
reporting period in 2015.
    After consideration of the comments received, we are finalizing our 
proposal to maintain attestation as the demonstration method for EHR 
reporting periods in 2015 through 2017 and the corresponding regulation 
text at Sec.  495.40.
c. Attestation Deadlines for the EHR Incentive Programs in 2015 through 
2017
    In the EHR Incentive Program in 2015 through 2017 proposed rule (80 
FR 20376), we proposed changes to the attestation deadlines for 
eligible hospitals and CAHs in connection with the proposal that these 
providers must complete an EHR reporting period between October 1, 2014 
and the end of the calendar year (CY) on December 31, 2015, and 
complete an EHR reporting period for 2016 between January 1, 2016 and 
December 31, 2016. Specifically, we proposed changes to the attestation 
deadlines as follows:
     For an EHR reporting period in 2015, an eligible hospital 
or CAH must attest by February 29, 2016.
     For an EHR reporting period in 2016, an eligible hospital 
or CAH must attest by February 28, 2017.
    In addition, we noted that providers would not be able to attest 
for an EHR reporting period in 2015 prior to January 1, 2016 in order 
to allow adequate time to make the system changes necessary to accept 
attestations. This change would not delay incentive payments for 
Medicare EPs because 2015 cannot be an EP's first payment year under 
section 1848(o)(1)(B)(v) of the Act. Thus, all EPs who qualify for an 
incentive payment for 2015 would be returning participants in the 
program and would have had the full CY 2015 as their EHR reporting 
period under our current policy. We received the following comments and 
our response follows:
    Comment: A number of commenters requested that CMS allow providers 
to attest to an EHR reporting period for 2015 prior to the finalization 
of the proposals contained in the EHR Incentive Programs in 2015 
through 2017 proposed rule for various reasons, including concerns 
about the load on CMS systems in the attestation period if all 
providers attest at the same time. Others commenters expressed similar 
concerns if hospital attestations are added to that total. Finally, a 
number of commenters requested that systems be opened early to allow 
eligible hospitals that are attesting for the first time to earn an 
incentive payment as quickly as possible.
    Response: First, we note that under the Administrative Procedure 
Act, we could not accept attestations for 2015 that are based solely on 
proposals made in a notice of proposed rulemaking. Second, as we stated 
in the EHR Incentive Program in 2015 through 2017 proposed rule (80 FR 
20376), the majority of eligible professionals would have been 
attesting for an EHR reporting period in 2015 of one full year at the 
close of CY 2015. This means that the high volume of attestations in 
January and February of 2015 has already been anticipated and 
preparations for that time have been made. Therefore, we do not expect 
the proposed changes to the attestation deadlines would significantly 
increase the load on CMS systems, and even with full participation 
among eligible hospitals and CAHs, only an additional 4,000 
attestations would be received at the close of the calendar year with 
the shift from fiscal year to calendar year reporting for these 
providers.
    Comment: A number of commenters requested an extension of the 
attestation period following the close of the year for EHR reporting 
periods in 2015. Some of these commenters recommended that data 
submission be allowed for 3 months or for 6 months following the close 
of the calendar year. Other commenters stated that large organizations 
need more time to complete attestations. A number of commenters 
requested that CMS allow greater flexibility in prolonging an 
attestation period for 2015 only. Still other commenters noted that 
there may be a lag after the end of the reporting period before all 
data can be collected and validated. These commenters suggested that we 
allow for a longer period of time in which to attest after the 
reporting period, which would allow for accurate collection, 
validation, documentation, and attesting to the data. Other commenters 
noted the volume of attestations and requested additional time, as the 
volume of providers that will be completing their attestations during 
that time period may tax the system and cause extensive delays while 
entering the data.
    Response: We believe that an attestation period of 2 months 
following the close of the calendar year (February 29, 2016 for an EHR 
reporting period in 2015) is appropriate because it is consistent with 
our current policy of

[[Page 62897]]

requiring attestation within the 2 months after the close of the fiscal 
year for returning eligible hospitals and CAHs or calendar year for 
returning EPs. We further note that this attestation period also aligns 
with the submission period for CQM reporting for PQRS. We understand 
the concern over a high volume of attestations. However, as noted 
previously, we do not anticipate that the proposed changes to the 
attestation deadlines would significantly increase the volume over what 
was expected for 2015. In addition, as we have done in past years, we 
will monitor progress, attestation volume, and provider readiness in 
real time as the attestation period progresses.
    Comment: A commenter requested that we clarify how the requirements 
of the program prior to the final rule relate to those after the 
effective date of the final rule in terms of the attestation windows 
and selection of an EHR reporting period. The commenter requested that 
new participants be able to attest to the current Stage 1 objectives 
and measures even after the effective date of this final rule with 
comment period for an EHR reporting period in 2015. The commenter also 
requested guidance on whether states will be required to take an 
approach consistent with CMS on this issue.
    Response: Any attestations accepted by a state for the Medicaid EHR 
Incentive Program prior to the effective date of this final rule with 
comment period must meet the requirements in effect at that time for 
the Medicaid EHR Incentive Program. In addition, the objectives and 
measures of meaningful use apply to both the Medicare and Medicaid EHR 
Incentive Programs, and the demonstration methods we adopt for Medicare 
would automatically be available to the states for use in their 
Medicaid programs.
    We refer the commenter to sections II.B.1.b.(4).(a). and II.E. of 
this final rule with comment period for an explanation of when in 2015 
the 90-day EHR reporting period and EHR reporting period for a payment 
adjustment year may occur. We further note that CMS will not be 
accepting attestations for an EHR reporting period in 2015 and 
subsequent years for any objective or measure which has been removed in 
this final rule with comment period in section II.B.1.b.(4).(b).
    Comment: A commenter stated that providers believe that the 
management of attestation deadlines and payment adjustments is very 
complicated and difficult to follow.
    Response: We note that this is part of the motive behind some of 
the changes to reporting periods for the Medicare and Medicaid EHR 
Incentive Programs. We further note that while this final rule with 
comment period makes additional changes to the program, we believe 
these changes will help to settle the program into a more regular and 
predictable schedule for all participants.
    After consideration of the comments received, we are finalizing the 
attestation deadlines for meaningful use in 2015 and 2016 as proposed. 
We note that any EP, eligible hospital or CAH that attested to 
meaningful use for the first time under Medicare or Medicaid for an EHR 
reporting period in 2015 prior to the effective date of this final rule 
with comment period will not be required to submit a new attestation.
d. New Participant Attestation Deadlines for Meaningful Use in 2015 and 
2016 To Avoid a Payment Adjustment
    In Sec.  495.4, the definition of an EHR reporting period for a 
payment adjustment year establishes special deadlines for attestation 
for EPs and eligible hospitals that are demonstrating meaningful use 
for the first time in the year immediately preceding a payment 
adjustment year. In the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20376), we noted that we are proposing a later 
deadline for attestation for 2015 only to allow enough time for all 
providers to complete a 90-day EHR reporting period after the 
anticipated effective date of the final rule. We proposed changes to 
the attestation deadlines for purposes of the payment adjustment years 
for EPs, eligible hospitals, and CAHs in the EHR Incentive Programs in 
2015 through 2017 proposed rule at 80 FR 20380 and 20381. We address 
those proposals and respond to the comments received in section II.E.2. 
of this final rule with comment period.
e. Methods for Demonstration of the Stage 3 Criteria of Meaningful Use 
for 2017 and Subsequent Years
    We proposed 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. We proposed to continue the existing optional 
batch file process for attestation in lieu of individual Medicare EP 
attestation through our registration and attestation system. This batch 
reporting process ensures that the objectives and measures of the 
program and the 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 stated that 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. 
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 proposed changes to the attestation process for 
the meaningful use objectives and measures, which would allow 
flexibility for providers during this transitional year (80 FR 16772).
    Comment: A few commenters suggested that EHR Incentive Program 
attestation be automated. EPs, eligible hospitals, or CAHs should be 
able to use their certified EHR technology to directly share EHR 
Incentive Program performance data with CMS, eliminating the need for 
the manual input of data into the agency's attestation portal. Allowing 
automated EHR Incentive Program attestation will improve participation 
in the program, cut down on possible manual input errors, and be more 
in line with the intent of supporting interoperability and the seamless 
transfer of electronic health care performance data.
    Response: We note that in the Stage 2 proposed rule we requested 
input on the potential of developing an automated electronic reporting 
system for the objectives and measures of the EHR Incentive Programs 
(77 FR 13764). We decided not to develop such a submission method at 
that time as the system update required could prove burdensome for 
providers, especially small practices and those operating proprietary 
systems, and we instead adopted the batch reporting option which does 
allow for a more automated process for large groups to submit their 
data to CMS (77 FR 54089). As noted in the Stage 2 final rule, we will 
continue to review and analyze the possibility of an electronic system 
to replace the current manual attestation as CMS continues to work 
toward program alignment with quality reporting programs, which support 
electronic submission of CQM data using CEHRT.
    After consideration of the comments received, we are finalizing our 
proposal to maintain attestation as the method of demonstration of 
meaningful use for the EHR Incentive Programs for 2017 and

[[Page 62898]]

subsequent years and the corresponding regulation text at Sec.  495.40.
(1) Meaningful Use Objectives and Measures in 2017 and CEHRT 
Flexibility in 2017
    In the Stage 3 proposed rule (80 FR 16772), in order to allow all 
providers to successfully transition to Stage 3 of the EHR Incentive 
Programs for a full year-long EHR reporting period in 2018, we proposed 
to allow flexibility for the EHR Incentive Programs in 2017. We stated 
that this transition period would allow providers to establish and test 
their processes and workflows for Stage 3 of the EHR Incentive Programs 
prior to 2018. Specifically, for 2017, we proposed that providers may 
either repeat a year at their current stage or move up stage levels. We 
also proposed that for 2017, a provider may not move backward in their 
progression and that 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.
    Finally, we proposed that 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.
    Comment: Many commenters supported allowing providers to choose or 
not choose Stage 3 in 2017. Commenters noted that the inability to 
select the stage of participation in prior years was a significant 
frustration for providers and that allowing choice and flexibility 
offers providers to the chance to review their performance and attest 
to the highest level they were able to achieve. However, many 
commenters were confused by this proposal and how this proposal related 
to the proposals in the EHR Incentive Programs in 2015 through 2017 
proposed rule which would remove the Stage 1 objectives and measures 
from the program.
    Response: We thank the commenters for their insight and reiterate 
that our intent in the selection of stage for the demonstration of 
meaningful use is intended to offer greater flexibility for providers. 
We note that the proposal which includes references to Stage 1 was 
published prior to the publication of the EHR Incentive Programs in 
2015 through 2017 proposed rule and therefore the proposal to change 
the stage designations at 80 FR 20352 through 20353 had not yet been 
made. In section II.B.2.a. of this final rule with comment period, we 
finalized a set of objectives and measures that all EPs, eligible 
hospitals, and CAHs must meet for an EHR reporting period in 2015, 
2016, and 2017, unless a provider chooses to meet the Stage 3 
objectives in 2017. Thus, we will not allow attestation to Stage 1 
objectives and measures in 2017 regardless of prior program 
participation. As stated previously, CMS will not be accepting 
attestations for an EHR reporting period in 2015 and subsequent years 
for any objective or measure which has been removed in this final rule 
with comment period in section II.B.1.b.(4).(b).
    After consideration of public comment received, we are finalizing 
our proposal with modifications to allow providers to attest to the 
Stage 3 objectives and measures defined at Sec.  495.24 for an EHR 
reporting period in 2017 instead of the objectives and measures for 
2015 through 2017 defined at Sec.  495.22 if they so choose.
(2) Stage and CEHRT Flexibility in 2017
    In the Stage 3 proposed rule (80 FR 16772 through 16773), we also 
proposed to allow providers flexible CEHRT options for an EHR reporting 
period in 2017 and noted that these options may impact the selection of 
objectives and measures to which a provider can attest. Specifically, 
under the CEHRT options for 2017, we proposed 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 
noted that providers who use only 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. We 
further explained this proposal at 80 FR 16773 stating that providers 
using only EHR technology certified in whole or in relevant part to the 
2014 Edition certification criteria may attest to the Stage 1 or Stage 
2 objectives and measures; and, providers using EHR technology 
certified in whole or in relevant part to the 2015 Edition 
certification criteria may elect to attest to the Stage 1 or Stage 2 
objectives and measures or to the Stage 3 objectives and measures if 
they have all the 2015 Edition functionality required to meet all Stage 
3 objectives.
    We noted 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 reiterated that providers may elect to attest 
to Stage 3 of the program using EHR technology certified to the 2015 
Edition beginning in 2017. Finally, in the Stage 3 proposed rule we 
stressed 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 (80 FR 16773).
    We sought comment on this flexibility option including alternate 
flexibility options and received the following comments on these 
proposals and our response follows:
    Comment: While some commenters expressed skepticism that providers 
would be ready to attest to Stage 3 in 2017, the majority of commenters 
were in support of the flexible options for Stage 3 in 2017, especially 
allowing for the timeline required to fully update to EHR technology 
certified to the 2015 Edition. While commenters generally expressed 
concern that most providers may not be ready to progress to Stage 3 in 
2017, they supported the proposal to allow providers to select the 
option for themselves in 2017, which would allow them to work toward 
that goal but to still successfully meet the requirements of the 
program in 2017, even if they do not meet the Stage 3 requirements. 
Additionally, some commenters noted that they would not support an 
alternate option or policy which required the selection of the Stage 3 
objectives and measures in 2017 if the provider has fully implemented 
EHR technology, but that they agreed that the flexibility to select or 
not select Stage 3 is a benefit for providers. A number of commenters 
requested that this flexibility also be extended into 2018 and noted 
that technology certified to the 2015 Edition may not be ready in time 
for a reporting period in 2018.
    Response: We are committed to working toward the goals outlined for 
Stage 3 of the EHR Incentive Programs, but we also recognize the need 
for balance and support of providers in making this transition. We 
agree that the option of participating in Stage 3 in 2017 should be 
encouraged but not required. Therefore, we will finalize our proposal 
to allow providers to choose Stage 3 participation in 2017, and will 
not require Stage 3 participation if the provider has fully implemented 
EHR technology certified to the 2015 Edition in 2017.
    However, we do reiterate that a provider must have the necessary 
functions certified to the 2015 Edition in order to successfully 
demonstrate Stage 3 if they so choose. As discussed in section II.B.3. 
of this final rule with

[[Page 62899]]

comment period, EHR technology certified to the 2015 Edition can 
support the Stage 2 objectives and measures, but EHR technology 
certified to the 2014 Edition on its own cannot support all of the 
Stage 3 objectives and measures. So even though EHR technology 
certified to the 2015 Edition is not required until 2018, a provider 
must at least have the functions of CEHRT certified to the 2015 Edition 
which are required to support the unique Stage 3 measures in order to 
participate in Stage 3 in 2017. For Stage 3 there are certain EHR 
technology functions which are not available within the 2014 Edition 
certification criteria, and if a provider chooses to attest to Stage 3 
in 2017 they must use EHR technology modules certified to the 2015 
Edition for those functions. These modules and module certified to the 
2014 Edition can be used together in many combinations to make up the 
whole EHR system and meet the definition of CEHRT required for the 
program. We direct readers to section II.B.3. of this final rule with 
comment period for further information on the CEHRT definition at Sec.  
495.4. See Tables 14, 15, and 16 in section II.B.3. for more 
information about which modules support specific Stage 3 objectives and 
measures.
    We believe providing flexibility in 2017 will allow for an easier 
transition and full scale upgrade to EHR technology certified to the 
2015 Edition for participation in 2018. We did not propose an extension 
of this flexibility into 2018 as we are committed to moving toward a 
single streamlined program to support long term sustainability and 
reduce the overall complexity for providers participating in the EHR 
Incentive Programs. We note that, as mentioned in section II.B.1.b.(3). 
of this final rule with comment period, we are finalizing a 90-day EHR 
reporting period for providers demonstrating Stage 3 in 2017 to further 
support providers seeking to move to Stage 3 in 2017.
    After consideration of the comments received, we are finalizing a 
modification to our proposal to allow providers using EHR technology 
certified to the 2015 Edition, in whole or in part, the option to 
attest to Stage 3 objectives and measures if they have the relevant 
CEHRT modules certified to the 2015 Edition certification criteria 
necessary to support Stage 3. (See Tables 14, 15, 16 in section II.B.3. 
for more information about which modules support specific Stage 3 
objectives and measures.) We further note that CMS will not be 
accepting attestations for an EHR reporting period in 2015 and 
subsequent years for any objective or measure which has been removed in 
this final rule with comment period in section II.B.1.b.(4).(b). 
Further we reiterate that certification to the 2011 Edition is no 
longer valid for use in the EHR Incentive Programs and a provider may 
not attest to a system with that certification in any year after 2014. 
Finally, we note that providers using only EHR technology certified to 
the 2014 Edition may not attest to the Stage 3 objectives and measures 
for an EHR reporting period in 2017. Therefore, we reiterate the 
following options for providers for Stage and CEHRT flexibility for an 
EHR reporting period in 2017:
    Providers using only EHR technology certified in whole or in 
relevant part to the2014 Edition certification criteria may attest to 
the objectives and measures of meaningful use defined at Sec.  495.22.
    Providers using EHR technology certified in relevant parts to 
the2014 Edition certification criteria and EHR technology certified in 
relevant parts to the 2015 Edition certification criteria may elect to:
     Attest to the objectives and measures at Sec.  495.22.
     Attest to the Stage 3 objectives and measures at Sec.  
495.24 if they have the 2015 Edition functionality required to meet the 
Stage 3 objectives and measures. (See Tables 14, 15, and 16 in section 
II.B.3. for more information about which modules support specific Stage 
3 objectives and measures.)
    Providers using only EHR technology certified in whole or in 
relevant parts to the 2015 Edition certification criteria may elect to:
     Attest to the objectives and measures at Sec.  495.22.
     Attest to the Stage 3 objectives and measures at Sec.  
495.24.
    We are adopting these policies at Sec.  495.40 with references to 
the objectives and measures outlined in Sec.  495.22 and Sec.  495.24 
for the applicable years.
(3) CQM Flexibility in 2017
    In the Stage 3 proposed rule (80 FR 16773), we proposed 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 for 
2017. 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, we proposed that 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, or 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.
    Similar to our rationale under the 2014 CEHRT Flexibility final 
rule (79 FR 52910 through 52933), we stated that 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 (80 FR 16773). We proposed that upon 
attestation, providers may select one of the proposed options available 
for their participation year and EHR Edition, and 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 proposed 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 received comments related to the reporting requirements for 
CQMs, which are addressed in section II.C. of this final rule with 
comment period. We also received a number of questions and comments on 
reporting clinical quality measures for the Medicaid program, which are 
addressed in section II.C. and II.G. of this final rule with comment 
period. We received no comments specific to the demonstration of these 
requirements beyond those previously addressed in section 
II.D.1.(e).(1). and (2) of this final rule with comment period in 
relation to the selection of stage, the selection of certified EHR 
technology, and the overall demonstration of meaningful use in 2017 and 
subsequent years via attestation.
    We are finalizing as proposed the policy to allow providers the 
flexibility to electronically report CQMs or to attest to CQMs using 
either EHR technology certified to the 2014 Edition or EHR technology 
certified to the 2015 Edition, independently of the Edition they use 
for their objectives and measures for an EHR reporting period in 2017. 
For further discussion of this final

[[Page 62900]]

policy, we direct readers to section II.C. of this final rule with 
comment period.
2. Alternate Method of Demonstration for Certain Medicaid Providers 
Beginning in 2015
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20377), we proposed that certain Medicaid EPs would have the 
option of attesting through the EHR Incentive Program Registration and 
Attestation system for the purpose of avoiding the Medicare payment 
adjustment. This alternate method would allow EPs who have previously 
received an incentive payment under the Medicaid EHR Incentive Program 
(for either AIU or meaningful use) to demonstrate that they are 
meaningful EHR users in situations where they fail to meet the 
eligibility criteria for the Medicaid EHR Incentive Program in a 
subsequent year.
    Comment: Many commenters agreed with our proposal to establish an 
alternate method of demonstrating meaningful use to allow Medicaid EPs 
to attest using the CMS registration and attestation system so they can 
avoid the Medicare payment adjustment. Some commenters questioned 
whether this would be available prior to February 28, 2016, to allow 
EPs to attest in cases where the state's attestation system was not 
ready by the deadline. Some commenters questioned whether attestation 
information submitted to CMS would be shared with the states.
    Response: We intend for this alternate method of demonstrating 
meaningful use to be available beginning January 1, 2016 for EPs 
attesting for their EHR reporting period in 2015. However, we proposed 
this method only for Medicaid EPs who did not meet the eligibility 
criteria and thus would not be able to attest to the Medicaid EHR 
Incentive Program for the same year and receive an incentive payment.
    We note that Medicaid EPs can avoid the Medicare payment adjustment 
by successfully demonstrating meaningful use to the state Medicaid 
agency under the Medicaid EHR Incentive Program, even if it occurs 
after the Medicare attestation period closes, as long as the 
attestation is accepted by the state. It would then be the state's 
responsibility to include that EP in the quarterly report on meaningful 
users, which we discuss in section II.G. of this final rule with 
comment period.
    Attestations from Medicaid EPs that come through the CMS 
registration and attestation system will be treated the same as other 
provider attestations that are submitted to that system for purposes of 
data sharing. We recognize that states collect, analyze, and use EHR 
Incentive Program attestation information for a number of purposes, 
such as informing other state programs and making policy decisions. 
However, we will not send information from those attestations to 
states, consistent with preceding practice.
    Comment: A commenter requested clarification regarding the 
reporting period for EPs who are in the Medicaid EHR Incentive Program 
and use the alternate method of attestation through the CMS 
registration and attestation system.
    Response: We proposed that EPs using this alternate method would be 
required to demonstrate meaningful use for the applicable EHR reporting 
period established for the Medicare EHR Incentive Program, which would 
depend on the year as well as the EP's prior participation in the 
program and stage of meaningful use. For example, if the EP is in their 
first year of demonstrating meaningful use, and the Medicare EHR 
Incentive Program has a 90-day EHR reporting period for EPs 
demonstrating meaningful use for the first time in that year, then the 
EP would use a 90-day EHR reporting period.
    We reiterate that an EP's attestation using this alternate method 
would not constitute a switch from the Medicaid EHR Incentive Program 
to the Medicare EHR Incentive Program. For the purposes of the Medicaid 
EHR Incentive Program, an EP's use of this alternate method would be 
treated the same as if the EP had not attested to meaningful use for 
that year. For an EP who uses this alternate method, their EHR 
reporting period in a subsequent year for the Medicaid EHR Incentive 
Program would be determined without regard to any previous attestations 
using this alternate method. For example, an EP could still have a 90-
day EHR reporting period for the Medicaid EHR Incentive Program for 
their first year of demonstrating meaningful use even though they had 
demonstrated meaningful use through this alternate method in a previous 
year.
    Comment: Commenters also asked if CMS would allow this policy for 
providers who had not yet attested in Medicare or Medicaid as of 2015, 
given that Medicaid still allows incentive payments for new 
participants until 2016. A number of commenters requested clarification 
on what scenarios would providers be allowed to use the alternate 
attestation and where would it be prohibited, if this did apply for 
2015. Specifically, these commenters inquired whether this alternate 
attestation option is available for providers who are attesting to AIU 
in 2015 or 2016 and also wish to attest to avoid the Medicare payment 
adjustment.
    Response: We did not propose this option for 2015. However, we 
understand there may be new participants, and especially newly 
practicing EPs or new hospitals, for whom this option might be relevant 
and beneficial. We have considered a number of scenarios that are 
consistent with our proposed policy which is to allow providers who are 
working toward achieving meaningful use in the Medicaid EHR Incentive 
Program to attest under Medicare to avoid the payment adjustment 
without switching if they are unable to attest under Medicaid for a 
given year. The option will be available for 2015 under the following 
scenarios:
     For an EHR reporting period 2015, an EP who has not 
successfully attested to AIU or meaningful use in either the Medicare 
or Medicaid program may use the alternate attestation option under the 
Medicare EHR Incentive Program to avoid a payment adjustment in 2016 
and 2017. This EP cannot qualify for an incentive payment under 
Medicare for 2015 because 2014 is the last first year that an EP may 
begin receiving Medicare incentive payments under section 1848(o) of 
the Act. The EP may attest to meaningful use in the Medicaid program 
for an EHR reporting period in 2016 if they meet the eligibility and 
other requirements for the Medicaid EHR Incentive Program.
     A provider may not use the alternate attestation option to 
attest to meaningful use in Medicare to avoid a payment adjustment in 
conjunction with an attestation for an incentive payment for AIU in the 
Medicaid program in the same year.
    Comment: A number of commenters requested clarification from a 
systems perspective on how CMS will offer the alternate attestation 
option and coordinate with states on implementation. Some commenters 
questioned if CMS is considering an option to allow the states 
flexibility to develop a no-payment attestation pathway as another 
option for the providers who are unable to switch but do not meet the 
thresholds for patient volume required to qualify for a Medicaid 
incentive payment. Another commenter requested that we describe any 
operational and technical changes states may need to make to their EHR 
Incentive Program.
    Response: We reiterate that the alternate attestation option for 
the purpose of avoiding a Medicare payment adjustment will be 
implemented within the Medicare

[[Page 62901]]

registration and attestation system only. As mentioned previously, 
Medicaid EPs seeking to exercise this option must attest in the 
Medicare system and in accordance with the requirements for the 
Medicare EHR Incentive Program in order to successfully demonstrate 
meaningful use and avoid the Medicare payment adjustment. The only 
requirement for state support of this proposal is to notify EPs of 
their eligibility to exercise this alternate option in partnership with 
CMS provider education and outreach efforts. We will not require 
additional reporting from states, nor require states to process 
additional systems changes. We will work with the states to coordinate 
any necessary information sharing and to monitor real-time use of the 
alternate attestation option once implemented.
    After consideration of the comments received, we are finalizing the 
proposal for this alternate method of demonstrating meaningful use for 
certain Medicaid EPs to avoid the Medicare payment adjustment with a 
modification allowing the alternate attestation for new participants in 
2015 as described previously.
3. Data Collection for Online Posting, Program Coordination, and 
Accurate Payments
    We proposed 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 noted 
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 the Stage 3 proposed rule (80 FR 16774), we 
proposed to collect the following information from providers to ensure 
providers keep their information up-to-date through the system of 
record for their NPI in the NPPES:
     Primary Practice Address (address, city, state zip, 
country code, etc.).
     Primary Business/Billing Address (address, city, state, 
zip, country code, etc.).
     Primary License information (for example, provide medical 
license in at least one state (or territory)).
     Contact Information (phone number, fax number, and contact 
email address).
     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 did not propose any changes to the registration for the Medicare 
and Medicaid EHR Incentive Programs.
    We received the following comments and our response follows:
    Comment: We received a number of comments requesting a wider range 
of publically available data on the Medicare and Medicaid EHR Incentive 
Programs including cross-referencing Medicaid participation and 
performance data.
    Response: We thank the commenters for their suggestions and will 
continue to work to promote data transparency and provide data across 
both programs on provider participation and performance. We refer 
readers to section II.G.4. of this final rule with comment period for 
further information on the types of information, CMS is requesting from 
states to support these efforts and note that we will continue to post 
data files for public use on the CMS Web site at: www.cms.gov/EHRIncentivePrograms on the data and reports section.
    Comment: Some commenters noted the inclusion of the health 
information exchange information in the providers' record within the 
NPPES system. A commenter opposed the inclusion, stating that not all 
providers have a direct address. However, the majority support the 
proposed enhancements to NPPES as a step in the right direction. Some 
commenters requested CMS take additional steps to develop some form of 
``centralized national healthcare provider directory'' to support 
health information exchange and care coordination. Some commenters made 
further suggestions as to how such a directory should be organized as 
well as the full extent of exchange information it should contain for 
each provider.
    Response: We note that CMS and ONC are committed to exploring 
potential models and opportunities to support improved access to the 
relevant contact information to facilitate health information exchange 
among providers. We understand that not all providers may have a direct 
address. Therefore, we proposed to include other exchange information 
in the system of record as noted in the Stage 3 proposed rule (80 FR 
16774). We also understand that not all providers who might participate 
in health information exchange are participating in the EHR Incentive 
Programs. However, we believe that this may be one step in the process 
to facilitate health information exchange among providers across a wide 
range of settings.
    After consideration of the public comments received, we are 
finalizing these proposals as proposed.
4. Hospital-Based Eligible Professionals
    As noted in the EHR Incentive Programs in 2015 through 2017 
proposed rule (80 FR 20378), several hospital associations, individual 
providers, and other stakeholders have raised concerns with our current 
definition of a hospital-based EP. Specifically, these stakeholders 
asserted that the limitation of hospital-based POS codes 21 and 23, 
covering inpatient and emergency room settings only, does not 
adequately capture all settings where services might be furnished by a 
hospital-based EP. They stated that POS 22, which covers an outpatient 
hospital place of service, is also billed by hospital-based EPs, 
especially in relation to certain CPT codes. These stakeholders 
expressed the belief that our current definition of hospital-based EP 
in the regulations is too narrow and will unfairly subject many EPs who 
are not hospital-based under our definition, but whom stakeholders 
would consider to be hospital-based, to the downward payment adjustment 
under Medicare in 2015. Accordingly, these stakeholders recommended 
that we consider adding additional place of service codes or settings 
to the regulatory definition of hospital-based EP. We noted that we 
appreciate this feedback from stakeholders and requested public comment 
on our current definition of a hospital-based EP under Sec.  495.4 for 
the EHR Incentive Programs. We sought public comment on whether 
additional place of service codes or settings should be included in our 
definition of a hospital-based EP. In addition, we sought comments on 
whether and how the inclusion of additional POS codes or settings in 
our definition of hospital-based EP might affect the eligibility of EPs 
for the EHR incentive payments under Medicare or Medicaid.
    We received the following comments and our response follows:
    Comment: A number of commenters on the EHR Incentive Program in 
2015 through 2017 proposed rule requested the addition of place of 
service code (POS 22) to the definition of hospital-based EP. Some of 
these comments stated that providers may practice across multiple 
settings and their organizational base may be the hospital outpatient 
setting, and as a result, they face significant challenges in meeting 
the requirements of the program. Some

[[Page 62902]]

commenters stated that certain physician specialties, such as 
pathologists, radiologists, and even some hospitalists, have reported 
challenges with the existing definition and that a change in the 
definition of hospital-based would provide more clarity for these 
physicians. A commenter stated that the definition of a hospital-based 
provider is fundamentally flawed and suggested to define a hospital-
based provider as a provider who performs 90 percent or more of their 
services in place of service 21, 22, and/or 23 (Inpatient Hospital, 
Outpatient Hospital, and Emergency Room Hospital). A commenter offered 
an example stating that a cardiac interventionist might not quality as 
hospital-based because 90 percent of their services were not billed POS 
21 or POS 23 even though they spend 100 percent of their time in the 
hospital setting. The commenter indicated that the interventionist 
treats many patients who are admitted as outpatients, reads 
echocardiograms for the hospital, and has no patient encounters, which 
are not included in the hospital EHR; but the provider also cannot 
independently meet the requirements of the program. Some commenters 
additionally requested that CMS include POS 51 (Inpatient Psychiatric 
Facility) in addition to POS 22 Observation Services Patients in the 
hospital-based determination.
    On the hospital side, a commenter expressed support for a change in 
the hospital-based designation because they are currently struggling 
with the hospital-based designation for the inclusion of services 
provided in hospital settings by providers who are designated EPs and 
that the hospital performance on the measures would be higher if these 
patient encounters were included. The provider recommended that all POS 
codes should be revisited and the requirements for hospital-based 
eligibility could be expanded to include all hospital-based POS codes 
that are rendered in the hospital settings including rehabilitation 
hospitals and hospital observations, which are otherwise not included 
in the numerators of their percentages.
    Commenters in support of a change were split on when such a change 
should be implemented. A commenter recommended that CMS change its 
definition beginning with 2017. Other commenters believe that CMS 
should retroactively make this correction, and refund physicians who 
were penalized because of this issue stating physicians who use POS 22 
typically are using the hospital-based EHR during the patient 
observation period, and should not be penalized.
    Many commenters opposed any change in the hospital-based 
designation. Some commenters stated that this proposal could compromise 
the purpose of the program. A commenter stated that changing the 
definition of hospital-based eligible professional at this time in the 
program could encourage fraud. If an EP who was previously eligible for 
the incentive would now be ineligible for payment adjustments due to 
the change, this would be unfair. Some commenters stated that 
redefining EP by once again including POS 22 in the ``hospital'' 
definition would not be reasonable so long as provider-based billing 
exists. The commenter suggested considering some combination of place 
of service and NPPES classification which does not exclude the large 
base of ambulatory providers who bill provider based.
    Another commenter stated that including POS 22 in the definition of 
a hospital-based EP could have major implications for the eligible 
hospital numerators and denominators. Additionally, the design and 
implementation of the various parts of a hospital's EHR system would 
have to be redesigned in order to change the status in addition to 
changing work flows and training to match that change, which would 
drastically impact the hospital's ability to meet the measures as well 
as their overall IT expenditures.
    Some commenters stated that adding POS 22 or another change to the 
designation may undermine the current understanding of the program and 
would require additional education and guidance to ambulatory providers 
who have already successfully attested. A commenter stated that they do 
not support re-classifying services provided in an outpatient hospital 
(POS 22) setting as hospital-based because of a concern that expanding 
the hospital-based definition to reduce the number of EPs for EHR 
Incentives may inhibit continuous hospital investments in ambulatory 
EHRs. The commenter noted that the ambulatory EHR space is an important 
component to the overall HIT ecosystem and that CMS should encourage 
investment in this area by excluding outpatient services from the 
hospital-based calculation. The commenter stated that the current 
definition of a hospital-based provider is consistent with the 
hospital's payment calculation, which is based on inpatient discharges 
and emergency department services, and is consistent with the 
collection of EHR Incentive Program information for hospitals. The 
commenter continued by stating that if CMS included POS 22 services in 
the hospital-based provider definition, CMS would need to revisit 
whether the inclusion of these services affects the hospital payment 
calculation and collection of EHR Incentive Program encounters for 
hospitals. Another commenter expressed a similar concern that changing 
the hospital-based designation may have unintended consequences on the 
hospital payment calculation, necessitating adjustments to all payments 
made to date if CMS chooses to make a change to the definition of 
hospital based.
    Other commenters stated this is a very complex issue and sought 
further clarification on the impact of a potential change, noting 
organizations that have many subspecialists who see patients in the 
hospital outpatient setting using an office or ambulatory workflow and 
that these providers may be required to bill with POS 22 due to the 
physical location of their offices. The commenter stated that the 
majority of these EPs are currently meeting the requirements of the 
program and will continue to practice medicine in the same manner going 
forward. However, the commenter also noted that there are EPs who are 
truly ``hospital-based,'' such as hospitalists, who are currently being 
held to the same standard as ambulatory providers, even though their 
workflow is not conducive to easily meeting such standards. The 
commenter then recommended that CMS allow providers who see both 
inpatient and ambulatory patients with a significant volume to choose 
whether they want to be excluded from the program or continue to 
participate as an individual eligible professional.
    Other recommendations from commenters included a mention of 
hardship exceptions for POS 22-related issues, a suggestion to allow 
EPs the right, in an expedited fashion, to petition for a change in 
their hospital-based status when there is a material change in their 
organizational affiliation (that is, a physician leaving a hospital-
based practice to join an outpatient physician practice), excluding 
patient encounters in POS 21 and POS 23 for an EP, and excluding the 
POS 21 and POS 23 encounters from Medicare payment adjustment.
    Response: The scenarios and examples described by the commenters 
are consistent with those we have heard from providers previously. 
However, we are concerned that there does not seem to be an 
identifiable factor that has changed since the program began and caused 
EPs who were previously designated hospital-based to be designated 
otherwise. In addition, the

[[Page 62903]]

comments both in support of and opposing a revision to the hospital-
based EP definition show the wide diversity of providers who may have 
services billed under a different POS who fall on both sides of the 
argument for and against an amendment of the definition. We see no 
method to modify the current definition to clearly identify EPs for 
whom inclusion in the definition might be reasonable and those for whom 
inclusion in the definition might be inappropriate. Further, we are 
concerned that any blanket redesignation of EPs in certain settings 
would result in the exclusion of patient encounters in those settings 
being captured in an EHR. Without a clear rationale for a change, and 
without a clear definition to change to, we cannot proceed to change 
the definition of hospital-based EP at this time.
    Therefore, we are not finalizing changes to the definition of 
hospital-based EP at this time. We will continue to consider this issue 
in the future as we explore program requirements for the MIPS.
5. Interaction With Other Programs
    We proposed no 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.C. of this final rule 
with comment period for the policies and requirements for CQM 
reporting.

E. Payment Adjustments and Hardship Exceptions

    Sections 4101(b) and 4102(b) of the HITECH Act, amending sections 
1848, 1853, and 1886 of the Act, require reductions in payments to EPs, 
eligible hospitals, and CAHs that are not meaningful users of certified 
EHR technology, beginning in CY 2015 for EPs, FY 2015 for eligible 
hospitals, and in cost EHR reporting periods beginning in FY 2015 for 
CAHs.
1. Statutory Basis for Payment Adjustments and Hardship Exceptions
a. Statutory Basis for Payment Adjustments and Hardship Exceptions for 
Eligible Professionals (EPs)
    Section 1848(a)(7) of the Act provides for payment adjustments, 
effective for CY 2015 and subsequent years, for EPs as defined in Sec.  
495.100, who are not meaningful EHR users during the relevant EHR 
reporting period for the year. Section 1848(a)(7) of the Act provides 
that 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 Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10) was enacted on April 16, 2015, after the publication 
of the Stage 3 proposed rule and the EHR Incentive Program in 2015 
through 2017 proposed rule. Section 101(b)(1)(A) of MACRA amended 
section 1848(a)(7)(A) of the Act to sunset the meaningful use payment 
adjustment for EPs at the end of CY 2018. Section 101(c) of MACRA added 
section 1848(q) of the Act requiring the establishment of a MIPS, which 
would incorporate certain existing provisions and processes related to 
meaningful use. The term ``applicable percent'' is defined in section 
1848(a)(7)(A)(ii) of the Act, as amended by section 101(b)(1)(A) of 
MACRA, 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 2018, 97 percent.
    In addition, section 1848(a)(7)(A)(iii) of the Act, as amended by 
section 101(b)(1)(A) of MACRA, provides that if, for CY 2018, 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.
    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 EHR 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 Sec.  495.102. We refer readers to the final rules for Stages 1 
and 2 (75 FR 44447 through 44448 and 77 FR 54093 through 54102) for 
more information.
b. 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[frac13] percent for FY 2015, 66[frac23] 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[frac13] 
of 75 percent) in FY 2015, 50 percent (66[frac23] 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 provided that such determinations are subject to annual 
renewal and that in no case may

[[Page 62904]]

a hospital be granted an exception for more than 5 years.
    Section 412.64(d) 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.
    We established regulations implementing these statutory provisions 
under Sec.  412.64. We refer readers to the final rules for Stages 1 
and 2 (75 FR 44460 and 77 FR 54102 through 54109) for more information.
c. Statutory Basis for Payment Adjustments and Hardship Exceptions for 
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 EHR 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 EHR 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 EHR reporting period beginning in FY 2016, 
its reimbursement would be reduced to 100.33 percent of its reasonable 
costs. For a cost EHR reporting period beginning in FY 2017 and each 
subsequent fiscal year, its reimbursement would be reduced to 100 
percent of reasonable costs. We established regulations implementing 
these statutory provisions under Sec.  413.70. We refer readers to the 
final rules for Stages 1 and 2 (75 FR 44464 and 77 FR 54110 through 
54111) for more information.
    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.
2. EHR Reporting Period for a Payment Adjustment Year
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
and the Stage 3 proposed rule, we proposed several changes to the 
definition of the EHR reporting period for a payment adjustment year 
for EPs, eligible hospitals, and CAHs at Sec.  495.4, in connection 
with other proposals made in those rules. For an explanation of these 
proposals, we refer readers to 80 FR 16774 through 16779 and 80 FR 
20378 through 20381.
a. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for EPs
    As follows is a summary of the comments received on the proposals 
for the EHR reporting period for a payment adjustment year for EPs (80 
FR 16774 through 16779 and 80 FR 20378 through 20381):
    Comment: We received a few comments supporting the proposed 
deadline of February 29, 2016 for new participants to attest in order 
to avoid a payment adjustment in CY 2016 in light of the other program 
changes proposed in the rule. Many commenters expressed concern with 
our proposal to remove the 90-day EHR reporting period for new 
participants. They noted that this will create an enormous barrier for 
new entrants and will likely deter participation in the program and 
others stated that new entrants need time to install and learn to use 
technology before beginning their first EHR reporting period. 
Commenters also requested an extended deadline ranging from 2 months to 
6 months additional time in 2016 for attestations for EHR reporting 
periods in 2015. Additionally some commenters requested clarification 
of the early attestation deadlines for new participant EPs in 2016 and 
2017.
    Response: We thank you for your comments and support. For 
discussion of the attestation deadlines for EPs we direct readers to 
section II.D. of this final rule with comment period. Regarding the 
comments on the attestation deadlines, we proposed that for EPs 
demonstrating meaningful use for the first time in 2016, the EHR 
reporting period for a payment adjustment year is any continuous 90-day 
period in CY 2016 and applies for purposes of the payment adjustments 
in CYs 2017 and 2018. To avoid the payment adjustment in CY 2017, the 
90-day period must occur within the first three quarters of CY 2016 and 
the EP must attest by October 1, 2016. We refer readers to 80 FR 20380 
through 20381 of the EHR Incentive Programs in 2015 through 2017 
proposed rule for additional information.
    We agree with the concerns expressed by commenters regarding our 
proposal to discontinue the 90-day EHR reporting period for a payment 
adjustment year for new participants who attest under Medicare 
beginning in 2017. We agree that a full year EHR reporting period could 
be a barrier for new entrants and could deter participation in the 
program especially as new entrants need time to install and learn to 
use technology before beginning their first EHR reporting period. 
However, we maintain that it is important to move all providers to the 
same EHR reporting period to simplify the program. So in 2018 all 
providers will attest to the Stage 3 definition of meaningful use for 
an EHR reporting period of the entire calendar year, with a limited 
exception for Medicaid providers who demonstrated AIU prior to 2017 and 
are demonstrating meaningful use for the first time. For these reasons, 
we will adopt a final policy that for EPs demonstrating meaningful use 
for the first time in 2017 under Medicare or Medicaid, the EHR 
reporting period for a payment adjustment year is any continuous 90-day 
period in CY 2017 and applies for purposes of the payment adjustments 
in CY 2018. To avoid the payment adjustment in CY 2018, the 90-day 
period must occur within the first three quarters of CY 2017 and the EP 
must attest by October 1, 2017.
    Comment: Some commenters noted that new participants in 2018 would 
be moving to Stage 3 and should have a 90 day EHR reporting period for 
that purpose, not just in Medicaid but also in Medicare. Other 
commenters stated that any provider in their first year, and all 
providers in the first year of a new stage, should have a 90-day 
reporting period.
    Response: We do not believe a 90-day EHR reporting period is 
necessary for new participants in 2018 as discussed in section 
II.B.1.b.(3).(a). of this final rule with comment period. However, we 
note that we are offering additional flexibility for any provider, new 
or returning, who elects to participate in Stage 3 in 2017 which we 
believe is a fair solution to support these providers' efforts to move 
forward in the program. As noted in section II.E.2. of this final rule 
with comment period, we are adopting a policy for EPs in the Medicaid 
program, and for eligible hospitals and CAHs who demonstrate Stage 3 in 
2017, allowing a 90-day EHR reporting period. We are adopting this 
policy based on public comment received (as discussed in section 
II.B.1.b.(3)(c) of this final rule with comment period) in relation to 
the EHR reporting period for 2017 in order to allow these providers 
adequate time to upgrade to the required 2015 Edition technology and to 
encourage providers to select the option to participate in the

[[Page 62905]]

Stage 3 objectives and measures which support our long term goals. For 
Medicaid EPs, and for new participants in Medicaid and Medicare, this 
90-day EHR reporting period for Stage 3 would also apply for the 
purposes of avoiding the payment adjustment in 2019 for returning 
participants and for the payment adjustment in 2018 for new 
participants who attest to Stage 3 prior to October 1, 2017.
    For Medicare EPs, we note that the EHR reporting period for a 
payment adjustment year for returning participants in 2017 and for all 
Medicare EPs in 2018 and subsequent years will be established through 
future rulemaking in association with the MIPs program discussed 
further in the comments and responses immediately following.
    Comment: We received a number of comments requesting clarification 
of how the policies proposed in the EHR Incentive Program in 2015 
through 2017 and Stage 3 proposed rules are affected by recent 
legislation modifying the HITECH Act provisions for payment adjustments 
for eligible professionals.
    Response: As noted previously, section 101(b)(1)(A) of MACRA 
amended section 1848(a)(7)(A) of the Act to sunset the EHR Incentive 
Program payment adjustment for EPs at the end of CY 2018. Thus, we are 
not finalizing the proposal (80 FR 16775) that for all EPs beginning 
with the CY 2019 payment adjustment year, 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, CY 2017 as the 
EHR reporting period for the CY 2019 payment adjustment year). We are 
also not finalizing the proposed limited exception for EPs 
demonstrating meaningful use under the Medicaid EHR Incentive Program 
for the first time (80 FR 16775). The reason we are not finalizing 
these proposals is because CY 2018 will be the last payment adjustment 
year for EPs under section 1848(a)(7)(A) of the Act, as amended by 
section 101(b)(1)(A) of MACRA. As noted previously, section 1848(q) of 
the Act, as added by section 101(c) of MACRA, requires the 
establishment of MIPS, which would incorporate certain existing 
provisions and processes related to meaningful use. We intend to 
implement MIPS through future rulemaking, which among other things 
would address the effect on Medicare Physician Fee Schedule payments in 
CY 2019 and subsequent years for certain EPs who are not meaningful EHR 
users for an applicable performance period. We encourage readers to 
review and respond to our request for information titled ``Request for 
Information Regarding Implementation of the Merit-based Incentive 
Payment System, Promotion of Alternative Payment Models, and Incentive 
Payments for Participation in Eligible Alternative Payment Models'' 
published in the October 1, 2015 Federal Register (80 FR 59102).
    After consideration of the public comments, we are finalizing the 
following changes to the EHR reporting period for a payment adjustment 
year for EPs as proposed, with a modification for 2017. In CY 2015, the 
EHR reporting period for a payment adjustment year for EPs who have not 
successfully demonstrated meaningful use in a prior year (``new 
participants'') is any continuous 90-day period in CY 2015. An EP who 
successfully demonstrates meaningful use for this period and satisfies 
all other program requirements will avoid the payment adjustments in 
CYs 2016 and 2017 if the EP successfully attests by February 29, 2016.
    In CY 2015, the EHR reporting period for a payment adjustment year 
for EPs who have successfully demonstrated meaningful use in a prior 
year (``returning participants'') is any continuous 90-day period in CY 
2015. An EP who successfully demonstrates meaningful use for this 
period and satisfies all other program requirements will avoid the 
payment adjustment in CY 2017 if the EP successfully attests by 
February 29, 2016.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for EPs who are new participants is any continuous 90-day period in CY 
2016. An EP who successfully demonstrates meaningful use for this 
period and satisfies all other program requirements will avoid the 
payment adjustment in CY 2017 if the EP successfully attests by October 
1, 2016, and will avoid the payment adjustment in CY 2018 if the EP 
successfully attests by February 28, 2017.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for EPs who are returning participants is the full CY 2016. An EP who 
successfully demonstrates meaningful use for this period and satisfies 
all other program requirements will avoid the payment adjustment in CY 
2018 if the EP successfully attests by February 28, 2017.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for EPs who are new participants is any continuous 90-day period in CY 
2017. An EP who successfully demonstrates meaningful use for this 
period and satisfies all other program requirements will avoid the 
payment adjustment in CY 2018 if the EP successfully attests by October 
1, 2017.
    We have revised the definition of ``EHR reporting period for a 
payment adjustment year'' under Sec.  495.4 to reflect these final 
policies. Table 18 contains a summary of the final policies.

[[Page 62906]]



                  Table 18--EHR Reporting Periods and Related Payment Adjustment Years for EPs
----------------------------------------------------------------------------------------------------------------
                                                      2015
-----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                            for a  payment       payment  adjustment in   payment  adjustment in
                                           adjustment year              CY 2016                  CY 2017
----------------------------------------------------------------------------------------------------------------
EPs who have not successfully          Any continuous           Yes, if EP successfully  Yes, if EP successfully
 demonstrated meaningful use in a       90[dash]day period in    attests by February      attests by February
 prior year (new participants).         CY 2015.                 29, 2016.                29, 2016.
EPs who have successfully              Any continuous           No.....................  Yes, if EP successfully
 demonstrated meaningful use in a       90[dash]day period in                             attests by February
 prior year (returning participants).   CY 2015.                                          29, 2016.
----------------------------------------------------------------------------------------------------------------
                                                      2016
----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                             for a payment        payment adjustment in    payment adjustment in
                                            adjustment year              CY 2017                 CY 2018.
----------------------------------------------------------------------------------------------------------------
EP new participants..................  Any continuous           Yes, if EP successfully  Yes, if EP successfully
                                        90[dash]day period in    attests by October 1,    attests by February
                                        CY 2016.                 2016.                    28, 2017.
EP returning participants............  CY 2016................  No.....................  Yes, if successfully
                                                                                          attest by February 28,
                                                                                          2017.
----------------------------------------------------------------------------------------------------------------
                                                      2017
----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                             for a payment        payment adjustment in    payment adjustment in
                                            adjustment year              CY 2018                  CY 2019
----------------------------------------------------------------------------------------------------------------
EP new participants..................  Any continuous           Yes, if EP successfully  N/A.
                                        90[dash]day period in    attests by October 1,
                                        CY 2017.                 2017.
EP returning participants............  N/A....................  N/A....................  N/A.
Medicaid EP returning participants     Any continuous           No.....................  Yes, if successfully
 demonstrating Stage 3.                 90[dash]day period in                             attest by February 28,
                                        CY 2017.                                          2018.
----------------------------------------------------------------------------------------------------------------

b. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for Eligible Hospitals
    As follows is a summary of the comments received on the proposals 
for the EHR reporting period for a payment adjustment year for eligible 
hospitals (80 FR 16776 through 16778 and 80 FR 20380 through 20381):
    Comment: We received a number of comments stating that new 
participant eligible hospitals should be allowed to attest prior to 
January 1, 2016 in order to earn an incentive payment and avoid the 
Medicare payment adjustment for 2016. We received comments in support 
of the proposed changes to the EHR reporting period for a payment 
adjustment year to allow for greater flexibility and more time for 
eligible hospitals to work toward successful demonstration of 
meaningful use.
    Response: We thank the commenters and note that the attestation 
period will be open for all providers in January of 2016 to attest for 
an EHR reporting period in 2015.
    Comment: Some commenters agreed with the proposal as described to 
align EHR reporting periods for the purpose of future payment 
adjustments and endorsed the proposal to continue with the current 
structure for these components. Some comments also supported a single 
deadline for new participants to attest to avoid the payment 
adjustments in 2017.
    Response: We appreciate the commenters' feedback and support. We 
strongly believe this will simplify the EHR Incentive Program and 
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.
    Comment: Some commenters expressed concerns about our proposal to 
require first-time participants to fulfill an EHR reporting period 2 
years in advance of the payment adjustment year. They believe that this 
policy change is unnecessarily confusing and unfairly penalizes first-
time participants. They recommended that CMS retain its current policy 
to allow first-time participants to avoid a penalty in the subsequent 
year.
    Some commenters noted that new participants in 2018 would be moving 
to Stage 3 and should have a 90 day EHR reporting period for that 
purpose. Other commenters stated that any provider in their first year, 
and all providers in the first year of a new stage, should have a 90 
day reporting period.
    Response: We recognize the commenters' concerns, and for the 
reasons stated in section II.E.2.a with regard to new participant EPs 
in 2017, we will adopt a final policy that for eligible hospitals 
demonstrating meaningful use for the first time in 2017 under Medicare 
or Medicaid, the EHR reporting period for a payment adjustment year is 
any continuous 90-day period in CY 2017 and applies for purposes of the 
payment adjustments in FY 2018. To avoid the payment adjustment in FY 
2018, the 90-day EHR reporting period must occur within the first three 
quarters of CY 2017 and the eligible hospital must attest by October 1, 
2017.
    However, we will adopt a final policy beginning in 2018 to require 
eligible hospitals (new participants and returning participants) that 
attest to meaningful use under Medicare to complete a full CY EHR 
reporting period that is 2-years before the payment adjustment year. We 
are adopting a limited exception of a 90-day EHR reporting period the 
year that is 2 years before the payment adjustment year for Medicaid 
participants demonstrating meaningful use for the first time that 
previously demonstrated AIU prior to 2017 to allow these providers to 
earn an incentive payment in the Medicaid program for 2018 without 
receiving an penalty in the Medicare program.

[[Page 62907]]

    We disagree that the change to a full-year EHR reporting period 
unfairly impacts new participant. We note that the prior exception to 
allow a 90-day EHR reporting period favors new participants over 
returning participants who have no such opportunity to avoid a payment 
adjustment in the subsequent year. We further note that new 
participants could have chosen to begin the program at any time since 
2011 unless they are newly practicing providers who are already 
afforded a hardship exception from the penalty.
    After consideration of the public comments, we are finalizing the 
following changes to the EHR reporting period for a payment adjustment 
year for eligible hospitals as proposed, with a modification for the 
EHR reporting period in 2017. For the reasons stated in section 
II.E.2.a. of this final rule with comment period for Medicaid EPs 
participating in Stage 3 in 2017, we are finalizing a similar policy 
for eligible hospitals to establish a 90-day EHR reporting for Stage 3 
participants in 2017 for the purposes of avoiding the payment 
adjustment in 2019 for returning participants and for the payment 
adjustment in 2018 for new participants who attest to Stage 3 prior to 
October 1, 2017. For further discussion of the policy related to the 
EHR reporting period in 2017 we direct readers to section 
II.B.1.b.(3).iii. of this final rule with comment period.
    In CY 2015, the EHR reporting period for a payment adjustment year 
for eligible hospitals that have not successfully demonstrated 
meaningful use in a prior year (new participants) is any continuous 90-
day period beginning on October 1, 2014 and ending on December 31, 
2015. An eligible hospital that successfully demonstrates meaningful 
use for this period and satisfies all other program requirements will 
avoid the payment adjustment in FYs 2016 and 2017 if the eligible 
hospital successfully attests by February 29, 2016.
    In CY 2015, the EHR reporting period for a payment adjustment year 
for eligible hospitals that have successfully demonstrated meaningful 
use in a prior year (returning participants) is any continuous 90-day 
period beginning on October 1, 2014 and ending on December 31, 2015. An 
eligible hospital that successfully demonstrates meaningful use for 
this period and satisfies all other program requirements will avoid the 
payment adjustment in FY 2017 if the eligible hospital successfully 
attests by February 29, 2016.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for eligible hospitals that are new participants is any continuous 90-
day period in CY 2016. An eligible hospital that successfully 
demonstrates meaningful use for this period and satisfies all other 
program requirements will avoid the payment adjustment in FY 2017 if 
the eligible hospital successfully attests by October 1, 2016, and will 
avoid the payment adjustment in FY 2018 if the eligible hospital 
successfully attests by February 28, 2017.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for eligible hospitals that are returning participants is the full CY 
2016. An eligible hospital that successfully demonstrates meaningful 
use for this period and satisfies all other program requirements will 
avoid the payment adjustment in FY 2018 if the eligible hospital 
successfully attests by February 28, 2017.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for eligible hospitals that are new participants is any continuous 90-
day period in CY 2017. An eligible hospital that successfully 
demonstrates meaningful use for this period and satisfies all other 
program requirements will avoid the payment adjustment in FY 2018 if 
the eligible hospital successfully attests by October 1, 2017 and will 
avoid the payment adjustment in FY 2019 if the eligible hospital 
successfully attests by February 28, 2018.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for eligible hospitals that are demonstrating Stage 3 is any continuous 
90-day period in CY 2017. An eligible hospital that successfully 
demonstrates meaningful use for this period and satisfies all other 
program requirements will avoid the payment adjustment in FY 2019 if 
the eligible hospital successfully attests by February 28, 2018.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for eligible hospitals that are returning participants and are not 
demonstrating Stage 3, is the full CY 2017. An eligible hospital that 
successfully demonstrates meaningful use for this period and satisfies 
all other program requirements will avoid the payment adjustment in FY 
2019 if the eligible hospital successfully attests by February 28, 
2018.
    Beginning in CY 2018, the EHR reporting period for a payment 
adjustment year for eligible hospitals is the entire calendar year that 
is two years before the payment adjustment year. For example, CY 2018 
is the EHR reporting period for the FY 2020 payment adjustment year. 
The exception to this general rule is for eligible hospitals that 
successfully demonstrated AIU under the Medicaid EHR Incentive Program 
for a payment year prior to 2017 and are demonstrating meaningful use 
for the first time under the Medicaid EHR Incentive Program in the 
calendar year that is two years before the payment adjustment year. For 
those eligible hospitals, the same 90-day EHR reporting period used for 
the Medicaid incentive payment will also apply for purposes of the 
Medicare payment adjustment year 2 years after the calendar year in 
which the eligible hospital demonstrates meaningful use. For example, 
if an eligible hospital has never successfully demonstrated meaningful 
use in a prior year and demonstrates under the Medicaid EHR Incentive 
Program that it is a meaningful EHR user for the first time in CY 2018, 
the EHR reporting period for the Medicaid incentive payments any 
continuous 90-day period within CY 2018, and the same 90-day period 
also serves as the EHR reporting period for the FY 2020 payment 
adjustment year under Medicare. An eligible hospital that successfully 
demonstrates meaningful use for the relevant period and satisfies all 
other program requirements will avoid the payment adjustment in the 
relevant year if the eligible hospital successfully attests by the date 
specified by CMS.
    We have revised the definition of ``EHR reporting period for a 
payment adjustment year'' under Sec.  495.4 to reflect these final 
policies. Table 19 contains a summary of the final policies, although 
it does not include years beyond 2018.

[[Page 62908]]



           Table 19--EHR Reporting Periods and Related Payment Adjustment Years for Eligible Hospitals
----------------------------------------------------------------------------------------------------------------
                                                      2015
-----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                            for a payment        payment adjustment in    payment adjustment in
                                           adjustment year              FY 2016                  FY 2017
----------------------------------------------------------------------------------------------------------------
Eligible hospitals that have not       Any continuous           Yes, if eligible         Yes, if eligible
 successfully demonstrated meaningful   90[dash]day period       hospital successfully    hospital successfully
 use in a prior year (new               from October 1, 2014     attests by February      attests by February
 participants).                         through December 31,     29, 2016.                29, 2016.
                                        2015.
Eligible hospitals that have           Any continuous           No.....................  Yes, if eligible
 successfully demonstrated meaningful   90[dash]day period                                hospital successfully
 use in a prior year (returning         from October 1, 2014                              attests by February
 participants).                         through December 31,                              29, 2016.
                                        2015.
----------------------------------------------------------------------------------------------------------------
                                                      2016
----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                             for a payment        payment adjustment in    payment adjustment in
                                            adjustment year              FY 2017                  FY 2018
----------------------------------------------------------------------------------------------------------------
Eligible hospital new participants...  Any continuous           Yes, if eligible         Yes, if eligible
                                        90[dash]day period in    hospital successfully    hospital successfully
                                        CY 2016.                 attests by October 1,    attests by February
                                                                 2016.                    28, 2017.
Eligible hospital returning            CY 2016................  No.....................  Yes, if eligible
 participants.                                                                            hospital successfully
                                                                                          attests by February
                                                                                          28, 2017.
----------------------------------------------------------------------------------------------------------------
                                                      2017
----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                             for a payment        payment adjustment in    payment adjustment in
                                            adjustment year              FY 2018                  FY 2019
----------------------------------------------------------------------------------------------------------------
Eligible hospital new participants...  Any continuous           Yes, if eligible         Yes, if eligible
                                        90[dash]day period in    hospital successfully    hospital successfully
                                        CY 2017.                 attests by October 1,    attests by February
                                                                 2017.                    28, 2018.
Eligible hospital Stage 3              Any continuous           No for returning         Yes, if eligible
 participants.                          90[dash]day period in    participants.            hospital successfully
                                        CY 2017.                                          attests by February
                                                                                          28, 2018.
Eligible hospital returning            CY 2017................  No.....................  Yes, if eligible
 participants.                                                                            hospital successfully
                                                                                          attests by February
                                                                                          28, 2018.
----------------------------------------------------------------------------------------------------------------
                                                      2018
----------------------------------------------------------------------------------------------------------------
                                         EHR reporting period      Applies to avoid a       Applies to avoid a
                                             for a payment        payment adjustment in    payment adjustment in
                                            adjustment year              FY 2019                  FY 2020
----------------------------------------------------------------------------------------------------------------
Eligible hospital new participants...  CY 2018................  No.....................  Yes, if eligible
                                                                                          hospital successfully
                                                                                          attests by February
                                                                                          28, 2019.
Eligible hospital Medicaid exception.  The continuous 90-day    No.....................  Yes, if eligible
                                        EHR reporting period                              hospital successfully
                                        for the Medicaid                                  attests by February
                                        incentive payment in                              28, 2019.
                                        CY 2018.
Eligible hospital returning            CY 2018................  No.....................  Yes, if eligible
 participants.                                                                            hospital successfully
                                                                                          attests by February
                                                                                          28, 2019.
----------------------------------------------------------------------------------------------------------------

c. Changes to the EHR Reporting Period for a Payment Adjustment Year 
for CAHs
    As follows is a summary of the comments received on the proposals 
for the EHR reporting period for a payment adjustment year for CAHs (80 
FR 16777 through 16779 and 80 FR 20381):
    Comment: We received a number of comments stating that CAHs should 
be allowed to attest in 2015 if they are demonstrating meaningful use 
for the first time in order to earn an incentive payment and avoid the 
2015 payment adjustment. We further received requests for clarification 
of whether the early attestation deadlines apply for CAHs in order to 
avoid future payment adjustments as first time participants.
    Response: As noted in section II.D. of this final rule with comment 
period, some new participant CAHs have already attested to meaningful 
use for an EHR reporting period in 2015. The early attestation 
deadlines do not apply to CAHs because of the alignment of the EHR 
reporting period with the payment adjustment year and the use of the 
cost report reconciliation process to reduce a CAH's Medicare 
reimbursement for reasonable costs incurred if the CAH does not 
successfully demonstrate meaningful use for the applicable EHR 
reporting period. Furthermore, for the reasons stated in section 
II.E.2.a. of this final rule with comment period with regard to new 
participant EPs in 2017, we will adopt a final policy that for CAHs 
demonstrating meaningful use for the first time in 2017 under Medicare 
or Medicaid, the EHR reporting period for a payment adjustment year is 
any continuous 90-day period in CY 2017 and applies for purposes of the 
payment adjustments in FY 2017.

[[Page 62909]]

    We will also adopt a final policy beginning in 2018 to require CAH 
(new participants and returning participants) that attest to meaningful 
use under Medicare to complete a full CY EHR reporting period that is 
the payment adjustment year. We are adopting a limited exception of a 
90-day EHR reporting period within the calendar year that is the 
payment adjustment year for Medicaid CAH participants demonstrating 
meaningful use for the first time that previously demonstrated AIU 
prior to 2017 to allow these providers to earn an incentive payment in 
the Medicaid program for 2018 without receiving an penalty in the 
Medicare program.
    After consideration of the public comments, we are finalizing the 
following changes to the EHR reporting period for a payment adjustment 
year for CAHs as proposed, with a modification for the EHR reporting 
period in 2017. For the reasons stated in section II.E.2.a. of this 
final rule with comment period for Medicaid EPs for Stage 3 in 2017, we 
are finalizing a similar policy for CAHs to establish a 90-day EHR 
reporting for Stage 3 participants in 2017 for the purposes of avoiding 
the payment adjustment for FY 2017. For further discussion of the 
policy related to the EHR reporting period in 2017 we direct readers to 
section II.B.1.b.(3).iii. of this final rule with comment period.
    In CY 2015, the EHR reporting period for a payment adjustment year 
for CAHs that have not successfully demonstrated meaningful use in a 
prior year (new participants) is any continuous 90-day period beginning 
on October 1, 2014 and ending on December 31, 2015. A CAH that 
successfully demonstrates meaningful use for this period and satisfies 
all other program requirements will avoid the payment adjustment in FY 
2015 if the CAH successfully attests by February 29, 2016.
    In CY 2015, the EHR reporting period for a payment adjustment year 
for CAHs that have successfully demonstrated meaningful use in a prior 
year (returning participants) is any continuous 90-day period beginning 
on October 1, 2014 and ending on December 31, 2015. A CAH that 
successfully demonstrates meaningful use for this period and satisfies 
all other program requirements will avoid the payment adjustment in FY 
2015 if the CAH successfully attests by February 29, 2016.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for CAHs that are new participants is any continuous 90-day period in 
CY 2016. A CAH that successfully demonstrates meaningful use for this 
period and satisfies all other program requirements will avoid the 
payment adjustment in FY 2016 if the CAH successfully attests by 
February 28, 2017.
    In CY 2016, the EHR reporting period for a payment adjustment year 
for CAHs that are returning participants is the full CY 2016. A CAH 
that successfully demonstrates meaningful use for this period and 
satisfies all other program requirements will avoid the payment 
adjustment in FY 2016 if the CAH successfully attests by February 28, 
2017.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for CAHs that are new participants is any continuous 90-day period in 
CY 2017. A CAH that successfully demonstrates meaningful use for this 
period and satisfies all other program requirements will avoid the 
payment adjustment in FY 2017 if the CAH successfully attests by 
February 28, 2018.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for CAHs that are demonstrating Stage 3 is any continuous 90-day period 
in CY 2017. A CAH that successfully demonstrates meaningful use for 
this period and satisfies all other program requirements will avoid the 
payment adjustment in FY 2017 if the CAH successfully attests by 
February 28, 2018.
    In CY 2017, the EHR reporting period for a payment adjustment year 
for CAHs that are returning participants and are not demonstrating 
Stage 3, is the full CY 2017. A CAH that successfully demonstrates 
meaningful use for this period and satisfies all other program 
requirements will avoid the payment adjustment in FY 2017 if the CAH 
successfully attests by February 28, 2018.
    Beginning in CY 2018, the EHR reporting period for a payment 
adjustment year for CAHs is the calendar year that begins on the first 
day of the second quarter 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 2018, the CAH must demonstrate 
it is a meaningful EHR user for an EHR reporting period of the full CY 
2018. The exception to this general rule is for CAHs that successfully 
demonstrated AIU under the Medicaid EHR Incentive Program for a payment 
year prior to 2017 and are demonstrating meaningful use for the first 
time under the Medicaid EHR Incentive Program 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. For those CAHs, the same 90-
day EHR reporting period used for the Medicaid incentive payment will 
also apply for purposes of the Medicare payment adjustment year. For 
example, if a CAH has never successfully demonstrated meaningful use in 
a prior year and demonstrates under the Medicaid EHR Incentive Program 
that it is a meaningful EHR user for the first time in CY 2018, the EHR 
reporting period for the Medicaid incentive payment is any continuous 
90-day period within CY 2018, and the same 90-day period also serves as 
the EHR reporting period for the FY 2018payment adjustment year under 
Medicare. A CAH that successfully demonstrates meaningful use for the 
relevant period and satisfies all other program requirements will avoid 
the payment adjustment in the relevant year if the CAH successfully 
attests by the date specified by CMS.
    We have revised the definition of ``EHR reporting period for a 
payment adjustment year'' under Sec.  495.4 to reflect these final 
policies. Table 20 contains a summary of the final policies, although 
it does not include years beyond 2018.

[[Page 62910]]



Table 20--EHR Reporting Periods and Related Payment Adjustment Years for
                                  CAHs
------------------------------------------------------------------------
                                  2015
-------------------------------------------------------------------------
                                                            Applies to
                               EHR reporting period for  avoid a payment
                                a payment  adjustment     adjustment  in
                                         year                FY 2015
------------------------------------------------------------------------
CAHs that have not            Any continuous 90-day      Yes, if CAH
 successfully demonstrated     period from October 1,     successfully
 meaningful use in a prior     2014 through December      attests by
 year (new participants).      31, 2015                   February 29,
                                                          2016.
CAHs that have successfully   Any continuous 90-day
 demonstrated meaningful use   period from October 1,
 in a prior year (returning    2014 through December
 participants).                31, 2015
------------------------------------------------------------------------
                                  2016
------------------------------------------------------------------------
                               EHR reporting period for     Applies to
                                 a payment adjustment         avoid a
                                         year                 payment
                                                           adjustment in
                                                              FY 2016
------------------------------------------------------------------------
CAH new participants........  Any continuous 90-day      Yes, if CAH
                               period in CY 2016          successfully
                                                          attests by
                                                          February 28,
                                                          2017.
CAH returning participants..  CY 2016.
------------------------------------------------------------------------
                                  2017
------------------------------------------------------------------------
                               EHR reporting period for     Applies to
                                 a payment adjustment         avoid a
                                         year                 payment
                                                           adjustment in
                                                              FY 2017
------------------------------------------------------------------------
CAH new participants........  Any continuous             Yes, if CAH
                               90[dash]day period in CY   successfully
                               2017                       attests by
                                                          February 28,
                                                          2018.
CAH Stage 3 participants....  Any continuous
                               90[dash]day period in CY
                               2017
CAH returning participants..  CY 2017.
------------------------------------------------------------------------
                                  2018
------------------------------------------------------------------------
                               EHR reporting period for     Applies to
                                 a payment adjustment         avoid a
                                         year                 payment
                                                           adjustment in
                                                              FY 2018
------------------------------------------------------------------------
CAH new participants........  Any continuous             Yes, if CAH
                               90[dash]day period in CY   successfully
                               2018                       attests by
                                                          February 28,
                                                          2018.
CAH returning participants..  CY 2018.
------------------------------------------------------------------------

3. Hardship Exceptions
    As stated previously, sections 1848(a)(7)(B) and 
1886(b)(3)(B)(ix)(II) of the Act provide the Secretary with 
discretionary authority to exempt, on a case by case basis, a provider 
from the application of the Medicare payment adjustment if the 
Secretary determines that compliance with the requirements for being a 
meaningful EHR user would result in a significant hardship. We have 
established various types of hardship exceptions for which providers 
may apply as well as deadlines for application. For more information, 
we refer readers to the Stage 2 final rule at 77 FR 54093 through 
54113.
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20381), we proposed no changes to the types of hardship 
exceptions available to EPs, eligible hospitals, and CAHs. Further, we 
proposed no changes to the existing hardship exception process and 
timelines under our regulations.
    In the Stage 3 proposed rule we proposed no changes to the types of 
exceptions previously finalized for EPs, eligible hospitals or CAHs (80 
FR 16775, 80 FR 16777 and 80 FR 16779), nor did we propose any new 
types of exceptions for 2017 and subsequent years. Accordingly, we 
proposed that the exceptions continue as previously finalized. As 
follows is a summary of the comments received for hardship exceptions:
    Comment: We received a number of comments requesting an extension 
of the hardship exception application deadline from July 1 to December 
31 of the year proceeding the payment adjustment year. A commenter 
noted that CMS allowed for providers to apply for a hardship exception 
in November of the year proceeding the payment adjustment year in 2014 
and that such a provision should be possible in every year.
    Response: We thank the commenters for their suggestions but 
disagree with their assessment. The extension of the hardship exception 
application deadline to later in the year is both unnecessary and a 
significant burden for the program and for those providers whose claims 
may need to be reprocessed. We note that the expedited processing and 
reprocessing of claims represents a significant cost which should be 
avoided where feasible. Furthermore, if the applicable EHR reporting 
period for a payment adjustment year occurs 2 years before the payment 
adjustment year, providers that fail to demonstrate meaningful use for 
that period will be aware of their status well in advance of the 
deadline for applying for a hardship exception, and thus no such 
extension is necessary. New participants in the program who are 
uncertain of their ability to meet the requirements of the program in a 
given year may apply for a hardship exception even if they later find 
they are able to successfully attest in the program. The provider is 
not required to withdraw the hardship exception application, and the 
application does not affect their subsequent attestation for meaningful 
use. Therefore, we do not believe a general extension of the hardship 
exception application deadline is necessary, although we may consider 
extensions in exceptional circumstances.
    Comment: A large number of commenters requested that CMS add

[[Page 62911]]

new hardship exception categories for the EHR Incentive Programs. 
Commenters believed that there should be additional exception 
categories, especially for providers experiencing issues with certified 
EHR technology and EHR vendors; providers who are unable to achieve 
meaningful use due to the all-or-nothing approach; providers practicing 
in multiple locations or who have transitioned between locations; 
providers who are beyond retirement age; specialty providers; providers 
who are new to the EHR Incentive Program and have not yet achieved 
meaningful use; providers who see observation patients; and fellows. 
Commenters believe providers who fall into any of these categories have 
significant reasons to be included in the list of those who qualify for 
hardship exceptions and should not receive payment adjustments.
    Response: We note that providers may already apply for a hardship 
exception under the extreme and uncontrollable circumstances category 
if they experience issues with a vendor product including issues 
related to upgrades and transitions from one product to another. In 
addition, we note that new participants have the same ability to apply 
for a hardship exception as any other provider. We also established 
hardship exception categories for newly practicing EPs, new eligible 
hospitals, and new CAHs. We do not believe there are acceptable 
standards to establish a category based on age or potential retirement 
status given the wide variation among providers and potential 
influencing factors. Finally, we believe that the existing categories 
are broad and comprehensive enough to cover many different 
circumstances where meeting the program requirements would be a 
significant hardship due to circumstances outside the control of the 
provider and related to their particular practice or organization.
    Comment: Some commenters requested clarification around whether the 
5-year limitation for hardship exceptions will be applicable to 
providers with PECOS specialties of diagnostic radiology (30), nuclear 
medicine (36), interventional radiology (94), anesthesiology (05), and 
pathology (22). Commenters believed these providers might retain the 
same PECOS specialty code for more than 5 years.
    Response: Under section 1848(a)(7)(B) of the Act, the Secretary has 
discretion, on a case-by-case basis, to exempt an EP from the Medicare 
payment adjustment if the Secretary determines, subject to annual 
renewal, that requiring the EP to be a meaningful EHR user would result 
in a significant hardship. Such exemptions are not granted once and 
applicable for a full five-year period. Under 495.102(d)(4)(iv)(C), an 
EP may receive a hardship exception if he or she has a primary 
specialty listed in PECOS as anesthesiology, radiology or pathology 6 
months prior to the first day of the payment adjustments that would 
otherwise apply. The following five specialty codes correspond to those 
primary specialties in PECOS: Diagnostic Radiology (30), Nuclear 
Medicine (36), Interventional, Radiology (94), Anesthesiology (05), or 
Pathology (22).
    Comment: A commenter expressed concern regarding the requirement 
that the hardship exception is subject to annual renewal, but in no 
case may an EP be granted an exception for more than 5 years. 
Specifically, the commenter stated that a large percentage of these EPs 
practice in areas that do not have availability of CEHRT for 
demonstration of meaningful use. Because these providers lack control 
over availability of CEHRT for more than 50 percent of patient 
encounters, they cannot demonstrate meaningful use. The commenter 
anticipates these providers to continue practicing at multiple 
locations beyond the 5 years allowed for hardship exceptions. Some 
commenters suggested a hardship exemption should be available for EPs 
working in long term post-acute care (LTPAC) which should continue 
beyond the 5-year time limit; while other commenters questioned what if 
there is not sufficient broadband access in the region and 5 years may 
not be enough time for some remote areas to be ``connected''. A 
commenter recommended simply eliminating the 5-year maximum for 
providers claiming this hardship exception.
    Response: We are sympathetic to the challenges identified by the 
commenters and believe that barriers to achieving meaningful use should 
be minimized over time. As noted earlier, the 5-year limitation on 
hardship exceptions is a statutory requirement under section 
1848(a)(7)(B) of the Act, and we do not have discretion to alter this 
requirement.
    Comment: We received a suggestion from a commenter for an 
indication in the registration system that would identify the new EPs, 
which may be helpful to assist with program management. The commenter 
indicated for a large group practice, it is very difficult to determine 
if an EP is considered ``new'' by CMS standards and therefore may 
qualify for a hardship exception for newly practicing EPs. Some EPs 
have moonlighted during residency or fellowship and may be considered 
eligible for this hardship exception.
    Response: We appreciate the commenter's suggestion about an 
indicator to identify a newly practicing EP in the registration system 
and will consider analysis to determine feasibility.
    Comment: Commenters supported the existing hardship exception 
structure and categories for the Medicare payment adjustment in the EHR 
Incentive Programs. Some commenters requested a change the hardship 
exception application date for eligible hospitals to reflect the 
realignment to the calendar year.
    Response: We appreciate the support expressed by commenters of our 
current process for hardship exceptions for eligible hospitals. We 
agree with the recommendation to modify the hardship exception 
application deadline for eligible hospitals to allow for adequate time 
between the close of the calendar year and the submission requirements 
for hardship applications. We will align the eligible hospital deadline 
with the EP deadline so that applications will be due on July 1 of the 
year preceding the payment adjustment year.
    We are finalizing no changes to the types of hardship exceptions 
already available to EPs, eligible hospitals, and CAHs, nor do we 
finalize any new types of hardship exceptions. We are finalizing one 
procedural change to the hardship exception application deadline for 
eligible hospitals to July 1 of the year preceding the payment 
adjustment year to align the application period with EPs in light of 
the change to align hospitals with the calendar year for the EHR 
reporting period for a payment adjustment year and the changed 
attestation deadlines as finalized in section II.E.2.b and II.D of this 
final rule with comment period. This change is reflected in Sec.  
412.64(d)(4).
4. 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 developed guidance on the 
appeals process, which is available on our Web site at www.cms.gov/EHRIncentivePrograms. We proposed no changes to this process and intend 
to continue to specify the appeals process in guidance available on our 
Web site.
    Comments: We received a number of comments with references to 
specific

[[Page 62912]]

instances of audits or appeals submitted. In addition, we received a 
wide range of recommendations for changes the auditors should make and 
for the requirements for the audit program. Finally, we received a 
number of comments expressing frustration with failed audits due to 
lack of response from the provider or the provider not receiving 
notification.
    Response: We thank the commenters for sharing their experiences and 
insight with us. While we will not respond to each individual 
circumstance in this final rule with comment period, as this is not the 
appropriate vehicle to address these individual concerns, we note that 
providers may contact us directly and we will work with them to 
understand their audit or appeal status, review any determinations and 
provide information related to the programs. We also appreciate those 
who provided suggestions for additional guidance which might assist the 
auditors to make determinations on certain requirements for the 
program. We have reviewed this information and will update our guidance 
in response to recommendations received. Finally, we note that it is 
incumbent on providers to maintain the appropriate contact information 
in the system of record and regularly verify that their contact 
information is correct. It is this contact information provided by the 
EP, eligible hospital, or CAH which we use to notify the provider of 
any status update or audit request for the EHR Incentive Programs. Once 
notification has been sent, it is also this contact information which 
is used by the auditors to communicate with the provider on status, 
documentation requests, and any other necessary items in order to 
expedite the audit process and ensure the use of verified and 
authorized contact information for the EP, eligible hospital or CAH.
    We are finalizing our proposal to maintain this policy as 
previously adopted.

F. Medicare Advantage Organization Incentive Payments

    We did not propose any changes to the existing policies and 
regulations for 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).)
    Comment: A commenter requested clarification that CMS is not 
changing the quality reporting requirements for MA organizations in 
this proposed rule so that MA providers may still meet the quality 
reporting requirements by way of their Healthcare Effectiveness Data 
and Information Set (HEDIS) submission. Another commenter requested 
that hardship exceptions be granted to MA providers under the same 
provisions available for non-MA providers.
    Response: We are confirming that we will continue to allow MA 
organizations to report HEDIS measures in lieu of CQMs for purposes of 
meaningful use for qualifying MA-EPs and MA-affiliated eligible 
hospitals.
    We did not propose any changes to the hardship exemption policy for 
MA providers in the proposed regulation. Therefore, the comment is 
outside the scope of the proposed rule and is not addressed in this 
final rule with comment period.

G. The Medicaid EHR Incentive Program

1. State Flexibility for Meaningful Use
    Consistent with our approach under both Stage 1 and 2, for Stage 3 
we proposed 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. We proposed at that under Stage 3 (80 FR 
16779), state flexibility would apply only with respect to the public 
health and clinical data registry reporting objective. We proposed that 
states could continue to specify the means of transmission of data and 
otherwise change the public health agency reporting objective as long 
as the state does not require functionality greater than what is 
required for Stage 3 and included in the 2015 Edition proposed rule.
    Similarly, in the preamble to the EHR Incentive Programs in 2015 
through 2017 proposed rule (80 FR 20349), we proposed to continue to 
offer states flexibility for the public health reporting objective as 
modified under Stage 2 for 2015 through 2017. We would continue the 
policy stated in the Stage 2 final rule (77 FR 53979) to allow states 
to specify the means of transmission of the data or otherwise change 
the public health measure as long as it does not require EHR 
functionality that supersedes that which is included in the 
certification requirements specified under the 2014 Edition 
certification criteria.
    Comment: Commenters requested clarification on the state 
flexibility that would be permitted. One commenter requested 
clarification on whether immunization registries would be included, 
whether states could continue to specify transport options, and whether 
states could decide not to declare readiness to accept submissions to 
clinical data registries for meaningful use purposes.
    Response: We note that the state flexibility to propose a revised 
definition of meaningful use with respect to particular public health 
measures continues as allowed in Stage 1 and Stage 2 at Sec.  
495.316(d)(2) and Sec.  495.332(f)(2). We note that the final rule has 
altered the structure of meaningful use under Stage 2 with respect to 
the public health and clinical data registry reporting measures, such 
that there is a single objective with a list of measures that providers 
may choose from. However, we would still permit states to exercise 
flexibility with respect to each of the Stage 2 items listed at Sec.  
495.316(d)(2)(ii) that still apply in 2015 through 2017 under this 
final rule. We will also take the following considerations into account 
when, as part of 'our review and approval of the state's Medicaid HIT 
plan, we review state requests for flexibility with respect to the 
public health reporting objective (Objective 8) for Stage 3 (see 
section II.B.2.b.(viii). of this final rule with comment period. We 
want to balance states' flexibility to customize the public health and 
clinical data registry requirements for meaningful use against ensuring 
providers have options to submit to registries that are most relevant 
to their practices. Therefore, we expect that for Stage 3 we would be 
more likely to approve requests under which a state would require an 
EPs, eligible hospitals and CAHs to submit to a specific registry 
meeting the specification of measures 1 through 4 or 6 rather than 
establishing specific requirements for measure 5.
    The flexibility to specify transmission standards remains unchanged 
from the Stage 2 Rule. In the Stage 2 final rule (77 FR 53979), we 
explained that a state could not require a different standard than the 
one included in 2014 ONC EHR certification criteria, but in cases where 
the 2014 ONC EHR certification criteria are silent, such as the means 
of transmission for a given public health objective, the state may 
propose changes to public health measures. We maintain this distinction 
for Stage 3 in relation to the 2015 ONC certification criteria for 
health IT.
    Comment: Most commenters supported the new provision to provide 
states with flexibility regarding the Stage 3 public health and 
clinical data

[[Page 62913]]

registry reporting objective. One commenter questioned whether a state 
could opt to not declare readiness to accept clinical data registries 
for meaningful use purposes, expressing concern that providers may 
prioritize reporting to federal clinical data registries over the 
public health reporting objectives. Another commenter expressed concern 
that that this flexibility would lead to differing objectives and 
measures among the states instead of a consistent, standard approach.
    Response: We proposed to continue to offer states flexibility under 
the Medicaid EHR Incentive Program in Stage 3, but subject to the same 
considerations discussed previously in Stage 2 (77 FR 53979). 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 they do not require 
functionality greater than what is required for Stage 3 and included in 
the 2015 Edition final rule. States may change the definition of 
meaningful use with respect to the public health registry and clinical 
data registry reporting objective as discussed in our earlier response. 
While this policy may lead to variations in the definition of 
meaningful use with respect to this objective among the states, we 
believe that it is important to allow states to better shape their 
public health policies and encourage providers to submit data to 
particular public health registries.
    States generally do not have discretion to categorically deny 
providers from using clinical data registries to meet the public health 
and clinical data registry reporting objective, so long as the clinical 
data repositories fall within federal rules and guidance. To address 
concerns that providers may be discouraged from attesting to public 
health registries, we reiterate that states can submit for CMS approval 
revisions to their SMHPs that would require that providers meet certain 
measures.
    We are finalizing the Stage 3 state flexibility provision generally 
as proposed, with only a minor change to update a cross-reference to 
the public health and clinical data registry objective.
2. EHR Reporting Period and EHR Reporting Period for a Payment 
Adjustment Year for First Time Meaningful EHR Users in Medicaid
    In the Stage 3 proposed rule (80 FR 16779), we proposed several 
amendments to the definitions of ``EHR Reporting Period'' and ``EHR 
reporting period for a payment adjustment year'' in Sec.  495.4 that 
would apply to providers attesting in the Medicaid EHR Incentive 
Program. While many of the proposed amendments would apply to providers 
attesting in either the Medicare or Medicaid EHR Incentive Program, we 
also proposed a limited exception for new meaningful EHR users in the 
Medicaid program beginning in 2017.
    In the EHR Incentive Programs in 2015 through 2017 proposed rule 
(80 FR 20353 and 20354), we proposed that all providers (EPs, eligible 
hospitals, and CAHs) would be required to complete an EHR reporting 
period within January 1 and December 31 of the calendar year in order 
to fulfill the requirements of the EHR Incentive Programs beginning in 
calendar year 2015 (except for eligible hospitals and CAHs in 2015, 
which may begin an EHR reporting period as early as October 1, 2014 and 
must end by December 31, 2015). We also proposed that for an EHR 
reporting period in 2015, eligible professionals may select an EHR 
reporting period of any continuous 90-day period from January 1, 2015 
through December 31, 2015; eligible hospitals and CAHs may select an 
EHR reporting period of any continuous 90-day period from October 1, 
2014 through December 31, 2015. These proposed amendments and the final 
policies adopted are discussed in sections II.B.1.b.(3).(i). and (ii). 
of this final rule with comment period.
    In the Stage 3 proposed rule (80 FR 16739), we proposed that 
beginning in 2017 and for all EPs, eligible hospitals, and CAHs, the 
EHR reporting period would be one full calendar year. This proposed 
amendment is discussed in section II.B.1.b.(3).(iii). of this final 
rule with comment period, and is finalized with a modification to begin 
for all providers in 2018 and multiple modifications to the EHR 
reporting period in 2017. For EPs, eligible hospitals, and CAHs that 
choose to meet Stage 3 in 2017, the EHR reporting period is any 
continuous 90-day period within CY 2017. For new participants, the EHR 
reporting period is any continuous 90-day reporting period within CY 
2017. These modifications regarding providers attesting to Stage 3 of 
meaningful use in 2017 applies to providers attesting to the Medicaid 
EHR Incentive Program as well.
    In the Stage 3 proposed rule (80 FR 16739), we also proposed a 
limited exception for Medicaid providers demonstrating meaningful use 
for the first time in 2017 and subsequent years. For that exception, we 
proposed 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 
proposed that this exception 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. As the last year that an eligible professional can 
begin participation in the Medicaid EHR Incentive Program is 2016, this 
limited exception would apply only to providers who received an 
incentive payment for adopt, implement, or upgrade of CEHRT in 2011 
through 2016, but did not receive an incentive payment for 
demonstration of meaningful use until 2017 or after. In this section, 
we address comments received on this limited exception for new 
meaningful EHR users in the Medicaid program.
    Comment: Several commenters supported the proposal to allow 
Medicaid providers to have a 90-day EHR reporting period for their 
first year of demonstrating meaningful use under the Medicaid EHR 
Incentive Program.
    Response: We refer readers to sections II.B.1.b.(3). and II.E.2. of 
this final rule with comment period with comment period for a 
discussion of our final policies for Medicaid providers for the EHR 
reporting period and the EHR reporting period for a payment adjustment 
year.
    We believe that these changes will allow flexibility for providers 
who have not demonstrated meaningful use in a previous year and will 
encourage providers to participate in the program.
    Comment: Some commenters opposed the proposed 90-day EHR reporting 
period for certain Medicaid providers because they believed it would 
cause confusion as it conflicts with the proposed Medicare policy. In 
addition, these commenters were concerned that providers attesting to 
the 90-day EHR reporting period for Medicaid would still be subject to 
the Medicare payment adjustment.
    Response: We recognize the possibility of provider confusion 
regarding EHR reporting periods between the Medicare and Medicaid EHR 
Incentive Programs under the final rule, but we believe that there are 
benefits that outweigh this potential concern. A 90-day EHR reporting 
period would allow Medicaid providers additional time and flexibility 
within their first year of demonstrating meaningful use to implement 
certified EHR technology and otherwise integrate

[[Page 62914]]

the meaningful use objectives into their practices. We believe that 
this will encourage participation in the program and move a greater 
number of providers towards 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. With regard to the question raised by commenters if 
providers attesting to the 90-day EHR reporting period for Medicaid may 
still be subject to the Medicare payment adjustment, we refer to our 
discussion of the EHR reporting period for the payment adjustment year 
in section II.E.2. of this final rule with comment period.
    Comment: Some commenters requested that CMS allow states to give 
providers the option to attest to ``at least 90 days or 3 calendar 
months,'' rather than 90 days within the calendar year, because it is 
more convenient for providers to run reports out of their CEHRT by 
month.
    Response: We believe that it is important to maintain a consistent 
EHR reporting period for providers in their first year of meaningful 
use and changing the EHR period at this point also risks provider 
confusion. Allowing 3 calendar months would open the possibility of a 
reporting period that is shorter than 90 days, and we believe that 90 
days is already a short period as compared to the entire year. 
Furthermore, a 90-day period need not be tied to the beginning or end 
of a month and permits flexibility for providers.
    Comment: A commenter requested that CMS provide outreach and 
education to assure understanding of the 90-day EHR reporting period 
for Medicaid providers demonstrating meaningful use for the first time.
    Response: We will provide outreach and education around this 
policy. Because the exception for new meaningful EHR users in the 
Medicaid program who had successfully attested to AIU prior to 2016 to 
allow a 90-day EHR reporting period in 2018 and subsequent years is 
consistent with existing policy with respect to Medicaid provider EHR 
reporting periods, we do not anticipate significant additional 
confusion.
3. Reporting Requirements
a. State Reporting on Program Activities
    In the Stage 3 proposed rule (80 FR 16779), we also proposed 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 
deadline. We proposed 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 proposed 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.
    In the Stage 3 proposed rule (80 FR 16779), we also noted our 
intent to consider 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 explained we were 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 CEHRT or on the 
basis of demonstrating they are meaningful users of CEHRT. We stated 
our belief that this data is useful to both CMS and the states for 
program implementation purposes, but that the benefits of including it 
in state reports might be outweighed by the burdens to states of 
reporting it and requested more information on state burdens and costs 
associated with complying with this requirement. We solicited 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 proposed 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 proposed 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 CEHRT 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 CEHRT and the amounts of incentive payments.
    We proposed 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.
    Finally, we proposed to include a deadline for states' quarterly 
reporting under the proposed amendments to Sec.  495.352, and requested 
public comment on a deadline of 30 days after the end of each federal 
fiscal year quarter.
    Comment: Commenters supported formalizing the process of how states 
report annually on the providers that have attested to AIU, or that 
have attested to meaningful use, but requested to submit annual reports 
within 60 days of the end of the second quarter of each federal fiscal 
year rather than the 45 days proposed in the rule. A commenter stated 
that this will alleviate systems and programming changes typically 
faced by states at the end of the calendar year, while another 
commenter expressed that states would need more time to produce current 
program year data to be included in the annual report.
    Response: We agree with the commenter's statements regarding the 
implications of year-end program changes and the need for additional 
time to produce related data. Therefore, we are finalizing these 
provisions to require that annual reports be submitted to CMS within 60 
days of the end of the second quarter of each federal fiscal year 
rather than 45 days, as was proposed. States should have ample time to 
prepare to submit the annual reports to CMS, and we are not adding 
additional data elements for states to report; therefore, the first 
report under this amendment will be due within 60 days of the end of 
the second quarter of

[[Page 62915]]

the federal fiscal year in which the final rule takes effect.
    Comment: Commenters supported our proposal to remove practice 
location from the annual report. A commenter noted that their state 
already reports practice location, but does not find this data point to 
be beneficial and is in favor of removing this requirement. Another 
commenter finds this requirement to be burdensome because it requires 
manual review of attestations in order to identify accurate data on 
practice locations, and fears this will lead to inaccurate data.
    Response: We appreciate the commenters' feedback on this topic. 
While we believe that there is a benefit to having states report this 
information in the annual reports, we believe that this benefit is 
outweighed by the burden of states having to collect and report this 
information on providers. Moreover, there is also a risk that 
inaccurate practice location data may be reported due to manual data 
collection processes. We believe that we can effectively oversee the 
program without states reporting this particular information. 
Therefore, we intend to remove the requirement at Sec.  
495.316(d)(1)(i) and (iii) that states report information about 
practice location for providers that qualify for incentive payments on 
the basis of having adopted, implemented, or upgraded CEHRT or on the 
basis of demonstrating they are meaningful users of CEHRT. We encourage 
states to collect and use practice location information, as it could 
prove useful and may differ from the business address information that 
is used for program administration purposes.
    Comment: Commenters supported the proposed requirement for states 
to submit quarterly progress reports to CMS within 30 days after the 
end of each federal fiscal year quarter and do not anticipate that this 
requirement would create any burden.
    Response: Based on the positive feedback we are finalizing the 
proposal with a modification to require the deadline of 30 days after 
the end of each federal fiscal year quarter that was discussed in the 
proposed rule. In order to give states sufficient time to prepare to 
submit the quarterly reports, the first report under the amendments to 
Sec.  495.352 will be due in the second quarter following the one in 
which the final rule takes effect.
    Comment: A commenter recommended that all public health measures 
collected or tracked through the state reporting activities be reported 
to the public health agency.
    Response: We support the notion of sharing public health measures 
collected through state reporting activities with the designated public 
health agency, but also recognize that the mechanism and interface 
between the reporting organization and the public health agency must be 
live, operational, and capable of interfacing with all parties 
involved. Additionally, our state reporting provisions are meant to 
cover reporting from state Medicaid agencies to CMS. We decline to add 
a requirement that state Medicaid agencies report this data to other 
entities, including public health agencies.
b. State Reporting on Meaningful EHR Users
    In the Stage 3 proposed rule at (80 FR 16780), we noted that CMS 
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. 
Accordingly, we proposed 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, in the manner 
prescribed by CMS, for Medicaid EPs and eligible hospitals that 
successfully attest to meaningful use for each payment year.
    We proposed that states would report quarterly 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's 
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).
    We also proposed that 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 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.
    We also proposed that 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.
    Comment: Most comments favored and expressed no concern with the 
associated requirements, nor anticipated burden. A commenter shared 
that he or she found the state reporting on Meaningful EHR Users to be 
time consuming and suggested that we use the National Level Repository 
(NLR) transactions to determine meaningful users and remove this burden 
from the states. In this commenter's view, the payment adjustment is a 
Medicare function; therefore states should be removed from the process. 
Another commenter requested that we further clarify who is exempt from 
the state reporting.
    Response: We intend to finalize these provisions as proposed for 
the reasons provided in the preamble to the Stage 3 proposed rule. As 
outlined in the Stage 3 proposed rule (80 FR 16780), we must have 
accurate and timely data from states regarding both EPs and eligible 
hospitals to ensure that meaningful 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 NLR 
are insufficient to determine which Medicaid providers should be 
exempted from the Medicare payment adjustments in an accurate and 
timely manner. Regarding the exemption with respect to reports on 
certain providers, we are not

[[Page 62916]]

requiring states to report on nurse practitioners, certified nurse-
midwives, or physician assistants because these provider types are not 
subject to the Medicare payment adjustments. The first report under 
this requirement will be due in the quarter following the one in which 
the rule takes effect.
4. Clinical Quality Measurement for the Medicaid Program
    In the Stage 3 proposed rule (80 FR 16780), we noted that states 
are responsible for determining whether and how electronic reporting of 
CQMs would occur, or whether they wish to allow reporting through 
attestation. If a state does require electronic reporting, the state is 
responsible for sharing the details on the process with its provider 
community. 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 CEHRT 
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.
    Comment: A commenter supported the proposal to continue allowing 
states to be responsible for determining how providers will report CQMs 
because not all states are at the same readiness level to accept eCQMs, 
and states must implement system changes to accommodate policy change.
    Response: We appreciate this comment, and we are finalizing this 
policy as proposed.
    Comment: A number of commenters provided feedback regarding 
Medicaid quality improvement initiatives and recommendations on how to 
best conduct outreach and engagement to providers and patients in 
various clinical settings. Commenters also recommended ways to 
publicize EP accomplishments in providing essential health services to 
patients benefiting from the Medicaid EHR Incentive Program. In 
addition, commenters encouraged CMS to continue its conversations with 
state Medicaid agencies and health groups in an effort to explore the 
issues faced by eligible providers attempting to meaningfully use EHR 
in areas with large numbers of uninsured populations. They also 
recommended that CMS continue to encourage state Medicaid programs to 
collaborate with public health agencies, and to assist in reducing 
barriers to the use of Federal funding to build public health 
information infrastructure. A commenter recommended changes to the 
Medicaid patient-volume rules.
    Response: We will consider these recommendations as we develop 
future planning for long-term delivery system reform and related 
policies. We note that some of these comments were outside of the scope 
of the proposed rules.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to evaluate fairly whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    The following is a discussion of the requirements contained in the 
proposed regulations that we believed were subject to PRA and 
collection of information requirements (ICRs) as a result of this final 
rule with comment period. This analysis finalizes our projections which 
were proposed in the March 30, 2015 Federal Register (80 FR 16781 
through 16787) and the April 15, 2015 Federal Register (80 FR 20381 
through 20386). The projected numbers of EPs, eligible hospitals, CAHs, 
MA organizations, MA EPs, and MA-affiliated hospitals were based on the 
numbers used in the impact analysis assumptions, as well as estimated 
federal costs and savings in the sections of the proposed rules. 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 actual burden would remain constant for 2015 through 
2017 as EPs, eligible hospitals, and CAHs would only need to attest 
that they have successfully demonstrated meaningful use in 2015 through 
2017. The only variable from year to year will be the number of 
respondents, as noted in the impact analysis assumptions.
    We solicited 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.  
495.24)

    This final rule with comment period specifies applicable criteria 
for demonstrating meaningful use of CEHRT for EHR reporting periods in 
2015 through 2017 and for Stage 3 in 2017 and subsequent years. The 
applicable criteria for demonstrating meaningful use for an EHR 
reporting period in 2015 through 2017 are based on modifications to the 
criteria previously set out in Stage 1 and 2 of the EHR Incentive 
Programs. These changes in the overall burden for providers reporting 
in 2015 through 2017 are discussed in further detail in the ICR 
analysis for 2015 through 2017 outlined in section III.B of this final 
rule with comment period. The ICRs in this section (that is, section 
III.A. of this final rule with comment period) reflect the provider 
burden associated with complying with and reporting of Stage 3 
requirements beginning in 2017 and each subsequent year.
    In Sec.  495.24 (redesignated from Sec.  495.7) we proposed that to 
successfully demonstrate meaningful use of CEHRT 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:
     The provider used CEHRT and specified the technology was 
used.
     The provider satisfied each of the applicable objectives 
and associated measures in Sec.  495.26.
    In Sec.  495.40 (redesignated from Sec.  495.8), we stipulated that 
providers must also successfully report the clinical quality measures 
selected by CMS to CMS or the states, as applicable. We estimated that 
the CEHRT 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 
noted that we also expect that the provider would enable the 
functionality required to complete

[[Page 62917]]

the objectives and associated measures that require the provider to 
attest that they have done so.
    We proposed that there would be five objectives and ten measures 
that would require an EP to enter numerators and denominators during 
attestation. Eligible hospitals and CAHs would have to attest they have 
met five objectives and ten measures that would require numerators and 
denominators. For objectives and associated measures requiring a 
numerator and denominator in the proposed rule, we limited our 
estimates to actions taken in the presence of certified EHR technology. 
We did not anticipate a provider would maintain two recordkeeping 
systems when CEHRT is present. Therefore, we assumed that all patient 
records that would be counted in the denominator would be kept using 
certified EHR technology. We expected 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 proposed that EPs would be required to report on a total of 8 
objectives and 16 associated measures. For the purpose of the proposed 
collection of information, we assumed that all eligible providers would 
comply with the requirements of meaningful use Stage 3. We proposed 
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 \21\). 
We estimated 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).
---------------------------------------------------------------------------

    \21\ Mean hourly rate for lawyers based on May 2013 Business and 
Labor Statistics (BLS) data.
---------------------------------------------------------------------------

    Comment: One commenter noted that the time to attest is likely 
accurate; however, they stated that the estimate does not reflect the 
dollars and resources spent on software upgrades, implementation costs, 
continuous auditing, and the gathering of data for calculation.
    Response: We appreciate the public comments on this burden 
analysis. However, this analysis specifically reflects the amount of 
time we estimate providers will take to prepare and report their 
meaningful use data through the Medicare and Medicaid EHR Incentive 
Programs Registration and Attestation System. We cannot account for 
other costs related to participation in these programs or for variation 
in how an individual provider may collect, calculate or document 
actions related to their unique business practices and systems 
workflows.
    After consideration of the public comments received, we are 
finalizing these burden estimates as proposed but have updated them to 
reflect policy changes implemented through this final rule with comment 
period.
    In this final rule with comment period, there were five objectives 
that will require an EP to enter numerators and denominators during 
attestation. Eligible hospitals and CAHs will 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 will maintain 
two recordkeeping systems when CEHRT is present. Therefore, we assume 
that all patient records that will be counted in the denominator will 
be kept using certified EHR technology. We expect it will take an 
individual provider or designee approximately 10 minutes to attest to 
each meaningful use objective and associated measure that requires a 
numerator and denominator to be generated, as well as each CQM for 
providers attesting in their first year of the program.
    Additionally, providers will be required to report they have 
completed objectives and associated measures that require a ``yes'' or 
``no'' response during attestation. For EPs, there are three objectives 
that 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 
fulfill the public health objective, and must implement at least five 
clinical decision support interventions. For eligible hospitals and 
CAHs, there are three objectives that 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 will 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 
will 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 do not account 
for the additional burden associated with the conduct or review of such 
analyses.
    Table 21 lists the Stage 3 objectives and associated measures for 
EPs and eligible hospitals and CAHs. We estimate the objectives and 
associated measures will take an EP 6 hours 52 minutes to complete, and 
will take an eligible hospital or CAH 6 hours 52 minutes to complete.
    We believe that 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 did not prepare lowest and highest burdens. Rather, we 
computed a burden for EPs and a burden for eligible hospitals and CAHs.

[[Page 62918]]



                                Table 21--Burden Estimates Stage 3--Sec.   495.24
----------------------------------------------------------------------------------------------------------------
                                                                             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 created or
                                                          maintained by
                                                          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 60% of
 electronically (eRx.).           prescriptions           all permissible
                                  electronically (eRx).   prescriptions
                                                          written by the
                                                          EP are queried
                                                          for a drug
                                                          formulary and
                                                          transmitted
                                                          electronically
                                                          using CEHRT.
                                                         2. Eligible
                                                          Hospital/CAH
                                                          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                   focused on improving    must implement
 high[dash]priority health        performance on          five clinical
 conditions.                      high[dash]priority      decision support
                                  health 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[dash]priori
                                                          ty health
                                                          conditions.
                                                         Measure 2: The
                                                          EP, eligible
                                                          hospital, or CAH
                                                          has enabled and
                                                          implemented the
                                                          functionality
                                                          for
                                                          drug[dash]drug
                                                          and
                                                          drug[dash]allerg
                                                          y interaction
                                                          checks for the
                                                          entire EHR
                                                          reporting period.
Use CPOE for medication,         Use CPOE for            Measure 1. More    10 minutes.......  10 minutes.
 laboratory, and diagnostic       medication,             than 60 percent
 imaging orders directly          laboratory, and         of medication
 entered by any licensed          diagnostic imaging      orders created
 healthcare professional,         orders directly         by the EP or
 credentialed medical             entered by any          authorized
 assistant, or a medical staff    licensed healthcare     providers of the
 member credentialed to and       professional,           eligible
 performing the equivalent        credentialed medical    hospital's or
 duties of a credentialed         assistant, or a         CAH's inpatient
 medical assistant; who can       medical staff member    or emergency
 enter orders into the medical    credentialed to and     department (POS
 record per state, local, and     performing the          21 or 23) during
 professional guidelines.         equivalent duties of    the EHR
                                  a credentialed          reporting period
                                  medical assistant;      are recorded
                                  who can enter orders    using CPOE.
                                  into the medical       Measure 2: More
                                  record per state,       than 60 percent
                                  local, and              of laboratory
                                  professional            orders created
                                  guidelines.             by the EP or
                                                          authorized
                                                          providers of the
                                                          eligible
                                                          hospital's or
                                                          CAH's inpatient
                                                          or emergency
                                                          department (POS
                                                          21 or 23) during
                                                          the EHR
                                                          reporting period
                                                          are recorded
                                                          using CPOE.
                                                         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 CPOE.

[[Page 62919]]

 
The EP provides patients or      The eligible hospital   Measure 1: For     10 minutes.......  10 minutes.
 their authorized                 or CAH provides         more than 80
 representatives electronic       patients or their       percent of all
 access to their health           authorized              unique patients
 information and patient-         representatives         seen by the EP
 specific education.              electronic access to    or discharged
                                  their health            from the
                                  information and         eligible
                                  patient-specific        hospital or CAH
                                  education.              inpatient or
                                                          emergency
                                                          department (POS
                                                          21 or 23):
                                                         (1) The patient
                                                          (or the
                                                          patient[dash]aut
                                                          horized
                                                          representative)
                                                          is provided
                                                          access to view
                                                          online,
                                                          download, and
                                                          transmit his or
                                                          her health
                                                          information; and.
                                                         (2) The provider
                                                          ensures the
                                                          patient's health
                                                          information is
                                                          available for
                                                          the patient (or
                                                          patient[dash]aut
                                                          horized
                                                          representative)
                                                          to access using
                                                          any application
                                                          of their choice
                                                          that is
                                                          configured to
                                                          meet the
                                                          technical
                                                          specifications
                                                          of the API in
                                                          the provider's
                                                          CEHRT.
                                                         Measure 2: The
                                                          EP, eligible
                                                          hospital or CAH
                                                          must use
                                                          clinically
                                                          relevant
                                                          information from
                                                          CEHRT to
                                                          identify
                                                          patient[dash]spe
                                                          cific
                                                          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 CEHRT to engage with         Use CEHRT to engage     Measure 1: During  10 minutes.......  10 minutes.
 patients or their authorized     with patients or        the EHR
 representatives about the        their authorized        reporting
 patient's care.                  representatives about   period, more
                                  the patient's care.     than 10 percent
                                                          of all unique
                                                          patients (or
                                                          their authorized
                                                          representatives)
                                                          seen by the EP
                                                          or discharged
                                                          from the
                                                          eligible
                                                          hospital or CAH
                                                          inpatient or
                                                          emergency
                                                          department (POS
                                                          21 or 23)
                                                          actively engage
                                                          with the EHR
                                                          made accessible
                                                          by the provider
                                                          and either:
                                                         (1) view,
                                                          download or
                                                          transmit to a
                                                          third party
                                                          their health
                                                          information; or.
                                                         (2) access their
                                                          health
                                                          information
                                                          through the use
                                                          of an API that
                                                          can be used by
                                                          applications
                                                          chosen by the
                                                          patient and
                                                          configured to
                                                          the API in the
                                                          provider's
                                                          CEHRT; or.
                                                         (3) a combination
                                                          of (1) and (2)..
                                                         Measure 2: For
                                                          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) during
                                                          the EHR
                                                          reporting
                                                          period, a secure
                                                          message was sent
                                                          using the
                                                          electronic
                                                          messaging
                                                          function of
                                                          CEHRT to the
                                                          patient (or the
                                                          patient-
                                                          authorized
                                                          representative),
                                                          or in response
                                                          to a secure
                                                          message sent by
                                                          the patient (or
                                                          the patient-
                                                          authorized
                                                          representative).

[[Page 62920]]

 
                                                         Measure 3:
                                                          Patient[dash]gen
                                                          erated health
                                                          data or data
                                                          from a non-
                                                          clinical setting
                                                          is incorporated
                                                          into the CEHRT
                                                          for more than 5
                                                          percent of all
                                                          unique patients
                                                          seen by the EP
                                                          or discharged by
                                                          the eligible
                                                          hospital or CAH
                                                          (POS 21 or 23)
                                                          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 CEHRT.          the first patient       patient to
                                  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
                                  CEHRT.                  CEHRT; and (2)
                                                          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
                                                          an electronic
                                                          summary of care
                                                          document from a
                                                          source other
                                                          than the
                                                          provider's EHR
                                                          system.
                                                         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:
                                                         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 medication
                                                          allergies.
                                                         Current Problem
                                                          list. Review of
                                                          the patient's
                                                          current and
                                                          active diagnoses.
The EP is in active engagement   ......................  Measure 1--        1 minute.........  1 minute.
 with a PHA or CDR to submit                              Immunization
 electronic public health data                            Registry
 in a meaningful way using                                Reporting: The
 CEHRT, except where                                      EP, eligible
 prohibited, and in accordance                            hospital, or CAH
 with applicable law and                                  is in active
 practice.                                                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 an
                                                          urgent care
                                                          setting (urgent
                                                          care ambulatory
                                                          for EP,
                                                          emergency or
                                                          urgent care
                                                          department for
                                                          eligible
                                                          hospitals and
                                                          CAHs).

[[Page 62921]]

 
                                                         Measure 3--
                                                          Electronic 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.
                                                         EPs must meet 2
                                                          measures and may
                                                          choose to report
                                                          to more than one
                                                          public health
                                                          registry or
                                                          clinical data
                                                          registry to meet
                                                          the objective.
                                 The eligible hospital   Measure 1--        1 minute.........  1 minute.
                                  or CAH is in active     Immunization
                                  engagement with a PHA   Registry
                                  or CDR to submit        Reporting: The
                                  electronic public       EP, eligible
                                  health data in a        hospital, or CAH
                                  meaningful way using    is in active
                                  CEHRT, except where     engagement with
                                  prohibited, and in      a public health
                                  accordance with         agency to submit
                                  applicable law and      immunization
                                  practice.               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 an
                                                          urgent care
                                                          setting (urgent
                                                          care ambulatory
                                                          for EP,
                                                          emergency or
                                                          urgent care
                                                          department for
                                                          eligible
                                                          hospitals and
                                                          CAHs).
                                                         Measure 3--
                                                          Electronic 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
                                                          ELR results.

[[Page 62922]]

 
                                                         Eligible
                                                          Hospitals and
                                                          CAHs must meet 4
                                                          measures and may
                                                          choose to report
                                                          to more than one
                                                          public health
                                                          registry and/or
                                                          clinical data
                                                          registry to meet
                                                          the objective.
Criteria Burden................  ......................  .................  6 hours 52         6 hours 52
                                                                             minutes.           minutes
Time to Attest and Report
 Clinical Quality Measures.
    Total--Criteria Burden.....  ......................  .................  6 hours 52         6 hours 52
                                                                             minutes.           minutes
----------------------------------------------------------------------------------------------------------------

    In this final rule with comment period, we estimate that it will 
take no longer than 6 hours and 52 minutes for an EP to report on each 
of the applicable objectives and associated measures. The total burden 
hours for an EP to attest to the criteria previously specified will 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 will be 6 hours 52 minutes. The total estimate 
annual cost burden for all EPs to attest to EHR technology and 
meaningful use objectives will 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 will attest that they have 
met the core meaningful use objectives and associated measures, and 
will electronically submit the clinical quality measures. We estimate 
that it will take no longer, than 6 hours and 52 minutes to attest that 
during the EHR reporting period, they used the certified EHR 
technology, specified 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 will 
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. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.  495.20 
through Sec.  495.60)

    In Sec.  495.40 we proposed that to successfully demonstrate 
meaningful use of CEHRT for meaningful use in 2015 through 2017, an EP, 
eligible hospital, or CAH (collectively referred to as ``provider'' in 
this section) must attest, through a secure mechanism in a specified 
manner, to the following during the EHR reporting period: (1) The 
provider used CEHRT and specified the technology was used; and (2) the 
provider satisfied each of the applicable objectives and associated 
measures in Sec.  495.22. In Sec.  495.40, we stipulated that providers 
must also successfully report the clinical quality measures selected by 
CMS to CMS or the states, as applicable. We estimated that the CEHRT 
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 expected 
that the provider would enable the functionality required to complete 
the objectives and associated measures for which they are required to 
attest.
    We proposed that EPs would be required to report on a total of ten 
objectives and associated measures and eligible hospitals and CAHs 
would report on a total of nine objectives and associated measures. 
There are six objectives that will require an EP to enter numerators 
and denominators during attestation. Eligible hospitals and CAHs will 
have to attest that they have met six 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 
CEHRT is present. Therefore, we assumed that all patient records that 
would be counted in the denominator would be kept using certified EHR 
technology. We expect it will take an individual provider or designee 
approximately 10 minutes to attest to each meaningful use objective and 
associated measure that requires a numerator and denominator to be 
generated, as well as approximately 1 hour 30 minutes to attest to CQM 
requirements.
    Additionally, providers would be required to report they have 
completed objectives and associated measures that require a ``yes'' or 
``no'' response during attestation. For EPs, there are three objectives 
that would require a ``yes'' or ``no'' response during attestation. For 
eligible hospitals and CAHs, there are 2 objectives and that would 
require a ``yes'' or ``no'' response during attestation. We expect that 
it would take a provider or their designee 1 minute to attest to each 
objective that requires a ``yes'' or ``no'' response.
    Providers would also be required to attest that they are protecting 
ePHI. We estimate completion of the analysis required to meet 
successfully the associated measure for this objective would take 
approximately 6 hours, which is identical to our estimate for the Stage 
1 and Stage 2 requirements. This burden estimate assumes that covered 
entities are already conducting and reviewing these risk analyses under 
current HIPAA regulations. Therefore, we have not accounted for the 
additional burden associated with the conduct or review of such 
analyses.
    We estimate the objectives and associated measures would take an EP 
6 hours 49 minutes to complete, and would take an eligible hospital or 
CAH 6 hours 48 minutes to complete.
    Comment: Some stated that CMS should account for the amount of time

[[Page 62923]]

required to prepare for attestation. They also stated that CMS should 
more carefully consider the multiple factors that contribute to the 
burden of physician reporting.
    Response: We appreciate the public comments on this burden 
analysis. However, this analysis specifically reflects the amount of 
time we estimate providers will take to prepare and report their 
meaningful use data through the Medicare and Medicaid EHR Incentive 
Programs Registration and Attestation System.
    After consideration of the public comments received, we are 
finalizing these burden estimates as proposed but have updated them to 
reflect policy changes implemented through this final rule with comment 
period. In this final rule with comment period, there are 10 objectives 
for EPs and 9 objectives for eligible hospitals and CAHs.
    Table 22 lists those objectives and associated measures for EPs and 
eligible hospitals and CAHs. EPs, eligible hospitals, and CAHs have 
nearly identical reporting burdens. Eligible hospitals and CAHs are 
required to report to one additional registry than EPs are required to 
report. However, EPs have an additional objective, Secure Electronic 
Messaging, which requires a ``yes'' or ``no'' response. Consequently, 
we have not prepared lowest and highest burdens. Rather, we have 
computed a burden for EPs and a burden for eligible hospitals and CAHs.

                                    Table 22--Burden Estimates--Sec.   495.22
----------------------------------------------------------------------------------------------------------------
                                                                            Burden estimate     Burden estimate
     Eligible professionals       Eligible hospitals       Measures         per  respondent     per  respondent
                                       and CAHs                                  (EPs)            (Hospitals)
----------------------------------------------------------------------------------------------------------------
                                             Objectives and Measures
----------------------------------------------------------------------------------------------------------------
Protect ePHI created or           Protect ePHI        Conduct or review   6 hours...........  6 hours.
 maintained by the CEHRT through   created or          a security risk
 the implementation of             maintained by the   analysis in
 appropriate technical             CEHRT through the   accordance with
 capabilities.                     implementation of   the requirements
                                   appropriate         under 45 CFR
                                   technical           164.308(a)(1),
                                   capabilities.       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),
                                                       and implement
                                                       security updates
                                                       as necessary and
                                                       correct
                                                       identified
                                                       security
                                                       deficiencies as
                                                       part of the
                                                       provider's risk
                                                       management
                                                       process.
Use clinical decision support to  Use clinical        1. Implement five   1 minute..........  1 minute.
 improve performance on            decision support    clinical decision
 high[dash]priority health         to improve          support
 conditions.                       performance on      interventions
                                   high[dash]priorit   related to four
                                   y health            or more clinical
                                   conditions.         quality measures
                                                       at a relevant
                                                       point in patient
                                                       care for the
                                                       entire EHR
                                                       reporting period.
                                                       Absent four
                                                       clinical quality
                                                       measures related
                                                       to an EP,
                                                       eligible hospital
                                                       or CAH's scope of
                                                       practice or
                                                       patient
                                                       population, the
                                                       clinical decision
                                                       support
                                                       interventions
                                                       must be related
                                                       to high-priority
                                                       health conditions.
                                                      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 CPOE for medication,          Use CPOE for        More than 60% of    10 minutes........  10 minutes.
 laboratory and radiology orders   medication,         medication, 30%
 directly entered by any           laboratory and      of laboratory,
 licensed healthcare               radiology orders    and 30% of
 professional who can enter        directly entered    radiology orders
 orders into the medical record    by any licensed     created by the EP
 per state, local and              healthcare          or authorized
 professional guidelines.          professional who    providers of the
                                   can enter orders    eligible
                                   into the medical    hospital's or
                                   record per state,   CAH's inpatient
                                   local and           or emergency
                                   professional        department (POS
                                   guidelines.         21 or 23) during
                                                       the EHR reporting
                                                       period are
                                                       recorded using
                                                       CPOE.
Generate and transmit             ..................  More than 50% of    10 minutes
 permissible prescriptions                             all permissible
 electronically (eRx).                                 prescriptions
                                                       written by the EP
                                                       are queried for a
                                                       drug formulary
                                                       and transmitted
                                                       electronically
                                                       using CEHRT.
                                  Generate and        More than 10% of    ..................  10 minutes.
                                   transmit            hospital
                                   permissible         discharge
                                   discharge           medication orders
                                   prescriptions       for permissible
                                   electronically      prescriptions
                                   (eRx).              (for new or
                                                       changed
                                                       prescriptions)
                                                       are queried for a
                                                       drug formulary
                                                       and transmitted
                                                       electronically
                                                       using CEHRT.

[[Page 62924]]

 
The EP who transitions their      The eligible        1. The EP,          10 minutes........  10 minutes.
 patient to another setting of     hospital or CAH     eligible hospital
 care or provider of care or       who transitions     or CAH that
 refers their patient to another   their patient to    transitions or
 provider of care provides a       another setting     refers their
 summary care record for each      of care or          patient to
 transition of care or referral.   provider of care    another setting
                                   or refers their     of care or
                                   patient to          provider of care
                                   another provider    (1) uses CEHRT to
                                   of care provides    create a summary
                                   a summary care      of care record;
                                   record for each     and (2)
                                   transition of       electronically
                                   care or referral.   transmits such
                                                       summary to a
                                                       receiving
                                                       provider for more
                                                       than 10 percent
                                                       of transitions of
                                                       care and
                                                       referrals.
Use clinically relevant           ..................  Patient[dash]speci  10 minutes........
 information from CEHRT to                             fic education
 identify patient[dash]specific                        resources
 education resources and provide                       identified by
 those resources to the patient.                       CEHRT are
                                                       provided to
                                                       patients for more
                                                       than 10% of all
                                                       unique patients
                                                       with office
                                                       visits seen by
                                                       the EP during the
                                                       EHR reporting
                                                       period.
                                  Use clinically      More than 10% of    ..................  10 minutes.
                                   relevant            all unique
                                   information from    patients admitted
                                   CEHRT to identify   to the eligible
                                   patient[dash]spec   hospital's or
                                   ific education      CAH's inpatient
                                   resources and       or emergency
                                   provide those       departments (POS
                                   resources to the    21 or 23) are
                                   patient.            provided
                                                       patient[dash]
                                                       specific
                                                       education
                                                       resources
                                                       identified by
                                                       CEHRT.
The EP who receives a patient     The eligible        The EP, eligible    10 minutes........  10 minutes.
 from another setting of care or   hospital or CAH     hospital or CAH
 provider of care or believes an   who receives a      performs
 encounter is relevant should      patient from        medication
 perform medication                another setting     reconciliation
 reconciliation.                   of care or          for more than 50%
                                   provider of care    of transitions of
                                   or believes an      care in which the
                                   encounter is        patient is
                                   relevant should     transitioned into
                                   perform             the care of the
                                   medication          EP or admitted to
                                   reconciliation.     the eligible
                                                       hospital's or
                                                       CAH's inpatient
                                                       or emergency
                                                       department (POS
                                                       21 or 23).
Provide patients the ability to   ..................  1. More than 50     10 minutes........
 view online, download, and                            percent of all
 transmit their health                                 unique patients
 information within 4 business                         seen by the EP
 days of the information being                         during the EHR
 available to the EP.                                  reporting period
                                                       are provided
                                                       timely online
                                                       access to view
                                                       online, download,
                                                       and transmit to a
                                                       third party their
                                                       health
                                                       information
                                                       subject to the
                                                       EP's discretion
                                                       to withhold
                                                       certain
                                                       information.
                                                      2. For 2015 and
                                                       2016: At least 1
                                                       patient seen by
                                                       the EP during the
                                                       EHR reporting
                                                       period (or his or
                                                       her authorized
                                                       representative)
                                                       views, downloads
                                                       or transmits his
                                                       or her health
                                                       information to a
                                                       third party
                                                       during the EHR
                                                       reporting period.
                                                       For 2017: More
                                                       than 5 percent of
                                                       unique patients
                                                       seen by the EP
                                                       during the EHR
                                                       reporting period
                                                       (or their
                                                       authorized
                                                       representatives)
                                                       views, downloads
                                                       or transmits
                                                       their health
                                                       information to a
                                                       third party
                                                       during the EHR
                                                       reporting period.

[[Page 62925]]

 
                                  Provide patients    1. More than 50     ..................  10 minutes.
                                   the ability to      percent of all
                                   view online,        unique patients
                                   download, and       who are
                                   transmit their      discharged from
                                   health              the inpatient or
                                   information         emergency
                                   within 36 hours     department (POS
                                   of hospital         21 or 23) of an
                                   discharge.          eligible hospital
                                                       or CAH are
                                                       provided timely
                                                       access to view
                                                       online, download
                                                       and transmit
                                                       their health
                                                       information to a
                                                       third party their
                                                       health
                                                       information.
                                                      2. For 2015 and
                                                       2016: At least 1
                                                       patient who is
                                                       discharged from
                                                       the inpatient or
                                                       emergency
                                                       department (POS
                                                       21 or 23) of an
                                                       eligible hospital
                                                       or CAH (or his or
                                                       her authorized
                                                       representative)
                                                       views, downloads,
                                                       or transmits to a
                                                       third party his
                                                       or her health
                                                       information
                                                       during the EHR
                                                       reporting period.
                                                      For 2017: More
                                                       than 5 percent of
                                                       unique patients
                                                       discharged from
                                                       the inpatient or
                                                       emergency
                                                       department (POS
                                                       21 or 23) of an
                                                       eligible hospital
                                                       or CAH (or his or
                                                       her authorized
                                                       representative)
                                                       view, download,
                                                       or transmit to a
                                                       third party their
                                                       health
                                                       information
                                                       during the EHR
                                                       reporting period.
Use secure electronic messaging   ..................  For 2015: For an    10 minutes........
 to communicate with patients on                       EHR reporting
 relevant health information.                          period in 2015,
                                                       the capability
                                                       for patients to
                                                       send and receive
                                                       a secure
                                                       electronic
                                                       message with the
                                                       EP was fully
                                                       enabled. For
                                                       2016: For at
                                                       least 1 patient
                                                       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 the
                                                       patient[dash]auth
                                                       orized
                                                       representative),
                                                       or in response to
                                                       a secure message
                                                       sent by the
                                                       patient (or the
                                                       patient[dash]auth
                                                       orized
                                                       representative)
                                                       during the EHR
                                                       reporting period.
                                                       For 2017: For
                                                       more than 5
                                                       percent of 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 the patient-
                                                       authorized
                                                       representative),
                                                       or in response to
                                                       a secure message
                                                       sent by the
                                                       patient (or the
                                                       patient[dash]auth
                                                       orized
                                                       representative)
                                                       during the EHR
                                                       reporting period.

[[Page 62926]]

 
The EP is in active engagement    ..................  Stage 1 EPs in
 with a public health agency to                        2015 must meet at
 submit electronic public health                       least 1 measure
 data from CEHRT except where                          in 2015, Stage 2
 prohibited and in accordance                          EPs must meet at
 with applicable law and                               least 2 measures
 practice.                                             in 2015, and all
                                                       EPs must meet at
                                                       least 2 measures
                                                       in 2016 and 2017.
                                                      Measure 1--
                                                       Immunization
                                                       Registry
                                                       Reporting: The EP
                                                       is in active
                                                       engagement with a
                                                       public health
                                                       agency to submit
                                                       immunization data.
                                                      Measure 2--
                                                       Syndromic
                                                       Surveillance
                                                       Reporting: The EP
                                                       is in active
                                                       engagement with a
                                                       public health
                                                       agency to submit
                                                       syndromic
                                                       surveillance data.
                                                      Measure 3--
                                                       Specialized
                                                       Registry
                                                       Reporting.
                                                      --The EP is in
                                                       active engagement
                                                       with a public
                                                       health agency to
                                                       submit data to a
                                                       specialized
                                                       registry.
                                  The eligible        Stage 1 eligible    1 minute..........  1 minute.
                                   hospital or CAH     hospitals and
                                   is in active        CAHs must meet at
                                   engagement with a   least 2 measures
                                   public health       in 2015, Stage 2
                                   agency to submit    eligible
                                   electronic public   hospitals and
                                   health data from    CAHs must meet at
                                   CEHRT except        least 3 measures
                                   where prohibited    in 2015, all
                                   and in accordance   eligible
                                   with applicable     hospitals and
                                   law and practice.   CAHs must meet at
                                                       least 3 measures
                                                       in 2016 and 2017.
                                                       Measure
                                                       1--Immunization
                                                       Registry
                                                       Reporting: The
                                                       eligible hospital
                                                       or CAH is in
                                                       active engagement
                                                       with a public
                                                       health agency to
                                                       submit
                                                       immunization data.
                                                       Measure
                                                       2--Syndromic
                                                       Surveillance
                                                       Reporting: The
                                                       eligible hospital
                                                       or CAH is in
                                                       active engagement
                                                       with a public
                                                       health agency to
                                                       submit syndromic
                                                       surveillance data.
                                                       Measure
                                                       3--Specialized
                                                       Registry
                                                       Reporting: The
                                                       eligible hospital
                                                       or CAH is in
                                                       active engagement
                                                       with a public
                                                       health agency to
                                                       submit data to a
                                                       specialized
                                                       registry.
                                                       Measure
                                                       4--Electronic
                                                       Reportable
                                                       Laboratory Result
                                                       Reporting: The
                                                       eligible hospital
                                                       or CAH is in
                                                       active engagement
                                                       with a public
                                                       health agency to
                                                       submit ELR
                                                       results.
Time to Attest to Objectives and  ..................  ..................  6 hours 49 minutes  6 hours 48
 Measures.                                                                                     minutes.
Time to Attest and Report         ..................  ..................  1 hour 30 minutes.  1 hour 30 minutes.
 Clinical Quality Measures.
    Total--Objectives +CQM        ..................  ..................  8 hours 19 minutes  8 hours 18
     Reporting.                                                                                minutes.
----------------------------------------------------------------------------------------------------------------

    We estimate that it will take no longer than 6 hours 49 minutes for 
an EP to attest to each of the applicable objectives and associated 
measures. The total burden hours for an EP to attest to the meaningful 
use objectives and measures and to report CQMs will be 8 hours 19 
minutes. We estimate that there could be approximately 595,100 non-
hospital-based Medicare EPs in 2015. Based on the historical data, we 
anticipate approximately 60 percent (357,060) of these EPs may attest 
to the objectives and measures of meaningful use. In addition, we 
believe approximately 30,000 Medicaid only EPs, or approximately 51 
percent of the Medicaid-only EPs, will successfully demonstrate 
meaningful use in 2015. The total estimated annual cost burden for all 
EPs to attest to meaningful use would be $297,076,291 (387,060 x 8 
hours 19 minutes x $92.25 (mean hourly rate for physicians based on May 
2013

[[Page 62927]]

BLS data)). Similarly, eligible hospitals and CAHs will attest that 
they have met the meaningful use objectives and associated measures, 
and would submit the clinical quality measures. We estimate that it 
will take no longer than 6 hours 48 minutes to attest to each of the 
applicable objectives and associated measures. Therefore, the total 
burden hours for an eligible hospital or CAH to attest to the 
meaningful use objectives and measures and to report CQMs, will be 8 
hours 18 minutes. We estimate that there are about 4,900 eligible 
hospitals and CAHs that may attest to the aforementioned criteria in FY 
2015 of which 95 percent are expected to demonstrate meaningful use. 
The total estimated annual cost burden for all eligible hospitals and 
CAHs to attest to meaningful use would be $2,451,872 (4,655 eligible 
hospitals and CAHs x $63.46 (8 hours 18 minutes x $63.46 (mean hourly 
rate for lawyers based on May 2013 BLS) data)).
    We provide the estimate of the burden for the approximately 13,635 
MA Eps in the MA organization burden section. The total annual burden 
estimates for meaningful use for modifications for 2015 through 2017 
are shown in Table 23.
    For the purpose of this collection of information, we assumed that 
all eligible providers will comply with the requirements of Meaningful 
Use as previously defined if the policies proposed in this rule were 
not finalized. Therefore, we estimate that the policies contained 
herein will result in an overall reduction in the reporting burden for 
providers of 1.45 hours to 1.9 hours for EPs and 2.62 hours for 
eligible hospitals and CAHs per respondent. While batch reporting for 
objectives and measures and group reporting for CQMs are available for 
EPs in the current program; the program is based upon successful 
individual provider demonstration of meaningful use and so individual 
totals are used to identify the estimated reduction in provider 
reporting burden. This reduction of burden is outlined in Table 23.

              Table 23--Reduction in Reporting Burden Hours
------------------------------------------------------------------------
                                                       Estimated burden
Burden under current program and   Estimated burden     per  respondent
      proposed modifications        per  respondent        eligible
                                          EPs         hospitals and CAHs
------------------------------------------------------------------------
Total Under Current Stage 2       9 hours 46 minutes  NA.
 Requirements at 42 CFR 495.6.
Core Set (including CQMs) +
 Least Burdensome Menu Set
 Criteria.
Total Under Current Stage 2       10 hours 13         10 hours 55
 Requirements at 42 CFR 495.6.     minutes.            minutes.
Core Set (including CQMs) + Most
 Burdensome Menu Set Criteria.
Total Under Proposed              8 hours 19 minutes  8 hours 18
 Modifications at 495.22.                              minutes.
All Objectives and Measures +
 CQMs.
Reduction from Least Burdensome   1 hour 27 minutes.  NA.
 Estimate.
Reduction from Most Burdensome    1 hour 54 minutes.  2 hour 37 minutes.
 Estimate.
------------------------------------------------------------------------

    Using the hourly costs associated with the reporting burden as 
mentioned previously, this reduction of 1.45 hours to 1.9 hours for EPs 
and 2.62 hours for eligible hospitals and CAHs represents a per 
response savings of $133.76 to $175.28 for EPs and $166.27 for eligible 
hospitals and CAHs. The total cost reduction in cost for providers 
demonstrating meaningful use is estimated at $48,534,332 at the lowest 
and $63,359,464 at the highest. These estimates are further outlined in 
Table 24.

                                                       Table 24--Reduction in Burden Cost Savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Burden reduction                       Reduction per
                       Number of responses                               hours           Hourly cost         respondent         Total cost reduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
387,060..........................................................               1.45             $92.25            $133.76                   $51,773,146
387,060..........................................................                1.9              92.25             175.28                    67,843,877
4,655............................................................               2.62              63.46             166.27                       773,987
Total Least......................................................  .................  .................  .................                    52,547,132
Total Most.......................................................  .................  .................  .................                    68,617,864
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    We estimate that the burden will be significantly less for 
qualifying MA organizations attesting to the meaningful use of their MA 
EPs, because qualifying MA EPs use the EHR technology in place at a 
given location or system, so if CEHRT is in place and the qualifying MA 
organization requires its qualifying MA EPs to use the technology, 
qualifying MA organizations will be able to determine at a faster rate 
than individual FFS EPs, that its qualifying MA EPs meaningfully used 
CEHRT. In other words, qualifying MA organizations can make the 
determination in masse if the CEHRT is required to be used at its 
facilities, whereas under FFS, each EP likely must make the 
determination on an individual basis. We further note that these 
differences also mean the total reduction in burden for MA 
organizations resulting from the modifications in this rule will be 
negligible. We estimate that, on average, it will take an individual 45 
minutes to collect information necessary to determine if a given 
qualifying MA EP has met the meaningful use objectives and measures, 
and 15 minutes for an individual to make the attestation for each MA 
EP. Furthermore, the individuals performing the assessment and 
attesting will not likely be the eligible professional, but non-
clinical staff. We believe that the individual gathering the 
information could be equivalent to a GS 11, step 1 (2015 unadjusted for 
locality rate), with an hourly rate of approximately $25.00/hour, and 
the person attesting (and who may bind the qualifying MA organization 
based on the attestation)

[[Page 62928]]

could be equivalent to a GS 15, step 1 (2015 unadjusted for locality 
rate), or approximately $50.00/hour. Therefore, for the estimated 
13,635 potentially qualifying MA EPs with assumed 100 percent 
successfully demonstrating meaningful use, we believe it will cost the 
participating qualifying MA organizations approximately $426,050 
annually to collect the required information and make the attestations 
([10,226 hours x $25.00]+[3,408 hours x $50.00]).

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

    We are revising 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 amendments to these reporting requirements will 
increase the burden on states beyond what was previously finalized 
under OMB control number 0938-1158 following the Stage 2 final rule. 
The deadlines will be consistent with our past practice, and the 
changes to the data elements to be reported on are either reduced or 
similar in burden. Similarly, we do not expect that the amendments 
regarding the 90-day EHR reporting period for first time meaningful 
users will impose a burden on states because those amendments would 
generally maintain the current policy.
    However, we are also amending Sec.  495.316 to include a new 
quarterly reporting requirement. States will 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 will 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 4 times per year at 20 hours per report the 
estimated cost is $13,460 (4560 hours x $3.00/hour).

                                                Table 25--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: 1. All non-whole numbers in this table are rounded to 2 decimal places.
2. There are no capital/maintenance costs associated with the information collection requirements contained in this rule. Therefore, we removed the
  associated column from Table 22.

V. Regulatory Impact Analysis

A. Statement of Need

    This final rule with comment period will implement the provisions 
of the American Recovery and Reinvestment Act (ARRA) of 2009 that 
provide incentive payments to EPs, eligible hospitals, and CAHs 
participating in Medicare and Medicaid programs that adopt and 
meaningfully use CEHRT. This final rule with comment period specifies 
applicable criteria for demonstrating the Stage 3 requirements for the 
EHR Incentive Programs. This final rule with comment period also 
specifies the applicable criteria for an EHR reporting period in 2015 
through 2017.

B. Overall Impact

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

[[Page 62929]]

    The portion of the final rule related to Stage 3 is one of two 
coordinated rules related to the EHR Incentive Programs. 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. Thus, there is an analysis that focuses on the impact 
associated with Stage 3 requirements for the EHR Incentive Program, the 
changes in quality measures that would take effect beginning in 2017, 
and other changes being 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 final rule with comment 
period, 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 meeting the requirements of the program 
will depend not only on the standards and requirements for 2017 and for 
eligible hospitals and EPs, but on future rules issued by the 
Department of Health and Human Services (DHHS).
    Based on the Stage 2 final rule, we expect spending under the EHR 
Incentive Programs for transfer payments to Medicare and Medicaid 
providers between 2015 and 2017 to be $14.2 billion. However, the 
policies in this final rule with comment period which are applicable 
for the EHR Incentive Programs in 2015 through 2017 do not change these 
estimates over the current period as the proposals in the EHR Incentive 
Programs in 2015 through 2017 proposed rule applied no changes to the 
payment of incentives or the application of payment adjustments for 
2015 through 2017.
    Our analysis of impacts for the policies in this final rule with 
comment period relate to the reduction in cost associated with provider 
reporting burden estimates for 2015 through 2017 as affected by the 
adopted changes to the current program and to the transfer payments for 
incentives for Medicaid providers and reductions in payments for 
Medicare providers through payment adjustments for 2018 and subsequent 
years. In the Stage 3 proposed rule, we noted our expectation that 
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 stated in the Stage 2 final rule (77 FR 54135 through 54136) 
that the statute provides Medicare and Medicaid incentive payments for 
the meaningful use of CEHRT. Additionally, the Medicaid program also 
provides incentives for the adoption, implementation, and upgrade of 
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 affected 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 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.
    All of these factors taken together make it impossible in this 
final rule with comment period to predict with precision the timing or 
rates of adoption and successful participation in the program. 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 uncertain.
    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 likely to qualify as meaningful users of 
EHRs were likely to purchase CEHRT. However, we believe that providers 
who have already purchased CEHRT and participated in Stage 1 or Stage 2 
of the EHR Incentive Program will experience significantly lower costs 
for participation in the program. We continue to believe that the 
short-term costs of the program 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 final rule with comment period.
    In addition, we include the impact of the EHR Incentive Programs in 
2015 through 2017. In relation to the existing program requirements 
outlined in the Stage 2 final rule (77 FR 53967 through 54162), we do 
not expect this final rule with comment period to result in more 
incentives paid or in more providers failing meaningful use and being 
assessed a payment adjustment. This is due to the nature of the 
modifications being implemented by this rule, which, while they reduce 
the reporting burden on providers, do not affect the clinical processes 
and IT functions required to meet the objectives and measures of the 
EHR Incentive Programs. The provisions of the modifications portion in 
this final rule with comment period do not fundamentally change the 
technology required to support participation in the Medicare and 
Medicaid EHR Incentive Programs. Under the current program, the 
requirement to report data on the measures and objectives which have 
now been identified as redundant to other more advanced measures being 
retained, or are duplicative of other measures using the same CEHRT 
function, is essentially requiring providers to report on the same 
action or process twice. Therefore, it is not the occurrence of the 
action or process which is reduced by the provisions in this final rule 
with comment period, but the burden associated with the duplicative and 
redundant reporting. In addition, the objectives and measures, which 
are considered topped out, have reached high performance and the 
statistical evidence demonstrates that the expected result of any 
provider attesting to the EHR Incentive Programs would be a score near 
the maximum. However, the analysis of these measures and their 
identification as topped out also takes into account the statistical 
likelihood that the functions of measures and the processes behind them 
would continue even without a requirement to report the results. 
Therefore, while the provisions result in a reduction in reporting 
requirements, this does not correlate to a change in the overall 
achievement of the measures and objective as compared to the current 
program. Finally, when compared against historical data, the shortened 
EHR reporting period in 2015 is expected to have a minimal impact on 
successful demonstration of meaningful

[[Page 62930]]

use. This expectation of minimal impact is based on a number of 
factors:
     The shortened EHR reporting period is for 2015 only and 
not for 2016 or 2017.
     Historical data on attestations shows no strong 
correlation between a shorter EHR reporting period and the ability of 
providers to attest for a second year, no correlation for providers 
returning to attest to a third or fourth year of meaningful use, and 
providers who would otherwise be in their first year of meaningful use 
would already have a 90-day EHR reporting period.\22\
---------------------------------------------------------------------------

    \22\ CMS Data and Reports: Quarterly Public Use Files for 
participation, Monthly Reports for performance rates: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html
---------------------------------------------------------------------------

     Performance data shows statistically negligible disparity 
among providers attesting for a 90-day EHR reporting period and those 
attesting for a full year EHR reporting period on the measures which 
have been identified as redundant, duplicative, and topped out.\23\
---------------------------------------------------------------------------

    \23\ CMS Data and Reports: Quarterly Public Use Files for 
participation, Monthly Reports for performance rates: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html
---------------------------------------------------------------------------

    For these reasons, we do not believe the modification provisions in 
this final rule with comment period will impact the overall estimates 
for incentive payments, payment adjustments, and the net transfer costs 
associated with the program. However, these provisions do affect the 
costs associated with the reporting burden on providers. The impacts 
directly attributable with the provisions in this final rule with 
comment period relate to both an hourly reduction per response and an 
overall reduction in the cost associated with provider reporting. The 
burden analysis for modifications in this final rule with comment 
period, as compared to the Stage 2 estimates, reduces the reporting 
burden for attestation for providers by approximately 1.45 hours to 1.9 
hours for EPs and 2.62 hours for eligible hospitals and CAHs per 
respondent. This burden estimate and analysis of the impact of the 
policies result in a total cost reduction estimated at $48,534,332 at 
the lowest and $63,359,464 at the highest. However, we believe the 
modifications portion of this final rule with comment period will have 
additional impacts--most notably, cost savings for hospitals and 
providers that would have additional time to meet the requirements of 
the program--which cannot be adequately estimated because of the wide 
variation among provider types, and therefore a designation as an 
economically significant rule under the Executive Order and a major 
rule under the Congressional Review Act is still applicable. The burden 
estimate and analysis of the impact of the policies implemented by the 
modifications of this final rule with comment period are outlined 
further in section III. of this final rule with comment period.

C. Anticipated Effects

    The objective of the remainder of this final 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--Stage 3
    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 final rule with 
comment period for Stage 3 of the EHR Incentive Programs. Therefore, to 
the extent that providers' implementation and adoption costs are 
attributable to this final rule with comment period, 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 participate in the EHR 
Incentive Programs. However, 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 criteria.\24\ As noted previously, this analysis 
focuses on the impact associated with Stage 3 requirements for 
providers, while the development and certification costs are addressed 
in the 2015 Edition final rule.
---------------------------------------------------------------------------

    \24\ 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 final rule on small entities unless the Secretary can 
certify that the regulation will not have a significant impact on a 
substantial number of small entities. In the healthcare sector, Small 
Business Administration (SBA) size standards define a small entity as 
one with between $7.5 to $38.5 million in annual revenues. For the 
purposes of the RFA, essentially all non-profit organizations are 
considered small entities, regardless of size. Individuals and states 
are not included in the definition of a small entity. Since the vast 
majority of Medicare providers (well over 90 percent) are small 
entities within the RFA's definitions, it is the normal practice of HHS 
simply to assume that all affected providers are ``small'' under the 
RFA. In this case, most EPs, eligible hospitals, and CAHs are either 
nonprofit or meet the SBA's size standard for small business. We also 
believe that the effects of the incentives program on many and probably 
most of these affected entities would be economically significant. 
Accordingly, this RIA section, in conjunction with the remainder of the 
preamble, constitutes the required Final Regulatory Flexibility 
Analysis (IFRFA). 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 EHR 
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 CEHRT 
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

[[Page 62931]]

2008. Nine in 10 acute care hospitals possessed CEHRT in 2013, 
increasing 29 percent since 2011. As of January 1, 2015, more than 95 
percent of eligible hospitals had successfully demonstrated meaningful 
use. In January 2014, a 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 EPs used any type of EHR systems, up from 18 
percent in 2001. The majority of EPs have already purchased CEHRT, 
implemented this new technology, and trained their staff on its use 
with over 60 percent earning an incentive payment for participation in 
the program prior to 2015. The costs for implementation and complying 
with the criteria of EHR Incentive Programs 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. Furthermore, the cost 
reductions provided by the EHR Incentive Programs in 2015 through 2017 
offer a benefit to these providers.
(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, the CBO 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. The potential costs 
savings in modifications to the EHR Incentive Programs portion of this 
final rule with comment period will benefit these providers as a 
reduction in the overall cost of program participation.
(2) Conclusion
    As discussed later in this analysis, we believe that there are many 
positive effects of adopting EHR on health care providers. We believe 
that the net effect on some individual providers may be positive. 
Furthermore, we believe that the provisions in this EHR Incentive 
Programs in 2015 through 2017 portion of this final rule with comment 
period will result in an overall reduction in the reporting burden for 
providers of all types. Accordingly, we believe that the object of the 
RFA to minimize burden on small entities is met by this final rule with 
comment period.
c. Small Rural Hospitals--Modifications
    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 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a metropolitan 
statistical area and has fewer than 100 beds.
    The Stage 3 portion of this final rule with comment period will 
affect the operations of a substantial number of small rural hospitals 
because they may be subject to adjusted Medicare payments in 2015 if 
they fail to adopt CEHRT by the applicable EHR reporting period. As 
stated previously, we have determined that this final rule with comment 
period will create a significant impact on a substantial number of 
small entities, and have prepared a Regulatory Flexibility Analysis as 
required by the RFA and, for small rural hospitals, section 1102(b) of 
the Act. Furthermore, any impacts that would arise from the 
implementation of CEHRT 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.
    There is no identifiable disparity among this group and the overall 
success rates for eligible hospitals and CAHs in meeting the 
requirements of the program; furthermore, 95 percent of eligible 
hospitals and CAHs have successfully participated as of January 1, 
2015. Finally, on the whole we anticipate an estimated reduction in the 
reporting burden on eligible hospitals as a group to be less than $1 
million. Therefore, we do not believe that the modifications portion of 
this final rule with comment period will have a significant impact on a 
substantial number of small entities.
d. 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 $144 million. UMRA does not address the 
total cost of a rule. Rather, it focuses on certain categories of cost, 
mainly those ``federal mandate'' costs resulting from--(1) imposing 
enforceable duties on state, local, or tribal governments, or on the 
private sector; or (2) increasing the stringency of conditions in, or 
decreasing the funding of, state, local, or tribal governments under 
entitlement programs.
    This final rule with comment period 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 EHR Incentive Program. While 
this entails certain procedural responsibilities, these do not involve 
substantial state expense. In general, each state Medicaid Agency that 
participates in the incentive program would be required to invest in 
systems and technology to comply. States would have to identify and 
educate providers, evaluate their attestations and pay the incentive. 
However, the federal government would fund 90 percent of the state's 
related administrative costs, providing controls on the total state 
outlay. In addition, the changes being made by the modifications 
portion of this final rule with comment period have very little impact 
on any state functions.
    The investments needed to meet the requirements of the program 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

[[Page 62932]]

would have a negative impact on providers that fail to meaningfully use 
CEHRT for the applicable EHR 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.
e. Federalism
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a final rule that imposes 
substantial direct requirement costs on state and local governments, 
preempts state law, or otherwise has federalism implications. This 
final rule with comment period 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 the Stage 3 portion of this final rule with comment 
period 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 requirements of the program for provider attestations. We are 
providing 90 percent Federal Financial Participation (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.
    The modifications portion of this final rule with comment period 
will not have a substantial direct effect on state or local 
governments, preempt state law, or otherwise have a Federalism 
implication.
2. Effects on EPs, Eligible Hospitals, and CAHs
a. Background and Assumptions
    Based on the actual count of provider's eligible for the program as 
of December 31, 2014 which were identified through the process of 
implementing payment adjustments for 2015, we estimated the numbers of 
EPs and eligible hospitals, including CAHs under Medicare, Medicaid, 
and MA for 2015 through 2017 and used the updated estimates throughout 
the analysis. These total potential eligible providers are as follows:
     About 660,000 Medicare FFS EPs (some of whom will also be 
Medicaid EPs).
    About 595,100 non-hospital based Medicare EPs.
     About 58,300 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physicians assistants).
     4,900 eligible hospitals comprising the following:
    ++ 3,397 acute care hospitals.
    ++ 1,395 CAHs.
    ++ 97 children's hospitals (Medicaid only).
    ++ 11 cancer hospitals (Medicaid only).
     16 MA organizations and 13,635 MA EPs
(1) EHR Incentive Programs in 2015 Through 2017
    There are no new costs associated with the modifications portion of 
this final rule with comment period. Furthermore, the estimates for the 
provisions affecting Medicare and Medicaid EPs, eligible hospitals, and 
CAHs are somewhat uncertain for the following reasons:
     The program is voluntary although payment adjustments will 
be imposed on Medicare providers if they are unable to meet the 
requirements of the program for the applicable EHR reporting period.
     The potential reduction in burden for EPs relate to 
assumptions of what options for meeting the requirements of the program 
they would otherwise attest to should the policies in this final rule 
with comment period not be adopted.
     The net costs and savings for any individual provider may 
not directly correlate to the total for the organization as larger 
organizations may employ economies of scale in EHR attestations.
(2) Stage 3
    The principal costs of the Stage 3 portion of final rule are the 
additional expenditures that will be undertaken by eligible entities in 
order to obtain the Medicaid incentive payments to adopt, implement or 
upgrade and demonstrate (or both) 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 uncertain 
for the following reasons:
     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 EHR reporting period.
     The criteria for the demonstration of meaningful use of 
CEHRT has been finalized for Stage 1 and Stage 2 and is being finalized 
for Stage 3, but may change over time.
     The impact of the financial incentives and payment 
adjustments on the rate of adoption of CEHRT by EPs, eligible 
hospitals, and CAHs is difficult to predict based on the information we 
have currently collected.
b. Industry Costs and Adoption Rates
(1) Modifications
    In the EHR Incentive Programs in 2015 through 2017 proposed rule, 
we proposed no new policies which would require changes to the 
development, certification, and implementation of CEHRT or to adoption 
rates as compared to the policies in the existing program outlined in 
the Stage 2 final rule (77 FR 54136 through 54146).
    As noted at the beginning of this analysis, it is difficult to 
predict the actual impacts of the policies in this proposed rule with 
certainty. We believe the assumptions and methods described herein are 
reasonable for estimating the financial impact of the provisions on 
providers participating in the Medicare and Medicaid programs, but 
acknowledge the wide range of possible outcomes.
(a) Medicare Eligible Professionals (EPs)
    In brief, the estimates of Medicare EP burden reduction are based 
on current participation as of January 1, 2015. We estimate that 
significant cost reductions for Medicare EPs participating in the EHR 
Incentive Program will result from the policies in this final rule with 
comment period when compared to the previous requirements for 2015. Our 
estimates of the reduction in burden cost savings are presented in 
Table 27. They reflect our assumptions about the proportion of EPs who 
will demonstrate meaningful use of CEHRT outlined in Table 26 based on 
historical data.

[[Page 62933]]



                          Table 26--Medicare EPs Demonstrating Meaningful Use of CEHRT
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar Year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare (in thousands).             660.0             667.8             675.5
Nonhospital-based Medicare EPs (in thousands).............             595.1             602.1             609.1
Percent of EPs who are Meaningful Users...................                60                65                70
Meaningful Users (in thousands)...........................             357.1             391.4             426.4
----------------------------------------------------------------------------------------------------------------


                               Table 27--Estimated Cost Reduction for Medicare EPs
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar Year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users (in thousands)...........................             357.1             391.4             426.4
Lowest Estimated Cost Savings.............................    $47,760,345.60    $52,353,664.00    $57,035,264.00
Highest Estimated Cost Savings............................    $62,585,476.80    $68,604,592.00    $74,739,392.00
----------------------------------------------------------------------------------------------------------------

(b) Medicare Eligible Hospitals and CAHs
    In brief, the estimates of hospital burden reduction are based on 
current participation as of January 1, 2015. We estimate that 
significant cost reductions for Medicare eligible hospitals and CAHs 
participating in the EHR Incentive Program will result from the 
policies in this final rule with comment period when compared to the 
previous requirements for 2015. Our estimates of the reduction in 
burden cost savings are presented in Table 29. They reflect our 
assumptions about the proportion of eligible hospitals and CAHs that 
will demonstrate meaningful use of CEHRT outlined in Table 28 based on 
historical data.

              Table 28--Medicare Eligible Hospitals and CAHs Demonstrating Meaningful Use of CEHRT
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar Year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................              3397              3397              3397
CAHs......................................................              1395              1395              1395
Percent Demonstrating Meaningful Use......................                95                97                99
Meaningful Users..........................................              4552              4648              4744
----------------------------------------------------------------------------------------------------------------


                   Table 29--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar Year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users..........................................              4552              4648              4744
Estimated Cost Savings....................................       $756,861.04       $772,822.96       $788,784.88
----------------------------------------------------------------------------------------------------------------

(c) Medicaid Only EPs
    We estimate that significant cost reductions for Medicaid only EPs 
participating in the EHR Incentive Program will result from the 
policies in this final rule with comment period when compared to the 
previous requirements for 2015. Our estimates of the reduction in 
burden cost savings are presented in Table 31. They reflect our 
assumptions about the proportion of Medicaid only EPs who will 
demonstrate meaningful use of CEHRT outlined in Table 30 based on 
historical data.

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


[[Page 62934]]


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

    It should be noted that since the Medicaid EHR Incentive Program 
provides that a Medicaid EP can receive an incentive payment in their 
first year because he or she has demonstrated meaningful use or because 
he or she has adopted, implemented, or upgraded CEHRT, these 
participation rates include only those Medicaid providers who are 
expected to demonstrate meaningful use. Providers who are dual-eligible 
have been included in the Medicare EP program estimates based on the 
total current volume of Medicare EPs who have demonstrated meaningful 
use in either Medicare or Medicaid as of January 1, 2015.
(d) Medicaid Only Hospitals
    The burden reduction for Medicaid only eligible hospitals assumes a 
similar participation rate for the demonstration of meaningful use as 
is applicable for Medicare eligible hospitals. We estimate that 
significant cost reductions for Medicaid only eligible hospitals 
participating in the EHR Incentive Program will result from the 
policies in this final rule with comment period when compared to the 
previous requirements for 2015. Our estimates of the reduction in 
burden cost savings are presented in Table 33. They reflect our 
assumptions about the proportion of Medicaid only eligible hospitals 
that will demonstrate meaningful use of CEHRT outlined in Table 32 
based on historical data.

                Table 32--Medicaid Only Eligible Hospitals Demonstrating Meaningful Use of CEHRT
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................               108               108               108
Percent Demonstrating Meaningful Use......................                95                97                99
Meaningful Users..........................................               103               105               107
----------------------------------------------------------------------------------------------------------------


                   Table 33--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
                                                                                Calendar year
                                                           -----------------------------------------------------
                                                                  2015              2016              2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users..........................................              4552              4648              4744
Estimated Cost Savings....................................        $17,125.81        $17,458.35        $17,790.89
----------------------------------------------------------------------------------------------------------------

(2) Stage 3
    In the Stage 2 final rule (77 FR 54136 through 54146), we estimated 
the impact on healthcare providers using information from four studies. 
In the absence of any more recent estimates that we are aware of, in 
this final rule with comment period, 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 final 
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 
upgrading systems or both. Based on these studies and current average 
costs for available CEHRT 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 likely 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 final 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 upgrading systems or both.
    Industry costs are important, in part, because EHR adoption rates 
will be a function of these industry costs and the extent to which the 
costs of ``certified EHRs'' are higher than the total value of EHR 
incentive payments available to EPs and eligible hospitals (as well as 
adjustments, in the case of the Medicare EHR incentive program) and any 
perceived benefits including societal benefits. Because of the 
uncertainties surrounding industry cost estimates, we have made various 
assumptions about adoption rates in the following analysis in order to 
estimate the budgetary impact on the Medicare and Medicaid programs.

[[Page 62935]]

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 upgrading systems or both.
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 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 upgrading 
systems or both.
3. Medicare and Medicaid Incentive Program Costs for Stage 3
    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 expected to be eligible for the 
program in 2017 and used these estimates for the following analysis of 
Stage 3 program costs.
     About 675,500 Medicare FFS EPs in 2017 (some of whom will 
also be Medicaid EPs).
     About 60,600 non-Medicare eligible EPs (such as dentists, 
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physician assistants) could be 
eligible to receive the Medicaid incentive payments in 2017.
     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)
     All eligible hospitals, except for children's and cancer 
hospitals, may qualify and apply for both Medicare and Medicaid 
incentive payments.
     About 16 MA organizations
a. Medicare Program Costs for Stage 3
    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 CEHRT 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.
(1) 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 34 shows the results of these calculations.

                          Table 34--Medicare EPs Demonstrating Meaningful Use of CEHRT
----------------------------------------------------------------------------------------------------------------
                                                                                 Calendar year
                                                             ---------------------------------------------------
                                                                  2017         2018         2019         2020
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare (thousands)......        675.5        683.3        691.1        698.8
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 35. They reflect actual historical data 
and our assumptions about the proportion of EPs who will demonstrate 
meaningful use of CEHRT. 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 35.

[[Page 62936]]



      Table 35--Estimated Costs (+) and Savings (-) for Medicare EPs Demonstrating Meaningful Use of CEHRT
                                                  [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
----------------------------------------------------------------------------------------------------------------

(2) 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 36.

  Table 36--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
                                                      CEHRT
                                                  [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.

b. Medicaid Incentive Program Costs for Stage 3
    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 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 37 shows our estimates for the net Medicaid costs for 
eligible hospitals and EPs.

[[Page 62937]]



                      Table 37--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.

(1) Medicaid EPs

        Table 38--Assumed Number of Nonhospital Based Medicaid EPs Who Would Be Meaningful Users of CEHRT
                                        [Population figures in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                           Calendar year
                                                 ---------------------------------------------------------------
                                                       2017            2018            2019            2020
----------------------------------------------------------------------------------------------------------------
A....................  EPs who meet the Medicaid           101.3           102.3           103.3           104.4
                        patient volume threshold.
B....................  Medicaid only Eps........            60.6            61.7            62.9            64.0
                       Total Medicaid EPs (A+B).           161.8           164.0           166.2           168.4
                       Percent of EPs receiving             44.7            30.9            20.7            14.3
                        incentive payment during
                        year.
                       Number of EPs receiving              72.4            50.7            34.5            24.0
                        incentive payment during
                        year.
                       Percent of EPs who have              67.9            74.7            78.0            81.1
                        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 CEHRT, these 
participation rates include not only meaningful users but eligible 
providers implementing CEHRT as well.
(2) 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 39. 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 
40 shows our assumptions about the remaining incentive payments to be 
paid.

   Table 39--Estimated Percentage of Hospitals That Could Be Paid for
     Meaningful Use and Estimated Percentage Payable by Fiscal 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 CEHRT are discussed in section V.C.4 of this 
final rule with comment period. 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.
4. Benefits for All EPs and All Eligible Hospitals
    In this final rule with comment period, we did not quantify 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, CEHRT) has 
not yet been collected, and although some studies question the benefits 
of health information technology, a 2011 study completed by ONC \25\ 
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. 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

[[Page 62938]]

Corporation for ONC \26\ 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. 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 return on investment within 16 months and annual savings 
thereafter.\27\ 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.\28\ As participation and adoption increases, there will 
be more opportunities to capture and report on cost savings and 
benefits.
---------------------------------------------------------------------------

    \25\ Buntin et al. 2011 ``The Benefits of Health Information 
Technology: A Review of the Recent Literature Shows Predominantly 
Positive Results'' Health Affairs.
    \26\ Shekelle et al. 2013 ``Health Information Technology: An 
Updated Systemic Review with a Focus on Meaningful Use 
Functionalities.
    \27\ 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.
    \28\ DeLeon et al. 2010, ``The business end of health 
information technology''.
---------------------------------------------------------------------------

5. Benefits to Society
    According to a CBO study, when used effectively, EHRs can enable 
providers to deliver health care more efficiently.\29\ For example, the 
study states that EHRs can reduce the duplication of diagnostic tests, 
prompt providers to prescribe cost-effective generic medications, 
remind patients about preventive care, reduce unnecessary office 
visits, and assist in managing complex care. This is consistent with 
the findings in the ONC study cited previously. Further, the CBO report 
claims that there is a potential to gain both internal and external 
savings from widespread adoption of health IT, noting that internal 
savings will likely be in the reductions in the cost of providing care, 
and that external savings could accrue to the health insurance plan or 
even the patient, such as the ability to exchange information more 
efficiently. However, it is important to note that the CBO identifies 
the highest gains accruing to large provider systems and groups and 
claims that office-based physicians may not realize similar benefits 
from purchasing health IT products. At this time, there is limited data 
regarding the efficacy of health IT for smaller practices and groups, 
and the CBO report notes that this is a potential area of research and 
analysis that remains unexamined. The benefits resulting specifically 
from this final rule with comment period 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 many cases, they 
represent the reduction in the time spent per each individual 
respondent to attest to the EHR Incentive Program objectives and 
measures. While this time may represent a reduced burden and the 
opportunity to reallocate recourses, there is no viable way to estimate 
that benefit over a wide range of provider types, practice sizes and 
other potential variables. For example, the reduction of about 2 hours 
per respondent for a small practice might be insignificant; however, 
for a practice of 1,000 providers it may represent as many as 2,000 man 
hours, which could be reallocated, to making other improvements in 
clinical processes and patient outcomes. Conversely, a large practice 
may instead leverage the batch reporting option and only see an overall 
reduction of 20 man hours as an organization while a small practice may 
find an even greater reduction than the estimate, which may amount to a 
significantly increased benefit and more time for the provider to spend 
in patient care.
---------------------------------------------------------------------------

    \29\ Congressional Budget Office: ``Evidence on the Costs and 
Benefits of Health Information Technology'' http://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf.
---------------------------------------------------------------------------

    In the Stage 2 final rule at 77 FR 54144, we discussed research 
documenting the association of EHRs with improved outcomes among 
diabetics \30\ and trauma patients,\31\ enhanced efficiencies in 
ambulatory care settings,\32\ and improved outcomes and lower costs in 
hospitals.\33\ 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.
---------------------------------------------------------------------------

    \30\ (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).
    \31\ 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.
    \32\ Chen, C et al. (2009) ``The Kaiser Permanente Electronic 
Health Record: Transforming and Streamlining Modalities Of Care. 
``Health Affairs'' 28(2):323-333.
    \33\ Amarasingham, R. et al. (2009) ``Clinical information 
technologies and inpatient outcomes: a multiple hospital study'' 
Archives of Internal Medicine 169(2):108-14.
---------------------------------------------------------------------------

6. Summary
    In this final rule with comment period, the burden estimate and 
analysis of the impact of the policies result in a total cost reduction 
estimated at $48,534,332 at the lowest and $63,359,464 at the highest 
for an EHR reporting period on an annual basis for 2015 through 2017. 
For further information on prior estimates of program costs we direct 
readers to the Stage 2 final rule (77 FR 54145).
    The total cost to the Medicare and Medicaid programs between 2017 
and 2020 is estimated to be $3.7 billion in transfers.

  Table 40--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

[[Page 62939]]

 
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 for Stage 3

    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 CEHRT and demonstrate meaningful use of CEHRT. 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 final rule with comment period. Additionally, we have 
used our discretion to 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 CEHRT. 
We recognize that there may be additional costs that result from 
various discretionary policy choices by providers. However, those costs 
cannot be estimated as the potential for variance by provider type, 
organization size, place of service, geographic location, patient 
population, and the impact of state and local laws is extensive and 
such variations are not captured in this analysis.

E. Accounting Statement and Table

    When a rule is considered a significant rule under Executive Order 
12866, we are required to develop an accounting statement indicating 
the classification of the expenditures associated with the provisions 
of this final rule with comment period. Monetary annualized benefits 
and non-budgetary costs are presented as discounted flows using 3 
percent and 7 percent factors in the following tables. We are not able 
to explicitly define the universe of those additional costs, nor 
specify what the high or low range might be to implement EHR technology 
in this final rule with comment period. We note that federal annualized 
monetized transfers represent the net total of annual incentive 
payments in the Medicare and Medicaid EHR Incentive programs less the 
reductions in Medicare payments to providers failing to demonstrate 
meaningful use as a result of the related Medicare payment adjustments.
(1) EHR Incentive Programs in 2015 Through 2017

 Table 41--Accounting Statement for Modifications: Classification of Estimated Cost Reductions and Benefits CYs
                                                2015 Through 2017
                                                  [in millions]
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                    Category
----------------------------------------------------------------------------------------------------------------
                                                                            Benefits
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Cost Reductions to                  Low estimate      High      .......  ..................
 Private Industry Associated with Reporting                               estimate
 Requirements.................................
                                               -----------------------------------------------------------------
                                                  2015         $52.8         $68.9       7%                    CYs 2015-2017.
                                                               $52.8         $68.9       3%
----------------------------------------------------------------------------------------------------------------
Qualitative--Other private industry and
 societal benefits associated with the
 reduction in provider reporting burden and
 with having additional time to meet the
 requirements of the program..................
----------------------------------------------------------------------------------------------------------------

    In this final rule with comment period, there is no estimated 
increase in costs associated with incentive payments or payment 
adjustments for the Medicare and Medicaid EHR Programs attributable to 
the modifications to the program proposed in the EHR Incentive Programs 
in 2015 through 2017 proposed rule.
(2) Stage 3
    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. Transfers related to the payment of EHR 
Incentive Payments for 2017 through 2020 based on the policies in this 
final rule with comment period and the estimated reduction in Medicare 
payments through the application of payment adjustments for the same 
period. We note that this estimate relates only to the policies in this 
final rule with comment period and does not address subsequent changes 
pertaining to the MIPS program as established by MACRA which will be 
further defined in future rulemaking.

[[Page 62940]]



     Table 42--Stage 3--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            Estimates          Unit   Period covered.
                                       dollar        (in millions)      discount
                                                                            rate
----------------------------------------------------------------------------------------------------------------
                                                  Primary estimate
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Costs to            2017               $478.1            7%   CY 2017.
 Private Industry Associated with                           $478.4            3%
 Reporting Requirements.
----------------------------------------------------------------------------------------------------------------
Qualitative--Other private industry     These costs would include the impact of EHR activities such as reduced
 costs associated with the adoption    staff productivity related to learning how to use the EHR technology, the
 of EHR technology.                      need for additional staff to work with HIT issues, and administrative
                                                              costs related to reporting.
----------------------------------------------------------------------------------------------------------------
                                                                       Transfers
----------------------------------------------------------------------------------------------------------------
                                         Year            Estimates          Unit   Period covered
                                       dollar        (in millions)      discount
                                                                            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.
----------------------------------------------------------------------------------------------------------------

VI. 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 final rule 
with comment period, and, if we proceed with a subsequent document, we 
will respond to the comments in the preamble to that document.

List of Subjects

42 CFR Part 412

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

42 CFR Part 495

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

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

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

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

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 
1501A-332), sec. 1206 of Pub. L. 113-67, and sec. 112 of Pub. L. 
113-93.


Sec.  412.64  [Amended]

0
2. Section 412.64 is amended by--
0
A. In paragraph (d)(4)(ii)(A) by removing the phrase ``April 1'' 
wherever it appears and adding the phrase ``July 1'' in its place.
0
B. In paragraph (d)(4)(ii)(B)(1) by removing the phrase ``April 1'' and 
adding the phrase ``July 1'' in its place.
0
C. In paragraph (d)(4)(ii)(B)(2) by removing the phrase ``April 1'' and 
adding the phrase ``July 1'' in its place.

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

0
3. 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
4. Section 495.4 is amended as follows:
0
A. Adding the definition of ``API'' in alphabetical order.
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)(i)(C)(4), and (1)(i)(D), 
respectively.
0
ii. Adding new paragraph (1)(i) introductory text.
0
iii. Adding new paragraphs (1)(ii) and (iii).
0
iv. Redesignating paragraphs (2)(i), (2)(ii), (2)(iii) introductory 
text, (2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and

[[Page 62941]]

(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 paragraphs (2)(i) introductory text.
0
vi. Adding new paragraphs (2)(ii) and (iii).
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 (1)(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 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 paragraphs (2)(ii) and (iii).
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 paragraphs (3)(ii) and (iii).
0
e. Amend the definition of ``Meaningful EHR user'' by:
0
i. In paragraph (1), by removing the reference ``Sec.  495.8'' and 
adding in its place the reference ``Sec.  495.40''.
0
ii. In paragraph (1), by removing the reference ``under Sec.  495.6 '' 
and adding in its place the reference ``under Sec. Sec.  495.20, 
495.22, and 495.24''.
    The additions and revision read as follows:


Sec.  495.4  Definitions.

* * * * *
    API stands for application programming interface.
    Certified electronic health record technology (CEHRT) means the 
following:
    (1) For any Federal fiscal year or calendar year before 2018, EHR 
technology (which could include multiple technologies) certified under 
the ONC Health IT Certification Program that meets one of the 
following:
    (i) The 2014 Edition Base EHR definition (as defined at 45 CFR 
170.102) and has been certified to the certification criteria that are 
necessary to be a Meaningful EHR User (as defined in this section), 
including the applicable measure calculation certification criterion at 
45 CFR 170.314(g)(1) or (2) for all certification criteria that support 
a meaningful use objective with a percentage-based measure.
    (ii) Certification to--
    (A) The following certification criteria:
    (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)(6).
    (4)(i) Medication list at 45 CFR 170.314(a)(6); or
    (ii) 45 CFR 170.315(a)(7).
    (5)(i) Medication allergy list 45 CFR 170.314(a)(7); or
    (ii) 45 CFR 170.315(a)(8).
    (6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or
    (ii) 45 CFR 170.315(a)(9).
    (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); and
    (B) Clinical quality measures at--
    (1) 45 CFR 170.314(c)(1) or 170.315(c)(1);
    (2) 45 CFR 170.314(c)(2) or 170.315(c)(2);
    (3) 45 CFR 170.314(c)(3) or 170.315(c)(3); and
    (C) Privacy and security at--
    (1) 45 CFR 170.314(d)(1) or 170.315(d)(1);
    (2) 45 CFR 170.314(d)(2) or 170.315(d)(2);
    (3) 45 CFR 170.314(d)(3) or 170.315(d)(3);
    (4) 45 CFR 170.314(d)(4) or 170.315(d)(4);
    (5) 45 CFR 170.314(d)(5) or 170.315(d)(5);
    (6) 45 CFR 170.314(d)(6) or 170.315(d)(6);
    (7) 45 CFR 170.314(d)(7) or 170.315(d)(7);
    (8) 45 CFR 170.314(d)(8) or 170.315(d)(8); and
    (D) The certification criteria that are necessary to be a 
Meaningful EHR User (as defined in this section), including the 
applicable measure calculation certification criterion at 45 CFR 
170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2) for all 
certification criteria that support a meaningful use objective with a 
percentage-based measure.
    (iii) The definition for 2018 subsequent years specified in 
paragraph (2) of this definition.
    (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--

[[Page 62942]]

    (i) At 45 CFR 170.315(a)(12) (family health history) and 45 CFR 
170.315(e)(3) (patient health information capture); and
    (ii) Necessary to be a Meaningful EHR User (as defined in this 
section), including the following:
    (A) The applicable measure calculation certification criterion at 
45 CFR 170.315(g)(1) or (2) for all certification criteria that support 
a meaningful use objective with a percentage-based measure.
    (B) Clinical quality measure certification criteria that support 
the calculation and reporting of clinical quality measures at 45 CFR 
170.315(c)(2) and (3).
* * * * *
    EHR reporting period. * * *
    (1) * * *
    (i) The following are applicable before 2015:
* * * * *
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) For the CY 2015 payment year, any continuous 90-day period 
within CY 2015.
    (B) For the CY 2016 payment year:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2016.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, the CY 2016.
    (C) For the CY 2017 payment year under the Medicaid EHR Incentive 
Program:
    (1) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2017.
    (2) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, the CY 2017.
    (3) For the EP demonstrating the Stage 3 objectives and measures at 
Sec.  495.24, any continuous 90-day period within CY 2017.
    (iii) The following are applicable beginning with the CY 2018 
payment year 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 2015:
* * * * *
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) For the FY 2015 payment year, any continuous 90-day period 
within the period beginning on October 1, 2014 and ending on December 
31, 2015.
    (B) For the FY 2016 payment year as follows:
    (1) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2016.
    (2) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, the CY 
2016.
    (C) For the FY 2017 payment year under the Medicaid EHR Incentive 
Program:
    (1) For the eligible hospital or CAH first demonstrating it is a 
meaningful EHR user, any continuous 90-day period within CY 2017.
    (2) For the eligible hospital or CAH that has successfully 
demonstrated it is a meaningful EHR user in any prior year, the CY 
2017.
    (3) For the eligible hospital or CAH demonstrating the Stage 3 
objectives and measures at Sec.  495.24, any continuous 90-day period 
within CY 2017.
    (iii) The following are applicable beginning with the FY 2018 
payment year 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 2015:
* * * * *
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) In 2015 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2015 and applies for the CY 2016 and 
2017 payment adjustment years.
    (2) If in a prior year an EP has successfully demonstrated he or 
she is a meaningful EHR user, the EHR reporting period is any 
continuous 90-day period within CY 2015 and applies for the CY 2017 
payment adjustment year.
    (B) In 2016 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2016 and applies for the CY 2017 and 
2018 payment adjustment years. For the CY 2017 payment adjustment year, 
the EHR reporting period must end before and the EP must successfully 
register for and attest to meaningful use no later than October 1, 
2016.
    (2) If in a prior year an EP has successfully demonstrated he or 
she is a meaningful EHR user, the EHR reporting period is CY 2016 and 
applies for the CY 2018 payment adjustment year.
    (C) In 2017 as follows:
    (1) If an EP has not successfully demonstrated he or she is a 
meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2017 and applies for the CY 2018 
payment adjustment year. For the CY 2018 payment adjustment year, the 
EHR reporting period must end before and the EP must successfully 
register for and attest to meaningful use no later than October 1, 
2017.
    (2) If an EP is demonstrating Stage 3 of meaningful use in 2017 
under Sec.  495.24 in the Medicaid program, the EHR reporting period is 
any continuous 90-day period within CY 2017 and applies for the FY 2019 
payment adjustment year.
    (2) * * *
    (i) The following are applicable before 2015:
* * * * *
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) In 2015 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within the period beginning on October 1, 2014 
and ending on December 31, 2015 and applies for the FY 2016 and 2017 
payment adjustment years.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
any continuous 90-day period within the period beginning on October 1, 
2014 and ending on December 31, 2015 and applies for the FY 2017 
payment adjustment year.
    (B) In 2016 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous

[[Page 62943]]

90-day period within CY 2016 and 2017 applies for the FY 2017 and 2018 
payment adjustment years. For the FY 2017 payment adjustment year, the 
EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2016.
    (2) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
CY 2016 and applies for the FY 2018 payment adjustment year.
    (C) In 2017 as follows:
    (1) If an eligible hospital has not successfully demonstrated it is 
a meaningful EHR user in a prior year, the EHR reporting period is any 
continuous 90-day period within CY 2017 and applies for the FY 2018 and 
2019 payment adjustment years. For the FY 2018 payment adjustment year, 
the EHR reporting period must end before and the eligible hospital must 
successfully register for and attest to meaningful use no later than 
October 1, 2017.
    (2) If an eligible hospital is demonstrating Stage 3 of meaningful 
use under Sec.  495.24, the EHR reporting period is any continuous 90-
day period within CY 2017 and applies for the FY 2019 payment 
adjustment year.
    (3) If in a prior year an eligible hospital has successfully 
demonstrated it is a meaningful EHR user, the EHR reporting period is 
CY 2017 and applies for the FY 2019 payment adjustment year.
    (iii) The following are applicable beginning in 2018:
    (A) Except as provided in paragraph (2)(iii)(B) of this definition, 
the EHR reporting period is 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, the EHR reporting period for that payment adjustment year is the 
same continuous 90-day period that is the EHR reporting period for the 
Medicaid incentive payment within the calendar year that is 2 years 
before that payment adjustment year.
    (3) * * *
    (i) The following are applicable before 2015:
* * * * *
    (ii) The following are applicable for 2015, 2016, and 2017:
    (A) In 2015 as follows:
    (1) The EHR reporting period is any continuous 90-day period within 
the period beginning on October 1, 2014 and ending on December 31, 2015 
and applies for the FY 2015 payment adjustment year.
    (B) In 2016 as follows:
    (1) If a CAH has not successfully demonstrated it is a meaningful 
EHR user in a prior year, the EHR reporting period is any continuous 
90-day period within CY 2016 and applies for the FY 2016 payment 
adjustment year.
    (2) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is CY 2016 and applies 
for the FY 2016 payment adjustment year.
    (C) In 2017 as follows:
    (1) If the CAH has not successfully demonstrated meaningful EHR use 
in a prior year the EHR reporting period is any continuous 90-day 
period within CY 2017 and applies for the FY 2017 payment adjustment 
year.
    (2) If a CAH is demonstrating Stage 3 of meaningful use under Sec.  
495.24, the EHR reporting period is any continuous 90-day period within 
CY 2017 and applies for that begins on the first day of second quarter 
of the FY 2017 payment adjustment year.
    (3) If in a prior year a CAH has successfully demonstrated it is a 
meaningful EHR user, the EHR reporting period is CY 2017 and applies 
for the FY 2017 payment adjustment year.
    (iii) The following are applicable beginning in 2018:
    (A) Except as provided in paragraph (3)(iii)(B) of this definition, 
the EHR reporting period is the calendar year that begins on the first 
day of 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. The EHR reporting 
period for that payment adjustment year is the same continuous 90-day 
period that is the EHR reporting period for the Medicaid incentive 
payment within the calendar year that that begins on the first day of 
the second quarter of the Federal fiscal year that is the payment 
adjustment year.
* * * * *


Sec.  495.6  [Redesignated as Sec.  495.20]

0
5. Redesignate Sec.  495.6 as Sec.  495.20.


Sec.  495.8  [Redesignated as Sec.  495.40]

0
6. Redesignate Sec.  495.8 as Sec.  495.40.


Sec.  495.10  [Redesignated as Sec.  495.60]

0
7. Redesignate Sec.  495.10 as Sec.  495.60.

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


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

    The following criteria are applicable before 2015:
* * * * *

0
9. Section Sec.  495.22 is added to read as follows:


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

    (a) General rules. (1) The criteria specified in this section are 
applicable for all EPs, eligible hospitals, and CAHs for 2015 through 
2017.
    (2) For 2017 only, EPs, eligible hospitals, and CAHs have the 
option to use the criteria specified for 2018 (as outlined at Sec.  
495.24) instead of the criteria specified in this section.
    (b) Criteria for EPs for 2015 through 2017--(1) General rule 
regarding criteria for meaningful use for 2015 through 2017 for EPs. 
Except as specified in paragraph (b)(2) of this section, EPs must meet 
all objectives and associated measures of the meaningful use criteria 
specified under paragraph (e) of this section to meet the definition of 
a meaningful EHR user.
    (2) Exclusion for non-applicable objectives. (i) An EP may exclude 
a particular objective contained in paragraph (e) of this section, if 
the EP meets all of the following requirements:
    (A) Must ensure that the objective in paragraph (e) of this section 
includes an option for the EP to attest that the objective is not 
applicable.
    (B) Meets the criteria in the applicable objective that would 
permit the attestation to the exclusion.
    (C) Attests.
    (ii) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (c) Criteria for eligible hospitals and CAHs for 2015 through 
2017--(1) General rule regarding criteria for meaningful use for 2015 
through 2017 for eligible hospitals and CAHs. Except as specified in 
paragraph (c)(2) of this section, eligible hospitals and CAHs must meet 
all objectives and associated measures of the meaningful use criteria 
specified under paragraph (e) of this section to meet the definition of 
a meaningful EHR user.

[[Page 62944]]

    (2) Exclusion for non-applicable objectives. (i) An eligible 
hospital or CAH may exclude a particular objective contained in 
paragraph (e) of this section, if the eligible hospital or CAH meets 
all of the following requirements:
    (A) Must ensure that the objective in paragraph (e) of this section 
includes an option for the eligible hospital or CAH to attest that the 
objective is not applicable.
    (B) Meets the criteria in the applicable objective that would 
permit the attestation to the exclusion.
    (C) Attests.
    (ii) An exclusion will reduce (by the number of exclusions 
applicable) the number of objectives that would otherwise apply in 
paragraph (e) of this section.
    (d) Many of the objectives and associated measures in paragraph (e) 
of this section rely on measures that count unique patients or actions. 
(1) If a measure (or associated objective) in paragraph (e) of this 
section references paragraph (d) of this section, then the measure may 
be calculated by reviewing only the actions for patients whose records 
are maintained using CEHRT. A patient's record is maintained using 
CEHRT if sufficient data was entered in the CEHRT to allow the record 
to be saved, and not rejected due to incomplete data.
    (2) If the objective and associated measure does not reference this 
paragraph (d) of this section, then the measure must be calculated by 
reviewing all patient records, not just those maintained using CEHRT.
    (e) Meaningful use objectives and measures for 2015 through 2017--
(1) Protect patient health information-- (i) Objective. Protect 
electronic protected health information created or maintained by the 
CEHRT through the implementation of appropriate technical capabilities.
    (ii) Measures--(A) EP measure. Conduct or review a security risk 
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), 
including addressing the security (to include encryption) of ePHI 
created or maintained by CEHRT in accordance with requirements under 45 
CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and implement security 
updates as necessary and correct identified security deficiencies as 
part of the EP's risk management process.
    (B) Eligible hospital or CAH measure. Conduct or review a security 
risk analysis in accordance with the requirements under 45 CFR 
164.308(a)(1), including Addressing the security (to include 
encryption) of ePHI created or maintained in CEHRT in accordance with 
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), 
and implement security updates as necessary, and correct identified 
security deficiencies as part of the eligible hospital's or CAH's risk 
management process.
    (2) Clinical decision support-- (i) Objective. Use clinical 
decision support to improve performance on high-priority health 
conditions.
    (ii) EP measures--(A) Measure. In order for EPs to meet the 
objective they must satisfy both of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures at a relevant point in 
patient care for the entire EHR reporting period. Absent four clinical 
quality measures related to an EP's scope of practice or patient 
population, the clinical decision support interventions must be related 
to high-priority health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP who writes fewer than 100 medication orders during the EHR 
reporting period may be excluded from the measure under paragraph 
(e)(2)(i)(A)(2) of this section.
    (C) Alternate specifications. An EP previously scheduled to be in 
Stage 1 in 2015 may meet an alternate objective and measure specified 
in paragraph (e)(2)(ii)(C)(1) and (2) in place of the measure outlined 
under paragraph (e)(2)(ii)(A)(1) of this section for an EHR reporting 
period in 2015 only.
    (1) Alternate objective. Implement one clinical decision support 
rule relevant to specialty or high clinical priority along with the 
ability to track compliance with that rule.
    (2) Alternate measure. Implement one clinical decision support 
rule.
    (iii) Eligible hospital and CAH measures--(A) Measure. In order for 
eligible hospitals and CAHs to meet the objective they must satisfy 
both of the following measures:
    (1) Implement five clinical decision support interventions related 
to four or more clinical quality measures at a relevant point in 
patient care for the entire EHR reporting period. Absent four clinical 
quality measures related to an eligible hospital or CAH's scope of 
practice or patient population, the clinical decision support 
interventions must be related to high-priority health conditions.
    (2) Enabled and implemented the functionality for drug-drug and 
drug-allergy interaction checks for the entire EHR reporting period.
    (B) Alternate specifications. An eligible hospital or CAH 
previously scheduled to be in Stage 1 in 2015 may meet an alternate 
measure described in paragraph (e)(2)(iii)(B)(2) of this section in 
place of the measure described in paragraph (e)(2)(iii)(A)(1) of this 
section for an EHR reporting period in 2015.
    (1) Alternate objective. Implement one clinical decision support 
rule relevant to a high priority hospital condition along with the 
ability to track compliance with that rule.
    (2) Alternate measure. Implement one clinical decision support 
rule.
    (3) Computerized provider order entry. (i) Objective. Use 
computerized provider order entry for medication, laboratory, and 
radiology orders directly entered by any licensed healthcare 
professional who can enter orders into the medical record per state, 
local, and professional guidelines.
    (ii) EP measures. (A) Measures. An EP must meet the following 3 
measures, subject to paragraph (d) of this section:
    (1) More than 60 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (2) More than 30 percent of laboratory orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (3) More than 30 percent of radiology orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
(1) For the measure specified in paragraph (e)(3)(ii)(A)(1) of this 
section, any EP who writes fewer than 100 medication orders during the 
EHR reporting period.
    (2) For the measure specified in paragraph (e)(3)(ii)(A)(2) of this 
section, any EP who writes fewer than 100 laboratory orders during the 
EHR reporting period.
    (3) For the measure specified in paragraph (e)(3)(ii)(A)(3) of this 
section, any EP who writes fewer than 100 radiology orders during the 
EHR reporting period.
    (C) Alternate exclusions and specifications. An EP previously 
scheduled to be in Stage 1 in 2015 may meet an alternate measure 
(e)(3)(ii)(C)(1) in place of the measure outlined under paragraph 
(e)(3)(ii)(A)(1) of this section, and may exclude the measures outlined 
under paragraphs (e)(3)(ii)(A)(2) and (3) of this section for an EHR 
reporting period in 2015. An EP previously scheduled to be in Stage 1 
in 2016 may exclude the measures outlined under

[[Page 62945]]

paragraphs (e)(3)(ii)(A)(2) and (3) of this section for an EHR 
reporting period in 2016.
    (1) Alternate measure 1 in 2015. Subject to paragraph (d) of this 
section--
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list seen by the EP during the EHR 
reporting period have at least one medication order entered using CPOE; 
or
    (ii) More than 30 percent of medication orders created by the EP 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (2) Alternate exclusions in 2015. An EP scheduled to be in Stage 1 
in 2015 may exclude the measures specified in paragraphs 
(e)(3)(ii)(A)(2) and (e)(3)(ii)(A)(3) of this section in 2015.
    (3) Alternate exclusions in 2016. An EP scheduled to be in Stage 1 
in 2016 may exclude the measure specified in paragraph (e)(3)(ii)(A)(3) 
of this section in 2016.
    (iii) Eligible hospital and CAH measures. (A) An eligible hospital 
or CAH must meet the following 3 measures, subject to paragraph (d) of 
this section:
    (1) More than 60 percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (2) More than 30 percent of laboratory orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (3) More than 30 percent of radiology orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry.
    (B) Alternate exclusions and specifications. (1) An eligible 
hospital or CAH previously scheduled to be in Stage 1 in 2015 may meet 
an alternate measure specified in paragraph (e)(3)(iii)(B)(2) of this 
section in place of the measure outlined under paragraph 
(e)(3)(iii)(A)(1) of this section, and may exclude the measures 
outlined under paragraphs (e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of 
this section for an EHR reporting period in 2015. An eligible hospital 
or CAH previously scheduled to be in Stage 1 in 2016 may exclude the 
measures outlined under paragraphs (e)(3)(iii)(A)(2) and (3) of this 
section for an EHR reporting period in 2016.
    (2) Alternate measure 1 in 2015. Subject to paragraph (d) of this 
section--
    (i) More than 30 percent of all unique patients with at least one 
medication in their medication list admitted to the eligible hospital's 
or CAH's inpatient or emergency department (POS 21 or 23) have at least 
one medication order entered using CPOE; or
    (ii) More than 30 percent of medication orders created by the 
authorized providers of the eligible hospital or CAH for patients 
admitted to their inpatient or emergency departments (POS 21 or 23) 
during the EHR reporting period are recorded using computerized 
provider order entry.
    (3) Alternate exclusions in 2015 and 2016. An eligible hospital or 
CAH scheduled to be in Stage 1 in 2015 may exclude the following 
measures in 2015 and eligible hospital or CAH scheduled to be in Stage 
1 in 2016 may exclude the following measures in 2016:
    (i) The measure specified in paragraph (e)(3)(iii)(A)(2) of this 
section.
    (ii) The measure specified in paragraph (e)(3)(iii)(A)(3) of this 
section.
    (4) Electronic prescribing--(i) Objective. For EPs, generate and 
transmit permissible prescriptions electronically (eRx); and, for 
eligible hospitals and CAHs, generate, and transmit permissible 
discharge prescriptions electronically (eRx).
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, more than 50 percent of all permissible prescriptions written 
by the EP are queried for a drug formulary and transmitted 
electronically using CEHRT.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who--
    (1) Writes fewer than 100 permissible prescriptions during the EHR 
reporting period; or
    (2) Does not have a pharmacy within his or her organization and 
there are no pharmacies that accept electronic prescriptions within 10 
miles of the EP's practice location at the start of his or her EHR 
reporting period.
    (C) Alternate specification. In 2015 an EP--
    (1) Previously scheduled to be in Stage 1 in 2015 may meet an 
alternate measure under paragraph (e)(4)(ii)(C)(2) of this section in 
place of the measure outlined under paragraph(e)(4)(ii)(A) of this 
section; and
    (2) Subject to paragraph (d) of this section, more than 40 percent 
of all permissible prescriptions written by the EP are transmitted 
electronically using CEHRT.
    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, more than 10 percent of hospital 
discharge medication orders for permissible prescriptions are queried 
for a drug formulary and transmitted electronically using CEHRT.
    (B) Exclusion in accordance with paragraph (c)(2) of this section. 
Any eligible hospital or CAH that does not have an internal pharmacy 
that can accept electronic prescriptions and is not located within 10 
miles of any pharmacy that accepts electronic prescriptions at the 
start of their EHR reporting period.
    (C) Alternate exclusions. (1) An eligible hospital or CAH 
previously scheduled to be in--
    (i) Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015; or
    (ii) Stage 2 in 2015 may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015.
    (2) An eligible hospital or CAH previously scheduled to be in--
    (i) Stage 1 in 2016, may exclude the measure specified in paragraph 
(e)(4)(iii)(A) of this section for an EHR reporting period in 2016; or
    (ii) Stage 2 in 2016, may exclude the measure specified in 
paragraph (e)(4)(iii)(A) of this section for an EHR reporting period in 
2016.
    (5) Health Information Exchange--(i) Objective. The EP, eligible 
hospital or CAH who transitions a patient to another setting of care or 
provider of care or refers a patient to another provider of care 
provides a summary care record for each transition of care or referral.
    (ii) EP measure. (A) Measure. Subject to paragraph (d) of this 
section, the EP who transitions or refers his or her patient to another 
setting of care or provider of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider 
for more than 10 percent of transitions of care and referrals.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who transfers a patient to another setting or refers a patient 
to another provider less than 100 times during the EHR reporting 
period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 
1 in 2015 may exclude the measure specified in paragraph (e)(5)(ii)(A) 
of this section for an EHR reporting period in 2015.

[[Page 62946]]

    (iii) Eligible hospital and CAH measure--(A) Measure. Subject to 
paragraph (d) of this section, the eligible hospital or CAH that 
transitions or refers its patient to another setting of care or 
provider of care must do the following:
    (1) Use CEHRT to create a summary of care record.
    (2) Electronically transmit such summary to a receiving provider 
for more than 10 percent of transitions of care and referrals.
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(5)(iii)(A) of this section for an EHR reporting period in 
2015.
    (6) Patient specific education--(i) Objective. Use clinically 
relevant information from CEHRT to identify patient-specific education 
resources and provide those resources to the patient.
    (ii) EP measure--(A) Measure. Patient-specific education resources 
identified by CEHRT are provided to patients for more than 10 percent 
of all unique patients with office visits seen by the EP during the EHR 
reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who has no office visits during the EHR reporting period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 
1 in 2015 may exclude the measure specified in paragraph (e)(6)(ii)(A) 
of this section for an EHR reporting period in 2015.
    (iii) Eligible hospital and CAH measure--(A) Measure. More than 10 
percent of all unique patients admitted to the eligible hospital's or 
CAH's inpatient or emergency department (POS 21 or 23) are provided 
patient-specific education resources identified by CEHRT.
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(6)(iii)(A) of this section for an EHR reporting period in 
2015.
    (7) Medication reconciliation--(i) Objective. The EP, eligible 
hospital or CAH that receives a patient from another setting of care or 
provider of care or believes an encounter is relevant performs 
medication reconciliation.
    (ii) EP measure--(A) Measure. Subject to paragraph (d) of this 
section, the EP performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is transitioned 
into the care of the EP.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
Any EP who was not the recipient of any transitions of care during the 
EHR reporting period.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 
1 in 2015 may exclude the measure specified in paragraph (e)(7)(ii)(A) 
of this section for an EHR reporting period in 2015.
    (iii) Eligible hospital or CAH measure. An eligible hospital or CAH 
must meet the following measure, subject to paragraph (d) of this 
section:
    (A) Measure. Subject to paragraph (d) of this section, the eligible 
hospital or CAH performs medication reconciliation for more than 50 
percent of transitions of care in which the patient is admitted to the 
eligible hospital's or CAH's inpatient or emergency department (POS 21 
or 23).
    (B) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph (e)(7)(iii)(A) of this section for an EHR reporting period in 
2015.
    (8) Patient electronic access--(i) EP objective. Provide patients 
the ability to view online, download, and transmit their health 
information within 4 business days of the information being available 
to the EP.
    (A) EP measures. An EP must meet the following 2 measures:
    (1) Measure 1: More than 50 percent of all unique patients seen by 
the EP during the EHR reporting period are provided timely access to 
view online, download and transmit to a third party their health 
information subject to the EP's discretion to withhold certain 
information.
    (2) Measure 2: For an EHR reporting period--
    (i) In 2015 and 2016, at least 1 patient seen by the EP during the 
EHR reporting period (or patient-authorized representative) views, 
downloads or transmits his or her health information to a third party 
during the EHR reporting period.
    (ii) In 2017, more than 5 percent of unique patients seen by the EP 
during the EHR reporting period (or their authorized representatives) 
views, downloads or transmits their health information to a third party 
during the EHR reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section--
(1) Any EP who neither orders nor creates any of the information listed 
for inclusion as part of the measure in paragraph (e)(8)(ii)(A)(1) or 
(2) of this section, except for ``Patient name'' and ``Provider's name 
and office contact information,'' is excluded from paragraphs 
(e)(8)(ii)(A)(1) and (2) of this section.
    (2) Any EP who conducts 50 percent or more of his or her patient 
encounters in a county that does not have 50 percent or more of its 
housing units with 4Mbps broadband availability according to the latest 
information available from the Federal Communications Commission on the 
first day of the EHR reporting period is excluded from paragraph 
(e)(8)(ii)(A)(2) of this section.
    (C) Alternate exclusion. An EP previously scheduled to be in Stage 
1 in 2015 may exclude the measure specified in paragraph 
(e)(8)(ii)(A)(2) of this section for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH objective. Provide patients the 
ability to view online, download, and transmit information within 36 
hours of hospital discharge.
    (A) Eligible hospital and CAH measures. An eligible hospital or CAH 
must meet the following 2 measures:
    (1) Measure 1. More than 50 percent of all unique patients who are 
discharged from the inpatient or emergency department (POS 21 or 23) of 
an eligible hospital or CAH have timely access to view online, download 
and transmit to a third party their health information.
    (2) Measure 2. For an EHR reporting period--
    (i) In 2015 or 2016, at least 1 patient (or patient-authorized 
representative) who is discharged from the inpatient or emergency 
department (POS 21 or 23) of an eligible hospital or CAH during the EHR 
reporting period views, downloads or transmits to a third party his or 
her information during the EHR reporting period; and
    (ii) In 2017, more than 5 percent of unique patients (or patient-
authorized representatives) discharged from the inpatient or emergency 
department (POS 21 or POS 23) of an eligible hospital or CAH during the 
EHR reporting period view, download or transmit to a third party their 
health information during the EHR reporting period.
    (B) Exclusion applicable under paragraph (c)(2) of this section. 
Any eligible hospital or CAH that is located in a county that does not 
have 50 percent or more of its housing units with 4Mbps broadband 
availability according to the latest information available from the FCC 
on the first day of the EHR reporting period is excluded from paragraph 
(e)(8)(iii)(A)(2) of this section.
    (C) Alternate exclusion. An eligible hospital or CAH previously 
scheduled to be in Stage 1 in 2015 may exclude the measure specified in 
paragraph

[[Page 62947]]

(e)(8)(iii)(A)(2) of this section for an EHR reporting period in 2015.
    (9) Secure messaging--(i) EP objective. Use secure electronic 
messaging to communicate with patients on relevant health information.
    (ii) EP measure--(A) Measure. For an EHR reporting period--
    (1) In 2015, the capability for patients to send and receive a 
secure electronic message with the EP was fully enabled during the EHR 
reporting period;
    (2) In 2016, for at least 1 patient 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 the patient-authorized 
representative), or in response to a secure message sent by the patient 
(or the patient-authorized representative) during the EHR reporting 
period; and
    (3) In 2017, for more than 5 percent of 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 the patient-
authorized representative), or in response to a secure message sent by 
the patient (or the patient-authorized representative) during the EHR 
reporting period.
    (B) Exclusion in accordance with paragraph (b)(2) of this section. 
An EP may exclude from the measure if he or she--
    (1) Has no office visits during the EHR reporting period; or
    (2) Conducts 50 percent or more of his or her patient encounters in 
a county that does not have 50 percent or more of its housing units 
with 4Mbps broadband availability according to the latest information 
available from the Federal Communications Commission on the first day 
of the EP's EHR reporting period.
    (C) Alternate specification. An EP previously scheduled to be in 
Stage 1 in 2015 may exclude the measure specified in paragraph 
(e)(9)(ii)(A) of this section for an EHR reporting period in 2015.
    (10) Public Health Reporting--(i) EP Public Health Reporting--(A) 
Objective. The EP is in active engagement with a public health agency 
to submit electronic public health data from CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(i)(A) of this section, an EP must choose from measures 1 
through 3 (as specified in paragraphs (e)(10)(i)(B)(1) through (3) of 
this section) and must successfully attest to any combination of two 
measures. The EP may attest to measure 3 (as specified in paragraph 
(e)(10)(i)(B)(3) of this section more than one time. These measures may 
be met by any combination 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.
    (2) Syndromic surveillance reporting. The EP is in active 
engagement with a public health agency to submit syndromic surveillance 
data.
    (3) Specialized registry reporting. The EP is in active engagement 
to submit data to specialized registry.
    (C) Exclusions in accordance with paragraph (b)(2) of this section. 
(1) Any EP meeting one or more of the following criteria may be 
excluded from the immunization registry reporting measure in paragraph 
(e)(10)(i)(B)(1) of this section if the EP:
    (i) Does not administer any immunizations to any of the populations 
for which data is collected by his or her jurisdiction's immunization 
registry or immunization information system during the EHR reporting 
period.
    (ii) Operates in a jurisdiction for which no immunization registry 
or immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of his or 
her EHR reporting period.
    (iii) Operates in a jurisdiction in which no immunization registry 
or immunization information system has declared readiness to receive 
immunization data from the EP at the start of the EHR reporting period.
    (2) Any EP meeting one or more of the following criteria may be 
excluded from the syndromic surveillance reporting measure described in 
paragraph (e)(10)(i)(B)(2) of the section if the EP:
    (i) Is not in a category of providers from which ambulatory 
syndromic surveillance data is collected by their jurisdiction's 
syndromic surveillance system;
    (ii) Operates in a jurisdiction for which no public health agency 
is capable of receiving electronic syndromic surveillance data from EPs 
in the specific standards required to meet the CEHRT definition at the 
start of the EHR reporting period.
    (iii) Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from EPs at 
the start of the EHR reporting period.
    (3) Any EP who meets one or more of the following criteria may be 
excluded from the specialized registry reporting measure described in 
paragraph (e)(10)(i)(B)(3) of this section if the EP:
    (i) Does not diagnose or treat any disease or condition associated 
with or collect relevant data that is required by a specialized 
registry in their jurisdiction during the EHR reporting period;
    (ii) Operates in a jurisdiction for which no specialized 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
    (iii) Operates in a jurisdiction where no specialized registry for 
which the EP is eligible has declared readiness to receive electronic 
registry transactions at the beginning of the EHR reporting period.
    (D) Alternate specifications. An EP previously scheduled to be in 
Stage 1 in 2015 may choose from measures 1 through 3 (as specified in 
paragraphs (e)(10)(i)(B)(1) through (3) of this section) and must 
successfully attest to any one measure in accordance with applicable 
law and practice for an EHR reporting period in 2015.
    (ii) Eligible hospital and CAH Public Health and Clinical Data 
Registry reporting objective. (A) Objective. The eligible hospital or 
CAH is in active engagement with a public health agency to submit 
electronic public health data from CEHRT, except where prohibited, and 
in accordance with applicable law and practice.
    (B) Measures. In order to meet the objective under paragraph 
(e)(10)(ii)(A) of this section, an eligible hospital or CAH must choose 
from measures 1 through 4 (as described in paragraphs (e)(10)(ii)(B)(1) 
through (4) of this section) and must successfully attest to any 
combination of three measures. These measures may be met by any 
combination, including meeting the measure specified in paragraph 
(e)(10)(ii)(B)(3) 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.
    (2) Syndromic surveillance reporting. The eligible hospital or CAH 
is in active engagement with a public health agency to submit syndromic 
surveillance data
    (3) Specialized registry reporting. The eligible hospital or CAH is 
in active engagement to submit data to a specialized registry.
    (4) 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.

[[Page 62948]]

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

0
10. Section 495.24 is added to read as follows:


Sec.  495.24  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.  495.40(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 non-applicable 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 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 EPs who adopt, implement or upgrade in 
their first payment year. For Medicaid EPs who adopt, implement or 
upgrade its CEHRT 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) and (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:

[[Page 62949]]

    (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 non-applicable 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 CEHRT 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 CEHRT. A patient's record is maintained using 
CEHRT if sufficient data was entered in the CEHRT 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 CEHRT.
    (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 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 
addressing the security (including encryption) of data created or 
maintained by 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.
    (ii) Eligible hospital/CAH protect patient health information--(A) 
Objective. Protect electronic protected health information (ePHI) 
created or maintained by the 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 
addressing the security (including encryption) of data created or 
maintained by 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. (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 60 
percent of all permissible prescriptions written by the EP are queried 
for a drug formulary and transmitted electronically using 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 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 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 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 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-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

[[Page 62950]]

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 60 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--
    (1) More than 60 percent of medication orders created by authorized 
providers of the eligible hospital's or CAH's inpatient or emergency 
department (POS 21 or 23) during the EHR reporting period are recorded 
using computerized provider order entry;
    (2) More than 60 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) More than 60 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 
patients (or patient-authorized representative) with timely electronic 
access to their health information and patient-specific education.
    (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 the patient-authorized representative) is 
provided timely access to view online, download, and transmit his or 
her health information; and
    (ii) The provider ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the API in the provider's CEHRT.
    (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)(5)(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)(5)(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 
patients (or patient-authorized representative) with timely electronic 
access to their health information and patient-specific education.
    (B) Measures. Eligible hospitals and CAHs must meet the following 
two measures:
    (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):
    (i) The patient (or patient-authorized representative) is provided 
timely access to view online, download, and transmit his or her health 
information; and
    (ii) The provider ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the API in the provider's CEHRT.
    (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)(5)(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 
CEHRT 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)(6)(i)(B)(1), (2), and (3) of this section except those measures for 
which an EP qualifies for an exclusion under paragraph (a)(3) of this 
section.
    (1) During the EHR reporting period, more than 10 percent of all 
unique patients (or their authorized representatives) seen by the EP 
actively engage with the electronic health record made accessible by 
the provider and either of the following:
    (i) View, download or transmit to a third party their health 
information;
    (ii) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii).

[[Page 62951]]

    (iv) For an EHR reporting period in 2017 only, an EP may meet a 
threshold of 5 percent instead of 10 percent for the measure at 
paragraph (d)(6)(i)(B)(1) of this section.
    (2) During the EHR reporting period--
    (i) For an EHR reporting period in 2017 only, for more than 5 
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; or
    (ii) For an EHR reporting period other than 2017, for more than 25 
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 CEHRT for more than 5 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)(6)(i)(B)(1), (2), 
and (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)(6)(i)(B)(1), (2), and (3) of this section.
    (ii) Eligible hospital and CAH coordination of care through patient 
engagement--(A) Objective. Use CEHRT 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)(6)(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 10 percent of all 
unique patients (or their authorized representatives) 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 and one of the following:
    (i) View, download or transmit to a third party their health 
information.
    (ii) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT.
    (iii) A combination of paragraphs (d)(6)(ii)(B)(1)(i) and (ii).
    (iv) For an EHR reporting period in 2017, an eligible hospital or 
CAH may meet a threshold of 5 percent instead of 10 percent for the 
measure at paragraph (d)(6)(ii)(B)(1) of this section.
    (2) During the EHR reporting period--
    (i) For an EHR reporting period in 2017 only, for more than 5 
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 (or their authorized representatives).
    (ii) For an EHR reporting period other than 2017, for more than 25 
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 (or their authorized representatives).
    (3) Patient generated health data or data from a non-clinical 
setting is incorporated into the CEHRT for more than 5 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. 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), (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, 
receives or retrieves a summary of care record upon the receipt of a 
transition or referral or 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 CEHRT.
    (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)(7)(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.
    (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 two of 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) Any EP who transfers a patient to another setting or refers a 
patient to another provider less than 100 times during the EHR 
reporting period must be excluded from paragraph (d)(7)(i)(B)(1) of 
this section.
    (2) Any EP 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 may be excluded from paragraphs (d)(7)(i)(B)(2) and 
(d)(7)(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 62952]]

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 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, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or 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 CEHRT.
    (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)(7)(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 two of 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 received 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)(7)(i)(B)(2) and 
(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)(7)(ii)(B)(1), and (2) 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 
or clinical data registry to submit electronic public health data in a 
meaningful way using CEHRT, 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 two 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 an urgent care setting
    (3) Electronic 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 as of 6 months prior to 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) Is not in a category of providers from which ambulatory 
syndromic surveillance data is collected by their jurisdiction's 
syndromic surveillance system.
    (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 from EPs as 
of 6 months prior to 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 as of 6 
months prior to 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 62953]]

    (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, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start of the EHR reporting period.
    (5) Any EP meeting at least one of the following criteria may be 
excluded from the clinical data registry reporting measure specified in 
paragraph (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 
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, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start 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 CEHRT, 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 (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 urgent care setting.
    (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 as of 6 months prior to 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 from eligible 
hospitals or CAHs as of 6 months prior to 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 as of 6 
months prior to 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 EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start of the EHR reporting period.
    (5) Any eligible hospital or CAH meeting at least one of the 
following criteria may be excluded from the clinical data registry 
reporting measure specified in paragraph (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.

[[Page 62954]]

    (ii) Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the EHR reporting period.
    (iii) Operates in a jurisdiction where no clinical data registry 
for which the EP, eligible hospital, or CAH is eligible has declared 
readiness to receive electronic registry transactions as of 6 months 
prior to the start 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 
from an eligible hospital or CAH as of 6 months prior to the start of 
the EHR reporting period.

0
11. Newly redesignated Sec.  495.40 is amended by:
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.  495.20 or Sec.  495.24''.
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.  495.20 or Sec.  495.24''.
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.  495.20 or Sec.  495.24 and Sec.  495.40''.
0
d. Revising paragraph (a)(2)(i)(B).
0
e. In paragraph (a)(2)(i)(D) by removing the cross-reference ``under 
Sec.  495.6(a)(4) or (h)(3)'' and adding in its place the cross-
reference ``in Sec.  495.20(a)(4) or (h)(3)''.
0
f. Adding paragraphs (a)(2)(i)(E) and (F).
0
g. 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.  495.20 or Sec.  495.24 and Sec.  495.40''.
0
h. 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.  495.20 or Sec.  495.24''.
0
i. Redesignating paragraph (b)(1)(iv) as paragraph (b)(1)(iii).
    j. 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.  495.20 or Sec.  
495.24 and Sec.  495.40''.
0
k. Revising paragraph (b)(2)(i)(B).
0
l. In paragraph (b)(2)(i)(D) by removing the cross-reference ``under 
Sec.  495.6(b)(4) or (i)(3)'' and adding in its place the cross-
reference ``in Sec.  495.20(b)(4) or (h)(3)''.
0
m. Adding paragraphs (b)(2)(i)(E), (F), and (G).
    The revisions and additions read as follows:


Sec.  495.40  Demonstration of meaningful use criteria.

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


Sec.  495.310  [Amended]

0
12. Section 495.310(d) is amended by removing the reference ``Sec.  
495.10 of this part'' and adding in its place the reference ``Sec.  
495.60''.
0
13. Section 495.316 is amended by:
0
a. Revising paragraph (c) introductory text.
0
b. In paragraphs (d)(1)(i) and (iii) removing the phrase ``The number, 
type, and practice location(s) of providers'' and adding in its place 
``The number and type of providers''.
0
c. 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 CEHRT, subject to CMS prior 
approval, but only with respect to the public health and clinical data 
registry reporting objective described in Sec.  495.24(d)(8).
* * * * *
    (f) Each State must submit to CMS the annual report described in 
paragraph (c) of this section within 60 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.

[[Page 62955]]

    (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.
    14. Section 495.352 is revised to read as follows:


Sec.  495.352  Reporting requirements.

    (a) Beginning with the first quarter of calendar year 2016, each 
State must submit to HHS on a quarterly basis a progress report, in the 
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 CEHRT 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 CEHRT and the amounts of incentive payments.
    (c) States must submit the quarterly progress reports described in 
this section within 30 days after the end of each federal fiscal year 
quarter.

    Dated: September 23, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 25, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-25595 Filed 10-6-15; 4:15 pm]
 BILLING CODE 4120-01-P