80 FR 62761 - Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 200 (October 16, 2015)
Page Range
62761-62955
FR Document
2015-25595
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.
Federal Register, Volume 80 Issue 200 (Friday, October 16, 2015)
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62761-62955]
From the Federal Register Online [www.thefederalregister.org]
[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
[[Page 62762]]
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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.thefederalregister.org/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
[[Page 62764]]
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.
[[Page 62765]]
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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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.
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\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.
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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.