[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Rules and Regulations]
[Pages 53968-54162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21050]
[[Page 53967]]
Vol. 77
Tuesday,
No. 171
September 4, 2012
Part II
Department of Health and Human Services
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45 CFR Part 170
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Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 413, and 495
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program--Stage 2; Health Information Technology: Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology;
Final Rules
Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 /
Rules and Regulations
[[Page 53968]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, and 495
[CMS-0044-F]
RIN 0938-AQ84
Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Stage 2
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule specifies the Stage 2 criteria that eligible
professionals (EPs), eligible hospitals, and critical access hospitals
(CAHs) must meet in order to qualify for Medicare and/or Medicaid
electronic health record (EHR) incentive payments. In addition, it
specifies payment adjustments under Medicare for covered professional
services and hospital services provided by EPs, eligible hospitals, and
CAHs failing to demonstrate meaningful use of certified EHR technology
(CEHRT) and other program participation requirements. This final rule
revises certain Stage 1 criteria, as finalized in the July 28, 2010
final rule, as well as criteria that apply regardless of Stage.
DATES: Effective dates: This final rule is effective on November 5,
2012, with the exception of the definition of ``meaningful EHR user''
in Sec. 495.4 and the provisions in Sec. 495.6(f), Sec. 495.6(g),
Sec. 495.8, Sec. 495.102(c), and part 495 subpart D, which are
effective September 4, 2012.
Applicability dates: Sections 495.302, 495.304, and 495.306 are
applicable beginning payment year 2013.
FOR FURTHER INFORMATION CONTACT: Elizabeth Holland, (410) 786-1309, or
Robert Anthony, (410) 786-6183, EHR Incentive Program issues or
Administrative appeals process issues. David Koppel, (410) 786-3255,
for Medicaid Incentive Program issues. Frank Szeflinski, (303) 844-
7119, for Medicare Advantage issues. Travis Broome, (214) 767-4450,
Medicare payment adjustment issues. Douglas Brown, (410) 786-0028, or
Maria Michaels, (410) 786-2809 for Clinical quality measures issues.
SUPPLEMENTARY INFORMATION:
Acronyms
ARRA American Recovery and Reinvestment Act of 2009
AAC Average Allowable Cost (of CEHRT)
ACO Accountable Care Organization
AIU Adopt, Implement, Upgrade (CEHRT)
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CCN CMS Certification Number
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
CPOE Computerized Provider Order Entry
CQM Clinical Quality Measure
CY Calendar Year
EHR Electronic Health Record
EP Eligible Professional
EPO Exclusive Provider Organization
FACA Federal Advisory Committee Act
FFP Federal Financial Participation
FFY Federal Fiscal Year
FFS Fee-For-Service
FQHC Federally Qualified Health Center
FTE Full-Time Equivalent
FY Fiscal Year
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIE Health Information Exchange
HIT Health Information Technology
HITPC Health Information Technology Policy Committee
HIPAA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical
Health Act
HMO Health Maintenance Organization
HOS Health Outcomes Survey
HPSA Health Professional Shortage Area
HRSA Health Resource and Services Administration
IAPD Implementation Advance Planning Document
ICR Information Collection Requirement
IHS Indian Health Service
IPA Independent Practice Association
IT Information Technology
LOINC Logical Observation Identifiers and Codes System
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAO Medicare Advantage Organization
MCO Managed Care Organization
MITA Medicaid Information Technology Architecture
MMIS Medicaid Management Information Systems
MSA Medical Savings Account
NAAC Net Average Allowable Cost (of CEHRT)
NCQA National Committee for Quality Assurance
NCVHS National Committee on Vital and Health Statistics
NPI National Provider Identifier
NPRM Notice of Proposed Rulemaking
ONC Office of the National Coordinator for Health Information
Technology
PAHP Prepaid Ambulatory Health Plan
PAPD Planning Advance Planning Document
PCP Primary Care Provider
PECOS Provider Enrollment, Chain, and Ownership System
PFFS Private Fee-For-Service
PHO Physician Hospital Organization
PHR Personal Health Record
PHS Public Health Service
PHSA Public Health Service Act
PIHP Prepaid Inpatient Health Plan
POS Place of Service
PPO Preferred Provider Organization
PQRS Physician Quality Reporting System
PSO Provider Sponsored Organization
RHC Rural Health Clinic
RPPO Regional Preferred Provider Organization
SAMHSA Substance Abuse and Mental Health Services Administration
SMHP State Medicaid Health Information Technology Plan
TIN Tax Identification Number
Table of Contents
I. Executive Summary and Overview
A. Executive Summary
1. Purpose of Regulatory Action
a. Need for the Regulatory Action
b. Legal Authority for the Regulatory Action
2. Summary of Major Provisions
a. Stage 2 Meaningful Use Objectives and Measures
b. Reporting on Clinical Quality Measures (CQMs)
c. Payment Adjustments and Exceptions
d. Modifications to Medicaid EHR Incentive Program
e. Stage 2 Timeline Delay
3. Summary of Costs and Benefits
B. Overview of the HITECH Programs Created by the American
Recovery and Reinvestment Act of 2009
II. Provisions of the Proposed Regulations and Analysis of and
Responses to Public Comments
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
1. Uniform Definitions
2. Meaningful EHR User
3. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
b. Changes to Stage 1 Criteria for Meaningful Use
c. State Flexibility for Stage 2 of Meaningful Use
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
(1) Discussion of Whether Certain EPs, Eligible Hospitals or
CAHs can meet all Stage 2 Meaningful Use Objectives Given
Established Scopes of Practice
(2) EPs Practicing in Multiple Practices/Locations
(3) Discussion of the Reporting Requirements of the Measures
Associated with the Stage 2 Meaningful Use Objectives
B. Reporting on Clinical Quality Measures Using Certified EHRs
Technology by Eligible Professionals, Eligible Hospitals, and
Critical Access Hospitals
1. Time Periods for Reporting Clinical Quality Measures
2. Certification Requirements for Clinical Quality Measures
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3. Criteria for Selecting Clinical Quality Measures
4. Clinical Quality Measures for Eligible Professionals
a. Statutory and Other Considerations
b. Clinical Quality Measures for Eligible Professionals for CY
2013
c. Clinical Quality Measures for Eligible Professionals
Beginning With CY 2014
5. Reporting Methods for Clinical Quality Measures for Eligible
Professionals
a. Reporting Methods for Medicaid EPs
b. Reporting Methods for Medicare EPs in CY 2013
c. Reporting Methods for Medicare EPs Beginning With CY 2014
d. Group Reporting Option for Medicare and Medicaid Eligible
Professionals Beginning With CY 2014
6. Clinical Quality Measures for Eligible Hospitals and Critical
Access Hospitals
a. Statutory and Other Considerations
b. Clinical Quality Measures for Eligible Hospitals and CAHs for
FY 2013
7. Reporting Methods for Eligible Hospitals and Critical Access
Hospitals
a. Reporting Methods in FY 2013
b. Reporting Methods Beginning With FY 2014
c. Electronic Reporting of Clinical Quality Measures for
Medicaid Eligible Hospitals
C. Demonstration of Meaningful Use and Other Issues
1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
b. Methods for Demonstration of the Stage 2 Criteria of
Meaningful Use
c. Group Reporting Option of Meaningful Use Core and Menu
Objectives and Associated Measures for Medicare and Medicaid EPs
Beginning With CY 2014
2. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
3. Hospital-Based Eligible Professionals
4. Interaction With Other Programs
D. Medicare Fee-for-Service
1. General Background and Statutory Basis
2. Payment Adjustment Effective in CY 2015 and Subsequent Years
for EPs Who Are Not Meaningful Users of CEHRT for an Applicable
Reporting Period
a. Applicable Payment Adjustments in CY 2015 and Subsequent
Calendar Years for EPs Who Are Not Meaningful Users of CEHRT
b. EHR Reporting Period for Determining Whether an EP Is Subject
to the Payment Adjustment for CY 2015 and Subsequent Calendar Years
c. Exception to the Application of the Payment Adjustment to EPs
in CY 2015 and Subsequent Calendar Years
d. HPSA Bonus Technical Change
e. Payment Adjustment Not Applicable to Hospital-Based EPs
3. Incentive Market Basket Adjustment Effective in FY 2015 and
Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR
Users for an Applicable Reporting Period
a. Applicable Market Basket Adjustment for Eligible Hospitals
Who Are Not Meaningful EHR Users for FY 2015 and Subsequent FYs
b. EHR Reporting Period for Determining Whether a Hospital is
Subject to the Market Basket Adjustment for FY 2015 and Subsequent
FYs
c. Exception to the Application of the Market Adjustment to
Hospitals in FY 2015 and Subsequent FYs
d. Application of Market Basket Adjustment in FY 2015 and
Subsequent FYs to a State Operating Under a Payment Waiver Provided
by Section 1814(B)(3) of the Act
4. Reduction of Reasonable Cost Reimbursement in FY 2015 and
Subsequent Years for CAHs That Are Not Meaningful EHR Users
a. Applicable Reduction of Reasonable Cost Payment Reduction in
FY 2015 and Subsequent Years for CAHs That Are Not Meaningful EHR
Users
b. EHR Reporting Period for Determining Whether a CAH Is Subject
to the Applicable Reduction of Reasonable Cost Payment in FY 2015
and Subsequent Years
c. Exception to the Application of Reasonable Cost Payment
Reductions to CAHs in FY 2015 and Subsequent FYs
5. Administrative Review Process of Certain Electronic Health
Record Incentive Program Determinations
E. Medicare Advantage Organization Incentive Payments
1. Definition (Sec. 495.200)
2. Identification of Qualifying MA Organizations, MA-EPs and MA-
Affiliated Eligible Hospitals (Sec. 495.202)
3. Incentive Payments to Qualifying MA Organizations for
Qualifying MA EPs and Qualifying MA-Affiliated Eligible Hospitals
(Sec. 495.204)
a. Amount Payable to a Qualifying MA Organization for Its
Qualifying MA EPs
b. Increase in Incentive Payment for MA EPs Who Predominantly
Furnish Services in a Geographic Health Professional Shortage Area
(HPSA)
4. Avoiding Duplicate Payments
5. Payment Adjustments Effective in 2015 and Subsequent MA
Payment Adjustment Years (Sec. 495.211).
6. Reconsideration Process for MA Organizations
F. Revisions and Clarifications to the Medicaid EHR Incentive
Program
1. Net Average Allowable Costs
2. Eligibility Requirements for Children's Hospitals
3. Medicaid Professionals Program Eligibility
a. Calculating Patient Volume Requirements
b. Practices Predominately
4. Medicaid Hospital Incentive Payment Calculation
a. Discharge Related Amount
b. Acute Care Inpatient Bed Days and Discharges for the Medicaid
Share and Discharge- Related Amount
c. Hospitals Switching States
5. Hospital Demonstrations of Meaningful Use--Auditing and
Appeals
6. State Flexibility for Stage 2 of Meaningful Use
7. State Medicaid Health Information Technology Plan (SMHP) and
Implementation Advance Planning Document (IAPD)
a. Frequency of Health Information Technology (HIT)
Implementation Advanced Planning Document (IAPD) Updates
b. Requirements of States Transitioning From HIT Planning
Advanced Planning Documents (P-APDs) to HIT IAPDs
III. Waiver of Delay in Effective Date
IV. Collection of Information Requirements
A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.
495.6 and Sec. 495.8)
B. ICRs Regarding Qualifying MA Organizations (Sec. 495.210)
C. ICRs Regarding State Medicaid Agency and Medicaid EP and
Hospital Activities (Sec. 495.332 Through Sec. 495.344)
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
1. Overall Effects
a. Regulatory Flexibility Analysis and Small Entities
(1) Number of Small Entities
(2) Conclusion
b. Small Rural Hospitals
c. Unfunded Mandates Reform Act
d. Federalism
2. Effects on Eligible Professionals, Eligible Hospitals, and
CAHs
a. Background and Assumptions
b. Industry Costs and Adoption Rates
c. Costs of EHR Adoption for EPs
d. Costs of EHR Adoption for Eligible Hospitals
3. Medicare Incentive Program Costs
a. Medicare Eligible Professionals (EPs)
b. Medicare Eligible Hospitals and CAHs
c. Critical Access Hospitals (CAHs)
4. Medicaid Incentive Program Costs
a. Medicaid EPs
b. Medicaid Hospitals
5. Benefits For All EPs and All Eligible Hospitals
6. Benefits to Society
7. General Considerations
8. Summary
9. Explanation of Benefits and Savings Calculations
D. Accounting Statement
E. Conclusion
Regulations Text
I. Executive Summary and Overview
A. Executive Summary
1. Purpose of Regulatory Action
a. Rationale for the Regulatory Action
In this final rule the Secretary of the Department of Health and
Human Services (the Secretary) will specify Stage 2 criteria beginning
in 2014 that eligible professionals (EPs), eligible hospitals, and
critical access hospitals (CAHs) must meet in order to qualify for an
incentive payment, as well as introduce changes to the program timeline
and detail Medicare payment adjustments. Recommendations on Stage 2
criteria from the Health IT
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Policy Committee (HITPC), a Federal Advisory Committee that coordinates
industry and provider input regarding the Medicare and Medicaid
Electronic Health Record (EHR) Incentive Programs were substantially
adopted, with consideration of current program data for the Medicare
and Medicaid EHR Incentive Programs. Our current program data is
derived from two sources. First, data elements from the registration
and attestation process of those providers who have already registered
and attested to Stage 1 of meaningful use. This includes demographic
information about the provider, the Certified EHR Technology (CEHRT)
used by the provider and their performance on the meaningful use
objectives and measures. Second, we have information from thousands of
questions providers submitted about the EHR Incentive Programs. These
questions provide insights into the difficulties faced by providers and
also into the areas of the EHR Incentive Programs that warrant
additional clarification.
b. Legal Authority for the Regulatory Action
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L.
111-5) amended Titles XVIII and XIX of the Social Security Act (the
Act) to authorize incentive payments to EPs, eligible hospitals, and
CAHs, and Medicare Advantage (MA) organizations to promote the adoption
and meaningful use of 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, Medicare
Advantage (MA) organizations (for certain qualifying EPs and hospitals
that meaningfully use CEHRT), subsection (d) hospitals and critical
access hospitals (CAHs) respectively. Sections 1848(a)(7), 1853(l) and
(m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward
payment adjustments, beginning with calendar or fiscal year 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 Stage 1 final
rule (75 FR 44316 through 44317).
2. Summary of Major Provisions
a. Stage 2 Meaningful Use Objectives and Measures
In the Stage 1 final rule we outlined Stage 1 meaningful use
criteria, we finalized a separate set of core objectives and menu
objectives for EPs, eligible hospitals and CAHs. EPs and hospitals must
meet the measure or qualify for an exclusion to all 15 core objectives
and 5 out of the 10 menu objectives in order to qualify for an EHR
incentive payment. In this final rule, we maintain the same core-menu
structure for the program for Stage 2. We are finalizing that EPs must
meet the measure or qualify for an exclusion to 17 core objectives and
3 of 6 menu objectives. We are finalizing that eligible hospitals and
CAHs must meet the measure or qualify for an exclusion to 16 core
objectives and 3 of 6 menu objectives. Nearly all of the Stage 1 core
and menu objectives are retained for Stage 2. The ``exchange of key
clinical information'' core objective from Stage 1 was re-evaluated in
favor of a more robust ``transitions of care'' core objective in Stage
2, and the ``Provide patients with an electronic copy of their health
information'' objective was removed because it was replaced by a ``view
online, download, and transmit'' core objective. There are also
multiple Stage 1 objectives that were combined into more unified Stage
2 objectives, with a subsequent rise in the measure threshold that
providers must achieve for each objective that has been retained from
Stage 1.
b. Reporting on Clinical Quality Measures (CQMs)
EPs, eligible hospitals, and CAHs are required to report on
specified clinical quality measures in order to qualify for incentive
payments under the Medicare and Medicaid EHR Incentive Programs. This
final rule outlines a process by which EPs, eligible hospitals, and
CAHs will submit CQM data electronically, reducing the associated
burden of reporting on quality measures for providers. EPs will submit
9 CQMs from at least 3 of the National Quality Strategy domains out of
a potential list of 64 CQMs across 6 domains. We are recommending a
core set of 9 CQMs focusing on adult populations with a particular
focus on controlling blood pressure. We are also recommending a core
set of 9 CQMs for pediatric populations. EPs should report on these
recommended CQMs if they are representative of their clinical practice
and patient population. Eligible hospitals and CAHs will submit 16 CQMs
from at least 3 of the National Quality Strategy domains out of a
potential list of 29 CQMs across 6 domains. For the Medicare EHR
Incentive Program, EPs, eligible hospitals, and CAHs in their first
year of demonstrating meaningful use must submit their CQM data via
attestation, and those beyond their first year must submit their CQM
data electronically via a CMS-designated transmission method. For EPs,
this includes an aggregate electronic submission or a patient-level
electronic submission through the method specified by the Physician
Quality Reporting System (PQRS) that would provide one submission for
credit in both the PQRS and Medicare EHR Incentive Program. For
eligible hospitals and CAHs, this includes an aggregate electronic
submission or a patient-level data submission through the method
similar to the Medicare EHR Incentive Program Electronic Reporting
Pilot, which is proposed for extension in the CY 2013 Hospital
Outpatient Prospective Payment System (OPPS) proposed rule (July 30,
2012, 77 FR 45188). For electronic submissions, patient-level data must
be submitted using the Quality Reporting Data Architecture (QRDA)
Category I format, and aggregate-level data must be submitted using the
QRDA Category III format.
c. Payment Adjustments and Exceptions
Medicare payment adjustments are required by statute to take effect
in 2015. We are finalizing a process by which payment adjustments will
be determined by a prior reporting period. Therefore, we specify that
EPs and eligible hospitals that are meaningful EHR users in 2013 will
avoid payment adjustment in 2015. Also, if such providers first meet
meaningful use in 2014, they will avoid the 2015 payment adjustment, if
they are able to demonstrate meaningful use at least 3 months prior to
the end of the calendar (for EPs) or fiscal year (for eligible
hospitals) and meet the registration and attestation requirement by
July 1, 2014 (for eligible hospitals) or October 1, 2014 (for EPs).
We also are finalizing exceptions to these payment adjustments.
This final rule outlines four categories of exceptions based on (1) the
lack of availability of internet access or barriers to obtaining IT
infrastructure; (2) a time-limited exception for newly practicing EPs
or new hospitals that will not otherwise be able to avoid payment
adjustments; (3) unforeseen circumstances such as natural disasters
that will be handled on a case-by-case basis; and (4) (EP only)
exceptions due to a combination of clinical features
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limiting a provider's interaction with patients or, if the EP practices
at multiple locations, lack of control over the availability of CEHRT
at practice locations constituting 50 percent or more of their
encounters.
d. Modifications to Medicaid EHR Incentive Program
We are expanding the definition of what constitutes a Medicaid
patient encounter, which is a required eligibility threshold for the
Medicaid EHR Incentive Programs. We include encounters for individuals
enrolled in a Medicaid program, including Title XXI-funded Medicaid
expansion encounters (but not separate Children's Health Insurance
Programs (CHIPs)). We also specify flexibility in the lookback period
for patient volume to be over the 12 months preceding attestation, not
tied to the prior calendar year.
We are also making eligible approximately 12 additional children's
hospitals that have not been able to participate to date, despite
meeting all other eligibility criteria, because they do not have a CMS
Certification Number since they do not bill Medicare.
These changes would take effect beginning with payment year 2013.
e. Stage 2 Timeline Delay
Lastly, we are finalizing a delay in the implementation of the
onset of Stage 2 criteria. In the Stage 1 final rule, we established
that any provider who first attested to Stage 1 criteria in 2011 would
begin using Stage 2 criteria in 2013. This final rule delays the onset
of those Stage 2 criteria until 2014, which we believe provides the
needed time for vendors to develop CEHRT. We are also introducing a
special 3-month EHR reporting period, rather than a full year of
reporting, for providers attesting to either Stage 1 or Stage 2 in 2014
in order to allow time for providers to implement newly certified
CEHRT. In future years, providers who are not in their initial year of
demonstrating meaningful use must meet criteria for 12-month reporting
periods. The 3-month reporting period allows providers flexibility in
their first year of meeting Stage 2 without warranting any delay for
Stage 3. This policy is consistent with CMS's commitment to ensure that
Stage 3 occurs on schedule (implemented by 2016).
3. Summary of Costs and Benefits
This final rule is anticipated to have an annual effect on the
economy of $100 million or more, making it an economically significant
rule under the Executive Order and a major rule under the Congressional
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis
that to the best of our ability presents the costs and benefits of the
final rule. The total Federal cost of the Medicare and Medicaid EHR
Incentive Programs between 2014 and 2019 is estimated to be $15.4
billion (these estimates include net payment adjustments for Medicare
providers who do not achieve meaningful use in 2015 and subsequent
years in the amount of $2.1 billion). In this final rule we have not
quantified the overall benefits to the industry, nor to EPs, eligible
hospitals, or CAHs participating in the Medicare and Medicaid EHR
Incentive Programs. Information on the costs and benefits of adopting
systems specifically meeting the requirements for the EHR Incentive
Programs has not yet been collected and information on costs and
benefits overall is limited. Nonetheless, we believe there are
substantial benefits that can be obtained by eligible hospitals and
EPs, including reductions in medical recordkeeping costs, reductions in
repeat tests, decreases in length of stay, increased patient safety,
and reduced medical errors. There is evidence to support the cost-
saving benefits anticipated from wider adoption of EHRs.
TABLE 1--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the HITECH EHR Incentive Program. (Fiscal year)--
(in Billions)
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Medicare eligible Medicaid eligible
Fiscal year ------------------------------------------------------------------------ Total
Hospitals Professionals Hospitals Professionals
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2014............................................................... $2.1 $1.9 $0.6 $0.5 $5.10
2015............................................................... 1.8 1.9 0.4 0.8 4.90
2016............................................................... 1.2 0.6 0.5 0.8 3.10
2017............................................................... 0.2 0.1 0.5 0.7 1.50
2018............................................................... -0.1 -0.2 0.1 0.7 0.50
2019............................................................... 0.0 -0.2 0.0 0.5 0.30
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B. Overview of the HITECH Programs Created by the American Recovery and
Reinvestment Act of 2009
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L.
111-5) amended Titles XVIII and XIX of the Social Security Act (the
Act) to authorize incentive payments to EPs, eligible hospitals, and
CAHs, and Medicare Advantage (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 entitled ``Medicare
and Medicaid Programs; Electronic Health Record Incentive Program,''
that specified the Stage 1 criteria that EPs, eligible hospitals, and
CAHs must meet in order to qualify for an incentive payment,
calculation of the incentive payment amounts, and other program
participation requirements (hereinafter referred to as the Stage 1
final rule). (For a full explanation of the amendments made by ARRA,
see the Stage 1 final rule (75 FR 44316).) In that final rule, we also
detailed that the Medicare and Medicaid EHR Incentive Programs will
consist of 3 different stages of meaningful use requirements.
For Stage 1, CMS and the Office of the National Coordinator for
Health Information Technology (ONC) worked closely to ensure that the
definition of meaningful use of CEHRT and the standards and
certification criteria for CEHRT were coordinated. Current ONC
regulations may be found at 45 CFR part 170.
For Stage 2, CMS and ONC again worked together to align our
regulations.
In the March 7, 2012 Federal Register (77 FR 13698), we published a
proposed rule that specified the potential Stage 2 criteria that EPs,
eligible hospitals, and CAHs would have to meet in order to qualify for
Medicare and/or Medicaid EHR incentive payments (hereinafter referred
to as the Stage 2 proposed rule). In addition, the proposed rule --(1)
proposed payment adjustments under Medicare for covered professional
services and hospital services provided
[[Page 53972]]
by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful
use of CEHRT and other program participation requirements; and (2)
proposed the revision of certain Stage 1 criteria, as well as criteria
that apply regardless of stage.
In the April 18, 2012 Federal Register (77 FR 23193), we published
a document that corrected typographical and technical errors in the
March 7, 2012 Stage 2 proposed rule.
Simultaneously in the March 7, 2012 Federal Register (77 FR 13832),
ONC published its notice of proposed rulemaking titled Health
Information Technology: Standards, Implementation Specifications, and
Certification Criteria for Electronic Health Record Technology, 2014
Edition; Revisions to the Permanent Certification Program for Health
Information Technology. The notice of proposed rulemaking proposed
revisions to the initial set of standards, implementation
specifications, and certification criteria in ONC's July 28, 2010 final
rule as well as the adoption of new standards, implementation
specifications, and certification criteria.
We urge those interested in this final rule to also review the ONC
final rule on standards and implementation specifications for CEHRT.
Readers may also visit http://www.cms.hhs.gov/EHRincentiveprograms and
http://healthit.hhs.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
We received approximately 6,100 items of timely correspondence in
response to our Stage 2 proposed rule published in the March 7, 2012
Federal Register. We received some comments that were outside the scope
of the proposed rule and therefore are not addressed in this final
rule. Summaries of the timely public comments that are within the scope
of the Stage 2 proposed rule and our responses to those comments are
set forth in the various sections of this final rule under the
appropriate headings. We have generally organized those sections by
stating our proposals, summarizing and responding to the timely public
comments received, and describing our final policy.
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
1. Uniform Definitions
As discussed in the proposed rule, in the Stage 1 final rule, we
finalized many uniform definitions for the Medicare FFS, Medicare
Advantage (MA), and Medicaid EHR incentive programs. These definitions
are set forth in part 495 subpart A of the regulations, and we proposed
to maintain most of these definitions, including, for example,
``Certified EHR Technology (CEHRT),'' ``Qualified EHR,'' ``Payment
Year,'' and ``First, Second, Third, Fourth, Fifth, and Sixth Payment
Year.'' We noted in the Stage 2 proposed rule that our definitions of
``CEHRT'' and ``Qualified EHR'' incorporate the definitions adopted by
ONC, and to the extent that ONC's definitions are revised, our
definitions would also incorporate those changes. For these
definitions, we refer readers to ONC's standards and certification
criteria final rule that is published elsewhere in this issue of the
Federal Register.
We did not receive any comments on our proposal and will continue
to use the existing definitions in part 495 subpart A, except where
stated otherwise in this final rule.
We stated that we would revise the descriptions of the EHR
reporting period to clarify that providers who are demonstrating
meaningful use for the first time would have an EHR reporting period of
90 days regardless of payment year. We proposed to add definitions for
the applicable EHR reporting period that would be used in determining
the payment adjustments, as well as a definition of a payment
adjustment year.
A summary of the comments pertaining to the EHR reporting period,
the applicable EHR reporting period for determining the payment
adjustments, and the definition of a payment adjustment year, as well
as our responses to those comments, can be found in sections II.A.3.a
and II.D.2 of this final rule.
2. Meaningful EHR User
We proposed to include clinical quality measure reporting as part
of the definition of ``meaningful EHR user'' under Sec. 495.4 instead
of as a separate meaningful use objective under Sec. 495.6.
Comment: A few commenters suggested that this change would create
confusion, but the majority supported this change to alleviate
confusion caused by the current situation. Many comments discussed the
specifics of clinical quality measures.
Response: We appreciate the support expressed for the proposal. We
continue to believe that separating clinical quality measures from the
meaningful use objectives and measures in Sec. 495.6 will reduce
confusion and finalize the change as proposed. We address comments on
the specifics of clinical quality measures in section II.B of this
final rule. While clinical quality measure reporting will no longer be
listed as a separate objective and measure in Sec. 495.6, as it is now
incorporated in the definition of meaningful EHR user in Sec. 495.4,
it remains a condition for demonstrating meaningful use.
We proposed to revise the third paragraph of the definition of
meaningful EHR user at Sec. 495.4 to refer specifically to the payment
adjustments and read as follows: ``(3) To be considered a meaningful
EHR user, at least 50 percent of an EP's patient encounters during an
EHR reporting period for a payment year (or during an applicable EHR
reporting period for a payment adjustment year) must occur at a
practice/location or practices/locations equipped with CEHRT.'' We did
not receive any comments on this revision and we are finalizing it as
proposed.
3. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the
Congress identified the broad goal of expanding the use of EHRs through
the concept of meaningful use. Section 1903(t)(6)(C) of the Act also
requires that Medicaid providers adopt, implement, upgrade or
meaningfully use CEHRT if they are to receive incentives under Title
XIX. CEHRT used in a meaningful way is one piece of the broader HIT
infrastructure needed to reform the health care system and improve
health care quality, efficiency, and patient safety. This vision of
reforming the health care system and improving health care quality,
efficiency, and patient safety should inform the definition of
meaningful use.
As we explained in our Stage 1 meaningful use rule and again in our
Stage 2 proposed rule, we seek to balance the sometimes competing
considerations of health system advancement (for example, improving
health care quality, encouraging widespread EHR adoption, promoting
innovation) and minimizing burdens on health care providers given the
short timeframe available under the HITECH Act.
[[Page 53973]]
Based on public and stakeholder input received during our Stage 1
rule, we laid out a phased approach to meaningful use. Such a phased
approach encompasses reasonable criteria for meaningful use based on
currently available technology capabilities and provider practice
experience, and builds up to a more robust definition of meaningful use
as technology and capabilities evolve. The HITECH Act acknowledges the
need for this balance by granting the Secretary the discretion to
require more stringent measures of meaningful use over time.
Ultimately, consistent with other provisions of law, meaningful use of
CEHRT should result in health care that is patient centered, evidence-
based, prevention-oriented, efficient, and equitable.
Under this phased approach to meaningful use, we update the
criteria of meaningful use through staggered rulemaking. We published
the Stage 1 final rule (75 FR 44314) on July 28, 2010, and this rule
finalizes the criteria and other requirements for Stage 2. We currently
are planning at least one additional update, and anticipate finalizing
the Stage 3 criteria through additional rulemaking in early 2014 with
Stage 3 starting in 2016. The stages represent an initial graduated
approach to arriving at the ultimate goal.
The Stage 1 meaningful use criteria, consistent with other
provisions of Medicare and Medicaid law, focused on electronically
capturing health information in a structured format; using that
information to track key clinical conditions and communicating that
information for care coordination purposes (whether that information is
structured or unstructured, but in structured format whenever
feasible); implementing clinical decision support tools to facilitate
disease and medication management; using EHRs to engage patients and
families and reporting clinical quality measures and public health
information. Stage 1 focused heavily on establishing the
functionalities in CEHRT that will allow for continuous quality
improvement and ease of information exchange. By having these
functionalities in CEHRT at the onset of the program and requiring that
the EP, eligible hospital or CAH become familiar with them through the
varying levels of engagement required by Stage 1, we believe we created
a strong foundation to build on in later years. Though some
functionalities were optional in Stage 1, all of the functionalities
are considered crucial to maximize the value to the health care system
provided by CEHRT. We encouraged all EPs, eligible hospitals and CAHs
to be proactive in implementing all of the functionalities of Stage 1
in order to prepare for later stages of meaningful use, particularly
functionalities that improve patient care, the efficiency of the health
care system and public and population health. The specific criteria for
Stage 1 of meaningful use are discussed in the Stage 1 final rule,
published on July 28, 2010 (75 FR 44314 through 44588). We are
finalizing certain changes to the Stage 1 criteria in section II.A.3.b.
of this final rule.
Stage 2: We stated in the Stage 2 proposed rule that our
Stage 2 goals, consistent with other provisions of Medicare and
Medicaid law, would expand upon the Stage 1 criteria with a focus on
ensuring that the meaningful use of EHRs supports the aims and
priorities of the National Quality Strategy. Specifically, Stage 2
meaningful use criteria would encourage the use of health IT for
continuous quality improvement at the point of care and the exchange of
information in the most structured format possible. Our proposed Stage
2 meaningful use requirements included rigorous expectations for health
information exchange including: more demanding requirements for e-
prescribing; incorporating structured laboratory results; and the
expectation that providers will electronically transmit patient care
summaries with each other and with the patient to support transitions
in care. Increasingly robust expectations for health information
exchange in Stage 2 and Stage 3 would support the goal that information
follows the patient. In addition, as we forecasted in the Stage 1 final
rule, we proposed that nearly every objective that was optional for
Stage 1 would be part of the core for Stage 2.
Stage 3: We anticipate that Stage 3 meaningful use
criteria will focus on: promoting improvements in quality, safety and
efficiency leading to improved health outcomes; focusing on decision
support for national high priority conditions; patient access to self-
management tools; access to comprehensive patient data through robust,
secure, patient-centered health information exchange; and improving
population health. For Stage 3, we currently intend to propose higher
standards for meeting meaningful use. For example, we intend to propose
that every objective in the menu set for Stage 2 be included in Stage 3
as part of the core set. While the use of a menu set allows providers
flexibility in setting priorities for EHR implementation and takes into
account their unique circumstances, we maintain that all of the
objectives are crucial to building a strong foundation for health IT
and to meeting the objectives of the HITECH Act. In addition, as the
capabilities of HIT infrastructure increase, we may raise the
thresholds for these objectives in both Stage 2 and Stage 3.
In the Stage 1 final rule (75 FR 44323), we published the following
Table 2 with our expected timeline for the stages of meaningful use.
Table 2--Stage of Meaningful Use Criteria by Payment Year as Finalized in 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Payment year
First payment year --------------------------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011............................... Stage 1............... Stage 1............... Stage 2.............. Stage 2.............. TBD
2012............................... ...................... Stage 1............... Stage 1.............. Stage 2.............. TBD
2013............................... ...................... ...................... Stage 1.............. Stage 1.............. TBD
2014............................... ...................... ...................... ..................... Stage 1.............. TBD
--------------------------------------------------------------------------------------------------------------------------------------------------------
We proposed changes to this timeline as well as its extension
beyond 2014. As we explained in the Stage 2 proposed rule, under the
timeline used in Table 2, an EP, eligible hospital, or CAH that became
a meaningful EHR user for the first time in 2011 would need to begin
their EHR reporting period for Stage 2 on January 1, 2013 (EP) or
October 1, 2012 (eligible hospital or CAH). The HITPC recommended we
delay by 1 year the start of Stage 2 for providers who became
meaningful EHR users in 2011. We stated in the proposed rule that Stage
2 of meaningful use would require changes to both technology and
workflow that cannot reasonably be expected to be completed in the time
[[Page 53974]]
between the publication of the final rule and the start of the EHR
reporting periods as listed in Table 2. We noted the similar concerns
we have heard from other stakeholders and agreed that, based on our
proposed definition of meaningful use for Stage 2, providers could have
difficulty implementing these changes in time. Therefore, we proposed a
1-year extension of Stage 1 of meaningful use for providers who
successfully demonstrated meaningful use for 2011. Our proposed
timeline through 2021, which we finalize in this rule with a notation
of the special EHR reporting period in 2014, is displayed in Table 3.
We refer readers to section II.D.2 of this final rule for a discussion
of the applicable EHR reporting period that will be used to determine
whether providers are subject to payment adjustments.
Table 3--Stage of Meaningful Use Criteria by First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage of meaningful use
First payment year --------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011................................................. 1 1 1 *2 2 3 3 TBD TBD TBD TBD
2012................................................. ....... 1 1 *2 2 3 3 TBD TBD TBD TBD
2013................................................. ....... ....... 1 *1 2 2 3 3 TBD TBD TBD
2014................................................. ....... ....... ....... *1 1 2 2 3 3 TBD TBD
2015................................................. ....... ....... ....... ....... 1 1 2 2 3 3 TBD
2016................................................. ....... ....... ....... ....... ....... 1 1 2 2 3 3
2017................................................. ....... ....... ....... ....... ....... ....... 1 1 2 2 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
*3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at state option) for Medicaid EPs. All
providers in their first year in 2014 use any continuous 90-day EHR reporting period.
We explained in the proposed rule that the Medicare EHR incentive
program and the Medicaid EHR incentive program have different rules
regarding the number of payment years available, the last year for
which incentives may be received, and the last payment year for
initiating the program. The last year for which an EP and an eligible
hospital or CAH can begin receiving Medicare incentive payments is 2014
and 2015 respectively. These providers would begin in Stage 1 of
meaningful use. Medicaid EPs and eligible hospitals can receive a
Medicaid EHR incentive payment for ``adopting, implementing, and
upgrading'' (AIU) to CEHRT for their first payment year, which is not
reflected in Table 3. For example, a Medicaid EP who earns an incentive
payment for AIU in 2013 would have to meet Stage 1 of meaningful use in
his or her next 2 payment years (2014 and 2015). The applicable payment
years and the incentive payments available for each program are
discussed in the Stage 1 final rule.
If we anticipate future criteria beyond Stage 3 of meaningful use,
we expect to update Table 3 in the rulemaking for Stage 3, which
remains on schedule for implementation in 2016.
Comment: We received numerous comments, which represented a
significant majority of all comments received, on the timing of the
stages of meaningful use. Commenters asserted that the timeline is too
aggressive and will result in many providers being unable to meet Stage
2 of meaningful use, particularly those who first attested in 2011 and
2012. The most common justification for this claim was the lack of
sufficient time between the publication of this final rule and the time
when a provider who first attested to meaningful use in 2011 or 2012
would have to begin Stage 2 of meaningful use. Some commenters
suggested that the time was insufficient regardless of resource
constraints, while others suggested that currently vendors of CEHRT
lack the necessary capacity to make the necessary upgrades to their
CEHRT products and implement them for their customers in time.
Commenters also pointed to competing priorities and demands on provider
time and resources, such as the transition to ICD-10, the various
programs and policies under the Affordable Care Act and other
priorities that diminish the time and resources that can be devoted to
reaching Stage 2 of meaningful use. Commenters offered several
suggestions on how to increase the time available between publication
of this final rule and the EHR reporting periods in 2014. The
suggestions included using a shorter than full year EHR reporting
period in 2014, delaying the start of Stage 2 until 2015 and using a
shorter than full year EHR reporting period in 2015, and delaying the
start of Stage 2 until 2015 with a full year EHR reporting period.
Several commenters suggested a minimum of 18 months is needed, while
others suggested longer periods.
Response: While our proposal would provide more than a year between
the publication of this final rule and the first day any provider would
start their EHR reporting period in 2014 for any stage of meaningful
use, we agree that additional time to demonstrate meaningful use in
2014 would be helpful to providers, many of whom will need to upgrade
to new technology as well as ensure they are able to meet all of the
objectives and measures for Stage 2. In considering what would be an
appropriate length of time between publication of this final rule and
the start of the EHR reporting periods for providers in 2014 for either
Stage 2 or Stage 1, we weighed two primary factors against the comments
calling for a delay. The first is that by delaying Stage 2 until 2015,
the movement towards improved outcomes that is the main goal of
meaningful use would be put off by a full year. This full-year delay
would have a ripple effect through the timeline of the stages as
providers move along their own timelines across the stages of
meaningful use. For this reason, we will not delay Stage 2 until 2015,
but instead we are using a 3-month EHR reporting period in 2014 as the
first year any provider would attest to Stage 2. The second
consideration is the data integrity of meaningful use attestations and
clinical quality measure submissions, especially as it relates to our
efforts towards alignment with other programs such as PQRS, Medicare
Shared Savings Program (SSP), and potentially others. The more robust
data set provided by a full year reporting period offers more
opportunity for alignment than the data set provided by a shorter
reporting period, especially compared across years. By altering the
reporting period from year to year the data is less comparable from
year to year. However, we agree with commenters that the use of a
shorter EHR reporting period in 2014 is necessary to allow sufficient
time for vendors to upgrade their CEHRT and for
[[Page 53975]]
providers to implement it. In an effort to preserve some data validity
with similar Medicare quality measurement programs, we are finalizing
3-month quarter EHR reporting periods in 2014 for certain providers
that are beyond their first year of meaningful use, rather than any
continuous 90-day period within the year as for first-time meaningful
users. For more information on alignment with other programs, we refer
readers to our discussion on clinical quality measures (see section
II.B.1. of this final rule).
While commenters generally suggested a shorter EHR reporting period
for the start of Stage 2 in any year rather than just Stage 2 in 2014,
we believe that most of the reasons for a shorter period are due to the
time constraints for vendor certification, upgrades and provider
implementation between publication of this final rule and the beginning
of Stage 2 in 2014. Any provider starting Stage 2 after 2014 will have
more time and therefore most of the constraints are lifted. We
acknowledge that not all constraints go away, but we believe that the
balance is sufficiently shifted such that the concerns of data validity
and program alignment outweigh the few remaining concerns with a full
year EHR reporting period for the provider's first year of Stage 2 if
it is after 2014. In addition, since ONC's 2014 Edition certification
is for all EHR systems, regardless of the stage of meaningful use the
provider using that system is in, there are far fewer implementation
concerns after 2014. For example, if a provider begins Stage 2 in 2015,
that provider would have been required to use CEHRT (that was certified
to the 2014 Edition EHR certification criteria) for the previous year
(2014) for Stage 1.
Finally, we considered that for the Medicaid EHR incentive program,
EPs work exclusively with the states as they must choose between either
the Medicare or Medicaid EHR incentive program. We do not know whether
shifting from an EHR reporting period of any continuous 90 days to a 3-
month quarter will provide any alignment benefits for Medicaid EPs, and
it could introduce system complexity for Medicaid agencies. Therefore,
we are maintaining flexibility for states to allow Medicaid EPs to
select any continuous 90-day EHR reporting period during 2014 as
defined by the state Medicaid program, or, if the state so chooses, any
3-month calendar quarter in 2014. As nearly all hospitals participate
in both Medicare and Medicaid, we are using the 3-month quarter EHR
reporting period for all hospitals to align both programs.
After consideration of the public comments received, we are
modifying our proposal with regard to the EHR reporting periods for
EPs, eligible hospitals and CAHs that attest to meaningful use for 2014
for their first year of Stage 2 or their second year of Stage 1. Our
final policy is as follows: For 2014, Medicare EPs will attest using an
EHR reporting period of January 1, 2014 through March 31, 2014; April
1, 2014 through June 30, 2014; July 1, 2014 through September 30, 2014;
or October 1, 2014 through December 31, 2014. For 2014, Medicare and
Medicaid eligible hospitals and CAHs will attest using an EHR reporting
period of October 1, 2013 through December 31, 2013; January 1, 2014
through March 31, 2014; April 1, 2014 through June 30, 2014; or July 1,
2014 through September 30, 2014. Medicaid EPs will attest using an EHR
reporting period of any continuous 90-day period between January 1,
2014 and December 1, 2014 as defined by the state Medicaid program, or,
if the state so chooses, any 3-month calendar quarter in 2014.
b. Changes to Stage 1 Criteria for Meaningful Use
We proposed the following changes to the objectives and associated
measures for Stage 1:
Computerized Provider Order Entry (CPOE)--In 2013 (CY for
EPs, FY for eligible hospitals/CAHs), we proposed that providers in
Stage 1 could use the alternative denominator of the number of
medication orders created by the EP or in the eligible hospital's or
CAH's inpatient or emergency department (POS 21 or 23) during the EHR
reporting period (for further explanation of this alternative
denominator, see the discussion of the CPOE objective in the Stage 2
criteria section at II.A.3.d. of this final rule).
A provider seeking to meet Stage 1 in 2013 can use either the
denominator defined in the Stage 1 final rule or the alternative
denominator to calculate the percentage for the CPOE measure. We also
proposed to require the alternative denominator for Stage 1 beginning
in 2014.
Comment: Commenters both supported and opposed the new denominator
for CPOE. Those supporting the proposed denominator did so for its
simplicity and greater accuracy for measuring actual CPOE usage. Those
opposing the proposed denominator did so either because they were
concerned with the burden associated with counting paper or other
orders that are never entered into the EHR or because of the potential
higher performance required by the proposed denominator.
Response: We proposed the alternative denominator to alleviate the
burden associated with measurement, not to create a higher performance
threshold. As we stated in the proposed rule, feedback from many
providers indicated that the alternative denominator was more easily
measurable. In response to concerns from commenters, we are finalizing
the alternative denominator for this measure and specify that providers
at any year in Stage 1 may elect to use either the denominator defined
in the Stage 1 final rule or the alternative denominator to calculate
the percentage for the CPOE measure. In response to comments, we are
not requiring that the alternative denominator be used beginning in
2014, which will give providers who may find it difficult to measure
the flexibility to continue to use the denominator defined in the Stage
1 final rule.
Vital Signs--For the objective of record and chart changes
in vital signs, the proposed Stage 2 measure would allow an EP to split
the exclusion and exclude blood pressure only or height/weight only
(for more detail, see the discussion of this objective in the Stage 2
criteria section at II.A.3.d. of the final rule). We proposed an
identical change to the Stage 1 exclusion as well, starting in CY 2013.
We also proposed changing the age limitations on vital signs for Stage
2 (for more detail, see the discussion of this objective in the Stage 2
criteria section). We proposed an identical change to the age
limitations on vital signs for Stage 1, starting in 2013 (CY for EPs,
FY for eligible hospitals/CAHs). These changes to the exclusion and age
limitations were proposed as an alternative in 2013 to the current
Stage 1 requirements but required for Stage 1 beginning in 2014.
Comment: While some commenters suggested that these changes would
be confusing, most commenters supported the changes and indicated that
they would provide added flexibility for providers who seek to
incorporate the recording of this data into their clinical workflow.
These commenters also noted that the age change reflects best clinical
practices. Some commenters suggested removing BMI and growth charts
from the measure since there are no best practices on BMI for patients
under 3 years of age and since providers who would not record height
and weight would not be able to provide BMI or growth charts.
Response: We appreciate the support for these changes and finalize
them as proposed. We also note that BMI and
[[Page 53976]]
growth charts are not required to meet this measure but are instead a
capability provided by CEHRT. Providers who claim the exclusion for
height and weight will not have data for CEHRT to create either BMI or
growth charts and this will not affect their ability to meet the
measure of this objective.
Comment: Some commenters requested clarification on whether
providers who provide ancillary services and do not normally record any
of these elements as part of their regular scope of practice can claim
the exclusion.
Response: If a provider believes that height and weight and/or
blood pressure are relevant to their scope of practice, they must
record those data elements and cannot qualify for the exclusion. We
believe that most providers who provide ancillary services can meet the
measure of this objective by obtaining this information from a
referring provider and recording the necessary data in their CEHRT.
Comment: Some providers asked for clarification on whether
providers who only occasionally record height and weight and/or blood
pressure are still permitted to claim the exclusions for this measure.
Response: We recognize that there are situations in which certain
providers may only record height and weight and/or blood pressure for a
very limited number of patients (for example, high-risk surgical
patients or patients on certain types of medication) but do not
normally regard these data as relevant to their scope of practice. When
a provider does not believe that height and weight and/or blood
pressure are typically relevant to their scope of practice but still
records these vital signs only in exceptional circumstances, the
provider is permitted to claim the exclusions for this measure.
After consideration of the public comments received, we are
finalizing the changes to vital signs as proposed. We are making
technical corrections to the regulation text at Sec. 495.6(d)(8) and
Sec. 495.6(f)(7) to clarify these are alternatives in 2013 and
required beginning in 2014.
Exchange Key Clinical Information--As noted in the
proposed rule, the objective of ``capability to exchange key clinical
information'' has been surprisingly difficult for providers to
understand, which has made the objective difficult for most providers
to achieve. We solicited comment on several options for this objective
that we believed would reduce or eliminate the burden associated with
this objective or increase the value of the objective. The first option
we considered was removal of this objective. The second option was to
require that the test be successful. The third option was to eliminate
the objective, but require that providers select either the Stage 1
medication reconciliation objective or the Stage 1 summary of care at
transitions of care and referrals objective from the menu set. The
fourth option was to move from a test to one case of actual electronic
transmission of a summary of care document for a real patient either to
another provider of care at a transition or referral or to a patient
authorized entity. We proposed the first option to remove this
objective and measure from the Stage 1 core set beginning in 2013 (CY
for EPs, FY for eligible hospitals/CAHs), but we also stated we would
evaluate all four options in light of the public comments we received.
Comment: While we received feedback and support from commenters on
all of the proposed options, the majority of commenters supported the
elimination of this objective for Stage 1. Some commenters instead
supported a more exact definition of data exchange for this measure,
and other commenters supported additional elements or additional
requirements for exchange to be included as part of the measure. Other
proposals included implementing a system that would allow case-by-case
reporting of data exchange that would allow CMS to measure successes
and failures by provider, vendor, and other elements.
Response: We appreciate the many suggestions from commenters on
clarifying data exchange and/or adding requirements to the measure. We
also appreciate the suggestion of a case-by-case reporting system for
data exchange. However, we are concerned that all of these options
would not alleviate but actually increase the burden of this measure
for providers by requiring them to document and submit substantially
greater information than is currently required by attestation. While
such a burden may be justified, we do not believe it is in this case
because the Stage 2 requirements for actual electronic exchange of
summary of care records create sufficient incentive to begin testing in
Stage 1 without there being an explicit meaningful use requirement to
do so. Because of these concerns and in reaction to the opinion of most
commenters, we are finalizing the removal of this objective and measure
for Stage 1 beginning in 2013. Although some commenters suggested
removing this objective earlier, we do not believe the timing of
publication of this final rule would allow us to implement such a
change and allow consistent reporting for all providers in 2012.
Therefore, this objective and measure will be removed from the Stage 1
criteria beginning in 2013 (CY for EPs, FY for eligible hospitals and
CAHs).
View Online, Download, and Transmit--We proposed for Stage
2 a new method for making patient information available electronically,
which would enable patients to view online, download, and transmit
their health information and hospital admission information. We discuss
in the Stage 2 criteria section at II.A.3.d the ``view online,
download, and transmit'' objectives for EPs and hospitals. We noted in
the proposed rule that starting in 2014, CEHRT would no longer be
certified to the Stage 1 EP and hospital core objectives of providing
patients with electronic copies of their health information (Sec.
495.6(d)(12) and (f)(11)) or the Stage 1 hospital core objective of
providing patients with electronic copies of their discharge
instructions upon request (Sec. 495.6(f)(12)), nor would it support
the Stage 1 EP menu objective of providing patients with timely
electronic access to their health information (Sec. 495.6(e)(5)).
Therefore starting in 2014, for Stage 1, we proposed to replace these
objectives with the new ``view online, download and transmit''
objectives.
Comment: There were a number of commenters who asked for
clarifications regarding the requirements of these objectives. Other
commenters raised concerns regarding the implementation of these
objectives in both Stage 1 and Stage 2.
Response: We discuss the clarifications and concerns raised by
commenters in our Stage 2 criteria at II.A.3.d regarding these
objectives. Please refer to those discussions for additional
information.
Comment: Some commenters supported this change while other
commenters disagreed with it. Those who disagreed with the proposed
change indicated that providers would not be ready to implement online
access to health information in Stage 1, and that it was unlikely that
providers could convince more than 50 percent of patients to sign up
for online access within the Stage 1 reporting period. These commenters
suggested eliminating all of the Stage 1 objectives for providing
electronic copies of health information or discharge summaries and not
replacing these objectives with the ``view, download, and transmit''
objectives.
Response: We disagree that the Stage 1 objectives for providing
patients with electronic copies of their health information and
discharge instructions should be eliminated without replacing
[[Page 53977]]
these objectives with the ``view online, download, and transmit''
objectives. We believe patient access to their health information is an
important aspect of patient care and engagement, and we further believe
that the capabilities of CEHRT in 2014 and beyond will enable providers
to make this information available online in a way that does not impose
a significant burden on providers.
We note that only the first measure of the ``view online, download,
and transmit'' objectives would be required for Stage 1. This means
that providers would only have to make information available online to
view online, download, and transmit for more than 50 percent of all
unique patients during the EHR reporting period in order to meet the
measure. We further clarify that providers are only required to make
this information available online to view online, download, and
transmit and that patients who do not access the information or would
not affect whether or not the provider is able to meet the measure. For
Stage 1, providers are not required to meet the second measure of more
than 5 percent of patients view online, download, or transmit to a
third party their health or hospital admission information. Providers
are only required to meet the second measure of the objectives in Stage
2. However, the exclusions for these objectives are available for
providers in Stage 1. Therefore, we are finalizing our proposal to
replace the existing Stage 1 EP and hospital objectives listed above
with the ``view online, download, and transmit'' objectives beginning
in 2014 for Stage 1. We are making a technical correction to the
regulations text to clarify that the existing Stage 1 objective at
Sec. 495.6(f)(11) is being replaced. We clarify in Table 4 the four
existing Stage 1 objectives that are being replaced. We are also making
a technical correction to the regulation text to remove the existing
exclusion for the objective at Sec. 495.6(f)(12)(iii) beginning in
2014 because the objective that this exclusion applies to is being
replaced.
Removing CQM Reporting from Stage 1 Objectives--We
proposed a revised definition of a meaningful EHR user at Sec. 495.4
which would incorporate the requirement to submit clinical quality
measures, as discussed in section II.A.2 of this final rule. We also
proposed to remove the objective to submit clinical quality measures
from Sec. 495.6 beginning in 2013 for Stage 1 to conform with this
change in the definition of a meaningful EHR user.
Comment: While some commenters indicated that this change would be
confusing, most commenters supported this change.
Response: We appreciate the support of commenters and believe that
removing the objective will actually alleviate confusion. Therefore, as
discussed earlier in II.A.2. of this final rule, we are finalizing as
proposed, the revised definition of a meaningful EHR user at Sec.
495.4 to include clinical quality measure submission, as well as the
removal of this objective from Sec. 495.6 beginning in 2013.
Public Health Objectives--For the Stage 1 public health
objectives, beginning in 2013, we proposed to add ``except where
prohibited'' to the regulation text in order to encourage all EPs,
eligible hospitals, and CAHs to submit electronic immunization data,
even when not required by state/local law. Therefore, if they are
authorized to submit the data, they should do so even if it is not
required by either law or practice. There are a few instances where
some EPs, eligible hospitals, and CAHs are prohibited from submitting
to a state/local immunization registry. For example, in sovereign
tribal areas that do not permit transmission to an immunization
registry or when the immunization registry only accepts data from
certain age groups (for example, adults).
Comment: Some commenters supported this change while others
disagreed with it. A number of commenters interpreted the proposed
addition of language as a change to either the measure of the
objectives or the exclusions that are currently in place.
Response: As noted in the proposed rule, the addition of this
language was intended to ensure that providers who are not required by
law or practice to submit data would do so and to make it clear that
EPs, eligible hospitals, and CAHs that are prohibited from submitting
data would not be required to submit such data. Immunizations was used
as a descriptive example in the proposed rule, but this change applies
to all Stage 1 public health objectives. The exclusions provided for
these objectives in Stage 1 are not affected by the addition of this
language and remain in place for all providers. Therefore, we are
finalizing the addition of this language as proposed.
Menu Set Exclusions Policy--We proposed to change the
policy on menu set exclusions for Stage 1 beginning in 2014. Please see
section II.A.3.d. of this final rule for a discussion of the proposal
and our final policy.
Electronic Prescribing
Comment: We received comments pointing out that we proposed a new
exclusion for electronic prescribing objective for Stage 2 regarding
the availability of pharmacies that can accept electronic
prescriptions. These commenters noted that if this exclusion was not
also made available for Stage 1 then it would create a strange scenario
where an EP might have to electronically prescribe during their 2 years
of Stage 1 and then meet an exclusion in Stage 2.
Response: We agree that it makes no sense to apply this exclusion
to e-prescribing in Stage 2, but not in Stage 1. We consider it an
oversight of our proposed rule that we did not include that exclusion
in our proposed changes to the Stage 1 criteria. We are finalizing an
exclusion for the e-prescribing objective in Stage 2 for any EP who
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/her EHR reporting period. We
are also finalizing the addition of this exclusion to Stage 1 starting
in CY 2013.
Table 4--Stage 1 Changes
------------------------------------------------------------------------
Effective year
Stage 1 objective Final changes (CY/FY)
------------------------------------------------------------------------
Use CPOE for medication orders Change: Addition of an 2013 [dash]
directly entered by any alternative measure Onward
licensed healthcare More than 30 percent (Optional).
professional who can enter of medication orders
orders into the medical created by the EP or
record per state, local and authorized providers
professional guidelines. of the eligible
hospital's or CAH's
inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period are recorded
using CPOE.
[[Page 53978]]
Generate and transmit Change: Addition of an 2013--Onward
permissible prescriptions additional exclusion (Required).
electronically (eRx). Any EP who: 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/her
EHR reporting period.
Record and chart changes in Change: Addition of 2013 Only
vital signs. alternative age (Optional).
limitations More than
50 percent of all
unique patients seen
by the EP or admitted
to the eligible
hospital's or CAH's
inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period have blood
pressure (for
patients age 3 and
over only) and height
and weight (for all
ages) recorded as
structured data.
Record and chart changes in Change: Addition of 2013 Only
vital signs. alternative (Optional).
exclusions.
Any EP who
(1) Sees no patients 3
years or older is
excluded from
recording blood
pressure;
(2) Believes that all
three vital signs of
height, weight, and
blood pressure have
no relevance to their
scope of practice is
excluded from
recording them;
(3) Believes that
height and weight are
relevant to their
scope of practice,
but blood pressure is
not, is excluded from
recording blood
pressure; or
(4) Believes that
blood pressure is
relevant to their
scope of practice,
but height and weight
are not, is excluded
from recording height
and weight.
Record and chart changes in Change: Age 2014--Onward
vital signs. limitations on (Required).
height, weight and
blood pressure.
More than 50 percent
of all unique
patients seen by the
EP or admitted to the
eligible hospital's
or CAH's inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period have blood
pressure (for
patients age 3 and
over only) and height
and weight (for all
ages) recorded as
structured data.
Record and chart changes in Change: Changing the 2014--Onward
vital signs. age and splitting the (Required).
EP exclusion.
Any EP who
(1) Sees no patients 3
years or older is
excluded from
recording blood
pressure;
(2) Believes that all
three vital signs of
height, weight, and
blood pressure have
no relevance to their
scope of practice is
excluded from
recording them;
(3) Believes that
height and weight are
relevant to their
scope of practice,
but blood pressure is
not, is excluded from
recording blood
pressure; or
(4) Believes that
blood pressure is
relevant to their
scope of practice,
but height and weight
are not, is excluded
from recording height
and weight.
Capability to exchange key Change: Objective is 2013--Onward
clinical information (for no longer required. (Required).
example, problem list,
medication list, medication
allergies, and diagnostic
test results), among
providers of care and patient
authorized entities
electronically.
Report ambulatory (hospital) Change: Objective is 2013--Onward
clinical quality measures to incorporated directly (Required).
CMS or the states. into the definition
of a meaningful EHR
user and eliminated
as an objective under
Sec. 495.6.
EP and Hospital Objectives: Change: Replace these 2014--Onward
Provide patients with an four objectives with (Required).
electronic copy of their the Stage 2 objective
health information (including and one of the two
diagnostics test results, Stage 2 measures..
problem list, medication
lists, medication allergies,
discharge summary,
procedures) upon request.
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: 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.
[[Page 53979]]
Hospital Objective: Provide Hospital Objective:
patients with an electronic Provide patients the
copy of their discharge ability to view
instructions at time of online, download, and
discharge, upon request. transmit information
about a hospital
admission.
EP Objective: Provide patients Hospital Measure: More
with timely electronic access than 50 percent of
to their health information all patients who are
(including lab results, discharged from the
problem list, medicatiion inpatient or
lists, and allergies) within emergency department
4 business days of the (POS 21 or 23) of an
information being available eligible hospital or
to the EP.. CAH have their
information available
online within 36
hours of discharge.
Public Health Objectives: Change: Addition of 2013--Onward
``except where (Required).
prohibited'' to the
objective regulation
text for the public
health objectives
under Sec. 495.6.
------------------------------------------------------------------------
Stage 1 Policy Changes
------------------------------------------------------------------------
Meeting an exclusion for a Meeting an exclusion 2014--Onward
menu set objective counts for a menu set (Required).
towards the number of menu objective does not
set objectives that must be count towards the
satisfied to meet meaningful number of menu set
use. objectives that must
be satisfied to meet
meaningful use..
------------------------------------------------------------------------
c. State Flexibility for Stage 2 of Meaningful Use
We proposed to offer states flexibility under the Medicaid
incentive program with the public health measures in Stage 2, similar
to that of Stage 1, subject to the same conditions and standards as the
Stage 1 flexibility policy. This applies to the public health measures
as well as the measure to generate lists of specific conditions to use
for quality improvement, reduction of disparities, research or
outreach. We clarify that our proposal included the existing public
health measures from Stage 1 as well as the new public health measures
proposed for Stage 2.
In addition, we stated that whether a state moved an objective to
the core or left it in the menu, states may also specify the means of
transmission of the data or otherwise change the public health measure,
as long as it does not require EHR functionality above and beyond that
which is included in the 2014 ONC EHR certification criteria.
We solicited comments on extending state flexibility as described
for Stage 2 of meaningful use and whether this remains a useful tool
for state Medicaid agencies.
Comment: Commenters requested clarification of the requirement that
states cannot require EHR functionality above and beyond that which is
included in the 2014 ONC EHR certification criteria. These commenters
point out that the Stage 2 public health measures require capabilities
beyond that which is included in the 2014 ONC EHR certification
criteria already.
Response: We assume commenters are referring to transmission
methods which are not included in 2014 Edition EHR certification
criteria adopted by ONC for public health objectives (immunizations,
electronically reportable lab results, syndromic surveillance, cancer
registries and specialized registries). This limitation applies only to
those capabilities and standards included in 2014 ONC EHR certification
criteria for a given public health objective. For example, a state
could not require a different standard than the one included in 2014
ONC EHR certification criteria. In cases where the 2014 ONC EHR
certification criteria are silent, such as the means of transmission
for a given public health objective, the state may propose changes to
public health measures.
Comment: Several commenters supported extending state flexibility
with meaningful use for Stage 2, but requested that CMS provide a
clearer definition of state flexibility. Commenters suggested that it
would be helpful to EPs and eligible hospitals if states follow a
common timeline for establishing state-specific requirements.
Response: We appreciate these comments and would like to clarify
that the state flexibility for Stage 2 remains defined the same way as
it is defined in Stage 1 at Sec. 495.316 (d)(2) and Sec. 495.322
(f)(2). Given that states are launching their programs at different
times and are therefore at different stages in the program lifecycle
and process, at this time we do not support the development of a common
timeline for establishing state-specific requirements. The parameters
remain the same as for Stage 1 and providers are subject to the
requirements found in Sec. 495.332. CMS approval of states' requests
will include a review of the outlined elements.
After consideration of the public comments received, we are
finalizing these provisions as proposed.
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
We proposed to continue the Stage 1 concept of a core set of
objectives and a menu set of objectives for Stage 2. In the Stage 1
final rule (75 FR 44322), we indicated that for Stage 2, we expected to
include the Stage 1 menu set objectives in the core set. We proposed to
follow that approach for our Stage 2 core set with two exceptions. We
proposed to keep the objective of ``capability to submit electronic
syndromic surveillance data to public health agencies'' in the menu set
for EPs. Our experience with Stage 1 is that very few public health
agencies have the ability to accept non-emergency or non urgent care
ambulatory syndromic surveillance data electronically and those that do
are less likely to support EPs than hospitals; therefore we do not
believe that current infrastructure supports moving this objective to
the core set for EPs. We also proposed to keep the objective of
``record advance directives'' in the menu set for eligible hospitals
and CAHs. As we stated in our Stage 1 final rule (75 FR 44345), we have
continuing concerns that there are potential conflicts between storing
advance directives and existing state laws.
We proposed new objectives for Stage 2, some of which would be part
of the
[[Page 53980]]
Stage 2 core set and others would make up the Stage 2 menu set, as
discussed below with each objective. We proposed to eliminate certain
Stage 1 objectives for Stage 2, such as the objective for testing the
capability to exchange key clinical information. We proposed to combine
some of the Stage 1 objectives for Stage 2. For example, the objectives
of maintaining an up-to-date problem list, active medication list, and
active medication allergy list would not be separate objectives for
Stage 2. Instead, we proposed to combine these objectives with the
objective of providing a summary of care record for each transition of
care or referral by including them as required fields in the summary of
care.
We proposed a total of 17 core objectives and 5 menu objectives for
EPs. We proposed that an EP must meet the criteria or an exclusion for
all of the core objectives and the criteria for 3 of the 5 menu
objectives. This is a change from our current Stage 1 policy where an
EP could reduce the number of menu set objectives that the EP would
otherwise need to meet by the number of menu set objectives that the EP
could exclude. We noted the feedback we received on Stage 1 from
providers and health care associations leads us to believe that most
EPs had difficulty understanding the concept of deferral of a menu
objective in Stage 1. Therefore, we proposed this change for Stage 2,
as well as for Stage 1 beginning in 2014, to make the selection of menu
objectives easier for EPs. We also proposed this change because we are
concerned that under the current Stage 1 requirements some EPs could
select and exclude menu objectives when there are other menu objectives
they can legitimately meet, thereby making it easier for them to
demonstrate meaningful use than EPs who attempt to legitimately meet
the full complement of menu objectives. Although we provided the
ability to do this in the selection of Stage 1 menu objectives through
2013, we stated that EPs participating in Stage 1 and Stage 2 starting
in 2014 should focus solely on those objectives they can meet rather
than those for which they have an exclusion. In addition, we noted the
exclusions for the Stage 2 menu objectives that we believe would
accommodate EPs who are unable to meet certain objectives because of
scope of practice. However, just as we signaled in our Stage 1
regulation, we stated our intent to propose in our next rulemaking that
every objective in the menu set for Stage 2 (as described later in this
section) be included in Stage 3 as part of the core set.
We explained that in the case where an EP meets the criteria for
the exclusions for 3 or more of the Stage 2 menu objectives, the EP
would have more exclusions than the allowed deferrals. EPs in this
situation would attest to an exclusion for 1 or more menu objectives in
his or her attestation to meaningful use. In doing so, the EP would be
attesting that he or she also meets the exclusion criteria for all of
the menu objectives that he or she did not choose. We stated that the
same policy would also apply for the Stage 1 menu objectives for EPs
beginning in 2014.
We proposed a total of 16 core objectives and 4 menu objectives for
eligible hospitals and CAHs for Stage 2. We proposed that an eligible
hospital or CAH must meet the criteria or an exclusion for all of the
core objectives and the criteria for 2 of the 4 menu objectives. We
proposed that the policy for exclusions for EPs discussed in the
preceding paragraph would also apply to eligible hospitals and CAHs for
Stage 1 beginning in 2014 and for Stage 2.
We received many comments on the appropriateness of individual
objectives placement in the core or menu set. We discuss these comments
below for each individual objective.
Comment: Commenters expressed concern over the small number of
objectives in the menu set. They were concerned that the small number
of objectives limited the usefulness of the menu set to providers.
Response: Stage 2 does contain a more specialized and smaller menu
set than Stage 1. We see this as a natural result of moving up the
staged path towards improved outcomes and adding fewer new objectives.
We also see specialization as necessary for meaningful use to be
applicable to all EPs. Due to comments received we are adding two
objectives for hospitals and one for EPs which will be in the menu, as
further explained later in this section.
After consideration of the public comments received, we finalize
the concept of a core and menu set for Stage 2.
We finalize a total of 17 core objectives and 6 menu objectives for
EPs for Stage 2. We finalize that an EP must meet the criteria or an
exclusion for all of the core objectives and the criteria for 3 of the
6 menu objectives unless an exclusion can be claimed for more than 3 of
the menu objectives in which case the criteria for the remaining non-
excluded objectives must be met.
We finalize a total of 16 core objectives and 6 menu objectives for
eligible hospitals and CAHs for Stage 2. We finalize that an eligible
hospital or CAH must meet the criteria or an exclusion for all of the
core objectives and the criteria for 3 of the 6 menu objectives.
We also finalize our proposal to change the menu set exclusions
policy for Stage 1. Beginning in 2014, qualifying for an exclusion from
a menu set objective will no longer reduce the number of menu set
objectives that an EP or hospital must otherwise satisfy to demonstrate
meaningful use for Stage 1. There is an exception for EPs who meet the
criteria to exclude five or more of the menu set objectives, in which
case the EP must meet the criteria for all of the remaining non-
excluded menu set objectives. This exception would not be applicable to
hospitals due to the number of hospital menu set objectives that
include exclusions.
(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs Can
Meet All Stage 2 Meaningful Use Objectives Given Established Scopes of
Practice
We noted in the proposed rule that we do not believe that any of
the proposed new objectives for Stage 2 make it impossible for any EP,
eligible hospital or CAH to meet meaningful use. Where scope of
practice may prevent an EP, eligible hospital or CAH from meeting the
measure associated with an objective, we discussed the barriers and
included exclusions in our descriptions of the individual objectives.
We proposed to include new exclusion criteria when necessary for new
objectives, continue the Stage 1 exclusions for Stage 2, and continue
the option for EPs and hospitals to defer some of the objectives in the
menu set unless they meet the exclusion criteria for more objectives
than they can defer as explained previously.
We recognized in the proposed rule that at the time of publication,
our data (derived internally from attestations) only reflected the
meaningful use attestations from Medicare providers. There have been no
significant changes in the data derived from meaningful use
attestations since the publication of the proposed rule.
We did not receive any comments on this provision.
(2) EPs Practicing in Multiple Practices/Locations
We proposed for Stage 2 to continue our policy that to be a
meaningful EHR user, an EP must have 50 percent or more of his or her
outpatient encounters 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
[[Page 53981]]
percent threshold through a combination of practices/locations equipped
with CEHRT. We gave the following in the proposed rule example: if the
EP practices at a federally qualified health center (FQHC) and within
his or her individual practice at 2 different locations, we would
include in our review all 3 of these locations, and CEHRT would have to
be available at one location or a combination of locations where the EP
has 50 percent or more of his or her patient encounters. If CEHRT is
only available at one location, then only encounters at this location
would be included in meaningful use assuming this one location
represents 50 percent or more of the EP's patient encounters. If CEHRT
is available at multiple locations that collectively represent 50
percent or more of the EP's patient encounters, then all encounters
from those locations would be included in meaningful use.
In the proposed rule we stated that we have received many inquiries
on this requirement since the publication of the Stage 1 final rule. We
define patient encounter as any encounter where a medical treatment is
provided and/or evaluation and management services are provided. This
includes both individually billed events and events that are globally
billed, but are separate encounters under our definition. We define a
practice/location as equipped with CEHRT if the record of the patient
encounter that occurs at that practice/location is created and
maintained in CEHRT. This can be accomplished in three ways: CEHRT
could be permanently installed at the practice/location, the EP could
bring CEHRT to the practice/location on a portable computing device, or
the EP could access CEHRT remotely using computing devices at the
practice/location. Although it is currently allowed under Stage 1 for
an EP to create a record of the encounter without using CEHRT at the
practice/location and then later input that information into CEHRT that
exists at a different practice/location, we do not believe this process
takes advantage of the value CEHRT offers. We proposed not to allow
this practice beginning in 2013. We have also received inquiries
whether the practice locations have to be in the same state, to which
we clarify that they do not. Finally, we received inquiries regarding
the interaction with hospital-based EP determination. The determination
of whether an EP is hospital-based or not occurs prior to the
application of this policy, so only nonhospital-based eligible
professionals are included. Furthermore, this policy, like all
meaningful use policies for EPs, only applies to outpatient settings
(all settings except the inpatient and emergency department of a
hospital).
Comment: Some commenters suggested that for EPs practicing in
multiple locations that meaningful use attestations should be limited
to just reporting on meaningful use for the most prevalent location due
to the difficulty in aggregating data across locations.
Response: We continue to believe that for the core measures,
aggregating data is not overly burdensome. We allow the numerators and
denominators calculated by CEHRT to be summed across an EP's various
practice locations.
Comment: We received request for clarification on what to do when
an EP is practicing in multiple locations that select different menu
objectives to pursue, and the EP does not control this selection.
Response: An EP who does not have the same menu objectives
implemented across each of their practice locations equipped with CEHRT
would attest to the three menu objectives that represent the greatest
number of their patient encounters. For example, if six menu objectives
are implemented between two locations, an EP would attest to the three
menu objectives implemented at the location where they have the
greatest number of encounters during the EHR reporting period. For
measures that utilize a percentage threshold, they can limit the
denominator to the location or locations that pursued that menu
objective.
After consideration of the public comments received, we are
finalizing the proposed provisions with the modifications previously
discussed.
(3) Discussion of the Reporting Requirements of the Measures Associated
With the Stage 2 Meaningful Use Objectives
In our experience with Stage 1, we found the distinction between
limiting the denominators of certain measures to only those patients
whose records are maintained using CEHRT, but including all patients in
the denominators of other measures, to be complicated for providers to
implement. We proposed to remove this distinction for Stage 2 and
instead include all patients in the denominators of all of the measures
associated with the meaningful use objectives for Stage 2. We believe
that by the time an EP, eligible hospital, or CAH has reached Stage 2
of meaningful use all or nearly all of their patient population should
be included in their CEHRT, making this distinction no longer relevant.
Comment: We received comments that maintain that this distinction
is still necessary for Stage 2 because there are situations where
significant patient records may still be maintained outside of CEHRT.
Examples provided by commenters include worker's compensation or other
special contracts for certain patients, specialized departments or
units in a hospital for which CEHRT is not tailored and patient
requests to keep their records on paper.
Response: We continue to believe that nearly all patient records
will be stored in CEHRT by the time a provider reaches Stage 2.
However, we acknowledge that if this assertion is correct then there is
no practical consequence of maintaining the distinction, while if it is
not, removing the distinction could have adverse impacts on providers.
After consideration of the comments, we are not finalizing our
proposed change. Instead, we maintain the distinction between measures
that include only those patients whose records are maintained using
CEHRT and measures that include all patients. Providers may 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's or CAH's inpatient or emergency department during
the EHR reporting period.
Comment: Some commenters suggested that the denominators should be
limited to either just Medicare-covered patients for those
participating in the Medicare EHR Incentive Program or just Medicaid-
covered patients for those participating in the Medicaid EHR Incentive
Program. Commenters presented two arguments in favor of this
suggestion. First, that requiring a provider to include all patients
was more burdensome than including just Medicare-covered or Medicaid-
covered patients and that this burden was not offset by the incentive
payments that are based (for Medicare only) on charges submitted to
Medicare. Second, that if identifiable patient data was included in
Medicare or Medicaid meaningful use reporting for patient not covered
by Medicare or Medicaid this would raise serious privacy concerns and
possibly require patient consent. Other commenters were supportive of
current denominators that does not account for payers.
[[Page 53982]]
Response: We discussed the burden differences between all patients
versus patients differentiated by payer in our Stage 1 final rule (75
FR44332). We continue to believe that it is highly unlikely that
providers will use different record keeping systems based on payer.
Where there are differences in patient populations such as age we
account for them directly in the measure not indirectly with payer as a
generalized proxy. The burden of breaking out the patients by payer for
purposes of meaningful use measurement would have only increased from
the publication of the Stage 1 final rule as measurement tools have
been designed and implemented to measure patients regardless of payer.
If at a future date, the demonstration of meaningful use includes the
submission of identifiable patient data we will certainly address the
privacy implications of that requirement. However, the Stage 1
objectives and measures and Stage 2 objectives and measures included in
this final rule do not require the submission of identifiable patient
information. We are not making any changes to this policy in this final
rule.
We proposed new objectives that could increase reporting burden. To
minimize the burden, we proposed to create a uniform set of
denominators that would be used for all of the Stage 2 meaningful use
objectives, as discussed later.
Many of our meaningful use objectives use percentage-based measures
if appropriate. To provide a check on the burden of reporting of
meaningful use, we proposed for Stage 2 to use 1 of 4 denominators for
each of the measures associated with the meaningful use objectives. We
focused on denominators because the action that moves something from
the denominator to the numerator usually requires the use of CEHRT by
the provider. These actions are easily tracked by the technology.
The four proposed denominators for EPs are--
Unique patients seen by the EP during the EHR reporting
period (stratified by age or previous office visit);
Number of orders (medication, labs, radiology);
Office visits, and
Transitions of care/referrals.
Comment: We received many comments supporting our efforts to
minimize the variety of denominators. Some commenters argued that any
variation (such as by age or orders of different types) should be
considered separate denominators.
Response: We appreciate the support for our proposal to minimize
the variety of denominators. Our base of four denominators are only
modified by information that must be entered into CEHRT in order to
meet meaningful use; therefore, we believe that such modifications
represent a small burden and are in keeping with our overall goal in
minimizing the variety of denominators.
In the proposed rule, we stated that the term ``unique patient''
means that if a patient is seen or admitted more than once during the
EHR reporting period, the patient only counts once in the denominator.
Patients seen or admitted only once during the EHR reporting period
will count once in the denominator. A patient is seen by the EP when
the EP has an actual physical encounter with the patient in which they
render any service to the patient. A patient seen through telemedicine
will also still count as a patient ``seen by the EP.'' In cases where
the EP and the patient do not have an actual physical or telemedicine
encounter, but the EP renders a minimal consultative service for the
patient (like reading an EKG), the EP may choose whether to include the
patient in the denominator as ``seen by the EP'' provided the choice is
consistent for the entire EHR reporting period and for all relevant
meaningful use measures. For example, a cardiologist may choose to
exclude patients for whom they provide a one-time reading of an EKG
sent to them from another provider, but include more involved
consultative services as long as the policy is consistent for the
entire EHR reporting period and for all meaningful use measures that
include patients ``seen by the EP.'' EPs who never have a physical or
telemedicine interaction with patients must adopt a policy that
classifies at least some of the services they render for patients as
``seen by the EP,'' and this policy must be consistent for the entire
EHR reporting period and across meaningful use measures that involve
patients ``seen by the EP''--otherwise, these EPs will not be able to
satisfy meaningful use, as they will have denominators of zero for some
measures. In cases where the patient is seen by a member of the EP's
clinical staff the EP can include or not include those patients in
their denominator at their discretion as long as the decision applies
universally to all patients for the entire EHR reporting period and the
EP is consistent across meaningful use measures. In cases where a
member of the EP's clinical staff is eligible for the Medicaid EHR
incentive in their own right (for example, nurse practitioners (NPs)
and certain physician assistants (PA)), patients seen by NPs or PAs
under the EP's supervision can be counted by both the NP or PA and the
supervising EP as long as the policy is consistent for the entire EHR
reporting period.
Comment: While generally supporting the concept of a unique patient
as a good tool to address the fact that not all meaningful use
objectives need be addressed at every patient encounter or rendering of
medical service, some commenters expressed concern about the ability to
identify unique patients across CEHRTs in situations where an EP
practices at multiple locations or in situations where an EP might
switch CEHRT during an EHR reporting period.
Response: We agree that determining unique patients across CEHRTs
is difficult. When aggregating performance on meaningful use measures
across multiple practice locations using different CEHRTs we do not
require that it be determined that a patient seen at one location was
not also seen at another location. While this could result in the same
patient appearing more than once in the denominator of unique patients
seen, we believe that the burden of seeking out these patients is
greater than any gain in measurement accuracy. Furthermore, it is not
possible for a provider to increase only the numerator with this policy
as any increase in the numerator would also increase the denominator.
Accordingly, we are adopting a final policy that will give EPs who
practice at multiple locations or switch CEHRT during the EHR reporting
period some flexibility as to the method for counting unique patients
in the denominators. We leave it up to the EP to decide for the EHR
reporting period whether to count a unique patient across all locations
equipped with different CEHRT (for example, 1 patient seen at 3
locations with different CEHRT counts once) or at each location
equipped with CEHRT (for example, 1 patient seen at 3 locations with
different CEHRT counts thrice). In cases where a provider switches
CEHRT products at a single location during the EHR reporting period,
they also have the flexibility to count a patient as unique on each
side of the switch and not across it (for example, 1 patient seen
before the switch and after the switch could be counted once or twice).
EPs in these scenarios must choose one of these methods for counting
unique patients and apply it consistently throughout the entire EHR
reporting period.
With the flexibility for EPs practicing in multiple locations using
different CEHRT or switching CEHRT during the
[[Page 53983]]
EHR reporting period, we otherwise finalize our description of ``unique
patient'' as proposed.
We proposed that an office visit is defined as any billable visit
that includes: (1) Concurrent care or transfer of care visits; (2)
consultant visits; or (3) prolonged physician service without direct,
face-to-face patient contact (for example, telehealth). A consultant
visit occurs when a provider is asked to render an expert opinion/
service for a specific condition or problem by a referring provider.
The visit does not have to be individually billable in instances where
multiple visits occur under one global fee.
Comment: We received comments requesting that we establish a list
of billing codes that constitute an office visit for purposes of
clarity.
Response: We continue to believe that the use of a list of billing
codes would inappropriately limit the discretion of EPs that we have
built into this measure. We finalize as proposed our description of an
office visit and emphasize that there is room for EP discretion in this
definition and that the most important consideration in utilizing that
discretion is that the policy apply for the entire EHR reporting period
and across all patients.
We proposed to describe transitions of care as the movement of a
patient from one setting of care (hospital, ambulatory primary care
practice, ambulatory specialty care practice, long-term care, home
health, rehabilitation facility) to another. Currently, the meaningful
use measures that use transitions of care require there to be a
receiving provider of care to accept the information. Therefore, a
transition home without any expectation of follow-up care related to
the care given in the prior setting by another provider is not a
transition of care for purpose of Stage 2 meaningful use measures as
there is no provider recipient. A transition within one setting of care
does not qualify as a transition of care. Referrals are cases where one
provider refers a patient to another, but the referring provider
maintains their care of the patient as well. Please note that a
``referral'' as defined here and elsewhere in this final rule is only
intended to apply to the EHR Incentive Programs and is not applicable
to other Federal regulations.
Comment: We have received many comments that determining when a
transition of care occurs is very difficult under our current Stage 1
rule, particularly when the provider is on the receiving end of the
transition of care. Commenters suggest that the only reliable way to
know if a patient saw another provider is to ask the patient at each
encounter and even then this is not guaranteed. Several suggestions
were presented to make the definition more precise on both the
receiving and transitioning side. They were as follows:--
Discharges for eligible hospitals/CAHs and referrals to
other providers who do not share the same CEHRT as the EP are very
clearly identified and should be the focus of the numerator/
denominator.
A transition within one setting of care does not qualify
as a transition of care. Referral is defined as care ``where one
provider refers a patient to another, but the referring provider
maintains their care of the patient as well.''
A patient is referred to another provider (for EPs) or a
patient is discharged (for eligible hospitals).
Sharing data with health plans.
Response: In reviewing the comments, we agree that a refinement of
our transitions of care definition is needed. We also agree with the
suggestions to point to specific events that identify a transition of
care has occurred without relying entirely on asking the patient.
Therefore, we revise our description of transitions of care for the
purpose of defining the denominator. For an EP who is on the receiving
end of a transition of care or referral, (currently used for the
medication reconciliation objective and measure), 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. The summary of care record can be
provided either by the patient or by the referring/transiting provider
or institution. We believe that both of these situations would create
information in the CEHRT that can be automatically recorded. For an EP
who is initiating a patient transfer to another setting and/or
referring a patient to another provider, (currently used for providing
summary of care documents at transitions of care), the initiating/
referring EP would count the transitions and/or referrals that were
ordered by the EP in the measure denominator. If another provider also
sees the same patient, only the EP who orders the transition/referral
would need to account for this transition for the purpose of this
measure. EPs are not responsible for including patient-initiated
transitions and referrals that were not ordered by the EP. For example,
if the EP creates an order for admission to a nursing home, this
transition of care would be counted in the EP's measure denominator. If
one of the EP's patients is admitted to a nursing home by another
provider, this transition would only have to be counted by the EP who
creates the order and not necessarily by other EPs who care for the
patient. We want to emphasize that these transitions of care/referral
descriptions have been developed for purposes of reducing the provider
measurement burden for the EHR Incentive Program and do not necessarily
apply to other programs or regulations. We also clarify that these
descriptions are minimum requirements. An EP can include in the
denominator transitions of care and referrals that fit the broader
descriptions of these terms, but are not one of the specific events
described previously.
The four proposed denominators for eligible hospitals and CAHs
are--
Unique patients admitted to the eligible hospital's or
CAH's inpatient or emergency department during the EHR reporting period
(stratified by age);
Number of orders (medication, labs, radiology);
Inpatient bed days; and
Transitions of care.
We noted in the proposed rule that our explanation of ``unique
patients'' and ``transitions of care'' for EPs would also apply for
eligible hospitals and CAHs.
Comment: Commenters suggested a problem with unique patients could
arise if a hospital switched CEHRT during the EHR reporting period.
Response: Our final policy on EPs who switch CEHRT during the EHR
reporting period counting unique patients in the denominator would also
apply for hospitals in the same situation.
Comment: We have received many comments that determining when a
transition of care occurs is very difficult under our Stage 1
regulations, particularly when the provider is on the receiving end of
the transition of care. Commenters suggest that the only reliable way
to know if a patient saw another provider is to ask the patient at each
encounter and even then this is not guaranteed. Several suggestions
were presented to make the definition more precise on both the
receiving and transitioning side, which we summarized previously in the
discussion of the proposed denominators for EPs.
Response: For the same reasons as discussed for EPs, we agree that
pointing to specific occurrences is needed to accurately measure this
denominator. For transitions of care when the hospital is on the
receiving end, (currently used for the medication reconciliation
objective and measure), we include all admissions to the inpatient and
emergency departments.
[[Page 53984]]
For transitions of care when the hospital is transitioning the patient,
(currently used for providing summary of care documents at transitions
of care), we include all discharges from the inpatient department and
after admissions to the emergency department when follow-up care is
ordered by an authorized provider of the hospital. As with EPs, these
are the minimum events that must be included in the denominator for the
transitions of care measure. Hospitals can include additional
transitions of care that match the full description of transitions of
care, but are not one of these specific events.
We proposed that admissions to the eligible hospital or CAH can be
calculated using one of two methods currently available under Stage 1
of meaningful use. The observation services method includes all
patients admitted to the inpatient department (POS 21) either directly
or through the emergency department and patients who initially present
to the emergency department (POS 23) and receive observation services.
Details on observation services can be found in the Medicare Benefit
Policy Manual, Chapter 6, Section 20.6. Patients who receive
observation services under both the outpatient department (POS 22) and
emergency department (POS 23) should be included in the denominator
under this method. The all emergency department method includes all
patients admitted to the inpatient department (POS 21) either directly
or through the emergency department and all patients receiving services
in the emergency department (POS 23).
Comment: Commenters expressed near universal support for the
continuance of the two options in defining an admission to the
emergency department.
Response: We continue to believe that not all information required
by meaningful use may be relevant to all encounters in the emergency
department and that this decision is best left to the hospital;
therefore, we are finalizing this as proposed.
We proposed that inpatient bed days are the admission day and each
of the following full 24-hour periods during which the patient is in
the inpatient department (POS 21) of the hospital. For example, a
patient admitted to the inpatient department at noon on June 5th and
discharged at 2 p.m. on June 7th will be admitted for 2-patient days:
the admission day (June 5th) and the 24 hour period from 12 a.m. on
June 6th to 11:59 p.m. on June 6th.
We did not receive comments on this proposal. This denominator is
not used by the proposed meaningful use objectives and measures nor the
finalized objectives and measures.
As discussed later in this section, we are including the menu
objective for hospitals of ``Provide structured electronic lab results
to ambulatory providers''. The measure associated with the objective
uses a denominator that was not included in our proposal. The
denominator is the number of electronic lab orders received by the
hospital from ambulatory providers. For this objective, we use the same
description of ``laboratory services'' as for our Stage 2 CPOE
objective: any service provided by a laboratory that could not be
provided by a nonlaboratory. We also use the definition of
``laboratory'' at Sec. 493.2 as for the Stage 2 CPOE objective. Any
order for a laboratory service will be considered a lab order. For the
order to be considered received electronically, it must be received by
the hospital utilizing an electronic transmission method and not
through methods such as physical electronic media, electronic fax,
paper document or telephone call.
After consideration of public comments, we are finalizing the
following denominators for EPs:
Unique patients seen by the EP during the EHR reporting
period (stratified by age or previous office visit);
Number of orders (medication, labs, radiology);
Office visits; and
Transitions of care/referrals including at a minimum one
of the following:
+ + 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.
We are finalizing the following denominators for eligible hospitals
and CAHs:
Unique patients admitted to the eligible hospital's or
CAH's inpatient or emergency department during the EHR reporting period
(stratified by age);
Number of orders (medication, labs, radiology);
Transitions of care including at a minimum one of the
following:
++ When the hospital is the recipient of the 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; and
Electronic lab orders received by the hospital from
ambulatory providers.
(4) Discussion of the Relationship of Meaningful Use to CEHRT
We proposed to continue our policy of linking each meaningful use
objective to certification criteria for CEHRT. As with Stage 1, EPs,
eligible hospitals, and CAHs must use the capabilities and standards
that are certified to meet the objectives and associated measures for
Stage 2 of meaningful use. In meeting any objective of meaningful use,
an EP, eligible hospital or CAH must use the capabilities and standards
that are included in certification. We noted that in some instances,
meaningful use objectives and measures require use that is not directly
enabled by certified capabilities and/or standards. In these cases, the
EP, eligible hospital and CAH is responsible for meeting the objectives
and measures of meaningful use, but the way they do so is not
constrained by the capabilities and standards of CEHRT. In the proposed
rule we gave the following example: in e-Rx and public health
reporting, CEHRT applies standards to the message being sent and
enables certain capabilities for transmission in 2014; however, to
actually engage in e-Rx or public health reporting many steps must be
taken outside of these standards and capabilities such as contacting
both parties and troubleshooting issues that may arise through the
normal course of business.
Comment: We received many comments that expressed confusion of when
the capabilities and standards included in certification must be used
and when they do not.
Response: Nearly all of these comments were objective-specific, so
we address them at the referenced objective. With each measure we
include a universal statement on the applicability of the specific
standards and capabilities included in the 2014 edition of
certification criteria for EHR technologies and, if applicable,
specific allowances for that measure.
After consideration of the public comments received, we are
finalizing these provisions as proposed.
(5) Discussion of the Relationship Between a Stage 2 Meaningful Use
Objective and Its Associated Measure
We proposed to continue our Stage 1 policy that regardless of any
actual or perceived gaps between the measure of an objective and full
compliance with the objective (such as a measure threshold of less than
100 percent or a
[[Page 53985]]
measure designed to account for circumstances where 100 percent
compliance in not the intention of the objective), meeting the criteria
of the measure means that the provider has met the objective for Stage
2.
We did not receive any comments and we are finalizing these
provisions as proposed.
(6) Objectives and Their Associated Measures
(a) Objectives and Measures Carried Over (Modified or Unmodified) From
Stage 1 Core Set to Stage 2 Core Set
Proposed Objective: Use computerized provider order entry (CPOE)
for medication, laboratory and radiology orders directly entered by any
licensed healthcare professional who can enter orders into the medical
record per state, local and professional guidelines to create the first
record of the order.
In the proposed rule, we outlined the following benefits of CPOE.
CPOE improves quality and safety by allowing clinical decision support
at the point of the order and therefore influences the initial order
decision. CPOE improves safety and efficiency by automating aspects of
the ordering process to reduce the possibility of communication and
other errors. Consistent with the recommendations of the HIT Policy
Committee, we proposed to expand the orders included in the objective
to medication (which was included in Stage 1), laboratory, and
radiology. We believe that the expansion to laboratory and radiology
furthers the goals of the CPOE objective, that such orders are commonly
included in CPOE roll outs and that inclusion of the entry of these
orders using CPOE is a logical step in the progression of meaningful
use. We note that this does not require the electronic transmission of
the order.
We proposed to continue to define CPOE as the provider's use of
computer assistance to directly enter medical orders (for example,
medications, consultations with other providers, laboratory services,
imaging studies, and other auxiliary services) from a computer or
mobile device. The order is then documented or captured in a digital,
structured, and computable format for use in improving safety and
efficiency of the ordering process. We further proposed that the CPOE
function of CEHRT must be used by the ordering provider or licensed
healthcare professionals under his or her direction to create the first
record of that order, or it would not count as CPOE. As this proposed
objective limits the use of CPOE to the creation of the first record of
the order (a more restrictive standard than in Stage 1), we invited
public comment on whether the stipulation that the CPOE function be
used only by licensed healthcare professionals remains necessary or if
CPOE can be expanded to include non-licensed healthcare professionals
such as scribes.
Comment: Commenters focused primarily on CPOE's value as the
trigger for clinical decision support interventions. It was suggested
the term be revised from computerized provider order entry to
computerized order evaluation. This focus led to the suggestion by
several commenters that as long as the ordering providers ``signs'' or
otherwise authorizes the order before it is carried out this should
count for CPOE. These commenters maintain that meaningful use should
not dictate any of the processes that lead up to this authorization
including who enters the order into CEHRT nor what types of record of
the order may exist prior to entry into CEHRT.
Response: We agree that CPOE as the trigger for CDS interventions
is the primary value creating function of CPOE. However, we disagree
that it is the only one. We believe automating aspects of and/or
eliminating steps in the ordering process prior to final authorization
of the order does reduce communication and other errors. Furthermore,
it is our understanding from both commenters and our own experiences
with CEHRT that many EHRs use the entry of the order as the trigger for
CDS interventions and either display them again at authorization or do
not display them at all at authorization. For these reasons, we
continue to focus the definition and measurement of CPOE on when and by
whom the order is entered into CEHRT and not on when it is authorized
by the ordering provider in CEHRT.
Comment: Commenters stated that the authentication of verbal orders
is already covered by the conditions of participation for hospitals at
42 CFR482.24(c)(1)(iii) which states that ``[a]ll verbal orders must be
authenticated based upon Federal and state law. If there is no state
law that designates a specific timeframe for the authentication of
verbal orders, verbal orders must be authenticated within 48 hours.''
Meaningful use should adopt this same standard.
Response: We are not adopting this standard for two reasons. First,
as this is in an incentive program, we do not believe it is logical to
base a requirement for meaningful use solely on a condition of
participation. Hospitals already must comply with the conditions of
participation, so we believe as an incentive program meaningful use
should be incentivizing behavior beyond the conditions of
participation. Second, as discussed later, we are not limiting the
communication of orders prior to CPOE to verbal orders so there is not
a direct corollary between this condition of participation and our
description of CPOE. Section 482.23(c)(2) also speaks to verbal orders.
First, it states, ``If verbal orders are used, they are to be used
infrequently. Second, it states, ``When verbal orders are used, they
must only be accepted by persons who are authorized to do so by
hospital policy and procedures consistent with Federal and state law.''
We discuss who may enter the order later in comment and response, but
reiterate our position that meaningful use should incentivize behavior
that benefits patients beyond that required by the conditions of
participation.
Comment: Commenters objected to our proposal to change our policy
regarding CPOE from ``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'' to ``the order created using the EHR
must be the first record of that order or it would not count as CPOE''.
The commenters stressed that if they used a process that created a
record of the order that was not part of the patient's medical record,
then the proposed policy requiring this record not be retained is not
advisable. The commenters asserted that even if it was not part of the
patient's medical record the initial record of the order could be used
for quality control purposes.
Response: Our proposed policy change was intended as an evolution
from the Stage 1 requirements for CPOE. However, after reviewing the
comments received, we agree that requiring an electronic or written
order that is not created using the CPOE function of CEHRT to not be
retained in order for it to count as CPOE could have unforeseen and
possibly detrimental consequences for quality control. We continue to
believe that our original proposal would have increased CPOE's ability
to improve safety and efficiency and encourage all providers to
streamline the ordering process to minimize the number of steps
involved. However, we do not have sufficient information to determine
whether the gains of the proposal are greater than or less than the
potential cost of not retaining written or electronic orders issued
before the use of the CPOE function. Therefore, we are not finalizing
the proposed revised
[[Page 53986]]
description of when the CPOE function must be utilized during the
ordering process and instead finalize our existing Stage 1 description
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. Based on the questions we have received on CPOE to date,
the limiting criterion is the first time the order becomes part of the
patient's medical record rather than the limitation of before any
action can be taken on the order. The provider must make the
determination as to what constitutes the patient's medical record and
what does not based on their existing policies and applicable state and
Federal law. Our only requirements in this regard are that the
determination be made by the provider prior to the start of the EHR
reporting period and be uniformly applied.
Comment: We have received many comments on who can enter the order
into CEHRT for it to count as CPOE. Four possibilities received comment
support. First, only the ordering provider be able to enter the order
into CEHRT. Second, any licensed healthcare professional who can enter
orders into the medical record per state, local and professional
guidelines can enter the order into CEHRT. This is the current policy
which was proposed to continue. Third, an expansion to any licensed,
certified or appropriately credentialed healthcare professional (some
commenters replaced medical assistant with healthcare professional) who
can enter orders into the medical record per state, local and
professional guidelines. Fourth, an expansion to allow anyone,
including those commonly referred to as scribes, enter the orders into
the medical record per state, local and professional guidelines. We
also note that there was some confusion among commenters as to our
current limitation and proposal of any licensed healthcare professional
using CPOE to create the first entry of the order into the patient's
medical record as we received many comments suggesting that nurses
should be able to enter the orders. We clarify that nurses who are
licensed and can enter orders into the medical record per state, local
and professional guidelines may enter the order into CEHRT and have it
count as CPOE.
Response: As we did not revise our description of when in the
ordering process the CPOE function must be used, we are inclined to not
revise our description of who may enter it into CEHRT. However, we are
particularly concerned with CPOE usage by EPs in this regard. Many EPs
practice without the assistance of other licensed healthcare
professionals. These EPs in their comments urged the expansion
indicated in the third possibility of credentialed healthcare
professionals/medical assistants. We believe that this expansion is
warranted and protects the concept that the CDS interventions will be
presented to someone with medical knowledge as opposed to a layperson.
The concept of credentialed healthcare professionals is over broad and
could include an untold number of people with varying qualifications.
Therefore, we finalize the more limited description of including
credentialed medical assistants. The credentialing would have to be
obtained from an organization other than the employing organization.
Our responses to earlier comments factored into this decision as well.
Based on the public comments received, questions submitted by the
public on Stage 1 and demonstrations of CEHRT we have participated in,
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 could be required to enter the order correctly,
evaluate CDS 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 CDS intervention or bypass the
intervention. We do not believe that a layperson is qualified to do
this, and as there is no licensing or credentialing of scribes, there
is no guarantee of their qualifications.
Comment: We received comments on a particular category of orders
referred to as ``protocol'' or ``standing'' orders. The defining
characteristic of these orders is that they are not created due to a
specific clinical determination by the ordering provider for a given
patient, but rather are pre-determined for patients with a given set of
characteristics (for example, administer medication X and order lab Y
for all patients undergoing a certain procedure or refills for given
medication). Commenters maintain that these orders require special
treatment in regards to when they are entered into CEHRT and who enters
them. Commenters indicate that administrative staff should be allowed
to enter them, but not override any CDS interventions that may appear.
Response: 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. We
therefore 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. We foresee two circumstances where a
provider would not want to exclude this category of orders. The first
is that they disagree that these type of orders warrant different
considerations and therefore enter them according to our description of
CPOE. The second is providers who are unable to separate them from
other orders in their calculation of the denominator and numerator.
Comment: Commenters mostly support the expansion to the laboratory
and radiology orders. Three concerns were raised. First, commenters
believed that as laboratory and radiology orders were new additions
they should have a lower threshold than medication orders. Second,
commenters desired a more descriptive definition on what constitutes a
laboratory and particularly a radiology order. Third, commenters
suggested that laboratory and radiology orders should be delayed for
EPs until more laboratory and radiology providers could receive the
order electronically.
Response: We discuss the measure separately later in this section
and address the comments on the threshold there. We describe laboratory
services as any service provided by a laboratory that could not be
provided by a non-laboratory. Laboratory is defined at 42 CFR 493.2 as:
``a facility for the biological, microbiological, serological,
chemical, immunohematological, hematological, biophysical, cytological,
pathological, or other examination of from the human body for the
purpose of providing information for the diagnosis, prevention, or
treatment of any disease or impairment of, or the assessment of the
health of, human beings. These examinations also include procedures to
determine, measure, or otherwise describe the presence or absence of
various substances or organisms in the body. Facilities only collecting
or preparing specimens (or both) or only serving as a mailing service
and not performing testing are not considered laboratories.'' We
describe radiologic services as any imaging service that uses
electronic product radiation. Electronic product radiation is defined
at 21 CFR 1000.3 as: ``any ionizing or nonionizing electromagnetic or
particulate radiation, or [a]ny sonic, infrasonic, or ultrasonic wave
that is emitted from an electronic product as the result of the
operation of an electronic circuit in such product.''
[[Page 53987]]
If the provider desires to include other types of imaging services that
do not rely on electronic product radiation they may do so as long as
the policy is consistent across all patients and for the entire EHR
reporting period. Finally, as we discuss in the next comment and
response, electronic transmission of the order is not a requirement for
CPOE.
Comment: Some commenters stated that while CPOE is a commonly
understood function in the hospital setting, in the ambulatory setting
its use is more ambiguous. For medication orders, the difference
between CPOE for the medication and e-prescribing the medication is
more subtle. The expansion to laboratory and radiology further
complicates this in the ambulatory setting as most laboratory and
radiology orders are sent to a third party which may or may not be able
to receive such orders electronically.
Response: While we agree that the concept of CPOE is a more
definitive action in the ordering process in the hospital setting, we
believe that it is still integral to the ambulatory setting and serves
the same purposes in both settings as a trigger for CDS interventions
and as a way to increase the efficiency and safety of the ordering
process. CPOE is the entry of the order into the patient's EHR that
uses a specific function of CEHRT. It is not how that order is filled
or otherwise carried out. For medications, on the ambulatory side CPOE
feeds into e-prescribing, and on the hospital side electronic
medication administration record may be used, but neither of these are
requirements for CPOE. For example, a medication could be entered into
CEHRT using CPOE and then be electronically transmitted to a pharmacy.
This would be both CPOE and e-prescribing. However, a medication could
be entered into CEHRT using CPOE and then a printed copy of the
prescription could be generated by CEHRT and given to the patient. This
would still be CPOE, but not e-prescribing. Similarly, whether the
ordering of laboratory or radiology services using CPOE in fact results
in the order being transmitted electronically to the laboratory or
radiology provider does not dictate whether CPOE was met. 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.
After consideration of the public comments received, we are
modifying this objective for EPs as Sec. 495.6(j)(1)(i) and for
eligible hospitals and CAHs at Sec. 495.6(l)(1)(i) to use the same
language as Stage 1 (with the addition of laboratory and radiology
orders), as we did not finalize our proposed changes to when the order
must be entered: ``Use computerized provider order entry (CPOE) for
medication, laboratory, and radiology orders directly entered by any
licensed healthcare professional who can enter orders into the medical
record per state, local, and professional guidelines.''
Proposed Measure: More than 60 percent of medication, laboratory,
and radiology orders created by the EP or authorized providers of the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) during the EHR reporting period are recorded using CPOE.
In Stage 1 of meaningful use, we adopted a measure of more than 30
percent of all unique patients with at least one medication in their
medication list seen by the EP or admitted to the eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) during the
EHR reporting period have at least one medication order entered using
CPOE. In the Stage 1 final rule, we adopted a threshold of 60 percent
for this measure for Stage 2.
In our proposed rule, we discussed how our experience with Stage 1
has shown that the denominator of all orders created by the EP or in
the hospital would not be unduly burdensome for providers and creates a
better measurement for CPOE usage, particularly for EPs who
infrequently order medications. We explained that the denominator
recommended by the HITPC of ``patients with at least one type of
order'' is a proxy measure for the number of orders issued. We asked
for comments on whether the barriers to collecting information for our
proposed denominator would be greater in a hospital or ambulatory
setting. We also requested that commenters suggest different
denominators or measures and encouraged any commenter proposing an
alternative denominator to discuss whether the proposed threshold or an
alternative threshold should be used for this measure and to include
any exclusions they believe are necessary based on their alternative
denominator.
We also stated in our proposed rule that we believed providers do
not roll out CPOE for only one order type, but rather for a package of
order types. The HITPC had recommended a percentage threshold for
laboratory orders, but a yes/no attestation of one order for radiology
(not for both laboratory and radiology, as we mistakenly stated in the
proposed rule). We also expressed concerns in the 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 proposed a percentage threshold
for all three types of orders: medication, laboratory, and radiology.
Comment: Commenters both supported and opposed the new denominator
for CPOE. Those supporting the proposed denominator did so for its
simplicity and greater accuracy for measuring actual CPOE usage.
Commenters that opposed the proposed denominator did so for one of two
reasons. Either they were concerned with the burden associated with
counting paper or other orders that are never entered into CEHRT or
they were concerned that the proposed denominator requires much higher
performance of CPOE usage. For example, in the hospital setting an
inpatient might have 20 orders during a stay. Under the proposed
denominator, 13 of those orders would have to be entered using CPOE,
while under the current denominator only one order would have to be
entered using CPOE. A few commenters opposed the new denominator for
both reasons.
Response: In regards to the perceived higher performance of CPOE
usage required by switching from the Stage 1 denominator to the Stage 2
proposed denominator, the sole purpose of the proxy measure for CPOE
used in Stage 1 was to alleviate the measurement burden, not create a
lower level of CPOE usage than implied by the percentage threshold.
Therefore, as a more accurate measure is possible, it should reflect
the percentage of CPOE use indicated by the established thresholds. In
regards to the burden of the measure, we had stated in our proposed
rule that the reason we believed we could move to the proposed
denominator was feedback from many providers indicating that they could
in fact measure the proposed denominator. In addition due to problems
associated with the proxy for EPs who have comprehensive medication
lists for their patients, but were not the ordering provider for many
of those medications some EPs were having to use an alternative measure
issued through guidance (https://questions.cms.gov/faq.php?id=5005&faqId=3257) that allowed them to only include patients
with medications the EP had ordered. We assume in determining the
measures of meaningful use that the patient's medical record conforms
to existing Federal and state laws, which we believe would generally
require that all orders issued by a provider for a patient become part
of the patient's medical record (for example, 42 CFR 482.24(c)(2)(vi)).
Therefore, the concept that some orders do not become part of
[[Page 53988]]
the CEHRT means that the provider is maintaining patient medical
records both electronically in CEHRT and outside of CEHRT using either
paper charts or another electronic system. When a provider starts their
first Stage 2 EHR reporting period, they will have been using CEHRT for
at least 15 months. In our proposed rule, we have stated our belief
that most providers would have fully transitioned patients' medical
records to CEHRT by the time they start Stage 2. However, as discussed
previously, we are leaving open the option for limiting certain
measures to only those records maintained in CEHRT. As this is one of
those measures, there is no reason to change the measure to accommodate
patient records not maintained in CEHRT as provider can choose to not
include records not maintained in CEHRT in the denominator. Thus, we
finalize the denominator as proposed.
Comment: Commenters requested clarification on whether the measure
puts all medication, laboratory and radiology orders in the same
denominator and therefore it was potentially possible to meet the 60
percent threshold without CPOE being used 60 percent of the time for
one or more order type, up to and including the possibility that CPOE
may never be used for one or more order type. Many commenters suggested
that if all orders were in the same denominator this was not a good
measure of the expansion of CPOE to laboratory and radiology and that
the orders should be broken out separately. Only a few commenters
suggested that the denominator should be the aggregate of all three
types of orders.
Response: We agree with the commenters that an aggregate
denominator does not best reflect our expansion to laboratory and
radiology and therefore create a separate denominator for each order
type. This is consistent with the suggestions of the majority of
commenters and most accurately reflects the use of CPOE. While CPOE
does not require the electronic transmission of the order, many CEHRT
will be linked to the technology systems that manage medication, as
well as those for laboratories and radiology departments. These systems
may be different thereby presenting unique challenges for each order
type that could result in differing roll out times and utilization
rates. In addition, a provider with a high number of one order type
compared to others may even be able to reach a combined threshold
without implementing CPOE for one or more of the order types. This
would negate the benefits of expanding CPOE to these order types. We
have 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: We received several suggestions on the percentage
threshold for medication orders to reduce it below 60 percent. The
suggestions ranged from 50 percent to 30 percent. Two reasons were
given. First, that 60 percent was simply too high. Second, that the
proposed denominator made 30 percent a much higher bar than it was when
the proxy was in place and the threshold should not be raised until we
have data based on the proposed denominator.
Response: As we stated previously, the purpose of the proxy
denominator was not to create a lower bar than CPOE usage at 30
percent, but to address measurement burden. While we agree that the
information generated using the proxy denominator for CPOE is different
from the finalized denominator, this is only true in a limited set of
circumstances, especially for EPs. For it to be different at all, a
provider must have ordered more than one medication for a patient
during the EHR reporting period. Furthermore, this is most likely
limited to providers who see a patient on more than one occasion. We
believe it would be highly unlikely that a provider would use CPOE to
order one medication and then not use it to order another during the
same encounter or admission. For these reasons, we believe that while
not a perfect correlation the information gained through Stage 1
attestations. The Stage 1 attestations provide a reasonable basis on
which to set the Stage 2 thresholds. We believe it is reasonable to
expect the actual use of CPOE to increase from 30 percent in Stage 1 to
60 percent in Stage 2 and consist with the expectations that were
finalized in the Stage 1 regulations. Therefore, for medication orders,
we finalize the threshold at 60 percent.
Comment: Some commenters maintain that the addition of laboratory
and radiology orders to CPOE is a new function and should not be
introduced at the same threshold.
Response: Based on the same logic supporting the 60 percent
threshold for medication orders (that is, 30 percent is reasonable when
CPOE is first introduced for an order type, and 60 percent in the next
stage following CPOE introduction), we agree with the commenters that
the thresholds should be different. We finalize a threshold of 30
percent for each laboratory and radiology orders.
After consideration of the public comments received, we are
splitting the proposed measure into three measures and changing the
threshold for radiology and laboratory orders at Sec. 495.6(j)(1)(ii)
for EPs and Sec. 495.6(l)(1)(ii) for eligible hospitals and CAHs.
More than 60 percent of medication orders created by the
EP or authorized providers of the eligible hospital's or CAH's
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period are recorded using CPOE.
More than 30 percent of laboratory orders created by the
EP or authorized providers of the eligible hospital's or CAH's
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period are recorded using CPOE.
More than 30 percent of radiology orders created by the EP
or authorized providers of the eligible hospital's or CAH's inpatient
or emergency department (POS 21 or 23) during the EHR reporting period
are recorded using CPOE.
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 CEHRT at 45 CFR 170.314(a)(1).
As discussed in the comment and response section, an EP, eligible
hospital or CAH can limit the denominators to only include medication,
laboratory and radiology orders for patients whose records are
maintained using CEHRT.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
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.
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
[[Page 53989]]
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.
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.
An EP through a combination of meeting the thresholds and/or
exclusions must satisfy all three measures for this objective.
A hospital must meet the thresholds for all three measures.
Proposed EP Objective: Generate and transmit permissible
prescriptions electronically (eRx).
In the proposed rule, we noted that the use of electronic
prescribing has several advantages over having the patient carry the
prescription to the pharmacy or directly faxing a handwritten or
typewritten prescription to the pharmacy. When the EP generates the
prescription electronically, CEHRT can recognize the information and
can provide decision support to promote safety and quality in the form
of adverse interactions and other treatment possibilities. The CEHRT
can also provide decision support that promotes the efficiency of the
health care system by alerting the EP to generic alternatives or to
alternatives favored by the patient's insurance plan that are equally
effective. Transmitting the prescription electronically promotes
efficiency and safety through reduced communication errors. It also
allows the pharmacy or a third party to automatically compare the
medication order to others they have received for the patient. This
comparison allows for many of the same decision support functions
enabled at the generation of the prescription, but bases them on
potentially greater information.
We proposed to continue to define prescription as the authorization
by an EP to dispense a drug that will not be dispensed without such
authorization. This includes authorization for refills of previously
authorized drugs. We proposed to define a permissible prescription as
all drugs meeting the definition of prescription not listed as a
controlled substance in Schedules II-V http://www.deadiversion.usdoj.gov/schedules/index.html. Although the Drug
Enforcement Administration's (DEA) interim final rule on electronic
prescriptions for controlled substances (75 FR 16236) removed the
Federal prohibition to electronic prescribing of controlled substances,
some challenges remain including more restrictive state law and
widespread availability of products both for providers and pharmacies
that include the functionalities required by the DEA's regulations. We
asked for public comments as to whether over the counter (OTC)
medicines will be routinely electronically prescribed and proposed to
continue to exclude them from the definition of a prescription.
In our proposed rule we discussed several different workflow
scenarios are possible when an EP prescribes a drug for a patient.
First, the EP could prescribe the drug and provide it to the patient at
the same time, and sometimes the EP might also provide a prescription
for doses beyond those provided concurrently. Second, the EP could
prescribe the drug, transmit it to a pharmacy within the same
organization, and the patient would obtain the drug from that pharmacy.
Third, the EP could prescribe the drug, transmit it to a pharmacy
independent of the EP's organization, and the patient would obtain the
drug from that pharmacy. Although each of these scenarios would result
in the generation of a prescription, the transmission of the
prescription would vary. In the first situation, there is no
transmission. In the second situation, the transmission may be the
viewing of the generation of the prescription by another person using
the same CEHRT as the EP, or it could be the transmission of the
prescription from the Certified EHR Technology used by the EP to
another system used by the same organization in the pharmacy. In the
third situation, the EP's Certified EHR Technology transmits the
prescription outside of their organization either through a third party
or directly to the external pharmacy. These differences in
transmissions create differences in the need for standards. We proposed
that only the third situation would require standards to ensure that
the transmission meets the goals of electronic prescribing. In the
first two scenarios one organization has control over the whole
process. In the third scenario, the process is divided between
organizations. In that situation, standards can ensure that despite the
lack of control the whole process functions reliably. To have
successfully e-prescribed, we proposed that the EP needs to use CEHRT
as the sole means of creating the prescription, and when transmitting
to an external pharmacy that is independent of the EP's organization
such transmission must use standards adopted for EHR technology
certification.
We did not receive any public comments on this objective,
therefore, we are finalizing this objective at Sec. 495.6(j)(2)(i) as
proposed.
Proposed EP Measure: More than 65 percent of all permissible
prescriptions written by the EP are compared to at least one drug
formulary and transmitted electronically using CEHRT.
We proposed a new exclusion for Stage 2 that would allow EPs to
exclude this objective if no pharmacies within 25 miles of an EP's
practice location at the start of his/her EHR reporting period accept
electronic prescriptions. This is 25 miles in any straight line from
the practice location independent of the travel route from the practice
location to the pharmacy. We stated that EP's practicing at multiple
locations would be eligible for the exclusion if any of their practice
locations that are equipped with CEHRT meet this criteria. An EP would
not be eligible for this exclusion if he or she is part of an
organization that owns or operates its own pharmacy within the 25-mile
radius regardless of whether that pharmacy can accept electronic
prescriptions from EPs outside of the organization. We also proposed an
exclusion for EPs who write fewer than 100 prescriptions during the EHR
reporting period.
Comment: Most commenters agreed with the exclusion of controlled
substances in the denominator. They were concerned about industry
readiness as well as potentially conflicting state regulations. Other
commenters expressed concerns that specialists (that is, surgeons,
psychiatrists) who write prescriptions that are not permissible (that
is, controlled substances) would not be able to meet the measure.
Response: We agree with the commenters and will continue to exclude
controlled substances from the denominator. However, we are also adding
an alternative denominator to provide additional flexibility for EPs
who are able to electronically prescribe controlled substances and want
to count these prescriptions in the measure.
Comment: Most commenters did not support the inclusion of OTC
medicines in this objective, as OTC medicines are not usually intended
for the pharmacy to fill. Those commenters who did support it noted
that OTC medicines are
[[Page 53990]]
prescribed often times because it allows patients to use their health
care spending accounts to pay for the cost.
Response: After consideration of public comments, we agree with the
majority of commenters in that OTC medicines should not be included as
a part of this objective. While some OTC medicines are ordered by the
EP, the low prevalence of such occurrences means the costs of including
them in both measurement and actual e-prescribing outweighs any benefit
of inclusion.
Comment: Most commenters thought the proposed threshold was too
high or just right. Those who thought it was too high expressed
concerns about the abilities of mail-order pharmacies to accept
electronic subscriptions. Some commenters suggested lowering the
threshold to 50 percent. Other commenters expressed concerns that
patients may prefer a paper prescription and suggested excluding those
patients from the denominator. The commenters who thought the proposed
threshold was ``just right'' noted that most EPs who successfully
demonstrated meaningful use for Stage 1 far exceeded the Stage 1
threshold of 40 percent.
Response: Preliminary analysis of Stage 1 meaningful use
attestation data shows that those EPs who successfully attested for
this measure exceeded the 40 percent threshold--many reporting
thresholds of 80-100 percent. However, the Surescripts Q4 2011 Report
suggests that close to 40 percent of physicians who began e-prescribing
in 2008 meet the 65 percent threshold. This report only represents the
earliest adopters. Based on public comments, we believe the 65 percent
threshold we proposed may be unattainable for many EPs and question
whether any real difference in provider behavior is achieved with a 65
percent threshold versus a 50 percent threshold. This lower threshold
also accounts for patients who may prefer a paper prescription, rather
than having their prescription sent to a pharmacy electronically. After
consideration of public comments, we are finalizing the threshold for
this measure at 50 percent.
Comment: Most commenters supported comparing prescriptions written
by the EP to a drug formulary, but not without concern. Many noted that
drug formularies are not always readily available, are linked to
specific payers, or may not otherwise be readily available.
Response: After review of the public comments, we realize this
measure needs to be further clarified. We recognize that not every
patient will have a formulary that is relevant for him or her.
Therefore, we require not that the CEHRT check each prescription
against a formulary relevant for a given patient, but rather that the
CEHRT check each prescription for the existence of a relevant
formulary. If a relevant formulary is available, then the information
can be provided. We believe that this initial check is essentially an
on or off function for the CEHRT and should not add to the measurement
burden. Therefore, with this clarification of the check we are
referring to, we are finalizing the drug formulary check as a component
of this measure. We look forward to the day when a relevant formulary
is available for every patient. We also modified the measure to use the
word ``query'' instead of ``compare'' because it better explains the
process in which the EP uses the CEHRT to consult the information
provided in the formulary.
Comment: Many commenters expressed concerns about patients who
request paper copies of their prescriptions and how they would be
accounted for in this measure. Commenters also expressed concerns about
patients who prefer to use mail-order pharmacies that do not accept
eRx.
Response: We have accounted for patient preferences by lowering the
threshold for this measure from 65 percent to 50 percent.
Comment: Many commenters expressed concerns that the word
``permissible'' was omitted from the proposed exclusion for EPs who
write fewer than 100 prescriptions during the EHR reporting period.
Response: We agree with commenters in that we inadvertently omitted
the word ``permissible'' from this exclusion. After consideration of
public comments, we are finalizing this exclusion as ``EPs who write
fewer than 100 permissible prescriptions during the EHR reporting
period.''
Comment: Many commenters supported this exclusion but expressed
concerns about how it was proposed and would be implemented. Some
commenters suggested reducing the radius to 10 miles or less in urban
areas and leaving it at 25 miles in rural areas. Other commenters
suggested revising this exclusion for EPs where less than 20 percent of
pharmacies e-prescribe within a 25-mile radius of their office. Other
commenters expressed concerns that there may only be a limited number
of pharmacies in their geographic area that can accept prescriptions
electronically. Yet others suggested including a grace period for EPs
in areas where no pharmacies e-prescribe at the beginning of their EHR
reporting period, but later begin accepting eRx.
Response: We appreciate the commenters' concerns about this
exclusion. We agree with commenters in that a 25-mile radius may be too
large. We believe the 10-mile radius is more reasonable as it takes the
country's geographic diversity (urban, suburban, rural areas) into
account. We are therefore finalizing that if no pharmacies within a 10-
mile radius of an EP's practice location at the start of the EHR
reporting period accept electronic prescriptions, the EP would qualify
for this exclusion, unless the EP is part of an organization that owns
or operates a pharmacy within the 10-mile radius. As for patient
preference, we agree with commenters that not all patients will want to
go to a particular pharmacy just because they accept electronic
prescriptions. However, we believe we accounted for patient preference
by lowering the threshold for the measure to 50 percent.
After consideration of public comments, we are revising the measure
at Sec. 495.6(j)(2)(ii) to read: ``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 further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(b)(3) and 45 CFR 170.314(a)(10).
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: (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/her EHR reporting period.
Consolidated Objective: Maintain an up-to-date problem list of
current and active diagnoses.
[[Page 53991]]
Consolidated Objective: Maintain active medication list.
Consolidated Objective: Maintain active medication allergy list.
For Stage 2, we proposed to consolidate the objectives for
maintaining an up-to-date problem list, active medication list, and
active medication allergy list with the Stage 2 objective for providing
a summary of care for each transition of care or referral. We stated
that we continue to believe that an up-to-date problem list, active
medication list, and active medication allergy list are important
elements to be maintained in CEHRT. However, the continued
demonstration of their meaningful use in Stage 2 would be required by
other objectives focused on the transitioning of care of patients
removing the necessity of measuring them separately. Providing this
information is critical to continuity of care, so we proposed to add
these as required fields in the summary of care for the following Stage
2 objective: ``The EP, eligible hospital or CAH who transitions their
patient to another setting of care or provider of care or refers their
patient to another provider of care should provide a summary care
record for each transition of care or referral.'' We stated that EPs
and hospitals would have to ensure the accuracy of these fields when
providing the summary of care, which we believe would ensure a high
level of compliance in maintaining an up-to-date problem list, active
medication list, and active medication allergy list for patients. The
required standards for these fields are discussed in the ONC standards
and certification final rule published elsewhere in this issue of the
Federal Register.
Comment: Overall, we received very few comments on our proposal to
consolidate the up-to-date problem list, active medication list, and
active medication allergy list objectives. Some commenters opposed our
proposal as they believe it would detract from the importance of these
items. However, the vast majority of those who commented on this
proposal supported the consolidation of these objectives.
Response: After consideration of public comments, we are finalizing
the consolidation of these objectives as proposed for the reasons
discussed in the proposed rule. The objectives of maintaining an up-to-
date problem list, active medication list, and active medication
allergy list will be consolidated with the Stage 2 objective for
providing a summary of care for each transition of care or referral.
Proposed EP Objective: Record the following demographics: preferred
language, gender, race and ethnicity, and date of birth.
Proposed Eligible Hospital/CAH Objective. Record the following
demographics: preferred language, gender, race and ethnicity, date of
birth, and date and preliminary cause of death in the event of
mortality in the eligible hospital or CAH.
We proposed to continue the policy that EPs, eligible hospitals and
CAHs collect baseline demographic data for all unique patients in the
EHR using OMB standards for race and ethnicity. The proposed rule
outlines some of the numerous benefits from recording basic patient
demographic information in the EHR, including improved patient-centered
care and management of the health of populations. In response to
multiple comments from the Stage 1 final rule regarding the preliminary
cause of death data element required for eligible hospitals and CAHs,
we clarified the following; this element is the preliminary cause of
death recorded by the hospital and is not required to be amended when
additional information becomes available, there is no specified
timeframe for recording this element, and we invited additional public
comment regarding these clarifications in the proposed rule. We also
asked for public comment on the burden and ability to include
additional measures of disability status, gender identity and/or sexual
orientation.
Comment: We received many comments suggesting CMS differentiate
between the terms sex and gender. One commenter provided the definition
that the term sex is used in recording vital health statistics that
describe the physiological characteristics at time of birth. The term
gender incorporates behaviors, roles, and expectations corresponding to
an individual's sex and is generally self reported.
Response: We appreciate this clarification and will incorporate the
change in terminology for the final rule using the term sex instead of
gender in EP, eligible hospital and CAH objectives for recording
demographics. This change in terminology aligns with vital statistic
reporting and the HHS final demographic data collection standards
published October 31, 2011.
Comment: Several commenters indicated that the collection of race
and ethnicity demographic information can be sensitive and patients may
be unwilling or uncomfortable reporting this information to the
individual collecting demographic data. Other comments supported CMS
clarification in the Stage 1 final rule that providers can be allowed
to account for patients who decline to provide elements of demographic
information. Additional comments suggested that a single system
parameter be developed to identify states that prohibit data reporting
should be available to the EHR.
Response: If a patient declines to provide information of ethnicity
or race or if capturing a patient's ethnicity or race is prohibited by
state law, this should be duly noted as structured data in the EHR and
this would still count as an entry for the purpose of meeting this
measure. A study by the Agency for Healthcare Research and Quality
(AHRQ) states that current state prohibitions on the collection of
ethnicity and race apply to health plans' collection of data at the
time of enrollment. Title VI of the Civil Rights Act of 1964 permits
health care organizations to collect race, ethnicity, and preferred
language patient data for the purpose of quality improvement.
Comment: Several commenters suggested that CMS use the same
definition for race and ethnicity as the Centers for Disease Control
and Prevention (CDC) and the United States Census Bureau. Other
commenters were concerned about the need to collect data granular
enough to identify differences between subpopulations and aligned
across government programs.
Response: We recognize that the CDC has developed codes that allow
for the mapping of more detailed race and ethnicity categories such as
those maintained by the U.S. Bureau of the Census to the less detailed
OMB standard. We appreciate that providers may need to collect more
granular demographic data to manage their patient populations. For
purposes of achieving Stage 2 of meaningful use, we will continue to
rely on the OMB standard as a minimum standard for the collection of
race and ethnicity data. EPs, eligible hospitals, and CAHs who wish to
collect more granular level data on patient race and ethnicity may do
so as long as they can map the data to 1 of the 5 races included in the
existing OMB standards. The standards associated with the meaningful
use objectives and measures are discussed further in the ONC standards
and certification criteria final rule and we refer readers to that
regulation published elsewhere in this issue of the Federal Register.
Comment: Many commenters agreed with the need to incorporate
disability status in EHR technology. However, it was also clear that
several of these commenters varied in their definition of disability
with interpretations that ranged from physical, mental, occupational,
and economic disability
[[Page 53992]]
status. Commenters also differed regarding the most appropriate
location for the capture and storage of disability status data elements
within the EHR. Suggestions for where to incorporate disability status
data varied (for example; from the demographic objective, to physician
notes, and/or the problem list component of the summary of care
document). Another commenter suggested that the demographic objective
should be limited to collecting data with static values and the active
problem list, electronic notes and/or care summary documents that are
continually updated would be more appropriate for recording changes in
patient disability status.
Response: We wish to clarify that the term disability status used
in the proposed rule was meant to be all-encompassing by incorporating
both the concepts of physical and cognitive disabilities as well as the
concept of functional status limitations that impact an individual's
capability to perform activities in different environments. This latter
concept incorporates metrics useful for planning and coordination
across care settings. Commenters varied in their responses regarding
the level of consensus on measurement standards for each of these
health status measures. Since publishing the proposed rule we have
learned that significant progress has been made regarding the capture
of functional status into the consolidated clinical document
architecture (C-CDA) standard for summary of care records. The C-CDA
Implementation Guide provides the following examples that may be
incorporated under functional status; assessments of a patient's
language, vision, hearing, activities of daily living, behavior,
general function, mobility, self-care status, physical state and
cognitive function.\1\ The C-CDA standards support the exchange of
clinical documents between those involved in the care of a patient and
allow for the re-use of clinical data for clinical care giving, public
health reporting, quality monitoring, patient safety and clinical
trials. This inclusion is addressed more fully under the discussion of
the transition of care objective in this final rule.
---------------------------------------------------------------------------
\1\ Implementation Guide for CDA Release 2.0 (US REALM) July
2012, (copyright) 2012 Health Level Seven, Inc. Ann Arbor, MI.
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We strongly support the adoption, implementation and meaningful use
of CEHRT for all individuals and the reduction of barriers for persons
with disabilities. In finalizing this rule, we also considered the
operational challenges that could result from the lack of consensus
noted by many commenters to incorporate a physical disability standard
measure in the demographic section of CEHRT at this time. As a result,
we will not require the collection of disability status data under the
demographic objective for Stage 2 of meaningful use. However, we
suggest that providers examine the questions developed by the HHS as
required by section 4302 of the Affordable Care Act. The questions
resulted from an interagency process and are closely aligned to the
Census Bureau's American Community Survey and the International
Classification of Disability. These questions may be found on the HHS
Web site at http://minorityhealth.hhs.gov/templates/content.aspx?ID=9232#1. The answers to these questions could be
incorporated as functional status or other data elements in the C-CDA
summary of care document mentioned above and discussed more fully in
the transition of care objective later in this rule.
We will continue to work with ONC, other federal agencies and seek
the advice of the HIT Policy Committee to explore further how
disability status could be included in meaningful use Stage 3.
Comments: Many commenters supported the proposed inclusion of
recording gender identity and/or sexual orientation as part of the
demographic objective. Other commenters suggested that the collection
of this information is extremely sensitive and could be considered
offensive for some patients especially when collected by administrative
staff. Still other commenters did not see the clinical significance of
collecting and recording this information in the demographic section of
the EHR. Others commenters were against recording gender identity and/
or sexual orientation because they did not consider this would provide
additional clinical benefit. Still others suggested that the reporting
of gender identity or sexual orientation be optional and up to
individual clinician judgment whether or not it is appropriate to
collect this information.
Similar to the comments for the proposed inclusion of disability
status, commenters noted both the data collection challenges and data
reporting burden. Many commenters were opposed to the mandatory
collection of all three additional measures for Stage 2 of meaningful
use and suggested that reporting could be optional.
Response: Considering the lack of consensus for the definition of
the concept of gender identity and/or sexual orientation as well as for
a standard measure of the concept and where it would be most
appropriate to store the data within the EHR, we will await further
development of a consensus for the goal and standard of measurement for
gender identity and/or sexual orientation. Additionally, we note that
many commenters raised concerns as to whether such data collection is
necessary for all EPs, eligible hospital, and CAH regardless of
specialty.
Comments: Several additional measures were suggested under the
demographic objective including; measuring the level of access to and
use of the internet, measuring computer literacy, and measuring
standardized occupation using established industry codes.
Response: We appreciate the numerous comments suggesting additional
demographic information that will allow providers to improve the
quality of individual patient centered care as well as population
health. We may consider these suggestions further in the development of
Stage 3 of meaningful use.
Comment: A minority of commenters recommended removing the
preliminary cause of death element altogether from the eligible
hospital/CAH objective. Others suggested that the eligible hospital/CAH
measure for preliminary cause of death be modified to simply capture
whether or not the patient had a cause of death recorded, regardless of
when that information was entered into the EHR, because the preliminary
cause of death may often be inaccurate since by law the coroner or
medical examiner makes the final determination for the patient's death
certificate.
Response: We appreciate the suggestion for measure simplification.
However, for this measure we want to respect the existing hospital
workflow where a clinician evaluates the patient to pronounce the
death. This preliminary cause of death is documented by the clinician
in the patient's chart. We recognize that these workflows may change as
EHR technology develops and becomes more widely adopted and the
exchange of health information is able to link to vital statistic
reporting. However, for the time being the measure of preliminary cause
of death under the demographic objective will remain unchanged.
After consideration of the public comments received, we are
modifying the meaningful use objective at Sec. 495.6(j)(3)(i) of our
regulations as follows: EPs ``Record all of the following demographics:
Preferred language, sex, race, ethnicity, and date of birth.''
After consideration of the public comments received, we are
modifying the meaningful use objective at Sec. 495.6(l)(2)(i) of our
regulations as
[[Page 53993]]
follows: Eligible hospitals and CAHs ``Record all of the following
demographics: Preferred language, sex, race, ethnicity, date of birth,
date and preliminary cause of death in the event of mortality in the
eligible hospital or CAH.''
Proposed Measure: More than 80 percent of all unique patients seen
by the EP or admitted to the eligible hospital's or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have demographics recorded as structured data.
Comment: Most commenters were supportive of the increased threshold
for this measure.
Response: Our analysis of the meaningful use data for Stage 1 found
that over 90 percent of EPs, eligible hospitals and CAHs were able to
successfully report the demographic measure. Therefore, based on
comments and actual performance data we do not foresee a burden in
increasing the measure threshold from more than 50 percent in Stage 1
to greater than 80 percent in Stage 2.
After consideration of public comments, we are finalizing this
measure for EPs at Sec. 495.6(j)(3)(ii) and for eligible hospitals and
CAHs at Sec. 495.6(l)(2)(ii) as proposed.
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 CEHRT at 45 CFR 170.314(a)(3).
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by
the EP or admitted to an eligible hospital or CAH inpatient or
emergency department (POS 21 or 23) during the EHR reporting period.
Numerator: The number of patients in the
denominator who have all the elements of demographics (or a specific
notation if the patient declined to provide one or more elements or if
recording an element is contrary to state law) recorded as structured
data.
Threshold: The resulting percentage must be more
than 80 percent in order for an EP, eligible hospital or CAH to meet
this measure.
If a patient declines to provide one or more demographic elements
this can be noted in the CEHRT and the EP or hospital may still count
the patient in the numerator for this measure. The required elements
and standards for recording demographics and noting omissions because
of state law restrictions or patients declining to provide information
will be discussed in the ONC standards and certification rule,
published elsewhere in this issue of the Federal Register.
Proposed Objective: Record and chart changes in the following vital
signs: height/length and weight (no age limit); blood pressure (ages 3
and over); calculate and display body mass index (BMI); and plot and
display growth charts for patients 0-20 years, including BMI.
We proposed to continue our policy objective from Stage 1 to
collect and record basic vital sign data for patients across health
care settings. In the proposed rule, we outlined the benefits of
documenting basic vital signs including that the data provides
important clinical information on both the patient's current condition
as well as the ability to track changes in patient status over time.
For Stage 2, we proposed to remove the age restrictions on recording
height/length and weight, and also proposed to remove the age
restrictions on calculating and displaying BMI and growth charts. In
addition, we proposed to modify the Stage 1 blood pressure guideline to
align with the American Academy of Pediatrics guideline recommendations
to measure blood pressure for children 3 years of age and older. We
also proposed to continue our exclusions policy from Stage 1 (with
modifications, as discussed below) for EPs who believe that recording
and charting vital signs is outside the scope of their practice.
Comment: Several commenters questioned why all providers need to
collect vital sign data when this information should be available from
a robust health information exchange across providers.
Response: We will continue the Stage 1 meaningful use policy that
any method of obtaining height, weight and blood pressure is acceptable
for the purpose of this objective as long as the information is
recorded as structured data in the CEHRT. As stated in the proposed
rule, the vital sign information can be entered into the patient's
medical record in a number of ways including: direct entry by the EP,
eligible hospital, or CAH; entry by a designated individual from the
EP, eligible hospital, or CAH's staff; data transfer from another
provider electronically, through an HIE or through other methods; or
data entered directly by the patient through a portal or other means.
Some of these methods are more accurate than others, and it is up to
the EP or eligible hospital to determine the level of accuracy needed
to care for their patient and how best to obtain this information. We
also look forward to the time when a more robust health information
exchange network will allow providers to share relevant data across
settings and/or alert providers when additional data should be
obtained.
Comment: We received comments requesting that CMS include a
statement clarifying which specialties would be included or excluded
from this objective.
Response: We appreciate commenter's efforts to clarify this
objective. However, we will continue our more general policy from Stage
1 (with modifications, as explained later) of allowing EPs to exclude
this objective if they believe recording and charting changes in vital
signs is not relevant to their scope of practice. We cannot define the
scope of practice and/or interventions necessary for each individual
patient and will continue to rely on provider determinations based on
individual patient circumstances. Consider a hypothetical example of an
elderly patient with multiple chronic conditions that includes
depression. When the patient is seen by his behavioral healthcare
provider to manage his depression, it is up to that provider to
determine whether it would be medically necessary to record and chart
the patient's weight in order to manage the patient's care.
After consideration of public comments, we are finalizing this
objective for EPs at Sec. 495.6(j)(4)(i) and for eligible hospitals
and CAHs at Sec. 495.6(l)(3)(i) as proposed.
Proposed Measure: More than 80 percent of all unique patients seen
by the EP or admitted to the eligible hospital's or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have blood pressure (for patients age 3 and over only) and height/
length and weight (for all ages) recorded as structured data.
We proposed to split the exclusions from Stage 1 such that an EP
could choose to record height/length and weight only and exclude blood
pressure, or record blood pressure only and exclude height/length and
weight. We encouraged comments on this split and whether it should go
both ways. We proposed to increase the threshold from more than 50
percent to more than 80 percent for this measure.
Comment: Several commenters agreed with the policy that height/
length, weight, and blood pressure do not each need to be updated by a
provider neither at every patient encounter nor even once per patient
seen during the EHR reporting period.
Response: We will maintain our policy from Stage 1 that it is up to
the EP or hospital to determine whether height/length, weight, and
blood
[[Page 53994]]
pressure each need to be updated, the level of accuracy needed to care
for their patient, and how best to obtain the vital sign information
that will allow for the right care for each patient.
Comment: Another commenter suggested that CMS clarify that the
growth charts and BMI are not part of the actual measure for this
objective.
Response: We clarify that to satisfy the measure of this objective,
the CEHRT must have the capability to calculate BMI and produce growth
charts for patients as appropriate. Since BMI and growth charts are
only produced when height/length and weight vital sign data are
captured in the CEHRT, the measure is limited to these data elements.
Overall commenters supported the added flexibility of our proposal
to split the exclusion and allow EPs to record blood pressure only or
height/length and weight only. Our analysis of the meaningful use data
for Stage 1 found that over 90 percent of EPs, eligible hospitals and
CAHs were able to successfully report the vital signs measure. We did
not propose additional measure elements that could increase the
reporting burden at this time.
After consideration of the public comments received, we are
finalizing this measure as proposed for EPs at Sec. 495.6(j)(4)(ii)
and for eligible hospitals and CAHs at Sec. 495.6(l)(3)(ii).
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 CEHRT at 45 CFR 170.314(a)(4). The ability to calculate
the measure is included in CEHRT.
To calculate the percentage, CMS and ONC have worked together to
define the following:
Denominator: Number of unique patients seen by the EP or
admitted to an eligible hospital's or CAH's inpatient or emergency
department (POS 21 or 23) during the EHR reporting period.
Numerator: Number of patients in the denominator who have
at least one entry of their height/length and weight (all ages) and/or
blood pressure (ages 3 and over) recorded as structured data.
Threshold: The resulting percentage must be more than 80
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusions: Any EP who sees no patients 3 years or older
is excluded from recording blood pressure. Any EP who believes that all
3 vital signs of height/length, weight, and blood pressure have no
relevance to their scope of practice is excluded from recording them.
Any EP who believes that height/length and weight are relevant to their
scope of practice, but blood pressure is not, is excluded from
recording blood pressure. Any EP who believes that blood pressure is
relevant to their scope of practice, but height/length and weight are
not, is excluded from recording height/length and weight.
Proposed Objective: Record smoking status for patients 13 years old
or older.
We stated in the proposed rule that accurate information on smoking
status provides context to a high number and wide variety of clinical
decisions, such as immediate needs for smoking cessation or long-term
outcomes for chronic obstructive pulmonary disease. Cigarette smoking
is a key component to the current Million Hearts Initiative (http://millionhearts.hhs.gov). We did not propose rules on who may record
smoking status or how often the record should be updated. In addition,
we proposed to continue the age limitation at 13 years old. We also
requested comments specifically on the possible inclusion of other
forms of tobacco use and second hand smoke.
Comment: We have received comments that assert that the objective
is not relevant to a significant number of EPs due to their scope of
practice and that it is redundant to the clinical quality measure
``National Quality Forum (NQF) 28: Preventive Care and Screening:
Tobacco Use: Screening and Cessation Intervention''. Some of the
comments suggest that it should be eliminated and those EPs for whom it
is relevant select the CQM.
Response: We disagree that the proposed objective and the clinical
quality measure identified by commenters serve the same purpose and
therefore only one should be included. The objective seeks to ensure
that information on smoking status is included in the patient's record.
Furthermore, that the information is stored in a structured format so
that it can automatically be identified by CEHRT as smoking status for
possible reporting or exchanging. We also note that the clinical
quality measure only focuses on patients 18 years or older, while the
objective focuses on patients 13 years or older. In addition, many
quality measures related to smoking are coupled with follow-up actions
by the provider such as counseling. We consider those follow-up actions
to be beyond the scope of what we hope to achieve for this objective
and would move the objective beyond the scope of practice for many
providers. We disagree that the objective is not relevant to EPs seeing
patient 13 years old or older. We note that this is intended to inform
the provider. The frequency of when the information is updated, detail
beyond the standard included in certification of EHR technology and
many other factors discussed later are all left up to the provider to
decide and fit to their scope of practice and their patient population.
Comment: We received conflicting suggestions in comments regarding
the age limitation. These comments can be divided into those suggesting
a lower age (as low as 8 to 12), those supporting 13 years old and
those who believe it should be raised to 18 to match the clinical
quality measures associated with smoking.
Response: It is apparent from the comments that the appropriate age
for smoking status is an elusive target highly dependent on the
situation. For example, it was suggested in comments that the age be
lowered for patients meeting certain characteristics such as parents
who smoke or other risk factors, while remaining at 13 for other
patients. In our review of the public comments, we do not believe a
consensus has been reached on a different age limitation than our Stage
1 age limitation of 13 years old and therefore finalize the age
limitation as proposed. As with other meaningful use objectives and
measures, this represents a minimum requirement. We encourage each and
every provider to evaluate whether their scope of practice and/or
patient population calls for collecting smoking status on patients
younger than 13 or more detailed information than required by this
objective.
Comment: There continues to be strong support for expanding smoking
to other forms of tobacco use. Commenters note that other types of
tobacco use are supported by the clinical quality measure ``NQF 28:
Preventive Care and Screening: Tobacco Use: Screening and Cessation
Intervention''.
Response: We refer readers to ONC's standards and certification
criteria final rule that is published elsewhere in this issue of the
Federal Register for discussions on the adoption of a standard that
would support other types of tobacco use. As ONC did not adopt a
standard supporting other forms of tobacco use, we do not expand the
objective.
Comment: Some commenters expressed strong support for the inclusion
of second-hand smoke either as part of this objective or as a separate
objective.
Response: We agree with the importance of collecting second-hand
smoke information for many EPs and hospitals. However, as with other
forms of tobacco use, there is not a standard on which to base the
requirement of
[[Page 53995]]
collection of this information as structured data.
After consideration of the public comments received, we are
finalizing this objective as proposed for EPs as Sec. 495.6(j)(5)(i)
and for eligible hospitals and CAHs at Sec. 495.6(l)(4)(i).
Proposed Measure: More than 80 percent of all unique patients 13
years old or older seen by the EP or admitted to the eligible
hospital's or CAH's inpatient or emergency departments (POS 21 or 23)
during the EHR reporting period have smoking status recorded as
structured data.
In our proposed rule, based on Stage 1 data showing performance on
this measure far exceeded the measure threshold of more than 50
percent, we proposed a threshold of more than 80 percent for this
measure for Stage 2 of meaningful use.
Comment: We received comments asking for clarification on what must
be recorded in the EHR and how often for the numerator to be met.
Response: Information on smoking status must be present as
structured data using the standard specified at 45 CFR 170.314(a)(11).
There is no requirement that the smoking status be entered into the
record by a specific person or category of persons, there is no
requirement that smoking status be entered into the CEHRT already in
the terminology of the standard and there is no requirement on how
frequently this information be updated. A patient indicating how many
packs he smokes a day on a new patient questionnaire which is then
entered by an administrative person and mapped in the CEHRT to one of
the responses in the standard is valid for this measure. A physician
could also ask a patient detailed questions to determine if the patient
is a current smoker, input the information into the CEHRT, and select
one of the responses of the standard. ONC has provided a mapping of
SNOMED CT[supreg] ID to the descriptions at 45 CFR 170.314(a)(11).
Comment: We received a few comments on the threshold. Most were
supportive, while others believe it should remain at 50 percent.
Response: Due to our analysis of performance on this measure from
Stage 1 and the support received from commenters, we are finalizing the
threshold as proposed.
After consideration of public comments, we are finalizing this
measure as proposed for EPs at Sec. 495.6(j)(5)(ii) and for eligible
hospitals and CAHs at Sec. 495.6(l)(4)(ii).
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 CEHRT at 45 CFR 170.314(a)(11).
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients age 13 or older
seen by the EP or admitted to an eligible hospital's or CAH's inpatient
or emergency departments (POS 21 or 23) during the EHR reporting
period.
Numerator: The number of patients in the denominator with
smoking status recorded as structured data.
Threshold: The resulting percentage must be more than 80
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusion: Any EP, eligible hospital, or CAH that neither
sees nor admits any patients 13 years old or older.
CQM Reporting as a Stage 2 Objective--We proposed to add CQM
reporting to the definition of ``meaningful EHR user'' under Sec.
495.4 instead of including it as a separate objective under Sec.
495.6. Accordingly, we did not propose a CQM reporting objective for
EPs and hospitals as part of the Stage 2 criteria under Sec. 495.6.
Comment: While some commenters indicated that this change would be
confusing, most commenters supported this change.
Response: We appreciate the support of commenters and believe
including CQM reporting in the definition of ``meaningful EHR user''
under Sec. 495.4 will actually alleviate confusion. Therefore, we are
not finalizing an objective related to the reporting of CQMs in the
Stage 2 criteria for meaningful use under Sec. 495.6. Although CQM
reporting is not listed as a separate objective and measure under Sec.
495.6, it remains a condition for demonstrating meaningful use.
Consolidated Objective: Implement drug-drug and drug-allergy
interaction checks.
For Stage 2, we proposed to make the objective for ``Implement
drug-drug and drug-allergy checks'' one of the measures of the core
objective for ``Use clinical decision support to improve performance on
high-priority health conditions.'' We 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 clinical decision support
that focuses on patient health and safety, we proposed to include this
functionality as part of the objective for using clinical decision
support.
We discuss comments regarding this consolidation in the discussion
of the clinical decision support objective.
Proposed Objective: Use clinical decision support to improve
performance on high-priority health conditions.
We proposed to modify the clinical decision support (CDS) objective
for Stage 2 such that CDS would be used to improve performance on high-
priority health conditions. We stated it would be left to the
provider's clinical discretion to select the most appropriate CDS
interventions for their patient population. We also proposed that the
CDS interventions selected must be related to five or more of the
clinical quality measures (CQMs) on which providers would be expected
to report. The goal of the proposed CDS objective is for providers to
implement improvements in clinical performance for high-priority health
conditions that will result in improved patient outcomes.
Comment: A few commenters voiced concern regarding the maturity of
the development of clinical decision support systems. Others voiced a
misconception that not all CEHRT includes pre-built CDS interventions
where both capabilities and content are vendor supplied. The commenter
went on to clarify that the CDS interventions must be specific to each
provider's requirements. Still others commented on the CMS change in
terminology from CDS ``rules'' to CDS ``interventions'' increases the
range of available interventions.
Response: We recognize commenters' concerns regarding the maturity
of CDS systems. Closely linked to the development of EHRs, there are
multiple factors impacting the evolution of CDS systems including; the
increasing availability and sophistication of information technology in
clinical settings, the increasing pace of publication of new evidence-
based guidelines for clinical practice and the continual evaluation and
improvements of CDS.\2\ We clarify that all CEHRT includes CDS
interventions. The companion ONC standards and certification criteria
final rule published elsewhere in this issue of the Federal Register
includes further information regarding the criteria necessary to
implement CDS in CEHRT
[[Page 53996]]
for Stage 2 of meaningful use. With each incremental phase of
meaningful use, CDS systems progress in their level of sophistication
and ability to support patient care. For Stage 2 of meaningful use, it
is our expectation that at a minimum, providers will select clinical
decision support 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, we will consider a broad range of CDS interventions
that improve both clinical performance and the efficient use of
healthcare resources in measuring providers' ability to demonstrate the
meaningful use of CEHRT for Stage 2.
---------------------------------------------------------------------------
\2\ Study Protocol for the Effects of computerized clinical
decision support systems on practitioner performance and patient
outcome: Methods of a decision-maker-researcher partnership
systematic review. R Brian Haynes*, Nancy L Wilczynski and the
Computerized Clinical Decision Support System (CCDSS) Systematic
Review Team. IMPLEMENTATION SCIENCE 2010, 5:12.
---------------------------------------------------------------------------
After consideration of the public comments received, we are
finalizing this objective as proposed for EPs at Sec. 495.6(j)(6)(i)
and for eligible hospitals and CAHs at Sec. 495.6(l)(5)(i).
Proposed Measure: We proposed two measures for EPs, eligible
hospitals and CAHs for this objective. Both of the measures must be met
in order for the provider to satisfy this objective:
1. Implement five clinical decision support interventions related
to five or more clinical quality measures at a relevant point in
patient care for the entire EHR reporting period; and
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.
We proposed to make the Stage 1 objective for ``implement drug-drug
and drug-allergy interaction checks'' one of the measures of the CDS
objective for Stage 2. Based on the HIT Policy Committee's
recommendation, we proposed that each CDS intervention must enable
providers to review all of the following attributes for the
intervention: developer of the intervention, bibliographic citation,
funding source of the intervention, and the release or revision date of
each intervention. The ONC standards and certification criteria final
rule published elsewhere in this issue of the Federal Register provides
additional information regarding the incorporation of the CDS in CEHRT.
We proposed that providers must implement the CDS intervention at a
relevant point in patient care when the intervention can influence
clinical decisionmaking before an action is taken on behalf of the
patient. We proposed that providers must implement five CDS
interventions that they believe will result in improvement in
performance for five or more of the clinical quality measures on which
they report. If none of the clinical quality measures is applicable to
an EP's scope of practice, the EP should implement a CDS intervention
that he or she believes will be effective in improving the quality,
safety, or efficiency of patient care.
Comment: Many commenters noted that at least one of the CDS
interventions implemented should be tied to efficiency goals (for
example, reducing the overuse of high-cost procedures).
Response: While we believe that it is entirely possible for a CDS
intervention to improve both the quality of care and improve healthcare
efficiency, we agree with the suggestion that at least one intervention
could be tied directly to improving the efficient use of healthcare
resources. In considering whether a CDS intervention increases
healthcare efficiency, providers can consider improvements in any
healthcare process. Some examples, of CDS interventions that may lead
to improvements in healthcare efficiency include, alerts when duplicate
tests, procedures or treatments are ordered for the same patient, using
clinical guidelines for direct patient care processes, documentation
templates to reduce variability in recording and alerting when outside
of specified parameters, and using evidence based pre-specified order
sets for blood products. Therefore, we are modifying the proposed CDS
measure such that four of the CDS interventions are related to four or
more CQMs, and the fifth CDS intervention should be related to
improving healthcare efficiency. We clarify that any of the five CDS
interventions may be related to both CQMs and improving healthcare
efficiency.
Comment: Various comments were received in response to the proposed
number of CDS interventions that are related to five or more CQMs. One
commenter noted the potential for improved provider reporting and user
efficiencies due to the inherent measure associations. Several
commenters welcomed this improved alignment of CQM measures and
reporting between the EHR Incentive Program and other CMS quality
programs. Other commenters expressed the difficult burden for
specialists and others who may not be able to identify sufficient CQMs
related to their patient population. Still other comments suggested
that providers could easily implement double the number of proposed CDS
interventions.
Response: Overall comments were supportive of the proposed number
of CDS interventions and of aligning these interventions with CQM
reporting. If none of the clinical quality measures are applicable to
an EP's scope of practice, the EP should implement a clinical decision
support intervention that he or she believes will be effective in
improving the quality, safety or efficiency of patient care. We believe
that the proposed clinical quality measures for eligible hospitals and
CAHs would provide ample opportunity for implementing clinical decision
support interventions related to high-priority health conditions.
Comment: Commenters also supported continuing the requirement for
providers to enable and implement drug-drug and drug-allergy
interaction checks for the entire reporting period under the new CDS
measure. An AHA Survey indicated that 73 percent of hospitals could
perform the drug/drug and drug/allergy check, as well as at least one
additional clinical decision support function in the Fall of 2011.
Response: We appreciate the commenters' overall support for
consolidating this Stage 1 objective into one of the required clinical
decision support measures. We also agree that drug-drug and drug-
allergy interaction checks are important CDS tools contributing to
improvements in patient safety and the overall quality of patient care.
Comment: Additional comments addressed concerns regarding the point
at which professionals will be able to exercise clinical judgment about
the CDS intervention before action is taken on behalf of the patient.
The specific concern is that some interventions are only triggered when
an action is about to be taken, and proposed that CMS revise this
criterion to ``before or at the time an action is taken.''
Response: We 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.'' We clarify that
the CDS implementation criterion which allow for CDS implementation at
a relevant point in patient care includes interventions that may occur
before or at the time an action is taken in the care delivery process.
Comment: Several commenters expressed concern with ``alert
fatigue'' associated with increased use of clinical decision support
interventions. These commenters cited studies that suggest
[[Page 53997]]
that multiple alerts may be disabled or ignored resulting in adverse
effects in the quality of care and patient safety.
Response: We recognize that ``alert fatigue'' is a potential
occurrence with the increased use of some types of clinical decision
support interventions. However, meaningful use seeks to leverage the
capabilities of CEHRT to improve patient care. The selection of CDS
interventions should weigh both the potential for unintended
consequences including alert fatigue against the benefits of each CDS
intervention, and the appropriate selection of an intervention type
that interferes minimally with the provider's clinical workflow and
cognitive burden. We believe such determinations are best left to
providers. CDS is included as a meaningful use objective because we
believe that the overall benefit of CDS is to improve patient safety
and the quality of care. Therefore, we will continue to require the
implementation of clinical decision support interventions in order to
achieve meaningful use. Finally, as defined in the ONC standards and
certification criteria final rule published elsewhere in this issue of
the Federal Register, CDS is ``not simply an alert, notification, or
explicit care suggestion.'' While some alerts may be helpful and
necessary, we encourage EPs and hospitals to consider the selection of
CDS interventions that are not alerts in order to reduce the burden of
alert fatigue. Examples of non-alert CDS may include patient or disease
specific order sets, referential decision support (presentation or
availability of clinical reference information such as diagnostic
guidance, dosing guidelines, or lab value interpretation assistance, or
patient or disease specific documentation forms/templates that remind
the provider to capture essential historical or physical exam findings
for a patient with a certain condition). A common example of a CDS
form/template would be a documentation form that is presented for
patients with diabetes that includes a required section for the
diabetic foot exam, where the same form would be presented for patients
without diabetes and with the diabetic foot exam section removed.
Comment: Several commenters requested the flexibility to be able to
change CDS interventions at any point during the reporting period so
that in effect they would not be implementing the CDS intervention
during the entire reporting period. Commenters cited provider
uncertainty at the beginning of a reporting period of which CQMs they
will ultimately report during the attestation process (for example, due
to low counts for the measures). Many commenters requested the
additional flexibility for providers to be permitted to implement CDS
interventions relevant to any of the finalized panel of clinical
quality measures specific to the provider type, even if the provider
ultimately chooses different clinical quality measures to report.
Commenters requested the opportunity to change CDS interventions during
the reporting period and not be penalized for the CDS measure that
requires the intervention during the entire reporting period.
Commenters also wanted clarification whether they have to align CDS
interventions with the same CQM measures reported for meaningful use.
Response: We expect providers to align CDS interventions with CQMs
to the extent possible, although we recognize that providers may not
know at the beginning of a reporting period which CQMs they will end up
selecting to report. Based on the comments, we clarify that EPs and
hospitals may implement CDS interventions that are related (as defined
in the proposed rule) to any of the clinical quality measures for EPs
and hospitals, respectively, and that are finalized for the EHR
Incentive Program for the relevant year of reporting. In other words,
providers are not required to implement CDS interventions that are
related to the specific CQMs that they choose to report for that year.
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. We will require
providers to implement a minimum of five CDS interventions for the
entire EHR reporting period. The provider may switch between CDS
interventions or modify them during the EHR reporting period as long as
a minimum of five are implemented for the entire EHR reporting period.
We expect that providers may choose to implement a greater number of
interventions from which they can select five interventions that have
been enabled for the entire EHR reporting period when they attest to
meaningful use.
Comment: Several providers recommend to be allowed to use their
clinical judgment regarding which clinical decision support
interventions would best benefit patients within the scope of their
practice.
Response: We thank providers for this comment and want to clarify
that in Stage 1; CMS allowed providers significant leeway in
determining the clinical support interventions most relevant to their
scope of practice. In Stage 2, we will continue to provide the
flexibility for providers to identify high-priority health conditions
that are most appropriate for CDS. As we stated in the proposed rule,
for Stage 2 we will not require the provider to demonstrate actual
improvements in performance on clinical quality measures for this
objective. Because CQMs focus on high-priority health conditions by
definition, to the extent possible, four of the five CDS interventions
that are implemented must be related to CQMs. Providers are also
reminded that the CDS interventions selected for Stage 2 represent only
a floor. 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.
Comment: Several commenters voiced concern that CDS interventions
must be predetermined at the beginning of an EHR reporting period but
providers do not have to choose CQMs until the end of the attestation
reporting period. There is concern that providers will be unable to
change the CDS interventions if they decide to change the related CQMs
in a reporting period.
Response: We proposed alignment with CQMs to facilitate provider
reporting and measurement, but as we clarified earlier, 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. 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 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: Commenters supported the inclusion of drug-drug and drug-
allergy checks noting that they are critical to ensuring the safety of
the medications prescribed for patients, and agree with the inclusion
of this measure. Other commenters noted the lack of an for EPs
[[Page 53998]]
who do not prescribe medications and thus would not be able to meet
this core set objective.
Response: We received similar feedback after publication of the
Stage 1 final rule and after careful consideration of the comments, we
will allow an exclusion to this measure for EPs that write fewer than
100 medication orders during the EHR reporting period. We did not
include this exclusion as a change to Stage 1 as this is primarily an
implementation of a function of CEHRT and there is no requirement to
update CEHRT in 2013. This exclusion aligns with the exclusion under
the objective CPOE for medication orders discussed earlier in this
rule.
Comment: There were several comments regarding the implementation
of CDS and the attributes required for each intervention. Commenters
did not believe that the information requested in order to support the
inclusion of CDS attributes would be available to many providers,
particularly for providers in a group practice. Commenters also
requested clarification whether these attributes would be required for
drug-drug and drug-allergy interactions. Other commenters requested
additional clarification regarding the extent that CDS attributes are
required when the interventions result from self-generated evidence.
Other comments addressed provider concerns regarding the need to
purchase additional expensive vendor products and upgrades to
incorporate these requirements.
Response: We appreciate the many comments for the proposed CDS
attributes. We clarify that the need for inclusion of attributes for
each CDS intervention also applies to drug-drug and drug-allergy
interventions as well as interventions based on self-generated
evidence. The companion ONC standards and certification criteria final
rule published elsewhere in this issue of the Federal Register further
describes CEHRT requirements for these CDS attributes in order to
ensure that all users of CEHRT will have access to this new
functionality. After consideration of the public comments and for the
reasons discussed earlier, we are modifying the measures for EPs at
Sec. 495.6(j)(6)(ii) and for eligible hospitals and CAHs at Sec.
495.6(l)(5)(ii) as follows:
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 . It
is suggested that one of the five clinical decision support
interventions be related to improving healthcare efficiency.
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 further specify that in order to meet this objective and
measure, an EP, eligible hospital, or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(a)(8) and (a)(2).
Replaced Objective: Provide patients with an electronic copy of
their health information.
Replaced Objective: Provide patients with an electronic copy of
their discharge instructions.
For Stage 2, we did not propose the Stage 1 meaningful use
objectives for EPs and hospitals to provide patients with an electronic
copy of their health information and discharge instructions upon
request. As we stated in the proposed rule, the HIT Policy Committee
recommended that these objectives be combined with the objectives for
view online, download, and transmit. We agreed with the HIT Policy
Committee and proposed to replace the Stage 1 objectives above with
objectives and measures for Stage 2 that would enable patients to view
online and download their health information and hospital admission
information. We stated that continued online access to such information
is more useful and provides greater accessibility over time and in
different health care environments than a single electronic
transmission or a one-time provision of an electronic copy, especially
when that access is coupled with the ability to download a
comprehensive point in time record.
We received no comments that supported the retention of these
objectives for Stage 2. Therefore, we are finalizing the replacement of
these objectives for EPs, eligible hospitals, and CAHs as proposed.
Please refer to the discussions later in this rule regarding view
online, download, and transmit objectives for both EPs and eligible
hospitals and CAHs for more information about the Stage 2 objectives
that replace these Stage 1 objectives.
Proposed EP Objective: Provide clinical summaries for patients for
each office visit.
In the proposed rule, we outlined the following benefits of
providing clinical summaries for patients for each office visit: A
summary of an office visit provides patients and their families with a
record of the visit. This record can prove to be a vital reference for
the patient and their caregivers about their health and actions they
should be taking to improve their health. Without this reference, the
patient must either recall each detail of the visit, potentially
missing vital information, or contact the provider after the visit.
Certified EHR technology enables the provider to create a summary
easily and in many cases instantly. This capability removes nearly all
of the barriers that exist when using paper records.
As noted in the proposed rule, clinical summaries for each office
visit are important because without this reference the patient must
either recall each detail of the visit, potentially missing vital
information, or contact the provider after the visit. We also noted
that this is a meaningful use requirement, which does not override an
individual's broader right under HIPAA to access his or her health
information. Providers must continue to comply with all applicable
requirements under the HIPAA Privacy Rule, including the access
provisions of 45 CFR 164.524. However, none of the HIPAA access
requirements preclude an EP from releasing electronic copies of
clinical summaries to their patients as required by this meaningful use
provision. For Stage 2, we proposed this as a core objective for EPs.
Comment: Some commenters believed that this objective should be
eliminated because the same information would be made available through
the objective to ``Provide patients the ability to view online,
download, and transmit their health information.'' Other commenters
suggested combining these objectives with a concomitant rise in the
measure threshold.
Response: While it is true that there may be overlap between the
information in the clinical summary and the information made available
through the objective to ``Provide patients the ability to view online,
download, and transmit their health information,'' we believe the
clinical summary after an office visit serves a different purpose than
online access to health information. A summary of an office visit
provides patients and their families with a record of the visit and
specific lab tests or specific follow-up actions and treatment related
to the visit. While this information is certainly part of the patient's
overall electronic health record, the clinical summary serves to
highlight information that is relevant to the patient's care at that
particular
[[Page 53999]]
moment. Therefore, we decline to eliminate or combine the objective.
After consideration of the public comments, we are finalizing the
meaningful use objective for EPs at Sec. 495.6(j)(11)(i) as proposed.
Proposed EP Measure: Clinical summaries provided to patients within
24 hours for more than 50 percent of office visits.
In the proposed rule, we proposed to maintain several policies
regarding this objective from Stage 1. As we stated, for purposes of
meaningful use, an EP could withhold information from the clinical
summary if they believe substantial harm may arise from its disclosure
through an after-visit clinical summary. An EP could also choose
whether to offer the summary electronically or on paper by default, but
at the patient's request must make the other form available. The EP
could select any modality (for example, online, CD, USB) as their
electronic option and would not have to accommodate requests for
different modalities. We also stated in the proposed rule that we do
not believe it would be appropriate for an EP to charge the patient a
fee for providing the summary. Finally, we stated that when a single
consolidated summary is provided for an office visit that lasts for
several consecutive days, or for an office visit where a patient is
seen by multiple EPs, that office visit must be counted only once in
both the numerator and denominator of the measure. We are finalizing
all of these policies for Stage 2 as proposed.
Comment: Many commenters suggested that the measure should be
changed from ``24 hours'' to ``1 business day.'' Other commenters
believed that this timeframe was too short, especially for specialty
providers who might not come into the office every day, and suggested
either changing the timeframe to 48 hours or reverting to the 72-hour
measure of Stage 1. Another commenter noted that delays past 24 hours
can sometimes occur outside of the provider's control--for example, in
the case of new patients where the provider might not have access to
adequate previous records.
Response: We believe that Certified EHR technology enables the
provider to create a summary with the required information easily and
in most cases instantly. The feedback we have received on this
objective in Stage 1 through discussions with providers indicates that
most providers make this clinical summary available as patients leave
the office visit, and we expect this workflow to continue for most
providers. Therefore a longer timeframe of 48 or 72 hours should not be
necessary for providing clinical summaries. We also note that the
clinical summary contains information relevant to the patient's office
visit and therefore the EP should not need to include information from
previous records for most patients. However, we believe the threshold
of more than 50 percent of office visits allows EPs to meet the measure
of this objective despite these challenges for a small number of
patients. We also agree that the measure should be changed from ``24
hours'' to ``1 business day'' since all providers may not have staff
available to issue clinical summaries prior to the close of a work week
or the beginning of a Federal holiday. Therefore, we are finalizing the
change from ``24 hours'' to ``1 business day.''
Comment: A number of commenters raised questions regarding the
provision of the clinical summary. They asked whether the summary
should be given automatically to each patient or whether offering the
summary at the end of an office visit was sufficient to meet the
measure. Commenters also asked whether patients who refused a copy of
the clinical summary should be counted in the numerator of the measure.
Response: It is the intention of this objective that clinical
summaries be automatically given to patients within 1 business day of
an office visit. However, we do recognize that some patients may
decline a physical copy of their clinical summary. In the event that a
clinical summary is offered to and subsequently declined by the
patient, that patient may still be included in the numerator of the
measure. We note that the clinical summary must be offered to the
patient; a passive indication of the clinical summary's availability
(for example, a sign at the reception desk, a note in form, etc.) would
not serve as offering the clinical summary and those patients could not
be counted in the numerator of the measure. However, the clinical
summary does not necessarily need to be printed before being offered to
the patient.
Comment: Commenters asked whether making clinical summaries
available on a patient portal or as part of the objective to ``Provide
patients the ability to view online, download, and transmit their
health information'' would meet the measure of this objective. Some
commenters suggested that patients should be permitted to demand an
electronic copy of clinical summaries where an EP has chosen to provide
them in hard copy form.
Response: We are continuing our policy from Stage 1 that the
clinical summary can be provided through a patient portal or through
other electronic means to satisfy this measure. A clinical summary
provided through the same means that the provider makes other patient
information available to meet the objective to ``Provide patients the
ability to view online, download, and transmit their health
information'' would also meet the measure of this objective. As stated
previously, an EP can choose whether to offer the summary
electronically or on paper by default, but at the patient's request
must make the other form available. The EP could select any modality
(for example, online, CD, USB) as their electronic option and would not
have to accommodate requests for different electronic modalities.
Comment: Some commenters suggested that this measure should be
based on the number of unique patients seen by the EP instead of office
visits. Other commenters suggested that the threshold for the measure
should be reduced.
Response: We do not agree that the measure should be based on
unique patients. The purpose of the clinical summary is to provide
patients and their authorized representatives with a record of an
office visit and specific lab tests or specific follow-up actions and
treatment related to that visit. Nor do we agree that the percentage
threshold of this measure should be reduced. We note that the threshold
for this measure in Stage 1 was also 50 percent; any reduction would
constitute a step backward for the meaningful use of this capability.
Comment: Some commenters suggested that EPs should be permitted to
charge a fee for provision of a clinical summary.
Response: Because the clinical summary is meant to summarize the
office visit and any lab tests, follow-up actions, or treatments
related to that visit, we do not believe it is appropriate for an EP to
charge patients additional fees for its provision. Also, because this
is a meaningful use requirement for the incentivized provider and not a
response to a patient request, we do not believe it is appropriate for
an incentivized provider to charge the patient. This is consistent with
our position for this objective in Stage 1 (75 FR 44358).
Comment: Commenters suggested that clinical summaries provided to
patient-authorized representatives should also be counted for this
measure.
Response: We agree that the provision of a clinical summary to a
patient-authorized representative should also be counted, and we have
amended the measure accordingly.
[[Page 54000]]
Comment: Many commenters believed that the list of required
elements to be included in the clinical summary was excessive and not
useful to the patient. Commenters suggested that the list be shortened
or left to the provider's discretion. Additionally, many commenters
asked for clarification on whether certain fields could be left blank
and still permit the EP to meet the measure of this objective. Finally,
a number of commenters suggested that this objective should focus on
whether the summary is provided and not on required information since
CEHRT cannot distinguish between information not provided in a clinical
summary because it is not relevant or because a provider has exercised
discretion to withhold it.
Response: This measure is focused on the provision of the clinical
summary. The clinical summary represents a patient's current care and
health as a snapshot in time. When provided, we believe it can
significantly improve a patient's overall awareness of the care they
are receiving as well as any conditions they may need to manage between
office visits. The required information listed at the end of this
section are provided as a way to standardize and prioritize for the
purposes of EHR technology certification the minimum amount of
information that must be available to EPs to select. Further, we
believe that the information in this minimum list is the most
applicable and beneficial to improving patient care. This is a list of
information, not a particular structure or format for the summary
handed to the patient.
We have no requirements on the design of the summary just the
information that must be present if it is in the CEHRT. The design of
the summary should reflect the context of the visit. For example, the
information of future appointments, referrals to other providers,
future scheduled tests, and clinical instructions could all appear in a
section of the summary called ``Next steps''. If all of these
information areas were empty then ``next steps'' could just be none and
all the feeding information elements would be covered. Alternatively,
if the summary is provided on letterhead that includes the office
location and the provider's name that information does not have to be
repeated in the text of the summary. We cannot emphasize enough that
this is required information for the summary not a particular required
structure for the summary. We do not believe that the list of required
information imposes an undue burden on providers because CEHRT will be
able to automatically generate the clinical summary with at least all
of the required information. In ONC's rule it has included in the
certification criterion that correlates to this objective the
capability for end-users to customize (for example, edit) the clinical
summary to make it more relevant to the patient encounter.
In circumstances where there is no information available to
populate one or more of the fields previously listed, either because
the EP can be excluded from recording such information (for example,
vital signs) or because there is no information to record (for example,
no medication allergies or laboratory tests), an indication that the
information is not available in the clinical summary would meet the
measure of this objective. The feedback we have received on this
objective in Stage 1 through discussions with providers indicates that
the absence of information in the clinical summary sometimes offers an
opportunity for reconciliation of misinformation; for example, if ``no
medication allergies'' is listed but the patient has one, he or she may
communicate that to the provider, thus improving the quality of the
data in the EHR. We do note that the measure of this objective already
focuses on provision of the clinical summary and is not specific to the
information which is provided within the clinical summary; the list of
required elements is meant to standardize the information given to
patients, not to create an additional measure for the objective.
We also refer providers to our discussion of what constitutes an
office visit. Many of the concerns we have heard regarding this summary
are the result of misunderstandings about what constitutes an office
visit. For example, in some cases removing sutures or giving allergy
shots do not represent an office visit if that is the only service
provided.
Comment: Commenters asked for clarification on ``current problem
list and any updates,'' ``current medication list and any updates,''
and ``current medication allergy list and any updates,'' since updates
would be included in any current problem list. They suggested
simplifying these requirements to ``current problem list;'' ``current
medication list;'' and ``current medication allergy list''.
Response: We agree that including the language ``and any updates''
is redundant since a current problem, medication, or medication allergy
list would already include updated information. We are amending this
language in the list of required elements below. However, the clinical
summary should include both a current problem list and any diagnosis
specifically related to the office visit as separate fields. The
diagnosis related to the office visit should be expressed in the
``Reason for the patient's visit'' field, though it may also be
included in the current problem list. We note that this is consistent
documentation available in the Consolidated Clinical Document
Architecture (CDA), which defines the ``Reason for the patient's
visit'' field as the provider's description of the reason for visit and
the ``Chief complaint field'' as the patient's own description.
Comment: Commenters asked for clarification on ``vital signs and
any updates'' and suggested simplifying this requirement to ``Vitals
taken during visit''.
Response: While we agree that vital signs taken during the visit
would be most useful in the clinical summary, we also recognize that
all vital signs may not be updated at each office visit. Therefore, we
are amending this language to ``Vital signs taken during the visit (or
other recent vital signs)'' in the list of required elements below.
Comment: Commenters asked us to clarify if the requirement relating
to the inclusion of laboratory test results applies only to test
results available at the time of the office visit or to test results
that become available after the clinical summary is issued.
Response: By laboratory test results, we mean for the clinical
summary to include results that are available at the time the clinical
summary is issued to the patient. As we stated in the proposed rule,
clinical summaries can quickly become out of date due to information
not available to the EP at the end of the visit. The most common
example of this is laboratory test results. We believe that EPs should
make this information known to the patient when the results are
available, but do not require that a new clinical summary must be
issued when information needs to be updated.
Comment: Commenters asked us to clarify if the list of diagnostic
tests pending indicates diagnostic tests that have been scheduled or
diagnostic tests for which results are not yet available.
Response: Diagnostic tests pending refers to diagnostic tests that
have been performed but for which results are not yet available.
Laboratory or diagnostic tests that have been scheduled but not yet
performed should be recorded under ``Future scheduled tests'' in the
list of required elements later in this section.
Comment: Some commenters asked us to define clinical instructions.
Other commenters asked if the instructions included as part of the care
plan were
[[Page 54001]]
redundant with the ``clinical instructions'' element in the list of
required information.
Response: By clinical instructions we mean care instructions for
the patient that are specific to the office visit. Although we
recognize that these clinical instructions at times may be identical to
the instructions included as part of the care plan, we also believe
that care plans may include additional instructions that are meant to
address long-term or chronic care issues, whereas clinical instructions
specific to the office visit may be related to acute patient care
issues. Therefore, we maintain these as separate items in the list of
required elements later.
Comment: A commenter noted that future appointments and future
scheduled tests might be stored in a scheduling system that is separate
from CEHRT and suggested that if the information is not available in
CEHRT that the EP be excluded from having to provide it as part of the
clinical summary.
Response: As noted previously, in circumstances where there is no
information available to populate one or more of the fields previously
listed, either because the EP can be excluded from recording such
information (for example, vital signs) or because there is no
information to record (for example, no medication allergies or
laboratory tests), an indication that the information is not available
in the clinical summary would meet the measure of this objective. This
would also be true if the information is not accessible through CEHRT.
Comment: Commenters asked for clarification regarding demographics
``maintained by EP.'' Specifically, they asked whether the EP was
required to enter demographics or whether these could be maintained by
a member of his or her staff.
Response: By demographics we mean the demographics maintained
within CEHRT. We do not intend to specify that only the EP can enter
such information into the EHR; demographic information can be entered
into CEHRT by any person or through any electronic interface with
another system. Therefore, we are amending the language to
``Demographic information maintained within CEHRT'' in our list of
required elements later in this section.
Comment: In regard to the inclusion of ``care plan field'' in the
list of required information, some commenters believed that the wording
was overly prescriptive since CEHRT could utilize multiple fields to
structure care plans. Other commenters requested a more detailed
definition of care plan.
Response: We agree that the language proposed could be viewed as
prescriptive, and we do not intend to limit the inclusion of the care
plan to a single field. Therefore, we are amending the language to
``Care plan field(s), including goals and instructions'' in our list of
required elements below. However, we decline to provide an alternate
definition that would limit the information in the care plan. We
believe that the definition we proposed in the proposed rule is
sufficient to allow for the inclusion of a variety of care plans in the
clinical summary. For purposes of the clinical summary, we define a
care plan as the structure used to define the management actions for
the various conditions, problems, or issues. A care plan must include
at a minimum the following components: problem (the focus of the care
plan), goal (the target outcome) and any instructions that the provider
has given to the patient. A goal is a defined target or measure to be
achieved in the process of patient care (an expected outcome).
Comment: Some commenters asked for clarification about what is
meant by patient decision aids.
Response: By patient decision aids we mean any educational resource
or tool that the provider believes can inform patient decisions about
their own care. An example is an educational handout on the pros and
cons of having surgery for a particular condition.
Comment: Some commenters noted that because EHRs capture medical
data, they will produce clinical summaries with medical terminology,
whereas patients should receive summaries with nonmedical terminology
and descriptions of both medications and lab test results that are easy
to read and contain actionable items.
Response: While we agree that clinical summaries with nonmedical
terminology and extended descriptions would be most beneficial to
patients, we also believe that the utility of this objective must be
balanced against the potential burden it places on EPs. Since clinical
summaries can be automatically generated from existing data in CEHRT,
this removes significant workflow barriers to providing a summary for
patients. We believe that requiring providers or their staff to render
all information in the clinical summary into nonmedical terms at this
time would impose a significant burden on providers and reduce the
number of clinical summaries that providers make available to patients,
thereby reducing the effectiveness of this objective. However, we note
that most of the information that is required as part of the clinical
summary should be easily understandable by most patients. Also, there
is nothing to prevent an EP from providing additional information if he
or she believes it would be more effective for the overall quality of
patient care. We further note that we anticipate that the capabilities
of CEHRT may soon allow for the provision of non-medical terminology
and extended descriptions and we are considering adding this
requirement in future stages of meaningful use.
Comment: One commenter noted that the clinical summary contains a
vast amount of protected health information (PHI) which could be
compromised if patients discard the clinical summary insecurely. The
commenter suggested requiring the clinical summary only for those
patients who affirm they want it to eliminate any provider
responsibility for security of the information.
Response: We do not believe that making protected health
information available to patients in any way compromises either
patients or providers. On the contrary, we believe that offering this
information is critical to improving the overall quality of patient
care by offering specific follow-up instructions, test results, and
care plan information to patients so that they can actively participate
in their own care. We believe that providers can take steps to inform
patients about the need to securely dispose of PHI, and we further note
that making clinical summaries available electronically through an
online portal or other means can be used to keep such PHI secure.
Therefore, we decline to change the measure for this objective.
After consideration of the public comments, we are finalizing the
meaningful use measure for EPs as ``Clinical summaries provided to
patients or patient-authorized representatives within 1 business day
for more than 50 percent of office visits'' at Sec. 495.6(j)(11)(ii).
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(e)(2).
We clarify that the following information (or an indication that
there is no information available) is required to be part of the
clinical summary for Stage 2:
Patient name.
Provider's name and office contact information.
Date and location of the visit.
Reason for the office visit.
Current problem list.
Current medication list.
Current medication allergy list.
[[Page 54002]]
Procedures performed during the visit.
Immunizations or medications administered during the
visit.
Vital signs taken during the visit (or other recent vital
signs).
Laboratory test results.
List of diagnostic tests pending.
Clinical instructions.
Future appointments.
Referrals to other providers.
Future scheduled tests.
Demographic information maintained within CEHRT (sex,
race, ethnicity, date of birth, preferred language).
Smoking status
Care plan field(s), including goals and instructions.
Recommended patient decision aids (if applicable to the
visit).
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of office visits conducted by the EP
during the EHR reporting period.
Numerator: Number of office visits in the denominator
where the patient or a patient-authorized representative is provided a
clinical summary of their visit within 1 business day.
Threshold: The resulting percentage must be more than 50
percent in order for an EP to meet this measure.
Exclusion: Any EP who has no office visits
during the EHR reporting period.
Removed Objective: Capability to exchange key clinical information.
In Stage 2, we proposed to move to actual use cases of electronic
exchange of health information through the following objective: ``The
EP, eligible hospital or CAH who transitions their patient to another
setting of care or provider of care or refers their patient to another
provider of care should provide summary care record for each transition
of care or referral.'' We also proposed to remove this objective for
Stage 1 as well, but requested comments on other options. Please refer
to the section titled ``Changes to Stage 1'' at II.A.3.b. of this final
rule for details of the options considered. We are finalizing the
removal of this objective as proposed in favor of the more robust,
actual use case of electronic exchange through a summary of care record
following each transition of care or referral. We believe that this
actual use case is not only easier for providers to understand but it
is also more beneficial because it contributes directly to the care of
the patient through enhanced coordination between providers. A prudent
provider will be preparing and testing to conduct actual exchange prior
to the start of Stage 2 during their Stage 1 EHR reporting periods.
Proposed Objective: Protect electronic health information created
or maintained by the CEHRT through the implementation of appropriate
technical capabilities.
In the proposed rule, we outlined the following benefits of
protecting health information: Protecting electronic health information
is essential to all other aspects of meaningful use. Unintended and/or
unlawful disclosures of personal health information could diminish
consumers' confidence in EHRs and electronic health information
exchange. Ensuring that health information is adequately protected and
secured will assist in addressing the unique risks and challenges that
may be presented by electronic health records.
Comment: A number of commenters supported the continued inclusion
of this objective, yet several commenters requested the elimination of
this objective as redundant to HIPAA regulations.
Response: We believe that it is crucial that EPs, eligible
hospitals, and CAHs evaluate the privacy and security implications of
CEHRT as part of the EHR Incentive Programs, particularly as they
pertain to 45 CFR 164.308(a)(1) and the protection and safeguarding of
personal health information in general. Therefore, we retain this
objective and measure for meaningful use in the final rule.
After consideration of the public comments, we are finalizing the
meaningful use objective for EPs at Sec. 495.6(j)(16)(i) and eligible
hospitals and CAHs at Sec. 495.6(l)(15)(i) as proposed.
Proposed Measure: Conduct or review a security risk analysis in
accordance with the requirements under 45 CFR 164.308(a)(1), including
addressing the encryption/security of data at rest in accordance with
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
and implement security updates as necessary and correct identified
security deficiencies as part of the provider's risk management
process.
In the proposed rule, we explained that this measure is the same as
in Stage 1 except that we specifically address the encryption/security
of data is that is stored in CEHRT (data at rest). Due to the number of
breaches reported to HHS involving lost or stolen devices, the HIT
Policy Committee recommended specifically highlighting the importance
of an entity's reviewing its encryption practices as part of its risk
analysis. We agree that this is an area of security that appears to
need specific focus. Recent HHS analysis of reported breaches indicates
that almost 40 percent of large breaches involve lost or stolen
devices. Had these devices been encrypted, their data would have been
secured. It is for these reasons that we specifically call out this
element of the requirements under 45 CFR 164.308(a)(1) for the
meaningful use measure. We did not propose to change the HIPAA Security
Rule requirements, or require any more than is required under HIPAA. We
only emphasize the importance of an EP or hospital including in its
security risk analysis an assessment of the reasonable and
appropriateness of encrypting electronic protected health information
as a means of securing it, and where it is not reasonable and
appropriate, the adoption of an equivalent alternative measure.
We proposed this measure because the implementation of CEHRT has
privacy and security implications under 45 CFR 164.308(a)(1). A review
must be conducted for each EHR reporting period and any security
updates and deficiencies that are identified should be included in the
provider's risk management process and implemented or corrected as
dictated by that process.
In the proposed rule, we emphasized that our discussion of this
measure and 45 CFR 164.308(a)(1) is only relevant for purposes of the
meaningful use requirements and is not intended to supersede what is
separately required under HIPAA and other rulemaking. Compliance with
the HIPAA requirements is outside of the scope of this rulemaking.
Compliance with 42 CFR Part 2 and state mental health privacy and
confidentiality laws is also outside the scope of this rulemaking. EPs,
eligible hospitals or CAH affected by 42 CFR Part 2 should consult with
the Substance Abuse and Mental Health Services Administration (SAMHSA)
or state authorities.
Comment: Some commenters asked if the Stage 2 requirements for this
objective contradict earlier Stage 1 requirements and HIPAA
regulations. Specifically, the addition of addressing encryption/
security of data at rest to the measure was raised as a concern.
Response: We do not believe that the Stage 2 measure of this
objective contradicts either the Stage 1 measure or current HIPAA
regulations. As noted in the proposed rule, this measure is the same as
in Stage 1 except that we specifically highlight the encryption/
security of data that is stored in CEHRT (data at rest). Recent HHS
analysis of reported breaches indicates that almost 40 percent of large
breaches (breaches affecting 500 or more individuals) involve lost or
stolen devices. Had these
[[Page 54003]]
devices been encrypted, their data would have been secured. It is for
these reasons that we specifically call out this requirement under 45
CFR 164.308(a)(1). We did not propose to change the HIPAA Security Rule
requirements, or require any more under this measure than is required
under HIPAA. We only emphasize the importance of an EP or hospital
including in its security risk analysis an assessment of the reasonable
and appropriateness of encrypting electronic protected health
information as a means of securing it, and where it is not reasonable
and appropriate, the adoption of an equivalent alternative measure.
Comment: Several commenters asked for clarification of what
constitutes an acceptable security risk analysis. Commenters also asked
if the security risk analysis required in the measure should apply to
health data stored in data centers with physical security.
Response: We did not propose to change the HIPAA Security Rule
requirements or impose additional requirements under this measure than
those required under HIPAA. A review must be conducted for each EHR
reporting period and any security updates and deficiencies that are
identified should be included in the provider's risk management process
and implemented or corrected as dictated by that process. We refer
providers to the requirements under 45 CFR 164.308(a)(1), including
addressing the encryption/security of data at rest in accordance with
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
of the HIPAA Security Rule for compliance. The HHS Office for Civil
Rights (OCR) has issued guidance on conducting a security risk
assessment pursuant to the HIPAA Security Rule (http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). The
scope of the security risk analysis for purposes of this meaningful use
measure applies only to data created or maintained by CEHRT. This
measure does not apply to data centers that are not part of CEHRT.
However, we note that such data centers may be subject to the security
requirements under 45 CFR 164.308(a)(1) and refer providers to the
HIPAA Security Rule for compliance information.
Comment: One commenter asked if the measure of the objective
required hospitals to report on data encryption methods.
Response: No, eligible hospitals and CAHs are not required to
report to CMS or the states on specific data encryption methods used.
However, they are required to address the encryption/security of data
at rest in accordance with requirements under 45 CFR 164.312(a)(2)(iv)
and 45 CFR 164.306(d)(3).
Compliance with 42 CFR Part 2 and state mental health privacy and
confidentiality laws is also outside the scope of this rulemaking. EPs,
eligible hospitals or CAH affected by 42 CFR Part 2 should consult with
the Substance Abuse and Mental Health Services Administration (SAMHSA)
or state authorities.
We are making a change in this final rule to the language of ``data
at rest'' to specify our intention of data that is stored in CEHRT.
After consideration of the public comments, we are finalizing the
meaningful use measure as ``Conduct or review a security risk analysis
in accordance with the requirements under 45 CFR 164.308(a)(1),
including addressing the encryption/security of data stored in CEHRT in
accordance with requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), and implement security updates as necessary and correct
identified security deficiencies as part of the provider's risk
management process'' for EPs ``at Sec. 495.6(j)(16)(ii) and eligible
hospitals and CAHs at Sec. 495.6(l)(15)(ii).
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 CEHRT at 45 CFR 170.314(d)(1) through 170.314(d)(8).
(b) Objectives and Measures Carried Over (Modified or Unmodified)
from Stage 1 Menu Set to Stage 2 Core Set
We signaled our intent in the Stage 1 final rule to move the
objectives from the Stage 1 menu set to the Stage 2 core set. The HIT
Policy Committee also recommended that we move all of these objectives
to the core set for Stage 2. We proposed to include in the Stage 2 core
set all of the objectives and associated measures from the Stage 1 menu
set, except for the objective ``capability to submit electronic
syndromic surveillance data to public health agencies'' for EPs, which
will remain in the menu set for Stage 2. As discussed later, we also
proposed to modify and combine some of these objectives and associated
measures for Stage 2--
Consolidated Objective: Implement drug formulary checks.
For Stage 2, we proposed to include this objective within the core
objective for EPs ``Generate and transmit permissible prescriptions
electronically (eRx)'' and the menu objective for eligible hospitals
and CAHs of ``Generate and transmit permissible discharge prescriptions
electronically (eRx).'' We believe that drug formulary checks are most
useful when performed in combination with e-prescribing, where such
checks can allow the EP or hospital to increase the efficiency of care
and benefit the patient financially. We address the comments related to
these proposals and state our final policy in the discussions of the
eRx objectives for EPs and hospitals.
Proposed Objective: Incorporate clinical lab test results into
CEHRT as structured data.
We propose to continue the policy from Stage 1 to incorporate
clinical lab test results into CEHRT as structured data. We believe
this measure contributes to the exchange of health information between
providers of care, facilitates the sharing of information with patients
and their designated representatives, and may reduce order entry errors
which will contribute to patient care improvements.
We did not receive any comments for this objective. We are
finalizing the meaningful use objective for EPs at Sec. 495.6(j)(7)(i)
and eligible hospitals and CAHs at Sec. 495.6(l)(6)(i) as proposed.
Proposed Measure: More than 55 percent of all clinical lab tests
results ordered by the EP or by authorized providers of the eligible
hospital or CAH for patients admitted to its inpatient or emergency
department (POS 21 or 23) during the EHR reporting period whose results
are either in a positive/negative or numerical format are incorporated
in CEHRT as structured data.
We proposed to increase the measure threshold from more than 40
percent for Stage 1 to more than 55 percent for Stage 2. We also
solicited public comment regarding the feasibility of continuing to
account for individual lab tests separately from group and panel tests.
In addition, we solicited comment on whether standards and other
capabilities would allow for the expansion of this measure to include
all quantitative lab results.
Comment: Many of the commenters voiced their concern that not all
EHRs are capable of splitting out individual test results from panel
tests and that it would not be feasible to require this for Stage 2 of
meaningful use. Other commenters suggested modifying the current
measure to use the number of laboratory test results in the EHR as the
numerator and the total laboratory test results from the Lab
Information System as the denominator. Others questioned the validity
of the current measure that counts orders in the denominator and
results in the numerator. Another comment is that not all providers
have
[[Page 54004]]
access to a lab interface system and not all lab interfaces are
compatible.
Response: We appreciate the many comments and suggestions submitted
regarding this measure which were carefully considered as we developed
the final regulation. Some commenters questioned the measure validity
suggesting that the measure is imperfect since the numerator and
denominator are incongruent. However, in considering the broader policy
goal underlying this measure (to incorporate lab results into CEHRT in
a standard format) the measure needs to be broad enough to allow
providers to incorporate laboratory orders and results from multiple
service providers. By incorporating all lab orders (whether panel or
individual) in the denominator, and all lab test results in the
numerator, providers will be able to capture structured lab data from a
broad range of provider laboratory information systems into the CEHRT.
We understand that the most likely scenario is that the denominator of
total lab orders (if panel orders are counted as one) will be less than
the numerator of laboratory results because results are provided for
each individual test rather than by panel. Therefore, it is highly
unlikely that the measure would impact a provider's ability to meet the
increased threshold in this scenario.
Providers will need to continue to report individual lab test
results recorded as structured data in the numerator, and in the
denominator report all individual lab-tests ordered whether or not they
are ordered individually or as part of a panel or group lab order. For
example, one panel order of ten individual lab tests could be counted
as 1 or 10 lab tests ordered in the denominator depending on the system
that is used to incorporate this data into the CEHRT. We will monitor
provider experience with this measure as technological capacity for the
reporting and exchange of lab data continues to evolve.
Comment: Other commenters mentioned uncertainty regarding the
proper vocabulary to use for the incorporation of lab test results in a
structured format. Several commenters went on to mention that there is
not one current vocabulary that encompasses all types of tests. Another
comment proposed that CMS work to amend the clinical laboratory
improvement amendments (CLIA) to require hospital labs to report
results in standard vocabulary such as the Logical Observation
Identifiers Names and Codes System (LOINC) by the time Stage 2 is
implemented in 2014.
Response: We refer readers to the ONC standards and certification
criteria final rule published elsewhere in this issue of the Federal
Register for vocabulary specifications.
Comment: Many commenters were confused by the clarification CMS
provided in the proposed rule for expanding the measure to all
quantitative results (all results that can be compared on as a ratio or
on a difference scale). Comments were mixed on whether this measure
should include all types of lab tests that produce quantitative
results. One commenter suggested CMS should allow ordinal responses for
the measure since that is what LOINC uses as the response rather than
counting test results with either a positive, negative or numeric
response since operationally, counting tests based on whether or not
they have two allowed answer choices is difficult, where counting tests
based on whether the LOINC code for them had a Scale of QN or Ord would
be quite simple. Another commenter suggested most people would assume
that ``numeric/quantitative tests'' would include decimals and whole
numbers as well as results reported in a range (for example, >7.4 or
<150) and ratios such as also titer levels (for example, 1:128).
Response: We appreciate the number of comments regarding an
expansion of the existing measure as well as further clarification.
Based on both CMS and companion ONC comments received, we clarify that
the measure incorporate all numeric/quantitative tests that report
whole or decimal numbers. The structured data for the numeric/
quantitative test results may include positive or negative affirmations
and/or numerical format that would include a reference range of numeric
results and/or ratios.
Comment: Most commenters agreed that the increase measure threshold
is appropriate. One commenter referenced a recent AHA survey that found
``60 percent of hospitals could perform this function in Fall 2011 at
the raised threshold''.
Response: Our analysis of the Stage 1 attestation data shows that
91.5 percent of EPs and 95 percent of eligible hospitals and CAHs were
able to successfully demonstrate meaningful use for this measure.
Therefore, combined with the AHA survey data results, we will adopt the
proposed threshold of 55 percent or more for this measure.
After consideration of the public comments received, we modify the
measure for EPs at Sec. 495.6(j)(7)(ii) and eligible hospitals and
CAHs at Sec. 495.6(l)(6)(ii) to:
More than 55 percent of all clinical lab tests results ordered by
the EP or by authorized providers of the eligible hospital or CAH for
patients admitted to its inpatient or emergency department (POS 21 or
23) during the EHR reporting period whose results are either in a
positive/negative affirmation or numerical format are incorporated in
CEHRT as structured data.
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 CEHRT at 45 CFR 170.314(b)(5).
Denominator: Number of lab tests ordered during the EHR
reporting period by the EP or by authorized providers of the eligible
hospital or CAH for patients admitted to its inpatient or emergency
department (POS 21 or 23) whose results are expressed in a positive or
negative affirmation or as a number.
Numerator: Number of lab test results which are expressed
in a positive or negative affirmation or as a numeric result which are
incorporated in CEHRT as structured data.
Threshold: The resulting percentage must be more than 55
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusion: Any EP who orders no lab tests where results
are either in a positive/negative affirmation or numeric format during
the EHR reporting period.
There is no exclusion available for eligible hospitals and CAHs
because we do not believe any hospital will ever be in a situation
where its authorized providers have not ordered any lab tests for
admitted patients during an EHR reporting period.
Proposed Objective: Generate lists of patients by specific
conditions to use for quality improvement, reduction of disparities,
research, or outreach.
In the proposed rule, we outlined the following benefits of
generating lists of patients by specific conditions: Generating patient
lists is the first step in proactive management of populations with
chronic conditions and is critical to providing accountable care. The
ability to look at a provider's entire population or a subset of that
population brings insight that is simply not available when looking at
patients individually. Small variations that are unnoticeable or seem
insignificant on an individual basis can be magnified when multiplied
across a population. A number of studies have shown that significant
improvements result merely due to provider awareness of population
level information. We believe that many EPs and eligible hospitals will
use these reports in combination with one of the
[[Page 54005]]
selected quality measures and decision support interventions to improve
quality for a high priority issue (for example, identify patients who
are in the denominator for a measure, but not the numerator, and in
need of an intervention). The capabilities and variables used to
generate the lists are defined in the ONC standards and certification
final rule published elsewhere in this issue of the Federal Register;
not all capabilities and variables must be used for every list.
We have combined the comments and responses for this objective with
the measure below. After consideration of the public comments, we are
finalizing the meaningful use objective for EPs at Sec. 495.6(j)(8)(i)
and eligible hospitals and CAHs at Sec. 495.6(l)(7)(i) as proposed.
Proposed Measure: Generate at least one report listing patients of
the EP, eligible hospital, or CAH with a specific condition.
We proposed to continue our Stage 1 policies for this measure. The
objective and measure do not dictate the specific report(s) that must
be generated, as the EP, eligible hospital, or CAH is best positioned
to determine which reports are most useful to their care efforts. The
report used to meet the measure can cover every patient or a subset of
patients. We believe there is no EP, eligible hospital, or CAH that
could not benefit their patient population or a subset of their patient
population by using such a report to identify opportunities for quality
improvement, reductions in disparities of patient care, or for purposes
of research or patient outreach; therefore, we did not propose an
exclusion for this measure. The report can be generated by anyone who
is on the EP's or hospital's staff during the EHR reporting period. We
also solicited comment on whether a measure that either increases the
number and/or frequency of the patient lists will further the intent of
this objective.
Comment: Most commenters voiced support for the objective and
measure and wish it to remain unchanged in the final rule, although
some commenters stated that the measure should only require
demonstration that a list can be created and not require a certain
number of patient lists until the needs to create certain patient lists
are better ascertained.
Response: We appreciate the support for this objective, and we note
that the measure of the objective remains unchanged from Stage 1.
Demonstration only of the capability to generate lists of patients by
specific conditions would represent a step backward from the Stage 1
measure, therefore we do not agree that this would be an appropriate
measure for Stage 2. We also believe there is ample evidence to support
the use of patient lists in a variety of quality improvement efforts.
Comment: Some commenters suggested that the measure requirements
should be increased, either to require more than one report be
generated during the EHR reporting period or to require that the report
generated is linked to one of the EP's or eligible hospital's clinical
decision support interventions. Another commenter suggested that the
measure should indicate how the list should be used.
Response: We believe that moving the objective from the menu set to
the core represents an adequate increase for Stage 2. We also continue
to believe that an EP, eligible hospital, or CAH is best positioned to
determine which reports are most useful to their care efforts.
Therefore, we do not propose to direct certain reports be created or
link reports to clinical decision support interventions at this time.
Comment: Some commenters suggested that lists should be generated
according to specific clinical conditions or include specific elements,
such as demographics, to aid analysis. One commenter wanted to know
whether EPs retain flexibility in deciding the lists they generate,
particularly in coordinating public health activities with state and
local public health departments and Medicaid agencies. Another
commenter suggested that the measure of the objective specify the
continuous use of the report throughout the EHR reporting period.
Response: As noted previously, we are continuing our policy from
Stage 1 that an EP, eligible hospital, or CAH is best positioned to
determine which reports are most useful to their care efforts.
Therefore, we do not propose to direct certain reports be created, nor
do we require that specific conditions or elements be required for the
reports. Also, we do not set requirements for the frequency of use of
the report.
Comment: A commenter asked us to clarify whether the EP must
generate the patient list or if the patient list could be generated by
a member of the EP's staff in order to meet the measure.
Response: For this and most meaningful use objectives, we do not
specify how information must be entered into CEHRT or who must complete
the required action to meet the measure. Therefore an EP or a member of
the EP's staff could generate the list and meet this measure. The
exception to this rule is for computerized provider order entry (CPOE)
of medication, laboratory, and radiology orders, which must be entered
by a licensed healthcare professional per state, local, and
professional guidelines.
After consideration of the public comments, we are finalizing the
meaningful use measure for EPs at Sec. 495.6(j)(8)(ii) and eligible
hospitals and CAHs at Sec. 495.6(l)(7)(ii) as proposed.
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 CEHRT at 45 CFR 170.314(a)(14).
Proposed EP Objective: Use clinically relevant information to
identify patients who should receive reminders for preventive/follow-up
care.
In the proposed rule, we described the following benefits of this
objective. By proactively reminding patients of preventive and follow-
up care needs, EPs can increase compliance. These reminders are
especially beneficial when long time lapses may occur as with some
preventive care measures and when symptoms subside, but additional
follow-up care is still required.
We also proposed to revise this objective for Stage 2 to ``Use
clinically relevant information to identify patients who should receive
reminders for preventive/follow-up care'' based on the HITPC
recommendation. An EP should use clinically relevant information stored
within the CEHRT to identify patients who should receive reminders. We
believe that the EP is best positioned to decide which information is
clinically relevant for this purpose.
Comment: A commenter stated that the language in the proposed
objective is in conflict with the proposed measure. The proposed
objective is to ``Use clinically relevant information to identify
patients who should receive reminders for preventive/follow-up,'' with
no indication that the reminder be sent. However, the proposed measure
refers to ``patient who had an office visit and were sent a reminder,
per patient preference.''
Response: We agree with the commenter that the objective as
proposed only speaks to the identification of the need for the reminder
and that the proposed measure requires that the reminder be sent. The
value of this objective is created when the reminder is sent to the
patient and therefore, we revise the objective accordingly.
Comment: Commenters requested request clarification of the
operative definition of ``reminder.'' Remembering to keep the
appointment is an important first step to follow-up and preventive care
and therefore should be counted.
[[Page 54006]]
Response: We believe that reminders should be limited to new
actions that need to be taken not of actions that are already taken.
For example, a reminder to schedule your next mammogram is a reminder
to take action, while a reminder that your next mammogram is scheduled
for next week is a reminder of action already taken. If we were to
allow for reminders of existing scheduled appointments then every
provider could meet this objective and measure without any patient ever
learning new information. So we clarify that reminders for preventive/
follow-up care should be for care that the patient is not already
scheduled to receive. Reminders are not necessarily just to follow up
with the reminding EP. Reminders for referrals or to engage in certain
activities are also included in this objective and measure.
After consideration of the public comments received, we are
modifying the objective at Sec. 495.6(j)(9)(i) to ``Use clinically
relevant information to identify patients who should receive reminders
for preventive/follow-up care and send these patients the reminders,
per patient preference.''
Proposed EP Measure: More than 10 percent of all unique patients
who have had an office visit with the EP within the 24 months prior to
the beginning of the EHR reporting period were sent a reminder, per
patient preference.
In Stage 1, the measure of this objective was limited to more than
20 percent of all patients 65 years old or older or 5 years old or
younger. Rather than raise the threshold for this measure, the HIT
Policy Committee recommended lowering the threshold but extending the
measure to all active patients. We proposed to apply the measure of
this objective to all unique patients who have had an office visit with
the EP within the 24 months prior to the beginning of the EHR reporting
period. We believe this not only identifies the population most likely
to consist of active patients, but also allows the EP flexibility to
identify patients within that population who can benefit most from
reminders. We solicited comments on the appropriateness of this
timeframe. We also recognize that some EPs may not conduct face-to-face
encounters with patients but still provide treatment to patients. These
EPs could be unintentionally prevented from meeting this core objective
under the measure requirements, so we proposed an exclusion for EPs who
have no office visits in order to accommodate such EPs. Patient
preference refers to the method of providing the reminder.
Comment: Commenters expressed concern that even with the proposed
revisions many patients in the denominator might not require a
reminder. One example given was some colonoscopies are done on a
schedule of once every ten years. Another example provided was
specialists who see some patients only for one-time consults.
Suggestions by commenters to deal with patients in the denominator who
do not require reminders involve either much more precise measurement
such as tracking and following up when CEHRT identifies the need for a
patient reminder, to specific exclusions of certain visit types in the
measure or to move the requirement to the menu set. Others suggested
that providers who do not typically send reminders be sent granted
exclusions.
Response: We agree that not every active patient will require a
reminder during the EHR reporting period, which is why the threshold is
far below 100 percent. We believe that a low threshold of 10 percent is
the best way to account for the contextually specific reasons a patient
might not be sent a reminder. We proposed an exclusion for EPs who
would typically not send reminders, specifically those without office-
based visits. This may not include all providers who do not typically
send reminders, but as an exclusion must contain definitive criteria we
believe it is a good exclusion. We did not receive in comments precise
criteria for an alternative exclusion.
Comment: We received many comments as to what constitutes an active
patient in a practice. Many voiced the opinion that given the 24 month
look back period in a typical practice, many patients would have moved
to another practice. One suggestion given for an alternate way to count
patients was to change the definition of ``active patients'' to be
either three or more visits in 24 months or two or more visits in 12
months. Other commenters recommended that the time limitation be
removed.
Response: We proposed active patients as a method to limit the
denominator to patients more likely to require a reminder. The goal is
to limit the denominator as much as possible without excluding patients
who should receive a reminder. After reviewing the comments, we change
the look back to patients with at least two office visits in the last
24 months. We believe this better establishes a relationship between
the provider and the EP. This would account for those specialists that
do not have continuing relationships with their patients, but rather
hand their care back to the referring provider.
Comment: Several commenters raised concerns with the requirement
that it be per patient preference. They asked for clarification on the
definition of ``per patient preference.'' Specifically commenters asked
if patient preference referred to whether the patient wanted reminders
or what method of communication they wanted to receive the reminders.
Second, clarification is requested on how providers should document
these preferences. Third, there is concern that an insufficient number
of patients will have their preferences recorded at the start of the
EHR reporting period and if so, any method of communication should
suffice for those patients.
Response: We clarify that patient preference is the method of
communication that patients prefer to receive their reminders such as
(but not limited to) by mail, by phone or by secure messaging. Given
the look back period associated with this measure, we agree that it is
not feasible to have all patient preferences recorded prior to the
start of the EHR reporting period. Therefore, we clarify that reminders
must be sent using the preferred communication medium only when it is
known by the provider. This is limited to the type of communication
(phone, mail, secure messaging, etc.) and does not extend to other
constraints like time of day. Patients may decline to provide their
preferred communication medium in which case the provider may select
the communication medium. A patient may also decline to receive
reminders. We believe that this will be rare enough that combined with
the 10 percent through, patients declining to receive reminders will
not affect the ability of an EP to meet this measure. It is our
expectation that providers will begin to collect this information and
that in the future as the look back period catches up to the
publication of this final rule it will become possible to require that
all reminders be sent per patient preference. We do not specify how
things are documented beyond the capabilities and standards included in
CEHRT.
After consideration of the public comments received, we are
modifying the measure at Sec. 495.6(j)(9)(ii) to ``More than 10
percent of all unique patients who have had 2 or more office visits
with the EP within the 24 months before the beginning of the EHR
reporting period were sent a reminder, per patient preference when
available.''
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(a)(14).
[[Page 54007]]
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients who have
had two or more office visits with the EP in the 24 months prior to the
beginning of the EHR reporting period.
Numerator: Number of patients in the denominator
who were sent a reminder per patient preference when available during
the EHR reporting period.
Threshold: The resulting percentage must be more
than 10 percent in order for an EP to meet this measure.
Exclusion: Any EP who has had no office visits
in the 24 months before the EHR reporting period.
Proposed EP Objective: Provide patients the ability to view online,
download, and transmit their health information within 4 business days
of the information being available to the EP.
In the 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. In addition, we
noted that this objective aligns with the Fair Information Practice
Principles (FIPPs),\3\ in affording baseline privacy protections to
individuals.\4\ In particular, the principles include Individual Access
(patients should be provided with a simple and timely means to access
and obtain their individually identifiable information in a readable
form and format). We indicated that this objective replaces the Stage 1
core objective for EPs of ``Provide patients with an electronic copy of
their health information (including diagnostic test results, problem
list, medication lists, medication allergies) upon request'' and the
Stage 1 menu objective for EPs of ``Provide patients with timely
electronic access to their health information (including lab results,
problem list, medication lists, and allergies) within 4 business days
of the information being available to the EP.'' The HIT Policy
Committee recommended making this a core objective for Stage 2 for EPs,
and we agreed with their recommendation consistent with our policy of
moving Stage 1 menu objectives to the core set for Stage 2. Consistent
with the Stage 1 requirements, we noted that the patient must be able
to access this information on demand, such as through a patient portal
or personal health record (PHR). However, we noted that providers
should be aware that while meaningful use is limited to the
capabilities of CEHRT to provide online access there may be patients
who cannot access their EHRs electronically because of their
disability. Additionally, other health information may not be
accessible. Finally, we noted that providers who are covered by civil
rights laws must provide individuals with disabilities equal access to
information and appropriate auxiliary aids and services as provided in
the applicable statutes and regulations.
---------------------------------------------------------------------------
\3\ In 1973, the Department of Health, Education, and Welfare
(HEW) released its report, Records, Computers, and the Rights of
Citizens, which outlined a Code of Fair Information Practices that
will create ``safeguard requirements'' for certain ``automated
personal data systems'' maintained by the Federal Government. This
Code of Fair Information Practices is now commonly referred to as
fair information practice principles (FIPPs) and established the
framework on which much privacy policy will be built. There are many
versions of the FIPPs; the principles described here are discussed
in more detail in The Nationwide Privacy and Security Framework for
Electronic Exchange of Individually Identifiable Health Information,
December 15, 2008. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
\4\ The FIPPs, developed in the United States nearly 40 years
ago, are well-established and have been incorporated into both the
privacy laws of many states with regard to government-held records
and numerous international frameworks, including the development of
the OECD's privacy guidelines, the European Union Data Protection
Directive, and the Asia-Pacific Economic Cooperation (APEC) Privacy
Framework.http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
---------------------------------------------------------------------------
Comment: Some commenters suggested that this objective should be
part of the menu set instead of a core objective for Stage 2. This
would permit EPs who do not believe they can meet the measure at this
time to select different objectives.
Response: We do not agree that this objective should be part of the
menu set. We proposed this objective as part of the core for EPs
because it is intended to replace the previous Stage 1 core objective
of ``Provide patients with an electronic copy of their health
information upon request'' and the Stage 1 menu objective of ``Provide
patients with timely electronic access to their health information.''
Although CEHRT will provide added capabilities for this objective, we
do not believe the objective itself is sufficiently different from
previous objectives to justify placing it in the menu set. Also, we
believe that patient access to their electronic health information is a
high priority for the EHR Incentive Programs and this objective best
provides that access in a timely manner.
Comment: Some commenters expressed the opinion that this objective
should not be included as part of meaningful use and was more
appropriately regulated under HIPAA and through the Office for Civil
Rights.
Response: We do not agree that this objective should not be
included in meaningful use. Although we recognize that many issues
concerning the privacy and security of electronic health information
are subject to HIPAA requirements, we believe that establishing an
objective to provide online access to health information is within the
regulatory purview of the EHR Incentive Programs and consistent with
the statutory requirements of meaningful use.
Comment: Some commenters suggested that this objective should be
combined with the objective to ``Provide clinical summaries for
patients after each office visit'' since much of the information
provided in these objectives is identical.
Response: While it is true that there may be overlap between the
information provided in the clinical summary and the information made
available through this objective, we believe the clinical summary after
an office visit serves a different purpose than online access to health
information. A summary of an office visit provides patients and their
families with a record of the visit and specific lab tests or specific
follow-up actions and treatment related to the visit. While this
information is certainly part of the patient's overall electronic
health record, the clinical summary serves to highlight information
that is relevant to the patient's care at that particular moment.
Therefore, we decline to combine the two objectives.
After consideration of the public comments, we are finalizing the
meaningful use objective for EPs at Sec. 495.6(j)(10)(i) as proposed.
Proposed EP Measures: We proposed two measures for this objective,
both of which must be satisfied in order to meet the objective:
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.
More than 10 percent of all unique patients seen by the EP during
the EHR reporting period (or their authorized representatives) view,
download or transmit to a third party their health information.
Exclusions: Any EP who neither orders nor creates any of the
information listed for inclusion as part of this measure may exclude
both
[[Page 54008]]
measures. Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude only the second measure.
As we stated in the proposed rule, transmission can be any means of
electronic transmission according to any transport standard(s) (SMTP,
FTP, REST, SOAP, etc.). However, the relocation of physical electronic
media (for example, USB, CD) does not qualify as transmission although
the movement of the information from online to the physical electronic
media will be a download.
Comment: Some commenters suggested that the timeframe for the first
measure should be expanded to 7 days, since the data required to be
provided in order to meet the measure of this objective would sometimes
be incomplete only 4 days after the patient's visit. Other commenters
suggested the timeline for the first measure should be shortened to 2
business days or 24 hours.
Response: We do not agree that the timeframe for the measure should
be lengthened. In the Stage 1 menu objective of ``Provide patients with
timely electronic access to their health information,'' we established
the measure for providing access within 4 business days. Also, we
believe that most of the information required by this measure, except
for lab tests, will be readily available within the specified time
period. However, we also believe that 24 hours or 2 business days would
not provide adequate time to make all information available online.
Therefore, we maintain the requirement of making information available
within 4 business days.
Comment: Some commenters asked for clarification on whether online
access had to be made available using CEHRT or if the information could
be made available through other means (patient portal, PHR, etc.).
Response: Both of the measures for this objective must be met using
CEHRT. Therefore, for the purposes of meeting this objective, the
capabilities provided by a patient portal, PHR, or any other means of
online access and that would permit a patient or authorized
representative to view, download, or transmit their personal health
information would have to be certified in accordance with the
certification requirements adopted by ONC. We refer readers to ONC's
standards and certification criteria final rule that is published
elsewhere in this issue of the Federal Register.
Comment: A commenter asked how long data should be made available
online before it can be removed. In a related topic, another commenter
asked which provider would be responsible for excluding data from
sharing when multiple providers share CEHRT.
Response: It is the goal of this objective to make available to the
patient both current and historical health information. Therefore, we
would anticipate that the data should be available online on an ongoing
basis. However, an EP may withhold or remove information from online
access if they believe substantial harm may arise from its disclosure
online. In regard to withholding data and which provider should be
responsible for making the determination when multiple providers share
CEHRT, we would expect that providers sharing the CEHRT would make a
joint determination regarding the information to be withheld.
Therefore, we leave this decision to the providers' discretion.
Comment: Some commenters asked for clarification on how access by
the patient is defined.
Response: We define access as having been given when the patient
possesses all of the necessary information needed to view, download, or
transmit their information. This could include providing patients with
instructions on how to access their health information, the Web site
address they must visit for online access, a unique and registered
username or password, instructions on how to create a login, or any
other instructions, tools, or materials that patients need in order to
view, download, or transmit their information.
Comment: Some commenters suggested that patients under the age of
18 should not have the same access to the same information to which
adult patients have access and requested a separate list of required
elements for patients under the age of 18.
Response: An EP may decide that online access is not the
appropriate forum for certain health information for patients under the
age of 18. Within the confines of the laws governing guardian access to
medical records for patients under the age of 18, we would defer to the
EP's judgment regarding which information should be withheld for such
patients. In lieu of providing online access to patients under the age
of 18, EPs could provide online access to guardians for patients under
the age of 18, in accordance with state and local laws, in order to
meet the measure of this objective. Providing online access to
guardians in accordance to state and local laws would be treated the
same as access for patients, and guardians could then be counted in the
numerator of the measure. We recognize that state and local laws may
restrict the information that can be made available to guardians, and
in these cases such information can be withheld and the patient could
still be counted in the numerator of the measure. No requirement of
meaningful use supersedes any Federal, State or local law regarding the
privacy of a person's health information.
Comment: Some commenters suggested that specialists should transmit
information to the patient's primary care provider rather than
providing online access to information in order to reduce the number of
portals a patient must visit, which could cause confusion.
Response: We believe that much of this information will be
transmitted between providers as part of the summary of care record
following a transition of care. However, we also believe there is value
to the patient in having online access to this information for all
providers they visit, including specialists. Therefore, we maintain
this measure for all EPs.
Comment: Many commenters voiced objections to the second measure of
this objective and the concept of providers being held accountable for
patient actions. The commenters believed that while providers could be
held accountable for making information available online to patients,
providers could not control whether patients actually accessed their
information. Many commenters also noted that the potential barriers of
limited internet access, computer access, and patient engagement with
health IT for certain populations (for example, rural, elderly, lower
income, visually impaired, non-English-speaking, etc.) might make the
measure impossible to meet for some providers. There were also a number
of comments stating that metrics used to track views or downloads can
be misleading and are not necessarily the most accurate measure of
patient usage. Commenters suggested a number of possible solutions to
allow providers to overcome these barriers, including eliminating the
percentage threshold of the measure or requiring providers to offer and
track patient access but not requiring them to meet a percentage
measure in order to demonstrate meaningful use. However, some
commenters believed that the measure was a reasonable and necessary
step to ensure that providers had accountability for engagement of
their patients in use of electronic health information and integration
of it into clinical practice. In
[[Page 54009]]
addition, commenters pointed to the unique role that providers can play
in encouraging and facilitating their patients' and their families' use
of online tools.
Response: While we recognize that EPs cannot directly control
whether patients access their health information online, we continue to
believe that EPs are in a unique position to strongly influence the
technologies patients use to improve their own care, including viewing,
downloading, and transmitting their health information online. We
believe that EPs' ability to influence patients coupled with the low
threshold of more than 10 percent of patients having viewed online,
downloaded, or transmitted to a third party the patient's health
information make this measure achievable for all EPs.
We recognize that certain patient populations face greater
challenges in online access to health information. We address the
potential barrier of limited Internet access in the comment regarding a
broadband exclusion below. We address the potential barrier to
individuals with disabilities through ONC's rules requiring that EHRs
meet web content accessibility standards. While we agree that excluding
certain patient populations from this requirement would make the
measure easier for EPs to achieve, we do not know of any reliable
method to quantify these populations for each EP in such a way that we
could standardize exclusions for each population. We also decline to
eliminate the percentage threshold of this measure because we do not
believe that a simple yes/no attestation for this objective is adequate
to encourage a minimum level of patient usage. However, in considering
the potential barriers faced by these patient populations, we agree
that it would be appropriate to lower the proposed threshold of this
measure to more than 5 percent of unique patients who view online,
download, or transmit to a third party the patient's health
information. In addition, we are concerned that blanket exclusions for
certain disadvantaged populations could serve to extend existing
disparities in electronic access to health information and violate
civil rights laws. All entities receiving funds under this program are
subject to civil rights laws. For more information about these laws and
their requirements (see http://www.hhs.gov/ocr/civilrights/index.html).
We believe that this lower threshold, combined with the broadband
exclusion detailed in the response that follow, will allow all EPs to
meet the measure of this objective.
Comment: Some commenters suggested an alternate definition of the
second measure based on the number of patients seen within the last 2
years that access their health information online.
Response: We believe that the current numerator and denominator for
this measure encourage the active online access by patients of their
health information. We further believe that broadening the time period
of this measure to patients seen within the last 2 years does not
encourage both EPs and current patients to use online access to health
information in the active management of their care, which is one of the
goals of the EHR Incentive Programs. Therefore, we decline to adopt
this suggested alternate definition.
Comment: Some commenters asked for clarification on how view is
defined.
Response: We define view as the patient (or authorized
representative) accessing their health information online.
Comment: Some commenters noted that the potential financial burden
of implementing an online patient portal to provide patients online
access to health information. These commenters noted the added time
burden for staff in handling the additional patient use of online
resources, which may increase costs through the hiring of additional
staff, as well as the need to modify their existing workflow to
accommodate additional online messages from patients. Some commenters
also believed that there would be an additional cost for sharing
content before standards exist for content types and formats.
Response: We do not believe that implementing online access for
patients imposes a significant burden on providers. While we note that
in some scenarios it may be possible for an EP to receive reimbursement
from private insurance payers for online messaging, we acknowledge that
EPs are generally not reimbursed for time spent responding to
electronic messaging. However, it is also true that EPs are generally
not reimbursed for other widely used methods of communication with
patients (for example, telephone). As we noted in the proposed rule,
many providers have seen a reduction in time responding to inquires and
less time spent on the phone through the use of health IT, including
online messages from patients. We expect the same will be true for
online access to health information by reducing continuous requests for
health records, test results, and other pertinent patient information.
Finally, we believe that the standards established for this objective
by ONC will serve as a content standard that will allow this
information to be more easily transmitted and uploaded to another
certified EHR, thereby reducing additional costs.
Comment: Some commenters noted that patient engagement could occur
effectively with or without online access, and patients should be
encouraged to use any method (for example, telephone, internet,
traditional mail) that suits them. These commenters noted that
engagement offline reduces both the need and value for engagement
online.
Response: We agree that patient engagement can occur effectively
through a variety of media, and we also believe that electronic access
to health information can be an important component of patient
engagement. We do not believe that offline engagement reduces the need
for online access, as patients may opt to access information in a
variety of ways. Because of the variety of ways that patients/families
may access information, we keep the threshold for this measure low. We
also note that online access to health information can enhance offline
engagement--for example, patients could download information from an
office visit with their primary care provider to bring with them for a
consult with a specialist--which is one of the primary goals of the EHR
Incentive Programs.
Comment: Some commenters expressed concern that vendors would not
be able to make these capabilities available as part of CEHRT in time
for the beginning of Stage 2.
Response: Many CEHRT vendors already make patient portals available
that would meet the certification criteria and standards required for
this measure. In fact, many vendors have already incorporated these
capabilities into their CEHRT products in order to meet the measure of
the Stage 1 objective to ``Provide patients with timely electronic
access to their health information.'' Although the Stage 2 measure
requires some additional capabilities, we believe vendors will be able
to make these capabilities available in time for the beginning of Stage
2.
Comment: Some commenters requested clarification on the exclusion
regarding an EP ``who neither orders nor creates any of the information
listed for inclusion as part of this measure may exclude both
measures.'' Because the list of required elements for this measure
includes the patient's name, provider's name, and office contact
information, these commenters suggested that no EP could qualify for
this exclusion.
[[Page 54010]]
Response: We amend the wording of the exclusion to accommodate
providers who do not order or create any of the information listed,
except for patient name, provider name, and office contact information.
Comment: Some commenters suggested that basing an exclusion on the
broadband data available from the FCC Web site (www.broadband.gov) was
suspect since the data originates from vendors.
Response: The broadband data made available from the FCC was
collected from over 3,400 broadband providers nationwide. This data was
then subject to many different types of analysis and verification
methods, from drive testing wireless broadband service across their
highways to meeting with community leaders to receive feedback.
Representatives met with broadband providers, large and small, to
confirm data, or suggest changes to service areas, and also went into
the field looking for infrastructure to validate service offerings in
areas where more information was needed. Therefore, we believe the data
is appropriate for the exclusion to this measure. We note that since
publication of our proposed rule the Web site has changed to
www.broadbandmap.gov and the speed used has changed from 4Mbps to
3Mbps. We are updating our exclusion to reflect these changes.
Comment: Some commenters believe that broadband exclusions should
be based on the patients' locations instead of the providers, since
county-level data may not be granular enough to capture all areas of
low broadband availability within a particular region.
Response: Although we agree that a broadband exclusion based
primarily on the individual locations of each patient seen would be
more accurate, we do not believe that there is any method of making
this determination for every patient without placing an undue burden on
the provider. We continue to believe that limited broadband
availability in the EP's immediate practice area, coupled with the low
threshold of this measure, adequately serves as an acceptable proxy for
determining areas where online access can present a challenge for
patients. Therefore, we retain the broadband exclusion as proposed.
Comment: Some commenters requested a clarification of the required
element of ``Any additional known care team members beyond the
referring or transitioning provider and the receiving provider.''
Response: With this element we mean for providers to indicate the
names and contact information for any other health care professionals
known to the EP. This could include referring providers, receiving
providers, or any other provider inside or outside the EP's practice
that provides care to the patient. We are amending the language for
this required element to ``Any known care team members.''
Comment: Some commenters suggested that growth charts should not be
included for either download or transmission, since these charts are
simply visualizations of the height and weight data elements.
Response: We believe that growth charts can be a useful tool for
both patients and providers, especially in instances where a patient
may elect to download or transmit their health information to another
provider. Therefore, we require them to be included to meet the measure
of this objective.
Comment: One commenter suggested that images should not be included
in the list of required elements to be provided to patients online.
They cited specific difficulties in image viewing online, as well as
concerns over file size.
Response: We note the commenter's concerns and further note that
images are not among the required elements to meet the measure of this
objective.
After consideration of the public comments, we finalize the first
meaningful use measure for EPs as proposed at Sec.
495.6(j)(10)(ii)(A). We finalize the second meaningful use measure for
EPs as ``More than 5 percent of all unique patients seen by the EP
during the EHR reporting period (or their authorized representatives)
view, download or transmit to a third party their health information''
at Sec. 495.6(j)(10)(ii)(B). We finalize the following exclusions for
EPs at Sec. 495.6(j)(10)(iii): ``Any EP who neither orders nor creates
any of the information listed for inclusion as part of both measures,
except for ``Patient name'' and ``Provider's name and office contact
information,'' may exclude both measures;'' ``Any EP that conducts 50
percent or more of his or her patient encounters in a county that does
not have 50 percent or more of its housing units with 3Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude only the
second measure''.
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(e)(1).
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:
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.
For the second measure for reporting on the number of unique
patients seen by the EP during the EHR reporting period (or their
authorized representatives) who view, download or transmit health
information, CMS and ONC have worked together to define the following
for this objective:
Denominator: Number of unique patients seen by the EP
during the EHR reporting period.
Numerator: The number of unique patients (or their
authorized representatives) in the denominator who have viewed online,
downloaded, or transmitted to a third party the patient's health
information.
Threshold: The resulting percentage must be more than 5
percent in order for an EP to meet this measure.
Exclusions: Any EP who neither orders nor creates any of
the information listed for inclusion as part of both measures, except
for ``Patient name'' and ``Provider's name and office contact
information,'' may exclude both measures. Any EP that conducts 50
percent or more of his or her patient encounters in a county that does
not have 50 percent or more of its housing units with 3Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude only the
second measure.
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.
[[Page 54011]]
Demographic information (preferred language, sex, race,
ethnicity, date of birth).
Care plan field(s), including goals and instructions, and
Any known care team members including the primary care
provider (PCP) of record.
As we stated in the proposed rule, this is not intended to limit
the information made available by the EP. An EP can make available
additional information and still align with the objective. In
circumstances where there is no information available to populate one
or more of the fields previously listed, either because the EP can be
excluded from recording such information (for example, vital signs) or
because there is no information to record (for example, no medication
allergies or laboratory tests), the EP may have an indication that the
information is not available and still meet the objective and its
associated measure. Please note that while some of the information made
available through this measure is similar to the information made
available in the summary of care document that must be provided
following transitions of care or referrals, the list of information
above is specific to the view online, download, and transmit objective.
Patients and providers have different information needs and contexts,
so CMS has established separate required fields for each of these
objectives.
Proposed Objective: Use clinically relevant information from
Certified EHR Technology to identify patient-specific education
resources and provide those resources to the patient.
In the proposed rule, we explained that providing clinically
relevant education resources to patients is a priority for the
meaningful use of CEHRT. Based on our experience with this objective in
Stage 1, we are clarifying that while CEHRT must be used to identify
patient-specific education resources, these resources or materials do
not have to be stored within or generated by the CEHRT. We are aware
that there are many electronic resources available for patient
education materials, such as through the National Library of Medicine,
that can be queried via CEHRT (that is, specific patient
characteristics are linked to specific consumer health content). The EP
or hospital should utilize CEHRT in a manner where the technology
suggests patient-specific educational resources based on the
information stored in the CEHRT. Certified EHR technology is certified
to use the patient's problem list, medication list, or laboratory test
results to identify the patient-specific educational resources. The EP
or hospital may use these elements or additional elements within CEHRT
to identify educational resources specific to patients' needs. The EP
or hospital can then provide these educational resources to patients in
a useful format for the patient (such as, electronic copy, printed
copy, electronic link to source materials, through a patient portal or
PHR).
In the Stage 1 final rule (75 FR 44359), we included the phrase
``if appropriate'' in the objective so that the EP or the authorized
provider in the hospital could determine whether the education resource
was useful and relevant to a specific patient. Consistent with the
recommendations of the HIT Policy Committee, we proposed to remove the
phrase ``if appropriate'' from the objective for Stage 2 because we do
not believe that any EP or hospital will have difficulty identifying
appropriate patient-specific education resources for the low percentage
of patients required by the measure of this objective.
We also recognized that providing education materials at literacy
levels and cultural competency levels appropriate to patients is an
important part of providing patient-specific education. However, we
continue to believe that there is not currently widespread availability
of such materials and that such materials could be difficult for EPs
and hospitals to identify for their patients.
Comment: Many commenters sought clarification on the meaning of the
term ``identified by CEHRT.'' They questioned how the CEHRT would
identify resources and whether the education resources had to be stored
in the CEHRT or if it could contain links to the materials.
Response: We clarified in the proposed rule (77 FR 13720) that
while CEHRT must be used to identify patient-specific education
resources, these resources or materials do not have to be stored within
or generated by the Certified EHR Technology. We refer readers to ONC's
standards and certification criteria final rule that is published
elsewhere in this issue of the Federal Register which describes the
capabilities and standards that CEHRT must include. For patient-
specific education materials, this includes a general functional
capability to identify educational materials as well as a capability to
do so using the HL7 Context-aware Information Retrieval ``Infobutton''
standard. This measure requires that an EP or hospital use the
capabilities CEHRT includes to identify patient education materials. To
clarify, although CEHRT will include the ability to identify education
materials using the HL7 Infobutton standard, such capability alone does
not need to be used in order to be counted in the numerator (that is,
the general capability to identify education materials also counts
towards the numerator).
After reviewing the public comments, we finalize the objective for
EPs at Sec. 495.6(j)(12)(i) and for eligible hospitals and CAHs at
Sec. 495.6(l)(9)(i) as proposed.
Proposed EP Measure: Patient-specific education resources
identified by Certified EHR Technology are provided to patients for
more than 10 percent of all office visits by the EP.
In the proposed rule, we noted that the Stage 1 measure for this
objective for EPs was ``More than 10 percent of all unique patients
seen by the EP are provided patient-specific education resources.''
Because we proposed this as a core objective for Stage 2, we proposed
to modify the measure for EPs to ``Patient-specific education resources
identified by CEHRT are provided to patients for more than 10 percent
of all office visits by the EP.'' We recognized that some EPs may not
conduct face-to-face encounters with patients but still provide
treatment to patients. These EPs could be prevented from meeting this
core objective under the previous measure requirements, so we proposed
to alter the measure to account for office visits rather than unique
patients seen by the EP. We also proposed an exclusion for EPs who have
no office visits in order to accommodate such EPs.
The resources will have to be those identified by CEHRT. If
resources are not identified by CEHRT and provided to the patient then
it will not count in the numerator. We do not intend through this
requirement to limit the education resources provided to patient to
only those identified by CEHRT. We proposed the threshold at only 10
percent for this reason. We believe that the 10 percent threshold both
ensures that providers are using CEHRT to identify patient-specific
education resources and is low enough to not infringe on the provider's
freedom to choose education resources and to which patients these
resources will be provided. The education resources will need to be
provided prior to the calculation and subsequent attestation to
meaningful use.
Comment: Many commenters expressed concerns about the availability
of resources that would be available at the appropriate literacy level
for their patient populations. Some stated that there is a dearth of
low-literacy materials available as most education sites are geared
toward
[[Page 54012]]
college-educated patients; others stated that most materials are
designed to be appropriate for a broad spectrum of literacy levels.
Some commenters expressed concerns about the lack of resources
available for non-English speaking patients. Yet other commenters were
unclear as to what appropriate sources of patient-specific education
would be. Some commenters expressed concerns that another alert within
the system may create physician fatigue.
Response: We understand the commenters concerns that the
educational materials identified by the CEHRT may not be appropriate
for certain patients. To accommodate these concerns, we are maintaining
the threshold for this measure at 10 percent. As we stated in our
proposed rule and in the Stage 1 Final Rule, we account for these
concerns by maintaining a low threshold for this objective.
Comment: Some commenters expressed concerns that the CEHRT, not the
provider, would ``choose'' which educational resources would be
provided to the patient.
Response: We cannot define the scope of practice and/or appropriate
educational resources to be shared with each individual patient and
will continue to rely on provider determinations based on individual
patient circumstances.
Comment: Many commenters were concerned that the denominator for
the EP measure included the number of office visits by the EP during
the EHR reporting period. Commenters agreed with the rationale that EPs
might not have the opportunity to provide educational materials to a
patient if the patient has not had an office visit with the EP,
however, commenters also stated that if an EP has a series of office
visits with a patient, it might not be appropriate to provide education
at each visit (for example, a patient with heart disease or high blood
pressure that would see the EP multiple times during the EHR reporting
period). To avoid the potential for presenting redundant information to
patients, commenters suggested that the denominator be based on unique
patients with office visits. This is consistent with the denominator
for eligible hospitals, as that denominator is based on unique patients
admitted. Additionally, commenters noted that counting unique patients
is more appropriate to account for patient-specific education resources
that are not provided in the context of an office visit, such as
reference materials available from a portal or PHR about a patient's
medications, conditions, or lab results.
Response: We agree with commenters in that counting unique patients
with office visits during the EHR reporting period for EPs, rather than
office visits, is a more appropriate denominator for this measure. A
patient with a chronic disease, such as diabetes or heart disease, may
have multiple office visits with an EP during the EHR reporting period.
While providing educational resources for these patients is important,
presenting the same materials each office visit may prove to be
redundant. We encourage EPs to refer educational resources to their
patients with multiple visits during the EHR reporting period at their
discretion.
Additionally, we do maintain that EPs with no office visits during
the EHR reporting period can be excluded from this measure. Therefore,
we are finalizing the denominator for this measure as the ``Number of
unique patients with office visits seen by the EP during the EHR
reporting period.''
Comment: Most commenters agreed that 10 percent was a reasonable
threshold for this measure as it was proposed.
Response: We agree with commenters and are finalizing 10 percent as
the threshold for this measure. It will remain unchanged from Stage 1.
After reviewing the public comments, we are finalizing the measure
for EPs at Sec. 495.6(j)(12)(ii) as ``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 further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(a)(15).
To calculate the percentage for EPs, CMS and ONC have worked
together to define the following for this objective:
Denominator: Number of unique patients with office visits
seen by the EP during the EHR reporting period.
Numerator: Number of patients in the denominator who were
provided patient-specific education resources identified by the
Certified EHR Technology.
Threshold: The resulting percentage must be more than 10
percent in order for an EP to meet this measure.
Exclusion: Any EP who has no office visits during the EHR
reporting period.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of all
unique patients admitted to the eligible hospital's or CAH's inpatient
or emergency departments (POS 21 or 23) are provided patient-specific
education resources identified by Certified EHR Technology.
After consideration of public comments, we are finalizing the
measure for eligible hospitals and CAHs at Sec. 495.6(l)(9)(ii) as
proposed.
We further specify that in order to meet this objective and
measure, an eligible hospital or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(a)(15).
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's or CAH's 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 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 proposed rule we outlined the following benefits of this
objective. Medication reconciliation allows providers to confirm that
the information they have on the patient's medication is accurate. This
not only assists the provider in their direct patient care, it also
improves the accuracy of information they provide to others through
health information exchange.
In the proposed rule, we noted that that when conducting medication
reconciliation during a transition of care, the EP, eligible hospital
or CAH that receives the patient into their care should conduct the
medication reconciliation. We reiterated that the measure of this
objective does not dictate what information must be included in
medication reconciliation. Information included in the process of
medication reconciliation is appropriately determined by the provider
and patient. In the proposed rule 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. We
proposed that the electronic exchange of information is
[[Page 54013]]
not a requirement for medication reconciliation.
Comment: Commenters requested that the definition of medication
reconciliation should specifically mention over-the-counter
medications, vitamins, herbal or other alternative care medications in
the definition.
Response: We believe our term medications is expansive and not
limiting. We in no way limit what any provider chooses to include or
not include in their conduct of a medication reconciliation. As we are
focused on the use of CEHRT to assist in medication reconciliation it
is not our intent to develop a definitive definition of what medication
reconciliation is.
Comment: Commenters stated that the objective is so reliant on
health information exchange that it should not be moved to core until
health information exchange capability increases.
Response: Robust health information exchange is certainly of great
assistance to medication reconciliation. However, it is not required
for medication reconciliation. Nor is electronic health information
exchange the only way EHRs can assist with medication reconciliation.
So while we believe that medication reconciliation will become easier
as health information exchange capability increases, it is not a
prerequisite to performing medication reconciliation.
After consideration of the comments received, we are finalizing
this objective as proposed for EPs at Sec. 495.6(j)(13)(i) and for
eligible hospitals and CAHs at Sec. 495.6(l)(10)(i).
Proposed Measure: The EP, eligible hospital or CAH performs
medication reconciliation for more than 65 percent of transitions of
care in which the patient is transitioned into the care of the EP or
admitted to the eligible hospital's or CAH's inpatient or emergency
department (POS 21 or 23).
In the proposed rule, we stated that although the HITPC recommended
maintaining this threshold at 50 percent we believed that due to this
measure's role in information exchange that we seek to promote through
meaningful use a higher measure was appropriate. Based on the
performance of providers in Stage 1, we proposed to raise the measure
to 65 percent.
Comment: If as stated in the proposed rule ``the majority chose to
defer this measure in Stage 1,'' commenters asserted that this is
insufficient information to justify raising the threshold to 65 percent
and move the objective to core. Other commenters assert that any
measure that moves from menu to core should maintain its Stage 1
threshold regardless of the particular measure's rate of deferral.
Response: After considering the arguments for lowering the
threshold to 50 percent and the lack of robust data in support of the
proposed threshold, we do lower the threshold to 50 percent. For this
measure in particular, we agree that since most providers chose to
defer this measure in Stage 1 the information available on performance
from Stage 1 meaningful EHR users is not as robust as for other
objectives and measures. We do not agree with the comment that all
objectives that move from menu to core should maintain the same
threshold. We believe such a blanket policy would be arbitrary and not
properly account for the information available for each objective and
measure. For example, if most Stage 1 meaningful EHR users had reported
on this measure, there would be a robust data set of performance on
which to judge a threshold. A blanket policy would ignore such
information.
Comment: The denominator of transitions of care during the EHR
reporting period for which the provider is the receiving part of the
transition is imprecise and therefore difficult to determine,
especially when neither the transitioning provider or patient notifies
the provider of the transition.
Response: We addressed this comment earlier in this section in our
discussion of meaningful use denominators and provided a minimum set of
specific actions that would indicate a transition of care has occurred.
Comment: While the objective speaks to relevant encounters, these
are not included in the measure. This makes measurement difficult for
those providers that conduct medication reconciliation at more than
just transitions of care. If providers were allowed to include these
encounters in the measure, measurement would both be easier and more
representative of the actual use of CEHRT by the provider.
Response: We continue to believe that what is a relevant encounter
is to variable to be included in the measure for all providers.
However, a provider who institutes a policy for medication
reconciliation at encounters encompassing more than just the minimum
actions defined by the transitions of care denominator can include
those encounters in their denominator and if medication reconciliation
is conducted at the encounter in the numerator as well.
After consideration of the comments, we are modifying the threshold
of the measure for EPs at Sec. 495.6(j)(13)(ii) and for eligible
hospitals and CAHs at Sec. 495.6(l)(10)(ii). 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).
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 CEHRT at 45 CFR 170.314(b)(4).
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 Objective: The EP, eligible hospital or CAH who
transitions their patient to another setting of care or provider of
care or refers their patient to another provider of care provides a
summary care record for each transition of care or referral.
In the proposed rule, we outlined the following benefits of this
objective. By assuring lines of communication between providers caring
for the same patient, all of the providers of care can operate with
better information and more effectively coordinate the care they
provide. Electronic health records, especially when linked directly or
through health information exchanges, reduce the burden of such
communication. The purpose of this objective is to ensure a summary of
care record is provided to the receiving provider when a patient is
transitioning to a new provider or has been referred to another
provider while remaining under the care of the referring provider.
In the proposed rule, we proposed to eliminate the Stage 1
objective for the exchange of key clinical information for Stage 2 and
instead include such information as part of the summary of care when it
is a part of the patient's electronic record. We also proposed to
incorporate two separate Stage 2 recommendations from the HIT Policy
Committee as required fields in the summary of care record--
[[Page 54014]]
Record care plan fields, including goals and instructions,
for at least 10 percent of transitions of care; and
Record team member, including primary care practitioner,
for at least 10 percent of patients.
ONC also proposed in their standards and certification criteria
rule (77 FR 13848 to include these as standard fields required to
populate the summary of care document so CEHRT will be able to include
this information. We provided a description of a ``care plan'' as well
as the minimum components it must include for purposes of meaningful
use, although we recognized that the actual content would be dependent
on the clinical context. We asked for comments on both our description
of a care plan and whether a description is necessary for purpose of
meaningful use.
We proposed certain elements that are listed in the proposed rule
(77 FR 13722) to be included in the summary care document. In
circumstances where there is no information available on an element,
either because the EP, eligible hospital or CAH can be excluded from
recording such information or because there is no information to
record, the EP, eligible hospital or CAH may leave the field(s) blank
and still meet the objective and its associated measure.
In addition, we proposed that all summary of care documents used to
meet this objective must include the following:
An up-to-date problem list of current and active
diagnoses.
An active medication list, and
An active medication allergy list.
We proposed that all summary of care documents must contain the
most recent and up-to-date information on these three elements to count
in the numerator. We proposed to define problem list as a list of
current and active diagnoses. We solicited comment on whether the
problem list should be extended to include, ``when applicable,
functional and cognitive limitations'' or whether a separate list
should be included for functional and cognitive limitations. We
proposed to define an up-to-date problem list as a list populated with
the most recent diagnoses known by the EP or hospital. We proposed to
define active medication list as a list of medications that a given
patient is currently taking. We proposed to define active medication
allergy list as a list of medications to which a given patient has
known allergies. We proposed to define allergy as an exaggerated immune
response or reaction to substances that are generally not harmful. In
the event that there are no current or active diagnoses for a patient,
the patient is not currently taking any medications, or the patient has
no known medication allergies, confirmation of no problems, no
medications, or no medication allergies would satisfy the measure of
this objective. Note that the inclusion and verification of these
elements in the summary of care record replaces the Stage 1 objectives
for ``Maintain an up-to-date problem list,'' ``Maintain active
medication list,'' and ``Maintain active medication allergy list.''
Comment: Commenters suggested that the required data for each type
of referral and transitions varies and that rather than creating a list
of elements, the provider should decide what is needed.
Response: While we agree that tailoring the summary of care
document for each referral and transition of care is desirable, we
disagree that this means a list of basic elements that should be in
each summary of care documents is not appropriate. We note that most
organizations that try and tackle the issue of summary of care
documents have required fields, core sets or other nomenclature for
elements that they believe should be in all summary of care documents.
For example, the CDA architecture used as the standard for the summary
of care document contains required and optional fields. The American
College of Physicians in their Neighborhood Model uses a core data set.
None of these organizations intend for their list of elements to be
limiting and nor do we intend our list to be limiting, but rather serve
as a minimum. In our proposed rule we went further and said that if the
provider does not have the information available to populate one or
more of the fields listed, either because they can be excluded from
recording such information (for example, vital signs) or because there
is no information to record (for example, laboratory tests), the
provider may leave the field(s) blank. The only exception to this is
the problem list, medication list, and medication allergy list.
Therefore, we are including a list of elements in this final rule.
Comment: Commenters stated that their understanding is that if any
of the fields specifically for problem list, medication list, or
allergy list is blank (meaning no entry of problems, medications or
allergies nor an indication that it is known by the provider that the
patient has no problems, medication or allergies), the EP or hospital
will not meet the measure, but that if any other information is blank,
the EP or hospital will still meet the measure. Please clarify whether
this is a correct understanding of the proposal.
Response: This understanding of our proposed rule is generally
correct. The problem list, medication list and medication allergy list
must also either contain problems, medications and medication allergy
or a specific notation that the patient has none. Leaving the field
entirely blank with no entry whatsoever would not meet the measure.
However, in cases where the provider does not have the information
available to populate one or more of the other fields listed, either
because they can be excluded from recording such information (for
example, vital signs) or because there is no information to record (for
example, laboratory tests), the provider may leave the field(s) blank.
Note this does not allow a provider to disable a listed field from
being generated by the CEHRT, but rather allows for when the CEHRT does
not contain information on which to generate an entry for the field.
Comment: Some commenters suggested the substitution of past medical
history for historical problem list in the list of required elements,
since past medical history could provide additional information
valuable to patient care.
Response: CMS' Evaluation and Management Services Guide defines a
past medical history as the patient's past ``experiences with
illnesses, operations, injuries and treatments'' (see http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf, p. 11). In
our proposed rule, we referred to ``current and historical problem
list'' as this is more concrete and standards based than the definition
for past medical history. We believe the concept of past medical
history is inclusive of current and historical problem list. We
understand that providers are more familiar with the term past medical
history and will evaluate expanding historical problem list to past
medical history for Stage 3. However, for Stage 2, we are finalizing
current and historical problem list. For summary of care documents at
transitions of care we encourage providers to send a list of items that
he or she believes to be pertinent and relevant to the patient's care,
rather than a list of all problems, whether they are active or
resolved, that have ever populated the problem list. While a current
problem list should always be included, the provider can use his or her
judgment in deciding which items historically present on the problem
list, PMHx list (if it exists in CEHRT), or surgical history list are
[[Page 54015]]
included given the clinical circumstances.
Comment: Commenters stated that it is too burdensome to determine
whether the problem list, medication list and medication allergy list
are included in each summary of care document.
Response: We disagree that this is too burdensome. We note that in
Stage 1 measuring the completeness of the problem list, medication list
and medication allergy list is already a requirement. Summary of care
documents are generated by the CEHRT based on the information available
to it. Therefore, there are only two causes of error that would have to
be discovered to make the determination of whether the problem list,
medication list and medication allergy list are included. The problem
list, medication list and medication allergy list do not contain
information for a given patient and/or there is an error in the
generation of the summary of care document. This discovery constitutes
the burden of this measure. We have already noted that the ability to
know whether the lists contain information is already a Stage 1
measure. The second issue is prevalent in nearly every meaningful use
measure that requires CEHRT to generate a measurement so that burden is
already integral to meaningful use.
Comment: Commenters stated that the different descriptions of
problem list throughout the proposed rule create confusion. The four
terms used are ``an up-to-date problem list of current and active
diagnoses'', ``problem list'', ``Current problem list and any updates
to it'' and ``problem list maintained by the hospital on the patient''.
CMS should use this term uniformly. Furthermore, the limitation of the
problem list to only current and active diagnoses is inconsistent with
how problem lists are used and historical problems should also be
included.
Response: We only proposed one definition of the base term
``problem list'', which is a list of current and active diagnoses. We
then use descriptors to tailor the term to the objective in which it is
being utilized. For example, ``up-to-date'' means that the problem list
in the CEHRT is populated with the most recent diagnoses known by the
EP or hospital. The description used for office visit summary ``Current
problem list and any updates to it'' was intended to separate problems
that were known before the visit and those that were determined during
the visit. We agree that our limitation of the ``problem list'' to just
current and active diagnoses is unnecessarily limiting. The C-CDA,
which is the standard adopted for EHR technology certification, for
summary of care documents states that ``at a minimum, all pertinent
current and historical problems should be listed''. We revise our
definition of ``problem list'' to include historical problems. This is
a minimum. We do not limit the provider to just including diagnoses on
the problem list. We agree that there should be just one definition of
the base term ``problem list''; however, we disagree that the same list
is appropriate for every case especially with the addition of the
historical problems. Some objectives call for the current problem list
which includes only those diagnoses of problems currently affecting the
patient. Other objectives call for the current and historical problem
list, which would include problems currently affecting the patient as
well as those that have been resolved. For purposes of clarity, we are
consolidating across all of the meaningful use objectives to just two
descriptions of our term ``problem list'': ``current problem list'' and
``current and historical problem list.'' This consolidation also
removes the need for a separate item of past relevant diagnosis as
these would be included in a historical problem list. We define active
medication list as a list of medications that a given patient is
currently taking. We define active medication allergy list as a list of
medications to which a given patient has known allergies. We define
allergy as an exaggerated immune response or reaction to substances
that are generally not harmful. Information on problems, medications,
and medication allergies could be obtained from previous records,
transfer of information from other providers (directly or indirectly),
diagnoses made by the EP or hospital, new medications ordered by the EP
or in the hospital, or through querying the patient. In the event that
there are no current or active diagnoses for a patient, the patient is
not currently taking any medications, or the patient has no known
medication allergies, confirmation of no problems, no medications, or
no medication allergies would satisfy the measure of this objective.
Comment: Many commenters recommended against any specification of
problem list content regarding functional and cognitive limitations
citing insufficient consensus around the appropriate classification of
these functions. Commenters also stated that if included, functional
and cognitive limitations should be further defined.
Response: As noted earlier in this final rule under the demographic
objective, we wish to clarify that both the concepts of physical and
cognitive disabilities as well as the concept of functional limitations
that impact an individual's capability to perform activities were
included in our description of disability status for the purpose of
this rule. The latter concept is a common metric for care planning and
care coordination across settings because knowledge of a patient's
abilities (for example, functional and/or cognitive status) are also
necessary for clinical practice. While many commenters noted the lack
of consensus for the terms and standards necessary to support the
inclusion of disability, functional and cognitive status assessment and
observations into the Consolidated CDA for summary of care records, we
understand that this standard was updated to include section- and data-
entry level templates that can describe a patient's functional and
cognitive status. However, we agree that there are insufficient
definitions for disability, functional and cognitive status assessment
and observations to include them as part of the problem list.
Therefore, we are including ``functional status, including functional,
cognitive and disability'' as a separate element in the summary of care
document.
Comment: In regard to the inclusion of ``care plan field'' in the
list of required information, some commenters believed that the wording
was overly prescriptive since CEHRT could utilize multiple fields to
structure care plans. Other commenters requested a more detailed
definition of care plan and/or the standards that are available or
required.
Response: We agree that the language proposed could be viewed as
prescriptive, and we do not intend to limit the inclusion of the care
plan to a single field. Therefore, we are amending the language to
``Care plan field(s), including goals and instructions'' in our list of
required elements below. However, we decline to provide an alternate
definition that would limit the information in the care plan. We
believe that the definition we proposed in the proposed rule is
sufficient to allow for the inclusion of a variety of care plans in the
clinical summary. For purposes of the clinical summary, we define a
care plan as the structure used to define the management actions for
the various conditions, problems, or issues. A care plan must include
at a minimum the following components: Problem (the focus of the care
plan), goal (the target outcome), and any instructions that the
provider has given to the patient. A goal is a defined target or
measure to be achieved in the process of patient care (an expected
outcome).
[[Page 54016]]
Comment: Commenters stated that while the care team members are
clearly important data elements and key to clinical coordination, they
recommended further research into true standards to support these
elements before any requirements are imposed.
Response: Our proposal is to include ``Any additional known care
team members beyond the referring or transitioning provider and the
receiving provider''. We believe that the ability to identify providers
is well established. We note that there is no requirement to identify
the role of each provider which we would agree are not well established
beyond PCP and referring provider. We also note that this is only for
cases when the other care team members are known by the transitioning
provider. These allowances are sufficient to accommodate the current
standard limitations and therefore we finalize as proposed.
Comment: As referrals are included in the denominator as well as
transitions of care, the summary of care document should include the
reason for the referral.
Response: We agree with this comment and add reason for referral
for EPs. The reason for the referral is the clinical question the
referring provider wants answered for a consultation or the procedure
to be performed. If the consultation is more open ended, then a brief
summary of the case details pertinent to referral suffices.
After consideration of the comments, 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.
After consideration of public comments, we are finalizing this
objective for EPs at Sec. 495.6(j)(14)(i) and for eligible hospitals
and CAHs at Sec. 495.6(l)(11)(i) as proposed.
Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy
both measures in order to meet the objective:
The EP, eligible hospital or CAH that transitions or refers their
patient to another setting of care or provider of care provides a
summary of care record for more than 65 percent of transitions of care
and referrals.
The EP, eligible hospital or CAH that transitions or refers their
patient to another setting of care or provider of care electronically
transmits a summary of care record using CEHRT to a recipient with no
organizational affiliation and using a different CEHRT vendor than the
sender for more than 10 percent of transitions of care and referrals.
First Measure: We proposed that if the provider to whom the
referral is made or to whom the patient is transitioned has access to
the medical record maintained by the referring provider, then the
summary of care record would not need to be provided and that patient
should not be included in the denominators of the measures of this
objective. We stated in the proposed rule that different settings
within a hospital using the same CEHRT would have access to the same
information, so providing a clinical care summary for transfers within
the hospital would not be necessary.
Comment: If as stated in the proposed rule ``the majority chose to
defer this measure in Stage 1'', commenters asserted this is
insufficient information to justify raising the threshold to 65 percent
and move the objective to core. Other commenters assert that any
measure that moves from menu to core should maintain its Stage 1
threshold regardless of the particular measure's rate of deferral.
Response: After considering the arguments for lowering the
threshold to 50 percent and the lack of a robust data set in support of
the proposed threshold, we do lower the threshold to 50 percent. For
this measure in particular, we agree that since most providers chose to
defer this measure in Stage 1 the information available on performance
from Stage 1 meaningful EHR users is not as robust as for other
objectives and measures. We do not agree with the comment that all
objectives that move from menu to core should maintain the same
threshold. We believe such a blanket policy would be arbitrary and not
properly account for the information available for each objective and
measure. For example, if most Stage 1 meaningful EHR users had reported
on this measure, there would be a robust data set of performance on
which to judge a threshold. A blanket policy would ignore such
information.
Comment: Commenters questioned and requested clarification on
situations where the recipient of the transition or referral is using
the same instance of CEHRT or otherwise has access to the CEHRT of the
transitioning or referring provider. Some of these commenters
acknowledged our proposal to address this situation were also split
between support for our proposal to exclude these from the denominator
versus allowing them to be in the denominator and numerator of both
measures. Also commenters expressed concern on whether this was a
measurable constraint. Finally, commenters requested clarification on
whether our proposal applied to one or both measures.
Response: We proposed that if the provider to whom the referral is
made or to whom the patient is transitioned has access to the medical
record maintained by the referring provider, then the summary of care
record would not need to be provided and that patient should not be
included in the denominators of the measures of this objective. We
believe that different settings within a hospital using CEHRT would
have access to the same information, so providing a clinical care
[[Page 54017]]
summary for transfers within the hospital would not be necessary. This
is a continuance of our current Stage 1 policy. In response to
comments, this policy applies to both measures. We clarify the first
sentence that access to the medical record could be through several
mechanisms. Some providers will be in the same organization and share
CEHRT outright. Other providers might grant remote access to their
CEHRT to providers not sharing their same CEHRT. We do not limit the
mechanisms through which access is granted. We disagree that this
access should count in the denominator or numerator of either measure.
A summary of care document generated by CEHRT conforms to specific
standards and could in many cases be automatically integrated into the
recipient's CEHRT. Access provides no such capability. For this reason,
we finalize our policy of excluding these transitions and referrals
from the denominator. However, if a transitioning or referring provider
provides both access and a summary of care document to providers
outside their organization and wishes to include them in their
denominator and as appropriate their numerator, they can do so.
Finally, while we agree that it some cases it may be difficult to
determine whether the recipient has access to the sender's CEHRT. We do
not believe that we should remove an accommodation due to measurement
difficulties. It is acceptable for a provider to include these
transitions and referrals in the denominator, but only if a summary of
care document is provided would it count in the numerator.
Comment: Commenters stated that there are some providers who may
engage in a small number of transitions of care and referrals and the
implementation burden of this objective is too high to require of those
with only a small number. This is particularly true as the requirement
for electronic health information exchange is introduced.
Response: We have previously allowed for a more than zero, but less
than 100 exclusion for our other objective requiring electronic health
information exchange (eRx); therefore, in response to these comments we
will apply that policy to this objective and measure as well and raise
the exclusion from zero to less than 100 transitions of care and
referrals. Transitions of care and referrals are additive so someone
with 50 transitions of care and 75 referrals would not qualify for the
exclusion.
After consideration of public comments, we are revising the measure
for EPs at Sec. 495.6(j)(14)(ii)(A) and for eligible hospitals and
CAHs at Sec. 495.6(l)(11)(ii)(A) to ``The EP, eligible hospital or CAH
that transitions or refers their patient to another setting of care or
provider of care provides a summary of care record for more than 50
percent of transitions of care and referrals.''
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 CEHRT at 45 CFR 170.314(b)(l) and (b)(2)(i).
To calculate the percentage of the first measure, CMS and ONC have
worked together to define the following for this objective:
Denominator: Number of transitions of care and
referrals during the EHR reporting period for which the EP or eligible
hospital's or CAH's inpatient or emergency department (POS 21 or 23)
was the transferring or referring provider.
Numerator: The number of transitions of care and
referrals in the denominator where a summary of care record was
provided.
Threshold: The percentage must be more than 50
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 is excluded from all three
measures.
Second Measure: For Stage 2, we proposed the additional second
measure for electronic transmittal because we believe that the
electronic exchange of health information between providers will
encourage the sharing of the patient care summary from one provider to
another and the communication of important information that the patient
may not have been able to provide, which can significantly improve the
quality and safety of referral care and reduce unnecessary and
redundant testing. Use of common standards can significantly reduce the
cost and complexity of interfaces between different systems and promote
widespread exchange and interoperability. In acknowledgement of this,
ONC has included certain transmission protocols in the proposed 2014
Edition EHR certification criteria.
These protocols would allow every provider with CEHRT to have the
tools in place to share critical information when patients are
discharged or referred, representing a critical step forward in
exchange and interoperability. Accordingly, we proposed to limit the
numerator for this second measure to only count electronic
transmissions which conform to the transport standards proposed for
adoption at 45 CFR 170.202 of the ONC standards and certification
criteria rule.
To meet the second measure of this objective, we proposed that a
provider must use CEHRT to create a summary of care document with the
required information according to the required standards and
electronically transmit the summary of care document using the
transport standards to which its CEHRT has been certified. No other
transport standards beyond those proposed for adoption as part of
certification would be permitted to be used to meet this measure.
In the proposed rule, we acknowledged the benefits of requiring the
use of consistently implemented transport standards nationwide, but at
the same time want to be cognizant of any unintended consequences of
this approach. ONC requested comments on whether equivalent alternative
transport standards exist to the ones ONC proposes to exclusively
permit for certification. These comments are addressed in the ONC
standards and certification final rule published elsewhere in this
issue of the Federal Register. We noted in the proposed rule that the
use of USB, CD-ROM, or other physical media or electronic fax would not
satisfy the measures for electronic transmittal of a summary of care
record. We discussed in the proposed rule, in lieu of requiring solely
the transmission capability and transport standard(s) included in a
provider's CEHRT to be used to meet this measure, also permitting a
provider to count electronic transmissions in the numerator if the
provider electronically transmits summary of care records to support
patient transitions using an organization that follows Nationwide
Health Information Network (NwHIN) specifications (http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_resources/1194). This could include those organizations that are
part of the NwHIN Exchange as well as any organization that is
identified through a governance mechanism ONC would establish through
regulation. We requested public comment on whether this additional
flexibility should be added to our proposed numerator limitations.
In the proposed rule we raised another potential concern that
another transport standard emerges after CMS' and ONC's rules are
finalized that is not adopted in a final rule by ONC as part of
certification, but nonetheless accomplishes the objective in the same
way. To mitigate this concern, ONC indicated in its proposed rule that
it
[[Page 54018]]
would pursue an off-cycle rulemaking to add as an option for
certification transport standards that emerge at any time after these
proposed rules are finalized in order to keep pace with innovation and
thereby allow other transport standards to be used and counted as part
of this measure's numerator. We asked for comments on how these
standards will further the goal of true health information exchange.
Additionally, in order to foster standards based-exchange across
organizational and vendor boundaries, we proposed to further limit the
numerator by only permitting electronic transmissions to count towards
the numerator if they are made to recipients that are--(1) not within
the organization of the transmitting provider; and (2) do not have
CEHRT from the same EHR vendor.
We proposed these numerator limitations because, in collaboration
with ONC, our experience has shown that one of the biggest barriers to
electronic exchange is the adoption of numerous different transmission
methods by different providers and vendors. Thus, we explained that it
would be prudent for Stage 2 to include these more specific
requirements and conformance to open, national standards as it will
cause the market to converge on those transport standards that can best
and most readily support electronic health information exchange and
avoid the use of proprietary approaches that limit exchange among
providers. We recognized that because the 2011 Edition EHR
certification criteria did not include specific transport standards for
transitions of care, some providers and vendors implemented their own
methods for Stage 1 to engage in electronic health information
exchange, some of which would no longer be an acceptable means of
meeting meaningful use if this proposal were finalized.
Therefore, in order to determine a reasonable balance that makes
this measure achievable yet significantly advance interoperability and
electronic exchange, we asked for comment on the following concerns
stakeholders may have relative to the numerator limitations we proposed
previously.
We discussed a potential concern related to the feasibility of
meeting this proposed measure if an insufficient number of providers in
a given geographic location (because of upgrade timing or some other
factor) have EHR technology certified to the transport standards ONC
has proposed to adopt. For example, a city might have had a widely
adopted health information exchange organization that still used
another standard than those proposed for adoption by ONC. While it is
not our intent to restrict providers who are engaged in electronic
health information exchange via other transport standards, we believe
requiring the use of a consistent transport standard could
significantly further our overarching goals for Stage 2.
We recognized that this limitation extends beyond the existing
parameters set for Stage 1, which specified that providers with access
to the same medical record do not include transitions of care or
referrals among themselves in either the denominator or the numerator.
We recognized that this limitation could severely limit the pool of
eligible recipients in areas where one vendor or one organizational
structure using the same EHR technology has a large market share and
may make measuring the numerator more difficult. We sought comment on
the extent to which this concern could potentially be mitigated with an
exclusion or exclusion criteria that account for these unique
environments. We believe the limitation on organizational and vendor
affiliations is important because even if a network or organization is
using the standards, it does not mean that a network is open to all
providers. Certain organizations may find benefits, such as competitive
advantage, in keeping their networks closed, even to those involved in
the care of the same patient. We believe this limitation will help
ensure that electronic transmission of the summary of care record can
follow the patient in every situation.
Even without the addition of the proposed exclusions under the
proposed measure, CEHRT would need to be able to distinguish between
(1) electronic transmissions sent using standards and those that are
not, (2) transmission that are sent to recipients with the same
organizational affiliation or not, and (3) transmissions that are sent
to recipients using the same EHR vendor or not. ONC sought comment in
their proposed certification rule as to the feasibility of this
reporting requirement for CEHRT.
Despite the possible unintended consequences of the parameters we
proposed for the numerator, in the proposed rule we stated that we
believed that these limitations would help ensure that electronic
health information exchange proceeds at the pace necessary to
accomplish the goals of meaningful use. We asked for comments on all
these points and particularly suggestions that would both push
electronic health information exchange beyond what is proposed and
minimize the potential concerns expressed previously.
The HIT Policy Committee recommended different thresholds for EPs
and hospitals for the electronic transmission measure, with a threshold
of only 25 instances for EPs. However, we proposed a percentage-based
measure is attainable for both EPs and eligible hospitals/CAHs and
better reflects the actual meaningful use of technology. It also
provides a more level method for measurement across EPs. We asked for
comments on whether there are significant barriers in addition to those
discussed above to EPs meeting the 10 percent threshold for this
measure.
Comment: There were several comments that doubted that the
technology will be ready for providers to meet this measure. They did
not believe there is enough vendor support to create, customize, and
implement the changes necessary to meet the new measure. Commenters
expressed concern that many of the technologies, from EHRs to HIEs and
transmission standards, needed to enable electronic health information
exchange currently do not exist.
Response: We disagree that it is premature to include this measure
for Stage 2. We note that as an incentive program it is expected that
the requirements will reach beyond what is commonplace today. Many
organizations and providers are successfully engaged in electronic
health information exchange today and by including this measure in
meaningful use those established practices will be adopted by a greater
number of providers.
Comment: A commenter suggested that ONC's certification rule was
the appropriate place to ensure cross-vendor interoperability, not the
Stage 2 measures and objectives.
Response: While we agree that meaningful use should be enabled by
the capabilities included in certification, the concept of meaningful
use is to incentivize the use of such capabilities not just the
acquisition of them.
Comment: Commenters expressed two concerns on the limitation on the
numerator that limited it to recipients with no organizational
affiliation and using a different CEHRT vendor. First, there was
concern that in some markets an organization or CEHRT vendor may
control such a significant share of the market that meeting 10 percent
is not possible. Second, even if the 10 percent threshold was feasible
in a given market, one organization or CEHRT vendor may have enough
market share
[[Page 54019]]
that the provider's referral patterns would inappropriately be
influenced to give preference to those using different CEHRT vendors or
outside their organizations. Commenters support appropriate information
exchange between all providers, where clinically relevant, regardless
of provider affiliations, but have these concerns on our proposed
measure for this objective. Commenters presented several different
solutions including removing one or both limitations, replacing the
limitations with an error reporting system for instances where
electronic health information exchange fails, moving the limitations to
the denominator and providing exclusions for areas of high vendor or
organizational market penetrations.
Response: We agree that the measure as proposed runs both risks
stated by commenters. Of the solutions presented by commenters, one
directly alleviates both of these concerns. In drafting the final rule,
we considered moving the limitations from the numerator to the
denominator of the measure, both concerns are addressed. For example,
if a provider makes 500 referrals during the EHR reporting period, 400
of which are to providers that either are affiliated with the same
organization or use the same CEHRT vendor, then only 100 referrals are
even eligible for the proposed numerator. This creates a bar that is
much higher than 10 percent, as 50 percent of the eligible instances
must be electronically transmitted to meet the proposed measure in this
example, which we agree has the possibility of influencing referral
patterns. However, applying the limitations of ``no organizational
affiliation'' and ``different CEHRT vendor'' to the denominator instead
of the numerator would result, in this example, in a denominator of 100
referrals instead of 500 and a true 10 percent threshold. There would
be no need to change referral patterns as there would be no negative
effect on the threshold for having a referral partner either in the
same organization or using the same CEHRT vendor. We firmly believe
that this solution is the best measure of the type of health
information exchange that we proposed to target and that is supported
in principle by nearly all commenters. However, we are not including
this solution in the final rule as explained in the response to the
next set of comments. Instead, we are removing the organizational and
vendor limitations from this measure solely due to the burden of making
these determinations for measurement.
Comment: Many commenters expressed concern over the ability to
measure this objective especially the organization and vendor
limitations. Commenters who were providers expressed concern over the
ability of their CEHRT vendor to measure this objective, while vendors
of CEHRT expressed concern over the ability of providers to measure the
objective. Combined, it appears that neither the provider nor the
vendor believed they could even measure on their own and had concerns
on their partners on which they placed their hopes for measurement.
Response: In the proposed rule we determined that the CEHRT would
have to be able to make three determinations to successfully calculate
the numerator for this measure: (1) Electronic transmissions sent using
standards and those that are not; (2) transmissions that are sent to
recipients with the same organizational affiliation or not; and (3)
transmissions that are sent to recipients using the same EHR vendor or
not. We stated that ONC will seek comment in their proposed
certification rule as to the feasibility of this reporting requirement
for certified EHR technologies. ONC received comments similar to ours
that making the determinations for the numerator was infeasible
particularly in regard to the organizational and vendor limitations.
Therefore, we are removing the organizational and vendor limitations
from this measure solely due to the burden of making these
determinations for measurement. Commenters did not suggest difficulties
with determining that the electronic transmission was sent using the
specified standards. Therefore, we finalize the stipulation that CEHRT
be used, including its accompanying standards for this measure
(``measure 2'').
However, we are not abandoning all efforts to ensure that cross
vendor electronic exchange is possible for all meaningful EHR users in
Stage 2. As discussed in the prior comment and response, the only
reason we are not finalizing the stipulations on the denominator is the
measurement burden. We believe that a third measure is needed that
reduces the burden relative to the proposed measure, but still ensures
that all providers have implemented CEHRT in a way that enables them to
electronically exchange summary of care documents with a recipient
using EHR technology designed by a different vendor. Therefore, we have
added a third measure (``measure 3'') that requires providers to use
their CEHRT to either--
Conduct one or more successful electronic exchanges of a
summary of care document, which is counted in measure 2 with a
recipient who has EHR technology designed by a different EHR technology
developer than the sender's EHR technology certified to 45 CFR
170.314(b)(2); or
Conduct one or more successful tests with the CMS
designated test EHR during the EHR reporting period.
For the first option in measure 3, the sender must verify that the
recipient's technology used to receive the summary of care record was
not designed by the same EHR technology developer that designed the
sender's EHR technology certified to 45 CFR 170.314(b)(2).
With respect to the second option in measure 3, and recognizing
past difficulties and lessons learned from a ``test'' oriented measure
in Stage 1, we have collaborated with ONC and NIST to initiate a
project that would result in a public facing (hosted online) ``test
EHR'' with which EPs, eligible hospitals, and CAHs could engage in
electronic exchange. We expect that most providers will satisfy the
first option in the normal course of meeting measure 2. However, in
those rare instances where that does not occur this other second option
would give every EP, eligible hospital, or CAH an alternative method to
meet measure 3 with minimal burden by successfully testing electronic
exchange with the CMS-designated test EHR. If this second option is
used, we clarify that the use of test information about a fictional
patient that would be identical in form to what would be sent about an
actual patient (for example, ``dummy data'') must be used for the
purposes of conducting a test with the CMS-designated test EHR.
Providers that use the same EHR technology certified to 45 CFR
170.314(b)(2) and share a network for which their organization either
has operational control or license to use can conduct one test that
covers all providers in the organization. For example, if a large group
of EPs with multiple physical locations use the same EHR technology
certified to 45 CFR 170.314(b)(2) and those locations are connected
using a network that the group has either operational control of or
license to use, then a single test would cover all EPs in that group.
Similarly, if a provider uses an EHR technology that is hosted (cloud-
based) on the developer's network, then a single test would allow all
EPs, eligible hospitals and CAHs using the EHR technology that is
hosted (cloud-based) on the developer's network to meet the measure.
While making this does impose a burden on the provider, we believe
the burden is outweighed by the benefits of ensuring that every
provider who
[[Page 54020]]
becomes a meaningful EHR user is capable of exchanging a summary of
care document electronically regardless of who developed the sender's
EHR and the recipient's EHR.
We also seek to note for readers that while we have significantly
reduced this objective's burden from what we proposed in measure 2, we
continue to believe that making vendor to vendor standards-based
exchange attainable for all meaningful EHR users is of paramount
importance. In that regard, and as we look toward meaningful use Stage
3, we will monitor the ease with which EPs, eligible hospitals, and
CAHs engage in electronic exchange, especially across different vendors
EHRs. If we do not see sufficient progress or that continued
impediments exist such that our policy goals for standards-based
exchange are not being met, we will revisit these more specific
measurement limitations and consider other policies to strengthen the
interoperability requirements included in meaningful use as well as
consider other policies and regulations through which the Department
could effect the outcome we seek. Finally, we also intend to consider
future meaningful use requirements that increase expectations for
standards-based exchange and make information that is exchanged more
searchable and usable for a broad array of clinical purposes imperative
to care improvement. We envision that these requirements would rely on
metadata tagging as well as more dynamic methods of electronic health
information exchange.
Comment: Commenters expressed support for including in this
measure's numerator electronic transmissions enabled by query-based
exchange models, including organizations using NwHIN Exchange
specifications. The commenters indicated that NwHIN Exchange
specifications are appropriate for exchange use cases not covered as
well by the Direct standards, and use of either standard should be
counted. This is particularly important in cases where the summary is
pulled instead of pushed. Providers and organizations that are part of
the NwHIN Exchange or other organizations using these standards should
receive credit for those exchanges in meeting interoperability
measures.
Response: In Stage 2, all providers should be able to use CEHRT to
share summary of care records in a ``push'' manner to support safe
transitions and informed referrals. ``Pull'' (query) transactions can
also support these goals. By ``pull'' transactions we refer to
instances where the receiving provider retrieves the summary of care
document from a location outside their own CEHRT as opposed to ``push''
transactions where the referring or transitioning provider sends the
summary of care document to the receiving provider. Thus, such
transactions should be counted towards the numerator of the provider
initiating the transitions or referrals when the recipient (the
provider ``receiving'' the transition or referral) actually receives or
downloads the patient's summary of care record relevant to the
transition or referral. The act of uploading the summary of care record
to a repository that can be queried by the recipient--without
validation that this query in fact occurred will not be sufficient to
count towards the numerator. While we acknowledge that there may not be
a simple, universal way for this to be measured, we believe it is
important to make this accommodation for those who elect to engage in
this form of exchange. Therefore, we are revising the second measure to
include in the sending provider's numerator instances where the
recipient receives the summary of care record via exchange facilitated
by an organization that is an NwHIN Exchange participant or in a manner
that is consistent with the governance mechanism ONC establishes for
the nationwide health information network. The referring or
transitioning provider would use their CEHRT to generate a summary of
care document and to provide it an organization that is a NwHIN
Exchange participant or in a manner that is consistent with the
governance mechanism ONC establishes for the nationwide health
information network. More information on NwHIN Exchange participants is
available at http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__nhin_exchange/1407. ONC issued a request for
information regarding a governance mechanism for the nationwide health
information network that is available at 77 FR 28543.
After considering the comments received, we are modifying the
second measure for EPs at Sec. 495.6(j)(14)(ii)(B) and for eligible
hospitals and CAHs at Sec. 495.6(l)(11)(ii)(B) to ``The EP, eligible
hospital or CAH that transitions or refers their patient to another
setting of care or provider of care provides a summary of care record
for more than 10 percent of such transitions and referrals either (a)
electronically transmitted using CEHRT to a recipient or (b) where the
recipient receives the summary of care record via exchange facilitated
by an organization that is a NwHIN Exchange participant or in a manner
that is consistent with the governance mechanism ONC establishes for
the nationwide health information network.''
We further specify that in order to meet this objective and
measure, an EP, eligible hospital, or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(b)(l) and (b)(2).
To calculate the percentage of the second measure, CMS and ONC have
worked together to define the following for this objective:
Denominator: Number of transitions of care and
referrals during the EHR reporting period for which the EP or eligible
hospital's or CAH's inpatient or emergency department (POS 21 or 23)
was the transferring or referring provider.
Numerator: The number of transitions of care and
referrals in the denominator where a summary of care record was a)
electronically transmitted using CEHRT to a recipient or b) where the
recipient receives the summary of care record via exchange facilitated
by an organization that is a NwHIN Exchange participant or in a manner
that is consistent with the governance mechanism ONC establishes for
the nationwide health information network. The organization can be a
third-party or the sender's own organization.
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 is excluded from all three
measures.
Third Measure: After considering the comments received, we are
adding a third measure for EPs at Sec. 495.6(j)(14)(ii)(C) and for
eligible hospitals and CAHs at Sec. 495.6(l)(11)(ii)(C) to ``An EP,
eligible hospital or CAH must satisfy one of the two following
criteria:
Conducts one or more successful electronic exchanges of a
summary of care document, which is counted in ``measure 2'' (for EPs
the measure at Sec. 495.6(j)(14)(ii)(B) and for eligible hospitals and
CAHs the measure at Sec. 495.6(l)(11)(ii)(B)) with a recipient who has
EHR technology that was designed by a different EHR technology
developer than the sender's EHR technology certified to 45 CFR
170.314(b)(2); or
Conducts one or more successful tests with the CMS
designated test EHR during the EHR reporting period.
We further specify that in order to meet this objective and
measure, an EP, eligible hospital, or CAH must use the
[[Page 54021]]
capabilities and standards of CEHRT at 45 CFR 170.314(b)(2).
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 is excluded from all three
measures.
(c) Public Health Objectives
General Public Health Discussion
In the proposed rule, due to similar considerations among the
public health objectives, we discussed them together. Some Stage 2
public health objectives are proposed to be in the core set while
others are proposed to be in the menu set. Each objective is identified
as either core or menu in the following discussion.
Capability to submit electronic data to immunization
registries or immunization information systems except where prohibited,
and in accordance with applicable law and practice.
Capability to submit electronic reportable laboratory
results to public health agencies, except where prohibited, and in
accordance with applicable law and practice.
Capability to submit electronic syndromic surveillance
data to public health agencies, except where prohibited, and in
accordance with applicable law and practice.
Capability to identify and report cancer cases to a state
cancer registry except where prohibited, and in accordance with
applicable law and practice.
Capability to identify and report specific cases to a
specialized registry (other than a cancer registry), except where
prohibited, and in accordance with applicable law and practice.
We proposed the following requirements, which will apply to all of
the public health objectives and measures. We proposed that actual
patient data is required for the meaningful use measures that include
ongoing submission of patient data.
We discussed in the proposed rule situations where PHAs partner
with health information exchange (HIE) organizations to facilitate the
submission of public health data electronically from EHRs. As we stated
in guidance for Stage 1, (see FAQ 10764 at: https://questions.cms.hhs.gov) we clarified that such arrangements with HIE
organizations, if designated by the PHA to simply transport the data,
but not transforming content or message format (for example, HL7
format), are acceptable for the demonstration of meaningful use.
Alternatively, if the intermediary is serving as an extension of the
EP, eligible hospital or CAH's CEHRT and performing capabilities for
which certification is required (for example, transforming the data
into the required standard), then that functionality must be certified
in accordance with the certification program established by ONC. In
this situation, the EP, eligible hospital or CAH must still ensure the
accomplishment of ongoing submission of reports to the actual
immunization information system or registry (whether performed by the
intermediary or not), except in situations when the PHA has explicitly
designated delivery of reports to the intermediary as satisfying these
requirements.
We proposed that an eligible provider is required to utilize the
transport method or methods supported by the PHA in order to achieve
meaningful use.
Unlike in Stage 1, under our proposed Stage 2 criteria a failed
submission will not meet the objective. An eligible provider must
either have successful ongoing submission or meet an exclusion
criterion.
We stated in the proposed rule that we expect that CMS, CDC and
PHAs will establish a process where PHAs will be able to provide
letters affirming that the EP, eligible hospital or CAH was able to
submit the relevant public health data to the PHA. This affirmation
letter could then be used by the EP, eligible hospital or CAH for the
Medicare and Medicaid meaningful use attestation systems, as well as in
the event of any audit. We requested comments on challenges to
implementing this strategy.
We proposed to accept a yes/no attestation and information
indicating to which PHA the public health data were submitted to
support each of the public health meaningful use measures.
Comment: Commenters asked for clarification of ongoing submission;
additionally, due to the amount of time needed to prepare for
submission of data, commenters asked for clarification on the timing to
determine if a public health authority has the capacity to accept
electronic data for ongoing submission. Other commenters noted that
being ``in queue'' or in the process of validation for ongoing
submission should count as meeting this measure. Commenters also noted
that credit should be given for having moved into ongoing submission
during Stage 1.
Response: To clarify the timing issue, the EP or hospital must
determine if the PHA has the capacity to accept electronic data using
the specification prescribed by ONC for the public health information
for the objectives of meaningful use within the first 60 days of the
EHR reporting period. If the PHA does not have the capacity to accept
reporting (including situations when the PHA accepts electronic data
but states it lacks capacity to enroll the EP, eligible hospital or CAH
during that reporting period), the EP or hospital can claim an
exclusion for this measure related to the data that cannot be accepted.
In determining whether the PHA has the capacity, CMS anticipates
developing a centralized repository for this information, including a
deadline for the PHA to submit information. If the PHA fails to provide
information to this centralized repository by the deadline, the
provider could claim the exclusion. In the event, that we are unable to
develop a centralized repository, providers will make the determination
of PHA capacity by working directly with the PHA as is currently the
case for Stage 1 of meaningful use. If the PHA does have the capacity,
the measure may be satisfied through any of the following general
public health criteria:
Ongoing submission was already achieved for an EHR
reporting period in a prior year and continues throughout the current
EHR reporting period using either the current standard at 45 CFR
170.314(f)(1) and (f)(2) or the standards included in the 2011 Edition
EHR certification criteria adopted by ONC during the prior EHR
reporting period when ongoing submission was achieved.
Registration with the PHA or other body to whom the
information is being submitted of intent to initiate ongoing submission
was made by the deadline (within 60 days of the start of the EHR
reporting period) and ongoing submission was achieved.
Registration of intent to initiate ongoing submission was
made by the deadline and the EP or hospital is still engaged in testing
and validation of ongoing electronic submission.
Registration of intent to initiate ongoing submission was
made by the deadline and the EP or hospital is awaiting invitation to
begin testing and validation.
The measure will not be met if the provider--
Fails to register their intent by the deadline; or
Fails to participate in the on-boarding process as
demonstrated by failure to respond to the PHA written requests for
action within 30 days on two separate occasions.
Comment: Several commenters expressed concern that no data
transport mechanism was included in the Stage 2 rule and/or EHR
certification. Some expressed concern that the lack of a
[[Page 54022]]
standard may result in EPs paying more for interfaces than received in
incentive payments. Other commenters supported including no transport
mechanism to allow maximum flexibility for public health authorities.
Response: While we understand the concern of supporting multiple
transport mechanisms, in order for data to flow to public health
authority, vendors must support the transport mechanism utilized by the
public health authority to which the EP or hospital reports. Public
health authorities have moved to standardize transport mechanisms where
feasible, and Health Information Exchanges are often facilitating the
transport of data to public health. We stand by our policy that allows
public health authorities to dictate the transport mechanism in their
jurisdiction. Further, we clarify that this is independent of the EHR
certification criteria as EHR certification does not address transport
for public health objectives.
Comment: Commenters suggested that the expectation that public
health agencies provide affirmation letters is too restrictive in
accomplishing the goal of established a record of communication between
the provider and the PHA. They maintain that there are simpler and less
burdensome ways such as automated acknowledgment messages from
immunization submissions.
Response: We agree that our proposal requiring it must be a letter
is too restrictive and revise our expectation to allow for any written
communication (which may be in electronic format) from the PHA
affirming that the EP, eligible hospital or CAH was able to submit the
relevant public health data to the PHA.
Comment: Commenters requested greater clarification on what is
meant by ongoing submission. Some suggested that it be transitioned to
a percentage measurement as with other objectives of meaningful use.
Response: We do not agree that a transition to a percentage
measurement best serves the public health objectives. First, a
percentage measure would only be applicable to those engaged in ongoing
submission, and as indicated in an earlier response, we are allowing
four different situations to meet the measure. Second, we believe that
the requirement to submit information would be under applicable law,
the agreements between the provider and PHA, or through meaningful use
which requires submissions except where prohibited, so it is not
necessary for meaningful use to monitor the already mandated
submission. For greater clarification, we describe successful ongoing
submission as electronic submission of reportable data during the
normal course of a provider's operations. This is not to say all data
that is reportable is sent to the PHA. A provider who is submitting any
reportable data during their normal course of their operations is
engaged in ongoing submission. A provider that can only submit
reportable data in a test environment or other circumstance that is not
part of their normal operations would not be engaged in ongoing
submission.
Where a measure states ``in accordance with applicable law and
practice,'' this reflects that some public health jurisdictions may
have unique requirements for reporting and that some may not currently
accept electronic data reports. In the former case, the proposed
criteria for this objective will not preempt otherwise applicable state
or local laws that govern reporting. In the latter case, EPs, eligible
hospitals, and CAHs will be excluded from reporting.
Comment: Several commenters requested the removal of ``except where
prohibited'' from the objective, while others expressed support for
this phrase. Those that did not support note that CMS does not have the
authority to direct reporting if not required by law or regulations,
while supporters applauded CMS for supporting reporting where allowed
but not required by law. Several commenters suggested removing the
phrase ``in accordance with applicable law,'' while other commenters
wrote in support of the addition of the phrase.
Response: We disagree with the commenters suggesting removal of
these phrases and will keep them as part of the final rule. The phrase
``except where prohibited'' is meant to allow exemptions from reporting
for providers who cannot by law report to the public health authority
within their jurisdiction. For example, a sovereign Indian Nation may
not be permitted to report immunization registry data to the public
health authority in their jurisdiction. The phrase is meant to
encourage reporting if a provider is authorized to do so. The ``in
accordance with applicable law'' phrase allows public health
authorities to utilize their existing laws and regulations for
reporting.
Proposed Objective: Capability to submit electronic data to
immunization registries or immunization information systems except
where prohibited, and in accordance with applicable law and practice.
We proposed to include this objective in the Stage 2 core set for
EPs, eligible hospitals and CAHs as recommended by the HITPC. We
discussed in the proposed rule that the Stage 1 objective and measure
acknowledged that our nation's public health IT infrastructure is not
universally capable of receiving electronic immunization data from
CEHRT, either due to technical or resource readiness. Immunization
programs, their reporting providers and federal funding agencies, such
as the CDC, ONC, and CMS, have worked diligently since the passage of
the HITECH Act in 2009 to facilitate EPs, eligible hospitals and CAHs
ability to meet the Stage 1 measure. We proposed for Stage 2 to take
the next step from testing to requiring actual submission of
immunization data. In order to achieve improved population health,
providers who administer immunizations must share that data
electronically, to avoid missed opportunities or duplicative
vaccinations. Stage 3 is likely to enhance this functionality to permit
clinicians to view the entire immunization registry/immunization
information system record and support bi-directional information
exchange.
We proposed that the threshold for Stage 2 should move from simply
testing the electronic submission of immunization data (with follow-up
submission if the test is successful) to ongoing submission. However,
we asked for comments on the challenges that moving this objective from
the menu set to the core set would present for EPs and hospitals.
Comment: Some commenters suggested that the term immunization
information systems was all encompassing making the inclusion of
immunization registries redundant.
Response: We agree that an information system could include
registries; however, we do not believe that modifying the objective
serves a distinct purpose and could confuse those accustomed to the
term immunization registries.
Comment: Commenters, although supportive of moving immunization
registry reporting from menu to core, expressed concern that PHAs did
not have the capacity to accept electronic data from additional
providers.
Response: We agree that not all PHAs will have the resources to
onboard providers for immunization registry reporting. The final rule
allows for an EP or hospital to be excluded from the measure if they
operate in a jurisdiction for which no immunization registry is capable
of accepting data. We further clarify that this exception applies not
only if the technical capacity to receive the data does not exist, but
also if the resources are not available within the
[[Page 54023]]
public health authority to initiate ongoing submission with the EP or
hospital. We also permit (as earlier stated) an EP or hospital to meet
the measure so long as they have registered to submit and are either
still in the process of testing and validation (within the time limits
established earlier), or are still awaiting an invitation to begin
submission.
Comment: Numerous commenters encouraged the inclusion of
bidirectional exchange of data with immunization registries. Many
commenters noted that the EP or eligible hospital cannot take advantage
of rich data and clinical decision support contained within an
immunization registry without bidirectional exchange.
Response: While we agree that the need for bidirectional data
exchange is clear, this measure aligns more with the goals of Stage 3
meaningful use stated in the proposed rule. Additionally, the standards
and mechanisms for bidirectional data exchange need to be more
standardized across public health authorities.
After consideration of the public comments received, we are
finalizing this objective for EPs at Sec. 495.6(j)(15)(i) and for
eligible hospitals and CAHs at Sec. 495.6(l)(12)(i) as proposed.
Proposed Measure: Successful ongoing submission of electronic
immunization data from CEHRT to an immunization registry or
immunization information system for the entire EHR reporting period.
Comment: Many commenters noted the lack of national standards for
the collection of immunization data with specific examples such as CVS
versus MVX coding vocabularies and also noted the need for centralized
data collection at a national level. Commenters noted that the lack of
standardization results in cost-prohibitive compliance with this
measure.
Response: We agree that during the implementation of Stage 1
reporting of immunization data, the need for a more harmonized standard
for immunization reporting was highlighted. To address this issue, the
option of using version HL7 2.3.1 versus 2.5.1 for certification was
removed and now only an HL7 2.5.1 message can be used for Stage 2
reporting of immunization data. The implementation guide for HL7 2.5.1
has been updated to remove much of the variability across states for
immunization registry reporting. However, if EPs prior to CY 2014 and
eligible hospitals and CAHs prior to FY2014 have achieved successful
ongoing submission using EHR technology certified to the 2011 Edition
EHR certification criteria (HL7 2.3.1 only) it is acceptable to
continue this ongoing submission and meet the Stage 2 measure for as
long as HL7 2.3.1 continues to be accepted by the immunizations
information system or immunization registry. EPs and eligible hospitals
and CAHs conducting submissions using HL7 2.5.1 will be able to get
their arrangement certified to the 2014 Edition EHR certification
criteria.
After consideration of the public comments received, we are
finalizing this measure at for EPs at 495.6(j)(15)(ii) and for eligible
hospitals and CAHs at 495.6(l)(12)(ii) as proposed, but we modify the
exclusions to conform with the general criteria for public health
objectives and to address redundancy in two of the proposed exclusions.
In the general criteria for public health objectives section we
established a centralized repository of information about PHA capacity.
If a PHA does not provide capacity information to this repository in
time for it to be made available to providers at the start of their EHR
reporting period, then the providers in that PHA's jurisdiction will
meet the modified exclusion. We proposed two exclusions: (1) The EP,
eligible hospital or CAH operates in a jurisdiction for which no
immunization registry or immunization information system is capable of
receiving electronic immunization data in the specific standards
required for CEHRT at the start of their EHR reporting period; and (2)
the EP, eligible hospital or CAH operates in a jurisdiction for which
no immunization registry or immunization information system is capable
of accepting the version of the standard that the EP, eligible hospital
or CAH's CEHRT can send at the start of their EHR reporting period. In
both cases the limitation is the ability of the immunization registry
or immunization information system to receive immunization data in the
standards required by ONC for EHR certification in 2014. Therefore, we
are combining these exclusions.
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 CEHRT at 45 CFR 170.314(f)(1) and (f)(2). However, if EPs
prior to CY 2014 and eligible hospitals and CAHs prior to FY 2014 have
achieved successful ongoing submission using EHR technology certified
to the 2011 Edition EHR certification criteria (HL7 2.3.1 only), it is
acceptable to continue this ongoing submission and meet the Stage 2
measure for as long as HL7 2.3.1 continues to be accepted by the
immunizations information system or immunization registry. We note that
our decision to continue to permit the use of EHR technology certified
to the 2011 Edition EHR certification criteria is a special
circumstance and emphasize that EPs, eligible hospitals, and CAHs will
still need EHR technology certified to the 2014 Edition EHR
certification criteria in order to meet the CEHRT definition beginning
with the FY/CY 2014 EHR reporting period.
Exclusions: Any EP, eligible hospital or CAH that meets
one or more of the following criteria may be excluded from this
objective: (1) The EP, eligible hospital or CAH does not administer any
of the immunizations to any of the populations for which data is
collected by their jurisdiction's immunization registry or immunization
information system during the EHR reporting period; (2) the EP,
eligible hospital or CAH operates in a jurisdiction for which no
immunization registry or immunization information system is capable of
accepting the specific standards required for CEHRT at the start of
their EHR reporting period (3) the EP, eligible hospital or CAH
operates in a jurisdiction where no immunization registry or
immunization information system provides information timely on
capability to receive immunization data; or (4) the EP, eligible
hospital or CAH operates in a jurisdiction for which no immunization
registry or immunization information system that is capable of
accepting the specific standards required by CEHRT at the start of
their EHR reporting period can enroll additional EPs, eligible
hospitals or CAHs.
The second exclusion will not apply if an entity designated by the
immunization registry or immunization information system can receive
electronic immunization data submissions. For example, if the
immunization registry cannot accept the data directly or in the
standards required by CEHRT, but if it has designated a Health
Information Exchange to do so on their behalf and the Health
Information Exchange is capable of accepting the information in the
standards required by CEHRT, the provider could not claim the second
exclusion.
Proposed Eligible Hospital/CAH Objective: Capability to submit
electronic reportable laboratory results to public health agencies,
except where prohibited, and in accordance with applicable law and
practice.
We proposed that this objective is in the Stage 2 core set for
eligible hospitals and CAHs. The same rationale for the
[[Page 54024]]
proposed changes between this proposed objective and that of Stage 1
are discussed earlier under the immunization registry objective. Please
refer to that section for details on our proposals in this regard.
Comment: Commenters, although supportive of moving electronic
laboratory reporting from menu to core, expressed concern that PHAs did
not have the capacity to accept electronic data from additional
providers.
Response: We agree that not all PHAs will have the resources to
onboard providers for electronic laboratory reporting. The final rule
allows for an EP, eligible hospital or CAH to be excluded from the
measure if they operate in a jurisdiction for which no public health
authority is capable of accepting electronic laboratory data. We
further clarify that this exception applies not only if the technical
capacity to receive the data does not exist, but also if the resources
are not available within the public health authority to initiate
ongoing submission with the EP, eligible hospital or CAH. We also
permit (as earlier stated) an EP, eligible hospital or CAH to meet the
measure so long as they have registered to submit and are either still
in the process of testing and validation, or are still awaiting an
invitation to begin submission.
Comment: Many commenters noted that lack of standards for reporting
electronic laboratory data to public health authorities and also noted
the variety of transport methods needed to support reporting to public
health.
Response: ONC has adopted an updated implementation guide for
electronic laboratory reporting from EHR technology in its 2014 Edition
EHR certification criteria. Additionally, the Centers for Disease
Control and Prevention in coordination with the Council of State and
Territorial Epidemiologists have created the national Reporting
Condition Mapping Table (http://www.cdc.gov/EHRmeaningfuluse/rcmt.html)
that provides further guidance on appropriate vocabularies usable for
reportable conditions across the country for reporting of ELR data.
Comment: Several commenters wrote in favor of expansion of this
requirement to be inclusive of the surveillance of healthcare
associated infections (HAI).
Response: While we agree that the reporting of healthcare
associated infections is a critical part of public health surveillance,
the methods and standards for reporting this information require very
different standards for electronic laboratory reporting of reportable
conditions. This measure aligns more with the goals of Stage 3
meaningful use.
Comment: Numerous commenters suggested that Electronic Laboratory
Reporting is outside the scope of EHRs and should be excluded from the
objectives. These commenters note that laboratory information systems
(LIMS) already have ELR capabilities, and most EHRs do not. One
commenter expressed concern that reporting from both laboratories and
providers may cause duplicate reporting of a single case. The same
commenter stated that many LIMS systems already have functionality to
identify which laboratory results need to be reported to public health,
which EHRs do not, and that building that capability into EHRs would be
duplicative and burdensome.
Response: We disagree with the statement that ELR is ``outside the
scope of EHRs and should be excluded'' because we share ONC's broad
interpretation of the term EHR technology. Eligible Hospitals can
choose to report data directly from any kind of EHR technology that has
been certified to the certification criteria adopted by ONC. This could
include EHR technology from a single EHR technology developer, a
separate modularly certified component such as a LIMS certified as an
EHR Module, or the technical capability offered by an HIE that is
certified as an EHR Module for electronic laboratory reporting.
After consideration of the public comments, we are finalizing this
objective for eligible hospitals and CAHs at 495.6(l)(13)(i) as
proposed.
Proposed Eligible Hospital/CAH Measure: Successful ongoing
submission of electronic reportable laboratory results from CEHRT to a
public health agency for the entire EHR reporting period as authorized,
and in accordance with applicable State law and practice.
Please refer to the general public health discussion regarding use
of intermediaries.
Most comments received related to this measure have been addressed
in the discussion of public health objectives in general or in the
discussion of the objective associated with this measure.
Comment: Commenters pointed out that the proposed measure includes
the statement ``as authorized, and in accordance with applicable State
law and practice.'' Some commenters believed the phrase was simply
redundant to the objective and was inconsistent with the other public
health measures. Other commenters expressed concern that the addition
of the phrase implied a more restrictive measure than other public
health measures particularly with the limit to state law as opposed to
just law.
Response: We agree with commenters that this phrase is redundant to
the objective and may introduce confusion. Therefore, we are revising
this measure to remove the phrase and make it consistent with the other
public health measures.
Based on consideration of those comments, we are modifying this
measure for eligible hospitals and CAHs at Sec. 495.6(l)(13)(ii) to
successful ongoing submission of electronic reportable laboratory
results from CEHRT to a public health agency for the entire EHR
reporting period.'' We also modify the exclusions to conform with the
general criteria for public health objectives. In the general criteria
for public health objectives, we plan to establish a centralized
repository of PHA capacity information. If a PHA does not provide
capacity information to this repository in time for it to be made
available to providers at the start of their EHR reporting period, then
the providers in that PHA's jurisdiction will meet the modified
exclusion. If the repository is not established, the eligible hospital
or CAH must consult their PHA jurisdiction for guidance.
We further specify that in order to meet this objective and
measure, an eligible hospital or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(f)(4).
Exclusions: The eligible hospital or CAH that meets one or
more of the following criteria may be excluded from this objective: (1)
operates in a jurisdiction for which no public health agency is capable
of receiving electronic reportable laboratory results in the specific
standards required for Certified EHR Technology at the start of the EHR
reporting period; (2) operates in a jurisdiction where no public health
agency provides information timely on capability to receive electronic
reportable laboratory results or (3) the eligible hospital or CAH
operates in a jurisdiction for which no public health agency that is
capable of accepting the specific standards required by CEHRT at the
start of their EHR reporting period can enroll additional eligible
hospitals or CAHs.
Proposed Objective: Capability to submit electronic syndromic
surveillance data to public health agencies except where prohibited,
and in accordance with applicable law and practice.
We proposed that this objective is in the Stage 2 core set for
eligible hospitals and CAHs and the Stage 2 menu set for EPs. The Stage
1 objective and measure
[[Page 54025]]
acknowledged that our nation's public health IT infrastructure is not
universally capable of receiving syndromic surveillance data from
CEHRT, either due to technical or resource readiness. Given public
health IT infrastructure improvements and new implementation guidance,
for Stage 2, we proposed that this objective and measure be in the core
set for hospitals and in the menu set for EPs. It is our understanding
from hospitals and the CDC that many hospitals already send syndromic
surveillance data. The CDC has issued the PHIN Messaging Guide for
Syndromic Surveillance: Emergency Department and Urgent Care Data
[http://www.cdc.gov/ehrmeaningfuluse/Syndromic.html] as cited in the
ONC final rule on EHR standards and certification. However, per the CDC
and a 2010 survey completed by the Association of State and Territorial
Health Officials (ASTHO), very few public health agencies are currently
accepting syndromic surveillance data from ambulatory, non-hospital
providers, and there is no corresponding implementation guide at the
time of this final rule. CDC is working with the syndromic surveillance
community to develop a new implementation guide for ambulatory and
inpatient discharge reporting of syndromic surveillance information,
which it expects will be available in the spring 2013. We anticipate
that Stage 3 might include syndromic surveillance for EPs in the core
set if the collection of ambulatory syndromic data becomes a more
standard public health practice in the interim.
The HIT Policy Committee recommended making this a core objective
for Stage 2 for EPs and hospitals. However, we did not propose to adopt
their recommendation for EPs. We specifically invited comment on the
proposal to leave syndromic surveillance in the menu set for EPs, while
requiring it in the core set for eligible hospitals and CAHs.
Comment: Commenters noted that keeping the objective as menu for
EPs is still problematic as most public health agencies are unable to
accept the data. Commenters also expressed that for providers that are
already reporting this objective, it makes sense to keep it as a menu
set option.
Response: We agree that although not all public health authorities
are able to accept syndromic surveillance data from Eligible
Professionals, since many EPs already report this measure and some
public health authorities have the ability to accept this data, the
measure will remain as a menu set option.
Comment: Commenters noted that moving the objective as core is
premature due to public health readiness. Commenters also expressed
that for hospitals that have already reporting this objective, it makes
sense to move the measure to core.
Response: We agree that not all public health authorities are able
to accept syndromic surveillance data from hospitals; however, our
exclusion criteria addresses this situation. Since many hospitals
already report this measure and many public health authorities have the
ability to accept this data, the measure will remain as core. If there
are no public health authorities for the hospitals to report syndromic
surveillance data to, the hospital can claim an exemption.
Comment: Many commenters noted that lack of standards for reporting
syndromic surveillance data to public health authorities.
Response: While a single national implementation guide exists for
syndromic surveillance data of emergency department data from
hospitals, currently an implementation guide does not exist for
syndromic surveillance reporting from the eligible professional. The
Centers for Disease Control and Prevention is working in conjunction
with the International Society for Disease Surveillance and draft
guidance is currently available for the reporting of ambulatory based
syndromic surveillance.
Comment: Several comments expressed concern about the level of
reporting. Concern was expressed from entities with multiple locations
that would need to report by facility or provider lever rather than as
an organization.
Response: Currently public health departments that collect
syndromic surveillance data streamline the data collection process and
collect data at an organization or facility level depending on the
provider. Syndromic surveillance data is not collected at the provider
level, although attestation would be at the provider level where
reporting by a single organization or facility could count for multiple
providers.
After consideration of the public comments received, we are
finalizing this objective for EPs in the menu set at Sec.
495.6(k)(3)(i) and for eligible hospitals and CAHs in the core set at
Sec. 495.6(l)(14)(i) as proposed.
Proposed Measure: Successful ongoing submission of electronic
syndromic surveillance data from CEHRT to a public health agency for
the entire EHR reporting period.
All comments received related to this measure have been addressed
in the discussion of public health objectives in general or in the
discussion of the objective associated with this measure. After
consideration of these public comments, we are finalizing this measure
as proposed for EPs in the menu set at Sec. 495.6(k)(3)(ii) and for
eligible hospitals and CAHs in the core set at Sec. 495.6(l)(14)(ii)
as proposed, but we modify the exclusions to conform with the general
criteria for public health objectives and to address redundancy in two
of the proposed exclusions. In the general criteria for public health
objectives, we plan to establish a centralized repository of PHA
capacity information. If a PHA does not provide capacity information to
this repository in time for it to be made available to providers at the
start of their EHR reporting period, then the providers in that PHA's
jurisdiction will meet the modified exclusion. We proposed two
exclusions: (1) The EP, eligible hospital, or CAH operates in a
jurisdiction for which no public health agency is capable of receiving
electronic syndromic surveillance data in the specific standards
required for Certified EHR Technology at the start of their EHR
reporting period; and (2) the EP, eligible hospital, or CAH operates in
a jurisdiction for which no public health agency is capable of
accepting the version of the standard that the EP's, eligible
hospital's or CAH's CEHRT can send at the start of their EHR reporting
period. In both cases the limitation is the ability of the PHA to
receive syndromic surveillance data in the standards required by ONC
for EHR certification in 2014. Therefore, we are combining these
exclusions.
We expect that the CDC will be issuing (in Spring 2013) the CDC
PHIN Messaging Guide for Ambulatory Syndromic Surveillance and we may
rely on this guide to determine which categories of EPs will not
collect such information.
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 CEHRT at 45 CFR 170.314(f)(3). However, if EPs prior to CY
2014 and eligible hospitals and CAHs prior to FY 2014 have achieved
successful ongoing submission using EHR technology certified to the
2011 Edition EHR certification criteria (HL7 2.3.1 only), it is
acceptable to continue this ongoing submission and meet the Stage 2
measure for as long as HL7 2.3.1 continues to be accepted by the PHA in
that jurisdiction. We note that our decision to continue to permit the
use of EHR technology certified to the 2011 Edition EHR certification
criteria is a special circumstance and
[[Page 54026]]
emphasize that EPs, eligible hospitals, and CAHs will still need EHR
technology certified to the 2014 Edition EHR certification criteria in
order to meet the CEHRT definition beginning with the FY/CY 2014 EHR
reporting period.
Exclusions: Any EP, eligible hospital or CAH that meets
one or more of the following criteria may be excluded from this
objective: (1) the EP is not in a category of providers that collect
ambulatory syndromic surveillance information on their patients during
the EHR reporting period; (2) the eligible hospital or CAH does not
have an emergency or urgent care department; (3) the EP, eligible
hospital, or CAH operates in a jurisdiction for which no public health
agency is capable of receiving electronic syndromic surveillance data
in the specific standards required by CEHRT at the start of their EHR
reporting period; (4) the EP, eligible hospital or CAH operates in a
jurisdiction where no public health agency provides information timely
on capability to receive syndromic surveillance data; or (5) the EP,
eligible hospital or CAH operates in a jurisdiction for which no public
health agency that is capable of accepting the specific standards
required by CEHRT at the start of their EHR reporting period can enroll
additional EPs, eligible hospitals or CAHs.
As was described under the immunization registry measure, the third
and fourth exclusions do not apply if the PHA has designated an HIE
organization or other intermediary to collect this information on its
behalf and that intermediary can do so in the specific Stage 2
standards and/or the same standard as the provider's CEHRT. An urgent
care department delivers ambulatory care, usually on an unscheduled,
walk-in basis, in a facility dedicated to the delivery of medical care,
but not classified as a hospital emergency department. Urgent care
centers are primarily used to treat patients who have an injury or
illness that requires immediate care but is not serious enough to
warrant a visit to an emergency department. Often urgent care centers
are not open on a continuous basis, unlike a hospital emergency
department, which will be open at all times.
(d) New Core and Menu Set Objectives and Measures for Stage 2
We proposed the following objectives for inclusion in the core set
for Stage 2: ``Provide patients the ability to view online, download,
and transmit information about a hospital admission'' and
``Automatically track medication orders using an electronic medication
administration record (eMAR)'' for hospitals; ``Use secure electronic
messaging to communicate with patients'' for EPs. We proposed all other
new objectives for inclusion in the menu set for Stage 2. While the HIT
Policy Committee recommended making all objectives mandatory and
eliminating the menu option, we believe a menu set is necessary for
some of these new objectives in order to give providers an opportunity
to implement new technologies and make changes to workflow processes
and to provide maximum flexibility for providers in specialties that
may face particular challenges in meeting new objectives.
Proposed Objective: Imaging results and information are accessible
through CEHRT.
In the proposed rule, we outlined the following benefits for this
objective. Making the image that results from diagnostic scans and
accompanying information accessible through CEHRT increases the utility
and efficiency of both the imaging technology and the CEHRT. The
ability to share the results of imaging scans will likewise improve the
efficiency of all health care providers and increase their ability to
share information with their patients. This will reduce the cost and
radiation exposure from tests that are repeated solely because a prior
test is not available to the provider.
We stated in the proposed rule that most of the enabling steps to
incorporating imaging relate to the certification of EHR technologies.
As with the objective for incorporating lab results, we encourage the
use of electronic exchange to incorporate imaging results into the
CEHRT, but in absence of such exchange it is acceptable to manually add
the image and accompanying information to CEHRT.
Comment: Some commenters expressed concerns over the ability of
CEHRT to store the images.
Response: We did not propose that CEHRT store the images. Storing
the images natively in CEHRT is one way to make them accessible through
CEHRT, but there are many other ways.
Comment: Commenters stated that unless a HIE organization existed
to facilitate imaging exchange, building out an unique interface for
each imaging provider is cost prohibitive. Second, commenters were
concerned that because stand-alone radiology centers are not subject to
the EHR Incentive Program they may not agreeing to provide their images
electronically to the provider through their EHR. These commenters
therefore suggest that it is premature to include this objective.
Response: We agree that many advances in infrastructure are needed
to fully enable this objective. We believe that from publication of
this final rule to the start of Stage 2 significant progress will be
made in part due to the inclusion of this objective in Stage 2. We do
agree that these improvements in infrastructure will vary based on
local conditions such as the presence of HIEs, the willingness of
radiology centers to link to EHRs, and other factors and note that is a
primary reason for this being a menu objective. We will also consider
these comments below in relation to setting the threshold for the
measure.
Comment: The resolution required for viewing imaging for diagnostic
purposes requires specific hardware which would be cost prohibitive for
all EPs. CMS should clarify that the image can be of any resolution.
Response: We do not impose limitations on the resolution of the
image. To the extent this is a concern, it would be a capability of
CEHRT not a requirement of meaningful use.
Comment: Commenters requested clarification on whether both the
image itself and the accompanying results and information must be
available, or just one or the other.
Response: The objective as proposed was intended to convey that the
image itself is the result and that narratives/explanations and other
information would be the additional information. Due to the many
comments we received requesting clarification, we are revising the
objective for clarity.
Comment: Commenters requested a more specific definition of
imaging.
Response: We believe that imaging is a well understood term in the
provider community. However, we agree that a more specific definition
is required for purposes of measuring meaningful use. We adopt the
description of radiology services from the Stage 2 CPOE objective as
the minimum description of imaging. Providers are free to use a more
expansive definition of imaging.
After review of the comments, we are revising the objective for EPs
at 495.6 (k)(1)(i) and for eligible hospitals and CAHs at
495.6(m)(2)(i) to ``Imaging results consisting of the image itself and
any explanation or other accompanying information are accessible
through CEHRT.''
Proposed Measure: More than 40 percent of all scans and tests whose
result is one or more images ordered by the EP or by an authorized
provider of the eligible hospital or CAH for patients admitted to its
inpatient or emergency department (POS 21 or 23) during the
[[Page 54027]]
EHR reporting period are accessible through CEHRT.
For Stage 2, we did not propose the image or accompanying
information (for example, radiation dose) be required to be structured
data. Images and imaging results that are scanned into the CEHRT may be
counted in the numerator of this measure. We defined accessible as
either incorporation of the image and accompanying information into
CEHRT or an indication in CEHRT that the image and accompanying
information are available for a given patient in another technology and
a link to that image and accompanying information. Incorporation of the
image means that the image and accompanying information is stored by
the CEHRT. We did not propose that meaningful use would impose any
additional retention requirements on the image. A link to the image and
accompanying information means that a link to where the image and
accompanying information is stored is available in CEHRT. This link
must conform to the certification requirements associated with this
objective in the ONC final rule published elsewhere in this issue of
the Federal Register. We encouraged comments on the necessary level of
specification and what those specifications should be to define
accessible and what constitutes a direct link.
Comment: Commenters suggested that the proposed threshold of 40
percent was too high given the dependency on the image provider and
electronic exchange infrastructure discussed in the objective. The most
popular suggested threshold was 10 percent. Commenters also suggested
that an exclusion be created for providers who have no access to
electronic images. A few of the commenters pointed to the lack of an
imaging provider that could make electronic images available. Others
were concerned that when a provider uses multiple imaging providers, 40
percent might be too high of a threshold even if at least one imaging
provider that could make electronic images available.
Response: After reviewing the comments, we agree that 40 percent is
too high of a threshold for this measure and revise it to 10 percent.
Providers, especially EPs, may use many imaging providers, and we do
not want an EP to have to defer this objective simply because they have
three imaging providers, and the one allowing electronic access
represents less than 40 percent of their orders. The comment regarding
complete lack of an imaging provider that could make electronic images
available speaks to the need for an exclusion. In considering an
exclusion for those providers who have no access to electronic images,
we take into account that it is a menu objective and also that there
may be providers who fall into a situation where access is more than
zero, but less than 10 percent. In regards to the menu, while it is
true that a provider may defer this measure, the number of measures in
the menu set are fewer and more specialized than in Stage 1.
Furthermore, as an exclusion no longer counts towards meeting a menu
objective, we are not concerned providers would choose this objective
only to exclude it. For this reason, we are finalizing an exclusion for
providers who have no access to electronic images. For those who cannot
meet the 10 percent threshold even with access to an imaging provider
who makes electronic images available, deferral remains a possibility
as well as shifting more orders to imaging providers that do allow
electronic access.
Comment: Several commenters disagreed with the proposed exclusion
for EPs and believed it was inconsistent with the objective. These
commenters believe the objective is intended for EPs who order imaging,
whether or not they interpret the imaging studies themselves. These
commenters suggested changing the exclusion to ``Any EP who orders
(less than 100/50/no) diagnostic scans or tests whose result is an
image during the EHR reporting period''.
Response: Our intention with the proposed exclusion was to
distinguish between ordering providers who have need of the image and
those that do not. Based on the comments the need to view the image
depends on a combination of factors including previous experiences with
the type of image, the imaging facility, the circumstances of the
patient, whether a similar image has been ordered before for the
patient and the reading clinician. Given the wide variety of factors,
we agree that it is not possible to create a distinct line between
ordering providers who need the image and those that do not. We believe
this line can be partly drawn by adopting the exclusion recommended by
comments with a high count of 100. This is both consistent with our
other objectives and as a high number indicates a particular benefit to
the provider as well as increasing the likelihood that factors align
for the ordering provider to need the image.
Comment: Commenters stated that the use of the term ``scan'' is
confusing and unnecessary. Scan frequently applies to actions and
concepts other than certain types of imaging procedures.
Response: We agree that the term scan has multiple uses, as any
scan would be an image and could be classified as a test. Therefore, we
remove the word scan from the measure as duplicative.
After reviewing the comments, we modify the measure for EPs at
Sec. 495.6 (k)(1)(ii) and for eligible hospitals and CAHs at Sec.
495.6(m)(2)(ii) to: More than 10 percent of all tests whose result is
one or more images ordered by the EP or by an authorized provider of
the eligible hospital or CAH for patients admitted to its inpatient or
emergency department (POS 21 or 23) during the EHR reporting period are
accessible through CEHRT.
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 CEHRT at 45 CFR 170.314(a)(12).
To calculate the percentage, CMS and ONC have worked together to
define the following for this measure:
Denominator: Number of tests whose result is one or more
images ordered by the EP or by an authorized provider on behalf of the
eligible hospital or CAH for patients admitted to its inpatient or
emergency department (POS 21 and 23) during the EHR reporting period.
Numerator: The number of results in the denominator that
are accessible through CEHRT.
Threshold: The resulting percentage must be more than 10
percent in order to meet this measure.
Exclusion: Any EP who orders less than 100 tests whose
result is an image during the EHR reporting period; or
Any EP who has no access to electronic imaging results at the start
of the EHR reporting period.
No access means that none of the imaging providers used by the EP
provide electronic images and any explanation or other accompanying
information that are accessible through their CEHRT at the start of the
EHR reporting period.
We solicited comments on a potential second measure for this
objective that would encourage the exchange of imaging and results
between providers. We considered a threshold of 10 percent of all scans
and tests whose result is one or more images ordered by the EP or by an
authorized provider of the eligible hospital or CAH for patients
admitted to its inpatient or emergency department (POS 21 or 23) during
the EHR reporting period and accessible through CEHRT also be exchanged
with another provider of care.
Comment: While most commenters agree with the principle of exchange
of images among providers of care, they nearly all agreed that this
measure would be premature for Stage 2 due to
[[Page 54028]]
infrastructure concerns. Some suggested that it be considered for Stage
3 as a logical next step from our proposed Stage 2 measure.
Response: Given the comments, we are not including this measure in
our final rule. We will consider the input provided when we develop our
proposal for Stage 3.
Proposed Objective: Record patient family health history as
structured data
In the proposed rule, we noted that every provider currently
requests a family health history from the patient in order to obtain
it. However, EHRs can allow the patient to contribute directly to the
record and allow the record to be shared among providers, thereby
greatly increasing the efficiency of collecting family health
histories. Family health history is a major risk indicator for a
variety of chronic conditions for which effective screening and
prevention tools are available.
Comment: Commenters generally supported the inclusion of recording
family health history as a menu set measure for EPs, eligible hospitals
and CAHs, while some suggested deferring the measure until Stage 3 when
they expect more robust standards will be available. Some commenters
also suggested family health history is best collected by primary care
physicians, not hospitals. Others still suggested modifying this
objective to allow for the use of unstructured data.
Response: ONC has adopted standards requiring CEHRT to be able to
use SNOMED-CT or the HL7 Pedigree standard to record a patient's family
health history. We refer readers to ONC's standards and certification
criteria final rule that is published elsewhere in this issue of the
Federal Register. As a readily available standard is being adopted, we
are maintaining this objective as proposed and including it in the menu
set. We continue to believe that family history is part of regular
physician and hospital workflow--even if it's collected at a very high
level. While it may primarily be the physicians working in the hospital
that consider this information, these same physicians typically use the
hospital EHR when evaluating their hospitalized patients so having this
information in the hospital EHR is just as important as having it in
the physician's own EHR. We will also finalize the exclusion for EPs
who have no office visits during the EHR reporting period to account
for scope of practice concerns and the common collection of this
information directly from patients.
After consideration of public comments, we are finalizing this
objective for EPs at Sec. 495.6 (k)(2)(i) and for eligible hospitals
and CAHs at Sec. 495.6(m)(3)(i) as proposed.
Proposed Measure: More than 20 percent of all unique patients seen
by the EP, or admitted to the eligible hospital or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have a structured data entry for one or more first-degree relatives.
We proposed to adopt the definition of first degree relative used
by the National Human Genome Research Institute of the National
Institutes of Health. A first degree relative is a family member who
shares about 50 percent of their genes with a particular individual in
a family. First degree relatives include parents, offspring, and
siblings. We considered other definitions, including those that address
both affinity and consanguinity relationships and encourage comments on
this definition. We noted that this is a minimum and not a limitation
on the health history that can be recorded. We did not propose a time
limitation on the indication that the family health history has been
reviewed. The recent nature of this capability in EHRs will impose a de
facto limitation on review to the recent past.
We proposed an exclusion to this measure for EPs who have no office
visits during the EHR reporting period. We believe that EPs who do not
have office visits will not have the face-to-face contact with patients
necessary to obtain family health history information.
Comment: Many commenters wondered why recording family health
history was limited to first-degree relatives. They noted that a
patient's grandparents or other relatives may have equally relevant
medical information that should be included in the EHR. Other
commenters pointed out that not all patients may know their family
health history, particularly patients who were adopted, and suggested
including a code for ``unknown'' or ``not relevant.'' They noted that
in some cultures, the patient may not be willing to provide the data or
that the data they have may be unreliable (such as informal adoptions
in Native American tribes).
Response: While information about second degree relatives may be
useful for some diagnoses and conditions, we believe collecting medical
history from first degree relatives is the floor, not the ceiling and
encourage providers to collect additional information as they see fit.
Additionally, we understand concerns about patients who may not know
their family history. In these situations, we would find it acceptable
for the provider to record the patient's family history as ``unknown.''
Either a structured data entry of ``unknown'' or any structured data
entry identified as part of the patient's family history and conforming
to the standards of CEHRT at 45 CFR 170.314(a)(13) must be in the
provider's CEHRT for the patient to count in the numerator.
Comment: Some commenters suggested we introduce this measure with a
lower threshold as this is a new requirement, but did not specify a
threshold. They noted that providers who might have previously captured
family history might not have that in a structured format or not coded
against the standards chosen for CEHRT. This history would have to be
redocumented.
Response: We proposed a low threshold of 20 percent. As this
measure is not reliant on other organizations and providers the way
imaging is we do not believe that is necessary to lower the threshold
further.
Comment: Some commenters suggested this measure may not apply to
certain specialty providers (for example, Urgent Care, Orthopedics) and
suggested including an exclusion.
Response: We proposed an exclusion to this measure for EPs who have
no office visits during the EHR reporting period. We continue to
believe that EPs who do not have office visits would not have the face-
to-face contact with patients necessary to obtain family health history
information. However, this exclusion may not apply to certain specialty
providers (like the aforementioned). We continue believe that recording
family health history, regardless of specialty, is can be an important
indicator for chronic conditions. Additionally, as this measure is
being finalized as part of the menu set, providers are not required to
report on this objective.
After consideration of public comments, we are finalizing the
measure for EPs at Sec. 495.6(k)(2)(ii) and for eligible hospitals and
CAHs at Sec. 495.6(m)(3)(ii) to ``More than 20 percent of all unique
patients seen by the EP, or admitted to the eligible hospital or CAH's
inpatient or emergency department (POS 21 or 23), during the EHR
reporting period have a structured data entry for one or more first-
degree relatives''.
We are finalizing the exclusion as proposed at Sec.
495.6(k)(2)(iii).
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 CEHRT at 45 CFR 170.314(a)(13).
[[Page 54029]]
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by
the EP or admitted to the eligible hospital's or CAH's inpatient or
emergency departments (POS 21 or 23) during the EHR reporting period.
Numerator: The number of patients in the
denominator with a structured data entry for one or more first-degree
relatives.
Threshold: The resulting percentage must be more
than 20 percent in order to meet this measure.
Exclusion: Any EP who has no office visits
during the EHR reporting period.
Proposed EP Objective: Capability to identify and report cancer
cases to a state cancer registry, except where prohibited, and in
accordance with applicable law and practice.
We outlined the following benefits of this objective in the
proposed rule. Reporting to cancer registries by EPs would address
current underreporting of cancer, especially certain types. In the past
most cancers were diagnosed and/or treated in a hospital setting and
data were primarily collected from this source. However, medical
practice is changing rapidly and an increasing number of cancer cases
are never seen in a hospital or are cared for primarily in the
outpatient setting. Data collection from EPs presents new challenges
since the infrastructure for reporting is less mature than it is in
hospitals. Certified EHR technology can address this barrier by
identifying reportable cancer cases and treatments to the EP and
facilitating electronic reporting either automatically or upon
verification by the EP.
We proposed to include ``except where prohibited and in accordance
with applicable law and practice'' because we want to encourage all EPs
to submit cancer cases, even in rare cases where they are not required
to by state/local law. Legislation requiring cancer reporting by EPs
exists in 49 states with some variation in specific requirements, per
the 2010 Council of State and Territorial Epidemiologists (CSTE) State
Reportable Conditions Assessment (SRCA) (http://www.cste.org/dnn/ProgramsandActivities/PublicHealthInformatics/StateReportableConditionsQueryResults/tabid/261/Default.aspx).'' If EPs
are authorized to submit, they should do so even if it is not required
by either law or practice.'' In accordance with applicable law and
practice'' reflects that some public health jurisdictions may have
unique requirements for reporting, and that some may not currently
accept electronic provider reports. In the former case, the proposed
criteria for this objective would not preempt otherwise applicable
state or local laws that govern reporting. In the latter case, eligible
professionals would be exempt from reporting.
Comment: Nearly all commenters who wrote in support of the
objective stated that the rule would decrease reporting burden for EPs
because cancer diagnosis reporting in mandatory in most states. One
commenter noted that the rule may increase compliance with mandatory
reporting by reducing time and effort needed to submit cancer diagnosis
report. Also, it was noted that incorporation of cancer reporting in
meaningful use Stage 2 for eligible providers will improve completeness
and quality of cancer reporting. Conversely, several of the commenters
who recommended moving the objective to Stage 3 or remove the objective
completely stated that inclusion of this object would place undue
burden on EPs, especially because primary care providers rarely report
to cancer registries. A commenter noted that the necessary EHR
functionality currently exists primarily in oncology specialty EHRs,
and EPs may be required to purchase additional modules to meet this
object, and further states that this would be cost-prohibitive to EPs
who only rarely diagnose cancer. One commenter suggested that the
detailed reporting requirements would be too time-consuming for most
EPs. Another commenter questions if responsibility for reporting cases,
or presumptive cases, would shift to primary care providers. Other
commenters suggest that the objective should be removed until such time
that a national central repository can be established to simplify
point-to-point connections.
Response: We agree that inclusion of this requirement is likely to
reduce reporting burden for those already required to report to cancer
registries. We also agree with commenters that this objective is not
relevant to all providers. For those EPs who do not meet the proposed
exclusion of not diagnosing or directly treating cancer, yet are not
already under a requirement to report to cancer registries, we note
that this is a menu objective and can be deferred. Between the proposed
exclusions and the option to defer, we do not believe the measure
imposes a reporting burden on providers who would not normally report
to cancer registries.
Comment: The objectives of specialized registries and cancer
registries reporting should be combined.
Response: In review of comments we found no compelling reason to
change our proposal. No commenter disputed that the reporting to cancer
registries has different level of existing reporting requirements and
supporting standards than other specialized registries.
Comment: One commenter suggested changing the final rule to read,
``public health central cancer registry'' to clearly distinguish them
from hospital-based cancer registries.
Response: We agree that the term public health central cancer
registry is better than just cancer registries and more inclusive than
just state cancer registries as used in the proposed objective, but not
the proposed measure.
After consideration of the public comments received, we are
modifying this objective for EPs at Sec. 495.6 (k)(4)(i) to
``Capability to identify and report cancer cases to a public health
central cancer registry, except where prohibited, and in accordance
with applicable law and practice.''
Proposed EP Measure: Successful ongoing submission of cancer case
information from CEHRT to a cancer registry for the entire EHR
reporting period.
Comment: Commenters are concerned that under the proposed menu set
providers will be required to choose one of: (1) Syndromic
surveillance; (2) submitting to cancer registries; or (3) submitting to
specialty registries if they do not meet the exclusions for all three.
The commenters believe that CMS should be providing physicians with a
legitimate selection of menu set measures from which to choose.
Response: Stage 2 does contain a more specialized and smaller menu
set than Stage 1. We see this as a natural result of moving up the
staged path towards improved outcomes. We also see it as necessary for
meaningful use to be applicable to all EPs. We use exclusions to ensure
that only those EPs who create reportable data have the obligation
under meaningful use to report it so this would not be a barrier to
meeting meaningful use. Furthermore, we added an objective to the menu
set in this final rule for EPs so it is no longer true that an EP would
be required to pick one of the three menu objectives mentioned by
commenters.
After consideration of the public comments received, we are
modifying this measure for EPs at Sec. 495.6 (k)(4)(ii) to
``Successful ongoing submission of cancer case information from CEHRT
to a public health central cancer registry for the entire EHR reporting
period'' and modify the exclusions to conform with the general criteria
for public health objectives.
We further specify that in order to meet this objective and
measure, an EP
[[Page 54030]]
must use the capabilities and standards of CEHRT 45 CFR 170.314(a),
(c)(l), (f)(5), and (f)(6).
Exclusions: Any EP that meets at least 1 of the following
criteria may be excluded from this objective: (1) The EP does not
diagnose or directly treat cancer; (2) the EP operates in a
jurisdiction for which no public health agency is capable of receiving
electronic cancer case information in the specific standards required
for CEHRT at the beginning of their EHR reporting period; (3) the EP
operates in a jurisdiction where no PHA provides information timely on
capability to receive electronic cancer case information; (4) the EP
operates in a jurisdiction for which no public health agency that is
capable of receiving electronic cancer case information in the specific
standards required for CEHRT at the beginning of their EHR reporting
period can enroll additional EPs.
Proposed EP Objective: Capability to identify and report specific
cases to a specialized registry (other than a cancer registry), except
where prohibited, and in accordance with applicable law and practice.
In the proposed rule, we outlined the following benefits of this
objective. We believe that reporting to registries is an integral part
of improving population and public health. The benefits of this
reporting are not limited to cancer reporting. We include cancer
registry reporting as a separate objective because it is more mature in
its development than other registry types, not because other reporting
is excluded from meaningful use. We have included this objective to
provide more flexibility in the menu objectives that EPs can choose. We
believe that specialized registry reporting could provide many EPs with
meaningful use menu option that is more aligned with their scope of
practice.
Comment: The overwhelming majority of individuals and groups who
commented on this objective expressed concern about the lack of
specificity of this objective. Their concerns include: (1) Lack of
specificity of the potential types of registries make planning for
vendors and EPs very difficult; (2) lack of information about who would
define which registries may be included; (3) leaving dozens or hundreds
of possibilities; (4) lack of clarity as to the definition of
'specialized registry; (5) lack of standards for many registries; (6)
or potential of needing to comply with standards not identified in the
proposed rule; and (7) lack of public health readiness to accept data
from EHRs.
Response: The purpose of this objective and measure is to give
meaningful use credit to those EPs who are engaged in ongoing
submission with specialized registries. It is not expected that every
EP will select this objective and measure from the menu nor even that
every EP will have the capability to submit to a specialized registry.
We are purposefully general in our description of specialized registry
because we do not wish to exclude certain registries in an attempt to
be more specific. The only limitation we place on our description of
specialized registries is that the specialized registry cannot be
duplicative of any of the other registries included in other meaningful
use objectives and measures. This means that an EP cannot meet the
immunization, syndromic surveillance or cancer objectives and this
objective by reporting to the same registry. EPs who either do not wish
to participate with a specialized registry or cannot overcome the
barriers to doing so can defer or exclude this measure as their
situation warrants.
Comment: Commenters expressed support for expansion of the
requirement to streamline and improve surveillance of healthcare-
associated infections (HAIs), with the goal of improving patient care
and safety.
Response: A registry that is focused on healthcare associated
infections could certainly be considered a specialized registry.
After consideration of the public comments received, we are
finalizing this objective for EPs at Sec. 495.6 (k)(5)(i) as proposed.
Proposed EP Measure: Successful ongoing submission of specific case
information from CEHRT to a specialized registry for the entire EHR
reporting period.
Comment: Since the lack of specificity and named standards make it
difficult to select this measure from the menu set, the actual viable
measures available in the menu set are reduced to four and burdensome
for providers who may need to pay for interfaces, costing the EPs extra
time and money above the cost of the CEHRT.
Response: Stage 2 does contain a more specialized and smaller menu
set than Stage 1. We see this as a natural result of moving up the
staged path towards improved outcomes. We also see it as necessary for
meaningful use to be applicable to all EPs. We include exclusions that
allow for those providers who do not create reportable data so every
provider who would is required to report public health data would have
public health data to report. Furthermore, we added an objective to the
menu in this final rule for EPs so it is no longer true that an EP
would be required to pick one of the three menu objectives. The purpose
of this measure is to provide meaningful use credit to those providers
engaged in the beneficial use of CEHRT of participating in specialized
registries. Other EPs can either meet the exclusions or defer this
objective and thereby avoid the burden of compliance with this
objective.
Comment: Given the large number of specialized registries, many of
which have national scope, the exclusions are rendered meaningless.
Response: We agree with this comment, and for purposes of the
exclusion only, we limit it to registries sponsored by national
specialty societies and specialized registries maintained by PHAs. We
believe this provides needed limitations on the exclusions. This
limitation does not apply to the specialized registries that can be
used to satisfy the measure as the benefits are not limited only to
reporting to registries operated by Public Health Agencies or national
medical specialty organizations. Specialized registries operated by
patient safety organizations and quality improvement organizations also
enable knowledge generation or process improvement regarding the
diagnosis, therapy and prevention of various conditions that affect a
population.
After consideration of the public comments received, we are
finalizing this measure for EPs at Sec. 495.6 (k)(5)(ii) as proposed,
but we modify the exclusions to conform with the general criteria for
public health objectives and in response to comments.
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT 45 CFR
170.314(f)(5) and (f)(6).
Exclusions: Any EP that meets at least 1 of the
following criteria may be excluded from this objective: (1) The EP does
not diagnose or directly treat any disease associated with a
specialized registry sponsored by a national specialty society for
which the EP is eligible, or the public health agencies in their
jurisdiction; (2) the EP operates in a jurisdiction for which no
specialized registry sponsored by a public health agency or by a
national specialty society for which the EP is eligible is capable of
receiving electronic specific case information in the specific
standards required by CEHRT at the beginning of their EHR reporting
period; (3) the EP operates in a jurisdiction where no public health
agency or national specialty society for which the EP is eligible
provides information timely on capability to receive information into
their specialized registries ; or (4) the EP
[[Page 54031]]
operates in a jurisdiction for which no specialized registry sponsored
by a public health agency or by a national specialty society for which
the EP is eligible that is capable of receiving electronic specific
case information in the specific standards required by CEHRT at the
beginning of their EHR reporting period can enroll additional EPs.
Proposed EP Objective: Use secure electronic messaging to
communicate with patients on relevant health information.
In the proposed rule, we outlined the following benefits of using
secure electronic messaging to communicate with patients: Electronic
messaging (for example, email) is one of the most widespread methods of
communication for both businesses and individuals. The inability to
communicate through electronic messaging may hinder the provider-
patient relationship. Electronic messaging is very inexpensive on a
transactional basis and allows for communication even when the provider
and patient are not available at the same moment in time. The use of
common email services and the security measures that may be used when
they are sent may not be appropriate for the exchange of protected
health information. Therefore, the exchange of health information
through electronic messaging requires additional security measures
while maintaining its ease of use for communication. While email with
the necessary safeguards is probably the most widely used method of
electronic messaging, for the purposes of meeting this objective,
secure electronic messaging could also occur through functionalities of
patient portals, PHRs, or other stand-alone secure messaging
applications.
We proposed this as a core objective for EPs for Stage 2. The
additional time made available for Stage 2 implementation made possible
the inclusion of some new objectives in the core set as proposed in the
proposed rule. We chose to identify objectives that address critical
priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html), with a
focus on one for EPs and one for hospitals.
For EPs, secure electronic messaging is critically important to two
NQS priorities--
Ensuring that each person/family is engaged as partners in
their care; and
Promoting effective communication and coordination of
care.
Secure messaging could make care more affordable by using more
efficient communication vehicles when appropriate. Specifically,
research demonstrates that secure messaging has been shown to improve
patient adherence to treatment plans, which reduces readmission rates.
Secure messaging has also been shown to increase patient satisfaction
with their care. Secure messaging has been named as one of the top
ranked features according to patients. Also, despite some trepidation,
providers have seen a reduction in time responding to inquires and less
time spent on the phone. We specifically sought comment on whether
there may be special concerns with this objective in regards to
behavioral health.
Comment: Some commenters noted that patient engagement and enhanced
patient-provider communications facilitated by an EHR are important
goals, and secure messaging between EPs and patients is an appropriate
objective to consider for Meaningful Use criteria.
Response: We appreciate the commenters support of this objective
and agree that electronic patient-provider communication is important
to improving the overall quality of patient care.
Comment: Some commenters suggested that this objective should be
part of the menu set instead of a core objective for Stage 2. This
would permit EPs who do not believe they can meet the measure at this
time to select different objectives.
Response: As we noted in the proposed rule, we placed this
objective in the core because we believe it addresses critical
priorities of the country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html):
Ensuring that each person/family is engaged as partners in their care;
and promoting effective communication and coordination of care. We also
believe that secure messaging could make care more affordable by using
more efficient communication vehicles when appropriate. Specifically,
research demonstrates that secure messaging has been shown to improve
patient adherence to treatment plans, which reduces readmission rates
(see Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008) ``Supporting
the patient's role in guideline compliance: a controlled study''
American Journal of Managed Care 14(11):737-44; Gustafson DH, Hawkins
R, Boberg E, Pingree S, Serlin RE, Graziano F, Chan CL (1999) ``Impact
of a patient-centered, computer-based health information/support
system'' American Journal of Preventive Medicine 16(1):1-9). Secure
messaging has also been shown to increase patient satisfaction with
their care (see Ralston JD, Carrell D, Reid R, Anderson M, Moran M,
Hereford J (2007) ``Patient Web services integrated with a shared
medical record: patient use and satisfaction'' Journal of the American
Medical Informatics Association 14(6):798-806). Therefore, we are
leaving this as a core objective for EPs for Stage 2.
Comment: Several commenters responded to our question about whether
there were special concerns about implementing this objective for
behavioral health patients. These commenters indicated that they did
not believe this objective posed a special concern and that it would
help behavioral health patients obtain needed support from clinicians.
Response: We appreciate the feedback from commenters regarding
behavioral health.
After consideration of the public comments, we are finalizing the
meaningful use objective for EPs at Sec. 495.6(j)(17)(i) as proposed.
Proposed EP Measure: A secure message was sent using the electronic
messaging function of CEHRT by more than 10 percent of unique patients
seen by the EP during the EHR reporting period.
Comment: Many commenters voiced objections to the measure of this
objective and the concept of providers being held accountable for
patient actions. The commenters believed that while providers could be
held accountable for making electronic messaging capabilities available
to patients and encouraging patients to use electronic messaging, they
could not control whether patients actually utilized electronic
messaging. However, some commenters believed that the measure was a
reasonable and necessary step to require vendors to make electronic
messaging tools more widely available and for providers to incorporate
electronic messaging into clinical practice. In addition, commenters
pointed to the unique role that providers can play in encouraging and
facilitating their patients' and their families' use of secure
messaging.
Response: While we recognize that EPs cannot directly control
whether patients use electronic messaging, we continue to believe that
EPs are in a unique position to strongly influence the technologies
patients use to improve their own care, including secure electronic
messaging. We believe that EPs' ability to influence patients coupled
with the low threshold make this measure achievable for all EPs.
Comment: Other commenters did not object to the principle of
providers
[[Page 54032]]
being held accountable for patient actions but noted that the potential
barriers of limited internet access, computer access, and electronic
messaging platforms for certain populations (for example, rural,
elderly, lower income, visually impaired, non-English-speaking, etc.)
might make the measure impossible to meet for some providers.
Commenters suggested a number of possible solutions to allow providers
to overcome these barriers: granting exclusions for certain patient
populations, lowering the proposed threshold of the measure, or
eliminating the percentage threshold of the measure.
Response: We recognize that certain patient populations face
greater challenges in utilizing electronic messaging. We address the
potential barrier of limited internet access in the comment regarding a
broadband exclusion below. While we agree that excluding certain
patient populations from this requirement would make the measure easier
for EPs to achieve, we do not know of any reliable method to quantify
these populations for each EP in such a way that we could standardize
exclusions for each population. In addition, we are concerned that
blanket exclusions for certain disadvantaged populations could serve to
extend existing disparities in electronic access to health information.
We also decline to eliminate the percentage threshold of this measure
because we do not believe that a simple yes/no attestation for
implementation of electronic messaging is adequate to encourage a
minimum level of patient usage. However, in considering the potential
barriers faced by these patient populations, we agree that it would be
appropriate to lower the proposed threshold of this measure to more
than 5 percent of unique patients sending an electronic message. We
believe that this lower threshold, combined with the broadband
exclusion detailed in the response below, will allow all EPs to meet
the measure of this objective.
Comment: Several commenters suggested that the exclusion for FCC-
recognized areas with under 50 percent broadband availability, which
was proposed in the objective to ``Provide patients the ability to view
online, download, and transmit their health information,'' should be
extended to the electronic messaging objective.
Response: We agree that the infrastructure required for electronic
messaging is similar to the infrastructure required for successful
usage of an online patient portal as described in the objective to
``Provide patients the ability to view online, download, and transmit
their health information.'' Therefore, we believe an exclusion to this
measure based on the availability of broadband is appropriate and are
finalizing the exclusion in the language below. We note that since
publication of our proposed rule the Web site has changed to
www.broadbandmap.gov and the speed used has changed from 4Mbps to
3Mbps. We updated our exclusion.
Comment: Some commenters expressed concern about including all
patients seen by the EP in the denominator and suggested limiting the
denominator instead to patients who have indicated secure electronic
messaging as their communication preference. Other commenters suggested
the denominator should not be limited to patients seen by the EP and
should also include patients who make inquiries or who attempt to make
an appointment with the EP during the reporting period.
Response: We do not agree that limiting the denominator to patients
who have indicated secure electronic messaging as their communication
preference is appropriate. The purpose of the measure is for EPs to
promote wider use of electronic messaging as a regular communication
vehicle for their patients, and we are concerned that limiting the
denominator in the manner suggested would not lead to an increase in
the promotion or usage of electronic messaging as an important
communication vehicle between patients and providers. We also do not
agree that expanding the denominator to patients not seen by the EP
during the reporting period is appropriate. Another purpose of the
measure is for secure messaging to include clinically relevant
information, and we do not believe that patients seeking introductory
information or making an appointment are likely to include clinically
relevant information in secure messaging.
Comment: Some commenters noted that patients whose only office
visit with an EP occurs near the end of the reporting period might not
be able to send an electronic message in time to be included in the
numerator of the measure.
Response: While we agree that patients with a single office visit
near the end of the reporting period may not utilize electronic
messaging and be eligible for inclusion in the numerator of the measure
during the EHR reporting period, we believe that the threshold of this
measure will be sufficiently low to permit EPs to meet the measure even
without the participation of these patients.
Comment: Several commenters requested clarification on the
definition of a secure message.
Response: We define a secure message as any electronic
communication between a provider and patient that ensures only those
parties can access the communication. This electronic message could be
email or the electronic messaging function of a PHR, an online patient
portal, or any other electronic means. However, we note that the secure
message also must use the electronic messaging function of CEHRT in
order to qualify for the measure of this objective.
Comment: Some commenters suggested that EPs or patients should be
permitted to use an electronic messaging function that is not part of
CEHRT in order to meet the measure.
Response: We believe that allowing patients to use multiple
electronic messaging functions in order to communicate with the
provider under this measure could create confusion for the EP and
potentially lead to electronic messages that are missed or not
responded to. We also believe that by encouraging patients to use the
electronic messaging function that is part of CEHRT EPs can better
ensure that electronic messages are sent securely to protect patient's
health information. Finally, we are concerned that CEHRT would not be
able to track electronic messaging that is not part of the EHR, which
would place an extra burden for reporting on EPs in meeting this
measure. For all of these reasons, we require that patients use the
electronic messaging function that is part of CEHRT in order to be
included in the measure of this objective.
Comment: Commenters agreed with our decision not to include in the
definition for this measure ``relevant health information.'' Commenters
did not believe CEHRT could support the categorization of electronic
messages in a way that would satisfy such a requirement.
Response: We appreciate the support offered by commenters. As we
stated in the proposed rule, the secure messages sent should contain
relevant health information specific to the patient in order to meet
the measure of this objective. We believe the EP is the best judge of
what health information should be considered relevant in this context.
We do not specifically include the term ``relevant health information''
in the measure because we believe the provider is best equipped to
determine whether such information is included. We agree that it would
be too great a burden for CEHRT to determine whether
[[Page 54033]]
the information in the secure message has such information.
Comment: Some commenters expressed concerns that we did not propose
to measure provider response to patient electronic messaging. These
commenters believed that the proposed measure places too much focus on
patient messaging and should instead focus on communication between
patient and provider. Some commenters suggested that the measure be
modified for responsiveness of an EP or staff to patient messaging
rather than the proposed percentage of patients who send a secure
message.
Response: As we stated in the proposed rule, there is an
expectation that the EP would respond to electronic messages sent by
the patient, although we do not specify the method of response or
require the EP to document his or her response for this measure. We
decline to specify the method of provider response because we believe
it is best left to the provider's clinical judgment to decide the
course of action which should be taken in response to the patient's
electronic message. An EP or staff member could decide that a follow-up
telephone call or office visit is more appropriate to address the
concerns raised in the electronic message. Therefore, we decline to
alter the measure to include provider response.
Comment: Commenters asked for clarification as to whether the EP
had to respond personally to electronic messaging or whether members of
the EP's staff could respond. Commenters also asked for clarification
regarding whether or not messages sent by a patient-authorized
representative would be recorded in this measure.
Response: There is not an expectation that the EP must personally
respond to electronic messages to the patient. Just as an EP's staff
respond to telephone inquiries or conduct office visits on behalf of
the EP, staff could also respond to electronic messages from the
patient. We also intend for electronic messages sent by a patient-
authorized representative to be included in the measure of this
objective and have modified the language of the measure below
accordingly.
Comment: Some commenters raised concerns regarding the security of
electronic messaging, specifically citing instances where family
members might have access to the patient's account or elderly patients
who would not know how to use a computer and would have to give account
access to a caregiver. Other commenters raised concerns regarding their
liability in providing access to such information or in responding to
an electronic message.
Response: We do not believe that secure electronic messaging poses
greater risks to exposure of protected health information than other
mediums such as telephone messaging, paper records, etc. In some cases
secure electronic messaging can provide even greater protection of
health information. We note that many patients grant access to health
information to family members and caregivers to facilitate care, and we
expect the same access to continue with secure electronic messaging.
Nor do we believe that secure electronic messaging exposes providers to
greater liability (for example, in areas of privacy protection or
malpractice) than other mediums such as telephone, mail, paper records,
etc. Previous research has demonstrated that better patient-provider
communication reduces the likelihood of malpractice claims being filed.
Comment: Some commenters noted that the potential financial burden
of implementing securing messaging as a part of their clinical or
administrative workflow. These commenters noted that EPs are not
reimbursed for the time spent responding to electronic messages and
that it can be time consuming for an EP to have multiple exchanges with
a patient via email.
Response: We do not believe that implementing electronic messaging
imposes a significant burden on providers. While we note that in some
scenarios it may be possible for an EP to receive reimbursement from
private insurance payers for online messaging, we acknowledge that EPs
are generally not reimbursed for time spent responding to electronic
messaging. However, it is also true that EPs are generally not
reimbursed for other widely used methods of communication with patients
(for example, telephone). As we noted in the proposed rule, many
providers have seen a reduction in time responding to inquires and less
time spent on the phone through the use of electronic messaging. In
addition, we note that EPs themselves do not have to respond to
electronic messages personally and can delegate this task to staff,
just as many EPs currently delegate telephone exchanges with patients
to staff.
After consideration of the public comments, we are finalizing the
meaningful use measure for EPs as ``A secure message was sent using the
electronic messaging function of CEHRT by more than 5 percent of unique
patients (or their authorized representatives) seen by the EP during
the EHR reporting period'' at Sec. 495.6(j)(17)(ii) and the exclusion
for EPs as ``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 3Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period'' at Sec. 495.6(j)(17)(iii).
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(e)(3).
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by
the EP during the EHR reporting period.
Numerator: The number of patients or patient-authorized
representatives in the denominator who send a secure electronic message
to the EP that is received using the electronic messaging function of
CEHRT during the EHR reporting period.
Threshold: The resulting percentage must be more than 5
percent in order for an EP 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 3Mbps broadband availability according
to the latest information available from the FCC on the first day of
the EHR reporting period.
Proposed Eligible Hospital/CAH Objective: Automatically track
medications from order to administration using assistive technologies
in conjunction with an electronic medication administration record
(eMAR).
In the proposed rule, we outlined the following benefits of
automatically tracking medications with eMAR: eMAR increases the
accuracy of medication administration thereby increasing both patient
safety and efficiency. The HIT Policy Committee has recommended the
inclusion of this objective for hospitals in Stage 2, and we proposed
this as a core objective for eligible hospitals and CAHs. The
additional time made available for Stage 2 implementation makes
possible the inclusion of some new objectives in the core set. eMAR is
critically important to making care safer by reducing medication errors
which may make care more affordable. eMAR has been shown to lead to
significant improvements in medication-related adverse events within
hospitals with associated decreases in cost. eMAR cuts
[[Page 54034]]
in half the adverse drug event (ADE) rates for non-timing medication
errors, according to a study published in the New England Journal of
Medicine (Poon et al., 2010, Effect of Bar-Code Technology on the
Safety of Medication Administration http://www.nejm.org/doi/abs/10.1056/NEJMsa0907115?query=NC). A study done to evaluate cost-benefit
of eMAR (Maviglia et al., 2007, Cost-Benefit Analysis of a Hospital
Pharmacy Bar Code Solution http://archinte.ama-assn.org/cgi/content/full/167/8/788) demonstrated that associated ADE cost savings allowed
hospitals to break even after 1 year and begin reaping cost savings
going forward.
We proposed to define eMAR as technology that automatically
documents the administration of medication into CEHRT using electronic
tracking sensors (for example, radio frequency identification (RFID))
or electronically readable tagging such as bar coding). The specific
characteristics of eMAR for the EHR Incentive Programs will be further
described in the ONC standards and certification criteria final rule
published elsewhere in this issue of the Federal Register.
By its very definition, eMAR occurs at the point of care so we did
not propose additional qualifications on when it must be used or who
must use it.
Comment: Some commenters suggested that this should be a menu
objective for Stage 2.
Response: As we stated in the proposed rule, we believe that eMAR
is critically important to making care safer by reducing medication
errors which may also make care more affordable. eMAR has been shown to
lead to significant improvements in medication-related adverse events
within hospitals with associated decreases in cost. Therefore, we
believe that the benefits to patient safety from eMAR warrant the
inclusion of this as a Stage 2 core objective for eligible hospitals
and CAHs.
After consideration of the public comments, we are finalizing the
meaningful use objective for eligible hospitals and CAHs at Sec.
495.6(l)(16)(i) as proposed.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of
medication orders created by authorized providers of the eligible
hospital's or CAH's inpatient or emergency department (POS 21 or 23)
during the EHR reporting period are tracked using eMAR.
Comment: A number of commenters questioned whether the measure
should apply to at least one instance of the administration of a dose
connected with a medication order or whether each individual dose
connected with a medication order should be included in the measure.
Some commenters believed that a single instance of administration of a
dose should constitute fulfillment of the measure, while others
believed that all doses administered rather than orders administered
would be a more precise and meaningful measurement.
Response: We believe that including each individual dose connected
with a medication order through this measure could yield denominators
that are very large. However, we believe that the benefits to patient
safety from eMAR are seen when all doses of a medication order are
tracked. Therefore, we clarify that we include in the numerator of this
objective medication orders for which all doses are tracked using eMAR,
and we are amending the measure language below to reflect this
clarification. If a medication is ordered but not all doses of the
medication are tracked using eMAR, then that order may not be included
in the numerator of the measure.
Comment: Some commenters raised the concern that certain rural and
low volume hospitals might face undue financial burden in implementing
this objective and proposed an exclusion for hospitals with either a
limited number of inpatient beds or a low average inpatient volume.
Some commenters suggested there should be an exclusion for very small
hospitals for whom eMAR could be a prohibitively expensive undertaking.
Other commenters noted that the difficulties in implementing eMAR were
outweighed by the significant benefits to patient safety.
Response: We agree with commenters who suggested that the potential
benefits to patient safety of eMAR are significant. While we agree that
certain hospitals may face challenges in implementing eMAR on a wider
scale, we believe that the low threshold for this measure lessens the
burden associated with implementation of eMAR for most rural and low
volume hospitals. We also note that CEHRT will include eMAR
capabilities, so the primary barrier to implementation for most
hospitals will be workflow.
However, we are also concerned that very small hospitals may have
local technical support and training issues that may make an automated
eMAR solution actually less effective than other approaches. We also
believe that very small hospitals will have fewer health care
professionals involved in the process of medication administration and
fewer patients for whom duplicative orders could present an issue,
which would also make an eMAR solution less effective. Therefore, we
believe these hospitals would not benefit from eMAR as much as larger
facilities and are finalizing an exclusion for these hospitals. Any
hospital with an average daily inpatient census of fewer than 10
patients may be excluded from meeting the measure of this objective.
For purposes of this exclusion, we define an average daily inpatient
census as the total number of patients admitted during the previous
calendar year divided by 365 (or 366 if the previous calendar year is a
leap year).
Comment: Some commenters stated that the percentage threshold of
this measure should be replaced with the implementation of eMAR in one
ward or unit of the hospital to limit burdensome measurement
requirements. Other commenters argued that changing the measure to one
ward or unit of the hospital would introduce ambiguity regarding what
constitutes a ward or unit, while a percentage threshold would allow
hospitals the flexibility to implement eMAR capabilities on a limited
basis.
Response: We believe that the low threshold of this objective does
not impose burdensome measurement requirements on hospitals, especially
since we do not anticipate a significant difference in the way CEHRT
will measure eMAR usage regardless of where it is implemented. We agree
that limiting the measure to implementation in a single ward or unit
could introduce ambiguity regarding the precise definition of ward or
unit, especially since some hospitals combine the locations and
workflows of certain units. We further note that the percentage
threshold does allow hospitals to implement eMAR in a limited capacity,
and that a hospital could potentially meet the low measure of this
objective by implementing in a single ward or unit or by implementing
in several smaller wards or units that combine to yield more than 10
percent of medication orders created during the EHR reporting period.
We believe the percentage measure of this objective yields maximum
flexibility for a hospital to implement eMAR in a way that is
clinically relevant to its individual workflow.
Comment: Some commenters requested clarification on whether eMAR
could be implemented solely in portions of an inpatient department or
solely in portions of an emergency department in order to meet the
measure, as opposed to implementing eMAR in both the inpatient and
emergency departments.
[[Page 54035]]
Response: As stated previously, we have attempted to provide
maximum flexibility for a hospital to implement eMAR in a way that is
clinically relevant to its individual workflow. Therefore, we do not
require that eMAR is implemented in both inpatient and emergency
departments in order to meet this measure, only that more than 10
percent of medication orders created by authorized providers of either
the inpatient or emergency department (POS 21 or 23) during the EHR
reporting period are tracked using eMAR. Hospitals could implement eMAR
in the inpatient department, the emergency department, or both
departments in order to meet the threshold of this measure.
After consideration of the public comments, we modify the
meaningful use measure as ``More than 10 percent of medication orders
created by authorized providers of the eligible hospital's or CAH's
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period for which all doses are tracked using eMAR'' for
eligible hospitals and CAHs at Sec. 495.6(l)(16)(ii) and finalize the
exclusion as ``Any eligible hospital or CAH with an average daily
inpatient census of fewer than 10 patients'' at Sec.
495.6(l)(16)(iii).
We further specify that in order to meet this objective and
measure, an eligible hospital or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(a)(16).
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of medication orders created
by authorized providers in the eligible hospital's or CAH's inpatient
or emergency department (POS 21 or 23) during the EHR reporting period.
Numerator: The number of orders in the
denominator for which all doses are tracked using eMAR.
Threshold: The resulting percentage must be more
than 10 percent in order for an eligible hospital or CAH to meet this
measure.
Exclusion: Any hospital with an average daily
inpatient census of fewer than ten (10) patients.
Proposed Eligible Hospital/CAH Objective: Generate and transmit
permissible discharge prescriptions electronically (eRx)
In the proposed rule, we outlined the following benefits of
electronic prescribing: 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 recognize the information and can provide
decision support to promote safety and quality in the form of adverse
interactions and other treatment possibilities. The CEHRT can also
provide decision support that promotes the efficiency of the health
care system by alerting the EP to generic alternatives or to
alternatives favored by the patient's insurance plan that are equally
effective. Transmitting the prescription electronically promotes
efficiency and safety through reduced communication errors. It also
allows the pharmacy or a third party to automatically compare the
medication order to others they have received for the patient. This
comparison allows for many of the same decision support functions
enabled at the generation of the prescription, but bases them on
potentially greater information.
We have combined the comments and responses for this objective with
the measure below. After consideration of the public comments, we are
finalizing the meaningful use objective for eligible hospitals and CAHs
at Sec. 495.6(m)(4)(i) as proposed.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of
hospital discharge medication orders for permissible prescriptions (for
new or changed prescriptions) are compared to at least one drug
formulary and transmitted electronically using CEHRT.
Comment: Most commenters voiced support for this as a menu set
item, with some commenters noting that the threshold for this measure
should remain low for Stage 2 because of the difficulty of using
electronic prescribing for all prescriptions, including controlled
substances.
Response: We appreciate the support for this objective, and we note
that the measure of the objective for eligible hospitals and CAHs for
Stage 2 is set at more than 10 percent of all discharge medication
orders for permissible prescriptions. We believe this sets a
sufficiently low threshold that would allow most hospitals to achieve
this measure and eliminates the inclusion of controlled substances,
which are not included as permissible prescriptions for the purposes of
this measure.
Comment: Most commenters noted that distinguishing new and altered
prescriptions from refills would be unnecessarily burdensome for
hospitals.
Response: Although we had initially proposed to limit this measure
to only new and altered prescriptions because we believed that
hospitals would not issue refill prescriptions, we agree with the
commenters that distinguishing refills from new and altered
prescriptions could be unnecessarily burdensome for hospitals.
Therefore, we are not imposing this limitation and include new,
altered, and refill prescriptions in the measure of discharge
medication orders for permissible prescriptions.
Comment: Some commenters expressed concerns about patient requests
for paper prescriptions instead of electronic prescriptions.
Response: We believe that the more than 10 percent of discharge
medication orders threshold is sufficiently low to accommodate patient
requests for paper prescriptions and still allow most, if not all,
hospitals to meet the measure of this objective.
Comment: Some commenters asked whether prescriptions electronically
transmitted to in-house pharmacies should be included in the measure
and if the standards specified by ONC for this measure would apply to
these transmissions.
Response: We are continuing the policy from Stage 1 that
prescriptions transmitted electronically within an organization (the
same legal entity) would be counted in the measure and would not need
to use the standards specified by ONC for this objective. However, a
hospital's CEHRT must meet all applicable certification criteria and be
certified as having the capability of meeting external transmission
requirements. In addition, the EHR that is used to transmit
prescriptions within the organization would need to be CEHRT.
The hospital would include in the numerator and denominator both
types of electronic transmission (those within and outside the
organization) for the measure of this objective. We further clarify
that for purposes of counting discharge prescriptions ``generated and
transmitted electronically,'' we considered the generation and
transmission of prescriptions to occur simultaneously if the prescriber
and dispenser are the same person and/or are accessing the same record
in an integrated EHR to create an order in a system that is
electronically transmitted to an internal pharmacy.
Comment: Some commenters asked for clarification regarding whether
drug-formulary checks had to be enabled for the entire EHR reporting
period, as required by the Stage 1 measure.
Response: No. The Stage 1 objective for drug-formulary checks has
been combined with this Stage 2 objective for generating and
transmitting permissible discharge prescriptions electronically.
Although the measure of the Stage 1 objective required the capability
for
[[Page 54036]]
drug-formulary checks to be enabled for the entire reporting period,
the measure of the Stage 2 objective specifies drug-formulary checks
should be performed for more than 10 percent of hospital discharge
medication orders for permissible prescriptions. We recognize that not
every patient will have a formulary that is relevant for him or her.
Therefore, we require not that the EHR check each prescription against
a formulary relevant for a given patient, but rather that the EHR check
each prescription for the existence of a relevant formulary. If a
relevant formulary is available, then the information can be provided.
We believe that this initial check is essentially an on or off function
for the EHR and should not add to the measurement burden. Therefore,
with this clarification of the check we are referring to, we are
finalizing the drug formulary check as a component of this measure. We
look forward to the day when a relevant formulary is available for
every patient. We modified the measure to use the word query instead of
compare.
Comment: Some commenters asked whether the measure of this
objective applied to inpatient departments, emergency departments, or
both.
Response: We specify that the measure of this objective applies to
medication orders for patients discharged from either the inpatient
(POS 21) department, the emergency department, or both the inpatient
and emergency departments of an eligible hospital or CAH during the EHR
reporting period.
Comment: One commenter asked for clarification of whether a patient
for whom no relevant drug formularies are available could be counted in
the numerator of the measure if the discharge prescription for that
patient is generated and transmitted electronically. Another commenter
suggested that patients for whom no relevant formularies are available
should not be counted in the measure.
Response: As noted in the proposed rule, we believe that the
inclusion of the comparison to at least one drug formulary enhances the
efficiency of the healthcare system when clinically appropriate and
cheaper alternatives may be available. In the event that a relevant
formulary is unavailable for a particular patient and medication
combination, a discharge prescription that is generated and
electronically transmitted should still be included in the numerator of
the measure. We do not agree that prescriptions for patients for whom
relevant formularies are unavailable should be excluded from this
measure.
Comment: Several commenters believed that the exclusion based on
the availability of a pharmacy capable of receiving electronic
prescriptions within 25 miles of the hospital's location was not
adequate for all areas, particularly rural areas. Some commenters
suggested that 10 miles is a more appropriate distance.
Response: We appreciate the commenters' concerns about this
exclusion. As stated in the proposed rule, we recognize that certain
areas may not have widespread availability of electronic prescribing in
all pharmacies, we believe that most hospitals will be able to fulfill
electronic prescriptions through an internal pharmacy. However, we
agree with commenters that basing the exclusion on a 25-mile radius
could place a significant burden on patients to travel to fill
prescriptions, especially in rural areas. Therefore, we are finalizing
a 10-mile radius at the start of the EHR reporting period. Hospitals
that do not have an internal pharmacy and that are located 10 miles
from a pharmacy that can receive electronic prescriptions at the start
of the EHR reporting period would be able to claim the exclusion for
this measure. We also believe that the low threshold of more than 10
percent of discharge prescriptions transmitted electronically would
make it possible for all hospitals to meet this measure.
Comment: Some commenters requested for clarification of whether
CEHRT would provide the capability to determine the availability of a
pharmacy capable of receiving electronic prescriptions within 25 miles
of the hospital's location.
Response: CEHRT will not provide the capability to determine
whether a hospital meets the exclusion for this measure. As stated in
the previous response, we are finalizing the exclusion for the
availability of a pharmacy capable of receiving electronic
prescriptions within 10 miles of the hospital's location. Therefore,
eligible hospitals and CAHs may use their own resources to make a
determination regarding the availability of a pharmacy capable of
receiving electronic prescriptions within 10 miles of the hospital's
location.
After consideration of the public comments, we modify the
meaningful use measure for eligible hospitals and CAHs as ``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'' at Sec. 495.6(m)(4)(ii) and we modify the exclusion for
eligible hospitals and CAHs at Sec. 495.6(m)(4)(iii) by changing the
radius from 25 miles to 10 miles.
We further specify that in order to meet this objective and
measure, an eligible hospital or CAH must use the capabilities and
standards of CEHRT at 45 CFR 170.314(a)(10) and (b)(3).
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 Eligible Hospital/CAH Objective: Provide patients the
ability to view online, download, and transmit information about a
hospital admission.
In the proposed rule, we noted that studies have found that
patients engaged with computer based information sources and decision
support show improvement in quality of life indicators, patient
satisfaction and health outcomes. (Ralston, Carrell, Reid, Anderson,
Moran, & Hereford, 2007) (Gustafson, Hawkins, Bober, S, Graziano, & CL,
1999) (Riggio, Sorokin, Moxey, Mather, Gould, & Kane, 2009) (Gustafson,
et al., 2001). In addition, we noted that this objective aligns with
the FIPPs,\5\ in affording baseline privacy protections to individuals.
We stated that we believe this information is integral to the
Partnership for Patents initiative and reducing hospital readmissions.
While this objective does not require all of the information sources
and decision support used in these studies, having a set of basic
information available advances these initiatives. The ability to have
this information online means it is always retrievable by the patient,
while the download function ensures that the patient can take the
information with them when secure internet access is not
[[Page 54037]]
available. However, providers should be aware that while meaningful use
is limited to the capabilities of CEHRT to provide online access, there
may be patients who cannot access their EHRs electronically because of
their disability. Additionally, other health information may not be
accessible. Finally, we noted that providers who are covered by civil
rights laws must provide individuals with disabilities equal access to
information and appropriate auxiliary aids and services as provided in
the applicable statutes and regulations.
---------------------------------------------------------------------------
\5\ Ibid.
---------------------------------------------------------------------------
We proposed this as a core objective for hospitals for Stage 2. We
also specified in the proposed rule the information that must be made
available as part of the objective, although we noted hospitals could
choose to provide additional information (77 FR 13730).
Comment: Some commenters suggested that this objective should be
part of the menu set instead of a core objective for Stage 2. This
would permit eligible hospitals and CAHs that do not believe they can
meet the measure at this time to select different objectives.
Response: We do not agree that this objective should be part of the
menu set. We proposed this objective as part of the core for eligible
hospitals and CAHs because it is intended to replace the previous Stage
1 core objective of ``Provide patients with an electronic copy of their
health information upon request'' and the Stage 1 core objective of
``Provide patients with an electronic copy of their discharge
information.'' Although CEHRT will provide added capabilities for this
objective, we do not believe the objective itself is sufficiently
different from previous objectives to justify placing it in the menu
set. Also, we believe that patient access to their discharge
information is a high priority for the EHR Incentive Programs and this
objective best provides that access in a timely manner.
Comment: Some commenters expressed the opinion that this objective
should not be included as part of meaningful use and was more
appropriately regulated under HIPAA and through the Office for Civil
Rights.
Response: We do not agree that this objective should not be
included in meaningful use. Although we recognize that many issues
concerning the privacy and security of information online are subject
to HIPAA requirements, we believe that establishing an objective to
provide online access to health information is within the regulatory
purview of the EHR Incentive Programs and consistent with the statutory
requirements of meaningful use.
After consideration of the public comments, we are finalizing the
meaningful use objective for eligible hospitals and CAHs at Sec.
495.6(l)(8)(i) as proposed.
Proposed Eligible Hospital/CAH Measure: There are 2 measures for
this objective, both of which must be satisfied in order to meet the
objective.
More than 50 percent of all patients who are discharged from the
inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH have their information available online within 36 hours
of discharge.
More than 10 percent of all patients who are discharged from the
inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH view, download or transmit to a third party their
information during the EHR reporting period.
Comment: A commenter questioned how long data should be made
available online before it can be removed.
Response: It is the goal of this objective to make available to the
patient both current and historical health information regarding
hospital discharges. Therefore, we would anticipate that the data
should be available online on an ongoing basis. However, an eligible
hospital or CAH may withhold or remove information from online access
for purposes of meaningful use if they believe substantial harm may
arise from its disclosure online.
Comment: Some commenters asked for clarification on whether online
access had to be made available using CEHRT or if the information could
be made available through other means (patient portal, PHR, etc.).
Response: Both of the measures for this objective must be met using
CEHRT. Therefore, for the purposes of meeting this objective, the
capabilities provided by a patient portal, PHR, or any other means of
online access and that would permit a patient or authorized
representative to view, download, or transmit their personal health
information would have to be certified in accordance with the
certification requirements adopted by ONC. We refer readers to ONC's
standards and certification criteria final rule that is published
elsewhere in this issue of the Federal Register.
Comment: Some commenters asked for clarification on how access by
the patient is defined.
Response: We define access as having been given when the patient
possesses all of the necessary information needed to view, download, or
transmit their discharge information. This could include providing
patients with instructions on how to access their health information,
the Web site address they must visit for online access, a unique and
registered username or password, instructions on how to create a login,
or any other instructions, tools, or materials that patients need in
order to view, download, or transmit their discharge information.
Comment: Some commenters suggested that patients under the age of
18 should not have the same access to the same information to which
adult patients have access and requested a separate list of required
elements for patients under the age of 18.
Response: An eligible hospital or CAH may decide that online access
is not the appropriate forum for certain health information for
patients under the age of 18. Within the confines of the laws governing
guardian access to medical records for patients under the age of 18, we
would defer to the eligible hospital's or CAH's judgment regarding
which information should be withheld for such patients. In lieu of
providing online access to patients under the age of 18, eligible
hospitals or CAHs could provide online access to guardians for patients
under the age of 18, in accordance with state and local laws, in order
to meet the measure of this objective. Providing online access to
guardians in accordance to state and local laws would be treated the
same as access for patients, and guardians could then be counted in the
numerator of the measure. We recognize that state and local laws may
restrict the information that can be made available to guardians, and
in these cases such information can be withheld and the patient could
still be counted in the numerator of the measure.
Comment: Many commenters voiced objections to the second measure of
this objective and the concept of providers being held accountable for
patient actions. The commenters believed that while providers could be
held accountable for making information available online to patients,
providers could not control whether patients actually accessed their
information. Many commenters also noted that the potential barriers of
limited internet access, computer access, and patient engagement with
health IT for certain populations (for example, rural, elderly, lower
income, non-English-speaking, etc.) might make the measure impossible
to meet for some providers. There were also a number of comments
stating that metrics used to track views or downloads can be misleading
and are not necessarily the most accurate measure of patient usage.
Commenters suggested a number of possible solutions to allow providers
to overcome these barriers, including
[[Page 54038]]
eliminating the percentage threshold of the measure or requiring
providers to offer and track patient access but not requiring them to
meet a percentage measure in order to demonstrate meaningful use.
However, some commenters believed that the measure was a reasonable and
necessary step to ensure that providers had accountability for
engagement of their patients in use of electronic health information
and integration of it into clinical practice. In addition, commenters
pointed to the unique role that providers can play in encouraging and
facilitating their patients' and their families' use of online tools.
Response: While we recognize that eligible hospitals and CAHs
cannot directly control whether patients access their health
information online, we continue to believe that eligible hospitals and
CAHs are in a unique position to strongly influence the technologies
patients use to improve their own care, including viewing, downloading,
and transmitting their health information online. We believe that the
eligible hospital's or CAH's ability to influence patients coupled with
the low threshold of more than 10 percent of patients who view online,
download, or transmit to a third party their information make this
measure achievable for all eligible hospitals and CAHs.
We recognize that certain patient populations face greater
challenges in online access to information. We address the potential
barrier of limited internet access in the comment regarding a broadband
exclusion below. We address the potential barrier to individuals with
disabilities through ONC's rules requiring that EHRs meet disability
accessibility standards. While we agree that excluding certain patient
populations from this requirement would make the measure easier for
eligible hospitals and CAHs to achieve, we do not know of any reliable
method to quantify these populations for each eligible hospital and CAH
in such a way that we could standardize exclusions for each population.
We also decline to eliminate the percentage threshold of this measure
because we do not believe that a simple yes/no attestation for this
objective is adequate to encourage a minimum level of patient usage.
However, in considering the potential barriers faced by these patient
populations, we agree that it would be appropriate to lower the
proposed threshold of this measure to more than 5 percent of unique
patients who view online, download, or transmit to a third party their
information. In addition, we are concerned that blanket exclusions for
certain disadvantaged populations could serve to extend existing
disparities in electronic access to information and violate civil
rights laws. All entities receiving funds under this program are
subject to civil rights laws. For more information about these laws and
their requirements (see http://www.hhs.gov/ocr/civilrights/index.html). We believe that this lower threshold, combined with the
broadband exclusion detailed in the response later in this section,
will allow all eligible hospitals and CAHs to meet the measure of this
objective.
Comment: Some commenters suggested making the numerator and
denominator language for this measure consistent with the language used
for this measure for EPs.
Response: We agree that there are some slight variations in
language between the measure for EPs and the measure for hospitals. To
the extent possible, we have harmonized the language between both.
Comment: Some commenters asked for clarification on how view is
defined.
Response: We define view as the patient (or authorized
representative) accessing their health information online.
Comment: Some commenters noted that the potential financial burden
of implementing an online patient portal to provide patients online
access to discharge information. These commenters noted the added time
burden for staff in handling the additional patient use of online
resources, which may increase costs through the hiring of additional
staff, as well as the need to modify their existing workflow to
accommodate potential online messages from patients. Some commenters
also believed that there would be an additional cost for sharing
content before standards exist for content types and formats.
Response: As noted in the proposed rule, studies have found that
patients engaged with computer based information sources and decision
support show improvement in quality of life indicators, patient
satisfaction and health outcomes (see Rosenberg SN, Shnaiden TL, Wegh
AA, Juster IA (2008) ``Supporting the patient's role in guideline
compliance: a controlled study'' American Journal of Managed Care
14(11):737-44; Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE,
Graziano F, Chan CL (1999) ``Impact of a patient-centered, computer-
based health information/support system'' American Journal of
Preventive Medicine 16(1):1-9; Ralston JD, Carrell D, Reid R, Anderson
M, Moran M, Hereford J (2007) ``Patient web services integrated with a
shared medical record: patient use and satisfaction'' Journal of the
American Medical Informatics Association 14(6):798-806). We believe
that the information provided as part of this measure is integral to
the Partnership for Patents initiative and reducing hospital
readmissions. We do not believe that implementing online access for
patients imposes a significant burden, financial or otherwise, on
providers. While we note that in some scenarios it may be possible for
an eligible hospital or CAH to receive reimbursement from private
insurance payers for online messaging, we acknowledge that eligible
hospitals and CAHs are generally not reimbursed for time spent
responding to electronic messaging. However, it is also true that
eligible hospitals and CAHs are generally not reimbursed for other
widely used methods of communication with patients (for example,
telephone). In addition, it will be part of the capability of CEHRT to
automatically populate most of the list of required elements to meet
this measure, which significantly reduces the administrative burden of
providing this information. Finally, we believe that the standards
established for this objective by ONC will serve as a content standard
that will allow this information to be more easily transmitted and
uploaded to another certified EHR, thereby reducing the cost of sharing
information.
Comment: Some commenters noted that patient engagement could occur
effectively with or without online access, and patients should be
encouraged to use any method (for example, telephone, internet,
traditional mail) that suits them. These commenters noted that
engagement offline reduces both the need and value for engagement
online.
Response: We agree that patient engagement can occur effectively
through a variety of media, and we also believe that electronic access
to discharge information can be an important component of patient
compliance and improving longitudinal care. We do not believe that
offline engagement reduces the need for online access, as patients may
opt to access information in a variety of ways. Because of the variety
of ways that patients/families may access information, we keep the
threshold for this measure low. Measuring other means of accessing
health information is beyond the scope of the EHR Incentive Programs.
We also note that online access to health information can enhance
offline engagement--for example, patients could download information
from a hospital admission
[[Page 54039]]
to bring with them for a consult on follow-up care--which is one of the
primary goals of the EHR Incentive Programs.
Comment: Some commenters expressed concern that vendors would not
be able to make these capabilities available as part of CEHRT in time
for the beginning of Stage 2.
Response: Many CEHRT vendors already make patient portals available
that would meet the certification criteria and standards required for
this measure. Although the Stage 2 eligible hospital/CAH measure
requires some additional required elements and fields capabilities, we
believe vendors will be able to make these capabilities available in
time for the beginning of Stage 2.
Comment: Some commenters suggested that basing the exclusion on the
broadband data available from the FCC Web site (www.broadband.gov) was
suspect since the data originates from vendors.
Response: The broadband data made available from the FCC was
collected from over 3,400 broadband providers nationwide. This data was
then subject to many different types of analysis and verification
methods, from drive testing wireless broadband service across their
highways to meeting with community leaders to receive feedback.
Representatives met with broadband providers, large and small, to
confirm data, or suggest changes to service areas, and also went into
the field looking for infrastructure to validate service offerings in
areas where more information was needed. Therefore, we believe the data
is appropriate for the exclusion to this measure. We note that since
publication of our proposed rule the Web site has changed to
www.broadbandmap.gov and the speed used has changed from 4Mbps to
3Mbps. We are updating our exclusion to reflect these changes.
Comment: Some commenters believe that broadband exclusions should
be based on the patients' locations instead of the providers, since
county-level data may not be granular enough to capture all areas of
low broadband availability within a particular region.
Response: Although we agree that a broadband exclusion based
primarily on the individual locations of each patient seen would be
more accurate, we do not believe that there is any method of making
this determination for every patient without placing an undue burden on
the provider. We continue to believe that limited broadband
availability in the eligible hospital's or CAH's immediate practice
area, coupled with the low threshold of this measure, adequately serves
as an acceptable proxy for determining areas where online access can
present a challenge for patients. Therefore, after consideration of the
public comments received, we are finalizing the broadband exclusion as
proposed.
Comment: Some commenters suggested that the required element of
``Problem list maintained by the hospital on the patient'' should be
made consistent with the required element in the objective of the same
name and changed to ``Problem list.'' Other commenters asked for
clarification of ``Relevant past diagnoses known by the hospital'' and
how this element differs from ``Problem list.''
Response: We agree that this language should be made standard. By
``Relevant past diagnoses known by the hospital'' we mean to indicate
historical entries in the patient's problem list. Therefore, we are
eliminating the ``Relevant past diagnoses'' element and modifying the
problem list element to ``Current and past problem list'' in the list
of required elements below.
Comment: Some commenters suggested that displaying all historical
medications for each patient under the required element of ``Medication
list maintained by the hospital on the patient (both current admission
and historical)'' would be too burdensome for hospitals. These
commenters suggested amending the required element to only the active
medication list maintained by CEHRT. They also expressed confusion over
the use of the term ``current admission'' since the information for
this measure would be posted after the patient's discharge.
Response: We believe that just as providing a historical problem
list for the patient can be useful, so too can providing a historical
list of all medications. To clarify the intention of this objective, we
are modifying the language in the list of required elements below to
read ``Active medication list and medication history. Current admission
referred to the admission and subsequent discharge that places the
patient in the denominator for this measure.
Comment: Some commenters suggested that ``Laboratory test results
(available at discharge)'' could result in a large number of test
results that could be confusing to patients. They suggested limiting
this required element to a subset of lab results of a particular type
or lab results from the last 24 hours of admission.
Response: We believe that a list of all laboratory test results can
be beneficial to longitudinal care, therefore, we decline to modify
this required element either by type of lab result or by any time
period beyond those lab test results available at discharge.
Comment: Some commenters suggested that the required element of
``Care transition summary and plan for next provider of care (for
transitions other than home)'' should be made consistent with the
required element in the objective of the same name and changed to
``Care plan field, including goals and instructions.'' Some commenters
also suggested that care transition plans are more appropriate for
providers than patients.
Response: By ``care transition summary and plan for next provider
of care'' we mean for eligible hospitals and CAHs to include both the
care plan field(s), including goals and instructions, and a copy of the
summary of care document that hospitals must generate and provide for
the core objective of ``The eligible hospital or CAH that transitions
their patient to another setting of care or provider of care or refers
their patient to another provider of care should provide summary care
record for each transition of care or referral.'' While we believe that
the summary of care documents are best exchanged directly with the
provider to whom the hospital is transitioning care or referring the
patient, we also believe that providing an electronic copy with
discharge information will ensure that the provider can easily access
the information after the transition of referral. We have modified the
language in the list of required elements below to reflect this.
After consideration of the public comments received, we are
finalizing the first meaningful use measure for eligible hospitals and
CAHs at Sec. 495.6(l)(8)(ii)(A) as proposed. We are modifying the
second meaningful use measure for eligible hospitals and CAHs to be
``More than 5 percent of all patients (or their authorized
representatives) who are discharged from the inpatient or emergency
department (POS 21 or 23) of an eligible hospital or CAH view, download
or transmit to a third party their information during the EHR reporting
period'' at Sec. 495.6(l)(8)(ii)(B), and the exclusion for eligible
hospitals and CAHs at Sec. 495.6(l)(8)(iii) as ``Any eligible hospital
or CAH that is located in a county that does not have 50 percent or
more of its housing units with 3Mbps broadband availability according
to the latest information available from the FCC on the first day of
the EHR reporting period is excluded from the second measure.''
We further specify that in order to meet this objective and
measure, an
[[Page 54040]]
eligible hospital or CAH must use the capabilities and standards of
CEHRT at 45 CFR 170.314(e)(1).
To calculate the percentage of the first measure for providing
patients timely access to discharge information, CMS and ONC have
worked together to define the following for this objective:
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.
To calculate the percentage of the second measure for reporting on
the 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 (or their authorized representatives) who view,
download or transmit health information, CMS and ONC have worked
together to define the following for this objective:
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 unique patients (or their
authorized representatives) in the denominator who have viewed online,
downloaded, or transmitted to a third party the discharge information
provided by the eligible hospital or CAH.
Threshold: The resulting percentage must be more than 5
percent in order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH will be excluded
from the second measure if it is located in a county that does not have
50 percent or more of its housing units with 3Mbps broadband
availability according to the latest information available from the FCC
on the first day of 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.
Current medication list and medication history.
Current medication allergy list and medication allergy
history.
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.
As noted in the proposed rule, this is not intended to limit the
information made available by the hospital. A hospital can make
available additional information and still align with the objective.
Please note that while some of the information made available through
this measure is similar to the information made available in the
summary of care document that must be provided following transitions of
care or referrals, the list of information above is specific to the
view online, download, and transmit objective. Patients and providers
have different information needs and contexts, so CMS has established
separate required fields for each of these objectives.
Proposed Eligible Hospital/CAH Objective: Record whether a patient
65 years old or older has an advance directive.
In our proposed rule, we noted that the HIT Policy Committee
recommended making this a core objective and also requiring eligible
hospitals and CAHs to either store an electronic copy of the advance
directive in the CEHRT or link to an electronic copy of the advance
directive. However, we proposed to maintain this objective as part of
the menu set for Stage 2, and we did not propose the requirement of an
electronic copy or link to the advance directive. As we stated in our
Stage 1 final rule (75 FR 44345), we have continuing concerns that
there are potential conflicts between storing advance directives and
existing state laws. Also, we believe that because of state law
restrictions, an advance directive stored in an EHR may not be
actionable. Finally, we believe that eligible hospitals and CAHs may
have other methods of satisfying the intent of this objective at this
time, although we recognize that these workflows may change as EHR
technology develops and becomes more widely adopted. Therefore, we did
not propose to adopt the HIT Policy Committee's recommendations for
this objective.
The HIT Policy Committee has also recommended the inclusion of this
objective for EPs in Stage 2. In our Stage 1 final rule (75 FR 44345),
we indicated our belief that many EPs will not record this information
under current standards of practice and will only require information
about a patient's advance directive in rare circumstances. We continue
to believe this is the case and that creating a list of specialties or
types of EPs that will be excluded from the objective will be too
cumbersome and still might not be comprehensive. Therefore, we did not
propose the recording of the existence of advance directives as an
objective for EPs in Stage 2. However, we solicited public comment on
this decision and encouraged commenters to address specific concerns
regarding scope of practice and ease of compliance for EPs. And we note
that nothing in this rule compels the use of advance directives.
Comment: While some commenters supported the HIT Policy Committee's
recommendations, many recommended that we keep this measure as part of
the menu set. We received several comments about a link or copy of the
advance directives, and these commenters generally supported our
proposal of not including this as part of the objective.
Response: While we appreciate the commenters support and the
HITPC's reiteration of their recommendation, neither the HITPC nor
other commenters provided new information that would address our
concerns regarding conflicting state laws.
Comment: While most commenters agreed that this objective should
not be extended to EPs at this time, a select few suggested adding it
as part of the menu set.
Response: We are not extending this objective to EPs. Our belief
that many EPs would not record this information under current standards
of practice was supported by commenters. Also, we continue to believe
that creating a list of specialties or types of EPs that would be
excluded from the objective would be too cumbersome and would not be
comprehensive.
After consideration of public comments, we are finalizing this
objective for eligible hospitals and CAHs at Sec. 495.6(m)(1)(i) as
proposed.
Proposed Eligible Hospital/CAH Measure: More than 50 percent of all
unique patients 65 years old or older admitted to the eligible
hospital's or CAH's inpatient department (POS 21) during the EHR
reporting period have
[[Page 54041]]
an indication of an advance directive status recorded as structured
data.
In the proposed rule, we explained that the calculation of the
denominator for the measure of this objective is limited to unique
patients age 65 or older who are admitted to an eligible hospital's or
CAH's inpatient department (POS 21). Patients admitted to an emergency
department (POS 23) should not be included in the calculation. As we
discussed in our Stage 1 final rule (75 FR 44345), we believe that this
information is a level of detail that is not practical to collect on
every patient admitted to the eligible hospital's or CAH's emergency
department, and therefore, have limited this measure only to the
inpatient department of the hospital.
Comment: A commenter indicated that nearly 70 percent of hospitals
could meet this measure in Fall 2011.
Response: Data collected from Stage 1 attestations shows that less
than 15 percent of hospitals deferred this measure.
After consideration of public comments, we are finalizing this
measure for eligible hospitals and CAHs at Sec. 495.6(m)(1)(ii) as
proposed. We are maintaining the exclusion for any eligible hospital or
CAH that admits no patients age 65 years old or older during the EHR
reporting period.
We further specify that in order to meet this objective and
measure, an EP must use the capabilities and standards of CEHRT at 45
CFR 170.314(a)(17).
Denominator: Number of unique patients age 65 or older
admitted to an eligible hospital's or CAH's inpatient department (POS
21) during the EHR reporting period.
Numerator: The number of patients in the denominator who
have an indication of an advance directive status entered using
structured data.
Threshold: The resulting percentage must be more than 50
percent in order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH that admits no
patients age 65 years old or older during the EHR reporting period.
(f) HIT Policy Committee Recommended Objectives Discussed in the
Proposed Rule Without Proposed Regulation Text
We did not propose these objectives for Stage 2 as explained at
each objective, but we solicited comments on whether these objectives
should be incorporated into Stage 2.
Hospital Objective: Provide structured electronic lab results to
eligible professionals.
Although the HITPC recommended this as a core objective for Stage 2
for hospitals, we did not propose this objective for the following
reasons as explained in the proposed rule. Although hospital labs
supply nearly half of all lab results, they are not the predominant
vendors for providers who do not share or cannot access their
technology. Independent and office laboratories provide over half of
the labs in this market. We stated that we were concerned that imposing
this requirement on hospital labs would unfairly disadvantage them in
this market. Furthermore, not all hospitals offer these services so it
would create a natural disparity in meaningful use between those
hospitals offering these services and those that do not. Finally, all
other aspects of meaningful use in Stage 1 and Stage 2 focus on the
inpatient and emergency departments of a hospital. This objective is
not related to these departments, and in fact excludes services
provided in these departments. We asked for comments on both the pros
and cons of this objective and whether it should be considered for this
final rule as recommended by the HITPC.
Comment: Nearly all of the commenters that supported the inclusion
of this objective based their support wholly or in part on the concept
that the benefits of hospitals providing structured electronic lab
results outweigh the costs of doing so. They point to specific
benefits, such as making it more likely that EPs will be able to meet
the meaningful use measure of incorporating clinical lab-test results
into CEHRT as structured data, as well as more general benefits of
structured electronic results.
Response: The large number of commenters in support of this
objective and the associated benefits they identified make a compelling
case for inclusion. In particular, inclusion of this objective will
enable EPs to incorporate laboratory test results into the CEHRT as
structured data, which in turn adds to the ability of CEHRT to provide
CDS and to calculate clinical quality measures. In addition, this
objective will improve consistency in the market by incentivizing the
use of the uniform standard for laboratory exchange transactions
included in CEHRT as established in ONC's certification criteria at
(ONC reference once available). However, the benefits identified are
somewhat tempered by the makeup of the commenters supporting the
inclusion of this objective, who are usually those who stand to benefit
(EPs, patient advocates and others), whereas those who did not support
inclusion are usually those who would bear the burden (hospitals and
vendors). We summarize and respond to the comments in opposition later.
However, due to the strong disagreements among commenters about the
inclusion of this objective, and also concern for market impact
discussed in the comments later, we will include it in the menu set of
Stage 2 and not in the core set as recommended by the HITPC and
supported by some of the commenters.
Comment: Several commenters questioned the applicability of this
objective to meaningful use. Most stated that it was not applicable for
several reasons. First, commenters asserted it is beyond the statutory
authority of the Medicare EHR Incentive Program, which is established
in sections of the statute that govern payment for hospital inpatient
services, whereas laboratory services are paid under a different
payment system. Second, as meaningful use is currently constrained to
the inpatient and emergency departments, it would be inconsistent to
expand it to include lab results for patients that are not admitted to
either the inpatient or emergency department of the hospital. Third,
systems used by hospitals to process and send laboratory results are
not traditionally considered part of CEHRT, and including those systems
in CEHRT could have many unintended consequences and costs.
Response: We believe the statute supports a definition of
meaningful use that is not limited to actions taken within the
inpatient department of a hospital. The meaningful use incentive
payments and payment adjustments for Medicare eligible hospitals are
established in sections of the Act that are under the hospital
inpatient prospective payment system (IPPS) (sections 1886(n) and
1886(b)(3)(B)(ix) of the Act, respectively). However, the statutory
definition of a ``meaningful EHR user'' under section 1886(n)(3) of the
Act does not constrain the use of CEHRT to the inpatient department of
the hospital. The definition requires in part that an eligible hospital
must use CEHRT ``for the electronic exchange of health information to
improve the quality of health care, such as promoting care
coordination'' (section 1886(n)(3)(A)(ii)), which the objective of
providing structured electronic lab results to ambulatory providers
would support. Moreover, the majority of hospital objectives for Stages
1 and 2 of meaningful use take into account actions performed in the
emergency department as well as the inpatient department. In the Stage
1 final rule, we indicated that we may consider
[[Page 54042]]
applying the Stage 2 criteria more broadly to all hospital outpatient
settings beyond the emergency department (75 FR 44322). One of the
primary reasons not to include outpatient settings in meaningful use
for hospitals is the potential for overlap with settings where EPs
typically would use CEHRT. We believe there is minimal risk of such
overlap with this objective, as it involves a function that is
controlled by the hospital, and for which EPs are a recipient and not a
provider of information. In regards to the third reason identified by
commenters, CEHRT and meaningful use already include the ability to
report electronic lab results to public health agencies, so
consequences and costs of such inclusion should have already occurred.
The impact of including these systems in certification is addressed in
the ONC regulation published elsewhere in this issue of the Federal
Register.
Comment: A few commenters supported this objective because they
believe that hospital labs have lagged behind independent labs in
providing electronic results.
Response: We agree that hospital lab reporting should be included
as a menu set objective, but without actual data demonstrating lags by
hospitals in laboratory exchange with ambulatory providers, we do not
find this to be a compelling reason to include the objective as part of
the core set.
Comment: Commenters believed this objective is inappropriate
because the meaningful use regulations do not apply to commercial
clinical laboratories, leading to an adverse market impact for
hospitals in competition with others that process laboratory results
for physician offices. The operational impacts of this objective are
significant. In the absence of functional health information exchanges,
hospitals would need to create and maintain separate, system-to-system
interfaces with each physician office that receives laboratory results
electronically, at considerable cost and effort. The transition to
using standardized code sets in laboratories that must continue to
function is challenging and burdensome, particularly for small
hospitals.
Response: For these reasons, we include this objective and measure
in the menu set. Those hospitals that see competitive benefits in
providing electronic lab results to ambulatory providers may wish to
select this as a menu set objective. Those who believe that building
out the capability to provide electronic lab results is not beneficial
in their competitive market environments can defer the objective.
Similarly, those hospitals that consider the burden too high can defer
this objective.
After consideration of public comments, we are including this
objective in the menu set for eligible hospitals and CAHs at Sec.
495.6(m)(6)(i) as ``Provide structured electronic lab results to
ambulatory providers.''
For each objective, we outline the benefits expected from that
objective. We did not include these benefits in our proposed rule and
we are adding them to this final rule. Hospitals sending structured lab
results electronically to EPs using CEHRT and in accordance with
designated standards will directly enhance the ability of EPs to meet
meaningful use objectives, including incorporating laboratory test
results into the EHR as structured data, generating lists of patients
with particular conditions, utilizing clinical decision support, and
enhancing the ability to calculate clinical quality measures. The
addition of this objective will help improve consistency in the market,
in contrast to today's environment in which inconsistencies in
interface requirements are hindering the delivery of structured
hospital lab results to ambulatory EHRs. This objective will also
benefit hospitals by creating a uniform standard for laboratory
exchange transactions, which will eliminate variation, reducing
interface costs and time to deploy.
Hospital Measure: Hospital labs send (directly or indirectly)
structured electronic clinical lab results to the ordering provider for
more than 40 percent of electronic lab orders received.
The measure for this objective recommended by the HIT Policy
Committee is that 40 percent of clinical lab test results
electronically sent by an eligible hospital or CAH will need to be done
so using the capabilities CEHRT. This measure requires that in
situations where the electronic connectivity between an eligible
hospital or CAH and an EP is established, the results electronically
exchanged are done so using CEHRT. To facilitate the ease with which
this electronic exchange may take place, ONC proposed that for
certification, ambulatory EHR technology will need to be able to
incorporate lab test results formatted in the same standard and
implementation specifications to which inpatient EHR technology will
need to be certified as being able to create.
Comment: Some commenters who support this objective raised concerns
that small hospitals might not be able to comply due to the burden
involved and suggest an unspecified exclusion for them.
Response: By including this objective as a menu set item, those
hospitals that view lab reporting to ambulatory practices as too
burdensome can defer this measure.
Comment: Some commenters supporting the measure indicated that they
would like to see hospital reference labs that are already providing
electronic lab results to ordering providers ``grandfathered'' into the
measure.
Response: There are two reasons that a hospital providing
electronic lab results already would need special consideration. First,
they are not using the standards of CEHRT where available. Second, they
may not have gotten the system they use certified. As it is meaningful
use of CEHRT we do not believe that we should include exceptions to the
use of CEHRT in meaningful use. We do not believe that providers must
``rip and replace'' existing systems. Existing systems that support the
standards of CEHRT can be certified for inclusion and those that do not
support the standards can defer the objective until they upgrade to the
standards of CEHRT.
Comment: Commenters expressed concern that if the objective is
included in meaningful use that the threshold is unattainable. They
noted that for a hospital to send electronic lab results the EP must be
able to receive electronic results and that current adoption rates do
not indicate that 40 percent of EPs will be able to receive electronic
lab results.
Response: The measure uses a denominator of electronic lab orders
received so this consideration is already built into the measure.
However, we do agree with commenters that 40 percent is a high
threshold for this completely new measure as it is dependent on
electronic health exchange. For the final measure we reduce the
threshold to 20 percent. While we considered lowering the threshold to
10 percent, the denominator limitation that the lab order must be
received electronically already limits the measure to those ordering
providers capable of submitting electronic orders and implies at least
some electronic health information exchange has been established
between the hospital and the ordering provider.
After considering the comments, we are finalizing this measure for
eligible hospitals and CAHs at Sec. 495.6(m)(6)(ii) as ``Hospital labs
send structured electronic clinical lab results to the ordering
provider for more than 20 percent of electronic lab orders received.''
[[Page 54043]]
In order to be counted in the numerator, the hospital would need to
use CEHRT to send laboratory results to the ambulatory provider in a
way that has the potential for electronic incorporation of those
results as structure data. Methods that have no potential for automatic
incorporation such as ``portal view'' do not count in the numerator. 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 CEHRT at 45 CFR 170.314(b)(6).
Denominator: The number of electronic lab orders received.
Numerator: The number of structured clinical lab results
sent to the ordering provider.
Threshold: The resulting percentage must be greater than
20 percent.
EP Objective/Measure: Record patient preferences for communication
medium for more than 20 percent of all unique patients seen during the
EHR reporting period.
We proposed that this requirement is better incorporated with other
objectives that require patient communication and is not necessary as a
standalone objective.
Commenters were supportive of the incorporation of this objective
and we continue to believe that it is better incorporated; therefore,
we are finalizing this provision as proposed.
Objective/Measure: Record care plan goals and patient instructions
in the care plan for more than 10 percent of patients seen during the
reporting period.
We proposed that this requirement is better incorporated with other
objectives that require summary of care documents and is not necessary
as a standalone objective.
Commenters were supportive of the incorporation of this objective
as proposed and we continue to believe that it is better incorporated;
therefore, we are finalizing this provision as proposed.
Objective/Measure: Record health care team members (including at a
minimum PCP, if available) for more than 10 percent of all patients
seen during the reporting period; this information can be unstructured.
We proposed that this requirement is better incorporated with other
objectives that require summary of care documents and is not necessary
as a standalone objective.
Commenters were supportive of the incorporation of this objective
as proposed and we continue to believe that it is better incorporated;
therefore, we are finalizing as proposed.
Objective/Measure: Record electronic notes in patient records for
more than 30 percent of office visits.
In the proposed rule, we encouraged public comment regarding the
inclusion of this objective/measure. We noted that narrative entries
are considered an important component of patient records and complement
the structured data captured in CEHRT. We also noted our understanding
that electronic notes are already widely used by providers and
therefore may not need to include this as a meaningful use objective.
Comment: Commenters agreed that existing technology has the
capability to capture notes in an electronic form for inclusion in the
patient record. Other commenters mentioned that not all CEHRT in use
currently include the capability to incorporate narrative clinical
documentation.
Response: We reiterate the statement in the proposed rule regarding
the important contribution of narrative clinical documentation in the
patient record. In light of the comments that not all CEHRT currently
has the capability to incorporate this clinical documentation, we agree
to incorporate this functionality to record electronic notes as an
additional menu objective for Stage 2 of meaningful use. The ONC
standards and certification criteria final rule associated with this
objective/measure is published elsewhere in this issue of the Federal
Register. We believe that inclusion of electronic patient notes to the
meaningful use menu objectives is another incremental step towards
maximizing the potential of EHR technology.
Comment: The HIT Policy Committee commented that this objective/
measure should apply to both EPs, eligible hospitals and CAHs because
some certified EHRs do not have clinical documentation and because they
believe that a complete record (including progress notes) is required
to deliver high quality, efficient care.
Response: We agree and are adopting this objective in the menu set
for Stage 2 for EPs, eligible hospitals and CAHs in order to allow
providers access to the most accurate and complete patient information
available electronically to support quality of care efforts across
patient care settings.
Comment: A commenter suggested that if this objective/measure
becomes part of the final rule it will require a clear definition of
how notes are defined and who may create, edit and sign them in order
to be included in the measure numerator. Other commenters requested
clarification of the term electronic note and whether it would include
nursing notes, flow sheets, operative reports, discharge summaries,
consults, etc. in addition to basic progress notes.
Response: For this objective, we have determined that any EP as
defined for the Medicare or Medicaid EHR Incentive Programs, or an
authorized provider of the eligible hospital's or CAH's inpatient or
emergency departments (POS 21 or 23) may author, edit, and provide an
electronic signature for the electronic notes in order for them to be
considered for this measure. We further define electronic notes as
electronic progress notes for the purpose of this measure. We will rely
on providers own determinations and guidelines defining when progress
notes are necessary to communicate individual patient circumstances and
for coordination with previous documentation of patient observations,
treatments and/or results in the electronic health record.
Comment: Many commenters agreed with the inclusion of the text
searchable certification requirement and agreed that portions of
clinical notes are already being collected electronically. The HIT
Policy Committee recommended inclusion of this measure because some
certified EHRs do not have clinical documentation, and believe that the
benefit of a complete patient record, including progress notes, is
required to deliver high quality, efficient care. Several commenters
were opposed to the inclusion of this additional measure in order to
limit the number of reporting objectives.
Response: Based on the multiple reasons stated in this preamble we
agree with the benefits of including the electronic progress notes
measure in the menu set for the Stage 2 meaningful use objectives. We
envision continued technological advances in the capture and processing
of text and diagrammatic data such as research of natural language
processing. We also believe there is added value in collecting both
narrative data and structured data in the EHR and using that
information to track key clinical conditions and communicating that
information for care coordination purposes. Therefore, we are including
this objective/measure to record electronic notes in the patient
records for more than 30 percent of office visits or unique patients
admitted to an eligible hospital's or CAH's inpatient or emergency
department (POS 21 or 23) as was originally recommended by the HITPC.
After consideration of public comments, we are finalizing this
objective for EPs at Sec. 495.6 (k)(6)(i) and for eligible hospitals
and CAHs at Sec. 495.6(m)(5)(i) as ``Record electronic notes in
patient records.''
[[Page 54044]]
We are adding the measure for EPs at Sec. 495.6(k)(6)(ii) and for
eligible hospitals and CAHs at Sec. 495.6(m)(5)(ii) of our regulations
to include this new measure:
EP Menu Measure: Enter at least one electronic progress note
created, edited and signed by an EP for more than 30 percent of unique
patients with at least one office visit during the EHR reporting
period. Electronic progress notes must be text-searchable. Non-
searchable notes do not qualify, but this does not mean that all of the
content has to be character text. Drawings and other content can be
included with searchable text notes under this measure.
Eligible Hospital/CAH Menu Measure: Enter at least one electronic
progress note created, edited and signed by an authorized provider of
the eligible hospital's or CAH's inpatient or emergency department (POS
21 or 23) for more than 30 percent of unique patients admitted to the
eligible hospital or CAH's inpatient or emergency department during the
EHR reporting period. Electronic progress notes must be text-
searchable. Non-searchable notes do not qualify, but this does not mean
that all of the content has to be character text. Drawings and other
content can be included with searchable text notes under this measure.
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 CEHRT at 45 CFR 170.314(a)(9).
To calculate the percentage, CMS and ONC have worked together to
define the following for these measures:
Denominator: Number of unique patients with at least one
office visit during the EHR reporting period for EPs or admitted to an
eligible hospital or CAH's inpatient or emergency department (POS 21 or
23) during the EHR reporting period.
Numerator: The number of unique patients in the
denominator who have at least one electronic progress note from an
eligible professional or authorized provider of the eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) recorded as
text-searchable data.
Threshold: The resulting percentage must be more than 30
percent in order for an EP, eligible hospital or CAH to meet this
measure.
Table B5--Stage 2 Objectives and Measures
----------------------------------------------------------------------------------------------------------------
Stage 2 objectives
--------------------------------------------------
Health outcomes policy priority Eligible hospitals and Stage 2 measures
Eligible professionals CAHs
----------------------------------------------------------------------------------------------------------------
CORE SET
----------------------------------------------------------------------------------------------------------------
Improving quality, safety, Use computerized Use computerized More than 60 percent of
efficiency, and reducing health provider order entry provider order entry medication, 30 percent
disparities. (CPOE) for medication, (CPOE) for medication, of laboratory, and 30
laboratory and laboratory and percent of radiology
radiology orders radiology orders orders created by the
directly entered by directly entered by EP or authorized
any licensed any licensed providers of the
healthcare healthcare eligible hospital's or
professional who can professional who can CAH's inpatient or
enter orders into the enter orders into the emergency department
medical record per medical record per (POS 21 or 23) during
state, local and state, local and the EHR reporting
professional professional period are recorded
guidelines. guidelines. using CPOE.
Generate and transmit ....................... More than 50 percent of
permissible all permissible
prescriptions prescriptions, or all
electronically (eRx). prescriptions written
by the EP and queried
for a drug formulary
and transmitted
electronically using
CEHRT.
Record the following Record the following More than 80 percent of
demographics: demographics: all unique patients
Preferred Preferred seen by the EP or
language. language. admitted to the
Sex........... Sex........... eligible hospital's or
Race.......... Race.......... CAH's inpatient or
Ethnicity..... Ethnicity..... emergency department
Date of birth. Date of birth. (POS 21 or 23) during
Date and the EHR reporting
preliminary cause of period have
death in the event of demographics recorded
mortality in the as structured data.
eligible hospital or
CAH..
Record and chart Record and chart More than 80 percent of
changes in vital changes in vital all unique patients
signs: signs: seen by the EP or
Height/length. Height/length. admitted to the
Weight........ Weight........ eligible hospital's or
Blood pressure Blood pressure CAH's inpatient or
(age 3 and over). (age 3 and over). emergency department
Calculate and Calculate and (POS 21 or 23) during
display BMI. display BMI. the EHR reporting
Plot and Plot and period have blood
display growth charts display growth charts pressure (for patients
for patients 0-20 for patients 0-20 age 3 and over only)
years, including BMI. years, including BMI. and height/length and
weight (for all ages)
recorded as structured
data.
[[Page 54045]]
Record smoking status Record smoking status More than 80 percent of
for patients 13 years for patients 13 years all unique patients 13
old or older. old or older. years old or older
seen by the EP or
admitted to the
eligible hospital's or
CAH's inpatient or
emergency departments
(POS 21 or 23) during
the EHR reporting
period have smoking
status recorded as
structured data.
Use clinical decision Use clinical decision 1. Implement five
support to improve support to improve clinical decision
performance on high- performance on high- support interventions
priority health priority health related to four or
conditions. conditions. 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. It is
suggested that one of
the five clinical
decision support
interventions be
related to improving
healthcare efficiency.
2. The EP, eligible
hospital, or CAH has
enabled and
implemented the
functionality for drug
and drug allergy
interaction checks for
the entire EHR
reporting period.
Incorporate clinical Incorporate clinical More than 55 percent of
lab-test results into lab-test results into all clinical lab tests
Certified EHR Certified EHR results ordered by the
Technology as Technology as EP or by authorized
structured data. structured data. providers of the
eligible hospital or
CAH for patients
admitted to its
inpatient or emergency
department (POS 21 or
23) during the EHR
reporting period whose
results are either in
a positive/negative
affirmation or
numerical format are
incorporated in
Certified EHR
Technology as
structured data.
Generate lists of Generate lists of Generate at least one
patients by specific patients by specific report listing
conditions to use for conditions to use for patients of the EP,
quality improvement, quality improvement, eligible hospital or
reduction of reduction of CAH with a specific
disparities, research, disparities, research, condition.
or outreach or outreach.
Use clinically relevant ....................... More than 10 percent of
information to all unique patients
identify patients who who have had two or
should receive more office visits
reminders for with the EP within the
preventive/follow-up 24 months before the
care and send these beginning of the EHR
patients the reminder, reporting period were
per patient preference. sent a reminder, per
patient preference
when available.
Automatically track More than 10 percent of
medications from order medication orders
to administration created by authorized
using assistive providers of the
technologies in eligible hospital's or
conjunction with an CAH's inpatient or
electronic medication emergency department
administration record (POS 21 or 23) during
(eMAR). the EHR reporting
period for which all
doses are tracked
using eMAR.
[[Page 54046]]
Engage patients and families in their Provide patients the ....................... 1. More than 50 percent
health care. ability to view of all unique patients
online, download, and seen by the EP during
transmit their health the EHR reporting
information within 4 period are provided
business days of the timely (within 4
information being business days after
available to the EP. the information is
available to the EP)
online access to their
health information
subject to the EP's
discretion to withhold
certain information.
2. More than 5 percent
of all unique patients
seen by the EP during
the EHR reporting
period (or their
authorized
representatives) view,
download, or transmit
to a third party their
health information.
Provide patients the 1. More than 50 percent
ability to view of all patients who
online, download, and are discharged from
transmit information the inpatient or
about a hospital emergency department
admission. (POS 21 or 23) of an
eligible hospital or
CAH have their
information available
online within 36 hours
of discharge.
2. More than 5 percent
of all patients (or
their authorized
representatives) who
are discharged from
the inpatient or
emergency department
(POS 21 or 23) of an
eligible hospital or
CAH view, download or
transmit to a third
party their
information during the
reporting period.
Provide clinical ....................... Clinical summaries
summaries for patients provided to patients
for each office visit. or
patient[dash]authorize
d representatives
within 1 business day
for more than 50
percent of office
visits.
Use Certified EHR Use Certified EHR Patient-specific
Technology to identify Technology to identify education resources
patient-specific patient-specific identified by CEHRT
education resources education resources are provided to
and provide those and provide those patients for more than
resources to the resources to the 10 percent of all
patient. patient. unique patients with
office visits seen by
the EP during the EHR
reporting period.
More than 10 percent of
all unique patients
admitted to the
eligible hospital's or
CAH's inpatient or
emergency departments
(POS 21 or 23) are
provided patient-
specific education
resources identified
by Certified EHR
Technology.
Use secure electronic ....................... A secure message was
messaging to sent using the
communicate with electronic messaging
patients on relevant function of Certified
health information. EHR Technology by more
than 5 percent of
unique patients (or
their authorized
representatives) seen
by the EP during the
EHR reporting period.
[[Page 54047]]
Improve care coordination............ The EP who receives a The eligible hospital The EP, eligible
patient from another or CAH who receives a hospital or CAH
setting of care or patient from another performs medication
provider of care or setting of care or reconciliation for
believes an encounter provider of care or more than 50 percent
is relevant should believes an encounter of transitions of care
perform medication is relevant should in which the patient
reconciliation. perform medication is transitioned into
reconciliation. the care of the EP or
admitted to the
eligible hospital's or
CAH's inpatient or
emergency department
(POS 21 or 23).
The EP who transitions The eligible hospital 1. The EP, eligible
their patient to or CAH who transitions hospital, or CAH that
another setting of their patient to transitions or refers
care or provider of another setting of their patient to
care or refers their care or provider of another setting of
patient to another care or refers their care or provider of
provider of care patient to another care provides a
provides a summary provider of care summary of care record
care record for each provides a summary for more than 50
transition of care or care record for each percent of transitions
referral. transition of care or of care and referrals.
referral. 2. The EP, eligible
hospital or CAH that
transitions or refers
their patient to
another setting of
care or provider of
care provides a
summary of care record
for more than 10% of
such transitions and
referrals either--(a)
electronically
transmitted using
CEHRT to a recipient
or (b) where the
recipient receives the
summary of care record
via exchange
facilitated by an
organization that is a
NwHIN Exchange
participant or in a
manner that is
consistent with the
governance mechanism
ONC establishes for
the nationwide health
information network.
3. An EP, eligible
hospital or CAH must
satisfy one of the two
following criteria:
(A) Conducts one or
more successful
electronic exchanges
of a summary of care
document, as part of
which is counted in
``measure 2'' (for EPs
the measure at Sec.
495.6(j)(14)(ii)(B)
and for eligible
hospitals and CAHs the
measure at Sec.
495.6(l)(11)(ii)(B))
with a recipient who
has EHR technology
that was developed
designed by a
different EHR
technology developer
than the sender's EHR
technology certified
to 45 CFR
170.314(b)(2); or
(B) Conducts one or
more successful tests
with the CMS
designated test EHR
during the EHR
reporting period.
Improve population and public health. Capability to submit Capability to submit Successful ongoing
electronic data to electronic data to submission of
immunization immunization electronic
registries or registries or immunization data from
immunization immunization Certified EHR
information systems information systems Technology to an
except where except where immunization registry
prohibited, and in prohibited, and in or immunization
accordance with accordance with information system for
applicable law and applicable law and the entire EHR
practice. practice. reporting period.
[[Page 54048]]
Capability to submit Successful ongoing
electronic reportable submission of
laboratory results to electronic reportable
public health laboratory results
agencies, except where from Certified EHR
prohibited, and in Technology to public
accordance with health agencies for
applicable law and the entire EHR
practice. reporting period.
Capability to submit Successful ongoing
electronic syndromic submission of
surveillance data to electronic syndromic
public health surveillance data from
agencies, except where Certified EHR
prohibited, and in Technology to a public
accordance with health agency for the
applicable law and entire EHR reporting
practice. period.
Ensure adequate privacy and security Protect electronic Protect electronic Conduct or review a
protections for personal health health information health information security risk analysis
information. created or maintained created or maintained in accordance with the
by the Certified EHR by the Certified EHR requirements under 45
Technology through the Technology through the CFR 164.308(a)(1),
implementation of implementation of including addressing
appropriate technical appropriate technical the encryption/
capabilities. capabilities. security of data
stored in CEHRT in
accordance with
requirements under 45
CFR 164.312(a)(2)(iv)
and 45 CFR
164.306(d)(3), and
implement security
updates as necessary
and correct identified
security deficiencies
as part of the
provider's risk
management process.
----------------------------------------------------------------------------------------------------------------
MENU SET
----------------------------------------------------------------------------------------------------------------
Improving quality, safety, ....................... Record whether a More than 50 percent of
efficiency, and reducing health patient 65 years old all unique patients 65
disparities. or older has an years old or older
advance directive. admitted to the
eligible hospital's or
CAH's inpatient
department (POS 21)
during the EHR
reporting period have
an indication of an
advance directive
status recorded as
structured data.
Imaging results Imaging results More than 10 percent of
consisting of the consisting of the all tests whose result
image itself and any image itself and any is one or more images
explanation or other explanation or other ordered by the EP or
accompanying accompanying by an authorized
information are information are provider of the
accessible through accessible through eligible hospital or
Certified EHR Certified EHR CAH for patients
Technology. Technology. admitted to its
inpatient or emergency
department (POS 21 and
23) during the EHR
reporting period are
accessible through
Certified EHR
Technology.
Record patient family Record patient family More than 20 percent of
health history as health history as all unique patients
structured data. structured data. seen by the EP or
admitted to the
eligible hospital or
CAH's inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period have a
structured data entry
for one or more first-
degree relatives.
Generate and transmit More than 10 percent of
permissible discharge hospital discharge
prescriptions medication orders for
electronically (eRx). permissible
prescriptions (for
new, changed, and
refilled
prescriptions) are
queried for a drug
formulary and
transmitted
electronically using
Certified EHR
Technology.
[[Page 54049]]
Record electronic notes Record electronic notes Enter at least one
in patient records. in patient records. electronic progress
note created, edited
and signed by an
eligible professional
for more than 30
percent of unique
patients with at least
one office visit
during the EHR
reporting period.
Enter at least one
electronic progress
note created, edited
and signed by an
authorized provider of
the eligible
hospital's or CAH's
inpatient or emergency
department (POS 21 or
23) for more than 30
percent of unique
patients admitted to
the eligible hospital
or CAH's inpatient or
emergency department
during the EHR
reporting period.
Electronic progress
notes must be text-
searchable. Non-
searchable notes do
not qualify, but this
does not mean that all
of the content has to
be character text.
Drawings and other
content can be
included with
searchable text notes
under this measure.
Provide structured Hospital labs send
electronic lab results structured electronic
to ambulatory clinical lab results
providers. to the ordering
provider for more than
20 percent of
electronic lab orders
received.
Improve Population and Public Health. Capability to submit ....................... Successful ongoing
electronic syndromic submission of
surveillance data to electronic syndromic
public health surveillance data from
agencies, except where Certified EHR
prohibited, and in Technology to a public
accordance with health agency for the
applicable law and entire EHR reporting
practice. period.
Capability to identify ....................... Successful ongoing
and report cancer submission of cancer
cases to a public case information from
health central cancer CEHRT to a public
registry, except where health central cancer
prohibited, and in registry for the
accordance with entire EHR reporting
applicable law and period.
practice.
Capability to identify ....................... Successful ongoing
and report specific submission of specific
cases to a specialized case information from
registry (other than a Certified EHR
cancer registry), Technology to a
except where specialized registry
prohibited, and in for the entire EHR
accordance with reporting period.
applicable law and
practice.
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B. Reporting on Clinical Quality Measures Using Certified EHR
Technology by Eligible Professionals, Eligible Hospitals, and Critical
Access Hospitals
The following sections address CQMs reporting requirements using
CEHRT. These include: EHR technology certification requirements;
criteria for CQM selection; time periods for reporting CQMs; issues
related to specifications for CQMs and transmission formats; reporting
options and CQMs for EPs; reporting methods for EPs; reporting options
and CQMs for eligible hospitals and CAHs; and reporting methods for
eligible hospitals and CAHs.
1. Time Periods for Reporting CQMs
This section addresses the reporting periods and submission periods
as they relate to reporting CQMs only. For a summary of the reporting
and submission periods proposed for CQMs, please refer to Table 5 in
the Stage 2 proposed rule (77 FR 13742).
We proposed that the reporting period for CQMs, which is the period
during which data collection or measurement for CQMs occurs, would
continue to track with the EHR reporting periods for the meaningful use
objectives and measures:
EPs: January 1 through December 31 (calendar year).
Eligible Hospitals and CAHs: October 1 through September
30 (federal fiscal year).
EPs, eligible hospitals, and CAHs in their first year of
meaningful use for Stage 1, any continuous 90-day period within the
calendar year (CY) or federal fiscal year (FY), respectively.
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To avoid a payment adjustment, Medicare EPs and eligible hospitals
that are in their first year of demonstrating meaningful use in the
year immediately preceding any payment adjustment year would have to
ensure that their 90-day EHR reporting period ends at least 3 months
before the end of the CY or FY, and that all submission is completed by
October 1 or July 1, respectively. For more information on payment
adjustments, see section II.D. of this final rule.
The submission period is the time during which EPs, eligible
hospitals, and CAHs may submit CQM information. We proposed the
submission period for CQM data generally would be the 2 months
immediately following the end of the EHR reporting period as follows:
EPs: January 1 through February 28.