```

[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Rules and Regulations]
[Pages 52909-52933]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21021]

[[Page 52909]]

Vol. 79

Thursday,

No. 171

September 4, 2014

Part III

Department of Health and Human Services

-----------------------------------------------------------------------

 Centers for Medicare & Medicaid Services

-----------------------------------------------------------------------

42 CFR Part 495

45 CFR Part 170

Medicare and Medicaid Programs; Modifications to the Medicare and 
Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and 
Other Changes to the EHR Incentive Program; and Health Information 
Technology: Revisions to the Certified EHR Technology Definition and 
EHR Certification Changes Related to Standards; Final Rule

Federal Register / Vol. 79 , No. 171 / Thursday, September 4, 2014 / 
Rules and Regulations

[[Page 52910]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 495

[CMS-0046-F and CMS-0052-F]
RINs 0938-AR71 and 0938-AS30

Office of the Secretary

45 CFR Part 170

RINs 0991-AB89 and 0991-AB97

Medicare and Medicaid Programs; Modifications to the Medicare and 
Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and 
Other Changes to the EHR Incentive Program; and Health Information 
Technology: Revisions to the Certified EHR Technology Definition and 
EHR Certification Changes Related to Standards

ACTION: Final rule.

-----------------------------------------------------------------------

AGENCY: Centers for Medicare & Medicaid Services (CMS), and Office of 
the National Coordinator for Health Information Technology (ONC), HHS.

SUMMARY: This final rule changes the meaningful use stage timeline and 
the definition of certified electronic health record technology (CEHRT) 
to allow options in the use of CEHRT for the EHR reporting period in 
2014. It also sets the requirements for reporting on meaningful use 
objectives and measures as well as clinical quality measure (CQM) 
reporting in 2014 for providers who use one of the CEHRT options 
finalized in this rule for their EHR reporting period in 2014. In 
addition, it finalizes revisions to the Medicare and Medicaid EHR 
Incentive Programs to adopt an alternate measure for the Stage 2 
meaningful use objective for hospitals to provide structured electronic 
laboratory results to ambulatory providers; to correct the regulation 
text for the measures associated with the objective for hospitals to 
provide patients the ability to view online, download, and transmit 
information about a hospital admission; and to set a case number 
threshold exemption for CQM reporting applicable for eligible hospitals 
and critical access hospitals (CAHs) beginning with FY 2013. Finally, 
this rule finalizes the provisionally adopted replacement of the Data 
Element Catalog (DEC) and the Quality Reporting Document Architecture 
(QRDA) Category III standards with updated versions of these standards.

DATES: These regulations are effective on October 1, 2014.

FOR FURTHER INFORMATION CONTACT:
Elizabeth Holland, (410) 786-1309.
Elisabeth Myers, (410) 786-4751.
Elise Sweeney Anthony, (202) 475-2485.

SUPPLEMENTARY INFORMATION:

I. Background

A. Statutory Basis

1. Standards, Implementation Specifications, and Certification Criteria
    The Health Information Technology for Economic and Clinical Health 
(HITECH) Act, Title XIII of Division A and Title IV of Division B of 
the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-
5) was enacted on February 17, 2009. The HITECH Act amended the Public 
Health Service Act (PHSA) and created ``Title XXX--Health Information 
Technology and Quality'' to improve health care quality, safety, and 
efficiency through the promotion of health IT and electronic health 
information exchange.
    Section 3004(b)(3) of the PHSA titled ``Subsequent Standards 
Activity'' provides that the ``Secretary shall adopt additional 
standards, implementation specifications, and certification criteria as 
necessary and consistent'' with the schedule published by the HIT 
Standards Committee. We consider this provision in the broader context 
of the HITECH Act to grant the Secretary the authority and discretion 
to adopt standards, implementation specifications, and certification 
criteria that have been recommended by the HIT Standards Committee and 
endorsed by the National Coordinator, as well as other appropriate and 
necessary health IT standards, implementation specifications, and 
certification criteria.
    In the September 4, 2012 Federal Register (77 FR 54163), the 
Secretary issued a final rule (the ``2014 Edition EHR certification 
criteria final rule'') that adopted the 2014 Edition EHR certification 
criteria and a revised Certified EHR Technology (CEHRT) definition. The 
standards, implementation specifications, and certification criteria 
adopted by the Secretary in the final rule established the capabilities 
that CEHRT must include in order to, at a minimum, support the 
achievement of meaningful use by eligible professionals (EPs), eligible 
hospitals, and CAHs under the Medicare and Medicaid EHR Incentive 
Programs beginning with the EHR reporting periods in FY/CY 2014.
2. Health IT Certification Programs
    Section 3001(c)(5) of the PHSA provides the National Coordinator 
with the authority to establish a certification program or programs for 
the voluntary certification of health IT. Specifically, section 
3001(c)(5)(A) specifies that the ``National Coordinator, in 
consultation with the Director of the National Institute of Standards 
and Technology, shall keep or recognize a program or programs for the 
voluntary certification of health information technology as being in 
compliance with applicable certification criteria adopted under this 
subtitle'' (that is, certification criteria adopted by the Secretary 
under section 3004 of the PHSA). The certification program(s) must also 
``include, as appropriate, testing of the technology in accordance with 
section 13201(b) of the [HITECH] Act.''
    Section 13201(b) of the HITECH Act requires that with respect to 
the development of standards and implementation specifications, the 
Director of the National Institute of Standards and Technology (NIST), 
in coordination with the HIT Standards Committee, ``shall support the 
establishment of a conformance testing infrastructure, including the 
development of technical test beds.'' The HITECH Act also indicates 
that ``[t]he development of this conformance testing infrastructure may 
include a program to accredit independent, non-Federal laboratories to 
perform testing.'' ONC has established the ONC HIT Certification 
Program for the purpose of testing and certifying health information 
technology, related to the compliance of health IT with adopted 
standards, implementation, and certification criteria. (see 76 FR 1262 
and 77 FR 54268). EHR technology capabilities certified through the ONC 
HIT Certification Program are required for use with the EHR Incentive 
Programs (see 76 FR 1262).
3. Medicare and Medicaid EHR Incentive Programs
    The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5) amended Titles XVIII and XIX of the Social Security Act (the 
Act) to authorize incentive payments to EPs, eligible hospitals, CAHs, 
and Medicare Advantage (MA) organizations to promote the adoption and 
meaningful use of certified electronic health record (EHR) technology. 
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act 
provide the statutory basis for the Medicare incentive payments made to 
meaningful EHR users. These statutory provisions govern EPs, MA

[[Page 52911]]

organizations (for certain qualifying EPs and hospitals that 
meaningfully use CEHRT, subsection (d) hospitals, and CAHs, 
respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 
1814(l) of the Act also establish downward payment adjustments, 
beginning with calendar or fiscal year 2015, for EPs, MA organizations, 
subsection (d) hospitals, and CAHs that are not meaningful users of 
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) 
and 1903(t) of the Act provide the statutory basis for Medicaid 
incentive payments.

II. Provisions of the December 7, 2012 Interim Final Rule With Comment 
Period and Analysis of and Responses to Public Comments

    In the December 7, 2012 Federal Register (77 FR 72985), CMS and ONC 
jointly published an interim final rule with comment period (IFC) 
titled ``Health Information Technology: Revisions to the 2014 Edition 
Electronic Health Record Certification Criteria; and Medicare and 
Medicaid Programs; Revisions to the Electronic Health Record Incentive 
Program'' (the ``December 7, 2012 IFC''). The Department of Health and 
Human Services (HHS) issued the December 7, 2012 IFC to replace the 
Data Element Catalog (DEC) standard and the Quality Reporting Document 
Architecture (QRDA) Category III standard adopted in the final rule 
published on September 4, 2012 in the Federal Register with updated 
versions of those standards. The December 7, 2012 IFC also revised the 
Medicare and Medicaid EHR Incentive Programs by: adding an alternative 
measure for the Stage 2 meaningful use objective for hospitals to 
provide structured electronic laboratory results to ambulatory 
providers; correcting the regulation text for the measures associated 
with the objective for hospitals to provide patients the ability to 
view online, download, and transmit information about a hospital 
admission; and making the case number threshold exemption for CQM 
reporting applicable for eligible hospitals and CAHs beginning with FY 
2013. This December 7, 2012 IFC also provided notice of CMS's intention 
to issue technical corrections to the electronic specifications for 
CQMs released on October 25, 2012.
    In this final rule, we discuss the provisions of the December 7, 
2012 IFC and describe our final policy. No comments within the scope of 
the IFC were timely received. However, we received some comments 
outside the scope of the December 7, 2012 IFC which provided 
recommendations for potential standards and policies to adopt in 
rulemaking for future stages of meaningful use. We are not addressing 
these comments in this rule. However, we will retain these comments for 
consideration in future rulemaking for the EHR Incentive Programs.

A. Adoption and Incorporation by Reference of Newer Versions of the DEC 
and QRDA III Standards

    In the 2014 Edition EHR certification criteria final rule (77 FR 
54163), we adopted the Data Element Catalog (DEC), August 2012 version, 
standard at 45 CFR 170.204(c) and incorporated the standard by 
reference at 45 CFR 170.299(m)(5). The DEC is included in the 
certification criterion at 45 CFR 170.314(c)(1), which requires EHR 
technology presented for certification to be able to electronically 
record all of the data identified in the DEC that would be necessary to 
calculate each CQM.
    Prior to the December 7, 2012 IFC (77 FR 72987), we performed a gap 
analysis to determine whether the August 2012 version of DEC (now 
referred to as ``DEC version 1.0'') still appropriately specified all 
of the data that EHR technology would need to capture to support the 
final 2014 CQM e-specifications. Based on that analysis, we determined 
that the version of the DEC we adopted in the final rule needed to be 
updated in order to correctly align with data capture expectations 
expressed by numerous 2014 CQM e-specifications. Therefore, we 
provisionally adopted replacing Version 1.0 of the DEC incorporated by 
reference at 45 CFR 170.299(m)(5) with the updated version (DEC, 
Version 1.1 (October 2012)) as the standard referenced by the 2014 
Edition EHR certification criterion at 45 CFR 170.314(c)(1).
    We also replaced the version of the Quality Reporting Document 
Architecture (QRDA) Category III (QRDA III) standard incorporated by 
reference at 45 CFR 170.299(f)(14) with the November 2012 balloted 
version of QRDA III as the standard referenced by the 2014 Edition EHR 
certification criterion at 45 CFR 170.314(c)(3). The November 2012 
balloted version of QRDA III clarifies ambiguities in the August 
version we had previously adopted in the 2014 Edition EHR certification 
criteria final rule (77 FR 54232); specifically, certain data that 
would need to be included in any QRDA III file submitted to CMS, such 
as a provider's National Provider Identifier (NPI) or Taxpayer 
Identification Number (TIN) in order for the electronic submission to 
be properly processed. Additionally, some of the required components 
have been changed to optional in the November 2012 balloted version of 
the standard, which may reduce the burden for EHR technology 
developers.
    While ONC is not required by statute to publish a final rule based 
on the previous publication of an interim final rule, we are using this 
joint rulemaking as an opportunity to respond to comments received on 
the December 7, 2012 IFC provisions concerning 45 CFR 170.299.
    We received no comments on the provisions concerning the DEC and 
QRDA III standards. For the reasons stated in the December 7, 2012 IFC, 
we are finalizing these provisions without modification.

B. Revisions to the Medicare and Medicaid EHR Incentive Programs

1. Meaningful Use Criteria
a. Stage 2 Hospital Objective for Providing Electronic Lab Results to 
Ambulatory Providers
    In the Stage2 final rule (77 FR 54041 through 54043), we included 
an objective and measure in the Stage 2 menu set for eligible hospitals 
and CAHs at 42 CFR 495.6(m)(6)(i) and (ii) to provide structured 
electronic lab results to ambulatory providers for more than 20 percent 
of electronic lab orders received.
    In the December 7, 2012 IFC we added an alternative measure 
allowing a method for calculating the denominator using all lab orders 
received rather than only those received electronically. This change 
was provisionally adopted to accommodate cases where hospitals send a 
large number of lab results electronically in response to orders they 
receive through non-electronic means or where a hospital receives a 
very small percentage of its total lab orders electronically and 
therefore could have difficulty meeting the measure threshold 
regardless of the number of lab results it sends electronically to 
ordering providers.
    We received no comments on this provision and are finalizing this 
provision without modification for the reasons previously stated.
b. Stages 1 and 2 Hospital Objective for View, Download, and Transmit
    In the Stage 2 final rule (77 FR 54041 through 54043), we included 
the following objective in the Stage 2 core set for eligible hospitals 
and CAHs at 42 CFR 495.6(l)(8)(i) and (ii). We also included the 
objective in the Stage 1 core set for eligible hospitals and CAHs at 42 
CFR 495.6(f)(12)(i)(B) and (ii)(B).

[[Page 52912]]

    Objective: Provide patients the ability to view online, download, 
and transmit information about a hospital admission.
    In the Stage 2 final rule (77 FR 53968), we inadvertently omitted 
the word ``unique'' from the regulation text for the denominators of 
the measures associated with this objective.
    In the December 7, 2012 IFC we made corrections to Sec.  
495.6(f)(12)(ii)(B), (l)(8)(ii)(A), and (l)(8)(ii)(B) to clarify that 
the measures for that objective for eligible hospitals and CAHs are 
based on the number of unique patients discharged from a hospital's 
inpatient or emergency department during the EHR reporting period.
    We received no comments on this provision and are finalizing this 
provision without modification for the reasons previously stated.
2. Case Number Threshold Exemption for CQM Reporting for Hospitals
    In the Stage 2 proposed rule, we solicited comments on whether a 
case number threshold would be appropriate for hospital CQM reporting, 
given the apparent burden on hospitals that very seldom have the types 
of cases addressed by certain measures. As we stated in the Stage 2 
final rule (77 FR 54080), many commenters noted that the implementation 
of a case number threshold for hospital CQM reporting would help reduce 
the burden placed on hospitals that very seldom have cases that would 
be counted in the denominator of certain CQMs.
    In the December 7, 2012 IFC we provisionally adopted a case 
threshold exemption applicable for eligible hospitals and CAHs in all 
stages of meaningful use beginning with FY 2013. Eligible hospitals and 
CAHs that demonstrate meaningful use for the first time and submit 
their CQMs using attestation would be able to qualify for the 
exemption. Eligible hospitals and CAHs with 5 or fewer discharges 
during the relevant EHR reporting period (if attesting to a 90-day EHR 
reporting period), or 20 or fewer discharges during the year (if 
attesting to a full year EHR reporting period) as defined by the CQM's 
denominator population could claim an exemption for that CQM.
    To be eligible for the exemption, Medicare-eligible hospitals and 
CAHs must use the same process outlined in the Stage 2 final rule (see 
77 FR 54080). This process includes submitting aggregate population and 
sample size counts for Medicare and non-Medicare discharges as defined 
by the CQM's denominator population for the EHR reporting period no 
later than November 30 after the end of the fiscal year containing the 
EHR reporting period (for example, November 30, 2013 for the hospital's 
EHR reporting period that occurs in FY 2013). Medicaid-only hospitals, 
including children's hospitals, must report this same information to 
the state to which they attest, in a manner specified by that state.
    We received no comments on this provision and we are finalizing 
this provision without modification for the reasons previously stated.
3. Technical Corrections to CQM Electronic Specifications
    In the interim final rule with comment period, we announced our 
intent to issue technical corrections to the electronic specifications 
for the 2014 CQMs on or around December 21, 2012.
    We received no comments on this provision and we are finalizing 
this provision without modification for the reasons previously stated.

III. Provisions of the May 23, 2014 Proposed Rule and Analysis of and 
Responses to Public Comments

    In the May 23, 2014 Federal Register (79 FR 29732), we published a 
proposed rule titled ``Medicare and Medicaid Programs; Modifications to 
the Medicare and Medicaid Electronic Health Record Incentive Programs 
for 2014; and Health Information Technology: Revisions to the Certified 
EHR Technology Definition.'' In this final rule, we discuss the 
provisions of that proposed rule, summarize and respond to the public 
comments timely received, and describe our final policy.
    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 Medicaid providers adopt, implement, upgrade, or meaningfully 
use CEHRT if they are to receive incentives under Title XIX of the Act. 
CEHRT used in a meaningful way is one piece of the broader health 
information technology 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.
    Certified EHR technology is defined for the Medicare and Medicaid 
EHR Incentive Programs at 42 CFR 495.4, which references the Office of 
the National Coordinator for Health Information Technology's (ONC) 
definition of CEHRT under 45 CFR 170.102. For Stages 1 and 2 of 
meaningful use, CMS and ONC worked closely to ensure that the 
definition of meaningful use of CEHRT and the standards and 
certification criteria for CEHRT were coordinated. The definition of 
CEHRT under 45 CFR 170.102 requires, beginning with Federal fiscal year 
(FY) and calendar year (CY) 2014, EHR technology certified to the 2014 
Edition EHR certification criteria. Therefore, all EPs, eligible 
hospitals, and CAHs must use 2014 Edition CEHRT to meet meaningful use 
under the Medicare and Medicaid EHR Incentive Programs beginning with 
FY 2014 and CY 2014.
    On September 4, 2012, we published in the Federal Register (77 FR 
53968 through 54162) a final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program--Stage 2,'' that 
established, among other final policies, the timeline for the stages of 
meaningful use through 2021 and the EHR reporting periods in 2014, as 
shown in Table 1 (77 FR 53973 through 53975).

                                             Table 1--Stage of Meaningful Use Criteria by First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Stage of meaningful use
      First payment  year       ------------------------------------------------------------------------------------------------------------------------
                                    2011       2012       2013       2014       2015       2016       2017       2018       2019       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

[[Page 52913]]

 
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.

    EPs, eligible hospitals, and CAHs that attest to meaningful use for 
an EHR reporting period in 2014 for their first year of Stage 2 or 
their second year of Stage 1 have a 3-month quarter EHR reporting 
period in CY 2014 (EPs) or FY 2014 (eligible hospitals and CAHs). For 
the Medicaid incentive payments for meaningful use, EPs have an EHR 
reporting period of any continuous 90-day period in CY 2014 as defined 
by the state Medicaid program, or, if the state so chooses, any 3-month 
CY quarter in 2014. EPs, eligible hospitals, and CAHs that demonstrate 
meaningful use for the first time in 2014 have an EHR reporting period 
of any continuous 90-day period in CY 2014 or FY 2014, respectively.

A. Proposed Changes to Meaningful Use Stage Timeline and the Use of 
CEHRT

1. Reporting in 2014
    We are revisiting some of the requirements for the Medicare and 
Medicaid EHR Incentive Programs for 2014. Many EHR vendors have 
indicated, through letters to CMS, public forums, listening sessions, 
survey data, and information related to the certification and testing 
process, that the amount of time available after the publication of the 
Stage 2 final rule was too short to make the required coding changes to 
enable their EHR products to be certified to the 2014 Edition of EHR 
certification criteria. We understand, based on information gained from 
EHR technology developers and ONC-Authorized Certification Bodies on 
timing, backlogs, and the certification case load, that many EHR 
products were certified later than anticipated. These late 
certifications impacted the corresponding time available to providers 
to effectively deploy 2014 Edition CEHRT and to make the necessary 
patient safety, staff training, system testing and workflow revisions 
in order to be prepared to demonstrate meaningful use in 2014. The 
availability of 2014 Edition CEHRT is further limited by the large 
number of providers needing to upgrade to 2014 Edition CEHRT. By the 
end of February 2014, over 350,000 providers received an EHR incentive 
payment for adopting, implementing, upgrading, or successfully 
demonstrating meaningful use with 2011 Edition CEHRT. In 2014, in order 
for providers to successfully demonstrate meaningful use for Stages 1 
or 2, all eligible providers needed to adopt, implement, or upgrade to 
2014 Edition CEHRT. However, through letters to CMS, public forums, 
listening sessions, and public comment at CMS meetings, many provider 
associations expressed concern that, although 2014 Edition CEHRT may be 
available for adoption, a several month backlog exists for the updated 
version to be installed and implemented so providers can successfully 
demonstrate meaningful use for an EHR reporting period in 2014. We also 
understand that the delay in availability may limit a provider's 
ability to fully implement 2014 Edition CEHRT across the facility. For 
example, a hospital may have different systems in multiple settings, 
which all require an update and integration. Alternatively, a provider 
may have certain 2014 Edition CEHRT functionality that, once 
implemented in a live setting, requires software patches or workflow 
changes.
    Accordingly, in an effort to grant more flexibility to providers 
who experienced 2014 Edition CEHRT product availability issues that 
impact the ability to fully implement 2014 Edition CEHRT to meet 
meaningful use, we proposed some changes for the Medicare and Medicaid 
EHR Incentive Programs for 2014. We proposed to allow EPs, eligible 
hospitals, and CAHs that could not fully implement 2014 Edition CEHRT 
for an EHR reporting period in 2014 due to delays in 2014 Edition CEHRT 
availability to continue to use 2011 Edition CEHRT or a combination of 
2011 Edition and 2014 Edition CEHRT for the EHR reporting periods in CY 
2014 and FY 2014, respectively. These proposed alternatives are 
available only for those providers that could not fully implement 2014 
Edition CEHRT to meet meaningful use for an EHR reporting period in 
2014 due to delays in 2014 Edition CEHRT availability.
    We proposed these options for the use of CEHRT to meet meaningful 
use for an EHR reporting period in 2014 only. We will maintain the 
existing policy that all providers must use 2014 Edition CEHRT for the 
EHR reporting periods in CY 2015, FY 2015, and in subsequent years, or 
until new certification requirements are adopted in subsequent 
rulemaking.
    Furthermore, in order to avoid inadvertently incentivizing the 
purchase of an outdated product that cannot be used to demonstrate 
meaningful use in a subsequent year, we proposed that to qualify for an 
incentive payment under Medicaid for 2014 for adopting, implementing, 
or upgrading CEHRT, a provider must adopt, implement, or upgrade to 
2014 Edition CEHRT only. A provider would not be able to qualify for a 
Medicaid incentive payment for 2014 for adopting, implementing, or 
upgrading to 2011 Edition CEHRT or a combination of 2011 and 2014 
Edition CEHRT. We proposed to revise the definition of ``Adopt, 
Implement or Upgrade'' under 42 CFR 495.302 to reflect this proposal.
    The edition of certified EHR technology available to a provider 
dictates the stage and version of the meaningful use objectives and 
measures the provider will be able to meet. For example, 2011 Edition 
CEHRT alone does not have the necessary functionality required to meet 
the Stage 2 objectives and measures. In addition, the edition of CEHRT 
determines which CQMs a provider calculates and reports because 
calculations are part of the software programming within the CEHRT 
system.
    The 3 options for the use of CEHRT editions and the available Stage 
of meaningful use objectives and measures associated with each option 
are as follows:
a. Using 2011 Edition CEHRT Only
    We proposed that all EPs, eligible hospitals, and CAHs that use 
only 2011 Edition CEHRT for their EHR reporting period in 2014 must 
meet the meaningful use objectives and associated measures for Stage 1 
under 42 CFR 495.6 that applied for the 2013 payment year, regardless 
of their current stage of meaningful use. We note that in the Stage 2 
final rule (77 FR 53975 through 53979), we finalized certain changes to 
the Stage 1 objectives and associated measures, with some changes 
applying beginning with 2013, while other changes applying beginning 
with

[[Page 52914]]

2014. For ease of reference, we refer to the Stage 1 objectives and 
associated measures under 42 CFR 495.6 applicable for 2013 as the 
``2013 Stage 1 objectives and measures,'' and refer to the Stage 1 
objectives and associated measures under 42 CFR 495.6 applicable for 
2014 as the ``2014 Stage 1 objectives and measures.'' Providers who 
choose this option must attest that they are unable to fully implement 
2014 Edition CEHRT because of issues related to 2014 Edition CEHRT 
availability delays when they attest to the meaningful use objectives 
and measures.
b. Using a Combination of 2011 and 2014 Edition CEHRT
    We proposed that all EPs, eligible hospitals, and CAHs using a 
combination of 2011 Edition CEHRT and 2014 Edition CEHRT for their EHR 
reporting period in 2014 may choose to meet the 2013 Stage 1 objectives 
and measures or the 2014 Stage 1 objectives and measures, or if they 
are scheduled to begin Stage 2 in 2014 under the timeline shown in 
Table 1, they may choose to meet the Stage 2 objectives and associated 
measures under 42 CFR 495.6. Providers who choose this option must 
attest that they are unable to fully implement 2014 Edition CEHRT 
because of issues related to 2014 Edition CEHRT availability delays 
when they attest to the meaningful use objectives and measures.
c. Using 2014 Edition CEHRT for 2014 Stage 1 Objectives and Measures in 
2014 for Providers Scheduled to Begin Stage 2
    A provider's ability to fully implement all of the functionality of 
2014 Edition CEHRT may be limited by the availability and timing of 
product installation, deployment of new processes and workflows, and 
employee training. This effect is compounded for providers in Stage 2 
as some providers may not be able to fully implement all of the 
functions included in 2014 Edition CEHRT necessary to meet the Stage 2 
objectives and measures in time to complete the EHR reporting period in 
2014. Therefore, under our proposal, providers scheduled to begin Stage 
2 for the EHR reporting period in 2014 who cannot fully implement all 
the functions of their 2014 Edition CEHRT required for Stage 2 
objectives and measures due to issues related to 2014 Edition CEHRT 
availability delays could use 2014 Edition CEHRT to attest to the 2014 
Stage 1 objectives and measures for the EHR reporting period in 2014. 
Providers scheduled to begin Stage 2 in 2014 who choose this option 
must attest that they are unable to fully implement 2014 Edition CEHRT 
because of issues related to 2014 Edition CEHRT availability delays 
when they attest to the meaningful use objectives and measures.
    The EHR reporting periods in 2014 already have been established, 
and we did not propose any changes. Under the current timeline shown in 
Table 1, providers that first demonstrated meaningful use Stage 1 in 
2011 or 2012 must begin Stage 2 in 2014. We proposed that the options 
regarding use of the various editions of CEHRT outlined earlier applies 
only to the EHR reporting periods in 2014 for the EHR Incentive 
Program. Providers scheduled to begin Stage 2 in 2014 that instead meet 
the Stage 1 criteria in 2014 must begin Stage 2 in 2015 as noted in 
Table 3. In 2015, all providers, except those in their first year of 
demonstrating meaningful use, must report based on a full year EHR 
reporting period. In addition, in 2015, all providers must have 2014 
Edition CEHRT in order to successfully demonstrate meaningful use.

                            Table 2--Proposed CEHRT Systems Available for Use in 2014
----------------------------------------------------------------------------------------------------------------
                                                 You would be able to attest for Meaningful Use:
    If you were scheduled to    --------------------------------------------------------------------------------
          demonstrate:           Using 2011 Edition     Using 2011 & 2014
                                    CEHRT to do:      Edition CEHRT to do:     Using 2014 Edition CEHRT to do:
----------------------------------------------------------------------------------------------------------------
Stage 1 in 2014................  2013 Stage 1        2013 Stage 1            2014 Stage 1 objectives and
                                  objectives and      objectives and          measures.
                                  measures*.          measures*.
                                                     --OR--................
                                                     2014 Stage 1
                                                      objectives and
                                                      measures*.
Stage 2 in 2014................  2013 Stage 1        2013 Stage 1            2014 Stage 1 objectives and
                                  objectives and      objectives and          measures*
                                  measures*.          measures*.             --OR--
                                                     --OR--................  Stage 2 objectives and measures.
                                                     2014 Stage 1
                                                      objectives and
                                                      measures*.
                                                     --OR--................
                                                     Stage 2 objectives and
                                                      measures*.
----------------------------------------------------------------------------------------------------------------
* Only providers that could not fully implement 2014 Edition CEHRT for the EHR reporting period in 2014 due to
  delays in 2014 Edition CEHRT availability.

    The following are example scenarios under our proposal.

    Example A: An EP initiated participation in the Medicare EHR 
Incentive Program in 2011. The EP successfully demonstrated 
meaningful use and received incentive payments for 2011, 2012, and 
2013. Based on the timeline in the Stage 2 final rule, the EP is 
required to use 2014 Edition CEHRT and demonstrate Stage 2 of 
meaningful use in 2014. Under our proposal, this EP who is scheduled 
to begin Stage 2 in 2014 would have the following options:
     Attest to the Stage 2 objectives and measures of 
meaningful use using 2014 Edition CEHRT in 2014 as scheduled.
     Attest to the Stage 2 objectives and measures of 
meaningful use using a combination of 2011 and 2014 Edition CEHRT in 
2014 if they are unable to fully implement 2014 Edition CEHRT due to 
delays in 2014 Edition CEHRT availability.
     Attest to the 2014 Stage 1 objectives and measures 
using 2014 Edition CEHRT or a combination of 2011 and 2014 Edition 
CEHRT in 2014 if they are unable to fully implement 2014 Edition 
CEHRT due to issues related to 2014 Edition CEHRT availability 
delays.
     Attest to the 2013 Stage 1 objectives and measures 
using 2011 Edition CEHRT or a combination of 2011 and 2014 Edition 
CEHRT in 2014 if they are unable to fully implement 2014 Edition 
CEHRT due to issues related to 2014 Edition CEHRT availability 
delays. Clinical quality measures must be submitted through 
attestation if attesting to the 2013 Stage 1 objectives and measures 
as discussed in section III.B. of this final rule.
    Example B: An EP initiated participation in the Medicare EHR 
Incentive Program in 2013. The EP successfully demonstrated 
meaningful use and received an incentive payment for 2013. Based on 
the timeline in the Stage 2 final rule, the EP is required to use 
2014 Edition CEHRT and demonstrate Stage 1 of meaningful use in 
2014. Under our proposal, this EP would have 1 of the following 
options:
     Attest using 2014 Edition CEHRT to the 2014 Stage 1 
objectives and measures of meaningful use in 2014 as scheduled.
     Attest using a combination of 2011 and 2014 Edition 
CEHRT and meet the 2014 Stage 1 objectives and measures of 
meaningful use in 2014 if they are unable to fully implement

[[Page 52915]]

2014 Edition CEHRT due to delays in 2014 Edition CEHRT availability.
     Attest using 2011 Edition CEHRT or a combination of 
2011 and 2014 Edition CEHRT and meet the 2013 Stage 1 objectives and 
measures of meaningful use in 2014 if they are unable to fully 
implement 2014 Edition CEHRT due to delays in 2014 Edition CEHRT 
availability. Clinical quality measures must be submitted through 
attestation if attesting to the 2013 Stage 1 objectives and measures 
as discussed in section II.B. of this rule.

    Comment: The majority of commenters supported the proposals 
presented. Commenters explained that a wide range of EHR vendor and 
developer issues impeded successful implementation of 2014 Edition 
CEHRT. These issues include software installation difficulties, testing 
delays, repeated updates, and software issues that required costly and 
time-consuming manual corrections. Commenters also raised patient 
safety concerns about the potential for errors stemming from software 
glitches and crashes associated with 2014 Edition CEHRT. Some 
commenters explained that these software installation and 
implementation problems had a negative effect on productivity, record 
accuracy, and overall EHR operations because essential functions were 
not ready on time. Commenters stated that these EHR software delays and 
other problems have rendered it impossible for providers to adequately 
implement 2014 Edition CEHRT, train their staff, and test all the 
required functions in time to demonstrate meaningful use for an EHR 
reporting period in 2014. Other commenters, many with several years of 
Stage 1 experience, further point out their EHR vendors do not even 
have 2014 Edition CEHRT available for them to install so they have been 
unable to upgrade their CEHRT edition.
    Many commenters added that waiting until 2015 to require the use of 
2014 Edition CEHRT for an EHR reporting period will give everyone 
enough time to get their EHRs stabilized. This stabilization would 
allow providers to implement additional features, products, and 
workflows to successfully meet the objectives and measures of 
meaningful use. Accordingly, the overwhelming majority of commenters 
welcome the changes proposed.
    Response: We appreciate the commenters and all stakeholders for the 
suggestions provided on the EHR Incentive Program. The large number of 
public comments received is a testament to the continued commitment 
among the health care and health IT industry to improving access to 
quality care for patients. We understand the changes required to move 
the EHR Incentive Program forward take time; and we have heard your 
concerns over the challenges of successfully implementing 2014 Edition 
CEHRT in time for an EHR reporting period in 2014. It is for this 
reason we proposed to offer providers options for the use of certified 
EHR technology in 2014. As confirmed by the overwhelming number of 
comments received in support of these proposals, we believe the changes 
proposed give providers the flexibility and time needed to adequately 
upgrade and fully implement 2014 Edition CEHRT. We look forward to 
working further with stakeholders as the next stages of the EHR 
Incentive Programs evolve, cognizant that stakeholder involvement 
remains critical to the continued success of this program.
    We also note that throughout this final rule, as in the proposed 
rule, we use the term ``vendor.'' We have added the term developer to 
this reference as some commenters used this term, and we note that in 
some cases, the developer and the vendor may be different entities. In 
other cases, products may be developed by the provider which means that 
the products were not purchased from an external vendor. For purposes 
of this final rule, we clarify that the term ``vendor'' shall include 
developers who create or develop health IT.
    Comment: Some commenters opposed the options for the use of CEHRT 
outlined in the proposed rule. These commenters explained that they 
successfully tested, upgraded, and implemented 2014 Edition CEHRT and 
characterized the proposals as unfair to those providers and EHR 
vendors who worked hard to ensure all Stage 2 requirements and software 
were ready on time. Some categorized these proposals as unfair to early 
adopters of EHR technology. These commenters believed the changes as 
proposed may provide a free pass to those who waited until the last 
minute to implement 2014 Edition CEHRT, and provide no benefit to those 
who are ready to move forward. Some commenters requested that we do not 
finalize this rule in any form, stating that although they acknowledge 
the EHR Incentive Programs presents some challenges, they believe some 
difficulties stem from stakeholders being simply unwilling to put in 
any effort.
    Other commenters stated that we should not finalize the proposals 
because they believe the EHR Incentive Programs are already too 
complicated given the different stages and requirements. These 
commenters believed adding more changes only further complicates a 
program already in need of simplification.
    Other commenters explained that the proposed rule should not be 
finalized because it does not support the effort to move the health 
care system forward, which is a clear goal of the EHR Incentive 
Programs and the meaningful use objectives and measures. These 
commenters expressed concern that the proposed changes might hinder the 
expansion of health information exchange; limit patients' access to 
their health care information; or delay the momentum of the EHR 
Incentive Program. These commenters stated that the changes supported 
by meaningful use, like providing beneficiaries with online access to 
their health information, represent a monumental achievement in health 
IT; and they expressed concern that the options for the use of CEHRT in 
2014 may result in delays in this effort. Similarly, commenters were 
concerned that this would delay forward progress in interoperability, 
which would be contrary to Congress' intent in passing the HITECH Act 
and would limit the exchange of health care data between providers 
which supports the coordination of care.
    Response: We appreciate those stakeholders who fully implemented 
2014 Edition CEHRT and are able to meet the objectives and measures of 
meaningful use for an EHR reporting period in 2014. We understand the 
challenges faced in accomplishing that goal and wish to recognize the 
tremendous amount of work from providers and EHR vendors in meeting 
these objectives and helping to move health IT forward.
    However, we disagree with these commenters to the extent the 
changes proposed somehow give providers that waited until the last 
minute a ``free pass'', or punish those providers who were early 
adopters. We received numerous comments, and verified through internal 
research on implementation and readiness, that EHR development and 
implementation delays caused many providers to be unable to fully 
implement 2014 Edition CEHRT. Our analysis further showed no 
identifiable correlation between a provider's efforts to prepare to 
demonstrate meaningful use--including successful past participation--
and the ability to obtain and implement CEHRT in a practice setting. 
Many providers had no control over their position in their vendor's 
queue for CEHRT installation, no influence on a product's development 
timeline, and no participation in the product's movement through the 
certification process. All of

[[Page 52916]]

which may have also contributed to the overall delay in 2014 Edition 
CEHRT availability. It is for these reasons we proposed these changes. 
Our intent in proposing these options was not to further complicate the 
program, to provide a benefit to certain providers, or to penalize 
other providers. Rather, we sought to be responsive to stakeholder 
concerns by proposing options for providers who were unable to fully 
implement 2014 Edition CEHRT for an EHR reporting period in 2014 
because of issues related to 2014 Edition CEHRT availability delays.
    We note that several commenters raised concerns about the potential 
impact of these proposals on health IT interoperability. However, we 
believe that the proposed options for the use of CEHRT in the short 
term will support moving interoperability forward over the long term. 
Allowing providers additional time to fully implement the 2014 Edition 
CEHRT required for health information exchange will support efforts to 
expand the use of this technology on the whole and continue providers' 
efforts to incorporate electronic health information exchange and care 
coordination into their practices.
    We also recognize the concerns expressed by commenters about how 
our proposals may affect patients and their families if progress on 
patient engagement initiatives is slowed. We understand that patients' 
electronic access to health information, supported by the meaningful 
use of EHR technology, comprises an integral part of improving patient-
provider engagement and patient health literacy. Again, we believe that 
the short-term delay will allow for more providers to continue forward 
progress and begin providing essential health information to their 
patients through certified EHR technology.
    In addition, we cannot ignore the overwhelming concern from 
providers, or the supporting data showing that many providers cannot 
successfully meet meaningful use for an EHR reporting period in 2014 
using 2014 Edition CEHRT because of issues related to 2014 Edition 
CEHRT availability delays. We believe that giving additional time to 
providers who have not otherwise been able to fully implement 2014 
Edition CEHRT in their practice will help them continue to make 
progress toward more advanced use of EHRs including the health 
information exchange and patient engagement objectives.
    In addition, requiring providers to rush implementation despite 
significant obstacles does not improve health care outcomes or best 
serve patient safety as a whole. Rather, we believe that the options 
proposed will allow providers and EHR vendors sufficient time to 
upgrade and safely and effectively implement the 2014 Edition CEHRT, 
which, in turn, will result in better health outcomes for patients.
    Finally, the actions involved in meeting the objectives and 
measures of meaningful use are not simply part of a reporting program, 
they are also based on changing behaviors and setting standards that 
drive toward improved clinical process and better outcomes for 
patients. For providers who could not otherwise participate because of 
a lack of 2014 Edition CEHRT, the allowance of flexibility in the use 
of CEHRT Editions means they may continue to be actively engaged in the 
processes and actions required by the program. For the 2013 Stage 1 
objectives and measures, this includes providing important information 
to patients about their care, implementing patient safety measures like 
automated drug interaction and drug allergy checks, and reporting on 
public health data. These objectives help to move the EHR Incentive 
Programs forward and to support delivery system transformation efforts 
through health IT.
    Comment: While most commenters support the proposal to provide 
options for providers using CEHRT to meet meaningful use in 2014, some 
commenters expressed concern about the cost and time required to modify 
state Medicaid EHR attestation systems to accommodate the program 
changes specified in the proposed rule. Some commenters requested that 
CMS allow states the flexibility to decline the changes proposed, or to 
make additional changes within state Medicaid EHR Incentive Programs 
beyond those proposed by CMS.
    Response: We recognize the potential burden that these changes may 
have on state system development and enhancement activity, and are 
aware that the changes specified in the proposed rule may have 
implications for cost, timing, and system changes. In order to 
accommodate these changes, we are committed to working with individual 
states to update contracts and funding requests in Implementation-
Advance Planning Documents (I-APDs) to enact the systems changes needed 
to support these policy changes. We remind states that enhanced Federal 
financial participation is available for EHR Incentive Program 
administration costs. We do not believe these concerns outweigh the 
benefits of the proposed options for the use of CEHRT, which we believe 
would enable providers who would otherwise be unable to meet meaningful 
use, to be able to do so in 2014.
    Comment: Several commenters reported that the proposed rule would 
increase the complexity of an already difficult transition from Stage 1 
to Stage 2 for many Medicaid EPs, and requested that we provide 
guidance to clarify any changes to the program that result from this 
final rule. Commenters requested clarification on whether this change 
is limited to the use of CEHRT for an EHR reporting period in 2014 for 
Medicaid given that state Medicaid programs must make administrative, 
system, and operational changes in response to the changes proposed, 
which may take significant time to complete.
    Response: We recognize the additional complexity introduced under 
these proposals for providers participating in the Medicaid EHR 
Incentive Program, but we believe that the benefits of giving providers 
option for using CEHRT in 2014 to meet meaningful use will outweigh any 
additional confusion that may occur. We will provide ongoing technical 
assistance and appropriate materials to state staff and providers to 
help them understand how the changes in this rule affect participation 
in the Medicaid EHR Incentive Program. We stress that the changes 
regarding the options for using CEHRT are limited to the EHR reporting 
period in 2014 for both Medicare and Medicaid. For 2015 and subsequent 
years, we proposed no changes regarding the use of CEHRT or the stage 
of meaningful use a provider must attest to, except for the change in 
the Stage 3 start date.
    Comment: Several commenters encouraged CMS to not adopt any changes 
or exclusions which affect the ability of providers serving patients 
residing in correctional facilities to meet the requirements of 
meaningful use.
    Response: We appreciate the commenters' feedback. However, we did 
not propose any changes that would uniquely affect providers serving 
patients in correctional facilities.
    Comment: We received numerous comments during this public comment 
period that were either unrelated to the EHR Incentive Program or 
outside the scope of the proposed rule. These comments included changes 
to Stage 2, requests for revisions to EHR reporting periods in years 
other than 2014, and suggestions for implementation of Stage 3.
    Response: We thank all the commenters for their suggestions and 
feedback on the EHR Incentive Programs. However, comments

[[Page 52917]]

unrelated to the proposals fall outside the scope of the proposed rule 
and are not be addressed in this final rule.
    Instead, we urge readers, especially those who provided comments 
pertaining to Stage 3, to wait until the release of the Stage 3 
proposed rule to provide comments on this particular area.
    Comment: We received multiple comments from providers on the delays 
in service and a perceived lack of communication from EHR vendors. 
Commenters stated that some vendors are still unable to provide them 
with 2014 Edition CEHRT, or that products they have in place have not 
yet been certified. Another provider requested that CMS compel EHR 
vendors to better communicate with their clients, especially in cases 
where they are not actively pursuing certification. These commenters 
stressed the need to be able to rely on EHR vendors, and the perceived 
lack of communication often inhibits trust in a business relationship. 
However, another commenter believed the proposed rule forced providers 
to blame vendors and system developers, in order to take advantage of 
the options for using CEHRT. This commenter added that such behavior 
did not foster a cooperative relationship between vendor and provider.
    Response: We recognize the concern and need for effective and 
timely communication with EHR vendors during the EHR certification 
process. We are committed to working with our federal partners at the 
ONC and industry stakeholder groups representing EHR vendors to create 
and disseminate meaningful use related resources for use in supporting 
providers.
    We stress that in this proposed rule, we did not intend to 
attribute fault to any stakeholder, including EHR vendors, always 
recognizing the success of this program hinges upon the cooperation of 
all stakeholders. Rather, the options we proposed recognize the overall 
difficulties and delays in the industry as a whole in getting 2014 
Edition CEHRT fully certified and implemented in time for providers to 
use for an EHR reporting period in 2014.
    Comment: Several commenters requested that we finalize this rule as 
quickly as possible and questioned the public comment period. A 
commenter stated that we did not specify the end of the comment period 
in the proposed rule. Other commenters requested that CMS either 
shorten or eliminate the public comment period entirely, or provide a 
definitive date for final rule implementation. In general, these 
commenters expressed concern that the comment period ending on July 21, 
2014 would delay the implementation of the rule and effectively limit 
providers to using the 4th quarter as their EHR reporting period. These 
commenters expressed concern that this timeframe is not feasible for 
eligible hospitals because the fourth quarter of FY 2014 began on July 
1, 2014, prior to the end of the comment period.
    Response: We thank the commenters for their suggestions but 
respectfully disagree with the concerns raised. First, we disagree with 
the commenter that stated that we did not specify the end of the public 
comment period. The proposed rule, as pointed out by other commenters, 
specified that the comment period ended on July 21, 2014. The comment 
period allows us to receive invaluable feedback on the proposals and 
gain a better understanding of the impact they may have on providers 
and the health care industry.
    Second, we acknowledge a perceived concern that the timing of this 
final rule effectively limits a provider's EHR reporting period in 2014 
to the fourth quarter. However, we believe this concern stems largely 
from a misunderstanding of the EHR reporting periods and the time 
allowed for attestation. There are two related actions required to 
report on the objectives and measures to demonstrate meaningful use. 
The first is to capture data for an EHR reporting period, the second is 
to attest to that data in the EHR Incentive Programs Registration and 
Attestation System. First, providers may capture data for any EHR 
reporting period of a three-month quarter within 2014 (CY for EPs, FY 
for eligible hospitals and CAHs) using the options in this final rule. 
For example, a provider may meet the meaningful use objectives and 
measures using the options in this final rule during the first quarter 
EHR reporting period in 2014 (October 2013 through December 2013 for 
eligible hospitals and CAHs, January 2014 through March 2014 for EPs). 
Second, a provider may submit their data and attest to meaningful use 
at any point from the end of the selected EHR reporting period through 
the end of the attestation period. The attestation period does not open 
and close after each reporting period. The attestation period opens at 
the end of the first reporting period of the year and is open the 
remainder of the year and finally closes 2 months after the end of the 
year (CY for EPs, FY for eligible hospitals and CAHs), not at the end 
of any given EHR reporting period.
    Therefore if an eligible hospital were unable to fully implement 
2014 Edition CEHRT for an EHR reporting period in 2014 because of 
issues related to 2014 Edition CEHRT availability delays, the options 
provided in this rule would allow that eligible hospital to use 2011 
Edition CEHRT, or a combination of 2011 and 2014 Edition CEHRT to meet 
meaningful use during any 3-month quarter EHR reporting period in FY 
2014. That eligible hospital could select the first, second, third, or 
fourth quarter of FY 2014 as its EHR reporting period and attest to 
meeting the meaningful use objectives and measures at the end of the 
year. Therefore, the last quarter of the year is not the only available 
quarter which a provider may use for their EHR reporting period in 
2014.
    Comment: Some commenters wanted us to extend the options for the 
use of CEHRT we proposed for 2014 into 2015. These commenters stated 
the additional flexibility would allow time for providers and EHR 
vendors to adequately implement the technology. Another commenter 
suggested extending the options for using CEHRT into 2015 in order to 
align the program with the upcoming ICD-10 transition.
    Response: The options detailed in the proposed rule apply to the 
use of CEHRT for the EHR reporting period in 2014 and do not extend to 
2015 or subsequent years. We believe the options proposed for 2014 
allow providers to continue moving forward with the meaningful use of 
certified EHR technology. However, to extend the proposed options for 
using CEHRT beyond the EHR reporting period in 2014 puts ongoing 
program goals at risk. We set the new standards for 2014 Edition CEHRT 
to achieve more advanced functionalities and drive toward enhanced 
information exchange and interoperability. We acknowledged in previous 
comment and response discussion that even these proposed options for 
the use of CEHRT represent some delay to forward progress. However, we 
believe our proposals would mitigate that delay by enabling more 
providers to participate in the program in 2014 while maintaining the 
requirement to use 2014 Edition CEHRT in 2015. But, allowing any 
further extension compounds the potential risk to health information 
exchange infrastructure and may detrimentally affect the alignment with 
related CMS programs such as PQRS and IQR. For these reasons, we did 
not propose extending the options for the use of CEHRT beyond 2014.
    Comment: A few commenters questioned whether providers ready to 
move forward with attestations should still do so. These commenters 
questioned whether providers who have adopted and are live with 2014 
Edition

[[Page 52918]]

CEHRT should use one of the CEHRT options proposed for the EHR 
reporting period in 2014. Some commenters further questioned if they 
should delay active installation of their 2014 Edition CEHRT to 
accommodate these changes.
    Response: Providers who have fully implemented 2014 Edition CEHRT 
must attest to the objectives and measures for their stage of 
meaningful use for an EHR reporting period in 2014. The proposed 
options for using CEHRT are available only to those providers who are 
unable to fully implement 2014 Edition CEHRT for an EHR reporting 
period in 2014 because of issues related to 2014 Edition CEHRT 
availability delays.
    We stated in the proposed rule that we strongly recommend EPs, 
eligible hospitals, and CAHs that have not yet purchased EHR technology 
to obtain 2014 Edition CEHRT as these providers will still need to use 
2014 Edition CEHRT for their EHR reporting period in 2015. This also 
applies for providers in the process of installing or implementing 2014 
Edition CEHRT. These providers should continue the implementation 
process as 2014 Edition CEHRT will be required for use for an EHR 
reporting period in 2015.
    In addition, we proposed that a Medicaid provider must adopt, 
implement, or upgrade to only 2014 Edition CEHRT if they wish to 
qualify for the adopt, implement, or upgrade incentive payment under 
Medicaid for their first participation year. This was proposed in order 
to avoid inadvertently incentivizing the purchase of an outdated 
product that cannot be used to demonstrate meaningful use in a 
subsequent year.
    Comment: A commenter requested clarification of what we meant by 
requiring Medicaid EPs to adopt, implement, or upgrade 2014 Edition 
CEHRT. The commenter questioned whether documentation of a plan to 
upgrade from older technology is sufficient.
    Response: We proposed that to receive an incentive payment for 
``adopt, implement, upgrade'' under Medicaid, EPs will need to adopt, 
implement, or upgrade (AIU) to 2014 Edition CEHRT only. As mentioned in 
the proposed rule, this requirement discourages the purchase of an 
outdated product that could not be used to meet meaningful use in 
subsequent years. We do not consider a plan to upgrade from older 
technology sufficient. We further note that Medicaid EPs who qualify 
for a first year incentive payment for AIU may be subject to the 
Medicare payment adjustment under section 1848(a)(7) of the Act if they 
do not demonstrate meaningful use for an applicable EHR reporting 
period.
    Comment: We received multiple comments on the proposed options for 
the use of CEHRT. Generally, the majority of commenters supported the 
proposed options, and several commenters requested clarification on one 
or more of the options. A few commenters generally objected to one or 
more of the options, finding the options for the use of CEHRT time 
consuming, complicated, confusing, or inconvenient.
    Some commenters requested that CMS clarify how the edition of CEHRT 
would dictate the stage of Meaningful Use under the CEHRT options. 
Specifically, commenters requested clarification on how the proposed 
options for the use of CEHRT would work with objectives, associated 
measures, and CQMs. Commenters questioned whether the options for the 
use of CEHRT extended to allowing options for measure selection. A few 
commenters suggested that we allow additional options for the use of 
CEHRT regardless of the Edition of CEHRT the provider has implemented. 
These options included: allowing providers to attest to Stage 2 with 
exclusion of one or more core objectives; allowing providers to report 
on either Stage 1 or 2, using either the 2011 or 2014 Edition CEHRT; 
allowing providers to choose between 2014 Stage 1 objectives and 
measures and the 2013 Stage 1 objectives and measures; and allowing 
providers to report on any version of CQMs.
    Many commenters wanted additional explanation of what we meant by a 
combination of 2011 and 2014 Edition CEHRT. These commenters requested 
that we clarify if the combination referred to set amounts of time, or 
whether a specific ratio between CEHRT editions was required, or 
whether a specific CEHRT edition needed to be used for each objective 
or measure. These commenters were also concerned that the coding 
differences between the software editions would make it difficult to 
use a combination of the two as proposed in the options for the use of 
CEHRT. Other commenters requested clarification if the combined 2011/
2014 option for the use of CEHRT could be used for providers practicing 
in multiple locations equipped with different editions of CEHRT.
    In addition, many commenters requested that guidance on the 
documentation requirements for the related reporting requirements be 
provided to program auditors for each potential option.
    Response: We appreciate the supportive comments regarding the 
options for the use of CEHRT proposed for meeting meaningful use for an 
EHR reporting period in 2014. Our priority is to promote the meaningful 
use of certified EHR technology and support the successful 
implementation of 2014 Edition CEHRT including the functionalities 
required to support enhanced patient engagement, interoperability, and 
health information exchange. We recognize clinical workflows, business 
procedures, and maintaining documentation may require modifications 
upon implementation of 2014 Edition CEHRT. In addition, we recognize 
that affected providers will need to consider multiple factors in 
determining the option for which they may be eligible. However, we 
believe the proposals outlined for the use of CEHRT in 2014 will allow 
affected providers the flexibility to choose the option which applies 
to their particular circumstances. Upon attestation, providers may 
select one of the options proposed and the EHR Incentive Program 
Registration and Attestation System will prompt the provider to attest 
to meeting the applicable objectives, measures, and CQMs based on their 
Edition of CEHRT. Furthermore, we note, as suggested by some 
commenters, that auditors will be provided guidance related to 
reviewing attestations associated with the options for using CEHRT.
    While we understand it may be cumbersome for providers to use a 
combination of 2011 and 2014 Edition CEHRT to meet meaningful use in 
2014, we expect the benefit of ultimately demonstrating meaningful use 
outweighs the complexity of using two CEHRT editions. We do not specify 
whether a provider must use 2011 Edition CEHRT or 2014 Edition CEHRT 
for a certain amount of time during the EHR reporting period, whether a 
certain amount of modules in one CEHRT edition or another is required, 
or whether a certain number of provider settings must have one CEHRT 
edition over another. This is because we expect there will be 
significant variation among practices based on the type of software 
used, the complexity of a provider's total systems, and the overall 
implementation timeline for 2014 Edition CEHRT installation.
    Providers who use a combination of 2011 Edition and 2014 Edition 
CEHRT will enter a certification number into the Registration and 
Attestation System, and they will be presented with a choice of 2013 
Stage 1 objectives and measures, or 2014 Stage 1 objectives and 
measures (and Stage 2 objectives and measures if

[[Page 52919]]

they were previously scheduled to begin Stage 2). Providers using a 
combination of 2011 Edition and 2014 Edition CEHRT who choose to attest 
to the 2013 Stage 1 meaningful use objectives and measures will report 
on only those objectives and measures and attest to the CQMs that were 
applicable for 2013. Providers using a combination of 2011 and 2014 
Edition CEHRT who choose to attest to the 2014 Stage 1 meaningful use 
objectives and measures will report on only those objectives and 
measures and submit the 2014 CQMs through attestation or electronic 
reporting. Providers using a combination of 2011 Edition and 2014 
Edition CEHRT who choose to attest to Stage 2 objectives and measures 
will attest to only the Stage 2 objectives and measures and submit the 
2014 CQMs through attestation or electronic reporting.
    Comment: We received numerous comments on the EHR reporting periods 
for both 2014 and 2015. For 2014, some commenters wanted us to allow 
providers to skip attestation entirely. Some commenters requested 
clarification regarding the EHR reporting period for providers 
employing the options outlined in the rule. Another commenter 
questioned whether it was possible to attest based on a 3rd quarter 
(April through June) instead of 4th quarter (July through September) 
EHR reporting period in FY 2014 using the CEHRT options proposed. Some 
commenters suggested that eligible hospitals should attest using any 
one quarter of the fiscal year, while others disagreed with using a 3-
month period by quarter.
    Another commenter suggested that CMS should generally allow a 90-
day reporting period for Stage 2, year 1, in order to allow ample time 
to test and meet the measures in Stage 2.
    However, the majority of commenters, focused on the 2015 reporting 
period and made suggestions regarding the length of the EHR reporting 
period. Several commenters requested that CMS consider 2015 a 
transition period with the use of 2014 Edition CEHRT. Many of these 
commenters suggested a 90-day attestation period for 2015, citing that 
providers and EHR vendors do not have enough time in 2014 to fully 
integrate 2014 Edition CEHRT. The majority of these commenters then 
requested a flexible 90-day period, explaining that the rule will not 
be finalized prior to the beginning of the last EHR reporting period. 
Commenters added reporting for a full year in 2015 is impossible if 
providers had to switch systems on the first of the year.
    Other commenters explained that a 90-day reporting period is needed 
for 2015 because the proposed extension is not enough given the time 
needed to adopt, implement, and operationalize a 2014 Edition CEHRT and 
all of the changes that accompany it. These commenters noted such a 
short extension does not adequately serve the purpose of the proposed 
rule. Finally, some commenters wanted a 90-day reporting period because 
of the delay in ICD-10 implementation, or because they believed Stage 2 
measures fell outside their control. Many commenters requested 
clarification regarding the ramifications of not being able to 
implement 2014 Edition CEHRT by January 1, 2015.
    Response: The special 3-month quarter EHR reporting period in 2014 
was established in the Stage 2 final rule and does not apply to 2015 or 
subsequent years. In the proposed rule, we did not propose to change 
the EHR reporting periods that were established in the Stage 2 final 
rule for 2014 or any subsequent year with regard to the incentive 
payments or payment adjustments. The purpose of the proposed rule was 
to provide options for the use of CEHRT to allow providers to meet 
meaningful use within the existing EHR reporting periods using the 
technology available to them. We are not considering changes to the EHR 
reporting periods for 2015 or subsequent years in this final rule for 
the same reasons we are not considering changing the edition of CEHRT 
required for 2015 or subsequent years. Changes to the EHR reporting 
period would put the forward progress of the program at risk, and cause 
further delay in implementing effective health IT infrastructure. In 
addition, further changes to the reporting period would create further 
misalignment with the CMS quality reporting programs like PQRS and IQR, 
which would increase the reporting burden on providers and negatively 
impact quality reporting data integrity.
    However, as stated previously in this final rule, providers may 
attest based on an EHR reporting period of any quarter in 2014 using 
the options specified in this final rule. We believe the options for 
using CEHRT proposed, as well as the ability for a provider to attest 
based on any quarter in 2014, strike a balance between being responsive 
to those providers unable to fully implement 2014 Edition CEHRT because 
of issues related to 2014 Edition CEHRT availability delay and 
continuing to move the EHR Incentive Program forward.
    Comment: Commenters questioned how states will verify that eligible 
providers are ``unable to fully implement 2014 Edition CEHRT because of 
issues related to 2014 Edition CEHRT availability delays'' when they 
attest to meaningful use objectives and measures for the Medicaid EHR 
Incentive Program. Commenters stated that without having detailed 
guidance on how states should capture and verify this new attestation 
requirement that states would be at a greater risk of making improper 
payments to providers.
    Response: We recognize the potential difficulties in adding this 
requirement for both providers and state Medicaid agencies, but still 
believe that it is necessary to ensure that this final rule is tailored 
to those providers who were unable to fully implement 2014 Edition 
CEHRT.
    Comment: Several commenters sought clarification on the 
circumstances under which providers could use the proposed options for 
the use of CEHRT outlined in the proposed rule. Commenters requested 
that CMS clarify or further define the terms ``unable to fully 
implement'' and ``2014 Edition CEHRT availability delays.''
    The comments pertaining to this particular area fell into several 
categories. The largest commenter group wanted precise definitions 
because they believed the proposed rule was not sufficiently clear. 
Several commenters remarked that we provided limited examples in the 
proposed rule. These commenters explained these terms, so critical to 
determining available options for using CEHRT, could encompass an 
endless number of scenarios. Other commenters wanted to know if 
providers retained the discretion to determine what these terms meant, 
and if not, who would ultimately decide what they meant. Some 
commenters suggested that the use of the proposed options should be 
based on a provider's determination that it could not effectively 
deploy 2014 Edition CEHRT. Other commenters wanted the options for 
using CEHRT expanded to more than just issues with 2014 CEHRT 
availability delays.
    Some commenters expressed concern that the language we used was too 
broad; while others stated that the language was too restrictive. 
Several commenters wanted us to either substitute or add to ``fully 
implement'' with a host of other terms, including deployment, 
operationalize, work, establish, institute, initiate, place, or 
execute. Several commenters expressed confusion about whether they 
could use the options for CEHRT when they have 2014 Edition CEHRT 
available, but could not train new personnel or establish new workflows 
because of late software installations.

[[Page 52920]]

    Many commenters requested timeframes or deadlines for when these 
terms would be applicable. For example, a commenter questioned what 
would be considered an adequate amount of time to complete all of the 
transitional processes (training, workflow, validation of reporting) 
post 2014 Edition CEHRT deployment.
    Other commenters suggested expanding the circumstances where an 
inability to fully implement or 2014 Edition CEHRT availability delays 
could be used. Specifically, many commenters remarked delays with 
implementation of 2014 Edition CEHRT consisted of more than just vendor 
related availability issues and added that we should clarify that many 
issues could be involved. A commenter noted that the time period to be 
considered for the option to report on Stage 1 should consist of not 
only the time for the vendor to obtain 2014 edition certification, but 
also should extend to all subsequent vendor and health care provider 
tasks required to fully operationalize Stage 2. Other commenters wanted 
us to consider an inability to fully test 2014 Edition CEHRT an 
appropriate circumstance under which to use the CEHRT options. Other 
commenters noted a lack of training on the new technology changes and 
requested that this be considered a valid reason for using the CEHRT 
options.
    Commenters explained that EHR vendors did not train providers in 
time, thereby resulting in an inability to attest to meaningful use. 
Other commenters stated that cost and staff turnover and changes caused 
their inability to fully implement 2014 Edition CEHRT, and wanted 
clarification on whether that qualified them to use the CEHRT options. 
Another commenter suggested we consider a financial hardship as a 
reason to be unable to fully implement 2014 Edition CEHRT because of 
issues related to 2014 Edition CEHRT availability delays.
    Some commenters stated problems associated with the 2014 Stage 1 
objectives and measures or the Stage 2 objectives and measures 
themselves should be considered as a suitable reason for using the 
CEHRT options. A commenter remarked that his vendor only released the 
capability for the lab result measure in June, and he still is waiting 
for the upgrade to be able to report on the measure.
    Many commenters expressed concern over attesting to Stage 2 because 
of a lack of 2014 Edition CEHRT availability associated with the Stage 
2 transitions of care measure requiring transmission of an electronic 
summary of care document using 2014 Edition CEHRT. This measure 
requires providers to send an electronic summary of care document for 
more than 10 percent of transitions or referrals. EPs especially 
expressed this concern because their 2014 implementation timeline may 
be 3 months behind eligible hospitals and CAHs given fiscal and 
calendar year differences. Commenters explained that even those EPs who 
did fully implement their own 2014 Edition CEHRT systems may still be 
unable to meet Stage 2 requirements due to other EPs and community 
hospitals lacking 2014 Edition CEHRT. Since Stage 2 requires electronic 
summary of care records for more than 10 percent of transitions of care 
to be electronically transmitted by the referring or transitioning EP 
using 2014 Edition CEHRT or facilitated by an eHealth Exchange 
participant, commenters indicated that the EP cannot guarantee receipt 
if the recipient or intermediary does not have the 2014 Edition CEHRT 
functionality required to receive the electronic document. These 
commenters suggested we allow an EP under these circumstances to attest 
to the Stage 1 objectives when insufficient opportunities exist to send 
summary of care records electronically because recipients did not fully 
implement 2014 Edition CEHRT.
    Other commenters raised concerns over other measures under the EHR 
Incentive Program, some requiring the specific use of 2014 Edition 
CEHRT. Many commenters wanted to know whether issues with direct 
messaging, portal non-use by patients, mapping problems, or other 
similar measure issues could be considered an inability to fully 
implement 2014 Edition CEHRT because of issues related to a 2014 CEHRT 
availability delay. A commenter explained that Stage 2's focus on 
cooperation among providers makes implementation difficult when not all 
providers are at the same capability level. Commenters maintained these 
issues fell outside the provider's control and should be considered 
suitable reasons to use the CEHRT options. Some commenters added that 
providers should be allowed to meet less than the required thresholds 
and still be considered to meet meaningful use for the EHR reporting 
period in 2014.
    Other commenters remarked that although they had no issues with 
2014 Edition CEHRT availability, providers could not meet several 
measure requirements because of late code releases on a short time 
frame. Therefore, these commenters suggested that all providers be 
allowed to use the CEHRT options. Similarly, many commenters wanted all 
restrictions for using the CEHRT options eliminated completely, and 
instead, allow all providers to use the options for CEHRT regardless of 
the reason.
    Response: We agree that some clarification is necessary regarding 
what we meant by ``not able to fully implement'' and ``delays in 2014 
Edition CEHRT availability'' in the proposed rule. We begin by 
addressing those commenters who pointed out that we did not provide 
examples which fully encompass every scenario where an inability to 
fully implement or a 2014 Edition CEHRT availability delay was 
possible, as well as those commenters who stated the terminology 
generally was vague and unclear. We did not provide an exhaustive list 
of every possible scenario in the proposed rule in recognition of the 
many different scenarios where a provider may not be able to fully 
implement 2014 Edition CEHRT for an EHR reporting period in 2014 due to 
delays in 2014 Edition CEHRT availability. We also did not propose 
alternate terminology for ``implement'', such as operationalize, 
institute, or initiate, as suggested by commenters because we wanted to 
use consistent terminology in the proposed rule.
    Next, we clarify what we meant by a delay in 2014 Edition CEHRT 
availability. As stated previously, we proposed the options for using 
CEHRT due to the overwhelming number of providers who informed us they 
could not meet the objectives and measures of meaningful use with 2014 
Edition CEHRT because, for example, they did not have the product 
installed, or were waiting for EHR vendor certification or for 
necessary software updates from the EHR vendor. Such delays then gave 
the provider little to no time to get the necessary training, system 
testing and workflow revisions in place to fully implement their 2014 
Edition CEHRT in time for an EHR reporting period in 2014. Thus, the 
delay in the 2014 Edition CEHRT availability resulted from one or more 
delays related to the development, certification, testing, and release 
of an EHR product by the EHR vendor which then results in the inability 
for a provider to fully implement 2014 Edition CEHRT for an EHR 
reporting period in 2014. In stating that the delays are attributable 
to the development, certification, testing, and release of an EHR 
product by the EHR vendor, we do not intend to infer that the EHR 
vendor is culpable. We recognize that vendors themselves may have 
experienced unexpected delays during the development process because of 
the compressed timeline between receipt of final requirements to the

[[Page 52921]]

deadline for implementation. This could include delays within the 
certification process as well. For example, if a vendor's actions were 
timely but the ONC Authorized Certification Body experienced a backlog 
due to a high volume of certification requests, a delay in the testing 
and certification of a product may have occurred. Further, as reflected 
in the special shortened EHR reporting period in 2014 established in 
the Stage 2 final rule, we anticipated potential delays from the volume 
of providers requiring a simultaneous software upgrade. Rather, we 
proposed the options for the use of CEHRT to alleviate provider and 
vendor burden in light of our research and analysis demonstrating that 
the scale of the problem was greater than anticipated when the Stage 2 
final rule was published. Accordingly, a provider's ability to use 
these flexible options for CEHRT is based on the provider's inability 
to fully implement 2014 Edition CEHRT based on these types of issues 
related to software development, certification and release of the 
product by the EHR vendor which affected 2014 CEHRT availability.
    We did not intend, as suggested by some commenters, to allow 
reasons such as a provider waiting too long to purchase the software 
or, as explained later in this section, a lack of staff or resources to 
constitute a ``delay'' for purposes of using one of the proposed CEHRT 
options. Therefore, we stress the delay in 2014 Edition CEHRT 
availability must be attributable to the issues related to software 
development, certification, implementation, testing, or release of the 
product by the EHR vendor which affected 2014 CEHRT availability, which 
then results in the inability for a provider to fully implement 2014 
Edition CEHRT.
    Next, we clarify what we meant by an inability to fully implement 
2014 Edition CEHRT. It is in this area where we intended to provide the 
broadest application. We start with examples of what does not 
constitute an inability to fully implement 2014 Edition CEHRT. We 
believe that beginning with what is not permissible, rather than what 
is, represents a far smaller set of circumstances that will both quell 
providers' concerns about audits and provide additional parameters on 
the use of the CEHRT options generally.
    Accordingly, we clarify that the following situations would not be 
permissible reasons to use the options for CEHRT because they do not 
constitute an inability to fully implement 2014 Edition CEHRT. First, 
providers that did not fully implement 2014 Edition CEHRT due to 
financial issues, such as the costs associated with implementing, 
upgrading, installing, testing, or other similar financial issues, 
would not be able to use the options for CEHRT for the EHR reporting 
period in 2014. Although we understand cost is a factor for health care 
providers, as it is with any other business, we proposed the options 
for CEHRT to address delays in the availability of 2014 Edition CEHRT, 
and not the costs associated with it. Therefore, we do not find cost to 
be a permissible reason for using one of the options for CEHRT. Rather, 
we point out that providers facing significant cost concerns relating 
to such things as insufficient internet access and insurmountable 
barriers to obtaining infrastructure (broadband access) have the option 
to file an application for a hardship exception.
    Second, with limited exception discussed later in this section, 
issues related to the meaningful use objectives and measures do not 
constitute an inability to fully implement 2014 Edition CEHRT. Several 
commenters mentioned that although 2014 Edition CEHRT was available, 
fully functioning, and implemented, they wanted to attest with one of 
the CEHRT options because of issues relating to one or more Stage 2 
objectives and measures, such as the inability to meet certain measure 
thresholds which increased from Stage 1 to Stage 2, an overall 
objection to Stage 2 measures generally, or concerns with measures 
believed to be outside a provider's control--such as an inability to 
obtain a beneficiary's email address. Again, we proposed alternate 
options only for those providers who could not fully implement 2014 
Edition CEHRT for a full EHR reporting period in 2014 because of issues 
related to 2014 Edition CEHRT availability delays. We did not propose 
these options in order for providers to be exempted from meeting Stage 
2 measure requirements. We do not find that an inability to meet one or 
more measures, as in the examples cited previously, fits within the 
rationale we proposed for using one of the CEHRT options. Rather, 
overall concerns and comments requesting changes or exemptions to one 
or more of the Stage 2 measures and objectives fall outside the scope 
of this rule, and will not be discussed with any further detail here. 
Accordingly, for the reasons stated previously, those providers who 
have fully implemented 2014 Edition CEHRT and cannot meet one or more 
measures for reasons unrelated to the inability to fully implement 2014 
Edition CEHRT due to delays in the product availability cannot use the 
options for the use of CEHRT and must attest to their stage of 
meaningful use using 2014 Edition CEHRT as originally intended.
    However, we recognize the concern raised by commenters, stated 
previously, that in the Stage 2 meaningful use objective for provision 
of a summary of care document during for more than 10 percent of 
transitions of care, the second measure requires electronic 
transmission using CEHRT, which implies that the recipient or 
intermediary is able to receive the summary of care document in the 
standard required for transmission. As mentioned by commenters, the 
sending provider may experience significant difficulty meeting the 10 
percent threshold, despite the referring provider's ability to send the 
electronic document, if the intermediary or the recipient of the 
transition or referral is experiencing delays in the ability to fully 
implement 2014 Edition CEHRT. We acknowledge referring providers may 
not be able to meet the summary of care measure in 2014, if receiving 
providers they frequently work with have not upgraded to 2014 Edition 
CEHRT. We therefore believe a limited exception is warranted for 
providers who could not meet the threshold for the Stage 2 summary of 
care measure requiring the transmission of an electronic summary of 
care document for more than 10 percent of transitions or referrals 
because the recipients of the transitions or referrals were impacted by 
issues related to 2014 Edition CEHRT availability delays and therefore 
could not implement the functionality required to receive the 
electronic summary of care document. Therefore, we consider the 
inability to fully implement to extend to those providers for the 
summary of care document measure at 42 CFR 495.6 (d)(14)(ii)(B) for EPs 
and (l)(11)(ii)(B) for eligible hospitals and CAHs. A referring 
provider under this circumstance may attest to the 2014 Stage 1 
objectives and measures for the EHR reporting period in 2014. However, 
the referring provider must retain documentation clearly demonstrating 
that they were unable to meet the 10 percent threshold for the measure 
to provide an electronic summary of care document for a transition or 
referral for the reasons previously stated.
    We stress that other issues related to objectives and measures, 
such as a failure to meet a measure threshold, or failure to conduct 
the activities required to meet a measure, will not be considered a 
suitable basis to use the CEHRT options outlined in this final rule.
    Next, we find staff changes and turnover to be an insufficient 
rationale

[[Page 52922]]

for a provider to use the CEHRT options. Some commenters explained that 
circumstances such as the termination or attrition of staff rendered 
them unable to train new staff in time to implement 2014 Edition CEHRT. 
However, we did not intend such rationale to be permissible. Rather, 
references we made in the proposed rule regarding the inadequate amount 
of time to train staff stemmed, again, from the fact that EHR vendors 
were delayed in installing 2014 Edition CEHRT, which, in turn, gave 
providers little to no time to train their staff on the new software. 
We consider staff turnover and changes, as well as any other similar 
situations, to be issues frequently encountered in the normal course of 
business and therefore insufficient grounds for a provider to use the 
CEHRT options.
    Finally, we do not find situations stemming from a provider's 
inaction or delay in implementing 2014 Edition CEHRT sufficient to use 
one of the CEHRT options. These situations include providers waiting 
too long to engage a vendor or a provider's inability or refusal to 
purchase the requisite software update. Such circumstances would not be 
permissible reasons to use the CEHRT options because they did not stem 
from a 2014 Edition CEHRT availability delay.
    We again stress that the proposed rule was intended to allow 
options for providers that were unable to fully implement 2014 Edition 
CEHRT for an EHR reporting period in 2014 due to issues relating to 
2014 Edition CEHRT availability delays. Therefore, we will not remove 
the requirement that a provider's inability to fully implement 2014 
Edition CEHRT was based on issues related to 2014 Edition CEHRT 
availability delays, because this requirement comprises the primary 
reason for the proposed rule.
    In deciding whether a provider can use a CEHRT option, we stress 
that the installation of 2014 Edition CEHRT alone is not the sole 
factor. Obviously, those providers still waiting for installation of 
2014 Edition CEHRT represent the most concrete example of those able to 
use the CEHRT options because it represents the clearest illustration 
of both a 2014 Edition CEHRT availability delay and lack of full 
implementation. However, those providers with 2014 Edition CEHRT 
installed may also be able to use the options for the use of CEHRT. 
Again, we stress that an availability delay is not based solely on 
whether the software is certified and then installed or not, as many 
commenters questioned. Rather, providers with 2014 Edition CEHRT 
installed may nonetheless face a 2014 CEHRT availability delay because 
they are waiting for vendor software updates, or the software itself is 
presenting problems with functionality, or when the software does not 
yet contain all required components. This also may include situations 
where a problem with the software presents a safety issue, such as when 
a drug allergy or drug interaction clinical decision support does not 
function properly, or cases where the vendor identified a functionality 
problem and sends out patches to fix the problem, requiring the 
provider to wait until the issue is resolved to use the software. We 
recognize these issues take time to resolve, and the overall delay in 
2014 Edition CEHRT availability may have constrained that time for many 
providers. So, although we cannot list every possible scenario, 
installed 2014 Edition CEHRT with delayed or missing software updates, 
or cases where the software itself renders a provider unable to 
reliably use the software would be permissible reasons to use the CEHRT 
options because such issues are considered to be a 2014 Edition CEHRT 
availability delay. We stress that this does not include, as explained 
earlier, circumstances where the software functions properly but the 
provider cannot meet one or more requirements of the measure or the 
increased thresholds on measures common to both stages. The basis for 
using one of the CEHRT options stems from a problem with first getting 
the software installed because of EHR vendor delays, and then fully 
implementing (including training, workflows, and related activities) 
2014 Edition CEHRT in time for a full EHR reporting period in 2014. We 
note that being able to implement 2014 Edition CEHRT for a part of the 
reporting period is not considered full implementation of 2014 Edition 
CHERT. Providers who are only able to implement 2014 Edition CEHRT for 
part of a reporting period would be permitted to use the CEHRT options 
in this rule.
    Along this vein, we received requests to define what is allowable 
for staff training, system testing and workflow revision under the 
proposed options for providers who are unable to fully implement 2014 
Edition CEHRT. An inability to train staff, test the updated system, or 
put new workflows in place because of delays associated with the 
installation of 2014 Edition CEHRT constitutes a failure to fully 
implement, and provides sufficient rationale to use the options for the 
use of CEHRT. We note several commenters wanted us to specify cutoff 
dates for training or workflows where we would find it suitable to 
allow using the CEHRT options. However, such limits would be impossible 
for us to adequately capture. Because the number and types of providers 
involved with the EHR Incentive Program vary greatly, we cannot simply 
state a hard date or exact time because a large hospital chain would 
possess different time and workflow requirements, for example, than a 
single EP. However, we can clarify that in order to use one of the 
options for the use of CEHRT, the provider must not have had enough 
time to fully implement 2014 Edition CEHRT, including training of 
staff, perform system testing, and establishing revised workflows in 
order to report for a full EHR reporting period. If a large hospital, 
for example, had their CEHRT installed in August, we expect that this 
hospital would not have enough time to be able to report for an EHR 
reporting period in 2014 because the hospital would not be able to 
train staff or establish the necessary changes in workflow. However, if 
a hospital had 2014 Edition CEHRT installed in January 2014 and decided 
to wait until August 2014 to begin training, testing and workflow 
activities, for example, then this rationale would not be sufficient to 
establish that the provider could not fully implement 2014 Edition 
CEHRT due to a delay in 2014 Edition CEHRT availability, because the 
delay was on the part of the hospital.
    Again, we note that we cannot capture every scenario where a 
provider can use an option for the use of CEHRT and understand a number 
of providers will likely choose to attest under one of the options 
proposed in this final rule. Given the number of stakeholders who 
raised problems with getting 2014 Edition CEHRT fully implemented and 
running, we expected a fairly wide use of the options for the use of 
CEHRT, which is why we proposed these provisions. However, as explained 
earlier, we also proposed the requirement that a provider must attest 
to an inability to fully implement 2014 Edition CEHRT due to issues 
relating to 2014 Edition CEHRT availability delays in order to use the 
CEHRT options. Although we understand the broad application that will 
likely ensue, we believe the parameters set forth earlier will provide 
further guidance to stakeholders in determining whether to use the 
options, while at the same time, continue to move the program forward 
toward the overall goal of the meaningful use of certified EHR 
technology.
    Comment: A number of commenters raised fairness concerns around 
those providers who met all requirements and

[[Page 52923]]

can report using 2014 Edition CEHRT in 2014. These commenters explained 
that such providers and EHR vendors were not being provided with any 
benefit from the options outlined in the proposed rule, or with meeting 
requirements as originally created. Some even suggested that we provide 
additional incentives to those providers who can report as scheduled, 
as an award for meeting all requirements in 2014. Other commenters 
requested that all providers be allowed to use the options for the use 
of CEHRT regardless of the reason.
    Response: We appreciate the commenters' feedback. However, the 
proposed rule was not intended to unfairly favor any stakeholder. 
Rather, we proposed this rule to provide relief to those providers who 
could not meet meaningful use for an EHR reporting period in 2014 using 
2014 Edition CEHRT because of vendor delays with software 
implementation. These providers were caught in situations where their 
vendors did not have 2014 Edition CEHRT ready, and therefore would be 
unable to meet meaningful use for an EHR reporting period in 2014. 
These providers would otherwise not be participating in the program 
which would weaken the overall momentum and diminish essential program 
goals such as continuing to build health information exchange 
infrastructure, increasing participation in essential public health 
reporting programs, and capturing and reporting data on clinical 
standards and quality.
    We applaud those providers and EHR vendors who met all requirements 
and upgraded in time for the EHR reporting period in 2014. We 
understand the time and effort that such a task entailed and continue 
to appreciate the work these pioneers accomplish in moving the EHR 
Incentive Program forward. But, allowing all providers, including those 
who have fully implemented 2014 Edition CEHRT, to use an alternate 
edition of CEHRT would simply be counterintuitive. If we allowed such a 
step, we expect many providers would choose the alternate options and 
continue to report on Stage 1, which would thereby leave us, as also 
noted by some commenters, with little to no data to review on Stage 2. 
Such circumstances, we fear, would later prove problematic in 
implementing Stage 3 and would go against our rationale to review Stage 
2 data in order to mold Stage 3. The entire overarching purpose of the 
EHR Incentive Program is to move providers towards advanced use of 
health IT to support reductions in cost, increased access, and improved 
outcomes for patients. However, allowing all providers--including those 
who can meet meaningful use using 2014 Edition CEHRT--to delay their 
forward progress would put these goals at significant risk. Therefore, 
providers must be able to show an inability to fully implement 2014 
Edition CEHRT because of delays in 2014 Edition CEHRT availability in 
order to use one of the options for the use of CEHRT.
    In addition, although we again applaud those providers who can meet 
meaningful use for an EHR reporting period in 2014 using 2014 Edition 
CEHRT as originally intended, we do not believe that an extra incentive 
for these providers is warranted. The dollar amounts of the incentive 
payments are established by statute, and we do not have authority to 
award additional amounts.
    Comment: Many commenters raised objections to the Stage 2 
objectives and measures. Some commenters stated the measure 
requirements for meeting meaningful use in 2014 are unreasonable. Other 
commenters suggested that the resources and costs required to meet the 
Stage 2 objectives and measures are substantial.
    A commenter stated that although EHR vendors do not have 2014 
Edition CEHRT ready, CMS and ONC continue to set requirements ahead of 
the pace of the market. Some commenters stated that the rush results in 
hurried check box measures, which vendors cannot have ready on time and 
which simply do not work. Other commenters cited general issues with 
2014 Edition CEHRT measures including lab interfaces, patient portals, 
and direct messaging functions.
    Many commenters took objections to the Stage 2 measures themselves. 
Some commenters stated it was unrealistic to expect the Medicare 
beneficiary population to be computer savvy or use email. Other 
commenters objected that labs, prescriptions, and radiology orders must 
be initiated electronically by a licensed clinician. These commenters 
stated that the lack of hand writing for such orders requires a great 
deal of changes in workflows for most practices and affects the 
staffing choices providers make in their practices.
    Many commenters objected to the data that needed to be entered for 
one or more of the Stage 2 measures themselves, finding them time 
consuming, intrusive, costly, and difficult to implement.
    Response: We appreciate the thoughtful input commenters provided 
regarding the Stage 2 meaningful use objectives and measures, including 
challenges in meeting certain measures and the number of objectives to 
report. The flexibility in this final rule recognizes the difficulties 
in meeting measures and objectives specifically due to the inability to 
fully implement 2014 Edition CEHRT based on delays in availability. 
However, modifications to the Stage 2 meaningful use objectives and 
measures were not included in the scope of the proposed rule and will 
not be considered in this final rule. We urge readers to wait until the 
release of the Stage 3 proposed rule to provide comments on ways to 
improve the meaningful use requirements.
    Comment: Some commenters requested clarity on how this will affect 
public health reporting with respect to HL7 version 2.3.1 and version 
2.5.1, and the effect on how providers will meet the measures or claim 
exclusions.
    Response: We proposed no changes to specific measures or to the 
exclusions related to the measures where exclusions apply. We expect 
providers will continue the process of enrolling with and reporting to 
public health agencies as per the requirements of the meaningful use 
objectives related to public health reporting. In addition, if a 
provider sent a test message to a public health agency in a previous 
EHR reporting period and chooses to report to 2013 Stage 1 objective 
and measures or 2014 Stage 1 objectives and measures for the 2014 
reporting period with one of the alternate options for the use of 
CEHRT, the provider is not required to send another test message to 
meet the public health measure for the 2014 reporting period.
    Comment: Some commenters requested that CMS clarify how the 
flexible CEHRT options would be applicable for a provider who practices 
in multiple locations. These commenters questioned how an EP should 
attest to meaningful use if 2014 Edition CEHRT is fully implemented in 
one location, but not in other locations. These providers seek 
clarification as to whether they can attest to meaningful use using 
patient data from only the location with the most encounters during an 
EHR reporting period, and exclude patient data from other locations.
    Response: EPs who practice in multiple locations which have been 
unable to fully implement 2014 Edition CEHRT for an EHR reporting 
period in 2014 due to CEHRT availability delays may attest using the 
options outlined in this final rule. If an EP uses different editions 
of CEHRT at multiple locations, he or she may choose to use the 
alternate CEHRT option that is best applied for his or her patient 
encounters across all locations during the EHR reporting period. 
However, these EPs

[[Page 52924]]

should then use the data from all patient encounters which occur at a 
location equipped with any edition of certified EHR technology, just as 
the EP would use the patient data from all locations equipped with 
CEHRT to meet meaningful use in any other year.
    However, if over 50 percent of the EP's patient encounters during 
the EHR reporting period occur at locations equipped with 2014 Edition 
CEHRT which has been fully implemented, the EP would not be eligible to 
use the flexibility options in this final rule and should therefore 
limit their denominators to only those patient encounters in locations 
equipped with fully implemented 2014 Edition CEHRT.
    Comment: Several commenters noted that it is unreasonable to expect 
first time providers to attest by October 1, 2014. These commenters 
suggested that providers who are attesting for the first time in 2014 
should be allowed to do so through the end of the calendar year.
    Response: It should be noted that new participants in the EHR 
Incentive Programs may choose any 90 days up to the end of the year to 
complete and EHR reporting period, and they have until the close of the 
attestation period (February 28, 2015 for EPs and November 30, 2014 for 
CAHS and eligible hospitals) to attest to meaningful use and receive an 
incentive payment for the EHR reporting period in 2014. Successfully 
demonstrating meaningful use for any reporting period in 2014 would 
allow these providers to avoid the 2016 payment adjustment. The October 
1, 2014 deadline is the date by which EPs who have not demonstrated 
meaningful use in a prior year must attest in order to also avoid the 
2015 payment adjustment. First time participants would otherwise be 
subject to the 2015 payment adjustment because they did not meet 
meaningful use in 2013. This does not apply to brand new providers who 
have an automatic 2 year exemption from the payment adjustments.
    However, we reiterate all new participants in 2014 may earn an 
incentive payment for 2014 and avoid the 2016 payment adjustment by 
successfully demonstrating meaningful use for an EHR reporting period 
of any continuous 90 days in 2014. Even if these providers do not meet 
the early attestation deadline and therefore receive a payment 
adjustment in 2015, they may still earn an incentive payment for 
meeting meaningful use for an EHR reporting period in 2014.
    Comment: Several commenters questioned whether they could attest 
for 2014 using a prior quarter in 2014 using 2011 Edition CEHRT and 
2013 Stage 1 objectives and measures, or whether they can only use the 
fourth quarter for an EHR reporting period. Other commenters stated 
generally whether any earlier reporting period could be used and 
requested clarification on the attestation deadlines for each quarterly 
reporting period.
    Response: Given commenter feedback, we recognize that some 
confusion exists in this area. We wish to reiterate the attestation 
deadline to attest for an EHR reporting period is not 60 days after the 
end of any given reporting period (3-month quarter or 90 days for new 
participants). The deadline is 2 months after the end of the federal 
fiscal year (for hospitals) or the calendar year (for EPs).).
    Therefore, we are clarifying that providers may attest to any 3-
month quarter EHR reporting period in 2014 from the date of completion 
of that reporting period, through the end of the open attestation 
period for the year. For EPs, this means any point after the close of 
their chosen reporting period through to 2 months after the end of the 
calendar year (February 28, 2015). For eligible hospitals and CAHs this 
means any point after the close of their chosen reporting period 
through to 2 months after the end of the fiscal year (November 30, 
2014).
    Comment: Several commenters requested clarification regarding the 
attestation process. Commenters rrequested that CMS clarify what 
documentation that would be required to show an inability to fully 
implement 2014 Edition CEHRT. A commenter recommended that CMS provide 
an attestation statement for providers to certify they could not fully 
implement the 2014 Edition CEHRT due to delays in availability. Another 
commenter suggested that CMS specify when the attestation system will 
be updated with the new requirements promulgated in the final rule.
    Response: For providers attesting for the EHR reporting period in 
2014, the system determines the CEHRT edition entered by the provider 
when the EHR certification number is entered. Providers utilizing the 
options proposed would be required to attest that they were unable to 
fully implement 2014 Edition CEHRT for a full EHR reporting period in 
2014 due to delays in 2014 Edition CEHRT availability. We did not 
propose requiring additional documentation from providers at the time 
of attestation beyond the data required to be entered into the 
Registration and Attestation System. We present further clarification 
of the full attestation process in section IV of this final rule.
    Comment: Several commenters questioned how the audit process would 
work given the flexible options for using certified EHR technology. 
These commenters sought clarification on what types of documentation 
would be required in cases of an audit. Some commenters request that 
CMS not require any documentation, in order to alleviate provider 
burden. However, other commenters, mainly those responsible for 
attestation, wanted us to require some level of documentation, in order 
to provide protection in cases of an audit. Commenters were generally 
concerned with auditors retroactively applying different standards than 
what is outlined in this rule.
    A few commenters wanted the provider's decision to use flexible 
attestation outside the auditor's purview completely. Other commenters 
were concerned with the auditor's focus given these flexible 
requirements. These commenters explained with such a small pool of 
Stage 2 attesters likely, auditors may not focus their efforts evenly 
across both Stages, thereby unfairly punishing the smaller Stage 2 
attester group, who succeeded in implementing and reporting using the 
2014 Edition CEHRT. These commenters suggested ensuring that audits 
were fairly conducted across both Stages, given the likelihood for a 
higher number of Stage 1 attesters.
    Response: We appreciate the commenters' feedback and would like to 
clarify some aspects of the audit process in response to the comments. 
Audits under the EHR Incentive Program do not occur based solely upon 
provider type, location, stage of meaningful use, or year of 
participation. Rather, we follow standard guidelines for programs 
conducting audits including auditing providers based on a random 
selection process, as well as selection based on key identifiers such 
as prior audit failure or known incidence of fraud.
    Therefore, although we acknowledge that the flexible options for 
CEHRT we proposed may modify a provider's timeline for implementation 
of meaningful use, we stress that a provider attesting to Stage 2 using 
the 2014 Edition CEHRT is no more likely to be subject to an audit than 
any other provider attesting in 2014.
    We also acknowledge providers' concerns about required 
documentation in cases of an audit. To alleviate those concerns, we 
wish to clarify that we will provide guidance to auditors relating to 
this final rule and the attestation process. This instruction should 
include requiring auditors to work closely with providers on the 
supporting documentation needed applicable to the

[[Page 52925]]

provider's individual case. We further stress that audit determinations 
are finalized on a case by case basis, which allows us to give 
individual consideration to each provider. We believe that such case-
by-case review will allow us to adequately account for the varied 
circumstances that may result in a provider selecting a different CEHRT 
option.
    Comment: Some commenters suggested that these changes would lead to 
many Medicaid EPs not submitting their 2014 attestations until after 
January 1, 2015; and if they are also Medicare providers they may be 
subject to the Medicare penalty if they did not submit a hardship 
exemption by the deadline. Many commenters are concerned that if states 
extend the attestation period in order to accommodate these changes, it 
will only result in slowing 2015 work flows. They believe that 
providers who are already struggling with navigating the requirements 
must add another layer of decisions in the process.
    Response: We do anticipate that if states require additional time 
to implement system changes to allow providers to attest to meaningful 
use under these proposed options, a contingent of Medicaid EPs may not 
be able to submit 2014 attestations until after January 1, 2015. 
However, if a provider meets meaningful use for an EHR reporting period 
for 2014 in the Medicaid program, they will not be subject to a 
Medicare payment adjustment in 2016 even if they attest after January 
1, 2015.
    It is true that Medicaid providers who do not meet meaningful use 
for an EHR reporting period in 2014, who are also Medicare providers, 
may be subject to the Medicare penalty if they did not submit a 
hardship exception application by the deadline. However, we note that 
the application deadline for providers who do not demonstrate 
meaningful use in 2014 is April 1, 2015 for eligible hospitals and July 
1, 2015 for EPs. Therefore, there is time for these EPs to apply for an 
exception if they find they are unable to meet meaningful use in the 
Medicaid program. Further clarification of hardship exceptions may be 
found in later in this section of this final rule. Regarding the 
deadline for attestations, states that have extended this deadline (and 
in many cases, on an annual basis) in the past, have had a significant 
number of EPs and eligible hospitals attest during that period. These 
states have not reported work flow delays as a result. It is important 
for states, with CMS support, to educate the provider community with 
the latest information related to meeting the requirements of 
meaningful use and to raise awareness on CEHRT requirements so 
providers can make informed decisions and successfully participate in 
the program.
    Comment: Some commenters expressed a variety of concerns around 
hardship exceptions for the Medicare payment adjustments. Some wanted 
clarification on the requirements for a hardship exception application 
for providers who were unable to implement 2014 Edition CEHRT due to 
delays in 2014 Edition CEHRT availability. A few commenters requested 
clarification that this final rule did not affect the ability for a 
provider to receive an incentive payment. Another commenter expressed 
frustration with losing his incentive payment should he choose to file 
a hardship exception application. Other commenters stated that their 
vendors refused to provide letters on their behalf to include with 
their hardship exception application. A commenter specifically 
questioned whether the 2014 Edition CEHRT hardship would remain in 
effect for payment year 2015. Several commenters suggested that we 
should allow hardship exceptions for those providers near retiring, as 
the cost to implement and upgrade EHR systems are far too costly for 
those with one or few more years of practice. Many commenters stated 
that the deadline to file a hardship application should be extended 
given the timing of this rule. Other commenters wanted us to consider a 
blanket hardship exemption allowing all EPs to skip attestations in 
2014 without penalty. These commenters noted establishing this 
alternative would push back penalties to 2016, allowing Medicare EPs to 
skip 2014 without affecting their Medicare reimbursement rates.
    Response: We thank the commenters for their input and we recognize 
that further clarification is required around the subject of hardship 
exceptions related to the 2014 Edition CEHRT availability delays. To 
clarify the basic deadlines, a provider who is unable to demonstrate 
meaningful use in 2014 may apply to qualify for a hardship exception 
for the 2016 payment adjustment at any point before April 1, 2015 for 
eligible hospitals and CAHS, and July 1, 2015 for EPs.
    The only providers for whom the hardship exception application 
deadline has already passed are providers seeking an exception from the 
2015 payment adjustment because they did not successfully demonstrate 
meaningful use in 2013. This may include providers that are 
participating in the program for the first time in 2014 and seek to 
demonstrate meaningful use by the deadline established for new 
participants to avoid the 2015 payment adjustment. A new participant 
who applied for a hardship by the July 1 deadline, and then later is 
able to meet meaningful use, may attest to their meaningful use data 
for 2014 without needing to withdraw the hardship application and 
without any other penalty.
    The proposals allow providers flexible options to meet meaningful 
use in order to qualify for an incentive payment for 2014, and to meet 
meaningful use to avoid the 2016 payment adjustment. These options are 
based on a provider's inability to fully implement 2014 Edition CEHRT 
caused by a delay in 2014 Edition CEHRT availability.
    Again, it is not necessary to extend the hardship exception 
application deadline for providers who are unable to meet meaningful 
use in 2014 and therefore wish to apply for an exception to the 2016 
payment adjustment. We reiterate that the deadline for eligible 
hospitals to apply for a hardship exception for the 2016 payment 
adjustment is April 1, 2015. The deadline for EPs to apply for a 
hardship exception for the 2016 payment adjustment is July 1, 2015. 
Comments requesting that we consider other types of hardship exceptions 
fall outside the scope of this rule and will not be addressed.
    Comment: Many commenters questioned whether the proposed changes 
would affect the payment incentives and payment adjustments for 2014 
and subsequent years. Some commenters requested clarification on the 
progression through the Stage of meaningful use and on the 
participation schedule if providers use one of the CEHRT options to 
meet meaningful use for an EHR reporting period in 2014. These comments 
included suggestions such as extending incentive payments indefinitely 
and suggestions to provide additional payment incentives for providers 
who meet meaningful use using 2014 Edition CEHRT in 2014 as scheduled. 
On payment adjustments, commenters requested that we delay all payments 
adjustments for multiple years or eliminate payment adjustments 
entirely.
    Response: First, the schedule of participation for a provider in 
the Medicare EHR Incentive Program for 2015 and subsequent years is not 
altered under this rule. For example, if a provider in the Medicare 
program first demonstrates meaningful use in 2012 that is Stage 1 Year 
1 for that provider. Subsequently, the stages and years

[[Page 52926]]

progress consecutively for the Medicare EHR Incentive Program whether 
or not the provider meets meaningful use; or whether or not the 
provider uses a different CEHRT option in 2014. So a Medicare provider 
who does Stage 1 Year 1 in 2012 would be in Stage 2 Year 2 in 2015 
regardless of their participation in the intervening years. One of the 
reasons we proposed this rule was because we recognized that 2014 is 
the last year to begin earning incentive payments under the Medicare 
EHR Incentive Program. This rule will allow providers to meet 
meaningful use and earn and incentive payment using the flexible CEHRT 
options for an EHR reporting period in 2014 if they were unable to 
fully implement 2014 Edition CEHRT due to 2014 Edition CEHRT 
availability delays. If a provider meets meaningful use in 2014, that 
provider may go on to earn incentive payments for successful 
participation in 2015 and 2016 in the Medicare EHR Incentive Program.
    However, both the incentive payment amounts and timing, and the 
payment adjustment amounts and timing, are set by the HITECH Act. The 
dollar amounts and timing of the incentive payments under Medicare and 
Medicaid are established by statute (see, for example, section 
1848(o)(1)(B) of the Act), and CMS does not have authority to extend or 
provide additional incentive payments. Similarly, the statute requires 
downward adjustments to Medicare payments beginning in 2015 (see, for 
example, section 1848(a)(7)(A) of the Act) if a provider is not a 
meaningful EHR user for an EHR reporting period for the payment 
adjustment year, and we do not have authority to delay or eliminate 
these adjustments.
    Comment: Several commenters suggested that we consider whether the 
regulation text under 42 CFR Part 495 should be further revised to 
reflect the proposed options for using CEHRT in 2014 and the 
corresponding objectives and measures of Stages 1 and 2 of meaningful 
use to which a provider would attest. In particular, the commenters 
noted that the regulation text for the Stage 1 criteria of meaningful 
use for EPs, eligible hospitals, and CAHs under Sec.  495.6 includes 
references to changes in the criteria applicable beginning in 2014.
    Response: We thank the commenters for their suggestions and agree 
that further changes to the regulation text will help to offer clarity 
for providers seeking to demonstrate meaningful use for 2014 under 
these options. Accordingly, we revised Sec.  495.6 to specify the 
flexible options for using CEHRT in 2014 and the objectives and 
associated measures of meaningful use to which providers using these 
options would attest. Specifically, these revisions indicate that for 
an EHR reporting period in 2014, if a provider could not fully 
implement 2014 Edition CEHRT due to delays in 2014 Edition CEHRT 
availability, the following apply. An EP, eligible hospital, or CAH 
that uses only 2011 Edition CEHRT must satisfy the objectives and 
measures for Stage 1 applicable for an EHR reporting period in 2013. An 
EP, eligible hospital, or CAH that uses a combination of 2011 Edition 
CEHRT and 2014 Edition CEHRT may choose to satisfy the objectives and 
measures for Stage 1 that were applicable for 2013 or the objectives 
and measures for Stage 1 that are applicable beginning with 2014, or if 
they are scheduled to begin Stage 2 in 2014, they may choose to satisfy 
the objectives and measures for Stage 2. An EP, eligible hospital, or 
CAH that is scheduled to begin Stage 2 in 2014, but is unable to fully 
implement all the functions of their 2014 Edition CEHRT required for 
the Stage 2 objectives and measures due to delays in 2014 Edition CEHRT 
availability, may choose to satisfy the objectives and measures for 
Stage 1 that are applicable beginning with 2014 using 2014 Edition 
CEHRT.
    As noted earlier, we proposed that EPs, eligible hospitals, and 
CAHs that use these options must attest that they are unable to fully 
implement 2014 Edition CEHRT because of issues related to 2014 Edition 
CEHRT availability delays when they attest to the meaningful use 
objectives and measures. In this final rule, we revised Sec.  495.8 to 
reflect this attestation requirement for providers that use the options 
for CEHRT in 2014 described in the preceding paragraph.
    After reviewing the public comments, and for the reasons stated 
previously, we are finalizing the proposals discussed in section 
III.A.1. of this final rule without modification as well as the 
revisions to the regulation text under Sec. Sec.  495.6, 495.8, and 
495.302.
2. Extension of Stage 2
    In the proposed rule, we noted that under the current timeline 
shown in Table 1, an EP, eligible hospital or CAH that first became a 
meaningful user in 2011 or 2012 would be required to begin Stage 3 on 
January 1, 2016 (the first day of CY 2016 for EPs) or October 1, 2015 
(the first day of FY 2016 for eligible hospitals or CAHs), 
respectively. However, because we intend to analyze the meaningful use 
Stage 2 data to inform our development of the criteria for Stage 3 of 
meaningful use, we proposed a 1-year extension of Stage 2 for those 
providers as is reflected in Table 3. We proposed that Stage 3 would 
begin in CY 2017 for EPs and FY 2017 for eligible hospitals and CAHs 
that first became meaningful users in 2011 or 2012. The goal of this 
proposed change is two-fold: first, to allow CMS and ONC to focus 
efforts on the successful implementation of the enhanced patient 
engagement, interoperability, and health information exchange 
requirements in Stage 2; and second, to use data from Stage 2 
participation to inform policy decisions for Stage 3.
    This proposed change would allow EPs, eligible hospitals, and CAHs 
that first became meaningful users in 2011 or 2012 to begin Stage 3 on 
January 1, 2017 (EPs) and October 1, 2016 (eligible hospitals and 
CAHs). We will maintain the existing timeline for providers that first 
became meaningful users in 2013 and for those that begin in 2014 and 
subsequent years or until new certification requirements are adopted in 
subsequent rulemaking, as shown in Table 3.

                                        Table 3--Proposed Stage of Meaningful Use Criteria by First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Stage of meaningful use
      First payment year      --------------------------------------------------------------------------------------------------------------------------
                                  2011       2012       2013        2014        2015       2016       2017       2018       2019       2020       2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.........................          1          1          1  1 or 2*              2          2          3          3        TBD        TBD        TBD
2012.........................  .........          1          1  1or 2*               2          2          3          3        TBD        TBD        TBD
2013.........................  .........  .........          1  1*                   2          2          3          3        TBD        TBD        TBD
2014.........................  .........  .........  .........  1*                   1          2          2          3          3        TBD        TBD
2015.........................  .........  .........  .........  ...........          1          1          2          2          3          3        TBD
2016.........................  .........  .........  .........  ...........  .........          1          1          2          2          3          3

[[Page 52927]]

 
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.

    Comment: Many commenters supported what they considered to be a 
delay of Stage 2. Some commenters requested that we delay the start of 
Stage 2 into 2015 for private practices given the significant changes 
to the EHR systems, which challenge small independent private practices 
to become knowledgeable about new features and allow enough time to 
train staff.
    Response: As confirmed by the overwhelming number of comments 
received in support of these proposals, we believe the changes proposed 
give providers the flexibility and time needed to adequately upgrade 
and implement 2014 Edition CEHRT. However, we do wish to clarify that 
the proposals do not delay the start of Stage 2, as characterized by 
several commenters. Rather, the proposals do two things: provide 
options to those providers who could not fully implement 2014 Edition 
CEHRT for an EHR reporting period in 2014 due to delays in the 
availability of 2014 Edition CEHRT, and extend Stage 2 through 2016 so 
that providers who would have started Stage 3 in that year will not do 
so until 2017. Moreover, although we welcome comments and suggestion on 
the EHR Incentive Program, we did not propose to delay the start of 
Stage 2 to 2015. The proposed rule was not intended to delay the 
forward progress from Stage 1 to Stage 2, but to provide relief for 
providers in any stage of meaningful use who were unable to fully 
implement 2014 Edition CEHRT as required for any stage or year of 
participation in the program. We believe the requirements of Stage 2 
build on the foundation of Stage 1, and are essential to moving toward 
advanced use of EHRs, enhanced interoperability and health information 
exchange, and ultimately will support efforts to improve patient care. 
For these reasons, we did not propose to change the schedule to begin 
Stage 2, the reporting requirements, or the objectives and measures of 
Stage 2 of meaningful use.
    Comment: Commenters generally agree with extending Stage 2 through 
2016 for providers who would have begun Stage 3; however, many 
commenters further suggested delaying Stage 3 indefinitely or at least 
for one or more additional years. Some commenters believe that starting 
Stage 3 in 2017 is premature. Some commenters requested that Stage 3 
remain optional or not even start until at least 2018. Other commenters 
requested that CMS not finalize Stage 3 yet or at all and continue with 
Stages 1 and 2 until we change the requirement in future rulemaking. 
Another commenter suggested we stay on Stage 1 for the next few years 
and then implement Stages 2 and 3 as optional pilot programs.
    Response: Although we always welcome suggestions on ways to improve 
the EHR Incentive Program, other changes to Stage 3 of meaningful use 
are not under consideration in this rule. We urge readers to wait until 
the release of the Stage 3 proposed rule to provide comments on this 
particular area including potential timing for implementation.
    Comment: Commenters generally supported delaying Stage 3 to allow 
time to evaluate prior performance so that we can incorporate lessons 
learned from Stage 2 into Stage 3, although some questioned whether the 
timing for Stage 3 would allow adequate reflection on performance in 
Stage 2. Some commenters stated that merely delaying Stage 3, as 
proposed, is not enough. A commenter specifically requested detail on 
how the data we obtain in Stage 2 would be analyzed and used in Stage 
3. Another requested that we conduct surveys of providers as part of 
Stage 3, to increase the quality of our educational guidance.
    Response: We appreciate the commenters' input and reiterate that we 
intend to use the data received on performance at Stages 1 and 2 of 
meaningful use to inform policy decisions in consideration for Stage 3. 
We also are engaged with our partners at ONC in conducting ongoing 
analysis into meaningful use participation among providers including 
both readiness for advanced use of EHRs and provider reflections on the 
functions of CEHRT including the objectives and measures which 
represent the greatest potential benefit for providers and patients. We 
will use this information to inform decision making for the provisions 
included in Stage 3 of meaningful use.
    After consideration of the public comments received, and for the 
reasons stated previously, we are finalizing the proposal to extend 
Stage 2 through CY 2016 for EPs and FY 2016 for eligible hospitals and 
CAHs that first became meaningful EHR users in CY/FY 2011 or 2012. 
These providers will begin Stage 3 in CY or FY 2017, respectively. 
Stage 3 objectives and measures and reporting criteria will be defined 
in future rulemaking.

B. Clinical Quality Measure Submission in 2014

    In the proposed rule, we described how beginning in 2014, as part 
of the definition of ``meaningful EHR user'' under 42 CFR 495.4, all 
eligible providers are required to select and report on CQMs from the 
relevant sets adopted in the Stage 2 final rule (77 FR 54069 through 
54075, and 77 FR 54081 through 54089) and further specified as noted in 
the December 7, 2012 interim final rule with comment period (77 FR 
72985) and published on the CMS eCQM Library [http://cms.gov/
Regulations-and-Guidance/Legislation/EHRIncentivePrograms/
eCQMLibrary.html], regardless of their stage of meaningful use 
or year of participation in the EHR Incentive Program. We proposed the 
following changes for reporting on clinical quality measures in 2014 
for EPs, eligible hospitals, and CAHs for the Medicare and Medicaid EHR 
Incentive Programs. The method of CQM submission under this proposal 
would depend on the edition of CEHRT a provider uses to record, 
calculate, and report its CQMs for the EHR reporting period in 2014.
    Due to limitations in the Registration and Attestation System for 
the EHR Incentive Program and other CMS data systems, the reporting 
options and methods for CQMs for 2014 would depend upon the edition of 
CEHRT that a provider uses for the EHR reporting period in 2014. If a 
provider elects to use only 2011 Edition CEHRT for the EHR reporting 
period in 2014, the provider would be required to report CQMs by 
attestation as follows:

[[Page 52928]]

     EPs would report from the set of 44 measures and according 
to the reporting criteria finalized in the Stage 1 final rule (75 FR 
44386 through 44411)--
    ++ Three core/alternate core;
    ++ Three additional measures; and
    ++ The reporting period would be any continuous 90 days within CY 
2014 for EPs that are demonstrating meaningful use for the first time 
or a 3-month CY quarter for EPs that have previously demonstrated 
meaningful use.
     Eligible hospitals and CAHs would report all 15 measures 
finalized in the Stage 1 final rule (75 FR 44411 through 44422).
     The reporting period would be any continuous 90 days 
within FY 2014 for hospitals that are demonstrating meaningful use for 
the first time or a 3-month FY quarter for hospitals that have 
previously demonstrated meaningful use.
    If a provider elects to use a combination of 2011 Edition and 2014 
Edition CEHRT and chooses to attest to the 2013 Stage 1 objectives and 
measures for its EHR reporting period in 2014, the provider would be 
required to report CQMs by attestation using the same measure sets and 
reporting criteria outlined earlier for providers who elect to use only 
2011 Edition CEHRT for the EHR reporting period in 2014. Because of the 
differences in how CQMs are calculated and tested between the 2011 and 
the 2014 Editions of CEHRT, we further proposed that a provider may 
attest to data for the CQMs derived exclusively from the 2011 Edition 
CEHRT for the portion of the reporting period in which 2011 Edition 
CEHRT was in place.
    If a provider elects to use a combination of 2011 Edition and 2014 
Edition CEHRT and chooses to attest to the 2014 Stage 1 objectives and 
measures or the Stage 2 objectives and measures, the provider would be 
required to submit CQMs in accordance with the requirements and 
policies established for clinical quality measure reporting for 2014 in 
the Stage 2 final rule and subsequent rulemakings. For further 
explanation, we refer readers to the following: For EPs--77 FR 54049 
through 54089, 77 FR 72985 through 72991, 78 FR 74753 through 74757; 
and for eligible hospitals and CAHs--77 FR 54049 through 54089, 77 FR 
72985 through 72991, 78 FR 50903 through 50906. We also proposed that a 
provider must submit CQMs in accordance with the requirements and 
policies established for 2014 in those rulemakings if the provider 
elects to use only 2014 Edition CEHRT for the entire duration of its 
EHR reporting period in 2014, regardless of the stage of meaningful use 
that the provider chooses to meet. For the Medicaid EHR Incentive 
Program, the method of reporting CQMs for EPs and eligible hospitals 
will continue to be at the state's discretion subject to our prior 
approval, as established in the Stage 2 final rule (77 FR 54075 through 
54078, and 54087 through 54089).
    Comment: We received a number of comments on a variety of issues 
relating to the CQMs under the EHR Incentive Program. These comments 
included multiple suggestions falling outside the scope of the 
proposals outlined in the proposed rule. These suggestions included 
changing or excluding one or more measures from the program, general 
objections to the measures or measure calculations, or suggestions for 
new measures for inclusion in the program. Other commenters suggested 
hospitals were simply not ready to report quality measures through 
electronic health data rather than chart abstraction. These commenters 
requested that we allow hospitals more time to move into the electronic 
world. Other commenters expressed concern over the difficulty 
specialists may encounter in reporting on the current CQMs as some CQMs 
are not relevant to their practice specialty or their patient 
population.
    Those comments falling within the scope of the proposed rule mainly 
sought clarification on CQM reporting given the flexible options 
proposed for the use of CEHRT. Some commenters questioned if a 
provider, using 2014 Edition CEHRT, could choose to attest to either 
Stage 1 or Stage 2 objectives and measures, and whether the provider 
would need to submit CQMs in accordance with the requirements 
established for clinical quality measure reporting for 2014 in prior 
final rules.
    Other commenters sought clarification on the proper CQM version to 
use for attestation. Specifically, commenters sought confirmation that 
a provider must report on the versions of the CQMs in use before 2014 
if they attest to the 2013 Stage 1 objectives and measures; and that a 
provider must report on the 2014 CQMs if they attest to the 2014 Stage 
1 objectives and measures or Stage 2 objectives and measures. A few 
commenters added that under these types of situations, making vendors 
support older versions of CQMs represents an obstacle and burden to 
participating using an alternate CEHRT option. A commenter added that 
most vendors who upgraded to 2014 will not be able to support 
requirements for the prior version of CQMs.
    Other commenters requested clarification regarding quality measure 
reporting and alignment across programs such as how the proposals 
affect requirements for the EHR Incentive Program and PQRS. Some 
commenters encouraged CMS to allow physician participation in PQRS in 
2014 to satisfy the quality measure portion of the EHR Incentive 
Program for 2014. These commenters pointed out that the use of an older 
edition may not support electronic quality measure reporting, thereby 
resulting in duplicative reporting in PQRS and the EHR Incentive 
Programs. The commenters believe such duplicative reporting will be 
confusing and burdensome to many providers, and requested that CMS 
consider reporting in PQRS sufficient to cover both programs.
    Response: As detailed in previous parts of this final rule, we 
proposed a limited number of changes for the EHR Incentive Programs in 
2014. These changes did not include alterations or exclusions to the 
CQMs themselves.
    We appreciate commenter's concern regarding the limited number of 
measures applicable to certain specialties and wish to provide some 
clarification in this area. For these providers, we encourage them to 
evaluate the entire list of CQMs and choose those CQMs most applicable 
to their practice, including the more broadly applicable preventive 
care CQMs. We understand cases may exist where an EP may not find a 
full set of CQMs where they have data for both the numerator and 
denominator. We remind providers that they may submit a zero as the 
denominator for a CQM if that is the resulting calculation displayed by 
their EHR, and as long as their EHR is certified to report the CQM for 
providers who are using 2014 Edition CEHRT.
    Next, we wish to address those comments raised in relation to CQM 
reporting for the purposes of meeting meaningful use for an EHR 
reporting period in 2014. We remind providers that for any of the 
options for the use of CEHRT, a provider may report CQMs on a 3 month 
quarter, or any 90 days if demonstrating meaningful use for the first 
time. A provider may also report a full year of CQM data if they so 
choose.
    We confirm that a provider who chooses to attest to the 2013 Stage 
1 objectives and measures must also report the CQMs that were 
applicable for 2013 through the registration and attestation system in 
the manner that was required for 2013 for the purposes of meeting 
meaningful use. Although we acknowledge that this requirement may cause 
some difficulty with maintaining older measure versions that cannot be

[[Page 52929]]

electronically reported, we believe for many providers it outweighs the 
risk of failing to meet meaningful use due to the inability to fully 
implement 2014 Edition CEHRT for an EHR reporting period in 2014.
    We further clarify that a provider who chooses to attest to the 
2014 Stage 1 objectives and measures or the Stage 2 objectives and 
measures must also report the 2014 CQMs in the manner that was required 
for 2014 for the purposes of meeting meaningful use. This includes 
attestation or electronic reporting of CQM data through the established 
reporting methods.
    Finally, while we understand and share the commenter's commitment 
to quality measurement alignment, we cannot accept submission of CQMs 
unless they are submitted using the previously established reporting 
methods for the EHR Incentive Program in 2014 using 2014 Edition CEHRT. 
In addition, we cannot accept CQM submissions for providers using only 
2011 Edition CEHRT unless they are submitted through the attestation 
process. We seek to align quality reporting programs where appropriate 
and reduce provider burden wherever possible, as shown by our previous 
efforts to align some of the reporting and submission requirements for 
the CQM portion of meaningful use with the EHR reporting option for 
PQRS. Moving forward, we will continue to evaluate ways to align these 
programs to reduce provider burden.
    Comment: Some commenters wanted clarification of the CQM submission 
in 2014 and alignment of the GPRO Web interface program with Meaningful 
Use in 2014 as a GPRO submitter. These commenters questioned if the 
option to submit quality measures via the GPRO web interface to report 
the 2014 CQMs and meet the meaningful use requirement for CQM reporting 
would still be available in 2014 if they are attesting to the 2014 
edition of CEHRT for Meaningful Use for either stage 1 or 2.
    Response: We appreciate the commenter for these questions and 
provide confirmation that this understanding is correct. Group 
practices that successfully complete the PQRS GPRO Web Interface in 
2014 will also satisfy the CQM component of meaningful use for the 
Medicare EHR Incentive Program as long as they use an EHR technology 
product certified to the 2014 edition certification criteria. However, 
we note that EPs within the group will still be required to separately 
attest to their meaningful use objectives through the Medicare EHR 
Incentive Programs Registration and Attestation System.
    Comment: Several commenters wanted the option of mixing and 
matching between 2013 and 2014 Stage 1 objectives and measures and the 
related CQMs. These commenters wanted the ability to pick some 2013 
stage 1 functional objectives and measures and then some 2014 stage 1 
functional objectives and measures and different versions of the CQMs 
in order to demonstrate meaningful use. Other commenters, along similar 
lines, wanted to mix and match between the 2013 Stage 1 functional 
objectives and the 2014 CQMs, or vice versa. Several commenters believe 
providers should have more flexibility in the CQMs they choose to 
report, regardless of the specific stage of meaningful use they meet.
    Response: We appreciate the commenters' suggestions. However, we 
did not propose the ability to mix and match between the meaningful use 
objectives and measures and the CQMs for different years for a number 
of reasons. First, the flexibility proposed leverages the existing 
definitions of meaningful use which are tied to the use of specific 
editions of CEHRT. These CEHRT Editions are required to support 
specific meaningful use objectives and measures as well as the clinical 
quality measures required for the program. Second, the complexity of 
the systems required to support attestation and CQM submission would 
mean we would be unable to operationalize that flexibility in time to 
allow providers to attest for an EHR reporting period in 2014 if we 
allowed for additional flexibility in this manner. Therefore, providers 
must attest to the required set of objectives and measures applicable 
for the CEHRT option they choose, as well as the CQMs that relate to 
that option. If a provider chooses the 2013 Stage 1 objectives and 
measures they must attest to the CQMs using the reporting requirements 
specified for 2013. Providers selecting this option for the use of 
CEHRT have the ability to electronically report the 2014 CQMs to 
quality programs such as PQRS and IQR separately for participation in 
those programs should they so choose.
    Comment: Some commenters expressed concern about the potential 
difficulty with reporting CQMs for the EHR reporting period in 2014 
under the options outlined in the proposed rule. These concerns 
included issues around the backward compatibility of 2014 Edition CEHRT 
to 2011 CQMs, as well as the overall changes to the CQMs available for 
providers to report in 2014 which may not include CQMs they reported on 
in previous years. In addition, some commenters mentioned that their 
EHR modules for reporting CQMs might be entirely separate from the rest 
of their CEHRT and therefore updated at a different point in time. 
Providers also mentioned that this could impact the integrity of the 
data for CQMs which are derived from 2011 Edition CEHRT or a 
combination of CEHRT editions. A commenter questioned whether an EP 
using 2011 Edition CEHRT for 60 days of a 90-day reporting period (and 
2014 Edition CEHRT for 30 days of the EHR reporting period), would only 
have to report on CQMs for that 60-day period if they chose to attest 
to the 2013 Stage 1 meaningful use objectives and measures.
    Response: We appreciate the commenters for their insight on how CQM 
reporting may be a challenge under the proposed options, especially 
given the nuances of how the CQMs are collected within the CEHRT. As 
discussed previously, we are not considering an option to decouple the 
CQMs applicable for use in 2013 from the 2013 Stage 1 objectives and 
measures, nor are we considering separating the 2014 CQMs from the 2014 
Stage 1 objectives and measures or the Stage 2 objectives and measures.
    However, providers are already permitted under the EHR Incentive 
Programs to use a different reporting period for the CQMs for 2014 than 
for the objectives and measures of meaningful use under Sec.  495.6. We 
believe this existing provision will help to mitigate the potential of 
a provider having a different timeline for implementation of a 2014 
Edition CEHRT module for CQMs than for the rest of their 2014 Edition 
CEHRT. This means that providers could use an earlier quarter of data 
derived from their 2011 Edition CEHRT to report CQMs if they use the 
option allowing for attestation to the 2013 Stage 1 objectives and 
measures using 2011 Edition CEHRT or a combination of 2011 and 2014 
Edition CEHRT. In addition, we confirm the commenter's query that if a 
provider chooses to use a combination of 2011 Edition and 2014 Edition 
CEHRT and attests to the 2013 Stage 1 meaningful use objectives and 
measures, that provider may use the 2011 Edition CEHRT for 60 days of a 
90-day reporting period (and 2014 Edition CEHRT for 30 days of the 
reporting period), and only report on CQMs for that 60-day period. We 
proposed allowing providers to use a subset of data for the CQMs in use 
for 2013 for any period of time in which the 2011 Edition CEHRT was in 
place if they are

[[Page 52930]]

attesting to the 2013 Stage 1 objectives and measures using a 
combination of 2011 Edition and 2014 Edition CEHRT. We believe this 
will help mitigate problems for providers that are seeking to use a 
combination of 2011 Edition and 2014 Edition CEHRT that may no longer 
have the same CQMs available in their 2014 Edition CEHRT. Finally, we 
will be clearly categorizing the data received from each reporting 
option in order to preserve the ability to effectively analyze the data 
received for the purposes of meaningful use.
    After reviewing the public comments, and for the reasons stated 
previously, we are finalizing the proposals discussed in this section 
(III.B) without modification.

C. Revision to the CEHRT Definition for Flexibility in 2014

    In the May 23, 2014 proposed rule, ONC proposed making a minor, but 
necessary, corresponding revision to the CEHRT definition at 45 CFR 
170.102 to support the CMS proposals to provide additional flexibility 
in the use of CEHRT for the Medicare and Medicaid EHR Incentive 
Programs during 2014. This proposal was intended to remove the cutoff 
date for the use of 2011 Edition CEHRT in order to allow for its 
continued use by providers to meet meaningful use for an EHR reporting 
period in 2014.
    ONC proposed revising the CEHRT definition to change certain 
Federal fiscal year (FY)/calendar year (CY) cutoffs in paragraphs (1) 
and (2) of the CEHRT definition under 45 CFR 170.102. These FY/CY 
cutoffs were finalized in ONC's 2014 Edition final rule (77 FR 54257 
through 54260). The policy in paragraph (1) of the definition applies 
to any fiscal year/calendar year up to and including 2013. The policy 
in paragraph (2) of the definition applies to FY 2014/CY 2014 and all 
subsequent years.
    Paragraph 1 sets forth policy that permitted the use of 2011 
Edition certified Complete EHRs and EHR Modules, a combination of 2011 
and 2014 Edition certified Complete EHRs and EHR Modules, and 2014 
Edition certified Complete EHRs and EHR Modules to be used to meet the 
CEHRT definition through the end of FY 2013/CY 2013. In addition, 
paragraph 2 establishes that, starting with FY 2014/CY 2014, only the 
use of 2014 Edition certified Complete EHRs and EHR Modules could be 
used to meet the CEHRT definition.
    Therefore, we proposed the following specific revisions to the 
CEHRT definition, which are necessary to support the added flexibility 
in the use of CEHRT for providers to meet meaningful use for an EHR 
reporting period in 2014. The effect of these revisions would be to 
allow EPs, eligible hospitals, and CAHs to use either 2011 Edition or a 
combination of 2011 Edition and 2014 Edition CEHRT, including certified 
Complete EHRs and EHR Modules, to meet the CEHRT definition required to 
meet meaningful use for an EHR reporting period in 2014.
    Specifically, ONC proposed modifying the CEHRT definition at 45 CFR 
170.102 to replace the following:
     ``2013'' with ``2014'' in the first sentence of paragraph 
(1).
     ``FY and CY 2014'' with ``FY and CY 2015'' in paragraph 
(1)(i) and (1)(iii).
     ``2014'' with ``2015'' in the first sentence of paragraph 
(2).

Overall, this proposed revision would make the first day of FY 2015 
(for eligible hospitals and CAHs) and CY 2015 (for EPs) the new 
required start date for exclusive use of 2014 Edition certified 
Complete EHRs and EHR Modules to meet the CEHRT definition.
    As discussed in sections III.A. and III.B. of this final rule, we 
received numerous comments about the options available for the use of 
CEHRT; however we received no comments specific to this proposal to 
change the definition of CEHRT at 45 CFR 170.102. We note that this 
change does not limit the ability of providers to use 2014 Edition 
CEHRT for an EHR reporting period in 2014 as scheduled. For the reasons 
stated previously, we are finalizing this provision as proposed with no 
further revisions.

IV. Attestation and the Options in This Final Rule

    We offer several points of clarification around attestation and the 
options finalized in this rule, as follows:
     The options outlined in this final rule may be used only 
by providers who are unable to fully implement 2014 Edition CEHRT for 
an EHR reporting period in 2014 due to delays in the availability of 
2014 Edition CEHRT.
     Providers will be required to attest to their inability to 
fully implement 2014 Edition CEHRT as part of the attestation process 
should they select one of the options outlined in this final rule.
     Providers may attest based on an EHR reporting period of 
any 3-month quarter (or any continuous 90 days for new participants) in 
2014 (CY for EPs; FY for eligible hospitals and CAHs) up until the 
close of the 2014 attestation period 2 months following the end of the 
fiscal or calendar year.
     Providers must attest to the objectives and measures 
supported by their CEHRT for the 2013 Stage 1 objectives and measures, 
the 2014 Stage 1 objectives and measures, or the Stage 2 objectives and 
measures, as well as the related CQMs specified, for each of the 
options. There are no options to attest to a mixed set of objectives or 
split the CQM reporting from the option selected.
     For providers attesting to 2014 Stage 1 objectives and 
measures or Stage 2 objectives and measures, the CQM reporting methods 
for the 2014 CQMs are available including attestation and electronic 
reporting options as outlined in section III.B of this regulation.
    Upon the effective date of this final rule, we generally expect the 
attestation process for the EHR reporting periods in 2014 to be as 
follows, although we recognize that operational or systems issues may 
require procedural changes:
     A provider will first select from the ONC's Certified 
Health IT Product List (CHPL) the certified Complete EHR(s) or 
certified EHR Module(s) they used for the EHR reporting period in 2014. 
Upon selecting the certified products used during the EHR reporting 
period, the provider will need to generate a ``CMS EHR Certification 
ID'' number for their attestation.
     If the provider selects from the CHPL only EHR technology 
certified to 2011 Edition certification criteria (to meet the CEHRT 
definition), the CHPL will create a ``CMS EHR Certification ID'' number 
that reflects only 2011 Edition EHR technology was selected. When this 
number is entered in the EHR Registration and Attestation System, it 
will interpret the number to mean that--
    ++ The provider is attesting to 2013 Stage 1 performance for 2014;
    ++ Reporting on the 2013 Stage 1 Objectives and Measures; and
    ++ Attesting to the CQMs that were applicable for 2013 (2011 
Edition).
     If the provider selects from the CHPL only EHR technology 
certified to 2014 Edition certification criteria (to meet the CEHRT 
definition), the CHPL will create a ``CMS EHR Certification ID'' number 
that reflects only 2014 Edition EHR technology was selected. When this 
number is entered in the EHR Registration and Attestation System, it 
will interpret the number and will then trigger the system to determine 
the provider's scheduled Stage of meaningful use participation.
    If the provider is scheduled to be in Stage 1 for 2014 the system 
identifies that--
    ++ The provider remains in Stage 1 for 2014 and is attesting to 
2014 Stage 1 performance;
    ++ Reporting on the 2014 Stage 1 Objectives and Measures; and

[[Page 52931]]

    ++ Reporting on the 2014 CQMs via attestation or electronic 
reporting.
     If the provider is scheduled to be in Stage 2 for 2014 the 
system will offer them a choice to select Stage 1 or Stage 2.
    If the provider selects Stage 1, the system then records that--
    ++ The provider is attesting to 2014 Stage 1 performance instead of 
their previously required Stage 2 performance level for 2014;
    ++ Reporting on the 2014 Stage 1 Objectives and Measures; and
    ++ Reporting on the 2014 CQMs via attestation or electronic 
reporting;

or

    If the provider selects Stage 2, the system then records that--
    ++ The provider is attesting to Stage 2 performance as scheduled 
for 2014;
    ++ Reporting on the Stage 2 Objectives and Measures; and
    ++ Reporting on the 2014 CQMs via attestation or electronic 
reporting
     If the provider selects from the CHPL a combination of EHR 
technology certified to the 2011 Edition and 2014 Edition certification 
criteria (to meet the CEHRT definition), the CHPL will create a 
specific ``CMS EHR Certification ID'' number that reflects the 
combination of 2011 Edition and 2014 Edition EHR technology was 
selected. When this number is entered in the EHR Registration and 
Attestation System, it will interpret the number and then ask the 
provider to select whether they intend to attest to the 2013 Stage 1 
objectives and measures or whether they intend to attest to the 2014 
Stage 1 objectives and measures or the Stage 2 objectives and measures.
    ++ If the provider selects 2013 objectives and measures, the 
provider remains in Stage 1 for 2014 and reports on the 2013 Stage 1 
objectives and measures and attests to the clinical quality measures as 
outline previously for 2011 Edition CEHRT.
    ++ If the provider selects 2014 objectives and measures, the system 
determines the provider's scheduled Stage of meaningful use and then 
provides the options as outlined previously for 2014 Edition CEHRT.
    Providers who use a 2011 Edition CEHRT number, or who make any 
selection which differs from their scheduled participation timeline, 
will be required to attest that they are unable to fully implement 2014 
Edition CEHRT for the EHR reporting period in 2014 because of issues 
related to 2014 Edition CEHRT availability delays.
    Providers must retain all relevant supporting documentation (in 
either paper or electronic format) used in the completion of the EHR 
Registration and Attestation System responses. Documentation to support 
attestation data for meaningful use objectives and CQMs must be 
retained for 6 years post-attestation. Documentation to support payment 
calculations (such as cost report data) should continue to follow the 
current documentation retention processes.
    In the attestation disclaimer, providers agree to keep such records 
as necessary to demonstrate meeting Medicare EHR Incentive Program 
requirements and to furnish those records to the Medicaid state agency, 
Department of Health and Human Services, or contractor acting on their 
behalf.

V. Collection of Information Requirements

    This document does not impose any new information collection 
requirements, that is, reporting, recordkeeping or third-party 
disclosure requirements, as defined under the Paperwork Reduction Act 
of 1995 (5 CFR 1320). However, it does make reference to the currently 
approved information collection request associated with the Electronic 
Health Record Incentive Program. The information collection 
requirements for the program are currently approved under OMB control 
number 0938-1158 with an expiration date of April 30, 2015.

VII. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) (Having 
an annual effect on the economy of $100 million or more in any 1 year, 
or adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This rule 
does not include provisions which incur significant additional cost 
beyond the expenditures previously estimated for incentive payments and 
operations costs for the EHR Incentive Programs in 2014. Therefore, 
this rule does not reach the economic threshold and thus is not 
considered a major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.0 million to $35.5 million in any 1 year. Individuals and 
states are not included in the definition of a small entity. We are not 
preparing an analysis for the RFA because we have determined, and the 
Secretary certifies, that this final rule would not have a significant 
economic impact on a substantial number of small entities. The 
reporting burden for small entities does not significantly change as a 
result of this rule therefore the impact on small entities would be 
negligible.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area for Medicare payment regulations and has fewer than 
100 beds. We are not preparing an analysis for section 1102(b) of the 
Act because we have determined, and the Secretary certifies, that this 
final rule would not have a significant impact

[[Page 52932]]

on the operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2014, that 
threshold is approximately $141 million. This final rule will have no 
consequential effect on state, local, or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. Because the programs allow that states may receive 
federal assistance for administrative costs incurred to support the 
Medicaid EHR Incentive Programs, this rule does not impose substantial 
costs on state or local governments, the requirements of Executive 
Order 13132 are not applicable.
    We proposed, for 2014 only, that EPs, eligible hospitals, and CAHs 
would be able to use either 2011 Edition, 2014 Edition or a combination 
of 2011 and 2014 Edition certified Complete EHRs and EHR Modules to 
meet the CEHRT definition and to demonstrate meaningful use during 
2014.
    To support the policy to provide added flexibility in the Medicare 
and Medicaid EHR Incentive Programs during 2014, ONC made a minor, but 
necessary, corresponding revision to the CEHRT definition specified at 
45 CFR 170.102, to change certain FY/CY cutoffs in paragraphs (1) and 
(2) of the CEHRT definition. These FY/CY cutoffs were finalized in 
ONC's 2014 Edition final rule (77 FR 54257 through 54260).
    This final rule will allow the flexibility to use 2011 Edition 
Certified EHR Technology, a combination of 2011 Edition and 2014 
Edition Certified EHR Technology, or solely 2014 Edition Certified EHR 
Technology in 2014, we do not believe that this will have a significant 
impact as it merely gives providers the flexibility to choose to retain 
and use their 2011 Edition CEHRT, a combination of 2011 and 2014 
Edition CEHRT, or 2014 Edition CEHRT in 2014. We finalized this policy 
in response to concerns that the availability of 2014 Edition CEHRT is 
quite limited. We refer readers to the impact analyses included in the 
final rule titled ``Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 2'' (77 FR 53698 through 54162). 
Similarly, ONC finalized the revised CEHRT definition to provide 
additional flexibility in support of our proposal and ONC does not 
believe that it will have a significant impact (see ``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'' (77 FR 54163 through 54292)).
    In accordance with the provisions of Executive Order 12866, this 
rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance, organizations (HMO), Medicare, Penalties, Privacy, 
Reporting and recordkeeping requirements.

45 CFR Part 170

    Computer technology, Electronic health record, Electronic 
information system, Electronic transactions, Health, Health care, 
Health information technology, Health insurance, Health records, 
Hospitals, Incorporation by reference, Laboratories, Medicaid, 
Medicare, Privacy, Reporting and recordkeeping requirements, Public 
health, Security.

    For the reasons stated in the preamble of this final rule, the 
Centers for Medicare & Medicaid Services and the Department of Health 
and Human Services confirms as final without changes the interim rule 
published on December 7, 2012 at 77 FR 72985 and further amend 42 CFR 
Part 495 and 45 CFR subtitle A, subchapter D, part 170 as set forth 
below:

Title 42--Public Health

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

0
1. The authority citation for part 495 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
2. Section 495.6 is amended by adding paragraphs (a)(4), (b)(4), 
(h)(3), and (i)(3) to read as follows:

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

    (a) * * *
    (4) Flexible options for using certified EHR technology in 2014. 
For an EHR reporting period in 2014, if an EP could not fully implement 
2014 Edition certified EHR technology due to delays in availability and 
uses--
    (i) Only 2011 Edition certified EHR technology, the EP must satisfy 
the objectives and associated measures of the Stage 1 criteria that 
were applicable for 2013; or
    (ii) A combination of 2011 Edition certified EHR technology and 
2014 Edition certified EHR technology, the EP may choose to satisfy one 
of the following sets of objectives and associated measures:
    (A) The Stage 1 criteria that were applicable for 2013.
    (B) The Stage 1 criteria that are applicable beginning 2014.
    (C) If the EP is scheduled to begin Stage 2 in 2014, the Stage 2 
criteria.
    (b) * * *
    (4) Flexible options for using certified EHR technology in 2014. 
For an EHR reporting period in 2014, if an eligible hospital or CAH 
could not fully implement 2014 Edition certified EHR technology due to 
delays in availability and uses--
    (i) Only 2011 Edition certified EHR technology, the eligible 
hospital or CAH must satisfy the objectives and associated measures of 
the Stage 1 criteria that were applicable for 2013;
    (ii) A combination of 2011 Edition certified EHR technology and 
2014 Edition certified EHR technology, the eligible hospital or CAH may 
choose to satisfy one of the following sets of objectives and 
associated measures:
    (A) The Stage 1 criteria that were applicable for 2013.
    (B) The Stage 1 criteria that are applicable beginning 2014.
    (C) If the eligible hospital or CAH is scheduled to begin Stage 2 
in 2014, the Stage 2 criteria.
* * * * *
    (h) * * *
    (3) Flexible options for using certified EHR technology in 2014. 
For an EHR reporting period in 2014, if an EP is scheduled to begin 
Stage 2 in 2014, but is unable to fully implement all the functions of 
2014 Edition certified EHR technology required for the objectives and 
associated measures of the Stage 2 criteria due to delays in 
availability, the EP may choose to satisfy the objectives and 
associated measures of the Stage 1 criteria that are applicable 
beginning 2014 using 2014 Edition certified EHR technology.
    (i) * * *
    (3) Flexible options for using certified EHR technology in 2014. 
For an EHR reporting period in 2014, if an eligible hospital or CAH is 
scheduled to begin

[[Page 52933]]

Stage 2 in 2014, but is unable to fully implement all the functions of 
2014 Edition certified EHR technology required for the objectives and 
associated measures of the Stage 2 criteria due to delays in 
availability, the eligible hospital or CAH may choose to satisfy the 
objectives and associated measures of the Stage 1 criteria that are 
applicable beginning 2014 using 2014 Edition certified EHR technology.
* * * * *

0
3. Section 495.8 is amended by adding paragraphs (a)(2)(i)(D) and 
(b)(2)(i)(D).

Sec.  495.8  Demonstration of meaningful use criteria.

    (a) * * *
    (2) * * *
    (i) * * *
    (D) For 2014 only, if the EP uses one of the options specified 
under Sec.  495.6(a)(4) or (h)(3), the EP must attest that he or she is 
unable to fully implement 2014 Edition certified EHR technology for an 
EHR reporting period in 2014 due to delays in 2014 Edition certified 
EHR technology availability.
* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (D) For 2014 only, if the eligible hospital or CAH uses one of the 
options specified under Sec.  495.6(b)(4) or (i)(3), it must attest 
that it is unable to fully implement 2014 Edition certified EHR 
technology for an EHR reporting period in 2014 due to delays in 2014 
Edition certified EHR technology availability.
* * * * *

0
4. Section 495.302 is amended by adding paragraph (4) to the definition 
of ``Adopt, implement or upgrade'' to read as follows:

Sec.  495.302  Definitions.

* * * * *
    Adopt, implement or upgrade * * *
    (4) For payment year 2014, the references to ``certified EHR 
technology'' in paragraphs (1) through (3) of this definition are 
deemed to be references to paragraph (2) of the definition of 
``Certified EHR Technology'' under 45 CFR 170.102 (that is, the 
definition of ``Certified EHR Technology'' for FY and CY 2015 and 
subsequent years).
* * * * *

Title 45--Public Welfare

PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION 
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION 
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

0
5. The authority citation for part 170 continues to read as follows:

    Authority:  42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C. 
552.

Sec.  170.102  [Amended]

0
6. In Sec.  170.102, the definition of ``Certified EHR Technology'' is 
amended as follows:
0
A. In paragraph (1) introductory text, by removing the year ``2013'' 
and adding in its place the year ``2014''.
0
B. In paragraph (1)(i), by removing ``; or'' and adding in its place 
``;''.
0
C. In paragraph (1)(iii), by removing the phrase ``FY and CY 2014'' and 
adding in its place the phrase ``FY and CY 2015'' and by removing the 
cross-reference ``paragraph (2);'' and adding in its place the cross-
reference ``paragraph (2) of this definition''.
0
D. In paragraph (2) introductory text, by removing the phrase ``FY and 
CY 2014'' and adding in its place the phrase ``FY and CY 2015''.

    Dated: August 19, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.

    Approved: August 27, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-21021 Filed 8-29-14; 4:15 pm]
BILLING CODE 4120-01-P
```