[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Rules and Regulations]
[Pages 72985-72991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29607]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 495
[CMS-0046-IFC]
RIN 0938-AR71
Office of the Secretary
45 CFR Part 170
RIN 0991-AB89
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
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC) and Centers for Medicare & Medicaid Services (CMS),
Department of Health and Human Services.
ACTION: Interim final rule with comment period.
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SUMMARY: The Department of Health and Human Services (HHS) is issuing
this interim final rule with comment period 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. This interim final rule with comment period also
revises the Medicare and Medicaid Electronic Health Record (EHR)
Incentive Programs by adding an alternative measure for the Stage 2
meaningful use (MU) 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 clinical quality measure (CQM) reporting
applicable for eligible hospitals and critical access hospitals (CAHs)
beginning with FY 2013. This rule also provides notice of CMS's
intention to issue technical corrections to the electronic
specifications for CQMs released on October 25, 2012.
DATES: Effective Date: This interim final rule with comment period is
effective January 7, 2013.
The incorporation by reference of certain publications listed in
the rule is approved by the Director of the Federal Register as of
January 7, 2013.
Comment Date: To be assured consideration, written or electronic
comments must be received at one of the addresses provided below, no
later than 5 p.m. on February 5, 2013.
ADDRESSES: Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. You may submit comments,
identified by RIN 0991-AB89 or RIN 0938-AR71, by any of the following
methods (please do not submit duplicate comments).
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word, Adobe
PDF, or Excel; however, we prefer Microsoft Word. http://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: Steven Posnack, Hubert H. Humphrey
Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201.
Please submit one original and two copies.
Hand Delivery or Courier: Office of the National
Coordinator for Health Information Technology, Attention: Steven
Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave.
SW., Washington, DC 20201. Please submit one original and two copies.
(Because access to the interior of the Hubert H. Humphrey Building is
not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the mail drop slots located in the main lobby of the building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to: A
person's social security number; date of birth; driver's license
number; state identification number or foreign country equivalent;
passport number; financial account number; credit or debit card
[[Page 72986]]
number; any personal health information; or any business information
that could be considered to be proprietary. We will post all comments
received before the close of the comment period at http://www.regulations.gov.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or U.S. Department
of Health and Human Services, Office of the National Coordinator for
Health Information Technology, Hubert H. Humphrey Building, Suite 729D,
200 Independence Ave. SW., Washington, DC 20201 (call ahead to the
contact listed below to arrange for inspection).
FOR FURTHER INFORMATION CONTACT:
Steven Posnack, Director, Federal Policy Division, Office of Policy and
Planning, Office of the National Coordinator for Health Information
Technology, 202-690-7151, for EHR technology standards and
certification criteria issues.
Elizabeth Holland, (410) 786-1309, or Robert Anthony, (410) 786-6183,
for Medicare EHR Incentive Program issues.
David Koppel, (410) 786-3255, for Medicaid EHR Incentive Program
issues.
Maria Michaels, (410) 786-2809, for clinical quality measures issues.
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'' (Title XXX) to improve health care quality,
safety, and efficiency through the promotion of HIT 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 HIT standards, implementation specifications, and
certification criteria.
2. HIT 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 HIT. 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.''
3. Medicare and Medicaid Electronic Health Record (EHR) Incentive
Programs
We described the legislative basis for the Medicare and Medicaid
EHR Incentive Programs in our Stage 1 and 2 final rules. Such
legislative basis remains the same for this interim final rule with
comment period. We refer readers to the Stage 1 and 2 final rules (75
FR 44316 through 44317; 77 FR 53970) for discussions of legislative
basis, including sections 1848(o), 1853(l) and (m), 1886(n), 1814(l),
1903(a)(3)(F), and 1903(t) of the Social Security Act (the Act).
B. Regulatory History
1. Standards, Implementation Specifications, and Certification Criteria
Rules
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 (MU) by eligible professionals (EPs),
eligible hospitals, and critical access hospitals (CAHs) under the
Medicare and Medicaid EHR Incentive Programs beginning with the EHR
reporting periods in FY/CY 2014.
The Secretary previously issued an interim final rule (75 FR 2014,
January 13, 2010) and final rule (75 FR 44590, July 28, 2010) which
adopted an initial set of standards, implementation specifications, and
certification criteria and a CEHRT definition to support MU (the ``2011
Edition EHR certification criteria final rule''). In the October 13,
2010 Federal Register (75 FR 62686), an interim final rule with comment
period was issued to remove certain implementation specifications
related to public health surveillance that had been previously adopted
in the final rule.
2. HIT Certification Programs Rules
In the 2014 Edition EHR certification criteria final rule
previously mentioned above, ONC made revisions to the permanent
certification program, including changing the program's name to the ONC
HIT Certification Program. Previously, the Secretary issued a final
rule on January 7, 2011 (76 FR 1262) establishing the permanent
certification program's requirements (now called the ONC HIT
Certification Program) and a final rule on June 24, 2010 (75 FR 36158)
establishing the temporary certification program.
3. Medicare and Medicaid EHR Incentive Programs Rules
CMS's final rule (the ``Stage 2 final rule'') implementing Stage 2
of meaningful use appeared in the September 4, 2012 Federal Register
(77 FR 53968). The final rule also contained some revisions to Stage 1
of meaningful use, beginning with EHR reporting periods in FY/CY 2013.
A correction notice appeared in the October 23, 2012 Federal Register
(77 FR 64755).
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II. Provisions of the Interim Final Rule With Comment Period
A. Adoption and Incorporation by Reference of Newer Versions of the DEC
and QRDA III Standards
1. Data Element Catalog
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 clinical quality measure (CQM).
On October 25, 2012, CMS released the final 2014 CQM electronic
specifications (e-specifications).\1\ In preparation for that release,
we performed a gap analysis to determine whether the DEC, August 2012
version (now referred to as ``DEC version 1.0'') still appropriately
specified all of the data that EHR technology would need to capture to
support these 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. Working
with our colleagues at the National Library of Medicine (NLM), a new
version of the DEC (version 1.1) \2\ is now available that fully aligns
with the final 2014 CQM e-specifications. By replacing the version of
the DEC that is currently incorporated by reference at 45 CFR
170.299(m)(5) with an updated version (Data Element Catalog, Version
1.1 (October 2012)), EHR technology certified under the ONC HIT
Certification Program will be capable of supporting the electronic
capture of all of the necessary data for CQM calculation and submission
by EPs, eligible hospitals, and CAHs for the Medicare and Medicaid EHR
Incentive Programs. Based on our expectation that EHR technology
testing and certification will begin in January 2013, if we do not act
now to immediately update the version of the DEC currently incorporated
by reference, EHR technology would be required to be tested and
certified to DEC version 1.0 and thus capture, in some cases, less data
than necessary to support the accurate calculation and reporting of the
2014 CQMs. As a consequence, CMS and the States would then receive
incomplete CQM data from EPs, eligible hospitals, and CAHs. Therefore,
we are replacing the version of the DEC that is currently incorporated
by reference at 45 CFR 170.299(m)(5) with the updated version (DEC,
Version 1.1 (October 2012)) that we are adopting as the standard
referenced by the 2014 Edition EHR certification criterion at 45 CFR
170.314(c)(1).
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\1\ http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/2014_ClinicalQualityMeasures.html.
\2\ http://www.nlm.nih.gov/healthit/dec/.
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2. Quality Reporting Document Architecture (QRDA) Category III (QRDA
III)
In the 2014 Edition EHR certification criteria final rule, we
adopted the QRDA III, Release 1, standard at 45 CFR 170.205(k) and
incorporated the standard by reference at 45 CFR 170.299(f)(14). The
QRDA III is included in the certification criterion at 45 CFR
170.314(c)(3), which requires EHR technology presented for
certification to be capable of electronically creating a data file for
transmission of clinical quality measurement data in accordance with
QRDA III and that can be electronically accepted by CMS.
As noted in the 2014 Edition EHR certification criteria final rule
(77 FR 54232), we adopted QRDA III (specifically, Quality Reporting
Document Architecture Category III, Release 1, Implementation Guide for
CDA Release 2 (US Realm) Based on HL7 CDA Release 2.0, August 2012)
even though it had not been balloted because we expected it to become a
normative standard in the near future and agreed with CMS's decision to
select this format rather than developing its own CMS-defined XML
template because QRDA III is a product of several years of industry
consensus work. The QRDA III standard has now been successfully
balloted (specifically, HL7 Implementation Guide for CDA[supreg]
Release 2: Quality Reporting Document Architecture--Category III, DSTU
Release 1 (US Realm) Draft Standard for Trial Use, November 2012).\3\
The November 2012 balloted version of QRDA III clarifies ambiguities in
the August version we adopted; 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. Finally, we are making this change because CMS intends to
implement its electronic submission systems to receive QRDA III files
formatted according to the November 2012 balloted version. For these
reasons, we are replacing the version of the QRDA III that is currently
incorporated by reference at 45 CFR 170.299(f)(14) with the November
2012 balloted version of QRDA III that we are adopting as the standard
referenced by the 2014 Edition EHR certification criterion at 45 CFR
170.314(c)(3).
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\3\ http://www.hl7.org/permalink/?CDAR2_IG_QRDA_CATIII_R1_NOV.
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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 Stage 2 final rule (77 FR 54041 through 54043), we included
the following objective and measure in the Stage 2 menu set for
eligible hospitals and CAHs at 42 CFR 495.6(m)(6)(i) and (ii):
Objective: Provide structured electronic lab results to ambulatory
providers.
Measure: Hospital labs send structured electronic clinical lab
results to the ordering provider for more than 20 percent of electronic
lab orders received.
The measure denominator is limited to lab orders received
electronically by the hospital. In our response to comments in the
Stage 2 final rule (77 FR 54042), we recognized that this measure is
based on some degree of electronic health information exchange taking
place between the hospital and the ordering provider. The measure
denominator assumes that if a hospital does not receive a lab order
electronically, it would be less likely to send the results
electronically to the ordering provider. Upon further consideration,
however, in cases where hospitals send a large number of lab results
electronically in response to orders they receive through non-
electronic means (for example, by phone or on paper), the measure might
not capture a hospital's performance of the objective. In addition, a
hospital that receives a very small percentage of its total lab orders
electronically could have difficulty meeting the measure threshold
regardless of the number of lab results it sends electronically to
ordering providers. For example, if a hospital receives 10,000 lab
orders and responds to 4,000 with structured electronic clinical lab
results, but only
[[Page 72988]]
100 of those orders were received electronically and of those 18 were
responded to with structured electronic clinical lab results, then the
hospital would score 18/100 and fail to meet the measure's 20-percent
threshold despite sending 4,000 structured electronic clinical lab
results.
While we continue to believe that most hospitals will find it
advantageous to use the existing measure, for the reasons discussed
previously, we are adding an alternative measure for this objective.
Hospitals can meet either the existing measure or the alternative
measure to satisfy the objective. The alternative measure is ``Hospital
labs send structured electronic clinical lab results to the ordering
provider for more than 20 percent of lab orders received'' at Sec.
495.6(m)(6)(ii)(B). The denominator, numerator, and threshold for this
alternative measure are as follows:
Denominator: The number of lab orders received from
ambulatory providers.
Numerator: The number of lab orders in the denominator for
which structured electronic clinical lab results were sent to the
ordering provider.
Threshold: The resulting percentage must be greater than
20 percent.
The existing measure of ``Hospital labs send structured electronic
clinical lab results to the ordering provider for more than 20 percent
of electronic lab orders received'' will be redesignated as 42 CFR
495.6(m)(6)(ii)(A). We clarify the numerator, denominator, and
threshold of the existing measure as follows:
Denominator: The number of electronic lab orders received
from ambulatory providers.
Numerator: The number of lab orders in the denominator for
which structured electronic clinical lab results were sent to the
ordering provider.
Threshold: The resulting percentage must be greater than
20 percent.
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 and two associated measures 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 and measure in the Stage 1 core set for
eligible hospitals and CAHs at 42 CFR 495.6(f)(12)(i)(B) and (ii)(B).
Objective: Provide patients the ability to view online, download,
and transmit information about a hospital admission.
Measures: (A) More than 50 percent of all patients who are
discharged from the inpatient or emergency department (POS 21 or 23) of
an eligible hospital or CAH have their information available online
within 36 hours of discharge; and
(B) More than 5 percent of all patients who are discharged from the
inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH (or their authorized representative) view, download or
transmit to a third party their information during the EHR reporting
period.
In the Stage 2 final rule (77 FR 53968), we inadvertently omitted
the word ``unique'' from the regulation text for the two measures. We
described in the preamble of the final rule (77 FR 54040) the
denominators of the measures as ``Number of unique patients discharged
from an eligible hospital's or CAH's inpatient or emergency department
(POS 21 or 23) during the EHR reporting period.'' However, the
regulation text for these measures incorrectly refers to ``all
patients'' instead of ``all unique patients.'' Because we intended for
the regulation text to be consistent with the measure specifications as
described in the preamble, we are correcting the regulation text at
Sec. 495.6(f)(12)(ii)(B), (l)(8)(ii)(A), and (l)(8)(ii)(B) to clarify
that these measures are based on the number of unique patients
discharged from a hospital's inpatient or emergency department during
the EHR reporting period.
2. Case Number Threshold Exemption for CQM Reporting for Hospitals
In the Stage 2 proposed rule, CMS solicited comments on whether a
case number threshold would be appropriate for hospital clinical
quality measures reporting, given the apparent burden on hospitals that
very seldom have the types of cases addressed by certain measures. We
requested comments on whether such thresholds should be established for
2013, noting that the issue would be mitigated beginning in 2014 by our
proposal to establish a larger menu set of CQMs from which hospitals
would select.
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. Commenters suggested a variety of possible implementation
mechanisms, but all commenters responded to the premise that the
threshold would be in effect in FY 2013.
In the Stage 2 final rule, we adopted a policy that would apply
beginning in FY 2014. Under such policy, eligible hospitals and CAHs
with 5 or fewer inpatient discharges per quarter or 20 or fewer
inpatient discharges per year (Medicare and non-Medicare combined), as
defined by a CQM's denominator population, would be exempted from
reporting on that CQM. We stated that the exemption would be available
in all stages of meaningful use beginning in FY 2014, but that eligible
hospitals and CAHs that submit CQMs through attestation (because they
are demonstrating meaningful use for the first time) would not be able
to qualify for the exemption. We explained that the burden of
submitting aggregate population and sample size counts in order to
qualify for the exemption would be at least equal to the effort
required to obtain and attest to the calculated CQM data.
Upon further review of this policy, we believe there are valid
reasons to make this policy applicable for EHR reporting periods in FY
2013, as well as for eligible hospitals and CAHs that are submitting
their CQMs through attestation. For FY 2013, eligible hospitals and
CAHs are required to submit information on each of the 15 CQMs that
were finalized for FYs 2011 and 2012 in the Stage 1 final rule (75 FR
44418 through 44420). Because they do not have a choice as to which
CQMs to report for FY 2013, hospitals may experience the burden of
revising workflow in order to accurately report on CQMs for which they
have fewer than 20 cases per year. In addition, after considering the
workflow redesign costs that could be incurred by training staff to
input data used in calculating low-volume CQMs, we have re-assessed the
burdens of attesting to calculated CQM data and submitting aggregate
population and sample size counts in order to qualify for the
exemption.
Therefore, we are finalizing a case threshold exemption that is
applicable for eligible hospitals and CAHs in all stages of meaningful
use beginning with FY 2013. Eligible hospitals and CAHs that are
demonstrating meaningful use for the first time and submitting 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 would be exempted from reporting on that CQM.
In FY 2013, since the reporting requirement is to report all 15 of
the CQMs finalized in the Stage 1 final rule, invoking the case
threshold exemption would reduce the number of CQMs a hospital would be
required to report by
[[Page 72989]]
the number of CQMs for which it does not meet the case threshold of
discharges as described earlier. For example, if the hospital submitted
aggregate population and sample size data reflecting 4 stroke patients
discharged in FY 2013, then the hospital would be exempt from reporting
the CQMs that include stroke patients as part of the denominator
population (that is, the 7 stroke CQMs out of the total 15 CQMs).
Therefore, this hospital would successfully meet the CQM reporting
requirements in FY 2013 if they submit the 8 remaining CQMs. If a
hospital does not reach the case threshold for all 15 CQMs, the
hospital would be exempt from reporting all CQMs.
Beginning in FY 2014, the reporting requirement is to report 16
CQMs covering at least 3 domains from a list of 29 CQMs. The hospital
would follow the same process as in FY 2013, but in order to be
exempted from reporting fewer than 16 CQMs it would need to qualify for
the case threshold exemption for more than 13 of the 29 CQMs. If the
hospital does not meet the case threshold for 13 or fewer CQMs, the
hospital would be able to report at least 16 CQMs. Likewise, if the
CQMs for which the hospital can meet the case threshold of discharges
do not cover at least 3 domains, the hospital would be exempt from the
requirement to cover the remaining domains. For example, if the
hospital does not meet the case threshold of discharges for 13 CQMs,
and thus could report 16 CQMs, but the 16 CQMs cover only 2 of the 3
domains, then the hospital would be exempt from covering the third
domain.
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), including 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.
3. Technical Corrections to CQM Electronic Specifications
During the time period since the final 2014 CQM e-specifications
were released on October 25, 2012, we have identified technical errors
in a few of the e-specifications that, if not corrected, would produce
inaccurate results. In order to maintain the integrity of the CQM(s)
affected by such errors, and to allow for accurate reporting of the
measure(s), CMS will issue technical corrections to the e-
specifications released on October 25, 2012. We expect to issue these
corrections on or around December 21, 2012. In order to meet this date,
we are encouraging individuals and organizations (in particular,
vendors and system implementers) that have identified logic or other
technical issues with any of the e-specifications released on October
25, 2012 to submit the issues to the following email address no later
than December 10, 2012 ([email protected]). The
corrected e-specifications will be required both for certification and
reporting purposes.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register to provide a period for public comment before the
provisions of the rule take effect in accordance with section 553(b) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we
can waive the notice and comment procedure if the Secretary finds good
cause that a notice and comment procedure is impracticable,
unnecessary, or contrary to the public interest, and incorporates a
statement of the finding and the reasons in the final notice or rule
that is issued.
A. Adoption of Newer Versions of the DEC and QRDA III Standards
Under the regulatory framework we have established, EHR technology
will be certified under the ONC HIT Certification Program and
subsequently used by EPs, eligible hospitals, and CAHs to participate
in the Medicare and Medicaid EHR Incentive Programs. We believe it
would be contrary to the public interest if EHR technology is required
to be certified to the versions of the DEC and QRDA III standards that
we adopted in the 2014 Edition EHR certification criteria final rule.
With respect to the DEC standard, the EHR technology would not be fully
capable of electronically capturing all potentially necessary CQM data
for electronic submission to CMS or the States under the Medicare and
Medicaid EHR Incentive Programs. With respect to the QRDA III standard,
the August 2012 version did not specify certain data that would need to
be included in a QRDA III file submitted to CMS in order for the
electronic submission to be properly processed. As we noted in section
II.A.1 of this interim final rule with comment period, this update is
necessary to prevent EHR technology from being required to be tested
and certified to DEC version 1.0 and thus capture, in some cases, less
data than necessary to support the accurate calculation and reporting
of the 2014 CQMs. As a consequence, this would lead to CMS and the
States receiving incomplete CQM data from EPs, eligible hospitals, and
CAHs. Similarly, with respect to our adoption of the November 2012
balloted version of QRDA III, we believe that this step is necessary
for a number of reasons, including: (1) The changes in the November
2012 version provide necessary clarifications that reduce
implementation ambiguity and ensure that the data CMS needs to properly
process electronically submitted QRDA III files is captured and
transmitted; and (2) CMS's intentions to implement its electronic
submission systems to receive QRDA III files formatted according to the
November 2012 balloted version. Accordingly, by adopting the new
versions of the DEC and QRDA III standards in this interim final rule
with comment period to replace the previously adopted versions, we can
facilitate the development and certification of EHR technology to
standards that can fully support the electronic capture and electronic
submission of CQM data under the Medicare and Medicaid EHR Incentive
Programs, which benefits the public interest.
Finally, because testing and certification of EHR technology to the
2014 Edition EHR certification criteria is expected to begin in January
2013, updating these standards in advance would avoid the scenario
where EHR technology would be certified to different versions of these
standards, and consequently, some EHR technology may need to be re-
developed and re-certified to meet the new versions of the standards.
Based on this timeframe for EHR technology developers, and the
additional time providers will need for adoption and implementation of
certified EHR technology, we believe it would be impracticable and
contrary to the public interest to undergo notice and comment
rulemaking to adopt the new versions of the DEC and QRDA III standards.
B. Modifications to Meaningful Use Hospital Objectives
The alternative measure for the Stage 2 hospital objective of
``provide structured electronic lab results to ambulatory providers''
(42 CFR 495.6(m)(6)) that we are finalizing in this rule relieves a
restriction on eligible
[[Page 72990]]
hospitals and CAHs. The correction of the regulation text for the
measures associated with the hospital objective of ``provide patients
the ability to view online, download, and transmit information about a
hospital admission'' (42 CFR 495.6(f)(12)(i)(B) and 495.6(l)(8)(i)) is
necessary to ensure accurate certification of EHR technologies. It
would also be impracticable and contrary to the public interest to
engage in notice and comment rulemaking to finalize these
modifications. Because these measures are percentage-based, they are
linked to the certification criteria that ONC has adopted at 45 CFR
170.314(g)(1) and (g)(2). Thus, if we did not institute these changes
in a timely manner, it could potentially delay the certification of EHR
technology to the 2014 Edition EHR certification criteria, which as
noted in the preceding section is expected to begin in January 2013. A
delay in the availability of certified EHR technology could negatively
affect hospitals' ability to make informed purchasing decisions and
shorten their timeframe to implement EHR technology certified to the
2014 Edition EHR certification criteria. We believe many hospitals
would benefit from the certainty of knowing these changes as they begin
their planning and analysis in advance of purchasing and updating their
EHR technology. Furthermore, if there were to be a delay in the
certification of EHR technology to the criteria adopted at 45 CFR
170.314(g)(1) and (g)(2), it could prevent hospitals from adopting and
using 2014 Edition EHR technology to meet the CEHRT definition in FY
2013. For these reasons, there is good cause to make the changes to the
objectives and measures effective prior to receiving public comment.
C. Case Number Threshold Exemption for CQM Reporting
The low case number threshold exemption we are finalizing in this
rule relieves a restriction on eligible hospitals and CAHs. It also is
contrary to the public interest, impracticable, and unnecessary to
engage in notice and comment rulemaking to finalize this exemption. As
CMS already received comments regarding the exemption being available
for those hospitals reporting CQMs beginning in FY 2013, we believe it
would be unnecessary to engage in another round of comments. In
addition, eligible hospitals and CAHs require immediate notification of
the exemption to be able to invoke it for EHR reporting periods in FY
2013; it would not be possible to engage in notice and comment
rulemaking in time. It also benefits the public interest if eligible
hospitals and CAHs, to the extent possible, do not encounter the burden
of complying with reporting on CQMs for which they have case numbers
beneath our thresholds. For these reasons, there is good cause to make
the case number threshold exemption effective prior to receiving public
comment.
IV. Response to Comments
Because of the number of public comments we normally receive on
Federal Register documents, we are not able to acknowledge or respond
to them individually. We will consider all comments we receive by the
date and time specified in the DATES section of this preamble, and,
when we proceed with a subsequent document, we will respond to the
comments in the preamble of that document.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VI. Regulatory Impact Statement
We have examined the impact of this interim final rule with comment
period as required by Executive Order 12866 on Regulatory Planning and
Review (September 30, 1993), Executive Order 13563 on Improving
Regulation and Regulatory Review (February 2, 2011), the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.), section 1102(b) of the Social
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
(2 U.S.C. 1532), and Executive Order 13132 on Federalism (August 4,
1999).
A. Executive Orders 12866 and 13563--Regulatory Planning and Review
Analysis
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
This interim final rule with comment period does not reach the economic
threshold and, thus, is not considered a major rule. Therefore, an RIA
has not been prepared.
B. Regulatory Flexibility Act and Social Security Act Section 1102(b)
The Regulatory Flexibility Act (RFA) requires agencies to analyze
options for regulatory relief of small businesses if a rule has a
significant impact on a substantial number of small entities.
Similarly, CMS is also required by section 1102(b) of the Act to
prepare an RIA if a rule will have a significant impact on the
operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. We
do not believe that the changes in this interim final rule with comment
period alter any of the prior analyses we performed for the 2014
Edition EHR certification criteria final rule or the Stage 2 final
rule; and therefore, the Secretary certifies that this interim final
rule with comment period will not have a significant impact on a
substantial number of small entities.
C. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule (including an interim
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. Because this interim final rule with comment period does
not impose any costs on state or local governments, the requirements of
Executive Order 13132 are not applicable.
D. Unfunded Mandates Reform Act of 1995
Section 202 of the Unfunded Mandates Reform Act of 1995 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. The current inflation-
adjusted statutory threshold is approximately $139 million. This
interim final rule with comment period will not impose an unfunded
mandate on state, local, and tribal governments or on the private
sector that will reach the threshold level.
The Office of Management and Budget reviewed this interim final
rule with comment period.
List of Subjects
42 CFR Part 495
Administrative practice and procedure, Electronic health records,
Health facilities, Health professions,
[[Page 72991]]
Health maintenance organizations (HMO), Medicaid, 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 set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR part 495 and the Department amends 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 as follows:
0
a. In paragraph (f)(12)(ii)(B), by removing the phrase ``all patients
who are discharged'' and adding in its place the phrase ``all unique
patients who are discharged''.
0
b. In paragraphs (l)(8)(ii)(A) and (B), by removing the phrases ``all
patients who are discharged'' and adding in its place the phrases ``all
unique patients who are discharged''.
0
c. By revising paragraph (m)(6)(ii).
The revision reads as follows:
Sec. 495.6 Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs.
* * * * *
(m) * * *
(6) * * *
(ii) Measures. Hospital labs send structured electronic clinical
lab results to the ordering provider for more than 20 percent of--
(A) The electronic lab orders received; or
(B) The lab orders received.
Title 45--Public Welfare
PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY
0
3. 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.
0
4. Amend Sec. 170.299 by revising paragraphs (f)(14) and (m)(5) to
read as follows:
Sec. 170.299 Incorporation by reference.
* * * * *
(f) * * *
(14) HL7 Implementation Guide for CDA[supreg] Release 2: Quality
Reporting Document Architecture--Category III, DSTU Release 1 (US
Realm) Draft Standard for Trial Use, November 2012, IBR approved for
Sec. 170.205.
* * * * *
(m) * * *
(5) Data Element Catalog, Version 1.1, October 2012, IBR approved
for Sec. 170.204.
* * * * *
Section 3004 of the Public Health Service Act and Sections 1102 and
1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program);
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: December 3, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: December 3, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-29607 Filed 12-4-12; 4:15 pm]
BILLING CODE 4150-45-P