Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs, 81824-81828 [2015-32931]
Download as PDF
<![CDATA[
81824
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
for comprehensive guidance on all
phases of the submission, application,
and award implementation process.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, Room 06N94B,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Will D. Spoon,
Program Analyst, Gulf Coast Ecosystem,
Restoration Council.
[FR Doc. 2015–32924 Filed 12–30–15; 8:45 am]
BILLING CODE P
Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment from the
Texas Patient Safety Organization, Inc.
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of Delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b–21 to b–26, (Patient Safety
Act) and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70732–
70814, provide for the formation of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of health care
delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
AHRQ has accepted a notification of
voluntary relinquishment from the
Texas Patient Safety Organization, Inc.
of its status as a PSO, and has delisted
the PSO accordingly. The Texas Patient
Safety Organization, Inc. submitted this
request for voluntary relinquishment
during expedited revocation
proceedings for cause.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on December 15, 2015.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.ahrq.gov/listed.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
federally approved PSOs.
AHRQ has accepted a notification
from the Texas Patient Safety
Organization, Inc., PSO number P0012,
to voluntarily relinquish its status as a
PSO. Accordingly, the Texas Patient
Safety Organization, Inc. was delisted
effective at 12:00 Midnight ET (2400) on
December 15, 2015. The Texas Patient
Safety Organization, Inc. submitted this
request for voluntary relinquishment
during expedited revocation
proceedings for cause.
The Texas Patient Safety
Organization, Inc. has patient safety
work product (PSWP) in its possession.
The PSO has met the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO.
In addition, according to sections
3.108(c)(2)(ii) and 3.108(b)(3) of the
Patient Safety Rule regarding
disposition of PSWP, the PSO has 90
days from the effective date of delisting
and revocation to complete the
disposition of PSWP that is currently in
the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
at https://www.pso.AHRQ.gov/
index.html.
Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2015–32914 Filed 12–30–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3323–NC]
Request for Information: Certification
Frequency and Requirements for the
Reporting of Quality Measures Under
CMS Programs
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Request for information.
AGENCY:
This request for information
seeks public comment regarding several
items related to the certification of
health information technology (IT),
including electronic health records
(EHR) products used for reporting to
certain CMS quality reporting programs
such as, but not limited to, the Hospital
Inpatient Quality Reporting (IQR)
Program and the Physician Quality
Reporting System (PQRS). In addition,
we are requesting feedback on how
often to require recertification, the
number of clinical quality measures
(CQMs) a certified Health IT Module
should be required to certify to, and
testing of certified Health IT Module(s).
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on February 1, 2016.
ADDRESSES: In commenting, refer to file
code CMS–3323–NC. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3323–NC, P.O. Box 8013,
Baltimore, MD 21244–8013.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
SUMMARY:
E:\FR\FM\31DEN1.SGM
31DEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3323–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
FOR FURTHER INFORMATION CONTACT: Lisa
Marie Gomez, 410–786–1175.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
The Health Information Technology
for Economic and Clinical Health Act
(Title IV of Division B of the American
Recovery and Reinvestment Act of 2009
(ARRA) and Title XIII of Division A of
the ARRA) authorizes incentive
payments under Medicare and Medicaid
for the adoption of and meaningful use
of certified EHR technology (CEHRT)
and downward payment adjustments
under Medicare for failure to
demonstrate meaningful use. Eligible
professionals (EPs), eligible hospitals,
and critical access hospitals (CAHs) that
seek to qualify for incentive payments
or avoid negative payment adjustments
under the Medicare and Medicaid EHR
Incentive Programs are required to use
CEHRT. Some CMS quality reporting
programs, such as the Hospital Inpatient
Quality Reporting (IQR) Program and
Physician Quality Reporting System
(PQRS), either require or provide the
option to use certified EHR technology,
as defined under the EHR Incentive
Program, for reporting quality data.
The Office of the National
Coordinator for Health Information
Technology’s (ONC’s) ‘‘2015 Edition
Health Information Technology (Health
IT) Certification Criteria, 2015 Edition
Base Electronic Health Record (EHR)
Definition, and ONC Health IT
Certification Program Modifications
Final Rule’’ (80 FR 62601) (2015 Edition
final rule), establishes the capabilities
and specifies the related standards and
implementation specifications that
CEHRT needs to include to support the
achievement of meaningful use by EPs,
eligible hospitals, and CAHs. ONC’s
Health IT Certification Program
provides a process by which Health IT
Module(s) can be certified so that they
meet the standards, implementation
specifications, and certification criteria
that have been adopted by the Secretary.
CEHRT is defined for the Medicare and
Medicaid EHR Incentive Programs in 42
CFR 495.4. The definition establishes
the requirements for EHR technology
that must be used by providers to meet
the MU objectives and measures or to
qualify for an incentive payment under
Medicaid for adopting, implementing,
or upgrading CEHRT. For example, a
Health IT Module is presented for
certification to a criterion with a
percentage-based measure and the
Health IT Module can meet the
‘‘automated numerator recording’’
criterion or ‘‘automated measure
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
81825
calculation’’ criterion. The CQM data
reported to us must originate from EHR
technology that is certified in
accordance with the ONC Health IT
Certification Program’s requirements (77
FR 54053).
As stated in the Medicare and
Medicaid Programs; Electronic Health
Record Incentive Program—Stage 3 and
Modifications to Meaningful Use in
2015 through 2017 final rule (80 FR
62894), in 2017, all EPs, eligible
hospitals, and CAHs have two options
to report CQM data, either through
attestation or use of established methods
for electronic reporting where feasible.
However, starting in 2018, EPs, eligible
hospitals, and CAHs participating in the
Medicare EHR Incentive Program must
electronically report CQMs using
CEHRT where feasible; and attestation
to CQMs will no longer be an option
except in certain circumstances where
electronic reporting is not feasible.
II. Solicitation of Comments
We are soliciting public input on the
following areas of certification and
testing of health IT, particularly relating
to how often to require recertification,
the number of CQMs a certified Health
IT Module should be required to certify
to, and the testing of certified Health IT
Module(s) in order to reduce the burden
and further streamline the process for
providers and health IT developers
while ensuring such products are
certified and tested appropriately for
effectiveness. The feedback will inform
CMS and ONC of elements that may
need to be considered for future rules
relating to the reporting of quality
measures under CMS programs. This
request for information is part of the
effort of CMS to streamline/reduce EP,
eligible hospital, CAH, and health IT
developer burden.
A. Frequency of Certification
We conduct an annual analysis of
CQM specifications in order to ensure
measure efficacy, accuracy, and clinical
relevance. Any updates to the
calculation of a CQM through this
process are released with the annual
updates to the electronic specifications
for EHR submission published by CMS
(https://www.cms.gov/Regulations-andGuidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html). Because we require the
most recent version of the CQM
specifications to be used for electronic
reporting methods (79 FR 67906 and 80
FR 49760), we understand that health IT
developers must make CQM updates
annually and providers must regularly
implement those updates to stay current
with the most recent CQM version. To
E:\FR\FM\31DEN1.SGM
31DEN1
tkelley on DSK3SPTVN1PROD with NOTICES
81826
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
ensure accuracy of the implementation
of these updates, we have considered
requiring recertification of already
certified EHR products with these
annual updates. We understand that
standards for electronically representing
CQMs continue to evolve, and believe
there may be value in retesting certified
Health IT Modules (including CEHRT)
periodically to ensure that CQMs are
being accurately calculated and
represented, and that they can be
reported as required. However, we have
not required this recertification to date.
With the continuing evolution of
technology and clinical standards, as
well as the need for a predictable cycle
from measure development to provider
data submission, we indicated, in the
Fiscal Year (FY) 2016 Hospital Inpatient
Prospective Payment Systems (IPPS)
and Long-term Care Hospital (LTCH)
Prospective Payment System (PPS) final
rule (80 FR 49760) (hereinafter referred
to as the FY 2016 IPPS/LTCH PPS final
rule), that we would be issuing a request
for information on the establishment of
an ongoing cycle for the introduction
and certification of new measures, the
testing of updated measures, and the
testing and certification of submission
capabilities.
While we believe that health IT
developers should test and certify their
products to the most recent version of
the electronic specifications for the
CQMs when feasible, we understand the
burdens associated with this
requirement and therefore, have not
historically required re-certification of
previously certified products when
updates are made to CQM electronic
specifications or to the standards
required for reporting. During the FY
2016 IPPS/LTCH PPS rulemaking
process, we received comments and
requests from stakeholders to change
this policy. We acknowledge that the
certification process can be burdensome
to health IT developers and believe that
annual certification could compress the
timeline for CQM and standard updates.
We also acknowledge that stakeholders
and providers reporting electronic
CQMs have an interest in ensuring that
their Health IT Module is tested and
certified to the most recent version of
electronic CQM specifications. We are
soliciting feedback regarding testing and
recertification, particularly relating to:
The requirement for CEHRT products to
be recertified when a new version of the
CEHRT is available in order to ensure
the accuracy of implementation; and the
requirement for Health IT Modules to
undergo annual CQM testing through
CMS approved testing tools and the
ONC Health IT Certification Program.
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
We are also seeking comment on the
following.
• What is the burden (both time and
money) of additional testing and
recertification?
• What are the benefits of requiring
additional testing and recertification?
• How will it affect the timeline for
CQM and standard updates?
• What are the benefits and
challenges of establishing a predictable
cycle from measure development to
provider data submission?
B. Changes to Minimum CQM
Certification Requirements
The Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program—Stage 3 and
Modifications to Meaningful Use in
2015 through 2017 final rule (80 FR
62761) specifies the meaningful use
criteria that EPs, eligible hospitals, and
CAHs must meet in order to qualify for
Medicare and Medicaid EHR incentive
payments and avoid downward
payment adjustments under Medicare.
We believe EHRs should be certified to
more than the minimum number of
CQMs as required by the ONC 2014
Edition Base EHR definition of a
minimum of 9 CQMs for EPs or 16 for
eligible hospitals and CAHs (80 FR
16771, see also 45 CFR 170.102). With
health IT developers having EHRs
certified to the minimum number of
CQMs, EPs, eligible hospitals, and CAHs
may have limited CQMs available to
them and may not be able to report on
CQMs that are applicable to their
patient population or scope of practice.
As stated in the preamble of the final
rule (80 FR 62895), we believe EPs,
eligible hospitals, and CAHs should
have a choice of which CQMs to report
so that they can report on those CQMs
most applicable to their patient
population or scope of practice.
Accordingly, we are soliciting comment
on the following policy options that
could provide greater choice for EPs,
eligible hospitals, and CAHs.
Specifically, we are soliciting comment
on: The feasibility of health IT
developers complying with the
requirements of each option in the first
year in which the requirements would
become effective; the impact of each
option on EPs, eligible hospitals/CAHs,
and health IT developers; and what we
would need to consider when assessing
each of these options.
• Option 1: Require EP health IT
developers to certify Health IT Modules
to all CQMs in the EP selection list; and
require eligible hospital/CAH health IT
developers to certify to all CQMs in the
selection list for eligible hospitals and
CAHs.
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
• Option 2: Incrementally increase
the number of CQMs required to be
certified each year until Health IT
Modules are certified for all CQMs
available for reporting by EPs, eligible
hospitals, and CAHs to meet their CQM
reporting requirements. For Option 2,
we invite input on the advantages and
disadvantages of an incremental
increase in the number of CQMs
required to be certified each year.
• Option 3: Require EP health IT
developers to certify health IT products
to more than the current minimum
number of CQMs required for reporting,
but not to all available CQMs.
For Option 3, we invite stakeholders’
input regarding the following
approaches that are specific examples of
implementation of the policy goal:
• Option A: An approach that would
set a minimum number of measures
health IT developers must certify to for
EP settings or eligible hospital/CAH
settings that is greater than the
minimum number required for provider
reporting. For example, EP health IT
developers could be required to certify
to a minimum of 15 measures, and
eligible hospital/CAH health IT
developers could be required to certify
to a minimum number of 25 measures.
We note that these numbers are
provided as examples only, and we
solicit comment on the appropriate
number health IT developers could be
required to certify to. Under this
approach, health IT developers could
choose from any measures in the list of
available CQMs.
• Option B: An EP-specific approach
that would require an EP health IT
developer to certify to all the measures
in a core/required set and all the
measures in at least one specialty
measure set relevant to the scope of
practice for which the product is
intended. We are looking for feedback
on the general concept of requiring
health IT developers to ensure that they
are certified to the types of measures
that are most relevant to their client
base. For example, if a product serves
multiple specialties, then it needs to be
certified to the measures that are most
likely needed by all of the specialties it
serves. On the other hand, if the product
is a niche product, such as a dental
product, then it only needs to be
certified to the measures that are
relevant for that particular section of the
market. As another example, we have
provided a pediatric recommended core
set 1 and an adult recommended core
1 https://www.cms.gov/Regulations-and-Guidance/
Legislation/EHRIncentivePrograms/Downloads/
2014_CQM_PrediatricRecommended_
CoreSetTable.pdf.
E:\FR\FM\31DEN1.SGM
31DEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
set 2 of measures. Note that none of the
measures in the core sets are currently
required for health IT developer
certification, but only recommended.
We solicit comment on whether we
should require health IT developers to
certify to all the measures in a core set
depending on whether the product is
intended to serve pediatric or adult
settings. We are considering a structure
for providing specialty measure sets
similar to those recommended under the
PQRS 3 which have been developed by
CMS together with specialty societies.
These specialty measure sets have been
developed to ensure that measures
represented within Specialty Measure
Sets accurately illustrate measures that
are relevant within a particular clinical
area. While soliciting general comment
on this proposed alternate approach, we
recognize that there may not be a
specialty measure set for every specialty
type eligible to participate in the EHR
Incentive Programs. We are working on
increasing the number of specialties for
which there is a Specialty Measure Set
in PQRS, but solicit comment on what
additional specialties would benefit
from a Specialty Measure Set and
whether there are efforts underway to
establish a list we could consider for our
programs. We also acknowledge that
there may not be e-specified CQMs
available for every Specialty Measure
Set and solicit comments on whether
this approach would achieve the desired
goal for all specialty types to have
certified measures relevant to their
scope of practice available in their
certified Health IT Module.
• Option C: Another approach with 3
options from which a health IT
developer must choose one:
++ Multispecialty health IT
developer—certifies all CQMs.
++ Primary care health IT developer—
certifies a set of primary care CQMs.
++ Specialty provider health IT
developer—certifies a minimum number
of CQMs on an ‘‘a la carte’’ basis.
For this approach, we solicit comment
on the number of measures that would
be reasonable to require for certification
under the ‘‘primary care health IT
developer’’ option as well as the
‘‘specialty provider health IT
developer’’ option. We invite general
comment on this overall approach.
We are soliciting public input on
other ways of grouping or classifying
measures to ensure applicability and
selection for providers. For example,
2 https://www.cms.gov/Regulations-and-Guidance/
Legislation/EHRIncentivePrograms/Downloads/
2014_CQM_AdultRecommend_CoreSetTable.pdf.
3 https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/PQRS/
MeasuresCodes.html.
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
one method of grouping measures could
be by those that are invasive (for
example, surgical), non-invasive, and
cognitive. Another method could be by
setting of care/venue.
As stated in the Medicare and
Medicaid Programs; Electronic Health
Record Incentive Program—Stage 3 and
Modifications to Meaningful Use in
2015 through 2017 final rule (80 FR
62895), any specific proposals for the
number of measures vendors would be
required to certified to would be
outlined in separate notice and
comment rulemaking such as the
Physician Fee Schedule or Inpatient
Prospective Payment Systems rules.
C. CQM Testing and Certification
ONC offers health IT certification for
CQMs to record and export, import and
calculate, and electronically report
CQMs through its ONC Health IT
Certification Program. This year, ONC
has adopted a new edition of
certification criteria in the 2015 Edition
final rule (80 FR 62601). One objective
of testing for the 2015 Edition CQM
criteria (80 FR 62651) is to increase
testing robustness (for example,
increasing number of test records,
robustly testing pathways by which a
patient can enter the numerator or
denominator of a measure), thereby
ensuring that all certified products have
capabilities commensurate to the
increased requirements enumerated in
the 2015 Edition final rule.
In the 2011 and 2014 Editions of
certification criteria, the certification
program sought to test basic capabilities
and minimum requirements. Our
expectation is that as time progresses
and technology improves, EHR systems
will have to demonstrate they are able
to perform to increasing levels of
complexity, including requirements to
identify errors, consume larger numbers
of test cases, and demonstrate stricter
adherence to standards. This is to
ensure that investments into certified
products yield the functionality
expected to improve health care.
Certification criteria also includes
optional and required elements that
allow end users and quality
improvement leaders to view, filter, and
export quality measure data. These data
enable point-of-care, iterative quality
improvement efforts to identify patients
whose care and conditions are not
compliant with evidence-based
guidelines, take action to improve their
engagement with care processes, and
achieve better outcomes.
CMS and ONC’s Health IT
Certification Program test CQM
functionality (for example, by testing a
health IT system’s ability to import,
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
81827
export, capture, calculate, and report
CQM data according to certain
standards) through the Cypress Testing
and Certification Tool by enabling
repeatable and rigorous testing of a
product’s capability to accurately
calculate CQMs.4 There are potential
areas of improvement to increase the
robustness of that testing. Therefore, we
are requesting information on the
following:
• What changes to testing are
recommended (or are not
recommended) to increase testing
robustness?
• How could CMS and ONC
determine how many test cases are
needed for adequate test coverage?
• Are there recommendations for the
format of test cases that could be
entered both manually and
electronically?
• What kind of errors should
constitute warnings rather than test
failures?
• Are there recommendations for or
against single measure testing?
• How could the test procedures and
certification companion guides
published by ONC be improved to help
you be more successful in preparing for
and passing certification testing?
CMS and ONC believe that increased
testing robustness adds value to the
process of certification, but
acknowledge that it would increase
health IT developer burden in certifying
their products. Therefore, we welcome
comments on the following:
• How can the CQM certification
process be made more efficient and how
can the certification tools and resources
be augmented or made more useable?
• What, if any, adverse implications
could the increased certification
standards have on providers?
• What levels of testing will ensure
that providers and other product
purchasers will have enough
information on the usability and
effectiveness of the tool without unduly
burdening health IT developers?
• Would flexibility on the vocabulary
codes allowed for test files reduce
burden on health IT developers?
• What are other ways in which the
Cypress testing tool could be improved?
• When 45 CFR 170.315(c)(1) requires
users to export quality measure data on
demand, how would you want that to be
accessed by users and what
characteristics are minimally required to
make this feature useful to end users?
• ONC finalized a 2015 Edition
certification criterion for filtering of
CQMs (45 CFR 170.315(c)(4)) to the
following filters:
4 https://projectcypress.org/.
E:\FR\FM\31DEN1.SGM
31DEN1
81828
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
++ Taxpayer Identification Number
(TIN).
++ National Provider Identifier (NPI).
++ Provider type.
++ Practice site address.
++ Patient insurance.
++ Patient age.
++ Patient sex.
++ Patient race and ethnicity.
++ Patient problem list data.
How useful are the ‘‘filtering’’ criteria
to end users of systems for the purpose
of safety and quality improvement? To
quality improvement staff and
organizations?
• Are there additional filters/data
would be helpful to stratify CQM-Filters
(45 CFR 170.315(c)(4)) data by?
• What, if anything additional,
regarding this testing/certification
should be published via the Certified
Health IT Product List?
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: December 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–32931 Filed 12–30–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
tkelley on DSK3SPTVN1PROD with NOTICES
[Document Identifier: CMS–R–284]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments must be received by
February 29, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
DATES:
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number __ Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–R–284 Medicaid Statistical
Information System (MSIS) and
Transformed—Medicaid Statistical
Information System (T–MSIS)
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
1. Type of Information Collection
Request: Revision of a currently
approved collection. Title of
Information Collection: Medicaid
Statistical Information System (MSIS)
and Transformed—Medicaid Statistical
Information System (T–MSIS); Use: The
data reported in MSIS/T–MSIS are used
by federal, state, and local officials, as
well as by private researchers and
corporations to monitor past and
projected future trends in the Medicaid
program. These data provide the only
national level information available on
enrollees, beneficiaries, and
expenditures. They also provide the
only national level information
available on Medicaid utilization. This
information is the basis for analyses and
for cost savings estimates for the
Department’s cost sharing legislative
initiatives to Congress. The collected
data are also crucial to our actuarial
forecasts. Form Number: CMS–R–284
(OMB control number: 0938–0345);
Frequency: Quarterly and monthly;
E:\FR\FM\31DEN1.SGM
31DEN1
]]>Agencies
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81824-81828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32931]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3323-NC]
Request for Information: Certification Frequency and Requirements
for the Reporting of Quality Measures Under CMS Programs
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This request for information seeks public comment regarding
several items related to the certification of health information
technology (IT), including electronic health records (EHR) products
used for reporting to certain CMS quality reporting programs such as,
but not limited to, the Hospital Inpatient Quality Reporting (IQR)
Program and the Physician Quality Reporting System (PQRS). In addition,
we are requesting feedback on how often to require recertification, the
number of clinical quality measures (CQMs) a certified Health IT Module
should be required to certify to, and testing of certified Health IT
Module(s).
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on February 1, 2016.
ADDRESSES: In commenting, refer to file code CMS-3323-NC. Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3323-NC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
[[Page 81825]]
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3323-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
FOR FURTHER INFORMATION CONTACT: Lisa Marie Gomez, 410-786-1175.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
The Health Information Technology for Economic and Clinical Health
Act (Title IV of Division B of the American Recovery and Reinvestment
Act of 2009 (ARRA) and Title XIII of Division A of the ARRA) authorizes
incentive payments under Medicare and Medicaid for the adoption of and
meaningful use of certified EHR technology (CEHRT) and downward payment
adjustments under Medicare for failure to demonstrate meaningful use.
Eligible professionals (EPs), eligible hospitals, and critical access
hospitals (CAHs) that seek to qualify for incentive payments or avoid
negative payment adjustments under the Medicare and Medicaid EHR
Incentive Programs are required to use CEHRT. Some CMS quality
reporting programs, such as the Hospital Inpatient Quality Reporting
(IQR) Program and Physician Quality Reporting System (PQRS), either
require or provide the option to use certified EHR technology, as
defined under the EHR Incentive Program, for reporting quality data.
The Office of the National Coordinator for Health Information
Technology's (ONC's) ``2015 Edition Health Information Technology
(Health IT) Certification Criteria, 2015 Edition Base Electronic Health
Record (EHR) Definition, and ONC Health IT Certification Program
Modifications Final Rule'' (80 FR 62601) (2015 Edition final rule),
establishes the capabilities and specifies the related standards and
implementation specifications that CEHRT needs to include to support
the achievement of meaningful use by EPs, eligible hospitals, and CAHs.
ONC's Health IT Certification Program provides a process by which
Health IT Module(s) can be certified so that they meet the standards,
implementation specifications, and certification criteria that have
been adopted by the Secretary. CEHRT is defined for the Medicare and
Medicaid EHR Incentive Programs in 42 CFR 495.4. The definition
establishes the requirements for EHR technology that must be used by
providers to meet the MU objectives and measures or to qualify for an
incentive payment under Medicaid for adopting, implementing, or
upgrading CEHRT. For example, a Health IT Module is presented for
certification to a criterion with a percentage-based measure and the
Health IT Module can meet the ``automated numerator recording''
criterion or ``automated measure calculation'' criterion. The CQM data
reported to us must originate from EHR technology that is certified in
accordance with the ONC Health IT Certification Program's requirements
(77 FR 54053).
As stated in the Medicare and Medicaid Programs; Electronic Health
Record Incentive Program--Stage 3 and Modifications to Meaningful Use
in 2015 through 2017 final rule (80 FR 62894), in 2017, all EPs,
eligible hospitals, and CAHs have two options to report CQM data,
either through attestation or use of established methods for electronic
reporting where feasible. However, starting in 2018, EPs, eligible
hospitals, and CAHs participating in the Medicare EHR Incentive Program
must electronically report CQMs using CEHRT where feasible; and
attestation to CQMs will no longer be an option except in certain
circumstances where electronic reporting is not feasible.
II. Solicitation of Comments
We are soliciting public input on the following areas of
certification and testing of health IT, particularly relating to how
often to require recertification, the number of CQMs a certified Health
IT Module should be required to certify to, and the testing of
certified Health IT Module(s) in order to reduce the burden and further
streamline the process for providers and health IT developers while
ensuring such products are certified and tested appropriately for
effectiveness. The feedback will inform CMS and ONC of elements that
may need to be considered for future rules relating to the reporting of
quality measures under CMS programs. This request for information is
part of the effort of CMS to streamline/reduce EP, eligible hospital,
CAH, and health IT developer burden.
A. Frequency of Certification
We conduct an annual analysis of CQM specifications in order to
ensure measure efficacy, accuracy, and clinical relevance. Any updates
to the calculation of a CQM through this process are released with the
annual updates to the electronic specifications for EHR submission
published by CMS (https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html). Because we require
the most recent version of the CQM specifications to be used for
electronic reporting methods (79 FR 67906 and 80 FR 49760), we
understand that health IT developers must make CQM updates annually and
providers must regularly implement those updates to stay current with
the most recent CQM version. To
[[Page 81826]]
ensure accuracy of the implementation of these updates, we have
considered requiring recertification of already certified EHR products
with these annual updates. We understand that standards for
electronically representing CQMs continue to evolve, and believe there
may be value in retesting certified Health IT Modules (including CEHRT)
periodically to ensure that CQMs are being accurately calculated and
represented, and that they can be reported as required. However, we
have not required this recertification to date. With the continuing
evolution of technology and clinical standards, as well as the need for
a predictable cycle from measure development to provider data
submission, we indicated, in the Fiscal Year (FY) 2016 Hospital
Inpatient Prospective Payment Systems (IPPS) and Long-term Care
Hospital (LTCH) Prospective Payment System (PPS) final rule (80 FR
49760) (hereinafter referred to as the FY 2016 IPPS/LTCH PPS final
rule), that we would be issuing a request for information on the
establishment of an ongoing cycle for the introduction and
certification of new measures, the testing of updated measures, and the
testing and certification of submission capabilities.
While we believe that health IT developers should test and certify
their products to the most recent version of the electronic
specifications for the CQMs when feasible, we understand the burdens
associated with this requirement and therefore, have not historically
required re-certification of previously certified products when updates
are made to CQM electronic specifications or to the standards required
for reporting. During the FY 2016 IPPS/LTCH PPS rulemaking process, we
received comments and requests from stakeholders to change this policy.
We acknowledge that the certification process can be burdensome to
health IT developers and believe that annual certification could
compress the timeline for CQM and standard updates. We also acknowledge
that stakeholders and providers reporting electronic CQMs have an
interest in ensuring that their Health IT Module is tested and
certified to the most recent version of electronic CQM specifications.
We are soliciting feedback regarding testing and recertification,
particularly relating to: The requirement for CEHRT products to be
recertified when a new version of the CEHRT is available in order to
ensure the accuracy of implementation; and the requirement for Health
IT Modules to undergo annual CQM testing through CMS approved testing
tools and the ONC Health IT Certification Program. We are also seeking
comment on the following.
What is the burden (both time and money) of additional
testing and recertification?
What are the benefits of requiring additional testing and
recertification?
How will it affect the timeline for CQM and standard
updates?
What are the benefits and challenges of establishing a
predictable cycle from measure development to provider data submission?
B. Changes to Minimum CQM Certification Requirements
The Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015
through 2017 final rule (80 FR 62761) specifies the meaningful use
criteria that EPs, eligible hospitals, and CAHs must meet in order to
qualify for Medicare and Medicaid EHR incentive payments and avoid
downward payment adjustments under Medicare. We believe EHRs should be
certified to more than the minimum number of CQMs as required by the
ONC 2014 Edition Base EHR definition of a minimum of 9 CQMs for EPs or
16 for eligible hospitals and CAHs (80 FR 16771, see also 45 CFR
170.102). With health IT developers having EHRs certified to the
minimum number of CQMs, EPs, eligible hospitals, and CAHs may have
limited CQMs available to them and may not be able to report on CQMs
that are applicable to their patient population or scope of practice.
As stated in the preamble of the final rule (80 FR 62895), we believe
EPs, eligible hospitals, and CAHs should have a choice of which CQMs to
report so that they can report on those CQMs most applicable to their
patient population or scope of practice. Accordingly, we are soliciting
comment on the following policy options that could provide greater
choice for EPs, eligible hospitals, and CAHs. Specifically, we are
soliciting comment on: The feasibility of health IT developers
complying with the requirements of each option in the first year in
which the requirements would become effective; the impact of each
option on EPs, eligible hospitals/CAHs, and health IT developers; and
what we would need to consider when assessing each of these options.
Option 1: Require EP health IT developers to certify
Health IT Modules to all CQMs in the EP selection list; and require
eligible hospital/CAH health IT developers to certify to all CQMs in
the selection list for eligible hospitals and CAHs.
Option 2: Incrementally increase the number of CQMs
required to be certified each year until Health IT Modules are
certified for all CQMs available for reporting by EPs, eligible
hospitals, and CAHs to meet their CQM reporting requirements. For
Option 2, we invite input on the advantages and disadvantages of an
incremental increase in the number of CQMs required to be certified
each year.
Option 3: Require EP health IT developers to certify
health IT products to more than the current minimum number of CQMs
required for reporting, but not to all available CQMs.
For Option 3, we invite stakeholders' input regarding the following
approaches that are specific examples of implementation of the policy
goal:
Option A: An approach that would set a minimum number of
measures health IT developers must certify to for EP settings or
eligible hospital/CAH settings that is greater than the minimum number
required for provider reporting. For example, EP health IT developers
could be required to certify to a minimum of 15 measures, and eligible
hospital/CAH health IT developers could be required to certify to a
minimum number of 25 measures. We note that these numbers are provided
as examples only, and we solicit comment on the appropriate number
health IT developers could be required to certify to. Under this
approach, health IT developers could choose from any measures in the
list of available CQMs.
Option B: An EP-specific approach that would require an EP
health IT developer to certify to all the measures in a core/required
set and all the measures in at least one specialty measure set relevant
to the scope of practice for which the product is intended. We are
looking for feedback on the general concept of requiring health IT
developers to ensure that they are certified to the types of measures
that are most relevant to their client base. For example, if a product
serves multiple specialties, then it needs to be certified to the
measures that are most likely needed by all of the specialties it
serves. On the other hand, if the product is a niche product, such as a
dental product, then it only needs to be certified to the measures that
are relevant for that particular section of the market. As another
example, we have provided a pediatric recommended core set \1\ and an
adult recommended core
[[Page 81827]]
set \2\ of measures. Note that none of the measures in the core sets
are currently required for health IT developer certification, but only
recommended. We solicit comment on whether we should require health IT
developers to certify to all the measures in a core set depending on
whether the product is intended to serve pediatric or adult settings.
We are considering a structure for providing specialty measure sets
similar to those recommended under the PQRS \3\ which have been
developed by CMS together with specialty societies. These specialty
measure sets have been developed to ensure that measures represented
within Specialty Measure Sets accurately illustrate measures that are
relevant within a particular clinical area. While soliciting general
comment on this proposed alternate approach, we recognize that there
may not be a specialty measure set for every specialty type eligible to
participate in the EHR Incentive Programs. We are working on increasing
the number of specialties for which there is a Specialty Measure Set in
PQRS, but solicit comment on what additional specialties would benefit
from a Specialty Measure Set and whether there are efforts underway to
establish a list we could consider for our programs. We also
acknowledge that there may not be e-specified CQMs available for every
Specialty Measure Set and solicit comments on whether this approach
would achieve the desired goal for all specialty types to have
certified measures relevant to their scope of practice available in
their certified Health IT Module.
---------------------------------------------------------------------------
\1\ https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/2014_CQM_PrediatricRecommended_CoreSetTable.pdf.
\2\ https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/2014_CQM_AdultRecommend_CoreSetTable.pdf.
\3\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/MeasuresCodes.html.
---------------------------------------------------------------------------
Option C: Another approach with 3 options from which a
health IT developer must choose one:
++ Multispecialty health IT developer--certifies all CQMs.
++ Primary care health IT developer--certifies a set of primary
care CQMs.
++ Specialty provider health IT developer--certifies a minimum
number of CQMs on an ``a la carte'' basis.
For this approach, we solicit comment on the number of measures
that would be reasonable to require for certification under the
``primary care health IT developer'' option as well as the ``specialty
provider health IT developer'' option. We invite general comment on
this overall approach.
We are soliciting public input on other ways of grouping or
classifying measures to ensure applicability and selection for
providers. For example, one method of grouping measures could be by
those that are invasive (for example, surgical), non-invasive, and
cognitive. Another method could be by setting of care/venue.
As stated in the Medicare and Medicaid Programs; Electronic Health
Record Incentive Program--Stage 3 and Modifications to Meaningful Use
in 2015 through 2017 final rule (80 FR 62895), any specific proposals
for the number of measures vendors would be required to certified to
would be outlined in separate notice and comment rulemaking such as the
Physician Fee Schedule or Inpatient Prospective Payment Systems rules.
C. CQM Testing and Certification
ONC offers health IT certification for CQMs to record and export,
import and calculate, and electronically report CQMs through its ONC
Health IT Certification Program. This year, ONC has adopted a new
edition of certification criteria in the 2015 Edition final rule (80 FR
62601). One objective of testing for the 2015 Edition CQM criteria (80
FR 62651) is to increase testing robustness (for example, increasing
number of test records, robustly testing pathways by which a patient
can enter the numerator or denominator of a measure), thereby ensuring
that all certified products have capabilities commensurate to the
increased requirements enumerated in the 2015 Edition final rule.
In the 2011 and 2014 Editions of certification criteria, the
certification program sought to test basic capabilities and minimum
requirements. Our expectation is that as time progresses and technology
improves, EHR systems will have to demonstrate they are able to perform
to increasing levels of complexity, including requirements to identify
errors, consume larger numbers of test cases, and demonstrate stricter
adherence to standards. This is to ensure that investments into
certified products yield the functionality expected to improve health
care. Certification criteria also includes optional and required
elements that allow end users and quality improvement leaders to view,
filter, and export quality measure data. These data enable point-of-
care, iterative quality improvement efforts to identify patients whose
care and conditions are not compliant with evidence-based guidelines,
take action to improve their engagement with care processes, and
achieve better outcomes.
CMS and ONC's Health IT Certification Program test CQM
functionality (for example, by testing a health IT system's ability to
import, export, capture, calculate, and report CQM data according to
certain standards) through the Cypress Testing and Certification Tool
by enabling repeatable and rigorous testing of a product's capability
to accurately calculate CQMs.\4\ There are potential areas of
improvement to increase the robustness of that testing. Therefore, we
are requesting information on the following:
---------------------------------------------------------------------------
\4\ https://projectcypress.org/.
---------------------------------------------------------------------------
What changes to testing are recommended (or are not
recommended) to increase testing robustness?
How could CMS and ONC determine how many test cases are
needed for adequate test coverage?
Are there recommendations for the format of test cases
that could be entered both manually and electronically?
What kind of errors should constitute warnings rather than
test failures?
Are there recommendations for or against single measure
testing?
How could the test procedures and certification companion
guides published by ONC be improved to help you be more successful in
preparing for and passing certification testing?
CMS and ONC believe that increased testing robustness adds value to
the process of certification, but acknowledge that it would increase
health IT developer burden in certifying their products. Therefore, we
welcome comments on the following:
How can the CQM certification process be made more
efficient and how can the certification tools and resources be
augmented or made more useable?
What, if any, adverse implications could the increased
certification standards have on providers?
What levels of testing will ensure that providers and
other product purchasers will have enough information on the usability
and effectiveness of the tool without unduly burdening health IT
developers?
Would flexibility on the vocabulary codes allowed for test
files reduce burden on health IT developers?
What are other ways in which the Cypress testing tool
could be improved?
When 45 CFR 170.315(c)(1) requires users to export quality
measure data on demand, how would you want that to be accessed by users
and what characteristics are minimally required to make this feature
useful to end users?
ONC finalized a 2015 Edition certification criterion for
filtering of CQMs (45 CFR 170.315(c)(4)) to the following filters:
[[Page 81828]]
++ Taxpayer Identification Number (TIN).
++ National Provider Identifier (NPI).
++ Provider type.
++ Practice site address.
++ Patient insurance.
++ Patient age.
++ Patient sex.
++ Patient race and ethnicity.
++ Patient problem list data.
How useful are the ``filtering'' criteria to end users of systems
for the purpose of safety and quality improvement? To quality
improvement staff and organizations?
Are there additional filters/data would be helpful to
stratify CQM-Filters (45 CFR 170.315(c)(4)) data by?
What, if anything additional, regarding this testing/
certification should be published via the Certified Health IT Product
List?
III. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Dated: December 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-32931 Filed 12-30-15; 8:45 am]
BILLING CODE 4120-01-P
