Medicare Program; Request for Information on the Use of Clinical Quality Measures (CQMs) Reported Under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and Other Reporting Programs, 9057-9060 [2013-02703]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3276–NC]
Medicare Program; Request for
Information on the Use of Clinical
Quality Measures (CQMs) Reported
Under the Physician Quality Reporting
System (PQRS), the Electronic Health
Record (EHR) Incentive Program, and
Other Reporting Programs
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Request for information.
AGENCY:
This request for information
solicits ways in which an eligible
professional (EP) might use the clinical
quality measures (CQM) data reported to
specialty boards, specialty societies,
regional health care quality
organizations or other non-federal
reporting programs to also report under
the Physician Quality Reporting System
(PQRS), as well as the Electronic Health
Record (EHR) Incentive Program. It also
solicits ways by which the entities
already collecting CQM data for other
reporting programs to submit this data
on behalf of EPs and group practices for
reporting under the PQRS and the EHR
Incentive Program. It also requests
information regarding section 601(b) of
the American Taxpayer Relief Act of
2012 which provides for treating an EP
as satisfactorily reporting data on
quality measures if the EP is
satisfactorily participating in a qualified
clinical data registry. We are requesting
information from medical specialty
societies, boards, and registries, other
third party registry vendors, eligible
professionals using registries to report
quality measures, and any other party
interested in providing information on
this request for information.
DATES: The information solicited in this
notice must be received at the address
provided below, no later than 5 p.m.
eastern standard time (e.s.t) April 8,
2013.
ADDRESSES: In commenting, refer to file
code CMS–3276–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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:45 Feb 06, 2013
Jkt 229001
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3276–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.
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–3276–NC,
Mail Stop S3–02–01, 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 information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Christine Estella, 410–786–0485.
SUPPLEMENTARY INFORMATION:
I. Background
A. Maintenance of Certification
Twenty-four member boards of the
American Board of Medical Specialties
(ABMS) currently recertify physician
specialists through the ABMS
Maintenance of Certification (MOC)
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
9057
process.1 The MOC assesses physicians’
commitment to lifelong learning
according to the following six core
competencies for quality patient care:
(1) Patient care; (2) medical knowledge;
(3) practice-based learning and
improvement; (4) interpersonal and
communications skills; (5)
professionalism; and (6) systems-based
practice. Generally speaking, the MOC
incorporates these six core
competencies through a four-part
process:
• Part I: Licensure and Professional
Standing
• Part II: Lifelong Learning and SelfAssessment
• Part III: Cognitive Expertise
• Part IV: Practice Performance
Assessment 2
Within this four-part process,
particularly in Part IV, certain member
boards require the reporting of quality
measures data using a registry or other
method associated with a member
board. More information on the ABMS
MOC can be found at https://www.abms.
org/Maintenance_of_Certification/
ABMS_MOC.aspx.
A. The Physician Quality Reporting
System
The Physician Quality Reporting
System (PQRS), as set forth in
subsections (a), (k) and (m) of section
1848 of the Social Security Act (the Act)
and as amended by section 601(b) of the
American Taxpayer Relief Act of 2012,
is a quality pay-for-reporting program
that provides incentive payments
through 2014, and beginning in 2015,
payment adjustments to eligible
professionals (EPs) based on whether or
not they satisfactorily report data on
quality measures for covered
professional services furnished during a
specified reporting period. The PQRS
(formerly the Physician Quality
Reporting Initiative or PQRI) was first
implemented in 2007 pursuant to the
Tax Relief and Health Care Act
(TRHCA) of 2006. Although the PQRS is
a quality pay-for-reporting program, the
PQRS is currently used as the basis for
other CMS programs that measure
performance. For example, the
application of the Value-Based Payment
Modifier in 2015 will be dependent on
the group practice’s participation in the
PQRS in 2013. (For additional
information, see the Calendar Year (CY)
2013 Medicare Physician Fee Schedule
(PFS) final rule with comment period
(77 FR 69306).).
1 https://www.abms.org/
Maintenance_of_Certification/ABMS_MOC.aspx.
2 https://www.abms.org/Maintenance_of
_Certification/ABMS_MOC.aspx.
E:\FR\FM\07FEN1.SGM
07FEN1
9058
Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
The claims-based reporting
mechanism was the only reporting
mechanism available for reporting PQRS
individual quality measures data under
the 2007 PQRS. However, the PQRS has
evolved to offer multiple reporting
mechanisms, reporting periods, and
criteria for satisfactory reporting for
purposes of reporting PQRS quality
measures data.
In 2008, the PQRS introduced use of
the registry-based reporting mechanism.
The registry-based reporting mechanism
has proven to be popular among eligible
professionals, and the number of
eligible professionals that participate in
PQRS via registry reporting continues to
increase. According to the 2010 PQRS
and e-Prescribing (eRx) Experience
Report, in 2008, 31 of 32 qualified
registries submitted data on behalf of
nearly 12,000 eligible professionals. The
number of eligible professionals for
which data was submitted by a registry
increased to 33,411 in 2009 (from 69 of
74 qualified registries) and to 56,214 in
2010 (from 89 of the 96 qualified
registries). Historically, eligible
professionals using the registry-based
reporting mechanism have been more
successful at meeting the criteria for
satisfactory reporting of the PQRS data
than through the claims-based reporting
mechanism.
mstockstill on DSK4VPTVN1PROD with NOTICES
1. Qualification Requirement for
Registries Submitting PQRS Quality
Measures Data on Behalf of Eligible
Professionals and Group Practices
The PQRS requires every registry that
wishes to submit data on PQRS quality
measures on behalf of its eligible
professionals to become ‘‘qualified’’
under the PQRS. The final qualification
process for registries that wish to
become qualified to submit PQRS
quality measures data for 2013 and
subsequent years can be found in the CY
2013 Medicare PFS final rule with
comment period (77 FR 69178).
Generally, the registry qualification
process for 2013 and subsequent years
requires a registry to possess certain
characteristics and submit a selfnomination statement that indicates that
the registry has these characteristics and
of the registry’s intent to submit PQRS
CQMs data on behalf of its eligible
professionals for the respective year.
2. Registries Classified as EHR Data
Submission Vendors
In lieu of serving as a registry under
the PQRS, registries that have access to
an EHR system may instead serve as an
EHR data submission vendor. Beginning
in 2014, a registry acting as an EHR data
submission vendor must have its EHR
system certified under the program
VerDate Mar<15>2010
17:45 Feb 06, 2013
Jkt 229001
established by the Office of the National
Coordinator for Health Information
Technology (ONC) as certified EHR
technology (CEHRT). (For more
information see the CY 2013 Medicare
PFS final rule with comment period (77
FR 69185).)
3. PQRS Reporting Options Using the
Registry-Based Reporting Mechanism
Since the inception of the registrybased reporting mechanism in 2008, we
have developed multiple criteria for
satisfactory reporting for individual
eligible professionals, and, beginning in
2013, group practices participating in
the group practice reporting option
(GPRO), using the registry-based
reporting mechanism to report PQRS
quality measures data. For example, we
previously have adopted criteria for
satisfactory reporting using qualified
registries in which eligible professionals
or group practices must report data on
a minimum of three measures or, for
individual eligible professionals only,
one measures group, a certain
percentage or number of cases. Eligible
professionals or group practices using
registries that serve as EHR data
submission vendors may, for 2013,
either report a minimum of 3 measures
for at least 80 percent of cases, or use
the reporting criterion that aligns with
the EHR Incentive Program. To meet the
criteria for satisfactory reporting using
an EHR data submission vendor for the
2014 PQRS incentive, eligible
professionals or group practices must
use the criteria that align with the EHR
Incentive Program. (For more detailed
information see the CY 2013 Medicare
PFS final rule with comment period (77
FR 69188).
4. Participation in a Qualified Clinical
Data Registry
Section 601(b) of the recently enacted
American Taxpayer Relief Act of 2012
amended section 1848(m)(3) of the Act
to allow eligible professionals to be
treated as satisfactorily submitting data
on quality measures for covered
professional services if the eligible
professional satisfactorily participates in
a qualified clinical data registry. For
2014 and subsequent years, the
Secretary is required to treat an eligible
professional as satisfactorily submitting
data on quality measures under the
PQRS program if, in lieu of reporting
PQRS quality measures the eligible
professional is satisfactorily
participating, as determined by the
Secretary, in a qualified clinical data
registry for the year.
The Secretary is required to establish
requirements for an entity to be
considered a qualified clinical data
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
registry, including a requirement that
the entity provide information, at such
time and in such manner, as the
Secretary determines necessary. In
establishing these requirements, the
Secretary must consider whether an
entity: Has mechanisms for
transparency of data, risk models, and
measures; requires submission of data
with respect to multiple payers;
provides timely performance reports to
participants at the individual level; and
supports quality improvement
initiatives. The pre-rulemaking process
established in sections 1890 and 1890A
of the Social Security Act does not
apply to measures used by a qualified
registry and registries may use NQFendorsed measures. The Secretary is
required to establish a process to
determine whether an entity meets the
requirements to be a qualified clinical
data registry. The process can involve a
determination by the Secretary or the
Secretary can designate one or more
independent organizations to make such
determination, or both approaches can
be used.
B. The EHR Incentive Program
The Health Information Technology
for Economic and Clinical Health Act
(the ‘‘HITECH Act’’) is included in the
American Recovery and Reinvestment
Act of 2009 (the ‘‘Recovery Act’’). The
HITECH Act authorized incentive
payments under Medicare and Medicaid
for eligible professionals (EPs), eligible
hospitals, and critical access hospitals
(CAHs) that adopt, implement, upgrade,
or demonstrate meaningful use of
certified EHR technology (CEHRT), and
beginning in 2015, payment adjustments
under Medicare for failing to
demonstrate meaningful use. Certified
EHR technology may include EHR
modules that calculate and report
clinical quality measures data. These
EHR modules can be part of the EP’s
CEHRT and used by registries and other
data submission vendors to report
clinical quality measures on behalf of
EPs.
The EHR Incentive Program will be
implemented in three stages. For CYs
2011, 2012, and 2013, EPs are required
to select and report from a list of 44
CQMs subject to the reporting criteria
established for those years. (For more
information see the July 28, 2010 EHR
Incentive Program final rule (75 FR
44409 through 44411) and the
September 4, 2012 EHR Incentive
Program Stage 2 final rule (77 FR
54057).) Beginning in 2014, EPs must
select and report from a list of 64 CQMs
that are contained in the 6 domains of
quality of care established in the
National Quality Strategy. The six
E:\FR\FM\07FEN1.SGM
07FEN1
Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
domains are: (1) Patient and Family
Engagement; (2) Patient Safety; (3) Care
Coordination; (4) Population and
Community Health; (5) Efficient Use of
Healthcare Resources; and (6) Clinical
Processes/Effectiveness. In order to
satisfy the CQM component of the EHR
Incentive Program beginning in 2014,
EPs must report nine CQMs covering at
least three domains. (For more
information see the September 4, 2012
EHR Incentive Program Stage 2 final
rule (77 FR 54058).)
II. Request for Information
3 https://www.abms.org/Maintenance_of_
Certification/ABMS_MOC.aspx.
We are seeking input from the public
on ways in which an eligible
professional might use the CQM data
reported to medical boards, specialty
societies, regional health care quality
organizations or other non-federal
reporting programs to fulfill
requirements of PQRS, and, although we
are not seeking to change the
requirements we established for the
EHR Incentive Program in 2014, the
EHR Incentive Program. We are seeking
input on how alignment of certain
requirements present in both federal
and non-federal CQM reporting
programs could reduce the burden for
eligible professionals and accelerate
quality improvement. We are also
seeking input on the amendments made
by section 601(b) of the American
Taxpayer Relief Act of 2012. Therefore,
we are soliciting comment on the
following questions:
• High level questions:
++ How are the current reporting
requirements for the PQRS and and the
reporting requirements in 2014 for the
EHR Incentive Program similar to the
reporting requirements already
established for the ABMS boards or to
other non-federal quality reporting
programs? How are they different? In
what ways are these reporting
requirements duplicative and can these
reporting programs be integrated to
reduce reporting burden on eligible
professionals?
++ Are there examples of other nonfederal programs under which eligible
professionals report quality measures
data?
++ What would be the benefits and
shortcomings involved with allowing
third-party entities to report quality data
to CMS on behalf of physicians and
other eligible professionals?
++ What entities have the capacity to
report quality data similar to those
reported under the PQRS, Value-based
Payment Modifier, and/or EHR
Incentive programs? If these entities
were to report such data to CMS, what
requirements should we include in the
reporting system used by such entities,
4 https://www.abms.org/Maintenance_of_
Certification/ABMS_MOC.aspx.
5 https://www.sts.org/national-database.
6 https://www.cardiosource.org/Science-AndQuality/Quality-Programs.aspx.
C. Maintenance of Certification
Twenty-four member boards of the
American Board of Medical Specialties
(ABMS) currently recertify physician
specialists through the ABMS
Maintenance of Certification (MOC)
process.3 The MOC assesses physicians’
commitment to lifelong learning
according to the following six core
competencies for quality patient care:
(1) patient care; (2) medical knowledge;
(3) practice-based learning and
improvement; (4) interpersonal and
communications skills; (5)
professionalism; and (6) systems-based
practice. Generally speaking, the MOC
incorporates these six core
competencies through a four-part
process:
• Part I: Licensure and Professional
Standing
• Part II: Lifelong Learning and SelfAssessment
• Part III: Cognitive Expertise
• Part IV: Practice Performance
Assessment 4
Within this four-part process,
particularly in Part IV, certain member
boards require the reporting of quality
measures data using a registry or other
method associated with a member
board. More information on the ABMS
MOC can be found at https://www.abms.
org/Maintenance_of_Certification/
ABMS_MOC.aspx.
D. Other Quality Reporting Programs
mstockstill on DSK4VPTVN1PROD with NOTICES
bridge the gap between science and
practice and to ensure patient access to
high-quality, appropriate and costeffective care.6
These programs are a small sampling
of quality reporting programs occurring
throughout the nation that provide
distinct reporting criteria for program
participation.
Several quality reporting programs
exist within private industry as well.
For example the Society of Thoracic
Surgeons (STS) established a national
database in 1989 as an initiative for
quality improvement and patient safety
among cardiothoracic surgeons. 5
Similarly, the American College of
Cardiology (ACC) has developed and
partnered with other organizations to
create numerous quality initiatives to
assist cardiovascular professionals to
VerDate Mar<15>2010
17:45 Feb 06, 2013
Jkt 229001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
9059
including requirements to ensure high
quality data?
++ How should our quality reporting
programs change/evolve to reduce
reporting burden on eligible
professionals, while still receiving
robust data on clinical quality?
• Questions regarding reporting
requirements for entities that report via
a registry under the PQRS for 2014 and
subsequent years or the EHR Incentive
Program if registry reporting is
established as a reporting method for
that program in future years:
++ What types of entities should be
eligible to submit quality measures data
on behalf of eligible professionals for
PQRS and the EHR Incentive Program?
Examples might include medical board
registries, specialty society registries,
regional quality collaboratives or other
entities. What qualification
requirements should be applicable to
such entities?
++ What functionalities should
entities qualified to submit PQRS
quality measures data possess? For
example, for CQMs that can be
electronically submitted and reported
under PQRS and the EHR Incentive
Program, should an entity’s
qualification to submit such measures
be based on whether they have
technology certified to ONC’s
certification criteria for CQM
calculation and/or electronic
submission?
++ What criteria should we require of
entities submitting quality measures
data to us on behalf of eligible
professionals? Examples might include
transparency of measures available to
EPs, specific frequency of feedback
reports, tools to guide improvement
efforts for EPs, ability to report aggregate
data, agreement to data audits if
requested, etc.
++ Should reporting entities be
required to publicly post performance
data?
++ Should we require an entity to
submit a yearly self-nomination
statement to participate in PQRS?
++ What should be included in the
data validation plan for these reporting
entities?
++ If CMS provided a reporting
option for PQRS and/or the EHR
Incentive Program through such entities,
what specification should CMS use to
receive the quality data information (for
example, Quality Reporting Document
Architecture [QRDA] 1 or 3, XML,
other)?
++ Should data submission timelines
for these reporting entities be modified
so that the submission timeframes for
these quality reporting programs are
aligned? For example, PQRS qualified
E:\FR\FM\07FEN1.SGM
07FEN1
9060
Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
registries are required to submit quality
measures data once, within 2 months
following the reporting period. How
much time are reporting entities outside
of PQRS afforded to submit quality
measures data? What challenges do
reporting entities face in reporting data
according to current timeframes?
++ What oversight (for example,
checks or audits) should be in place to
ensure that data is submitted and
calculated properly by entities?
• Questions regarding selection of
measures related to registry reporting
under PQRS for 2014 and subsequent
years and for the EHR Incentive Program
if registry reporting is established as a
reporting method for that program in
future years:
++ Should we require that a certain
proportion of submitted measures have
particular characteristics such as being
NQF-endorsed or outcome-based?
++ Should we require that the quality
measures data submitted cover a certain
number of the six national quality
strategy domains?
++ To what extent would third-party
entities struggle to meet reporting for
measures currently available under
PQRS and EHR Incentive Program?
• Questions regarding registry
measures reporting criteria:
++ If we propose revised criteria for
satisfactory reporting under PQRS and
for meeting the CQM component of
meaningful use under the EHR Incentive
Program, how many measures should an
eligible professional be required to
report to collect meaningful quality
data? For example, for reporting periods
occurring in 2014, eligible professionals
using CEHRT must report 9 measures
covering at least 3 domains to meet the
criteria for satisfactory reporting for the
2014 PQRS incentive and meet the CQM
component of achieving meaningful use
for the EHR Incentive Program. (For
more information see the EHR Incentive
Program Stage 2 final rule (77 FR 54058)
and the CY 2013 Medicare PFS final
rule with comment period (77 FR
69192).) If we were to align reporting
criteria with reporting requirements for
other non-federal reporting programs, in
future years, should we propose to
require reporting on a different number
of measures than what is currently
required for the PQRS in 2013 and the
EHR Incentive Program under the Stage
2 final rule or should the non-federal
reporting programs align with CMS
criteria?
++ For PQRS, should eligible
professionals still be required to report
quality measures data on a certain
percentage of their applicable patients,
such as 80 percent, for 2014 and
subsequent years? Or, should we require
that eligible professionals report on a
certain minimum number of patients,
such as 20, rather than a percentage?
(Catalog of Federal Domestic Assistance
Program No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: January 9, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2013–02703 Filed 2–4–13; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Device Good
Manufacturing Practice Advisory
Committee, certain device panels of the
Medical Devices Advisory Committee,
the National Mammography Quality
Assurance Advisory Committee, and the
Technical Electronic Products Radiation
Safety Standards Committee in the
Center for Devices and Radiological
Health. Nominations will be accepted
for current vacancies and those that will
or may occur through December 31,
2013.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees, and therefore encourages
nominations of appropriately qualified
candidates from these groups.
SUMMARY:
Because scheduled vacancies
occur on various dates throughout each
year, no cutoff date is established for the
receipt of nominations. However, when
possible, nominations should be
received at least 6 months before the
date of scheduled vacancies for each
year, as indicated in this notice.
DATES:
All nominations for
membership should be sent
electronically to cv@oc.fda.gov, or by
mail to Advisory Committee Oversight &
Management Staff, 10903 New
Hampshire Ave., Bldg. 32, rm. 5103,
Silver Spring, MD 20993–0002.
Information about becoming a member
on a FDA advisory committee can also
be obtained by visiting FDA’s Web site
at https://www.fda.gov/
AdvisoryCommittees/default.htm.
ADDRESSES:
For
specific Committee/Panel questions,
contact the following persons listed in
table 1 of this document.
FOR FURTHER INFORMATION CONTACT:
TABLE 1
Committee/certain device panels of the medical devices advisory committee
mstockstill on DSK4VPTVN1PROD with NOTICES
Contact person
LCDR Sara Anderson, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1544, Silver Spring, MD 20993, 301–796–7046, email:
Sara.Anderson@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1613, Silver Spring, MD 20993, 301–796–6639, email:
Shanika.Craig@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993, 301–796–5290, email:
Natasha.Facey@fda.hhs.gov.
VerDate Mar<15>2010
17:45 Feb 06, 2013
Jkt 229001
PO 00000
Frm 00034
Fmt 4703
National Mammography Quality Assurance Advisory Committee.
Dental Products Panel.
Hematology and Pathology Devices Panel.
Orthopaedic and Rehabilitation Devices Panel.
Technical Electronic Product Radiation Safety Standards Committee.
Anesthesiology and Respiratory Therapy Devices Panel.
Gastroenterology and Urology Devices Panel.
Microbiology Devices Panel.
Obstetrics and Gynecology Devices Panel.
Radiological Devices Panel.
Device Good Manufacturing Practice Advisory Committee.
General Hospital and Personal Use Devices Panel.
Immunology Devices Panel.
Ophthalmic Devices Panel.
Neurological Devices Panel.
Sfmt 4703
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9057-9060]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02703]
[[Page 9057]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3276-NC]
Medicare Program; Request for Information on the Use of Clinical
Quality Measures (CQMs) Reported Under the Physician Quality Reporting
System (PQRS), the Electronic Health Record (EHR) Incentive Program,
and Other Reporting Programs
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This request for information solicits ways in which an
eligible professional (EP) might use the clinical quality measures
(CQM) data reported to specialty boards, specialty societies, regional
health care quality organizations or other non-federal reporting
programs to also report under the Physician Quality Reporting System
(PQRS), as well as the Electronic Health Record (EHR) Incentive
Program. It also solicits ways by which the entities already collecting
CQM data for other reporting programs to submit this data on behalf of
EPs and group practices for reporting under the PQRS and the EHR
Incentive Program. It also requests information regarding section
601(b) of the American Taxpayer Relief Act of 2012 which provides for
treating an EP as satisfactorily reporting data on quality measures if
the EP is satisfactorily participating in a qualified clinical data
registry. We are requesting information from medical specialty
societies, boards, and registries, other third party registry vendors,
eligible professionals using registries to report quality measures, and
any other party interested in providing information on this request for
information.
DATES: The information solicited in this notice must be received at the
address provided below, no later than 5 p.m. eastern standard time
(e.s.t) April 8, 2013.
ADDRESSES: In commenting, refer to file code CMS-3276-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-3276-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.
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-3276-NC, Mail
Stop S3-02-01, 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 information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Christine Estella, 410-786-0485.
SUPPLEMENTARY INFORMATION:
I. Background
A. Maintenance of Certification
Twenty-four member boards of the American Board of Medical
Specialties (ABMS) currently recertify physician specialists through
the ABMS Maintenance of Certification (MOC) process.\1\ The MOC
assesses physicians' commitment to lifelong learning according to the
following six core competencies for quality patient care: (1) Patient
care; (2) medical knowledge; (3) practice-based learning and
improvement; (4) interpersonal and communications skills; (5)
professionalism; and (6) systems-based practice. Generally speaking,
the MOC incorporates these six core competencies through a four-part
process:
\1\ https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
---------------------------------------------------------------------------
Part I: Licensure and Professional Standing
Part II: Lifelong Learning and Self-Assessment
Part III: Cognitive Expertise
Part IV: Practice Performance Assessment \2\
\2\ https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
Within this four-part process, particularly in Part IV, certain
member boards require the reporting of quality measures data using a
registry or other method associated with a member board. More
information on the ABMS MOC can be found at https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
A. The Physician Quality Reporting System
The Physician Quality Reporting System (PQRS), as set forth in
subsections (a), (k) and (m) of section 1848 of the Social Security Act
(the Act) and as amended by section 601(b) of the American Taxpayer
Relief Act of 2012, is a quality pay-for-reporting program that
provides incentive payments through 2014, and beginning in 2015,
payment adjustments to eligible professionals (EPs) based on whether or
not they satisfactorily report data on quality measures for covered
professional services furnished during a specified reporting period.
The PQRS (formerly the Physician Quality Reporting Initiative or PQRI)
was first implemented in 2007 pursuant to the Tax Relief and Health
Care Act (TRHCA) of 2006. Although the PQRS is a quality pay-for-
reporting program, the PQRS is currently used as the basis for other
CMS programs that measure performance. For example, the application of
the Value-Based Payment Modifier in 2015 will be dependent on the group
practice's participation in the PQRS in 2013. (For additional
information, see the Calendar Year (CY) 2013 Medicare Physician Fee
Schedule (PFS) final rule with comment period (77 FR 69306).).
[[Page 9058]]
The claims-based reporting mechanism was the only reporting
mechanism available for reporting PQRS individual quality measures data
under the 2007 PQRS. However, the PQRS has evolved to offer multiple
reporting mechanisms, reporting periods, and criteria for satisfactory
reporting for purposes of reporting PQRS quality measures data.
In 2008, the PQRS introduced use of the registry-based reporting
mechanism. The registry-based reporting mechanism has proven to be
popular among eligible professionals, and the number of eligible
professionals that participate in PQRS via registry reporting continues
to increase. According to the 2010 PQRS and e-Prescribing (eRx)
Experience Report, in 2008, 31 of 32 qualified registries submitted
data on behalf of nearly 12,000 eligible professionals. The number of
eligible professionals for which data was submitted by a registry
increased to 33,411 in 2009 (from 69 of 74 qualified registries) and to
56,214 in 2010 (from 89 of the 96 qualified registries). Historically,
eligible professionals using the registry-based reporting mechanism
have been more successful at meeting the criteria for satisfactory
reporting of the PQRS data than through the claims-based reporting
mechanism.
1. Qualification Requirement for Registries Submitting PQRS Quality
Measures Data on Behalf of Eligible Professionals and Group Practices
The PQRS requires every registry that wishes to submit data on PQRS
quality measures on behalf of its eligible professionals to become
``qualified'' under the PQRS. The final qualification process for
registries that wish to become qualified to submit PQRS quality
measures data for 2013 and subsequent years can be found in the CY 2013
Medicare PFS final rule with comment period (77 FR 69178). Generally,
the registry qualification process for 2013 and subsequent years
requires a registry to possess certain characteristics and submit a
self-nomination statement that indicates that the registry has these
characteristics and of the registry's intent to submit PQRS CQMs data
on behalf of its eligible professionals for the respective year.
2. Registries Classified as EHR Data Submission Vendors
In lieu of serving as a registry under the PQRS, registries that
have access to an EHR system may instead serve as an EHR data
submission vendor. Beginning in 2014, a registry acting as an EHR data
submission vendor must have its EHR system certified under the program
established by the Office of the National Coordinator for Health
Information Technology (ONC) as certified EHR technology (CEHRT). (For
more information see the CY 2013 Medicare PFS final rule with comment
period (77 FR 69185).)
3. PQRS Reporting Options Using the Registry-Based Reporting Mechanism
Since the inception of the registry-based reporting mechanism in
2008, we have developed multiple criteria for satisfactory reporting
for individual eligible professionals, and, beginning in 2013, group
practices participating in the group practice reporting option (GPRO),
using the registry-based reporting mechanism to report PQRS quality
measures data. For example, we previously have adopted criteria for
satisfactory reporting using qualified registries in which eligible
professionals or group practices must report data on a minimum of three
measures or, for individual eligible professionals only, one measures
group, a certain percentage or number of cases. Eligible professionals
or group practices using registries that serve as EHR data submission
vendors may, for 2013, either report a minimum of 3 measures for at
least 80 percent of cases, or use the reporting criterion that aligns
with the EHR Incentive Program. To meet the criteria for satisfactory
reporting using an EHR data submission vendor for the 2014 PQRS
incentive, eligible professionals or group practices must use the
criteria that align with the EHR Incentive Program. (For more detailed
information see the CY 2013 Medicare PFS final rule with comment period
(77 FR 69188).
4. Participation in a Qualified Clinical Data Registry
Section 601(b) of the recently enacted American Taxpayer Relief Act
of 2012 amended section 1848(m)(3) of the Act to allow eligible
professionals to be treated as satisfactorily submitting data on
quality measures for covered professional services if the eligible
professional satisfactorily participates in a qualified clinical data
registry. For 2014 and subsequent years, the Secretary is required to
treat an eligible professional as satisfactorily submitting data on
quality measures under the PQRS program if, in lieu of reporting PQRS
quality measures the eligible professional is satisfactorily
participating, as determined by the Secretary, in a qualified clinical
data registry for the year.
The Secretary is required to establish requirements for an entity
to be considered a qualified clinical data registry, including a
requirement that the entity provide information, at such time and in
such manner, as the Secretary determines necessary. In establishing
these requirements, the Secretary must consider whether an entity: Has
mechanisms for transparency of data, risk models, and measures;
requires submission of data with respect to multiple payers; provides
timely performance reports to participants at the individual level; and
supports quality improvement initiatives. The pre-rulemaking process
established in sections 1890 and 1890A of the Social Security Act does
not apply to measures used by a qualified registry and registries may
use NQF-endorsed measures. The Secretary is required to establish a
process to determine whether an entity meets the requirements to be a
qualified clinical data registry. The process can involve a
determination by the Secretary or the Secretary can designate one or
more independent organizations to make such determination, or both
approaches can be used.
B. The EHR Incentive Program
The Health Information Technology for Economic and Clinical Health
Act (the ``HITECH Act'') is included in the American Recovery and
Reinvestment Act of 2009 (the ``Recovery Act''). The HITECH Act
authorized incentive payments under Medicare and Medicaid for eligible
professionals (EPs), eligible hospitals, and critical access hospitals
(CAHs) that adopt, implement, upgrade, or demonstrate meaningful use of
certified EHR technology (CEHRT), and beginning in 2015, payment
adjustments under Medicare for failing to demonstrate meaningful use.
Certified EHR technology may include EHR modules that calculate and
report clinical quality measures data. These EHR modules can be part of
the EP's CEHRT and used by registries and other data submission vendors
to report clinical quality measures on behalf of EPs.
The EHR Incentive Program will be implemented in three stages. For
CYs 2011, 2012, and 2013, EPs are required to select and report from a
list of 44 CQMs subject to the reporting criteria established for those
years. (For more information see the July 28, 2010 EHR Incentive
Program final rule (75 FR 44409 through 44411) and the September 4,
2012 EHR Incentive Program Stage 2 final rule (77 FR 54057).) Beginning
in 2014, EPs must select and report from a list of 64 CQMs that are
contained in the 6 domains of quality of care established in the
National Quality Strategy. The six
[[Page 9059]]
domains are: (1) Patient and Family Engagement; (2) Patient Safety; (3)
Care Coordination; (4) Population and Community Health; (5) Efficient
Use of Healthcare Resources; and (6) Clinical Processes/Effectiveness.
In order to satisfy the CQM component of the EHR Incentive Program
beginning in 2014, EPs must report nine CQMs covering at least three
domains. (For more information see the September 4, 2012 EHR Incentive
Program Stage 2 final rule (77 FR 54058).)
C. Maintenance of Certification
Twenty-four member boards of the American Board of Medical
Specialties (ABMS) currently recertify physician specialists through
the ABMS Maintenance of Certification (MOC) process.\3\ The MOC
assesses physicians' commitment to lifelong learning according to the
following six core competencies for quality patient care: (1) patient
care; (2) medical knowledge; (3) practice-based learning and
improvement; (4) interpersonal and communications skills; (5)
professionalism; and (6) systems-based practice. Generally speaking,
the MOC incorporates these six core competencies through a four-part
process:
---------------------------------------------------------------------------
\3\ https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
---------------------------------------------------------------------------
Part I: Licensure and Professional Standing
Part II: Lifelong Learning and Self-Assessment
Part III: Cognitive Expertise
Part IV: Practice Performance Assessment \4\
\4\ https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
---------------------------------------------------------------------------
Within this four-part process, particularly in Part IV, certain
member boards require the reporting of quality measures data using a
registry or other method associated with a member board. More
information on the ABMS MOC can be found at https://www.abms.org/Maintenance_of_Certification/ABMS_MOC.aspx.
D. Other Quality Reporting Programs
Several quality reporting programs exist within private industry as
well. For example the Society of Thoracic Surgeons (STS) established a
national database in 1989 as an initiative for quality improvement and
patient safety among cardiothoracic surgeons. \5\ Similarly, the
American College of Cardiology (ACC) has developed and partnered with
other organizations to create numerous quality initiatives to assist
cardiovascular professionals to bridge the gap between science and
practice and to ensure patient access to high-quality, appropriate and
cost-effective care.\6\
---------------------------------------------------------------------------
\5\ https://www.sts.org/national-database.
\6\ https://www.cardiosource.org/Science-And-Quality/Quality-Programs.aspx.
---------------------------------------------------------------------------
These programs are a small sampling of quality reporting programs
occurring throughout the nation that provide distinct reporting
criteria for program participation.
II. Request for Information
We are seeking input from the public on ways in which an eligible
professional might use the CQM data reported to medical boards,
specialty societies, regional health care quality organizations or
other non-federal reporting programs to fulfill requirements of PQRS,
and, although we are not seeking to change the requirements we
established for the EHR Incentive Program in 2014, the EHR Incentive
Program. We are seeking input on how alignment of certain requirements
present in both federal and non-federal CQM reporting programs could
reduce the burden for eligible professionals and accelerate quality
improvement. We are also seeking input on the amendments made by
section 601(b) of the American Taxpayer Relief Act of 2012. Therefore,
we are soliciting comment on the following questions:
High level questions:
++ How are the current reporting requirements for the PQRS and and
the reporting requirements in 2014 for the EHR Incentive Program
similar to the reporting requirements already established for the ABMS
boards or to other non-federal quality reporting programs? How are they
different? In what ways are these reporting requirements duplicative
and can these reporting programs be integrated to reduce reporting
burden on eligible professionals?
++ Are there examples of other non-federal programs under which
eligible professionals report quality measures data?
++ What would be the benefits and shortcomings involved with
allowing third-party entities to report quality data to CMS on behalf
of physicians and other eligible professionals?
++ What entities have the capacity to report quality data similar
to those reported under the PQRS, Value-based Payment Modifier, and/or
EHR Incentive programs? If these entities were to report such data to
CMS, what requirements should we include in the reporting system used
by such entities, including requirements to ensure high quality data?
++ How should our quality reporting programs change/evolve to
reduce reporting burden on eligible professionals, while still
receiving robust data on clinical quality?
Questions regarding reporting requirements for entities
that report via a registry under the PQRS for 2014 and subsequent years
or the EHR Incentive Program if registry reporting is established as a
reporting method for that program in future years:
++ What types of entities should be eligible to submit quality
measures data on behalf of eligible professionals for PQRS and the EHR
Incentive Program? Examples might include medical board registries,
specialty society registries, regional quality collaboratives or other
entities. What qualification requirements should be applicable to such
entities?
++ What functionalities should entities qualified to submit PQRS
quality measures data possess? For example, for CQMs that can be
electronically submitted and reported under PQRS and the EHR Incentive
Program, should an entity's qualification to submit such measures be
based on whether they have technology certified to ONC's certification
criteria for CQM calculation and/or electronic submission?
++ What criteria should we require of entities submitting quality
measures data to us on behalf of eligible professionals? Examples might
include transparency of measures available to EPs, specific frequency
of feedback reports, tools to guide improvement efforts for EPs,
ability to report aggregate data, agreement to data audits if
requested, etc.
++ Should reporting entities be required to publicly post
performance data?
++ Should we require an entity to submit a yearly self-nomination
statement to participate in PQRS?
++ What should be included in the data validation plan for these
reporting entities?
++ If CMS provided a reporting option for PQRS and/or the EHR
Incentive Program through such entities, what specification should CMS
use to receive the quality data information (for example, Quality
Reporting Document Architecture [QRDA] 1 or 3, XML, other)?
++ Should data submission timelines for these reporting entities be
modified so that the submission timeframes for these quality reporting
programs are aligned? For example, PQRS qualified
[[Page 9060]]
registries are required to submit quality measures data once, within 2
months following the reporting period. How much time are reporting
entities outside of PQRS afforded to submit quality measures data? What
challenges do reporting entities face in reporting data according to
current timeframes?
++ What oversight (for example, checks or audits) should be in
place to ensure that data is submitted and calculated properly by
entities?
Questions regarding selection of measures related to
registry reporting under PQRS for 2014 and subsequent years and for the
EHR Incentive Program if registry reporting is established as a
reporting method for that program in future years:
++ Should we require that a certain proportion of submitted
measures have particular characteristics such as being NQF-endorsed or
outcome-based?
++ Should we require that the quality measures data submitted cover
a certain number of the six national quality strategy domains?
++ To what extent would third-party entities struggle to meet
reporting for measures currently available under PQRS and EHR Incentive
Program?
Questions regarding registry measures reporting criteria:
++ If we propose revised criteria for satisfactory reporting under
PQRS and for meeting the CQM component of meaningful use under the EHR
Incentive Program, how many measures should an eligible professional be
required to report to collect meaningful quality data? For example, for
reporting periods occurring in 2014, eligible professionals using CEHRT
must report 9 measures covering at least 3 domains to meet the criteria
for satisfactory reporting for the 2014 PQRS incentive and meet the CQM
component of achieving meaningful use for the EHR Incentive Program.
(For more information see the EHR Incentive Program Stage 2 final rule
(77 FR 54058) and the CY 2013 Medicare PFS final rule with comment
period (77 FR 69192).) If we were to align reporting criteria with
reporting requirements for other non-federal reporting programs, in
future years, should we propose to require reporting on a different
number of measures than what is currently required for the PQRS in 2013
and the EHR Incentive Program under the Stage 2 final rule or should
the non-federal reporting programs align with CMS criteria?
++ For PQRS, should eligible professionals still be required to
report quality measures data on a certain percentage of their
applicable patients, such as 80 percent, for 2014 and subsequent years?
Or, should we require that eligible professionals report on a certain
minimum number of patients, such as 20, rather than a percentage?
(Catalog of Federal Domestic Assistance Program No. 93.773
Medicare--Hospital Insurance Program; and No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: January 9, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-02703 Filed 2-4-13; 11:15 am]
BILLING CODE 4120-01-P
