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 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 http://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 http://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 http://www.abms.org/ Maintenance_of_Certification/ABMS_MOC.aspx. 2 http://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 http://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 http://www.abms.org/Maintenance_of_ Certification/ABMS_MOC.aspx. 5 http://www.sts.org/national-database. 6 http://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 http://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 http://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]]

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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 http://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\ http://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\ http://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 http://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\ http://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\ http://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 http://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\ http://www.sts.org/national-database.
    \6\ http://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