[Federal Register Volume 69, Number 79 (Friday, April 23, 2004)]
[Notices]
[Pages 22045-22047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Medicare Prescription Drug, Improvement, and Modernization Act of 
2003, Section 1013: Suggest Priority Topics for Research

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice to suggest priority topics for research.

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SUMMARY: AHRQ, on behalf of the Department of Health and Human 
Services, invites suggestions from interested organizations and 
knowledgeable individuals regarding the highest priorities for 
research, demonstration, and evaluation projects to support and improve 
the Medicare, Medicaid, and State Children Health Insurance (SCHIP) 
programs.

DATES: The statutory deadline for development of the initial priority 
list and the need to consider the FY 2006 priority list during this 
summer's budget development process requires expedited timelines for 
formulation of the initial and FY 2006 priority lists. Research 
recommendations must be received by May 7, 2004, to be considered for 
the initial priority list and by July 1, 2004,

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to be considered for the FY 2006 priority list.

ADDRESSES: Recommendations for consideration and possible inclusion in 
the initial priority list and/or the FY 2006 priority list may be 
submitted to the Department through the U.S. Food and Drug 
Administration (FDA) Dockets Management Division at: http://www.fda.gov/dockets/ecomments.
    The Docket ID for this request is 2004S-0170 Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest 
Priority Topics for Research.

FOR FURTHER INFORMATION CONTACT: Questions about the comment process 
should go to the FDA Dockets Management Division, (301) 827-6860. Hours 
are 9 a.m. to 4 p.m., Eastern Time, Monday through Friday.
    Copies of E-Comments received through the FDA Dockets system are 
available on the FDA Web site at: http://www.fda.gov/ohrms/dockets/dockets/dockets.htm.

SUPPLEMENTARY INFORMATION:

1. Background

    Section 1013 of Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 authorizes research, demonstrations, and 
evaluations to improve the quality, effectiveness, and efficiency of 
the Federally administered Medicare program and of two programs for 
which funding and administration is shared with the States: Medicaid 
and SCHIP.
    The research and other activities undertaken and authorized by this 
provision may address:
    (1) The outcomes, comparative clinical effectiveness, and 
appropriateness of health care items and services (including 
prescription drugs); and
    (2) Strategies for improving the efficiency and effectiveness of 
Medicare, Medicaid, and SCHIP programs, including the ways in which 
health care items and services are organized, managed, and delivered 
under such programs.
    The statute:
    (a) Requires the establishment of a priority setting process for 
identifying the most important topics to address,
    (b) Establishes a timetable for development of an initial priority 
list and completion of the research, and
    (c) Requires ongoing consultation with relevant stakeholders.
    To review the text of section 1013, ``Research on outcomes of 
health care items and services,'' go to: http://www.medicare.gov/MedicareReform/108s1013.pdf.

2. The Priority Setting Process

    Recommendations for research that are made by the Centers for 
Medicare & Medicaid Services (CMS), the States, and other stakeholders 
will be reviewed and prioritized by a steering committee composed of 
representatives from the following components of the U.S. Department of 
Health and Human Services:
     Office of [the] Assistant Secretary for Budget, 
Technology, and Finance (ASBTF),
     Office of [the] Assistant Secretary for Planning 
and Evaluation (ASPE),
     Agency for Healthcare Research and Quality 
(AHRQ, the agency designated by the statute to carry out the research);
     Centers for Medicare & Medicaid Services (CMS);
     Food and Drug Administration (FDA); and,
     Other components of the Office of the Secretary.
    If issues arise for which the expertise of other components of the 
U.S. Department of Health and Human Services or other Federal 
departments would be helpful in prioritizing suggested research topics, 
representatives from those entities will be added to, or consulted by 
the steering committee as warranted.
    Steering committee staff will prepare a preliminary ranking of 
suggested topics for study, taking into consideration factors suggested 
by the terms of section 1013(a)(2)(C): i.e., health care items or 
services that impose high costs on Medicare, Medicaid or SCHIP 
programs, those which may be underutilized or overutilized and those 
which may significantly improve the prevention, treatment or cure of 
diseases and conditions which impose high direct or indirect costs on 
patients or society.

3. Timetable

    Section 1013 requires the development of an initial priority list 
six months after enactment of the legislation (June 2004) and 
completion of the initial research syntheses 18 months thereafter 
(December 2005), one month before the effective date of the 
prescription drug benefit.
    The statute does not establish timetables for priority-setting 
after the initial list or the completion of subsequent research. 
Because the statute requires annual appropriations for funding the 
research and other activities authorized by this section, the 
Department will link the timetable for the priority-setting process for 
FY 2006 and subsequent years to its process for development of the 
Department's budget.

4. Stakeholder Consultation

    The statute requires a broad, ongoing process of consultation with 
relevant stakeholders. Because two of the programs addressed by the 
statute are administered by the States, the Department will work with 
the States to develop an effective process for identifying their 
priority recommendations for research.
    To meet the requirement for ongoing consultation with other 
stakeholders, the Department will issue a specific solicitation for 
research recommendations every year, will permit stakeholders to submit 
research recommendations throughout the year, and will host a series of 
listening sessions with different sectors of the health care community 
to provide additional opportunities for submitting recommendations. 
Information regarding the initial ``listening sessions'' will be 
announced shortly.

5. Requirements

    Scope of recommendations: While the statute does not limit the 
scope of the initial priority list, recent congressional activity 
suggests that the initial priority list should be directed toward 
evaluating existing evidence regarding the comparative clinical 
effectiveness of prescription drugs in anticipation of the Medicare 
prescription drug benefit. Therefore, the Department requests that 
recommendations for the initial priority list focus on prescription 
drugs, although all recommendations will be considered. Submissions for 
the FY 2006 priority list may address other health care items or 
services as well, or program improvement strategies for organizing, 
managing, or delivering those items or services.
    Justification: Because section 1013 is intended to fund research to 
improve the ``quality, effectiveness, and efficiency'' of the Medicare, 
Medicaid, and SCHIP programs, each submission must justify and explain 
how each recommended research project will contribute to that goal and 
why it should be considered a ``priority.'' With respect to research 
suggestions regarding prescription drugs, recommendations should 
include a rationale regarding potential impact of the research and 
might also address the most useful approaches for analyzing and 
presenting that evidence (e.g., by disease or condition or by drug 
class and, if so, under which drug classification system).
    Identification of affiliation: Individuals who are submitting 
recommendations on behalf of a ``stakeholder organization,'' such as a

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provider, purchaser, supplier, or insurer of health care items or 
services, or those receiving services under the Medicare, Medicaid or 
SCHIP programs are invited to identify their organizational 
affiliation. This will enable the Department of assess the 
effectiveness of its efforts to ensure broad consultation with relevant 
stakeholders.

    Dated: April 16, 2004.
Carolyn M. Clancy,
Director.
[FR Doc. 04-9190 Filed 4-22-04; 8:45 am]
BILLING CODE 4160-90-M