[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]
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