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.

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, 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 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.