06-69. Medicare Prescription Drug, Improvement, and Modernization Act of 2003; Section 1013: Identification of Priority Topics for Effective Health Care Research

AGENCY:

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

ACTION:

Notice of invitation to submit research recommendations.

SUMMARY:

The U.S. 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.

The research and other activities undertaken and authorized by the above-captioned or above referenced statutory 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 such programs, including the ways in which such 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 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, please visit Section 1013. Research on Outcomes of Health Care Items and Services (PDF 21.7 KB) or http://www.medicare.gov/​medicarereform/​108s1013.htm (text).

Current priority conditions being studied focus on topics particularly relevant to Medicare beneficiaries. The next set of priority conditions will be expanded to include conditions relevant to the Medicaid and SCHIP programs.

The current priority conditions are:

• Arthritis and non-traumatic joint disorders.
• Cancer.
• Chronic obstructive pulmonary disease and asthma.
• Dementia including Alzheimer's disease.
• Depression and other mood disorders.
• Diabetes mellitus.
• Ischemic heart disease.
• Peptic ulcer disease and dyspepsia.
• Pneumonia.
• Stroke and hypertension.

DATES:

Research recommendations for the next priority conditions list must be received by March 1, 2006.

ADDRESSES:

Recommendations for consideration and possible inclusion in the next priority list may be submitted electronically to the Effective Health Care Program Web site, http://www.EffectiveHealthCare.ahrq.gov,, or e-mailed to [e-mail].

Recommendations may also be mailed to: AHRQ Effective Health Care Program c/o Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850.

All comments will be posted in an electronic reading room at: http://www.EffectiveHealthCare.ahrq.gov.

FOR FURTHER INFORMATION CONTACT:

Effective Health Care Program at [phone] or Effective [e-mail].

More information about the Effective Health Care Program is available at http://www.EffectiveHealthCare.ahrq.gov.

SUPPLEMENTARY INFORMATION:

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 Secretary.
• Assistant Secretary for Planning and Evaluation (ASPE).
• Assistant Secretary for Budget, Technology, and Finance (ASBTF).
• Centers for Medicare & Medicaid Services (CMS).
• Food and Drug Administration (FDA).
• Agency for Healthcare Research and Quality (AHRQ, the agency designated by the statute to carry out the research).

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): 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.

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 and will permit stakeholders to submit research recommendations throughout the year.

Dated: December 28, 2005.

Carolyn M. Clancy,

Director.