Proposed NIH/NIA Legislation:
H.R. 3293, the FY 2010 Labor, HHS, Education Appropriations – On July 24, 2009, the House passed H.R. 3293 by a roll call vote of 264 to 153. The $730.5 billion FY 2010 spending bill provides $160.7 billion in discretionary spending, $11 billion more than in 2009 and $1.8 billion more than President Obama requested. The NIH Funding level in the bill remained unchanged at the full conference level and provides a 3.1 percent overall increase from FY 2009 Enacted level– a total of $31.258 billion.
On July 28, the Senate subcommittee approved its $163.1 billion discretionary spending draft, which is approximately $300 million more than the House-passed bill. Floor action on the Senate measure was not expected before the Senate recess on Aug 7.
H.R. 2987, the Cure and Understanding Through Research for Alzheimer’s Disease (La Cura Act) of 2009 – On June 19, Congresswoman Linda Sanchez (D-CA) introduced H.R. 2987 in the House. The measure proposes to amend the Public Health Service Act to ensure sufficient resources and increase efforts for research at the National Institutes of Health relating to Alzheimer's disease, to authorize an education and outreach program to promote public awareness and risk reduction with respect to Alzheimer's disease (with particular emphasis on education and outreach in Hispanic populations) and for other purposes. The measure is pending action by the House Committee on Energy and Commerce.
H.R. 3286/S. 1492 – On July 22, Representative Markey (D-MA) and Senator Barbara Mikulski (D- MD) introduced the Alzheimer’s Breakthrough Act of 2009. H.R. 3286/S. 1492 would increase the authorization level for Alzheimer’s disease (AD) research, and require the Director of NIA to make supporting AD research a priority for the Institute. In addition, the legislation would require an expansion of clinical research on AD with a focus on (1) early diagnosis and detection, (2) the relationship of vascular disease and AD, and (3) expediting the translation of research findings into effective treatments and prevention strategies. The bill would require the Secretary, HHS, within three years of enactment of the legislation and every three years thereafter, to convene a summit on AD for the purpose of providing a detailed overview of current research activities at NIH, as well as to discuss and solicit input to potential areas of collaboration related to research, prevention, and treatment of AD between NIH and other Federal agencies.
H.R. 3170, the FY 2010 Financial Services and General Government Appropriations Act. – On July 16, the House passed H.R. 3170 by a vote of 219-208. This legislation contains many government-wide provisions applicable to NIH. Of note, it continues the A-76 prohibition regarding competitive sourcing and contains a new provision that would require each department or agency to develop an inventory of service contracts. Regarding the annual cost-of-living allowance for Federal employees, H.R. 3170 does not contain a pay raise provision since the House agrees with the Administrations’ request of two percent.
S. 1110, the Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009 – On May 20, Senator Harry Reid (D-NV) introduced S. 1110. Of interest to NIH, provisions would authorize the Commission to advise the Secretary, through the Agency for Healthcare Research and Quality (AHRQ) and NIH, on priorities for health services research. In addition, it would authorize the Commission to have access to all raw data and research conducted or funded by the Federal government, including data and research produced by NIH, the Centers for Medicare & Medicaid Services (CMS), and AHRQ. Finally, NIH and AHRQ would be required, not less than twice a year, to submit a report to the Commission containing information on any research conducted which has relevance for the determinations and recommendations being considered by the Commission. S. 1110 was referred to the Senate Committee on Finance.
S. 1142, the Informed Health Care Decision Making Act of 2009 – On May 21, Senator Jack Reed (D-RI), introduced S. 1142. The bill would require the disclosure of comparative clinical effectiveness information in labeling and advertisements (if no such information exists, then such a disclosure must be made). In order to carry out this new mandate, the Secretary, acting through the U.S. Food and Drug Administration (FDA), would be required to establish methodological standards for the sources of evidence appropriate for inclusion of comparative clinical effectiveness information in labeling and advertisements.
Comparative clinical effectiveness in this legislation is defined as “the clinical outcomes, effectiveness, safety, and clinical appropriateness of a drug or device in comparison to 1 or more drugs or devices, respectively, approved to prevent, diagnose, or treat the same health condition for the same patient demographic subpopulation.” S. 1142 was referred to the Senate Committee on Health, Education, Labor, and Pensions.
Comparative Effectiveness Research (CER) NIH Committees and Legislation
Dr. Richard Hodes, NIA Director, and Dr. Elizabeth Nabel, National Heart, Lung and Blood Institute (NHLBI) Director, serve as co-chairs for the NIH CER Coordinating Committee. Dr. Richard Suzman, NIA Division of Behavioral and Social Research, is a member of the NIH Agency for Healthcare Research and Quality Workgroup (AHRQ) Dr. Marie Bernard, NIA Deputy Director, is representing Dr. Richard Suzman on the Trans-NIH Comparative Effectiveness Portfolio Workgroup.
Several legislative measures have been proposed to amend the CER provisions passed in the American Recovery and Reinvestment Act of 2009 (ARRA). CER provisions have been proposed and may be included in the final Health Reform bills.
H.R. 3200 – On July 17, the House Committee on Ways and Means approved, by a vote of 23-18, H.R. 3200, America’s Affordable Health Choices Act of 2009. Of the over 40 amendments offered, only the 794-page manager’s amendment was adopted. Provisions establishing a center for comparative effectiveness research remain in this version. An amendment offered by Wally Herger (R-CA) to prohibit CMS from using federally-funded clinical comparative effectiveness research data to make coverage decisions was rejected by a vote of 15-26.
H.R. 2520/S. 1099 – On May 20, Representative Ryan (R-WI) and Senator Tom Coburn (R-OK) introduced H.R. 2520 and S. 1099, respectively, the Patients’ Choice Act. Of interest to NIH is section 904, which would terminate the Federal Coordinating Council for Comparative Effectiveness Research established by the American Recovery and Reinvestment Act (P.L. 111-16). The legislation would also establish an interagency coordinating committee to develop a national strategic plan for disease prevention. The NIH Director would be a member of this committee. H.R. 2520 was jointly referred to the House Committees on Energy and Commerce and Ways and Means. S. 1099 was referred to the Senate Committee on Finance.
Small Business Innovation Research (SBIR) and Small Business Technology Research (STTR) Legislation:
On July 23, the Senate passed S. 1390, the National Defense Authorization Act for Fiscal Year 2010. Included in this authorization bill, as an amendment, was the full text of the Senate-passed bill S. 1233, the SBIR/STTR Reauthorization Act of 2009. This latter measure includes the increase of the SBIR set-aside from 2.5 to 3.5 percent and the increase of the STTR from 0.3 to 0.6, which would bring the total for the program to 4.1 percent. The House passed its version of the National Defense Authorization Act in June. Conferees have been named and the measure was ready for conference to begin on August 5.
S. 1513 – On July 24, the Senate passed S. 1513, a bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958. The bill would extend the current extension from July 31 to September 30, 2009. The bill was debated in the House on July 28, and passed under suspension by voice vote on July 29.
NIA Congressional Briefings:
On July 21, at the request of Representative Lucille Roybal-Allard (D-CA), Dr. Richard Hodes, Dr. Richard Suzman, Dr. Sid Stahl, and Dr. Tamara Jones, met with Mrs. Roybal-Allard and her staff to provide an update on the NIA Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging.
(For more information, contact Dr. Tamara Jones, Legislative Officer, NIA, Ph. 301-451-8835.)