Proposed NIH/NIA Legislation:
New NIH/NIA Legislation:
Patient Protection and Affordable Care Act (H.R. 3590 /P.L. 111- 148) included several provisions of interest to NIH/NIA:
- National Center on Minority and Health Disparities (NCHMD) Designated as an Institute. Designates NCMHD as an Institute; include NCHMD Centers of Excellence as institutions eligible to receive endowments; and require the NCHMD Director to plan, coordinate, and review and evaluate research and other activities conducted or supported by the ICs.
- Interagency Working Group on Health Care Quality. Requires the President to convene a working group, which includes NIH, to address national priorities regarding improving health care quality.
- Patient Decision Aids. Requires the Secretary, acting through AHRQ and in coordination with other agencies including NIH and CDC, to establish a program to award grants or contracts regarding patient decision aids.
- Pain Research. Adds a new section to the PHS Act to “encourage” the research. The Pain Consortium, in consultation with DPCPSI, is required to make recommendations on pain research initiatives that could be paid by the Common Fund. The Secretary (through the IOM) must hold a conference to establish an interagency pain research coordinating committee.
- Comparative Effectiveness Research. Establishes a non-profit institute called the Patient-Centered Outcomes Research Institute (PCORI), a Board of Governors to oversee the institute, and a trust fund to pay for the research. PCORI is authorized to set research priorities and a research agenda. PCORI is authorized to conduct or support CER, develop research methodologies, develop data resources, obtain and use data from the Federal government, and establish advisory panels to advise on research priorities, among other provisions. NIH is listed as a member of the Board of Governors and as a member of the Methodology Committee.
- Cures Acceleration Network. Establishes a Cures Acceleration Network (CAN) at NIH to provide funding to bridge the gap between laboratory discoveries and life-saving therapies, in the form of medical products, drugs or devices, or biological products. .
- National Prevention Fund and Strategy. Establishes a prevention trust or special fund provided to the Secretary for prevention and wellness activities. Provisions require creation of the “National Prevention, Health Promotion and Public Health Council” with membership from numerous Federal agencies, including HHS, and departments to coordinate and provide leadership in prevention, wellness and public health across the Federal government, as well as “to restrain the rate of growth in public and private sector health care costs.” Requires the development of a national prevention and wellness strategy.
Two Preventive Services Task Forces. Requires the Director of AHRQ to convene an independent Task Force on Clinical Preventive Services responsible for developing recommendations for the clinical health care community. Their recommendations must consider clinical preventive best practice recommendations from AHRQ, NIH, CDC, IOM, specialty medical associations, patient groups, and scientific societies. The Director of CDC is required to convene an independent Task Force on Community Preventive Services responsible for developing recommendations for the public health community.
S. 3253 – On April 28, 2010, the House passed by voice vote S. 3253, a bill to provide for an additional temporary extension of programs under the Small Business Act and the Small Business Investment Act of 1958 through July 31, 2010. The Senate passed the measure, introduced by Senator Mary Landrieu (D-LA), Chair, Senate Committee on Small Business and Entrepreneurship, under unanimous consent on April 22, the same day as it was introduced. S. 3253 was cleared for the President’s signature.
S. 3036, The National Alzheimer’s Project Act – This measure introduced by Senator Evan Bayh (D-IN) on 2/24/2010, proposes to establish in the Office of the Secretary of Health and Human Services the Office of the National Alzheimer's Project. The bill has been referred to the Committee on Health, Labor and Pensions for further action.
H.R. 5037 – On April 15, 2009, Representative Mike Doyle (D-PA), along with cosponsors Representatives Henry Waxman (D-CA), Rick Boucher (D-VA), and Debbie Wasserman Schultz (D-FL), introduced H.R. 5037, the Federal Research Public Access Act of 2010. H.R. 5037 would require each Federal agency with extramural research expenditures of over $100 million to develop a specified Federal research public access policy that is consistent with and advances the purposes of the agency. The bill would make each Federal research public access policy applicable to: (1) researchers employed by the Federal agency whose works remain in the public domain; and (2) researchers funded by the agency. The bill specifically excludes from this policy the following: (1) research progress reports presented at professional meetings or conferences; (2) laboratory notes, preliminary data analyses, notes of the author, phone logs, or other information used to produce final manuscripts; (3) classified research, research resulting in works that generate revenue or royalties for authors (such as books) or patentable discoveries, to the extent necessary to protect a copyright or patent; or (4) authors who do not submit their work to a journal or works that are rejected by journals. H.R. 5037 would also require annual reports from each agency on its Federal research public access policy. The measure was referred to the House Committee on Oversight and Investigations. An identical bill, S. 1373, was introduced on June 25, 2009, by Senators Joseph Lieberman (IND-CT) and John Cornyn (R-TX).
H.R. 2987, the Cure and Understanding through Research for Alzheimer’s Disease (La Cura Act) of 2009 -Introduced in the House on June 19, 2009, by Congresswoman Linda Sanchez (D-CA). 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, 2009, Representative Markey (D-MA) and Senator Barbara Mikulski introduced (D- MD) introduced the Alzheimer’s Break Through Act of 2009. H.R. 3286/S. 1492 would increase the authorization level for Alzheimer’s disease (AD) research, and require the Director of the 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 3 years of enactment of the legislation and every 3 years thereafter, to convene a summit on AD for the purpose of providing a detailed overview of current research activities at the NIH, as well as to discuss and solicit input to potential areas of collaboration between the NIH and other Federal agencies related to research, prevention and treatment of AD. The measure is pending action by the House Energy and Commerce and the Senate HELP Committees.
H.R. 3170, the FY 2010 Financial Services and General Government Appropriations Act- On July 16, 2009, the House passed H.R. 3170 by a vote of 219-208. This legislation contains many government-wide provisions applicable to NIH. Of note, this legislation 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. This measure has passed the House and was referred to the Senate for action.
On May 20, 2009, Senator Harry Reid (D-NV) introduced S. 1110, the Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009. Of interest to NIH are provisions that would authorize the Commission to advise the Secretary, through 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, 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 is still pending action by the Senate Committee on Finance.
On April 28, the House Appropriation Subcommittee on Labor, HHS, Education (Representative David Obey [D-WI], Chairman) held its annual overview hearing on NIH. Dr. Francis Collins, Director, testified on the FY2011 President’s Budget, accompanied by Drs. Anthony S. Fauci, Director, NIAID; Griffin Rodgers, Director, NIDDK; and Tom Insel, Director, NIMH.
On May 5, the Senate Appropriation Subcommittee on Labor, HHS, Education (Senator Tom Harkin [D-IA], Chairman) held its annual overview hearing on NIH. Dr. Francis Collins, Director, testified on the FY2011 President’s Budget.
Tamara Jones, Ph.D.
National Institute on Aging