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Washington Highlights: June 5, 2009

AAMC Cosponsors Hill Briefing on Recovery Act Funds

The AAMC June 1 cosponsored the first in a series of congressional briefings on how the National Institutes of Health (NIH) is investing federal support provided by the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) to advance medical research. Anthony Fauci, M.D., director, National Institute of Allergy and Infectious Diseases (NIAID), outlined for a standing-room only audience plans for three NIAID Signature Projects directed at stopping the HIV pandemic, advancing immunology and vaccine development, and addressing biodefense and emerging infectious diseases. A Web cast of the briefing and Dr. Fauci's slides are available online.

The Ad Hoc Group for Medical Research is hosting this series in conjunction with the Congressional Biomedical Research Caucus. Other co-sponsors include the American Heart Association, American Society of Nephrology, Association of Independent Research Institutes, Coalition for Life Sciences, Federation of American Societies for Experimental Biology (FASEB), Research!America, and the Society for Neuroscience. The AAMC is a member of the Ad Hoc Group steering committee. Thomas Insel, M.D., director, National Institute of Mental Health, is scheduled to speak at the next briefing, planned for July 10.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

AAMC Comments on OHRP Advanced Notice of Proposed Rule Making

The AAMC June 3 submitted comments on an HHS Office of Human Research Protection (OHRP) Advanced Notice of Proposed Rule Making that would enable the office to hold external Institutional Review Boards (IRB) directly accountable for meeting regulatory requirements of the department's regulations for the protection of human subjects.

The AAMC comment letter supports an expansion of OHRP's regulatory oversight from its current exclusive focus on the institution engaged in human subjects research to the external IRB (and the organization of which it is a part) that has the responsibility for reviewing that research. The AAMC believes the change would provide more encouragement to institutions to implement a variety of cooperative IRB review arrangements, without being forced to retain regulatory liability even where regulatory responsibilities have been appropriately assigned to an external IRB.

Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543

Irena Tartakovsky, Senior Science Policy Analyst
AAMC Biomedical and Health Sciences Research
itartakovsky@aamc.org
(202) 862-6134

Budget Committees Give Appropriators More Funds

The House and Senate Budget Committees June 3 released revised FY 2010 allocations for the Appropriations committees that will result in an additional $3.8 billion in discretionary spending. The Budget committees increased the overall FY 2010 allocation for the 12 annual appropriations bills to $1.086 trillion as a result of the Congressional Budget Office re-estimating the costs of programs in the President's budget. The revision was necessary because the President had not released the full details of his budget when Congress approved the FY 2010 budget resolution (S. Con. Res 13) April 29.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

NHSC Creates New Application Cycle for Recovery Funding

The National Health Service Corps (NHSC) June 2 announced that it would begin accepting applications for loan repayment using funds provided by the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). ARRA provides an additional $300 million for the NHSC to be spent in FYs 2009 and 2010.

As of June 2, the NHSC will accept loan repayment applications continuously until ARRA funds are expended or Sept. 30, 2010, whichever comes first. For the first time, clinicians do not need to be employed in an approved site in a Health Professional Shortage Area when applying, but must be available to begin work within 30 days of being notified that their application has been accepted. NHSC anticipates most applications will be processed within eight weeks of the submission of a complete application.

Of the $300 million ARRA provides to the NHSC, $200 million is expected to be used for more than 3,300 new loan repayment awards. ARRA requires $75 million of the $300 million to remain available through Sept. 30, 2011, for "extending service contracts and the recapture and reallocation of funds in the event that a participant fails to fulfill his or her term of service." ARRA also designates 20 percent of NHSC funds for field operations.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

PPAC Provides Recommendations on Time, Cost Burden from Compliance with CMS Programs

Staff from the Centers for Medicare and Medicaid Services (CMS) June 1 delivered testimony on programs of interest to physicians at the quarterly meeting of the Practicing Physicians Advisory Council (PPAC). The meeting covered a variety of topics relevant to physicians, including value-based purchasing programs and the Medicare Recovery Audit Contractor (RAC) program.

Citing inequities between payments to hospitals and physicians, PPAC recommended CMS reconsider non-payment for copy costs associated with medical record requests, as CMS currently reimburses hospitals but not physicians. Further, PPAC recommended CMS assess the costs attributed to physician participation in the Physician Quality Reporting Initiative (PQRI), e-prescribe and RAC programs, as PPAC members expressed significant time and cost burdens associated with program compliance.

PPAC members commented on the RAC program, which the Tax Relief and Healthcare Act of 2006 (P.L. 109-432) requires to expand nationwide by January 2010. RACs are tasked with reviewing Medicare Part A and B claims to detect and correct improper payments, non-covered services, incorrectly coded services, and duplicate services and are paid by CMS on a contingency fee basis. According to CMS officials, RACs are slated to begin claim reviews in a number of states this June.

PPAC is a mandated advisory body to HHS that provides input on regulatory issues and carrier manual instructions.

Information:
Will Dardani, Constituent Services Specialist
AAMC Health Care Affairs
wdardani@aamc.org
(202) 828-0541

HHS Secretary Testifies on FY 2010 Budget

Secretary of Health and Human Services (HHS) Kathleen Sebelius June 2 testified before the House Labor-HHS-Education Appropriations Subcommittee about the department's FY 2010 budget request and the administration's efforts on health care reform. Though her prepared remarks did not focus on medical research, Committee Chair David Obey (D-Wis.) and several members of the subcommittee questioned Secretary Sebelius about the administration's request for the National Institutes of Health (NIH). Full committee Ranking Member Jerry Lewis (R-Calif.) also inquired about the administration's plan to avoid an impending "cliff," once funds from the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) expire. Secretary Sebelius acknowledged the "enormous dividends" that the ARRA investment in NIH will yield, and pledged to work with the administration to develop a multi-year plan to address NIH funding beginning in FY 2011.

Secretary Sebelius also emphasized the administration's emphasis on strengthening the health care workforce and mitigating health disparities.

Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

NIH Director's Advisory Committee Discusses Recovery Funds

The National Institutes of Health (NIH) Advisory Committee to the Director (ACD) June 4 convened to discuss, among other items, the research community's response to new funding opportunities under the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). Acting Director Raynard Kington, M.D., Ph.D., noted that applications received to date for ARRA's headline programs are running far higher than many expected. For example, NIH has received more than 20,000 applications for "Challenge Grants." He noted that with contributions from NIH Institutes and Centers, the funding total for these awards may exceed $400 million, double NIH's original estimate.

The committee inquired about NIH's preparations for review and management of these programs. Dr. Kington, Sally Rockey, Ph.D., Acting Deputy Director for Extramural Research, and other staff noted that, in addition to NIH preparations-which the ACD generally applauded- the Office of Management and Budget (OMB) is coordinating reporting requirements for ARRA funding across federal agencies. NIH will provide guidance to investigators and institutions for providing information, but NIH will not be able to modify or revise the reporting forms or other instructions issued by OMB. A recurring message from ACD members was the importance of communication in the research community on the broad scope of these activities and the role of biomedical research in advancing the nation's immediate and long-term economic interests.

Jeremy Berg, Ph.D., Director of the National Institute of General Medical Sciences updated the ACD on support of new investigators. Citing AAMC data, Dr. Berg underscored once again concerns about an increasing gap, on average, from time of first faculty appointment in medical school to subsequent application and receipt of a first NIH research grant. Given already increased timelines for training and faculty appointment, Dr. Berg noted that this additional gap is further cause for concern that the nation's pool of biomedical scientists is increasingly older and that young scientists will be discouraged from careers in biomedical research. NIH has created a new category of "early stage investigators" defined as individuals who are new or first-time NIH investigators and who also are within ten years of completing terminal degree (such as Ph.D.) or within ten years of completing residency (or equivalent) for physician or similar investigators.

Dr. Berg also presented data on applications and awards under the National Academies' inspired "Pathway to Independence Awards" (K99/R00), for which there were 910 applicants and 183 awardees in FY 2007, and 816 and 180 respectively in FY 2008. The ACD noted that relatively few (less than 10 percent) of applicants, and an even smaller percentage of awardees, are physician scientists.

Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

House Subcommittee Approves NSF Spending Bill

The House Commerce-Justice-Science Appropriations Subcommittee June 4 approved by voice vote a draft of its FY 2010 spending bill. According to a summary table prepared by the subcommittee, the draft bill includes $6.94 billion for the National Science Foundation (NSF), a $446 million (6.9 percent) increase over FY 2009. The funding level falls $108.5 million short of the President's recommended $7.05 billion for NSF.

Within the NSF total, the subcommittee provides $5.64 billion for research and related activities, a $459 million (9 percent) boost over the FY 2009 funding level, but $91.2 million less than the President's budget. The full House Appropriations committee tentatively is scheduled to consider the draft bill on June 9, with floor consideration potentially occurring the week of June 15.

Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

On the Agenda in Washington . . .

June 9: HHS Secretary Sebelius to Testify before Senate Subcommittee
2:30 p.m., 124 Senate Dirksen Building
Secretary of Health and Human Services (HHS) Kathleen Sebelius is scheduled to testify before the Senate Labor-HHS-Education Appropriations Subcommittee on the department's FY 2010 budget request.

June 9: House Appropriations Committee to Consider 302(b) Allocations, CJS Bill
Time TBA, Location TBA
The House Appropriations Committee tentatively is scheduled to consider 302(b) spending allocations and the FY 2010 Commerce-Justice-Science Appropriations bill.

June 16: HIT Policy Committee to Meet
10 a.m. to 1 p.m., Hubert H. Humphrey Building (200 Independence Ave., SW) or via Web cast and teleconference
The Health Information Technology Policy Committee established by the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) is scheduled to hold its second meeting. The meeting will be open to the public and will include presentations by the committee's work groups.