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Washington Highlights: February 26, 2010

AAMC Report Highlights How ARRA Funds Are Fueling Research and Driving Economic Growth

The AAMC Feb. 22 released a new report detailing how the nation's medical schools and teaching hospitals are advancing science, improving health, and stimulating economic growth with funding provided to the National Institutes of Health (NIH) through the American Recovery and Reinvestment Act (ARRA, P.L. 111-5).

The report, "From Recovery to Discovery - ARRA Funding and Medical Research," features 83 letters from leaders at AAMC-member institutions. Addressed to the president and members of Congress, the letters highlight how NIH ARRA grants have been used to advance scientific and medical innovation, improve the health of local communities, and stimulate economic growth.

In the report's cover letter, AAMC President and CEO Darrell G. Kirch, M.D., noted, "Investment in medical research is not only an important part of the nation's economic short-term recovery plan, it also is an essential element in creating long-term investments in innovation that improve the nation's health."

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

AAMC Submits Letter to MedPAC on DGME and IME Policies

The AAMC Feb. 17 submitted a letter to the Medicare Payment Advisory Commission (MedPAC) making several recommendations to support direct graduate medical education (DGME) and indirect medical education (IME) policies that would help sustain the missions of teaching hospitals and medical schools.

In the letter, the AAMC expresses concern about signs indicating an erosion of support by the Medicare program for the educational, research and patient care missions of teaching hospitals. This concern is further increased by the instability of the Medicaid programs, which has led a number of states to eliminate or reduce GME payments to teaching hospitals.

The letter points out that in spite of a decreased level of support, many academic medical centers are working to improve their delivery system to increase quality. In addition they are spending significant institutional resources to improve residency training by incorporating new educational strategies into their curricula.

The letter specifically recommends the commission:

  • Endorse the current IME payment level;
  • Recommend that Congress lift Medicare's resident limits;
  • Expand current levels of funding for the special missions of teaching hospitals by calling for support from all payers;
  • Request CMS to analyze whether a teaching adjustment is needed in the outpatient prospective payment system;
  • Urge Congress to reaffirm Title VII health professions programs through reauthorization and increased appropriation levels;
  • Recommend that CMS support policies that enhance training in nonhospital settings;
  • Recommend counting all resident training time in the DGME and IME payment methodologies; and
  • Recommend that CMS assign residents' initial residency periods in their second year of training.

Contact:
Karen Fisher, J.D., Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

Diana Mayes, Specialist
AAMC Health Care Affairs
dmayes@aamc.org
(202) 828-0498

HHS, NIH and FDA Announce New Regulatory Science Initiatives

Secretary of Health and Human Services Kathleen Sebelius, Director of the National Institutes of Health (NIH) Francis S. Collins, M.D., Ph.D., and Commissioner of the Food and Drug Administration (FDA) Margaret Hamburg, M.D., Feb. 24 announced new collaborative initiatives by the NIH and the FDA to promote regulatory science.

The secretary announced a new NIH-FDA Joint Leadership Council to foster collaborative efforts to "help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process."

In addition, the NIH and the FDA Feb. 23 issued a joint request for applications titled, "Advancing Regulatory Science through Novel Research and Science-Based Technologies." The agencies are making available $6.75 million over three years for work in regulatory science which, according to the NIH and the FDA, "should add to the scientific knowledge base by providing new methods, models or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development."

Contact:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

NIH Announces Seven New Common Fund Initiatives

Director of the National Institutes of Health (NIH) Francis Collins, M.D., Ph.D., Feb. 25 announced seven new scientific initiatives that will be funded through the NIH Common Fund. The Fund was created to encourage collaborative research programs across the NIH institutes and centers and to accomplish work that no single institute could do alone.

The seven initiatives all are scheduled to begin during FY 2010 and are estimated to utilize a total of $17.8 million from the Common Fund in FY 2010, with additional funds likely to be allocated in future years.

The seven new scientific initiatives are:

  • Library of Integrated Network-based Cellular Signatures Program
  • Protein Capture Reagents Program
  • Knockout Mouse Phenotyping Program
  • Science of Behavior Change Program
  • NIH Induced Pluripotent Stem (iPS) Cell Center
  • Global Health Program
  • Regulatory Science Program

Contact:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

NIH Moves to Amend Stem Cell Guidelines on Definition Issue

The National Institutes of Health (NIH) Feb. 23 announced in the Federal Register it is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the Guidelines it issued on July 7, 2009, to "establish policy and procedures under which the NIH will fund such research..." [see Washington Highlights, July 10, 2009].

In the final Guidelines, hESCs are defined as: "...cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers." The definition in the draft version of the Guidelines did not reference the inner cell mass of blastocysts.

NIH has determined that the definition in the final Guidelines "had the unintended consequence of excluding certain hESCs which may otherwise be appropriate for Federal funding. For example, the current definition excludes hESCs from an embryo which fails to develop to the blastocyst stage."

NIH is proposing the following new definition: "For the purpose of these Guidelines, 'human embryonic stem cells (hESCs)' are pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers."

Three previously approved stem cell lines have been placed on administrative hold pending final approval of the new definition.

Comments on the change are being accepted for 30 days, ending March 25, 2010.

Contact:
Tony Mazzaschi, Senior Director
AAMC Scientific Affairs
tmazzaschi@aamc.org
(202) 828-0059

White House Holds Health Reform Summit

In an effort to revive health care reform, President Obama, Vice President Biden, Secretary of Health and Human Services (HHS) Kathleen Sebelius, Senate and House leadership, and designated Members of Congress Feb. 25 convened at a White House health care reform summit [see Washington Highlights, Feb. 19] to discuss "ideas for making our health care system work better for the American people." The televised discussions focused on controlling costs, insurance reforms, reducing the deficit, and expanding coverage.

In his opening remarks, President Obama said, "focus not just on where we differ but focus on where we agree." House and Senate leaders, in their opening statements, agreed upon the urgent need to reform the health care system, but continued to differ on the appropriate way to move forward. During the summit, several Republicans raised concerns over the proposed Medicare cuts and the absence of a permanent fix to the current Medicare physician payment system. Additionally, the discussion focused on the need to bend the cost curve by reducing medical errors, coordinating doctor care, and improving prevention and wellness. As a way to reduce fraud and abuse in Medicare spending, President Obama reiterated the importance of the proposed independent payment advisory board [see Washington Highlights, Jan. 22] included in the Senate-passed health care reform bill (H.R. 3590).

At the conclusion of the summit, President Obama stated, "starting over is not possible." The president encouraged summit attendees to find ways to "bridge the gap" between the proposed ideas while expanding coverage to those with preexisting conditions and to those without health insurance.

Contact:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418

House VA Health Subcommittee Examines FY 2011 Budget

The House Veterans Affairs (VA) Subcommittee on Health held a Feb. 23 hearing on the FY 2011 Veterans Health Administration budget. Witnesses focused on the VA major and minor construction accounts to improve critical VA infrastructure [see Washington Highlights, Feb. 5].

Blake C. Ortner, Senior Associate Legislative Director, Paralyzed Veterans of America (PVA), testified on behalf of the Independent Budget and echoed recommendations of the Friends of VA Medical Care and Health Research (FOVA). Mr. Ortner highlighted the degrading VA research infrastructure and the lack of a direct funding mechanism that causes this neglect. In his testimony Mr. Ortner notes that VA has found "a clear need for research infrastructure improvements throughout the system, including many that impact on life safety."

PVA, in concert with the Independent Budget and FOVA organizations, recommends "an appropriation in FY 2011 of $300 million dedicated exclusively to renovating existing research facilities to address the current and well-documented shortfalls in research infrastructure."

The AAMC is a member of the FOVA executive committee.

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

House Science and Technology Committee Holds Hearings on Scientific Research

The House Science and Technology Committee Feb. 23 and 24 heard testimony on a wide range of issues relating to the biomedical research community as part of the committee's effort to reauthorize the America COMPETES Act (P.L. 110-69) [see Washington Highlights, Jan.22].

On Feb. 23 the Subcommittee on Research and Science Education held a hearing to examine the research and research training infrastructure of universities and colleges. Subcommittee Chair Daniel Lipinski (D-Ill.) recognized that "successful R & D takes more than intellectual freedom and grant funding" and that "you also need state-of-the-art lab space, networks, instruments, and computing facilities." Chairman Lipinski also stated his concern that "unless we actively modernize our R & D facilities, we could not only be spending federal research dollars inefficiently, but we could lose our position as scientific leaders."

Witnesses, including representatives from the Medical College of South Carolina, the University of Arizona, Pennsylvania State University, and the University of Illinois Urbana-Champaign, pointed out that state support for research-related expenses has declined with the economy, as has philanthropic giving and other sources of private funding. They noted that global competitiveness will be difficult to maintain, top faculty will be harder to recruit and retain, and student education and readiness will continue to decline if a long-term commitment to research infrastructure is not made.

On Feb. 24 the Subcommittee on Technology and Innovation heard testimony regarding ways in which the National Institute of Standards and Technology (NIST) could better serve the needs of the biomedical research community. Subcommittee Chair David Wu (D-Ore.) commented that, in light of the ongoing debate surrounding health reform, discussion was needed to "examine how we can use science to reduce health care costs while improving care for patients." He also stated that "NIST needs to be more connected to industry and academia to innovatively respond to the demands of this rapidly changing industry."

Witnesses agreed that NIST needs to play a more active role in the life sciences and that the institute needs to expand and re-organize. The panel also testified about the lack of standards across different labs and states. All witnesses agreed that NIST has tremendous capacity to build standards for the community, but that doing so would require expansion of NIST staff, development of an advisory board/panel, and the possible establishment of joint university-NIST centers for biomedical research.

The full Science and Technology Committee also heard testimony regarding the administration's FY 2011 research and development budget proposal in a separate hearing Feb. 24 with Office of Science and Technology Policy Director John Holdren.

Contact:
Shannon Curtis, Legislative Analyst
AAMC Government Relations
scurtis@aamc.org
(202) 828-0558

Senate Approves Job Creation Bill

The Senate Feb. 24 approved (70-28) legislation that, among other provisions, temporarily would exempt payroll taxes paid by employers on individuals hired in 2010. The Hiring Incentives to Restore Employment Act, approved as a substitute amendment (SA 3310) to H.R. 2847, also would provide additional business tax credits for firms that retain new employees and increases allowable business expense deductions. The legislation also includes a one-year extension to the Highway Trust Fund. The scaled-down $15 billion package now awaits House action.

Contact:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418

On the Hill . . .

Effective Feb. 28, Rep. Neil Abercrombie (D-Hawaii) will resign his seat in the House of Representatives to run for governor. Hawaiians will vote for his successor in a special election scheduled for May 22. Rep. Abercrombie sits on the House Committees on Armed Services and Natural Resources.

On the Agenda in Washington

March 2: Board of Scientific Counselors Advisory Committee Meeting
10 a.m.; Dial-In Only, 866-880-0098; access code: 9887280
The Board of Scientific Counselors, Coordinating Center for Infectious Diseases will hold a meeting via teleconference to discuss H1N1 influenza response and updates from the Centers for Disease Control and Prevention.

March 3: House Education and Labor Committee FY 2011 Education Budget Hearing
9:30 a.m.; 2175 Rayburn House Office Building, Washington, D.C.
The House Education and Labor Committee will hold a hearing on the FY 2011 budget request for the Department of Education, focusing on spurring innovation and change in the nation's education system and how improved education can help the economy. Secretary of Education Arne Duncan will provide testimony.

March 4: Office of the National Coordinator for Health Information Advisory Committee Meeting
10 a.m.; Dial-In only. RSVP for call-in information.
Office of the National Coordinator for Health Information will hold a meeting to provide recommendations to the National Coordinator on a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. RSVP to Judy Sparrow at 202-205-4528 or judy.sparrow@hhs.gov.

March 5: Ad Hoc Group for Medical Research Briefing with NIGMS Director
12:00p.m.; B-339 Rayburn House Office Building, Washington, DC
The Ad Hoc Group for Medical Research and the Congressional Biomedical Research Caucus will host a Congressional luncheon briefing on Friday, March 5, featuring Jeremy Berg, Ph.D., Director of the National Institute of General Medical Sciences. RSVP to Hayzell Gollopp at hgollopp@aamc.org.