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Washington Highlights: March 20, 2009

Ad Hoc Group Calls for Increase in NIH Budget

Stating that in the "post-stimulus" era, "we need to make sure that the total funding available to NIH does not decline and that we can resume a steady, sustainable growth that will enable us to complete the President's vision of doubling our investment in basic research," Mary J.C. Hendrix, Ph.D., urged Congress to increase funding for NIH by at least 7 percent in FY 2010.

Dr. Hendrix, President and Scientific Director for the Children's Memorial Research Center at Northwestern University's Feinberg School of Medicine, testified on behalf of the Ad Hoc Group for Medical Research during a March 18 public witness hearing before the House Labor-HHS-Education Appropriations Subcommittee. She also is a member of the AAMC's Advisory Panel on Research.

Noting she is an active cancer researcher who runs an institute that employs more than 500 staff, Dr. Hendrix thanked Congress for including "the extraordinary investment in medical research" through NIH in the American Recovery and Reinvestment Act, as well as the $938 million increase in NIH funding in the Omnibus Appropriations Act for FY 2009. She told the subcommittee, "These are difficult times for our nation and for people all around the globe, but the affirmation of science as the key to a better future is a strategic step forward. All of us in the medical research community are committed to do our utmost to fulfill the faith that you and the American people have placed in us."

Dr. Hendrix told the subcommittee, "The funding increases in the ARRA and the FY 2009 omnibus will provide an immediate infusion of funds into the nation's proven and highly competitive medical research enterprise to sustain the pursuit of improved diagnostics, better prevention strategies and new treatments for many devastating and costly diseases…"

Cautioning that "Large fluctuations in funding will be disruptive to training, to careers, long range projects and ultimately to progress," Dr. Hendrix emphasized, "The research engine needs a predictable, sustained investment in science to maximize our return."

The AAMC is a member of the Steering Committee of Ad Hoc Group for Medical Research, a coalition of more than 300 patient and voluntary health groups, medical and scientific societies, academic and research organizations, and industry.

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

HPNEC Request $550 Million for Titles VII and VIII

Tina Cheng, M.D., M.P.H., chief of the Division of General Pediatrics and Adolescent Medicine and Professor of Pediatrics and Public Health at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health, March 18 testified before the House Labor-HHS-Education Appropriations Subcommittee on behalf of the Health Professions and Nursing Education Coalition (HPNEC). Dr. Cheng, who also serves as president of the Academic Pediatric Association, conveyed HPNEC's recommendation that the subcommittee provide $550 million for Title VII and VIII health professions and nursing education programs in FY 2010.

Thanking the subcommittee for health professions funding in the American Recovery and Reinvestment Act (P.L. 111-5) and the FY 2009 Omnibus Appropriations Act (P.L. 111-8), Dr. Cheng emphasized that "these investments provide a crucial springboard to begin to wholly reverse chronic underfunding of these programs and address existing and looming shortages of health professionals." Additionally, she cited "numerous recent, highly regarded publications," including a December 2008 Institute of Medicine report which characterized the programs as "an undervalued asset."

Witnesses for the Academic Family Medicine Advocacy Alliance, American Association for Geriatric Psychiatry, and the American Dental Education Association, also supported additional funding for Title VII programs at the hearing. The AAMC coordinates HPNEC, a group of more than 60 national organizations advocating increased support for Title VII and Title VIII.

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

Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525

AAMC Registers Concern Over Status of Grants.gov

AAMC President and CEO Darrell G. Kirch, M.D., March 16 wrote Peter Orszag, Ph.D., director of the Office of Management and Budget (OMB), to register the AAMC's increasing concern about operational problems with Grants.gov, the central portal for the federal government's competitive grant programs. Dr. Kirch noted that, "The AAMC has received messages of grave concern from our constituents about major service and operational deficiencies in the program and fear that increased deterioration in this essential service as volume increases may hamper efforts to implement the Recovery Act [P.L. 111-5]."

Dr. Kirch asked Dr. Orszag to provide on-going oversight of the Grants.gov system to ensure it is adequately resourced and staffed: "We urge that you and your colleagues work to ensure that adequate resources are allocated to solve the short- and long-term operational problems with Grants.gov."

Dr. Kirch also asked that Dr. Orszag "authorize the agencies managing the competitive grant programs functioning within the system to provide applicants with appropriate flexibility to compensate for the performance flaws currently in evidence with the system." Dr. Kirch said, "No applicant should be disadvantaged by an inadequate or malfunctioning application submission portal."

OMB has noted that problems with the Grants.gov system pose a major risk to the effective dissemination of Recovery Act resources. The National Institutes of Health (NIH) March 16 extended by one day a grant submission deadline due to problems with the HHS-managed resource on that date. NIH said, "We will continue to closely monitor the situation at Grants.gov and will make adjustments as necessary to ensure applicants' ability to submit on-time." It is expected that NIH may revert applications for some mechanisms to paper should performance woes continue with the Grants.gov portal.

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

Ways and Means Subcommittee Discusses MedPAC Annual Report

A March 17 Ways and Means Subcommittee on Health hearing focused on the Medicare Payment Advisory Commission's (MedPAC) March Report to Congress on the Medicare Payment Policy. Subcommittee Chair Pete Stark (D-Calif.) in his opening statement said, "Improvements to Medicare and reforms to the program must be, and will be, part of this year's larger health care reform agenda. As we pursue comprehensive health reform, MedPAC's insight into health delivery and spending in Medicare is of great value."

MedPAC Chair Glenn Hackbarth, J.D., in his opening statement discussed and made recommendations for Medicare fee-for-service (FFS) payment systems and the Medicare Advantage (MA) program. He also discussed other key health care initiatives including a greater investment in information about comparative effectiveness and medical home as a mechanism for coordinated care.

During the hearing Rep. Shelley Berkley (D-Nev.) raised concerns about a current shortage of primary care providers and specialists in certain areas of the country. In his response, Chairman Hackbarth agreed that fewer medical students are seeking careers in primary care, largely due to poor reimbursement levels. He added that physician shortages of any time threaten to reduce the quality, as well as availability, of health care services.

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

Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

MedPAC Discusses Medical Education Project

At its March 12-13 meeting, the Medicare Payment Advisory Commission (MedPAC) discussed a project entitled "Medical education in the U.S. - Is it supporting needed delivery system reforms?" MedPAC staff presented a draft chapter of this project for possible inclusion in the commission's June Report to Congress. This issue was first addressed at the commission's October meeting when they heard from a three-person panel on medical education [see Washington Highlights, Oct. 10, 2008].

MedPAC staff presented findings from a study that looked at whether residency training programs equip future physicians with the skills they need to implement the delivery system changes MedPAC has recommended in recent years. The study was conducted by RAND researchers who conducted 26 semi-structured interviews with internal medicine program directors to assess the extent to which their program curricula focused on the following topics: practice-based learning, system-based practice, interpersonal communication, health information technology (IT), and training in non-hospital settings.

The preliminary survey results show that most programs interviewed provide at least some training in the selected topics, but overall their curricula fall short of providing the full range. For example, programs generally include instruction on evidence-based medicine and communication about end-of-life care, but lack formal training and experience in areas such as outpatient care coordination, multidisciplinary teamwork, awareness of health care costs, comprehensive health IT, and training in non-hospital settings. MedPAC staff noted that some of the factors that affect programs' curricula include the amount of faculty expertise; residents' baseline level of skills and knowledge; and a dearth of information on the best educational methods for teaching residents in topics such as care coordination. MedPAC staff also pointed out that Medicare regulations regarding residency training in nonhospital sites appear to be a major barrier that discourages training in ambulatory sites, such as physician offices.

Following the presentation, commissioners discussed issues related to medical education that need further investigation. These issues range from the role of undergraduate education and accreditation to how Medicare can better address workforce issues and foster continuing medical education.

Commissioner Peter Butler, COO of Rush University Medical Center, wrapped up the session by expressing his support for the inclusion of a chapter on medical education in the June report. He also suggested that further staff work should include interviews with Designated Institutional Officers (DIOs), who are responsible for all of the residency programs at their respective institutions.

Information:
Karen Fisher, 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

AAMC Asks CMS to Begin a New Effort on Clinical Trial Policy

The AAMC sent a March 12 letter to the Centers for Medicare and Medicaid Services (CMS) requesting it begin a new effort on setting requirements for Medicare coverage of clinical trials. The AAMC letter notes that the CMS policy on clinical trials is "confusing to implement, lacking consistency with other Medicare policies that affect clinical trials, and variable in its application due to differing interpretations by Medicare contractors."

The letter states that, to date, CMS has been unsuccessful in clarifying the clinical trial policy that was initially issued in 2000. The AAMC suggests that a new effort should have the dual goals of: 1) increasing the enrollment of Medicare beneficiaries in clinical trials; and 2) giving providers sufficient clarity about the requirements. The AAMC also urges CMS to issue this new policy through rulemaking, not through the national coverage decision (NCD) that is the current vehicle for the clinical trials policy. According to the letter, "The NCD process was never intended to tackle the complexities raised by clinical trial coverage and should no longer be used for that purpose."

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

AAMC Supports Transparency in Regulatory Review Process

The AAMC March 16 submitted a response to the Office of Management and Budget's (OMB's) Feb. 26 request for public comments on the principles and procedures governing regulatory review. The AAMC letter asks for increased transparency in the regulatory process, including more frequent use of the Advanced Notice of Proposed Rulemaking.

The AAMC also recommends that data used to support a proposal should be made available to the public at the time the proposed regulation is released to allow time for data analysis and an assessment of the impact of the proposal. The AAMC suggests that federal agencies establish clear guidelines to distinguish when an agency is making a "clarification" and when it is establishing new policy. The letter also expressed concern about the cumulative effect, both in terms of cost and administrative burden, of federal regulations on academic medicine, particularly biomedical research.

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

HHS Names David Blumenthal As National Coordinator for Health Information Technology

The Department of Health and Human Services (HHS) March 20 announced the selection of David Blumenthal, M.D., M.P.P., as the Obama Administration's choice for National Coordinator for Health Information Technology. As the National Coordinator, Dr. Blumenthal will lead the implementation of a nationwide interoperable, privacy-protected health information technology infrastructure as called for in the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). The ARRA includes a $19.5 billion investment in health information technology.

"Health information technology is a critical part of the President's strategy to reform our health care system and as one of the nation's leading health information technology experts, Dr. Blumenthal has the experience and the vision to help make this effort a reality," said HHS spokeswoman Jenny Backus.

Dr. Blumenthal most recently served as a physician and director of the Institute for Health Policy at The Massachusetts General Hospital/Partners HealthCare System in Boston, Mass. He was also Samuel O. Thier Professor of Medicine and Professor of Health Care Policy at Harvard Medical School. There, he also served as director of the Harvard University Interfaculty Program for Health Systems Improvement. Prior to that, he was senior vice president at Boston's Brigham and Women's Hospital and served as executive director of the Center for Health Policy and Management and as a lecturer on Public Policy at the John F. Kennedy School of Government.

During the late 1970's, Dr. Blumenthal worked on Senator Edward Kennedy's Senate Subcommittee on Health and Scientific Research. More recently, Dr. Blumenthal served as a senior health adviser to the Obama for America campaign.

NSF Describes Recovery Act Implementation

The National Science Foundation (NSF) March 18 issued a notice to presidents of colleges and universities and heads of other NSF awardee institutions, describing plans for implementing the $3 billion provided to NSF through the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). According to the notice, the "majority" of the $2 billion allocated for research and related activities will be used for unfunded, highly rated proposals "that are already in house and will be reviewed and/or awarded prior to September 30, 2009." Program officers also will contact institutions whose high quality proposals were declined on or after Oct. 1, 2008, due to lack of funding; some of these decisions may be reversed. Additionally, this spring NSF plans to post ARRA-supported solicitations for its Major Research Instrumentation program, Academic Research Infrastructure program, and the Science Masters program.

The notice specifies that ARRA-funded grants will be "standard grants with durations of up to 5 years … [which] will allow NSF to structure a sustainable portfolio." NSF also plans to prioritize funding for new investigators and high-risk, high-return research projects. Additional information about ARRA-related procedures and weekly reports on disbursements and obligations is available on the NSF's Recovery Act website.

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

HHS Announces Members of CER Coordinating Council

The U.S. Department of Health and Human Services (HHS) March 19 announced members of a newly created 15-person council to help coordinate and guide investments in comparative effectiveness research (CER) funded by the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). The Federal Coordinating Council for Comparative Effectiveness Research will assist federal agencies in coordinating research to help determine the "relative strengths and weaknesses of various medical interventions;" develop ways to build and expand on current priorities; and issue recommendations on how to utilize $400 million allocated to the HHS Secretary through the ARRA to advance CER. As specified in the Recovery Act, the council will not recommend clinical guidelines for payment, coverage or treatment.

Twelve of the members represent agencies or offices within HHS; a representative from the Veterans Administration, the Department of Defense, and the Office of Management and Budget also were named to the group. The council will hold a public listening session on April 14 to receive public input and ensure all deliberations are open and transparent.

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

Sen. Conrad Introduces Visa Waiver Program Reform

Senator Kent Conrad (D-N.D.), March 18 introduced a bill (S. 628) to authorize the Conrad State 30 permanently with additional reforms. The bill is similar to legislation he sponsored in the 110th Congress (S. 2672).

Congress March 11 passed legislation (H.R. 1127) to extend through Sept. 30, 2009, the Conrad State 30 program, sending the bill to the President for his signature. The legislation was introduced Feb. 23 by Rep. Zoe Lofgren (D-Calif.), to prevent the program's March 6 expiration.

Currently, the Conrad State 30 program allows physicians on J-1 visas to waive the J-1 requirement to return to their home country for two years if they agree to serve for three years in a U.S. underserved area. Each state is allowed 30 such waivers.

Like the previous version, S. 628 would:

  • Permanently authorize the Conrad State 30 program;
  • Allow physicians on H-1B visas to enter the program;
  • Exempt physicians who participate in the program from green card caps; and
  • Provide a mechanism by which the per state caps can increase beyond 30 waivers.

S. 628 would also prohibit H-1B visa physicians from serving in "flex-slots," positions located outside underserved areas. Additionally, it would reset H-1B visa physicians' visa expiration to 6 years from the time they enter the Conrad State 30 program.

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