AAMC Home   Tomorrow's Doctors Tomorrow's Cures
  Home  Government Affairs   Newsroom   Meetings   Publications Shopping Cart   Site Map    

Washington Highlights: May 5, 2006

HHS Secretary Leavitt Testifies on FY 2007 Budget

Secretary of Health and Human Services (HHS) Michael Leavitt May 3 testified before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Subcommittee members expressed concern over the Administration's proposed cuts to the Centers for Disease Control and Prevention (CDC) and the level funding of the National Institutes of Health (NIH), especially in light of an anticipated flu pandemic. Leavitt testified that he is committed to maintaining momentum in research and "fought hard to keep [NIH] funding flat" in this deficit reduction budget.

Other issues of concern to the subcommittee included the importance of prevention initiatives, support for rural and aging populations, and health professions training. Sen. Dick Durbin (D-Ill.) worried that the country is not keeping up with the demand for health professionals, and Sen. Larry Craig (R-Idaho) asked how the Administration reconciles expanding Community Health Centers while reducing support for training programs that help staff the centers.

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

HHS OIG Sends Open Letter to Health Care Providers

Health and Human Services Inspector General Daniel R. Levinson April 24 issued "An Open Letter to Health Care Providers" that, as in the past, touts the advantages to providers of using the OIG's Self Disclosure Protocol (SDP) to notify the government when certain conduct is discovered that may subject the provider to liability.

In the letter, Mr. Levinson encourages hospitals that discover improper arrangements under the physician self-referral ("Stark") and anti-kickback laws to use the SDP, especially in situations involving a financial benefit knowingly conferred by a hospital upon one or more physicians; for example, when a physician pays the hospital below fair market value for a good or service. While no promises are made as to the possible financial penalties that the government has the authority to impose, Mr. Levinson writes that the "OIG will generally settle matters for an amount near the lower end of this continuum" when the SDP is employed.

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

Senate Bills Outline Medical Liability Reform

Sens. John Ensign (R-Nev.) and Rick Santorum (R-Pa.) May 3 introduced separate bills that would help preserve access to healthcare services by reforming the medical liability system. Majority Leader Bill Frist (R-Tenn.) stated that "hopefully we will be debating these bills sometime in the next 3 to 4 days."

According to a draft of Sen. Ensign's bill, the "Medical Care Access Protection Act of 2006" (S.22), includes several of the AAMC-supported provisions contained in the House-passed "Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2005 "(H.R. 5) [see Washington Highlights, July 29, 2005]. However, S.22 follows Texas medical liability laws by limiting awards for non-economic damages at $750,000, including up to $250,000 from a physician, up to $250,000 from a single institution, and up to $250,000 from a second institution.

According to draft language, Sen. Santorum's specialty-specific bill, the "Healthy Mothers and Healthy Babies Access to Care Act" (S. 23), would establish a cap similar to S. 22; however, it would only apply to obstetricians and gynecologists.

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

Senators Introduce Public Access Bill

Sens. John Cornyn (R-Texas) and Joseph Lieberman (D-Conn.) May 2 introduced the "Federal Research Public Access Act of 2006" (S. 2695). The bill requires that federal agencies with annual extramural research expenditures of more than $100 million make publicly available manuscripts of journal articles that resulted from research funded by that agency. The final manuscripts must be available on the Internet for users to access without charge within six months after publication in peer-reviewed journals.

The introduction of this legislation occurs one year after National Institutes of Health Director Elias Zerhouni, M.D., initiated a voluntary public access policy. Members of Congress, including Rep. Ernest Istook (R-Okla.) at an April 6 House appropriations hearing, have expressed their desire that publicly-funded research be made widely available to the public, free of charge [see Washington Highlights, April 14].

The legislation is expected to affect 11 agencies, including the National Science Foundation and the departments of Agriculture, Education, Health and Human Services, and Homeland Security.

Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525

House Budget Impasse Shows Signs of Ending

House Appropriations Chair Jerry Lewis (R-Calif.) has proposed moving $6 billion from defense and foreign aid to domestic programs in an effort to secure House passage of the FY 2007 budget resolution (H.Con.Res. 376). The House Republican leadership has been trying to negotiate a budget plan that satisfies both conservatives, who want to cap discretionary spending at the $873 billion proposed by the Administration, and moderates, who are seeking more funding for health, education, and job training programs.

Chairman Lewis May 4 released House Appropriations subcommittee allocations (also known as 302(b) allocations). Under the proposed allocations, which will be formally approved by the full Appropriations Committee the week of May 8, the Defense subcommittee would get $4 billion less than the Administration's planned $23 billion increase. This difference would be made up in a forthcoming defense supplemental spending bill. The Foreign Operations subcommittee would get $2.4 billion less than the Administration's request, but still receive a 2.9 percent increase over FY 2006.

The Labor-HHS-Education subcommittee would get an allocation of $141.9 billion, which is $843 million (0.6 percent) over the FY 2006 enacted level and $4.136 billion (3 percent) over the President's budget. Republican moderates, led by Reps. Mike Castle (Del.) and Nancy Johnson (Conn.), have been pushing for an increase of $7.2 billion over the Administration's budget for programs in the Labor-HHS bill. While praising the leadership's efforts to seek a compromise, Rep. Castle indicated he would still vote against the budget resolution unless the final number for health and education programs is closer to the $7.2 billion target sought by the moderates. It is unknown how many moderates would vote for the resolution under Chairman Lewis's proposed plan.

Earlier, GOP leaders gained support for the resolution when Chairman Lewis and other appropriators dropped their opposition to the measure after an agreement was reached to extend earmark reforms to authorizing as well as appropriations bills. No date has been set for House floor action on the budget resolution. House leaders face pressure to pass the budget before the May 15 statutory deadline when appropriations bills can be brought to the House floor without a budget resolution.

No date has been set for House floor action on the budget resolution. House leaders face pressure to pass the budget before the May 15 statutory deadline when appropriations bills can be brought to the House floor without a budget resolution.

The Senate passed its budget plan in March. Even if the House passes its budget, it will have a difficult time reconciling its plan with the Senate's, which would permit an additional $16 billion in discretionary spending over the President's budget.

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

President Bush, Senate Address Pandemic Flu Preparedness

The White House May 3 released its Implementation Plan for the National Strategy for Pandemic Influenza, a more detailed set of guidelines than the overview released in November 2005. Though the report describes actions at all levels of government, it emphasizes that "the center of gravity of the pandemic response … will be in communities," and encourages individuals, states and localities to plan accordingly.

Meanwhile, the Senate May 4 approved (77-21) its FY 2006 Emergency Supplemental Appropriations bill (H.R. 4939), sending the bill to Conference with the House passed version. The $108.9 billion price tag of the Senate bill, which includes an amendment adding $2.3 billion for pandemic flu preparedness, is well over the Administration's $92.2 billion proposal and the House's $91.9 billion measure that passed March 16. The President has threatened to veto any bill exceeding $94.5 billion, which represents his original request and the additional flu funding. In a different amendment, the Senate May 3 voted 53-46 to add $289 million to the supplemental to fund the flu vaccine compensation fund, as proposed by Sen. Edward Kennedy (D-Mass.).

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

GAO Report Shows Major Teaching Hospitals Pay Less For SCODs

The Government Accountability Office (GAO) April 28 released a report on the variation in acquisition costs among hospitals. The report is part of a series of legislatively mandated reports that are intended to provide the Centers for Medicare and Medicaid Services (CMS) with information that could help the agency set future payment rates for specified covered outpatient drugs (SCOD) and radiopharmaceuticals. As mandated by Medicare Modernization Act of 2003, CMS is required to set Medicare payment rates for SCODs equal to hospitals' average acquisition costs, starting in fiscal year 2006.

The GAO report, drawing data from a survey of approximately 1,200 hospitals between July 1, 2003, and June 30, 2004, determined that SCOD and radiopharmaceutical prices vary across hospitals. The study examined the effects of three hospital characteristics on prices (teaching status, location, and size of the outpatient department) and factored in the cost differences of the multiple SCODs that hospitals purchased. Major teaching hospitals paid on average 3.2 percent less for SCODs than non-teaching hospitals. Teaching status did not affect the prices paid for nine radiopharmaceuticals that are purchased in unit doses, the form purchased by most hospitals. When all three factors were taken into consideration, the study found that large major teaching hospitals in urban areas paid prices, on average, that were an estimated 4 percent lower for SCODs and 3 percent lower for radiopharmaceuticals.

The report also notes GAO's concerns with regard to the accuracy of the average sales price (ASP) methodology currently used by CMS to set prices for SCODs. Specifically, it mentions the inconsistency in calculating ASPs across manufacturers that has resulted from a lack of detailed instructions from CMS.

The report recommends that CMS validate manufacturers' reported drug ASPs either by using a survey of hospitals conducted once or twice every 10 years, or by finding a similarly accurate and efficient method. For radiopharmaceuticals, the GAO report recommends using unit-dose prices paid by hospitals as the data source for setting payment rates.

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

NRC-IOM Panel Named to Revise Stem Cell Guidelines

The National Academies' National Research Council (NRC) and Institute of Medicine (IOM) May 2 announced the appointment of a committee to monitor and revise the Guidelines for Human Embryonic Stem Cell Research, issued by an NRC-IOM panel in February 2005. This new committee will provide updates to the voluntary guidelines based on comments from the community. These updates will be issued in periodic reports, and workshops will be held to keep the committee informed of developments in the field.

The Human Embryonic Stem Cell Research Advisory Committee will be co-chaired by R. Alta Charo, J.D., Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin Law School and Medical School, and Richard O. Hynes, Ph.D., HHMI Investigator, and Daniel K. Ludwig Professor for Cancer Research, Center for Cancer Research and Department of Biology Massachusetts Institute of Technology. Dr. Hynes co-chaired - along with Dr. Jonathan Moreno (see below) - the panel that developed the 2005 Guidelines.

Members of the 14-member panel from the medical school community include:

  • Eli Y. Adashi, M.D., M.S., Dean of Medicine and Biological Sciences, Brown University;
  • Brigid L.M. Hogan, Ph.D., Chair, Department of Cell Biology, Duke University Medical Center;
  • Terry Magnuson, Ph.D., Chair, Department of Genetics, University of North Carolina;
  • Jonathan D. Moreno, Ph.D., Director, Center for Biomedical Ethics, University of Virginia;
  • Stuart H. Orkin, M.D., HHMR Investigator and Chair, Department of Pediatric Oncology, Dana-Farber Cancer Institute;
  • E. Albert Reece, M.D., Ph.D., Vice Chancellor and Dean, University of Arkansas for Medical Sciences;
  • Joshua R. Sanes, Ph.D., Director, Center for Brain Science, Harvard University; and
  • John Wagner, M.D., Professor of Pediatrics and Director of Pediatric Hematology/Oncology at the University of Minnesota Medical School.

Adam P. Fagen, Ph.D., and Bruce Altevogt, Ph.D., will staff the committee as Study Co-Directors.

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