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Washington Highlights: January 6, 2006

President Signs Appropriations Bills

President Bush Dec. 30 signed the FY 2006 Labor, Health and Human Services, and Education appropriations bill (H.R. 3010, P.L. 109-149), which provides $142.5 billion in discretionary funding. The President also signed Dec. 30 the FY 2006 Defense appropriations bill (H.R. 2863, P.L. 109-148), which includes a 1 percent across-the-board cut of all discretionary spending except for those programs under the Department of Veterans Affairs, including VA medical care and research [see Washington Highlights, Dec. 2].

The following funding levels include the 1 percent across-the-board cut:

  • $28.4 billion is included for the National Institutes of Health (NIH), a cut of $81 million (0.3 percent) below FY 2005.
  • $295 million is provided for Title VII and VIII health professions programs, a 34.5 percent cut. This includes a 51.5 percent cut to the Title VII health professions programs, and a 0.7 percent cut to the Title VIII nursing programs.
  • $125.5 million for the National Health Service Corps, a decrease of $5.9 million (4.5 percent) below FY 2005.
  • $319 million for the Agency for Healthcare Research and Quality (AHRQ), level with last year. All money is derived from transfers from other agencies, so this funding is not subject to the 1 percent across-the-board cut.
  • $495 million for the Health Resources and Services Administration's Bioterrorism Hospital Preparedness program, which is $19 million less than the program received in FY 2005.
  • $5.83 billion for the Centers for Disease Control and Prevention for a $1.33 billion increase. This includes $1.577 billion for the state and local terrorism preparedness and response programs, $46 million less than last year.

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

AAMC Joins AMA Amicus Brief on LabCorp v. Metabolite

The AAMC Dec. 23 joined with the American Medical Association (AMA) and several other medical organizations in filing a "friend of the court" brief in a patent case now before the U.S. Supreme Court. LabCorp v. Metabolite concerns a patent on a diagnostic test for blood homocysteine levels. The controversy concerns a single claim in the patent that embraces the concept of correlating homocysteine levels and deficiency in B vitamins, a factor in cardiovascular and other disorders. Metabolite had sued LabCorp, a clinical diagnostics firm, for infringing this claim of the patent. The lower courts ruled that the claim provides the patent licensee (Metabolite) with the right to exclude others from performing this correlation, no matter what methods are used to determine homocysteine levels.

In October, the Supreme Court unexpectedly agreed to hear the question whether the patent claims a natural law or principle, which are not patentable under Federal statute. Our amicus brief argues that the claim is illegal and that a physician who merely performs the mental act of correlating a test result with the vitamin deficiency should not be liable for patent infringement. "A physician who learns - from the medical literature, colleagues, continuing medical education, or other public sources - of the naturally occurring association between homocysteine and vitamin deficiency cannot put that knowledge out of mind. Knowledge of basic scientific facts such as a correlation between a test result and a possible disease state is essential to the practice of medicine."

While the issue may seem arcane, the case is being closely followed by business, medical, and legal communities and by patient advocates. Previous court deliberations on what constitutes "patentable subject matter" have had far reaching consequences. AAMC and its fellow amici believe that upholding the contested claim could have highly deleterious consequences for medical practice and the public health.

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

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

President Signs Cord Blood Bill

President Bush Dec. 20 signed legislation (H.R. 2520) to improve the collection of stem cells from umbilical cord blood for treatment and research. The House originally passed the bill May 24 [see Washington Highlights, May 27]. The Senate approved an amended version of the bill Dec. 16, and the House passed it the following day.

The Stem Cell Therapeutic and Research Act of 2005 (P.L. 109-129) authorizes $15 million a year for fiscal years 2007-2010 for the collection and storage of cord blood stem cells, with the goal of reaching a total inventory of 150,000 units. The law also merges the existing national bone marrow transplant system and with the new cord blood program, and authorizes $186 million over 5 years for new program, to be named the C.W. Bill Young Cell Transplantation Program.

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

GAO Issues Report on FDLP Consolidation Loans

The Government Accountability Office (GAO) Jan. 5 released a report requested by House Education and Workforce Committee Ranking Member George Miller (D-Calif.) on the budgetary effects of consolidation loans offered through the Federal Direct loan program (FDLP). The report, entitled "Potential Effects of Making Fiscal Year 2006 Consolidation Loans Exclusively through the Direct Loan Program," estimates $3.1 billion could be saved on the basis of subsidy cost estimates presented in the President's budget for FY 2006.

The GAO was also asked to consider the extent and reasons this estimated budgetary effect might change as subsidy costs are re-estimated in future years and how Federal Family Education Loan program (FFELP) lenders and borrowers might be affected if consolidation loans were made exclusively through FDLP. The GAO stresses that the estimated savings in the report rely heavily on underlying assumptions, including economic conditions, such as interest rates; loan performance, such as the portion of loans that default; and loan volume. Additionally, the report finds providing consolidation loans exclusively through FDLP would "reduce lender revenues, the total volume of consolidation loans originated, and certain borrower benefits, such as repayment incentives provided by lenders, including lower interest rates, for on-time borrower repayments."

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

AHRQ Seeks Input on Effective Health Program

The Agency for Healthcare Research and Quality (AHRQ) is hosting a Jan. 11 forum to solicit input on topics for its new Effective Health Care Program. This program, authorized under Section 1013 of the Medicare Modernization Act, reviews the effectiveness of alternative treatments for significant health conditions. The program's first report was released Dec. 14 [see Washington Highlights, Dec. 16].

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