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Washington Highlights: October 26, 2007

Senate Passes HHS Funding Bill

The Senate Oct. 23 passed its FY 2008 Labor-HHS-Education appropriations bill (H.R. 3043) by a veto-proof margin of 75-19, with five Democrats not present to vote. A total of 29 Republicans voted for the bill. The bill provides $149.9 billion in discretionary spending, which is $5.4 billion over the FY 2007 level and $9.6 billion more than the President's budget request.

The Senate bill is $1.9 billion less than the bill passed by the House July 18 [see Washington Highlights, July 20], a difference that will have to be reconciled by the House and Senate conferees on the bill. The President has stated that he will veto both versions of the bill because tehy exceed his budget request.

The Senate bill includes $29.9 billion for the National Institutes of Health (NIH), an increase of $1 billion (3.5 percent) over the FY 2007 level, and $250 million over the House bill. However, the Senate and the House both adopted the Administration's proposal to increase the amount of the transfer from NIH to the Global HIV/AIDS fund from $99 million in FY 2007 to $300 million for FY 2008. As a result, the increase over FY 2007 in the NIH program level in the Senate bill is $799 million (2.8 percent), compared to $549 million (1.9 percent) in the House bill.

The Senate bill essentially freezes funding for Title VII health professions programs at the FY 2007 level, providing $189.7 million, a $5 million (2.7 percent) increase. The bill increases the Title VIII nursing programs by $20 million (13.4 percent) to $169.7 million.

An amendment offered by Sen. Wayne Allard (R-Colo.) proposed to cut by 10 percent funding for any program deemed "ineffective" by the Office of Management and Budget's Program Assessment Rating Tool (PART), including Titles VII and VIII and a handful of other programs. The amendment was defeated, 68-21.

Sens. Chuck Schumer (D-N.Y.) and Kay Bailey Hutchison (R-Texas) sponsored an amendment to allow up to 61,000 foreign nurses to enter the country as a means of relieving the nursing shortage. Sen. Dick Durbin (D-Ill.) offered an amendment to modify the Schumer-Hutchinson proposal to require employers (excluding those in health professions shortage areas) petitioning for the nursing green cards to pay a $1,500 fee; the revenues collected from the fees would fund nursing education grants in the United States. Both amendments were adopted by unanimous consent.

Sens. Charles Grassley (R-Iowa) and Bernard Sanders (I-Vt.) offered an amendment to establish the "American Competitiveness Scholarship." The program authorizes the Director of the NSF to make $15,000 scholarships to individuals pursuing degrees in "mathematics, engineering, computer science, nursing, medicine, or other clinical medical program, or technology, or science program designated by the Director." The amendment also increases the fee for H1-B visas from $1,500 to $3,500 to pay for the program. The amendment was adopted by unanimous consent.

The bill cuts the Children's Hospitals Graduate Medical Education program by $97 million (33 percent) to $200 million.

The Senate stripped a provision from the bill that would have expanded federal funding for human embryonic stem cell research. Under the Administration's current policy, federal funding is limited to stem cell lines created before Aug. 9, 2001. The deleted provision would have permitted funding for cell lines created before June 15, 2007.

The Senate also adopted (65-28) an amendment offered by Senator Mike Enzi (R-Wyo.) to cancel a provision in the House bill to redistribute FY 2007 funds for city HIV/AIDS programs to 10 locations across the country. The House proposal would have been funded by reductions in other national AIDS programs in FY 2008.

Prior to final passage of the bill, the Senate rejected (40-54) a Republican amendment to recommit the bill to the Appropriations Committee to be revised to provide no more than $140.9 billion in discretionary funding.

Democratic staff in both the House and Senate report that Nov. 1 is the target date for holding the House-Senate conference on the bill, with the conference report report going to the House and Senate floors the week of Nov. 5. The congressional leadership has not decided whether the Labor-HHS bill will be the first FY 2008 appropriations bill sent to the White House.

The Senate appointed the following Senators as conferees: Harkin (D-Iowa), Inouye (D-Hawaii), Kohl (D-Wis.), Murray (D-Wash.), Landrieu (D-La.), Durbin (D-Ill.), Reed (D-R.I.), Lautenberg (D-N.J.), Byrd (D-W.Va.), Specter (R-Pa.), Cochran (R-Miss.), Gregg (R-N.H.), Craig (R-Idaho), Hutchison (R-Texas), Stevens (R-Alaska), Shelby (R-Ala.) and Domenici (R-N.Mex.)

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

Senate Urges CMS to Continue Clinical Trial Reimbursement

The Senate Oct. 23 approved by unanimous consent an amendment (S.Amdt. 3401) to the FY 2008 Labor-HHS-Education appropriations bill (H.R. 3043, see related article) offered by Senators Ben Cardin (D-Md.) and Sam Brownback (R-Kan.) that expresses the sense of the Senate that "the Secretary of Health and Human Services should maintain 'deemed status' coverage under the Medicare program for clinical trials that are federally funded or reviewed as provided for by the Executive Memorandum of June 2000." Though non-binding, the amendment urges CMS to continue allowing reimbursement for services rendered to Medicare beneficiaries enrolled in clinical trials.

In anticipation of the vote, the AAMC, the American Society of Clinical Oncology, and the Association of American Cancer Institutes sent an Oct. 23 letter to Sens. Cardin and Brownback in support of the amendment. The letter states, "While we applaud the agency's decision not to proceed with its draft policy, a message from the Senate in opposition will help ensure that they do not move forward with any change in status for federally funded or reviewed trials."

Though the Oct. 17 CMS final decision on national coverage of clinical trials decided to postpone any action [See Washington Highlights, Oct. 19], it is not clear if CMS will re-visit the issue in the future.

Information:
Atul Grover, Director, Government Relations
AAMC Health Care Affairs/Government Relations
agrover@aamc.org
(202) 828-0666

Temporary Extension Could Delay HEA Reauthorization

The House Oct. 23 passed the "Third Higher Education Extension Act of 2007" (H.R. 3927) to extend temporarily the Higher Education Act (HEA, P.L. 105-244) through April 30, 2008. Authority for the HEA expired on Sept. 30, 2003; however, several extensions have been enacted, making no policy changes but allowing uninterrupted administration of the programs authorized under the law. The current extension is set to expire Oct. 31.

The Senate July 24 passed the "Higher Education Amendments of 2007" (S. 1642) to reauthorize the HEA for 5 years [See Washington Highlights, July 27]. House Education and Labor Committee Chair George Miller (D-Calif.) is expected to introduce his own version of the reauthorization bill later this session. During the Oct. 23 debate on the bill, Education Subcommittee Chair Ruben Hinojosa (D-Texas) stated, "Given the length of time that has lapsed between when the Higher Education Act should have been reauthorized and now, we believed that it was critical that the 110th Congress and the stakeholders in the higher education community take a fresh look at the new law."

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

Chairman Kennedy Requests Timeline for PSO Implementation

Senate HELP Committee Chair Edward Kennedy (D-Mass.) Oct. 18 sent a letter to Secretary of Health and Human Services Michael Leavitt requesting by Nov. 2 a "detailed" timeline for implementation of the AAMC-supported Patient Safety and Quality Improvement Act (P.L. 109-41). Enacted in July 2005, the law establishes "Patient Safety Organizations" (PSOs) to collect and analyze confidential patient safety data that are voluntarily submitted by providers. "Extremely disappointed and troubled" that HHS has not yet finalized regulations for the law, Chairman Kennedy states that he is "committed" to full implementation of the law.

Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

Senate Judiciary Holds Hearing on University Research and Patents

The Senate Judiciary Committee Oct. 24 held a hearing on the "Role of Federally-Funded University Research in the Patent System." Committee Chair Patrick Leahey (D-Vt.) introduced the hearing as being occasioned by an earlier issue arising in the operation of a government facility by a university contractor, but the witnesses testified broadly on topics of university technology transfer and the 1980 Bayh-Dole Act.

The witnesses included: Arti K. Rai, J.D., Professor of Law, Duke University Law School; Elizabeth Hoffman, Ph.D., Executive Vice President and Provost of Iowa State University; Robert Weissman, Director, Essential Action (a public interest organization); and Charles Louis, Ph.D., Vice Chancellor for Research, University of California-Riverside. As with the similar hearing on Bayh-Dole held in July by the House Judiciary Committee, the witnesses testified that there was no need for a major overhaul of current law [See Washington Highlights, July 20].

Weissman, the witness most critical of the status quo, focused his written testimony on the government's "abrogation" of responsibility to ensure that pharmaceuticals resulting from federally funded research be more generally affordable and proposed stronger exercise of "march-in" rights and other reforms. Rai distinguished how Bayh-Dole's provisions may have different effects on, for example, software development than on pharmaceuticals. Rai did not recommend major revisions to Bayh-Dole, but proposed closer examination of the provision for "determination of exceptional circumstances" by which a Federal agency can alter the disposition of property rights for particular research projects. Louis and Hoffman were both strongly supportive of current law, noting examples of socially beneficial products commercialized from university-based research.

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

HHS Appeals Order to Release Claims Data

The Department of Health and Human Services (HHS) Oct. 19 filed an appeal with the U.S. Circuit Court of Appeals for the District of Columbia in the case Consumers' Checkbook/Center for the Study of Services v. HHS. Consumers' Checkbook, a non-profit group, had sued for the release of Medicare claims data under the Freedom of Information Act to analyze the data and report metrics on physician performance. HHS contends that release of the data, which includes physician, but not patient, identifiers, violates the privacy of physicians. In August, the U.S. District Court for D.C. rejected the privacy argument and ordered HHS to release the information.

Information:
Mary Patton, Senior Specialist
AAMC Health Care Affairs
mpatton@aamc.org
(202) 862-6297