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

Washington Highlights: June 22, 2007

Senate Panel Approves HHS Funding Bill

The Senate Appropriations Committee June 21 approved the FY 2008 Labor-HHS-Education appropriations bill. The bill, which had been approved by the Labor-HHS-Education Appropriations Subcommittee on June 19, includes $29.9 billion for NIH, an amount that is described as an increase of $1 billion (3.5 percent) over the FY 2007 level, and $250 million over the level in the House Subcommittee bill approved June 7.

However, it is believed that the Senate subcommittee took the same approach as the House subcommittee 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. Both the House and Senate bills fall short of the projected 3.7 percent increase in the Biomedical Research and Development Price Index (BRDPI) for FY 2008.

The bill provides $329.6 million for the Agency for Healthcare Research and Quality (AHRQ), which is a $10.6 million (3.3 percent) increase over last year. The bill cuts the Children's Hospitals Graduate Medical Education program by $97 million (33 percent) to $200 million. The Title VII health professions programs are level funding at the FY 2007 level of $184.7 million, and the Title VIII nursing programs are increased by $20 million to $169.7 million.

The schedule for Senate floor consideration of the bill is uncertain. The House Appropriations Committee is tentatively scheduled to consider its bill the week of July 9.

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

Bush Vetoes Stem Cell Legislation; Override Effort Expected to Fail

President Bush June 20 vetoed the "Stem Cell Research Enhancement Act of 2007" (S. 5). The House had cleared the bill on June 7 by a vote of 247-176. The Senate passed the bill by a vote of 63-34 in April. A Senate vote to override the veto is expected to fail. This is the third veto by President Bush in his 5 plus years in office, and the second time he has vetoed stem cell legislation.

The bill would require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. Federal funding for research would be limited to stem cells that meet the following requirements:

  • The stem cells were derived from human embryos donated from in vitro fertilization clinics for the purpose of fertility treatment and were in excess of the needs of the individuals seeking such treatment;

  • The embryos would never be implanted in a woman and would otherwise be discarded; and

  • Such individuals donate the embryos with written informed consent and receive no financial or other inducements.

Senate Democrats included a stem cell provision in the FY 2008 Labor, Health and Human Services, and Education Appropriations bill, which funds the National Institutes of Health (NIH) and was approved by the Senate Appropriations Committee on June 21 (see related story). The provision allows federal funding for research on stem cell lines derived before June 15, 2007.

In a White House event announcing the veto, President Bush issued an executive order directing the HHS and NIH "to ensure that any human pluripotent stem cell lines produced in ways that do not create, destroy, or harm human embryos will be eligible for federal funding." The White House acknowledged that this research is already eligible for funding. The President also ordered NIH to expand the Embryonic Stem Cell registry to include all types of human pluripotent stem cells.

Information:
Tony Mazzaschi, Senior Associate Vice President
AAMC Biomedical Health Sciences Research
tmazzaschi@aamc.org
(202) 828-0059

Circuit Court Upholds Ruling on Control of Biological Samples

The 8th U.S. Circuit Court of Appeals unanimously upheld a lower court ruling that tissue and blood samples donated by patients to Washington University School of Medicine in St. Louis for prostate cancer research belong to the institution and cannot be reclaimed by the donors. The AAMC joined several major research universities in an amicus brief in support of upholding the decision of the District Court in favor of Washington University.

In the first ruling to date by a federal appeals court on research participants' ownership rights in their tissue samples, the three-judge panel said the donors voluntarily made an irrevocable gift to Washington University when they donated their biological samples and, therefore, the specimens belong to the school. The original case, Washington University v. William J. Catalona, centered on whether tissue donors can reclaim or redirect the use of samples donated to a research institution to another institution or specific researcher.

Information:
Stephen Heinig, Senior Research Fellow
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

Senate Committee Approves HEA Reauthorization Package

The Senate Committee on Health, Education, Labor, and Pensions June 20 approved a pair of Higher Education Act (HEA) reauthorization bills: the "Higher Education Amendments of 2007" (S.1642) and the "Higher Education Access Act." The bills include several changes to federal student loans, financial aid administration oversight, and accreditation. According to a press release from Chairman Edward Kennedy (D-Mass.), the bills would increase student aid by more than $17 billion.

The "Higher Education Access Act" increases the cap on the economic hardship deferment from 3 years to 6 years, allowing qualifying resident physicians to postpone federal loan repayments. The "College Cost Reduction Act of 2007" (H.R. 2669), approved by the House Education Committee June 13, eliminates this limit completely [see Washington Highlights, June 15]. The Senate bill also decreases the debt-to-income ratio necessary to qualify for the economic hardship deferment and create an income-based repayment system for federal educational loans. This system would cap repayment at 15 percent of the amount by which a borrower's adjusted gross income exceeds 150 percent of the poverty line.

Of particular importance to financial aid administration, the student loan oversight language in S. 1642 differs from the "Student Loan Sunshine Act" (H.R. 890), passed by the House May 9 [see Washington Highlights, May 11], as follows:

  • Allows financial aid administrators to participate on lender advisory boards with reimbursement for travel and related activities;

  • Exempts travel for training sessions sponsored by lenders from prohibited gifts;

  • Does not require lenders to notify institutions before issuing private educational loans.

S. 1642 would require the public disclosure of accrediting agencies' findings and official "comments of the affected institution." The bill also would require consideration of an institution's "mission" as part of the standards for accrediting agencies. In an April 12 letter, the AAMC stated its opposition to the inclusion of these provisions in HEA reauthorization.

Information:
Matthew Shick, Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 828-0525

Senate Finance Leaders, Member of Congress Express Concern with Inpatient Proposed Rule

Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Charles Grassley (R-Iowa) urged Centers for Medicare and Medicaid Services (CMS) Acting Administrator Leslie Norwalk in a June 19 letter to base any planned cuts to prospective Medicare hospital reimbursement rates on actual, not "speculative," changes in coding practices by hospitals. The potential cuts are included in the May 3 FY 2008 Medicare Inpatient Prospective Payment System (IPPS) proposed rule's new "Medicare Severity" diagnosis-related groups [see Washington Highlights, May 11].

The letter states, "These prospective payment reductions are based on speculative conclusions about how these changes will be implemented and they may have a negative financial impact, particularly on rural hospitals." The letter praises CMS for proposing to improve the current payment system's ability to recognize patient severity of illness, but suggest that the proposal be implemented before determining whether adjustments for inappropriate coding are necessary.

In a statement accompanying the release of the letter, Chairman Baucus said, "The financial stability of rural hospitals should not be gambled on guesses about how this new system will operate…. We can't get ahead of ourselves and put our hospitals-especially our vital rural hospitals-in jeopardy."

The letter follows a June 12 letter to Norwalk signed by 269 Representatives expressing opposition to a portion of the FY 2008 IPPS proposed rule that cuts $25 billion in hospital inpatient operating and capital payments. The letter was spearheaded by Reps. John Lewis (D-Ga.) and Jerry Weller (R-Ill.).

Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Office of Governmental Relations
ldavisboyle@aamc.org
(202) 828-0526

Grassley Urges CMS to Improve Uncompensated Care Data Collection

Senate Finance Committee Ranking Member Charles Grassley (R-Iowa) June 20 sent a letter urging Centers for Medicare and Medicaid Services (CMS) Acting Administrator Leslie Norwalk to expedite efforts to improve data collection methods related to uncompensated care provided by hospitals.

According to the letter, CMS is considering recommendations made by the Medicare Payment Advisory Commission (MedPAC) to improve worksheet S-10 on the hospital Medicare cost report. Hospitals use worksheet S-10 to report costs incurred for providing uncompensated care, as required under the Balanced Budget Refinement Act of 1999. The letter notes that the MedPAC recommendations included a revised worksheet with definitions and detailed guidance on what should and should not be included when reporting data on uncompensated care. Grassley asks CMS when the suggested changes will be implemented and when the data reported in the revised worksheet will be available.

According to his letter, Grassley intends to use the data "to guide important decisions in numerous policy areas." In a statement accompanying the letter, Grassley said, "Congress and CMS need accurate data to set Medicare policy. This information has implications on tax-exempt policy, too." Grassley also indicated that he intends to review how improvements to uncompensated care filings by Medicare-participating hospitals will complement a separate Internal Revenue Service effort to improve and standardize the reporting of community benefit by non-profit hospitals.

Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Office of Governmental Relations
ldavisboyle@aamc.org
(202) 828-0526

House Panel Approves Drug Safety Package

The House Committee on Energy and Commerce June 21 combined and approved nine draft bills seeking to renew Food and Drug Administration (FDA) user fees and to improve drug safety regulations. The Health Subcommittee approved the measures June 19.

Four of the bills reauthorize existing laws, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Modernization Act (MDUFMA), which authorize FDA to collect fees from drug companies and device manufacturers for product review, approval and subsequent safety monitoring. The measure extends FDA's authority to collect the fees through FY 2012, and includes an "appropriations trigger," which reduces drug company user fees by a corresponding increase in appropriations. The Committee also approved renewals of the Pediatric Research Equity Act (P.L. 108-155) and the Best Pharmaceuticals for Children Act (P.L. 107-109), which allow FDA to require pediatric testing of new drugs.

The remaining measures propose a series of initiatives addressing drug safety, including a contentious bill imposing penalties for noncompliance with Risk Evaluation and Mitigation Strategy (REMS) requirements, and a bill limiting financial conflicts of interest of FDA advisory panel members.

Also included in the package is a bill establishing a new drug and device clinical trials registry and a separate results database, to be publicly available online. The measure incorporates registry provisions from H.R. 1561, a drug safety bill introduced March 19 by Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.). The committee draft does not require a "non-promotional" summary of results, as mandated in H.R. 1561, and delays applicability of device trials until after FDA approval.

The Senate passed its own omnibus bill (S. 1082) on May 9 [see Washington Highlights, May 11].

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

Senators Urge Title VII Restoration

A total of 54 Senators signed a letter urging appropriators to restore funding for the Title VII health professions programs to the FY 2005 level of $300 million. The letter, sent June 18 to Labor, Health and Human Services, and Education Appropriations Subcommittee Chair Tom Harkin (D-Iowa) and Ranking Member Arlen Specter (R-Pa.), was originally submitted May 4 with 39 signatures [see Washington Highlights, May 11]. The leads on the letter, Senators Jack Reed (D-R.I.) and Pat Roberts (R-Kan.) reopened the letter May 15 to accommodate additional signatures. The final list included Majority Leader Harry Reid (D-Nev.), 10 members of the Appropriations Committee, and 13 Republicans.

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

Nussle Nominated to Head OMB

President Bush June 19 announced that he is nominating former Iowa Congressman and House Budget Committee Chair Jim Nussle to replace Rob Portman as director of the Office of Management and Budget (OMB). Nussle ran for governor of Iowa last year and was defeated.

In his announcement of the nomination, President Bush described Nussle as a "strong advocate for fiscal discipline." White House Chief of Staff Joshua B. Bolten, a former OMB director, said in a Washington Post interview that Nussle's appointment is a sign that the administration intends to "hew closely to the low-tax, low-spending routes that are part of Republican orthodoxy."