September 2007 Advocacy Update

Congress Passes Short-Term Funding for NIH and Federal Government
With the start of federal fiscal year (FY) 2008 set to begin on October 1 and no appropriations bills passed, this week Congress passed a continuing resolution (CR) to continue funding the National Institutes of Health (NIH) and other federal programs at current levels until November 16 or until Congress completes FY 2008 funding bills, whichever comes first.

The House of Representatives approved FY 2008 appropriations legislation for the NIH and other Department of Health and Human Services (HHS) in late July. The Senate has not yet considered its version of the bill and Senate Majority Leader Harry Reid (D-NV) has indicated it is unlikely to do so in the near future, raising the likelihood that the Labor-HHS funding bill will be combined with additional funding bills into an omnibus type of bill.

Though the proposed funding levels in both the House and Senate Labor-HHS funding bills fall far short of the 6.7 percent increase for NIH advocated by ASH and the biomedical research community, President Bush has already indicated his intention to veto the bill because of the increases that are provided in these bills for NIH (a 1.9 percent net increase in the House bill; a 2.8 percent net increase in the Senate) and other health and education. As a result, congressional leaders have raised the possibility of combining the Labor-HHS bill with the Defense funding bill or another similar bill that the President views as a priority in order to lessen the likelihood of a veto.

It is a very tight year for the entire federal budget and grassroots support for NIH funding remains critical. It is important for ASH members to continue to weigh in with Congress about the need for increased funding for NIH. Please visit the ASH Advocacy Center to send an e-mail to your Senators to strengthen support for NIH funding.

NIH Announces Plans to Implement Presidential Executive Order on Stem Cell Research; Congressional Efforts to Expand Research Continue
Earlier this summer, on the same day he vetoed the Stem Cell Research Enhancement Act (S. 5), President Bush issued Executive Order 13435 to explore methods to expand the number of approved stem cell lines "without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus. On September 18, the NIH announced plans to implement the policy set forth in that Executive Order.

Meanwhile congressional leaders are continuing their efforts to expand federally funded stem cell research. Senate Labor-HHS Appropriations Subcommittee Chairman Tom Harkin (D-IA) and Subcommittee Ranking Member Arlen Specter (R-PA) have included a provision in the Senate version of the FY 2008 Labor-HHS funding bill that would essentially overturn the President's veto of the S. 5 and make additional embryonic stem cell lines available for federal funding.

The language inserted by Senators Harkin and Specter, the chief Senate sponsors of the Stem Cell Research Enhancement Act, would allow federal research funding on stem cell lines derived before June 15, 2007; current Bush Administration policy allows for federal funds to only be used for research on embryonic stem cell lines derived prior to August 9, 2001. The language was not included in the House version of the FY 2008 Labor-HHS funding bill, however, and House Appropriations Committee Chairman David Obey (D-WI) has indicated a reluctance to include this language in a final bill because of the President's existing veto threat due to funding increases.

Senate leaders have also indicated plans to attempt to override the President's veto of S. 5 at some point during the 110th Congress; however, it remains unclear whether or not the bill has the two-thirds majority support necessary to override the veto.

Legislation Signed by President Renews Prescription Drug and Medical Device User Fees
On September 27, 2007, President Bush signed The Food and Drug Administration Amendments Act of 2007 (H.R. 3580), which was passed by wide margins in the House and Senate earlier in the week. The law reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act through 2012. Without passage of this legislation, these programs, which collect fees from drug and medical device manufacturers to help defray costs incurred by the agency while reviewing products that require its approval, were set to expire on September 30.

In addition to maintaining prescription drug and medical device user fees, the legislation also:

• Contains provisions that enhance FDA review and oversight of drugs already on the market by giving the agency the authority to mandate drug label changes, as well as conduct post-market studies;
  
  
• Creates clinical trial registry and results databases;
  
  
• Includes a number of prescription drug safety provisions;
  
  
• Enhances provisions for pediatric pharmaceutical research and approval by requiring drug manufacturers who submit an application to market a new active ingredient, indication, dosage form, dosing regimen, or route of administration to also submit a pediatric assessment; and
  
  
• Requires a 5 percent reduction in the amount of conflict-of-interest waivers granted by the agency to members of its advisory panels by 2012.

Physicians Facing Significant Payment Cuts Unless Congress Acts
Earlier this summer, CMS proposed reducing physician payments for Medicare patients by 9.9 percent in 2008.

ASH is very involved in working with Congress to avert these drastic cuts. For the past five years, estimated cuts to the Medicare physician payment rate have been temporarily avoided through legislation.

On August 1, the House passed legislation to reauthorize and expand the State Children's Health Insurance Program (SCHIP); the House bill also would have replaced scheduled Medicare physician payment cuts of 15 percent over the next two years with two years of positive updates of 0.5 percent and would have repealed the Physician Quality Reporting Initiative (PQRI) bonus program. However, because the House bill differed from the Senate SCHIP bill, which did not include these additional Medicare payment issues, these provisions were ultimately stripped from the final version of the bill currently being considered by Congress. Congressional leaders have indicated that they plan to take up legislation addressing the physician payment issue later this year, and the Senate Finance Committee has begun to draft legislation that would eliminate the scheduled cuts.

If Congress does not take action this year, Medicare will cut physician reimbursement by 9.9 percent in January 2008. Please visit the ASH Advocacy Center today to urge your Representative and Senators to prevent the scheduled Medicare payment cuts to physicians.

House Passes Resolution Recognizing Sickle Cell Disease Awareness Month
The House of Representatives has passed a non-binding resolution recognizing Sickle Cell Disease Awareness Month. The resolution (H.Con.Res. 210), introduced by Representative Danny Davis (D-IL), passed the House on September 25 by a unanimous vote of 415-0. A similar resolution (S.Con.Res. 46) has also been introduced in the Senate by Senator Barack Obama (D-IL) and may be considered in the near future.

NIH Loan Repayment Programs Available
NIH announced the availability of educational loan repayment under the NIH Extramural Loan Repayment Program for Clinical Researchers (LRP-CR). The agency plans to fund 930 loan repayment recipients in fiscal year 2008. Applications will be accepted until December 1, 2007, via the NIH Loan Repayment Web site.

ASH Urges Stafford Loan Limit Increase
A group of almost 60 health professions associations, including ASH, sent a September 4 letter to U.S. Secretary of Education Margaret Spellings urging her to increase the aggregate combined Stafford loan limit for health professions students from $189,125 to $223,793.

NIH News and Information
View the latest issues of the NIH Public Bulletin and NIH News in Health for information on the latest news, public events, and activities at the Institutes.

Practice Update
For the latest information concerning physician reimbursement issues and other issues of importance to practicing physicians, please see the latest ASH Practice Update.

ASH Advocacy Center
Join ASH's on-line advocacy campaigns concerning research and practice issues by visiting the ASH Advocacy Center.

If you have any questions or need additional information about any of the items in this Update, please contact the ASH Government Relations and Practice office at 202-776-0544 or via e-mail at grassroots@hematology.org.