May 2007 Advocacy Update (part one)

FY 2008 NIH Funding Update; Continued Grassroots Efforts Needed
Congress is continuing the process of drafting the bills that will fund federal departments, agencies, and programs for fiscal year (FY) 2008. Both the House and Senate Labor-HHS Appropriations Subcommittees have held hearings examining funding for the National Institutes of Health (NIH) during which the directors of the various Institutes at NIH have had the opportunity to testify about the ongoing activities and needs at their institute.

House Appropriations Committee Chairman David Obey (D-WI), who is also Chair of the Labor-HHS Appropriations Subcommittee, has indicated that the Subcommittee could begin consideration of the FY 2008 Labor-HHS bill as early as next week. Congressional leaders in the House remain hopeful that the House will be able to consider all 12 of the annual spending bills by the end of June, while the Senate hopes to complete action on its versions of the bill prior to the month-long August congressional recess.

ASH, along with the biomedical research community, continues to advocate for an increase of 6.7 percent for FY 2008 over the final FY 2007 levels, despite a proposed budget from the White House for FY 2008 that includes proposed cuts totaling $310 million for NIH. A letter to the House Labor-HHS Appropriations Subcommittee in support of this 6.7 percent increase for NIH was cosigned by 182 members of the House. An identical letter to the Senate Appropriations Committee has thus far gained the support of 21 senators.

Despite this strong show of support for NIH, grassroots advocacy by researchers around the country is necessary to ensure hematologic research is adequately funded at NIH. For more information about FY 2008 NIH funding and to participate in ASH's most recent online advocacy campaign, please visit the ASH Advocacy Center.

House Overwhelmingly Passes GINA
The House of Representatives approved H.R. 493, the Genetic Information Nondiscrimination Act (GINA), on April 25 by a vote of 420 to 3. The final bill is a compromise of versions approved by three different committees. ASH supported passage of the bill as it would prohibit employers or insurers from collecting or using genetic information when making decisions related to hiring, firing, health coverage or insurance premiums. The Society thanks all of its members who participated in ASH advocacy efforts concerning this legislation.

The Senate Health, Education, Labor, and Pensions (HELP) Committee approved its version (S. 358) of the bill on January 31, but Senator Tom Coburn (R-OK) has placed a hold on the bill. It is expected his concerns will be addressed, and the bill will be passed by the Senate. President Bush has indicated his support for legislation to protect genetic information privacy and has stated he will sign the bill.

Senate Begins Consideration of PDUFA Reauthorization
Earlier this week, the Senate began consideration of legislation that would, among its many provisions, reauthorize the Prescription Drug User Fee Act (PDUFA).

S. 1082, the Food and Drug Administration Revitalization Act, includes a five-year reauthorization for PDUFA, which is currently set to expire on September 30, 2007. Originally enacted in 1992 to provide resources for the Food and Drug Administration (FDA) to improve drug review and supplement FDA funding, in order to speed new treatments to patients through sound medical, scientific, and regulatory decisions, PDUFA user fees to finance much of the work of FDA. The bill also contains measures to increase post-approval drug safety efforts at the FDA and reauthorizations of incentives and requirements for pediatric research, as well as a reauthorization of the medical device user fee program.

Though many members of the Senate have expressed concern with some of the drug safety provisions contained within the bill, two other issues – prescription drug reimportation and generic biologics – have drawn deeper criticism and concerns from a number of senators and the Bush Administration.

An amendment offered to the bill on Wednesday would allow for the reimportation of prescription drugs from outside the U.S. – an issue which President Bush has repeatedly threatened to veto. Additionally, although Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Edward Kennedy (D-MA) had indicated that language allowing for an approval path for generic (or follow-on biologics) would be included in S. 1082, that now appears less likely. Supporters of legislation providing for an approval process for generic biologics are working with Senate leaders to negotiate an agreement to have generic biologic legislation considered by the Senate later this summer.

Though the House has begun holding committee hearings on the issues of PDUFA reauthorization, drug safety, and approval of generic biologics, no timetable has been set for consideration of legislation similar to S. 1082 by the full House.

Medicare Proposes Revised Clinical Trial Policy
The Centers for Medicare and Medicaid Services (CMS) has proposed new rules to govern Medicare coverage of services provided to beneficiaries enrolled in clinical research studies. Under the Clinical Trial Policy, first developed in September 2000, Medicare pays for certain items and services for Medicare beneficiaries involved in clinical trials. The proposal includes new eligibility standards that all trials must meet to qualify for coverage. These include:

1. "[Specify and fulfill the] method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or [the] study is terminated early."

2. "[Contain] a discussion of the results will generalize to the Medicare population to infer whether Medicare patients may benefit from the intervention. In particular, the protocol describes the potential impact of age-specific and other factors on outcomes and whether the research study is powered sufficiently to draw conclusions with respect to the Medicare population."

ASH is concerned that these new requirements might deter some investigators or institutions from pursuing Medicare reimbursement for clinical services provided to patients enrolled in clinical trials and patients from participating. ASH welcomes comments on the proposal as the Society prepares its response to CMS. If you have any particular concerns or comments, please contact ASH Director of Government Relations and Practice, Mila Becker, at mbecker@hematology.org by Monday, May 7.

ASH Weighs in on Review of Medicare Coverage Policy for Erythropoietin-Stimulating Agents (ESAs)
ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) and local carriers concerning the development of a Medicare coverage policy for darbepoetin alfa and epoetin alfa after recent studies linked the treatments with increased risk for serious side effects. Of particular concern to ASH are potential restrictions in the use of ESAs for treatment of anemia in patients with hematologic malignancies not on chemotherapy. ASH's comments indicate that there is data to support the use of ESAs in patients with anemia associated with low-risk myelodysplasia. ASH also recommended that the use of ESAs to treat anemic patients with hematologic malignancies requires further studies, and in the meantime, coverage of these patients should be on a case by case basis. ASH also will be presenting comments to the FDA's Oncologic Drugs Advisory Committee (ODAC) on May 10, 2007. In addition to meeting with CMS officials and monitoring the development of this regulatory policy, ASH is also closely monitoring this issue legislatively and members of the ASH Committee on Practice will be meeting with congressional offices in May.

Updated Federal Grants Information on ASH Web Site
Be sure to visit the Federal Research Grant Opportunities page on the ASH Web site for a frequently-updated list of the latest hematology-related funding opportunities available through the National Institutes of Health and other federal agencies and departments. ASH has recently made this page easily accessible through the Education and Careers section of the Web site. We encourage members to visit this listing regularly to view the latest available grants.