August 2007 Advocacy Update

ASH Submits Comments to Medicare on Second Round of Proposed Revisions to Clinical Trial Policy
On July 19, the Centers for Medicare and Medicaid Services (CMS) announced a reconsideration of proposed revisions to the Medicare National Clinical Trial Policy, to be renamed the "Clinical Research Policy" (CRP). For more information, please see ASH's summary of the major issues contained in the current proposal.

ASH's comments on the most recent proposed revisions focused on concerns about proposed new requirements for public release of research study information and self-certification requirements.

Update on ESA Final National Coverage Decision: ASH Requests Reconsideration
CMS posted a national coverage determination (NCD) for coverage of erythropoiesis-stimulating agents (ESAs) for non-renal uses on July 30.

The new policy does not include myelodysplasia (MDS), which means that ESA treatment for Medicare beneficiaries with MDS is covered – as ASH had advocated – without any conditions or limitations. However, the NCD includes several limitations for patients undergoing ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy. ASH is particularly concerned about the restriction of coverage when a patient's hemoglobin rises above 10g/dL after the first four weeks of therapy and has recommended that this be an area in which CMS should reconsider its policy.

During the ASH annual meeting in December, the Practice Forum will address this issue. The Practice Forum, "Evidence, Safety, and Clinical Decision Making: The Case of ESAs" is scheduled for Saturday, December 8 at 6:00 p.m.

Congress Recesses for Month of August; Leaves NIH Funding Bill Unfinished
The House and Senate have adjourned for the remainder of the month of August without completing action on fiscal year (FY) 2008 funding for the National Institutes of Health (NIH).

Though the House approved FY 2008 appropriations legislation for the NIH and the Department of Health and Human Services (HHS) in late July, the Senate has not yet considered its version of the bill and is unlikely to do so before the end of the current FY on September 30, raising the likelihood that the Labor-HHS funding bill will be combined with additional funding bills into an "omnibus" type of bill.

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 visit the ASH Advocacy Center and send an e-mail to their Senators to strengthen support for NIH funding.

Senate Close to Consideration of Genetic Nondiscrimination Legislation
Just prior to recessing for the month of August, the Senate was close to consideration of its version of the Genetic Information Nondiscrimination Act (GINA) (S. 358). The House passed its version of the bill (H.R. 493) by a vote of 420-3 on April 25.

This legislation prohibits health insurers from using individuals' genetic information to deny coverage or determine rates or premiums. In addition, the bill would bar employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions.

Similar legislation has easily passed the Senate in the last several Congresses, but has stalled in the House. With the House having already passed its version of GINA this year and President Bush's indication of support for legislation to protect genetic information privacy, there is still a real opportunity this year to enact legislation.

Please join ASH's advocacy efforts on this issue by visiting the ASH Advocacy Center and contacting your Senators in support of GINA.

NIH Seeks Input from Researchers on Peer Review Process
NIH recently released a Request for Information seeking comments regarding NIH's support of biomedical research, including peer review, with "the goal of examining the current system to optimize its efficiency and effectiveness." This request is related to the recently-announced formation of the Peer Review Working Group of the Advisory Committee to the NIH Director, which has been asked "to gather information from the external community and explore possible enhancements to all aspects of the system used by NIH to support biomedical and behavioral science, including the two-tiered review process."

ASH will be submitting comments in response to NIH's Request for Information. If you have any particular concerns or comments on this issue, please contact ASH Research Advocacy Manager Tracy Becker at tbecker@hematology.org.

NCRR to Update Strategic Plan
In July, the National Center for Research Resources (NCRR) issued a notice indicating that it was seeking to update its Strategic Plan and was seeking input from the biomedical research community during this process. Rather than seeking to change the current focus of the Center or what its mission is, NCRR has indicated that its goal in revising the Strategic Plan is to ensure that NCRR remains responsive to the emerging needs of biomedical researchers and provides them with the infrastructure, tools, and training they need to understand, detect, treat, and prevent a wide range of diseases.

ASH will also be sharing the ASH Research Agenda with NCRR to ensure that the Strategic Plan incorporates hematology and the needs of hematology researchers.

If you have any concerns or comments to be incorporated into the ASH response, please contact ASH Research Advocacy Manager Tracy Becker at tbecker@hematology.org.

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.

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.