2010-06-24

SGR Fix Caught in Stalemate Between House and Senate
House Democratic leaders have stated that they will not take up a Senate-passed six-month patch to Medicare provider payments unless the Senate acts to pass certain jobs measures. House Speaker Nancy Pelosi released a statement calling the current Senate bill an insufficient temporary fix. The face-off between the two chambers may further delay any action to stop the 21 percent cut in payment rates that doctors began experiencing June 18 when the Centers for Medicare and Medicaid Services (CMS) began processing payments dating back to June 1, the date the cut was slated to go into effect. Read more.

ASH Urges CMS to Reconsider the Elimination of Consult Codes
ASH is urging CMS to reconsider the elimination of consult codes in the 2011 Medicare Physician Fee Schedule Rule. ASH has suggested that CMS revise its guidelines regarding prolonged visits and new patients and/or create a mechanism for reimbursing physicians for a comprehensive report back to a referring physician. Read more.

FDA Grants Accelerated Approval to Nilotinib for the Treatment of Adult Ph+ CML Patients
The U. S. Food and Drug Administration (FDA) granted accelerated approval to nilotinib (Tasigna^® Capsules, Novartis Pharmaceuticals Corporation), an orally administered kinase inhibitor, for the treatment of adult patients with newly diagnosed Philadelphia-chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Read more.

FDA Announcement of Pfizer Voluntary Withdrawal of Cancer Treatment Mylotarg From U.S. Market
Pfizer, Inc., announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML). The company took the action at the request of the FDA after results from a recent clinical trial raised new concerns about the product's safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials. Read more.

ASH Responds to NIH-FDA Joint Leadership Council With Translational and Clinical Research Priorities and Recommendations for Increased Efficiency
ASH submitted a response to the National Institutes of Health (NIH) and FDA Joint Leadership Council's request for comments on how the agencies can collaborate more effectively to advance the translation of biomedical research discoveries into approved diagnostics and therapies. ASH provided comments on specific areas in which the NIH and FDA can further coordinate and target efforts to develop and promote promising new therapies using the latest basic research discoveries and technological advances. The Society's comments focused on the following three priorities:

• Harmonization of existing policies and regulations on clinical trial operations
• Facilitation of research translation and product development for regenerative medicine
• Support for specific preclinical research and product development of potential therapies for rare or neglected disorders

ASH Recommends Hematologic Conditions Be Included in HHS Initiative on Multiple Chronic Conditions
ASH recommended to the Department of Health & Human Services (HHS) that four hematologic conditions should be included in a HHS initiative concerning patients who experience multiple chronic conditions. The conditions include disorders of hemoglobin, hereditary hemochromatosis, myeloproliferative diseases, and hemophilia. This HHS initiative focuses on patients with a minimum of two chronic conditions and provides a framework to improve the health of these individuals by strengthening coordination of HHS agencies and collaboration with external stakeholders.

Medicare Releases Updates of the Quarterly Average Sales Price (ASP)
CMS has posted the July 2010 ASP and Not Otherwise Classified (NOC) pricing files and crosswalks and revisions to previous Quarterly Pricing Files.

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