November 2007 Practice Update

FDA Announces Changes to ESA Labeling
On November 8, 2007, the FDA approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs). Additional details are available on the ASH Web site. The expert panel that developed the ASH-ASCO 2007 Clinical Practice Guideline Update on the use of EPO and Darbo is currently considering the label changes to assess their relevance to the 2007 recommendations. The FDA’s new label information can be found here.

ASH Continues to Track Local Carrier Policies on ESA Coverage for MDS
Visit the ASH Web site to learn about local Medicare carrier draft policies concerning ESA coverage for MDS patients and to view ASH’s "model policy." ASH continues to monitor the development of local carrier policies concerning ESA coverage. Please contact Government Relations and Practice Specialist Stephanie Kart (skart@hematology.org or 202-776-0544) for additional assistance and insight on the ESA coverage policy for your state.

Medicare Releases 2008 Physician Fee Schedule; Legislation Under Consideration to Repeal Physician Payment Cuts
ASH’s summary and analysis of the 2008 Physician Fee Schedule Rule and its impact on hematology is available on the ASH Web site. ASH will be developing comments to submit to Medicare during the comment period in December. Meanwhile, the Senate Finance Committee continues to consider legislation that would reverse the physician payment cuts for one or possibly two years, but t he details of the proposal remain undetermined.

Take Action: It is critical that all physicians contact their Members of Congress to urge passage of legislation to prevent the scheduled cuts before the end of this year. To join ASH’s advocacy efforts, please visit the ASH Advocacy Center to send an e-mail to Congress.

Medicare Releases 2008 Final Hospital Outpatient Prospective Payment System (HOPPS) Rule: Payment for Radioimmunotherapy Agents (RIT) Dramatically Reduced
ASH’s summary and analysis of the HOPPS rule’s impact on hematology is available on the ASH Web site. The rule can be found at the HHS Web site. The rule contains several issues of specific interest to ASH, including payment for the BEXXAR therapeutic regimen used in the treatment of non-Hodgkin’s lymphoma. ASH had requested that CMS pay separately for the supply of Tositumomab including for the dosimetric dose of I-131 Tositumomab. However, CMS is considering only the therapeutic dose of Tositumomab a separately payable service. CMS states that unlabeled Tositumomab is not approved as either a drug or a radiopharmaceutical and therefore is considered to be a supply which is not separately paid under HOPPS, but rather is packaged into the payment for administration (G3001). In addition, the dosimetric dose is considered to be a diagnostic radiopharmaceutical and as such is now considered a packaged service. The result is that the total payment for BEXXAR will cover less than half of the hospital’s cost of the drug regimen. Although this is now a final rule, the manufacturer is hoping to have the rate corrected before it goes into effect.

Practice-Related Events at the ASH Annual Meeting
Visit the ASH Web site for information about special sessions of particular interest to the practice community during the 49th Annual ASH Meeting December 8-11 in Atlanta, GA.

Mark Your Calendar for Highlights of ASH
In partnership with the Washington State Medical Society and the Texas Oncology Society, ASH will host Highlights of ASH February 1-2 in Seattle, WA and February 8-9 in Austin, TX. The only official Highlights of ASH is occurring this year on two dates, in two locations, but with one great program. Mark your calendar for Seattle, WA, on February 1-2, or Austin, TX, on February 8-9. Attend the ONLY official Highlights of ASH to interact with experts in the field, discover top scientific research presented at the 2007 ASH Annual Meeting, and network with colleagues. Registration is now open and discounted early-bird registration rates are available until December 31. Attendance is limited; reserve your spot today.