2011-10-14

News from Washington

MedPAC Recommends Plan to Overhaul Physician Payment; Overlooks Concerns About Offsets
Despite overwhelming provider opposition, the Medicare Payment Advisory Commission (MedPAC), an advisory committee to Congress, approved a proposal to repeal the physician payment formula. ASH has long advocated to eradicate the flawed formula, however, has joined with other physician groups in opposing MedPAC's proposed fix because it would pay for the cost of the repeal through significant cuts and long-term freezes to physicians. Read more.

ASH Updates on Drug Shortages and News from the U.S. Food & Drug Administration

ASH Calls for Increased FDA Authority and Resources to Address Drug Shortages
Calling the increase in national drug shortages "a tsunami of medical risk," ASH Committee on Practice Chair Lawrence A. Solberg Jr., MD, PhD, offered several recommendations on strategies to combat drug shortages during a special September meeting of the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research. ASH also submitted comments to a House of Representatives September 23rd hearing, "Examining the Increase in Drug Shortages." ASH was the first organization to ask Congress to hold hearings on the problem of drug shortages. Read more about ASH's advocacy efforts related to drug shortages, the latest information on hematologic drug shortages, and resources for physicians. ASH's recommendations to the FDA and Congress are also available online.

Important Information Regarding ATRA (Trentinoin)
ASH has heard from a number of concerned members who have experienced difficulty in obtaining ATRA (Trentinoin) for their Acute Promyelocytic Leukemia (APL) patients.  ASH alerted the U.S. Food & Drug Administration (FDA) about our concerns and contacted Teva Pharmaceuticals (the manufacturer of ATRA) about the shortage.  The manufacturer reports that it is now shipping limited supplies of the product. For continued updates on this shortage and other hematologic drug shortages, please visit ASH's drug shortage page on the ASH Website.  If you have any questions and/or are experiencing any issues accessing ATRA, please contact ASH Government Relations Manager Stephanie Kaplan at skaplan@hematology.org or 202-776-0544.

Congressman Cummings Investigates Marked-Up Prices of Drugs in Short Supply
Representative Elijah Cummings (D-MD-7th), a ranking member of the U.S. House of Representatives' Oversight and Government Reform Committee, launched an investigation into the prescription drug "gray market" — where companies sell critical medications that are in short supply at exorbitantly marked-up prices — part of a recent congressional focus on drug shortages. Representative Cummings requested information from five companies that sell drugs but do not manufacture them or treat patients. He said a preliminary investigation found that some companies charge drug prices dozens of times higher than the typical price negotiated with manufacturers and distributors. Read more.

FDA Drug Safety Announcement: Sprycel (Dasatinib) and Risk of Pulmonary Arterial Hypertension
The FDA is warning the public that the leukemia drug Sprycel (Dasatinib) may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label. Read more.

Takeda Pulls FDA Application for Expanded Use of Cancer Drug Velcade
Millennium: The Takeda Oncology Company has decided to withdraw its supplemental new drug application (sNDA) for Velcade in combination with rituximab for the treatment of relapsed follicular lymphoma, citing "business reasons." The decision was made after further evaluation based on discussions with external advisors and FDA. In the U.S. Velcade is approved for use in patients with multiple myeloma and those with mantle cell lymphoma who have received at least one prior therapy. In follicular lymphoma, Millennium says that it will continue to support evaluation of the drug in various patient subgroups including diffuse large B-cell lymphoma. The compound is also being tested in clinical trials of previously untreated mantle cell lymphoma. Read more.

FDA Approves Soliris for Rare Pediatric Blood Disorder
The FDA approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke. Atypical HUS accounts for 5 to 10 percent of all cases of hemolytic uremic syndrome. Soliris is a targeted therapy that works by inhibiting proteins that play a role in aHUS. Read more.

News from Medicare

Register for the November 17-18 CMS Accountable Care Organization Learning Session
The third and final Accountable Care Organization (ACO) Accelerated Development Learning Session (ADLS) will be held on November 17-18 at the Centers for Medicare & Medicaid Services (CMS) in Baltimore, MD. The ACO Accelerated Development Learning Session is designed to teach providers interested in becoming ACOs what steps they can take to improve care delivery and how to develop an action plan for moving toward providing better coordinated care. Registration is free and open for teams of between two and four senior leaders from health-care delivery organizations interested in forming an ACO or from an existing ACO. More information including registration is available on the CMS Accelerated Development Learning Website.

2010 Physician Quality Reporting Initiative Feedback Reports Now Available
CMS has announced that the 2010 Physician Quality Reporting Initiative (PQRI) feedback reports are available for download on the Physician and Other Health Care Professionals Quality Reporting Portal.

National Provider Call on PQRS & eRx Incentive Program
CMS will host a national provider call on the Physician Quality Reporting System & Electronic Prescribing (eRx) Incentive Program on Tuesday, October 18, from 1:30 – 3:00 pm ET. The call will include program announcements and an overview of the eRx Incentive Program feedback reports. A question and answer session will follow the presentation. Registration is required for this call.

October 2011 Average Sales Price (ASP) Files Now Available
CMS has posted the October 2011 ASP and NOC pricing files and crosswalks. The ASP pricing files and crosswalks for July 2011, April 2011, January 2011, and October 2010 have also been updated. All are available for download on the CMS website.

News & Information from ASH

ASH Announces First Consultative Hematology Course; Register Today
ASH is pleased to announce the Society's first Consultative Hematology Course. This special session, developed for community based hematologist-oncologists, will be offered during the 2011 ASH Annual Meeting in San Diego, on Monday, December 12, from 7:30 – 11:30 a.m. Utilizing an interactive, case-based format, the course is designed to provide updates in non-malignant hematology to community practitioners who were trained as hematologist-oncologists, but who now see patients with non-malignant hematologic disorders on a less frequent basis. Expert faculty will provide participants with updates in six different areas and opportunities for Q&A. For more information or to register, visit the ASH website.

Register for ASH's October Webinar on Stroke, Renal Disease, and Treatment with Hydroxyurea in Adults with Sickle Cell Disease and ASH's November Webinar on Pain in Sickle Cell Disease
Registration is open for ASH's October Webinar on Stroke, Renal Disease, and Treatment with Hydroxyurea in Adults with Sickle Cell Disease. This complimentary webinar, scheduled for Wednesday, October 26 at 8:00 p.m. EST, will feature presentations by Ken Ataga, MD, Sophie Lanzkron, MD, MHS, and John J. Strouse, MD, PhD, regarding to management of renal disease and stroke and the use of hydroxyurea in adults with sickle cell disease. Registration is also available for the ASH Webinar on Pain in Sickle Cell Disease, scheduled for November 14 at 8:00 p.m. EST. This webinar will focus on the biology and pathophysiology of pain in sickle cell disease, the management of acute painful crises including new approaches to pain crisis treatment, and the patient experience of pain. Speakers include Jennifer Haythornthwaite, PhD, Wally Smith, MD and Carlton Haywood, PhD, and Tim McCavit, MD. For more information or to register, visit the ASH website. 

New Category Added to Consult a Colleague: Anemias
Consult a Colleague is a service for ASH members that helps facilitate the exchange of information between hematologists and their peers. ASH has just added a new category for consults covering the broad range of anemias. The full list of available categories is below:

• Anemias
• Hemostasis/Thrombosis
• Leukemias
• Lymphomas
• Lymphoproliferative Disorders
• Multiple Myeloma & Waldenström’s Macroglobulinemia
• Myeloproliferative Disorders
• Myelodysplastic Syndromes

To learn more or to submit a request, visit www.hematology.org/consult. Assigned Colleagues will respond to inquiries within one to two business days either by email or phone.

Earn CME Credits from Blood
ASH, in partnership with Medscape, provides monthly opportunities to earn Continuing Medical Education (CME) credits by completing an Accreditation Council for Continuing Medical Education (ACCME) accredited activity in Blood. This month's activity is titled "Intravenous iron for the treatment of fatigue in nonanemic, premenopausal women with low serum ferritin concentration." 

Advance Registration Open for 2011 Annual Meeting in San Diego
Advance registration and housing for the 53nd ASH Annual Meeting, in San Diego on December 10-13, 2011, is now open. Register online today. If you have questions, contact the ASH Meetings Department at meetings@hematology.org or 202-776-0544.

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