April 2012 Practice Update (part two)

2012-04-26

Updates on Hematologic Drug Shortages and News from the FDA

ASH Advocacy to Combat Drug Shortages Influences Legislation in the U.S. Senate
ASH advocacy on drug shortages is making a difference as the Senate considers drug shortage legislation as part of their review of a larger bill known as the Prescription Drug User Fee Act (PDUFA). On April 25, the Senate Committee on Health, Education, Labor, and Pensions (HELP) marked-up and approved its version of the PDUFA legislation, which includes prescription drug shortages provisions. The drug shortage portion of the legislation would create a mandatory "early warning system" that requires manufacturers to provide early notification to Food and Drug Administration (FDA) of a discontinuance or "meaningful disruption" of drugs which are life-supporting, life-sustaining or used in the prevention of a debilitating disease or condition. Additionally, the legislation would establish a federal taskforce to mitigate and prevent drug shortages; develop record-keeping criteria to study the impact of drug shortages and related trends; provide the FDA with greater authority to expedite reviews of drugs and inspections of facilities; and direct the HHS Secretary and a working group to perform a study on drug shortages to review stockpiling, price gouging and gray market activities. Read more.

New Senate Drug Shortage Bill Focuses on Economic Incentives
Senator Orrin Hatch (R-UT), Ranking Member of the Senate Committee on Finance, released draft drug shortage legislation, ThePatient Access to Drugs in Shortage Act intended to provide economic incentives for drugs defined within the critical drug shortage parameters. Senator Hatch's proposal is in addition to legislation the Senate Health, Education, Labor & Pensions Committee has been developing. To provide market stability and more incentives to manufacturer to produce low-cost drugs, Senator Hatch proposes to exclude some medications from the 340B drug discount and Medicaid rebate programs and base reimbursement for these drugs on Wholesale Acquisition Cost instead of Average Sales Price. Read more.

FDA Workshop Discusses Minimal Residual Disease as a Biomarker for Evaluating Leukemia Drugs
On April 18, the Food and Drug Administration (FDA) hosted a public workshop to discuss the use of minimal residual disease (MRD) as a biomarker for evaluating new drugs for the treatment of Acute Lymphoblastic Leukemia (ALL). ASH participated in the planning of the meeting along with the FDA and several other cancer-related organizations. The meeting was the first in a series of workshops intended to bring together scientific and advocacy communities and the pharmaceutical and in vitro diagnostic device industries to help develop processes and procedures to qualify MRD as a biomarker of efficacy and/or response to treatment in a group of hematological malignancies. The presentations from the workshop and the briefing document can be found on the FDA's website. 

News from CMS

How to Avoid Medicare Electronic Prescribing Penalties: CMS Offers Information
Hematologists can take steps now to avoid the 2013 Medicare electronic prescribing penalties by determining if they meet the program's exclusion criteria or fall under one or more significant hardship exemption categories. Eligible professionals and CMS-selected group practices participating in the Electronic Prescribing (eRx) Incentive Program GPRO, who were unsuccessful electronic prescribers in 2011, can avoid the 2013 eRx payment adjustment by meeting the specified reporting requirements between January 1 and June 30, 2012. Read more. 

News from ASH

Register for ASH's April Webinar on Oral Anticoagulants: The Old and the New
Registration is open for the ASH Webinar on Oral Anticoagulants: The Old and the New, scheduled for May 31 at 8:00 p.m., ET. Aimed at practicing hematologists, oncologists, hospitalists, general practitioners and other clinicians who manage venous thrombosis, the objective of this webinar is to provide clinicians with the information needed to discuss the virtues and drawbacks of the various available oral anticoagulants with their patients, to optimize use of these agents in the treatment of VTE, and to manage anticoagulant-related bleeding. For more information about this and other ASH webinars, visit www.hematology.org/webinars.

ASH Launches Blood Journal App
ASH has released the Blood journal app for iPhone and iPad. This free application allows users to access First Edition articles, conduct full-text searches, and view listings of articles by author and date with the in-app browser. The app also allows users to share articles via email and Twitter and download multiple issues on their devices and access them regardless of Internet connectivity, a feature not readily available on many other journal apps. Read more.

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 "The Characteristics and Outcomes of Parainfluenza Virus Infections in 200 Patients with Leukemia or Recipients of Hematopoietic Stem Cell Transplantation." 

Take Advantage of ASH's Consult a Colleague Service
Consult a Colleague is a service for ASH members that helps facilitate the exchange of information between hematologists and their peers. The full list of available categories is below:

  • Anemias
  • Hematopoietic Cell Transplantation
  • 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 two business days either by email or phone.

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