August 2008 Practice Update
FDA Orders Change in ESA Labeling
On July 30, 2008, the Food and Drug Administration (FDA) ordered changes in the label for erythropoiesis-stimulating agents (ESAs). These changes respond to recommendations made by the FDA's Oncologic Drugs Advisory Committee (ODAC) on March 13 of this year. The label updates to the three ESAs currently on the market, Aranesp, Procrit®, and Epogen, alter the previous labeling in two critical ways.
First, the FDA said the drugs should not be used with patients who are expected to be cured of cancer. Amgen, the principal manufacturer of these agents, had pressed for language that would allow for the use of ESAs in cancer patients who are expected to be cured but who cannot receive blood transfusions.
Second, the changes advise that ESA therapy should not begin when a patient's hemoglobin levels exceed or equal 10 g/dL. These restrictions were added due to concerns about possible shortened survival, increased disease progression, or thrombotic events in some patients.
The label changes are consistent with the Centers for Medicare and Medicaid Services' (CMS) national coverage decision (NCD) of July 30, 2007, which denies reimbursement for the use of ESAs at hemoglobin levels greater than 10 g/dL. The revised label does not address the use of ESAs in patients with myelodysplasia. For hematology, the changes will mostly affect the treatment for Hodgkin lymphoma, intermediate grade lymphoma, and mantel cell lymphoma where physicians have curative intent.
A copy of the "ASH-ASCO 2007 Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin" is available in ASH’s scientific journal, Blood. Visit Policy and Practice News for more information.
ASH Signs on to Letter re: ICD-10
ASH has signed on to a letter of concern regarding CMS’s plan to rapidly implement the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10). Among other concerns, the letter urges CMS to allow for appropriate pilot testing and sufficient time to implement these significant changes.
In addition, please note that CMS’s annual update of the ICD-9 is complete, and will take effect on October 1. These updates are available on the CMS Web site for review.
ASH Comments on Draft Coverage Policy Regarding Zevalin for Patients with Non-Hodgkins Lymphoma
ASH submitted comments to Wisconsin Physicians Services (WPS), the local fiscal intermediary for a large number of states, in response to the draft local coverage decisions (LCD): Monoclonal Antibody; Ibritumomab Tiuxetan Therapeutic Regimen (DL 12324). The Society is supportive of the WPS policy and believes it provides the appropriate criteria for Medicare coverage.
Ortho Biotech Announces Voluntary Recall of Procrit® Batch
Citing safety concerns, on August 6, Ortho Biotech announced a voluntary recall of one manufacturing lot (P114942A) of Procrit® (epoetin alpha). Slight cracks were detected in a small number of the vials manufactured in this lot. Please see Ortho Biotech’s press release and letter to health-care professionals for further details.
CMS Releases Potential National Coverage Decision Topics
On July 30, 2008, CMS released a number of potential topics for review prior to formally deciding whether or not to open a National Coverage Decision (NCD). ASH will monitor these topics and comment where appropriate, paying particularly close attention to the topics of thrombopoiesis stimulating agents and pharmacogenomic testing.
Centers for Medicare and Medicaid Services Updates
CMS has added a new Hemophilia and Clotting Factor and HCPCS Code. CMS has also expanded the population eligible for coverage of Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management.
CMS Provides Instructions for Accessing PQRI Feedback Reports
CMS has published two articles that give step-by-step instructions for professionals and organizations to access their 2007 PQRI Feedback Reports. The articles for individual professionals and for organizations are available on the CMS Web site.
CMS Releases Final CY 2009 Payment Regulations for Inpatient Hospitals and Initiates Quality Care Incentives
On July 31, 2008, CMS posted the final acute care inpatient prospective payment rule (IPPS). It will be published in the federal register on August 19, 2008. The final IPPS rule updates payment policies and rates for more than 3,500 hospitals that are paid under Medicare’s diagnosis related group (DRG) payment system. Overall, the final rule is estimated to increase Medicare payments to acute care hospitals by nearly $4.75 billion. With a few exceptions, the rule is effective on October 1, 2008.
Of particular interest to hematologists is the addition of "Deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures" to the Hospital Acquired Condition (HAC) initiative. Essentially, Medicare will not pay more for conditions that were acquired in the hospital if they were reasonably preventable through the application of evidence-based guidelines. The agency believes that selecting DVT/PE for these procedures will have the positive effect of encouraging attention to risk assessment prior to surgery.
For additional information on this provision as well as other details about the final rule, visit Policy and Practice News.
Joint Commission Identifies Potential Blood Management Measures
The Joint Commission’s Blood Management Performance Measures Technical Advisory Panel (TAP) has identified 19 Blood Management Candidate Measures addressing key aspects of Blood Management. At this time, The Joint Commission is requesting stakeholder review and public comment on these measures. ASH is preparing a response, and encourages members to comment individually as well. The Joint Commission response survey is available online. Responses must be received by Tuesday, August 19, 2008.
Additional Information about the Blood Management Performance Measures Project is available on the Joint Commission Web site.
ASH State-of-the-Art Symposium Advance Registration Closing Soon
Don’t miss your chance to register for the ASH State-of-the-Art Symposium at the discounted advance registration rate; August 29 is the last day to register and save. Join our expert speakers and your colleagues to discuss latest research and treatment options for hematologic malignancies, myelodysplasia, and myeloproliferative disease on September 12-13 in Chicago, IL.
Blood Moves to Weekly Publication Schedule
Blood, the journal of the American Society of Hematology (ASH), will change from a semimonthly to weekly schedule effective with the January 1, 2009, issue.
The move to a weekly schedule will get important clinical and research information to members and readers more quickly, as well as provide convenient portability of the print journal due to more convenient size, greater visibility for content features, and increase traffic to the journal’s Web site based on distribution of weekly e-Table of Contents.
The journal will increase the solicitation and publication of Review articles, Perspective, and "How I Treat" articles to ensure sufficient material of interest to the Blood readership. The number of primary research articles will remain stable. The entire Table of Contents will be reorganized effective with the January 1, 2009, issue to better reflect the balance of articles being published and to help readers find articles of interest more easily.
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