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Medicare & Medicaid Ruling Poses Significant Threat to Radioimmunotherapy (RIT) Treatment

November 26, 2007
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Copyright:PR Newswire
Source:PR Newswire
Wordcount:555

NEW YORK, Nov. 26 /PRNewswire-USNewswire/ -- The Lymphoma Research Foundation (LRF) wrote to Michael Leavitt, Secretary of the U.S. Department of Health & Human Services (HHS), requesting him to immediately review the 2008 hospital outpatient prospective payment system (HOPPS) for radioimmunotherapies (RIT) issued by the Centers for Medicare & Medicaid Services (CMS).

RIT is a cancer therapy that delivers radioactive molecules directly to specific lymphoma cells to kill them. Bexxar (tositumomab) and Zevalin (ibritumomab tiuxetan), the two approved RIT drugs, represent important treatment options for individuals with non-Hodgkin lymphoma, including patients who have undergone other treatments that are no longer providing therapeutic benefit. For some of these patients, radioimmunotherapy may be the only effective option available. LRF and other members of the cancer advocacy community are very concerned that the 2008 reimbursement levels will deny patients' access to this very important treatment option.

As Leonard Rosen, Chair of LRF's Public Advocacy Committee stated in the letter to Secretary Leavitt, "It is our understanding that the 2008 payment rates will be significantly less than the cost of acquisition, preparation, and handling of radioimmunotherapies. If this payment situation is not resolved, hospital outpatient departments will be unable to stock these therapies, and this treatment option will be effectively eliminated for non- Hodgkin lymphoma patients."

To rectify this situation, LRF offered Secretary Leavitt the following recommendations:

    -- The Centers for Medicare & Medicaid Services (CMS) should consider the
       radioimmunotherapy regimen a specified covered outpatient drug, or
       SCOD.  In the Calendar Year 2008 rule, the agency improperly splits the
       radioimmunotherapy regimen into separate elements and considers the
       initial doses to be diagnostic rather than therapeutic doses.  This is
       at odds with the Food and Drug Administration labeling of the products
       and with current practice.
    -- CMS should cover the cost of compounding radioimmunotherapies.
       Elimination of the compounding fee creates another obstacle to the
       willingness of institutions to make this therapy available to their
       patients, because these institutions find the payment inadequate to
       meet their costs.
    -- The agency should consider setting payment for radioimmunotherapies on
       the basis of 106 percent of average sales price (ASP) or a composite
       ambulatory payment classification (APC) that would reflect the entire
       cost of the radioimmunotherapy regimen.

The letter closed with the following message, "Mr. Secretary, this is a matter of public health that demands your personal intervention. We fear that these radioimmunotherapies will simply not be available for treatment of non- Hodgkin lymphoma patients after the new year if the payment rates for these products are not adjusted."

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About the Lymphoma Research Foundation

The Lymphoma Research Foundation (LRF) is the nation's largest voluntary health organization devoted exclusively to funding lymphoma research and providing patients and health care professionals with critical information on the disease. LRF's mission is to eradicate lymphoma and serve those touched by this disease.

More than 85 cents of every dollar spent goes to research and programming. As of the close of FY 2006, LRF has funded $34.7 million in lymphoma-specific research. LRF also provides a comprehensive series of programs and services for patients, survivors and loved ones affected by lymphoma, including our toll-free Lymphoma Helpline and Clinical Trials Information Service, in-person patient education programs, webcasts/teleconferences and support services.

For more information, visit www.lymphoma.org

SOURCE Lymphoma Research Foundation

CONTACT: Marion F. Swan, Lymphoma Research Foundation (LRF), +1-646-465-9126, or +1-347-920-6680, mswan@lymphoma.org


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