CMS Revises Proposed Restrictions On Anemia Medicare Coverage

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Medicare Coverage

CMS on Mondayannounced a final decision that will limit Medicare coverage for use ofanemia medications -- Aranesp, manufactured by Amgen, and Procrit, manufactured by Johnson & Johnson -- in cancer patients, but the decision is less restrictive than a proposal announced in May, the New York Times reports.

Accordingto the 61-page "national coverage determination," Medicare will coverthe medications, synthetic forms of the protein erythropoietin, totreat anemia caused by chemotherapy but not anemia caused by cancer.The decision eliminated provisions in the previous proposal under whichMedicare would not have covered use of the anemia medications duringchemotherapy for certain forms of cancer or in combination with thecancer treatments Avastin, manufactured by Genentech, or Erbitux, manufactured by ImClone Systems.

Inaddition, under the decision, Medicare will cover the anemiamedications in cancer patients whose hemoglobin levels decrease to lessthan 10 grams per deciliter, compared with nine grams per deciliterunder the previous proposal (Pollack, New York Times,7/31). The decision will allow local Medicare contractors to determinewhether to cover the anemia medications for use in patients withmyelodysplastic syndrome, a condition that can lead to leukemia (CQ HealthBeat,7/30). CMS officials decided to revise the previous proposal after theagency received more than 2,600 comments from physicians, patientgroups and medical societies "who said the proposed restrictions wenttoo far, were not based on scientific evidence and would possibly harmpatients," according to the Times (New York Times, 7/31).

ActingCMS Administrator Herb Kuhn in a statement said, "Our goal was tomaintain physician autonomy while ensuring the safety of our Medicarebeneficiaries" (Chase, Wall Street Journal, 7/31).Sanford C. Bernstein analyst Geoffrey Porges said that CMS decided torevise the previous proposal in the "face of massive outcry frompatients, cancer physicians and others in the cancer community" (Bloomberg/Los Angeles Times, 7/31).

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Effect on Companies

The decision could "provide some relief" for Amgen and J&J, as someanalysts had said that the previous proposal could have reduced use ofthe anemia medications by as much as half, the Times reports (New York Times, 7/31).

AnAmgen spokesperson said, "We are continuing to review the CMS decisionand will work cooperatively with CMS to ensure that patients receivethe treatment they need." A spokesperson for the J&J Ortho Biotechdivision said that company officials have not completed a review of thedecision (Wall Street Journal, 7/31).

Durable Medical Equipment

In related news, CMS on Friday proposed a rule that would requiresuppliers of durable medical equipment to post a $65,000 bond toparticipate in Medicare, CQ HealthBeat reports. Accordingto CMS, the "surety bond" would "ensure that Medicare can recovererroneous payments ... that result from fraudulent or abusive supplierbilling practices."

In addition, CMS announced plans toincrease the time period in which suppliers of durable medicalequipment can bid on Medicare contracts as part of a competitivebidding program (CQ HealthBeat, 7/27).

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