Medicare Beneficiaries Cannot Obtain Medications For 'Off-Label' Uses Through Prescription Drug Benefit

Armen Hareyan's picture

Medicare beneficiaries often cannot obtain medications prescribedfor "off-label" uses -- such as the treatment of pain, rare diseasesand other conditions -- through the prescription drug benefit,according to a report released on Thursday by the Medicare Rights Center, USA Today reports. Under rules issued last year by CMS,prescription drug plans can deny coverage for medications prescribedfor "off-label" uses. According to the report, based on telephone callsto MRC from Medicare beneficiaries, the medications prescribed for"off-label" uses for which prescription drug plans most commonly denycoverage include:

  • The pain medications Actiq and Fentora, which FDAhas approved for the treatment of pain related to cancer but physicianshave prescribed for the treatment of other forms of pain;
  • Thenausea medication Zofran, which FDA has approved for the treatment ofthe nausea in chemotherapy patients but physicians have prescribed forthe treatment of the condition in other patients; and
  • Theirritable bowel syndrome medication Lotronex, which FDA has approvedfor use in women but physicians have prescribed to some men.

The report cited a 2006 article in the Archives of Internal Medicinethat said more than 20% of prescriptions for the 500 most commonly usedmedications in the U.S. are for off-label uses. The report did notinclude an estimate of the number of Medicare beneficiaries affected bythe rules on coverage for medications prescribed for "off-label" usesunder the prescription drug benefit.

MRC President Robert Hayessaid, "For the first time in more than 40 years, we have a Medicarestatute interpreted as not covering medically necessary care." However,CMS officials maintain that the rules allow Medicare beneficiaries toobtain medications prescribed for "off-label" uses, provided that theyappear on three lists of approved treatments.


Jeffrey Kelman, chief medical officer for the Center for Beneficiary Choices at CMS, said, "There has to be some reason for using (the drugs)" (Appleby, USA Today, 8/2).

IMS Health Report

More than 50% of Medicare beneficiaries who pay for medications out ofpocket decided not to enroll in the prescription drug benefit lastyear, according to a report released on Thursday by IMS Health, Bloomberg/Long Island Newsdayreports. According to the report, those 7.4 million Medicarebeneficiaries might have decided not to enroll in the prescription drugbenefit because they believed that the premiums would have exceededtheir out-of-pocket costs.

"A lot of people did what's calledthe 'kitchen-table test': They basically added up the cost of drugsthey're taking now, and if it was less than Part D, they didn'tenroll," Cheryl Matheis, director of health strategies for AARP,said. However, she added that such Medicare beneficiaries should "befactoring in the risk and thinking of this as insurance" andrecommended that they enroll in the prescription drug benefit(Bloomberg/Long Island Newsday, 8/2).


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