Medicare Beneficiaries Often Cannot Obtain Necessary Medications For 'Off-Label' Uses Through Prescription Drug Benefit, Report Finds

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Pharmacy / Pharmacist
Article Date: 06 Aug 2007 - 11:00 PDT

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Medicare beneficiaries often cannot obtain medications prescribed for "off-label" uses -- such as the treatment of pain, rare diseases and 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 prescribed for "off-label" uses. According to the report, based on telephone calls to MRC from Medicare beneficiaries, the medications prescribed for "off-label" uses for which prescription drug plans most commonly deny coverage include:

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

The report cited a 2006 article in the Archives of Internal Medicine that said more than 20% of prescriptions for the 500 most commonly used medications in the U.S. are for off-label uses. The report did not include an estimate of the number of Medicare beneficiaries affected by the rules on coverage for medications prescribed for "off-label" uses under the prescription drug benefit.

MRC President Robert Hayes said, "For the first time in more than 40 years, we have a Medicare statute interpreted as not covering medically necessary care." However, CMS officials maintain that the rules allow Medicare beneficiaries to obtain medications prescribed for "off-label" uses, provided that they appear 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 of pocket decided not to enroll in the prescription drug benefit last year, according to a report released on Thursday by IMS Health, Bloomberg/Long Island Newsday reports. According to the report, those 7.4 million Medicare beneficiaries might have decided not to enroll in the prescription drug benefit because they believed that the premiums would have exceeded their out-of-pocket costs.

"A lot of people did what's called the 'kitchen-table test': They basically added up the cost of drugs they're taking now, and if it was less than Part D, they didn't enroll," Cheryl Matheis, director of health strategies for AARP, said. However, she added that such Medicare beneficiaries should "be factoring in the risk and thinking of this as insurance" and recommended that they enroll in the prescription drug benefit (Bloomberg/Long Island Newsday, 8/2).

Related Broadcast Coverage
ABC's "Good Morning America" on Wednesday profiled a Medicare beneficiary who experienced problems with access to medication for a lung infection. The segment includes comments from the Medicare beneficiary and Judith Stein, executive director of the Center for Medicare Advocacy (Cuomo, "Good Morning America," ABC, 8/1). Video of the segment and expanded ABC News coverage are available online. Additional ABC News resources on Medicare Part D are available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.