Judge Rules that CMS Misinterpreted
Off-Label Drug Coverage Standard

 

This month, as a result of a challenge filed in court by the Medicare Rights Center in 2007, a judge held that the current interpretation of the coverage standard for drugs used off-label under the Medicare prescription drug benefit, also known as Part D, is unreasonable and does not reflect Congress’s intent to cover such drugs. Since Part D began, the Centers for Medicare and Medicaid Services (CMS) has not covered drugs used for off-label indications—drugs used for treatments other than those approved by the Food and Drug Administration—if the use is not listed in the statutorily identified, privately owned and published drug guides known as compendia. However, Judge Harold Baer of the U.S. District Court in the Southern District of New York ruled, as Medicare Rights Center had argued, that the list of compendia in the Medicare law was not meant to be restrictive, but to be an illustrative example of materials that may be used to determine if coverage of a drug used for off-label purposes is appropriate. 

The suit noted that in the United States over 20 percent of prescriptions written for the 500 most commonly used drugs are for off-label uses.

Medicare Rights Center filed suit on behalf of plaintiffs Judith M. Layzer, who recently lost her battle with ovarian cancer, and Ray J. Fischer, who suffers from a rare form of muscular dystrophy. Both plaintiffs used off-label drugs as treatment for their conditions. While these uses were supported by peer-reviewed medical literature, they were not included in the compendia listed in the Medicare statute.

In addition to challenging the interpretation of the Part D statute through litigation, the Medicare Rights Center has pursued a legislative remedy, seeking clarification from Congress that off-label drug treatments can be covered under Part D if there is evidence of efficacy in peer-reviewed literature such as the New England Journal of Medicine.  

That effort was successful with respect to anticancer chemotherapy drugs with the passage of the Medicare Improvements for Patients and Providers Act (MIPPA) in 2008, which took effect in January 2009, clarified that peer-reviewed medical literature may be used for coverage decisions of off-label drug treatments of cancer.

In the wake of the ruling, U.S. Representatives Thornberry and Carnahan have taken legislative action to clarify the Medicare off-label coverage policy by re-introducing the Part D Off-Label Prescription Parity Act.  Building off MIPPA, the Act makes clear that the same coverage standard should apply across the program.

-From “ Judge Rules that CMS Misinterpreted Off-Label Drug Coverage Standard”, Medicare Watch , March 10, 2011, Volume 2, Issue 9 , Medicare Rights Center; Medicare Rights Center Press Releases “ Judge Rules in Favor of Plaintiffs Seeking Medicare Coverage of Off-Label,
Medically Necessary Drugs”, March 8, 2011 and “Statement by Medicare Rights Center President Joe Baker on the Re-Introduction of the Part D Off-Label Prescription Parity Act”, March 11, 2011.

 

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