Off-Label on the Table
July 15, 2010 Volume 1, Issue 20
Legislation Introduced to Expand Access to Part D Coverage
On Thursday, July 15, U.S. Representatives Mary Jo Kilroy (D-OH) and Mac Thornberry (R-TX) announced the introduction of the bipartisan Part D Off-Label Prescription Parity Act (H.R. 5732). The bill allows Medicare to cover prescriptions used for off-label indications when such use is supported by peer-reviewed medical literature, as is the case under Part B and for Part D cancer drugs. Currently, under Part D, for medications used to treat conditions other than cancer, Medicare will not cover drugs used for off-label indications if they are not listed in statutorily identified compendia, privately owned and published drug guides. The legislation brings Part D rules in line with other parts of the Medicare program, and expands treatment options by allowing coverage of safe and effective drugs based on the most up-to-date published medical literature.
The Medicare Rights Center has followed this issue closely since the implementation of Part D in 2006, and continues to receive calls on its Part D Appeals hotline from consumers who are unable to access medically necessary drugs used for off-label indications. In addition to working toward a legislative remedy, Medicare Rights has challenged in federal court the regulations that govern Medicare coverage of off-label drug treatments.
Medicarewatch@medicarerights.org
What is an Off - Label prescription. In layman's terms is when a drug is on your formulary prescription list, and the company refuses to pay for the drug.
Exception is when the Doctor request the prescription(prior approval) and it is used in step therapy or quantity limits. Also, if your Doctor prescribes a drug for another use other than what the US Food and Drug Administration approved the drug for.
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