Washington, Jul 15 -

U.S. Representatives Mac Thornberry (TX-13) and Mary Jo Kilroy (OH-15) today announced introduction of the bipartisan Part D Off-Label Prescription Parity Act (H.R. 5732) to allow Medicare coverage of medications when use is supported by experts.  Currently, many Medicare consumers with serious and sometimes life-threatening conditions are unable to access safe and effective medications under Medicare Part D.  Only Medicare Part B and Part D medications used to treat cancer, but not other medical conditions, are eligible for coverage. 

“Every Medicare patient should receive up-to-date care whenever possible.  This includes giving patients access to safe and effective medications, chosen by them and their doctors, that can help improve their lives.  This bill updates Medicare’s prescription drug program to provide coverage for these kinds of treatments,” said Rep. Thornberry.

The bill would give Part D plans the same flexibility allowed under other parts of the Medicare program and in the commercial insurance market.

“Doctors and patients should be able to decide the best safe and effective medications for their treatments,” said Rep. Kilroy.  “We must fight for the right to be treated with the best, safest medicine in consultation with our physicians, not a government bureaucrat.”Off-label prescribing is widespread in the medical community as an essential means of providing patients with optimal medical care.  According to an article in The Archives of Internal Medicine, in 2001, the last year for which data is readily available, 21 percent of 725 million prescriptions written for the 500 most commonly used drugs were for off-label uses.

Individuals are being denied medically necessary treatment that could vastly improve their quality of life, even if a doctor prescribes such medication according to his or her professional judgment and the use of the drug is supported by peer-reviewed medical literature. 

Under Medicare Part B, CMS allows carriers to consider “the major drug compendia, authoritative medical literature and/or accepted standards of medical practice” in determining whether an off-label use is medically accepted.  In 2008, through the Medicare Improvements for Patients and Providers Act (MIPPA), Congress required CMS to apply the Part B standard to Part D cancer drugs used off-label. 

The bill has also been supported by the National Multiple Sclerosis Society and the Medicare Rights Center.

# # #