May 10, 2011 | Posted By Danielle Holley, JD, MS

In March, Congress reintroduced a bill: the “Part D Off-Label Prescription Parity Act.” (H.R. 1055) (See info here)  Currently, Part D covers off-label drug treatments for cancer but not for those patients who suffer other chronic conditions.  These patients can seek payment for off-label use under Medicare Part B, for those off-label drugs that are supported by peer-reviewed medical literature or in a compendium.  The goal with the Part D legislation is to adopt the standard under Part B to allow for chronic conditions, including others than cancer, to have payment for off-label drugs that not only are listed in compendia but also are supported in peer-reviewed literature.  Currently, the bill is still stuck in the Subcommittee on Health.

This is important legislation to create parity across the Medicare plans but also to recognize the balance needed in allowing for off-label drug use.  It has been shown that off-label drug use varies somewhere between 21% to 50% depending upon the drug and classification (1).   It is important that this legislation recognizes that off-label drug use can be beneficent for patients, but may also have harmful effects.  I have argued elsewhere  (2) that we need to have some regulation for off-label drug use because of the potential for harmful side-effects, and the legislation proposed along with Medicare Part B regulations demonstrate that need for off-label drug use to be governed by the standard of care either as noted in a compendia or supported in peer-reviewed literature.  A case heard by the federal court in the Southern District of New York, upheld this by stating that Medicare must cover off-label drug use for treatment that is medically necessary as supported by compendia or peer-reviewed literature.  

Off-label drug use can be extremely beneficial and it is important to not the overly limit the art of medicine.  It is equally important that we not draw arbitrary lines by not allowing patients to access and be covered for these important off-label drug uses that have been supported in the literature or compendia.  The healthcare system already has enough hurdles to jump through and Congress creating more hurdles by singling out certain diseases or not being consistent in their coverage is unjust and detrimental to patients, physicians, and the physician-patient relationship.  We need to set regulations to both protect patients and physicians but also respect the physician-patient relationship by being consistent and allowing for innovative uses that have been established as effective treatment.  

(1) Danielle Holley, Comment, Balancing on the Edge: The Implications and Acceptability of Off-Label Drug Use, 19 ALBANY J. SCI & TECH 633, 633 (2009).  
(2) Id.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

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