PART D:
Off-Label Coverage War Heats Up
Published on Sun Jul 22, 2007
Pharmacists' role: Know when exceptions and appeals could help.
A new report slamming the feds for allowing Part D denials for "off-label" prescriptions could be just what you need ...quot; new fuel in the fight to get clients the drugs that they require.
The study, released Aug. 2 by the Medicare Rights Center, charges that Medicare beneficiaries are being denied Part D coverage for prescription drugs that are medically appropriate but "off-label." The report contends that a regulation issued by the Bush administration last year misinterprets statute. That misinterpretation in turn opened the door for prescription drug plans (PDPs) to begin denying coverage for drugs prescribed for an "off-label" use, the report authors charge.
Old way: Traditionally, Medicare law has allowed contractors to have some discretion in covering drugs for uses outside U.S. Food & Drug Administration labeling and the compendia. In fact, CMS itself allows that federal Medicare law governing inpatient drug coverage outside of Part D requires that "all off-label uses listed in specific compendia must be covered, and other unlisted uses are at contractor discretion."
New way: But with the new rule in place, there's no longer "contractor discretion" in the case of Part D. The rule specifically prohibits Part D coverage of off-label prescriptions unless the prescribed use is supported in one of three specific medical compendia:
• American Hospital Formulary Service Drug Information,
• DRUGDEX Information System, or
• United States Pharmacopeia Drug Information. Impact: The three compendia print overviews of new uses of medications supported by surveys of clinical studies and peer-reviewed medical literature. If a drug is not covered by one of the three guides, Part D plans cannot cover the drug. That's the case "regardless of the extent of medical necessity and proof showing the effectiveness of the drug for that use, including peer-reviewed clinical research published in medical journals," says the report. The Pressure Is On Responding to the report just after its release, the Centers for Medicare & Medicaid Services' (CMS) Jeffrey Kelman countered that Medicare rules allow patients to get doctor-prescribed off-label drugs if the drugs are listed in one of the three drug reference guides as useful for the condition they are suffering.
"There has to be some reason for using [the drugs]," says Kelman, chief medical officer for Medicare's Center for Beneficiary Choices.
But pharmacists are likely to consider that double-speak. The new rule fails to recognize the accepted definition of off-label as one that extends beyond the three leading compendia in cases where physicians can point to other peer-reviewed support for the prescribed use.
Example: A recent article in the Journal of Clinical Oncology recommends requiring Medicare Part D PDPs to consider peer-reviewed literature from "reliable sources" when making coverage determinations, for example, [...]
