CMS Proposes Changes to Its Policies Governing Off-Label Uses of Anticancer Drugs and Biologicals

A recently issued proposed change to Medicare policy could significantly affect Medicare payment for anticancer drugs and biologicals. The Centers for Medicare and Medicaid Services (CMS) has proposed a laundry list of changes to the physician fee schedule and Medicare Part B reimbursement. Included among them are important rules regarding CMS’s selection of drug compendia used to determine medically accepted indications for off-label uses of drugs and biologicals in an anticancer chemotherapeutic regimen. If a use is not identified as a medically accepted indication in one of the CMS-approved compendia, no payment will be made under Medicare Part B for that drug when administered for that use. Accordingly, it is critical that these proposed rules be understood by all stakeholders, including oncology drug manufacturers, as well as hospitals and physicians that administer these products. To the extent that these proposed rules could result in the disruption of care or significantly alter coverage and reimbursement, stakeholders should consider submitting comments to CMS during the comment period.

For the full story, please view the PDF.