Compounded Drugs Under Medicare Part B: Payment and Oversight.

摘要

Compounded drugs are customized medications that meet specific needs of individual patients and are produced in response to a licensed practitioners prescription. Compounded drugs that are contaminated pose a severe threat to public health and safety. An outbreak of fungal meningitis and other fungal infections in late 2012 was linked to contaminated injectable compounded drugs. As of October 2013, the Centers for Disease Control and Prevention had reported over 700 cases linked to this outbreak. Although certain compounded drugs can be eligible for coverage under Medicare Part B, Medicare does not pay for compounded drugs when the Food and Drug Administration determines that an entity is producing compounded drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act). In light of the 2012 outbreak and increased scrutiny of compounded drugs, we sought to determine the extent to which Part B paid for compounded drugs and to examine Medicare Administrative Contractors (MAC) policies and procedures for reviewing and processing claims for compounded drugs.