Review of Terminated Drugs in the Medicare Part D Program

Of the approximately $115 billion in gross drug costs included in Medicare Part D sponsors' prescription drug event (PDE) data for calendar years 2006 and 2007, CMS accepted PDE data totaling $112.1 million associated with 2,967 terminated drugs. Terminated drugs are discontinued drugs that have passed their shelf life or drugs that have been pulled from the market for health or safety reasons. Such medications could be weak, ineffective, or detrimental to beneficiaries' health. However, Federal regulations do not specifically prohibit coverage of terminated drugs under the Part D program.

We recommended that CMS issue regulations to prohibit Medicare Part D coverage of terminated drugs and, in the interim, publish a list of these drugs on its Web site. CMS did not concur with our finding or recommendation. We maintain that our recommendation is valid.