Classes of Exclusions Used by States, 2003

1. THE COMMONWEALTH FUND Rizzo, Fox, Trail, and Crystal, State Pharmacy Assistance Programs: A Chartbook—Updated and Revised, January 2007 Classes of Exclusions Used by States, 2003 • To be covered under Medicare Part D, a drug must be available by prescription, FDA-approved, and used for the medically accepted indication. Covered Part D drugs include prescription drugs, biological products, insulin and related medical supplies, and vaccines. Part D specifically excludes drugs or classes of drugs that are excluded from coverage under Medicaid, including weight-loss or gain drugs, cosmetic or hair-loss drugs, drugs used for relief of cough and colds, prescription vitamins, over-the-counter drugs, barbiturates, and benzodiazepines. Part D also excludes drugs currently covered under Medicare Part B. • Most SPAPs also excluded some, but not all, of these drugs from coverage. • Like Medicare, most SPAPs for which we have data excluded non-FDA-approved experimental drugs. With the exception of Indiana and Kansas, 20 out of 22 SPAPs exclude experimental drugs. • Most states excluded lifestyle drugs, including hair-loss and impotency drugs. However, Massachusetts, New York, and South Carolina do cover some lifestyle drugs. • Eleven states excluded outpatient drugs that are already covered by Medicare. While these exclusions were initially directed at excluding the few outpatient drugs covered under Medicare Part B that are administered by a physician, depending on the specific statutory language, this could also be interpreted to extend to Part D covered drugs inthe future. • Fourteen states also excluded drugs for which there is no manufacturer rebate agreement. • Five states also had other exclusions. Illinois SeniorCare excluded drugs that are available from the Department of Health. Vermont’s VScript Expanded program for moderate-income seniors covered only maintenance drugs. Michigan excluded injectable and oral AIDS drugs, injectable drugs, allergy serums, and DESI drugs (drug efficacy study implementation drugs, approved by the FDA solely on the basis of safety prior to 1962). Maine excluded DESI drugs (according to 2002 survey).