Some key elements include requiring plans to include at least 2 drugs in each approved therapeutic category and class. The Centers for Medicare & Medicaid Services (CMS) may require more than 2 drugs if additional agents “present unique and important therapeutic advantages” and if excluding “may substantially discourage enrollment…by beneficiaries with certain disease states.”
The guidelines allow Part D plans to place “very high cost and unique items” in a specialty tier outside of the usual tiered cost-sharing. CMS indicates that specialty tiers must meet the following criteria for approval:
- Only 1 tier is exempted from cost sharing exceptions
- Only Part D drugs with plan negotiated prices exceeding $500/month can be placed in the specialty tier
- Cost sharing in the specialty tier is limited to 25% in the initial coverage range (or the actuarial equivalent for plans with decreased or no deductible basic alternative benefit design)
A recent evaluation of Medicare drug plans by the Kaiser Family Foundation found that most plans use these specialty tiers and some charge patients more than the 25% recommended by CMS. Eight of the 35 plans evaluated charged beneficiaries 30% to 33% of the cost of agents in the specialty tier. For at least one agent (etanercept for rheumatoid arthritis), a plan covered the drug but charged enrollees 75% of the cost – for a patient share of $1276.
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