CMS issued final prescription drug rules for Medicare Advantage (Part C) and Prescription Drug (Part D) plans for 2020 that will permit Part C plans to implement step therapy protocols for specialty drugs but declined to finalize rules permitting Part D plans to exclude drugs from formularies in Medicare’s protected classes under specific circumstances. Medicare’s protected classes rules permit beneficiaries to have access to “all or substantially all” drugs in 6 specific classes.

Final Rule Details

Under the final rule, Part C plans can require providers to implement step therapy protocols for Part B drugs, which are typically specialty medications administered by physicians. However, it’s limited to new prescriptions and requires review and approval by plans’ Pharmacy and Therapy Committees, mirroring requirements in Part D. The rule declines to adopt proposed rules that would have allowed Part D plans to exclude drugs in Medicare’s protected classes (antidepressants; antipsychotics; anticonvulsants; immunosuppressants for treatment of transplant rejection; antiretrovirals; and antineoplastics) from formularies if 1) a drug price increased beyond a certain threshold; or 2) the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market.