CMS' final prescription drug rule: 6 things to know

CMS issued a final rule May 16 that makes several changes to Medicare Advantage and Part D. The final rule is a scaled-back version of the proposed rule.

Six things to know:

1. CMS declined to implement a proposed measure that would give insurers more flexibility around the coverage of "protected classes" of drugs. Current policy requires Medicare Part D plans to cover drugs in the following six categories: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics. The proposed rule wanted to create exemptions to this "protected class" policy. CMS declined to allow plan sponsors to exclude a protected class drug from its formulary if it exceeded a certain price threshold or it was a new formulation of an existing single source drug. 

2. However, under the final rule, Part D plans have greater leeway to implement step therapy and use prior authorization, even within the protected classes. The only class that is not able to use step therapy is antiretroviral drugs. 

3. The rule also finalized regulations for how Medicare Advantage plan can apply step therapy to physician-administered drugs under Part B. The policy will only cover the first time a patient tries a medication and it can be reviewed. 

4. The rule also formally implements a ban on pharmacy "gag clauses," where pharmacists are prohibited from informing consumers that they could save money by paying out-of-pocket instead of through their health plan. A law was signed by President Donald Trump earlier this year that makes the practice illegal.

5. CMS also declined to implement a plan that would have passed price concessions negotiated by pharmacies onto patients. 

6. Under the finalized rule, Part D plans must build a tool that can be integrated into provider EHRs or E-prescribing systems to help equip clinicians with more data on drug pricing. Plan sponsors will have until Jan. 1, 2021, to launch a tool that’s compatible with at least one provider system.

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