CMS's Second Swing at Part D Protected Classes Might Work

By Leslie Small

On Nov. 26, CMS issued a proposed rule that would let Medicare Advantage and Part D plans limit coverage of certain drugs in the six "protected classes," which include antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals and antineoplastics.

Under CMS's Contract Year 2020 Medicare Advantage and Part D Drug Pricing Proposed Rule, plans would be able to:

(1) Implement broader use of prior authorization and step therapy for protected-class drugs than is currently allowed;

(2) Exclude a protected-class drug from a formulary if it represents only a new formulation of an existing drug (regardless of whether the existing drug is still on the market); and

(3) Exclude a protected-class drug from a formulary if its price increases, relative to the price in a baseline month and year, beyond the rate of inflation.

This is not the first time an administration has tried to make changes in Part D's protected classes. In 2014, the Obama administration proposed a rule that, among other Part D changes, would have effectively removed the protected status of antidepressants, antipsychotics and immunosuppressants. After facing backlash from a number of health care stakeholders and lawmakers from both major parties, CMS backed off the proposal.

But some industry experts tell AIS Health it's possible that the Trump administration's plan could have more success than its predecessor.

"The concerns around beneficiary access to drugs in those classes is going to be similar, the same or maybe even greater than the Obama-era proposal," Miryam Frieder, a vice president at Avalere, tells AIS Health. However, "the environment is different enough that there is certainly the possibility that one could see this moving forward."

Wall Street analysts viewed the protected-classes proposal as good news for managed care firms.

"We remain bullish" on MA and Part D players in light of the potential new regulations, Leerink analyst Ana Gupte advised investors. She cited UnitedHealth Group, Humana Inc. and WellCare Health Plans Inc. as particularly likely to benefit, as well as Aetna Inc., Anthem, Inc. and Cigna Corp.

From Health Plan Weekly