CMS nixes proposed Part D protected drug class changes made by Trump admin

Drug prices
The Centers for Medicare & Medicaid Services removed flexibility for participants in a Part D drug model to not cover all drugs in certain protected classes. (Getty/Tero Vesalainen)

The Biden administration has walked back a last-minute bid by its predecessor to give Part D plans the ability to restrict access to certain classes of drugs such as antidepressants.

The Centers for Medicare & Medicaid Services announced a change on late Tuesday to the Part D Payment Modernization Model, a voluntary model that tests changes to the program. It walked back two changes set to take effect in 2022 that offered insurers more flexibility on how they structure their formularies.

The Trump administration announced the two controversial changes on Jan. 19, a day before President Biden’s inauguration.

One of the changes would allow participating Part D plans to treat five of six protected drug classes as they would other drug classes.

Part D requires plans to cover all drugs in the six classes: antidepressants, immunosuppressants, antipsychotics, anticonvulsants and antiretrovirals. But the model would have changed that requirement for each of those classes instead of antiretrovirals.

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The change would have meant that plans did not have to cover all of the drugs in the affected classes, which sparked fierce pushback from patient advocacy groups.

The Trump administration contended that the changes were needed to give plans “greater ability to negotiate with manufacturers, ensuring formulary inclusion and favorable access,” according to a fact sheet released back in January.

Another change would have allowed Part D plan participants to include on their formulary at least one drug per class as opposed to the current requirement of two.

But both of those changes are now nixed by the Biden administration, which did not divulge why it pulled the changes in a request for applications for the model released Tuesday. The administration set a deadline of April 16 for any applications.

The HIV+Hepatitis Policy Institute said that the changes would have been able to deny coverage of drugs to Medicare beneficiaries.

“We are thankful to the Biden administration for quickly realizing the detrimental impact this proposal would have had on the elderly and the disabled who rely on critical medications to stay health,” said Carl Schmid, the institute’s executive director, in a statement Tuesday on the changes.

The American Medical Association also thanked the administration for pulling the changes. 

"This ill-considered waiver would have denied vulnerable patients access to necessary and potentially life-saving medications," AMA President Susan Bailey said in a statement. "They can breathe a sigh of relief knowing that the administration was looking out for them.”

The Trump administration tried to make changes to the protected classes before.

The administration in 2019 proposed that formulary management tools such as step therapy and prior authorization be applied to drugs in protected classes. However, CMS eventually decided to scale back those changes in a final rule.