WASHINGTON — The Trump administration wants to give private Medicare plans the flexibility to exclude from their formularies certain drugs, including some like antidepressants and AIDS medications, in hopes the increased negotiating power will help the plans bring down drug costs for patients and for the Medicare program itself.

It was the first in a series of changes that the Trump administration put forth in a new regulation late on Monday, all of which largely nibble around the edges of the underlying problem of high drug prices. Each of the polices are nonetheless likely to inflame drug companies and allied patient advocates who have said similar policy proposals could limit patient access to medicines.

Under current law, private Medicare drug plans are required to cover “all or substantially all” drugs in six classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics. The original intent was to make sure insurers did not deny vulnerable patients access to potentially lifesaving drugs.


President Trump’s plan, if finalized, would allow broader use of so-called formulary management tools in the protected classes, which could ultimately allow plans to exclude certain drugs from the protected classes. Insurers could exclude drugs that are a new formulation of an already covered drug, or drugs for which the price has increased more than inflation.

“By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans,” health secretary Alex Azar wrote in a Monday blog post.

Azar specifically blasted Sunovion, which makes an antipsychotic called Latuda, for hiking its prices between 2013 and 2017 by an annual average of 19 percent.

The drug industry and allied patient advocates have warned the Trump administration to stay away from changes to the protected classes.

The Partnership for Part D Access, which includes drug makers like Sunovion as well as a handful of patient groups, has urged HHS to walk away from the idea.

“As an essential patient safeguard in Part D, the protected classes stand as a guarantee that patients with the most complex conditions will have access to the full spectrum of medications under Part D,” the group writes on its website.

The administration attempted to preemptively address those concerns Monday.

“It’s important to remember that if seniors don’t like a plan that takes advantage of these new flexibilities, they are in the driver’s seat,” Azar wrote. “They have the option to choose a different plan that better meets their needs.”

The Trump administration’s new regulation, if finalized, would also marginally increase drug pricing transparency. The administration proposed Monday requiring Medicare Part D plans adopt software that discloses to doctors when there’s a cheaper drug available than the one they’re prescribing. The regulation also proposes requiring drug pricing information in Medicare beneficiaries’ explanation of benefits.

Other proposals included in the 100-plus-page regulation codify policies already introduced by the administration through less formal means, such as allowing private Medicare Advantage plans to use step therapy.

Under the proposed regulation, plans would not be able to implement the changes until 2020.

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