Patient Groups Warn Against Weakening Protected Classes Drugs

This post originally appeared in Inside Health Policy on February 26. 2021

Nearly 140 patient groups are urging the Biden administration to block an 11th-hour Trump-era policy change to let drug plans ignore Medicare protections of some of the most vulnerable patients, and the head of the HIV+Hepatitis Policy Institute warned of litigation if the administration doesn’t block the policy. 

Patient lobbyists were given some hope when the Biden HHS postponed a Feb. 3 webinar for plans interested in participating in a demonstration that would waive patient protections, but the solicitation for participation is still active and submissions are due next week.
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Partnership for Part D Access sent a letter Thursday (Feb. 25) cosigned by 138 patient groups urging HHS to reverse a change to a demonstration that would weaken two pillars of patient protections in Part D: protected drug classes and the requirement that insurers cover at least two drugs in each class.

The policies are included in the request for applications for the third year of a Part D demonstration, called the Part D Payment Modernization Model. The demo shares savings with plans that lower Part D catastrophic spending in return for those plans risking penalties when they exceed spending targets. Currently, plans don’t risk anything in the catastrophic phase, other than the 15 percent of spending for which they are responsible.

The six protected classes ensure that Medicare Part D beneficiaries with serious conditions, including epilepsy, HIV, mental illness, cancer and organ transplants, have access to all medications available in those classes.

Given that the policy is merely a change to an existing demonstration, it would be easier for the administration to reverse than a regulation.

There are two ways to block the policy. First, the change was released after 4 p.m. on the last day Trump was in office, so it falls well within the time period covered by Biden administration’s freeze on midnight regulations, a patient advocate said. Also, CMS is allowed to change or rescind the demonstration at any time.

If the Biden administration doesn’t protect the protected classes, patients advocates are willing to sue, according to HIV+Hepatitis Policy Institute Executive Director Carl Schmid. Schmid said the demonstration is supposed to test new approaches to care coordination and delivery and the changes made by the Trump administration go too far.

“I think that there could be legal challenges based on that they are swaying too far for a demonstration project,” Schmid said.