CMS proposes changes to prescription drug rules: 7 things to know

CMS issued a proposed rule Nov. 26 that includes changes to Medicare Advantage and Part D.

Here are seven things to know:

1. The proposed rule, which focuses on "protected classes" of drugs, provides Medicare Advantage and Part D plans more tools to negotiate lower drug prices.

2. 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 would create exemptions to the "protected class" policy.

3. The proposed rule would allow Part D plans to implement broader use of step therapy and prior authorization, even within protected classes. The proposed rule would also allow Part D plans to exclude a protected class drug if it's a new formulation of an existing product or if the price of the drug increased more than the rate of inflation.

4. Under the proposed rule, Medicare Part D plans would be required to provide enrollees and their physicians with a patient's out-of-pocket cost obligations for prescription drugs when a prescription is written.

5. The proposed rule implements a statutory requirement that prohibits pharmacy gag clauses in Part D.

6. The proposed rule codifies a policy to allow "step therapy" in Medicare Advantage for Part B drugs. "The use of utilization management tools, such as step therapy, for Part B drugs would enhance the ability of MA plans to negotiate Part B drug costs and ensure that taxpayers and MA enrollees face lower per unit costs or pay less overall for Part B drugs while maintaining medically necessary access to Medicare-covered services and drugs," states the proposed rule.

7. CMS said it is considering a policy that would require pharmacy rebates to be passed on to seniors.

More articles on pharmacy:

5 recent pharma layoffs
Novartis has spent $15B to reinvent itself
AstraZeneca starts search for new CEO under pressure from stakeholders

 

Copyright © 2025 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


You can unsubscribe from these communications at any time. For more information, please review our Privacy Policy
.
 

Articles We Think You'll Like