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.

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