Administration Proposes Part D Changes

(The following has been adapted from BioNJ’s Public Policy Alert)

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule to make several changes to the Medicare Advantage and Part D programs. In particular, the proposed rule targets Part D “6 protected classes”, step therapy in Medicare Advantage for Part B drugs, and price concessions at point of sale.

Current Medicare Part D policy requires that formularies include all drugs in six categories or “protected” classes: antidepressants, antipsychotics, anticonvulsants for epilepsy, immunosuppressants for treatment of transplant rejection, antiretrovirals and antineoplastics. With limited exceptions, all Part D plans must include all drugs in these categories on formularies.

The proposed rule would make several changes to existing policy:

  • First, the proposed rule would allow Part D plans to increase use of prior authorization and step therapy for treatments in protected class categories. Step therapy — also known as fail first — can have a detrimental impact on ensuring Patients with epilepsy receive the right treatment at the right time.
  • Second, the proposed rule would exclude a drug from the formulary if the drug represents a new formulation that is not a “significant innovation” of an existing single source protected class drug or biologic.
  • Third, the rule would propose to exclude a protected class product from a formulary should the price of the drug increase beyond inflation over a prescribed look back period.

The proposed rule also reaffirms recently announced CMS policy related to step therapy for Part B drugs provided via Medicare Advantage plans. CMS had announced earlier this summer that Medicare Advantage plans beginning in 2019 could employ step therapy for Part B drugs as a utilization management strategy. Medicare Advantage Part B step therapy would only apply to new prescriptions and would be reviewed and approved by the Medicare Advantage plan’s pharmacy and therapeutics committee.

Finally, the proposed rule takes aim at “transparency” in Medicare prescription drugs through concepts such as requiring plans to develop a real-time prescription benefit tool by January 1, 2020. CMS also notes that the agency is considering for future plan years — as early as 2020 — a requirement that pharmacies charge Part D beneficiaries the lowest possible cost for a prescription inclusive of negotiations between pharmacies and manufacturers. CMS estimates this change could lower beneficiary out-of-pocket costs by $12 to $15 billion over ten years.

Click here  for a copy of the proposed rule.

CMS also authored a  blog post  announcing the proposed rule. Comments are due by midnight on January 25, 2019. While BioNJ continues to review the contents of the rule, we are concerned the proposed rule could reduce timely Patient access to lifesaving treatments. Epilepsy Services of NJ (ESNJ) will continue to work with BioNJ, We Work for Health NJ and their public policy partners for additional information on this proposed rule.

For more information on this proposed rule and for guidance with contacting your elected representative, please contact Adeola Sonaike, ESNJ’s Senior Vice President, Health, at or 609-392-4900 ext.11

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