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Changes to Part D Formulary Flexibilities under Biden Administration

It is inevitable that the Biden administration would review and make changes to the Part D drug pricing agenda set forth by the Trump administration and those changes are coming rapidly. A prior Part D Payment Modernization proposal of allowing Part D Plans to offer fewer drugs per category and class for the six "protected classes" has been ended. The formulary flexibilities would have been part of 2022 applications for a the Part D Payment Modernization model. CMS' Center for Innovation said they ultimately decided against that piece of the proposal due to advocates and providers' concerns that beneficiaries could be negatively impacted. 

One thing is for certain, more changes will be coming related to Part D drug pricing. Applications to take advantage of other provisions in the payment model are still due to CMS April 16, 2021. 

CMMI said it decided not to move forward with the changes based on stakeholder feedback and other considerations. Patient advocates and many providers opposed the additional flexibilities, warning that they could put beneficiaries' health at risk by denying them access to some medications. The agency probably reinstated downside risk for the 2022 plan year because of a court-mandated change in the effective date Medicare drug rebate rule, which removed safe harbor protections for drug manufacturer rebates under the anti-kickback statute. The rule is scheduled to take effect Jan. 1, 2023, a year later than HHS originally planned.


healthcare, life sciences

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