Medicare Part D plans get more flexibility to make midyear changes


Medicare Part D prescription drug plan sponsors will have flexibility to make maintenance changes to their formularies in 2019 as part of a broader effort to lower costs for Part D enrollees.

The ability to make so-called “maintenance changes” to a formulary can now be made prior to receiving approval from the Centers for Medicare & Medicaid Services after the agency finalized a proposal in a rule updating regulations governing Medicare Part D and Medicare Advantage.

Pills and capsules atop a spread of $100 bills Kenishirotie/Thinkstock
CMS generally approves maintenance changes, such as removing a brand-name drug and substituting a generic equivalent when it is approved or after the publication of new clinical guidelines, or when a plan moves a drug to a higher tier or adds prior authorization to it, although in the past there were delays associated with the change.

The new rule allows plans to make formulary changes immediately upon generic approval assuming certain requirements are met, including generally advising Part D plan members beforehand that changes can occur without a specific advance notice and later providing information about any specific generic substitutions that occur.

The agency cited a Medicare Payment Advisory Commission June 2016 report to Congress as the source of the proposal. That report notes that while plan sponsors can notify beneficiaries of changes when they alert CMS, it can take up to 6 months to get formal notice of an approval, leaving some plan sponsors waiting.

CMS noted that the proposed changes drew concerns, particularly regarding changes that could be made without giving patients a chance to discuss them with their doctors about transitioning to a new medication and other concerns. However, the rule states that the policy “strikes the right balance between providing beneficiaries with access to needed drugs and Part D sponsors with flexibility to administer plans.”

Another area in the rule that CMS expects will generate savings is a new policy on biosimilars that affects beneficiaries receiving low-income subsidy benefits. Going forward, the agency will treat biosimilars and interchangeable biological products the same as generics in terms of determining copays for low-income subsidy enrollees.

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