Medicare Part B Allowing Step Therapy

The Centers for Medicare & Medicaid Services (CMS) announced a change in guidance on the use of step therapy on Part B drugs in Medicare Advantage plans.  In 2012, CMS prohibited the use of step therapy on Part B drugs.  CMS reversed that decision and will now permit the use of step therapy.

The CMS change becomes effective January 1, 2019 and allows the use of step therapy for new patients initiating therapy on a Part B drug.  Patients receiving Part B drugs today are excluded from the step therapy requirements.  The existing exception process for Part B drugs allows beneficiaries to bypass the preferred product for medically necessary conditions.

This change will allow Part B plans to guide therapy to preferred products for new patients.  By regulation, the Medicare Advantage plan’s preferred option in the step therapy must be a covered Part B or Part D drug.

Biosimilars may experience increased use on Medicare Advantage plans if they receive preferred placement in the step therapy protocol.  Originator biologics remain available to those receiving treatment before the step therapy implementation or for medical necessity exceptions.  Medicare Advantage plans use of step therapy on Part B drugs may accelerate biosimilar uptake in the future.


Published September 2018

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