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December 6, 2018

CMS to expand, make permanent step therapy in Medicare Advantage

AGA opposes step therapy,  which can prevent timely access to the most effective treatment.

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The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that, if finalized, would create new regulations allowing Medicare Advantage (MA) plans to apply step therapy to physician-administered and other Part B drugs as a way of lowering the costs of drugs and improving care for Medicare beneficiaries. AGA is concerned that these proposed changes will limit access for current and future beneficiaries and will add to the growing regulatory burden that physicians already face. 

MA plans are private health plans that offer Medicare-approved health coverage to Medicare-eligible enrollees. MA plans provide both Part A and Part B coverage and some MA plans also provide prescription drug coverage (MA-PD plans).

Key changes proposed in the rule include:


    • Permitting MA plans to require a beneficiary try and fail a plan-specified Part B therapy (or therapies) before providing access to the therapy originally prescribed.


    • Allowing MA plans to require a beneficiary try and fail an off-label (but medically accepted) indication before providing access to a drug for an FDA-approved (or on-label) indication.


    • Permitting MA-PD plans to require a beneficiary try and fail a Part D drug(s) before providing access to a physician-administered or other Part B drug.


    • Permitting MA-PD plans to require a beneficiary try and fail a Part B drug(s) before providing access to a Part D drug.



The proposed policy changes closely match guidance announced in early August and implemented for 2019 and, if finalized, will cement these changes. Comments on the proposed rule are due Jan. 25, 2019.


AGA believes that patients should be given a clear, equitable and transparent appeals process when subjected to step therapy protocols. We have been advocating on Capitol Hill in support of H.R.2077, the Restoring Patients Voice Act, so that patients with private insurance can access the most effective treatment in a timely manner.


Take action: Ask your member of Congress to cosponsor H.R.2077. Recently, AGA joined the Crohn’s & Colitis Foundation for a congressional briefing on IBD during which Aline Charabaty Pishvaian, MD, discussed the burden and challenges of IBD, including barriers to care and therapy. Read more on the AGA Community.


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