September 7, 2018
The Honorable Seema Verma
Administrator Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Hubert H. Humphrey Building, Room 445–G
200 Independence Avenue, SW
Washington, DC 20201
Re: Memo of August 7th Regarding Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage
The undersigned organizations representing physicians thank the Centers for Medicare and Medicaid Services (CMS) for its attention to the negative impacts of high drug prices on Medicare and Medicaid beneficiaries, physicians, and the health care system. However, we have serious concerns about CMS’s recent notification to Medicare Advantage plans that they will no longer be prohibited from utilizing step therapy protocols for physician administered drugs covered under Medicare Part B beginning in 2019. We find the growing trend towards the use of restrictive and burdensome utilization management tactics by payors concerning and urge CMS to reconsider its stance on this critical patient care issue.
Step therapy protocols that require patients to try and fail certain treatments before allowing access to other, potentially more appropriate treatments can both harm patients and undercut the physician-patient decision-making process. The most appropriate course of treatment for a given medical condition depends on the patient’s unique clinical situation and the care plan developed by the physician in close consultation with that patient. While a particular drug or therapy might be generally considered appropriate for a condition, the presence of comorbidities, potential drug-drug interactions, or patient intolerances, for example, may necessitate the selection of an alternative drug as the first course of treatment. Step therapy requirements often fail to allow for such considerations, resulting in delays in getting patients the right treatments at the right time and unnecessary complications in the physicianpatient decision-making process.
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