Medicare Advantage Data

Neurosurgery Urges CMS to Ban Step Therapy in Medicare

  • Drugs and Devices

The Honorable Chiquita Brooks-LaSure Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Via Electronic Delivery

Re: Step Therapy for Part B Drugs in Medicare Advantage

Dear Administrator Brooks-LaSure,

The undersigned organizations, representing millions of Medicare beneficiaries with life-threatening, complex, chronic conditions and/or the physicians who care for them, are asking the Centers for Medicare and Medicaid Services (CMS) to ensure that beneficiaries enrolled in Medicare Advantage plans continue to have appropriate and timely access to the therapies they need to properly manage their conditions. We are asking that the agency move swiftly to reinstate the step therapy prohibition in Medicare Advantage (MA) plans for Part B drugs as described in the September 17, 2012, HPMS memo Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services.

Step therapy and prior authorization are both forms of utilization management, and we share the concerns for MA beneficiary access to care described by the HHS Office of Inspector General (OIG) in their report, Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care. As highlighted by the OIG report, although some of denials are ultimately reversed by MA organizations, negative consequences from avoidable delays in medically necessary care are not absolved. 1 Critical delays in obtaining the best medicines for the best outcomes may ultimately lead to increased costs for the Medicare program and its beneficiaries as well.

Our groups were disappointed by the rescission of this important prohibition by the previous administration. Since step therapy has been allowed for Part B drugs since 2019 there have been multiple cases of patient harm. In September 2021, several groups presented CMS leaders with clear instances of patient harm that resulted in, but were not limited to, patients becoming legally blind, longterm hospitalizations, infections, increased disease activity, and disability. We appreciate that CMS took the time to meet with patient and physician stakeholder groups and listen to our testimony; however, we are concerned that step therapy remains permissible, and patients continue to be harmed by the practice.

Click here to view the full Neurosurgery Urges CMS to Ban Step Therapy in Medicare.