More Than 50 Groups Sign Letter Urging HHS to Reject Proposed Changes to Medicare Part D

February 5, 2019

ASCO, along with over 50 other organizations, signed a letter from the American Cancer Society Cancer Action Network (ACS CAN) to the Department of Health and Human Services (HHS) urging the agency to reject proposed changes to Medicare Part D that could harm patient access to essential therapies, including cancer care. Specifically, provisions in the proposal target patient protections under six protected drug classes: anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. The letter also raises concerns about parts of the proposed rule that would allow the use of step therapy and other restrictive utilization management practices that ASCO opposes.

Prior Authorization Requirements

The current proposal would allow Part D plans to impose further prior authorization requirements on drugs within the six protected classes. Such requirements include step therapy, in which a health plan requires a patient to try and fail on a lower cost or generic drug before it will cover the drug the doctor originally prescribed. This type of “fail first” therapy can unnecessarily impede patient access to needed cancer care and lead to irreversible disease progression and other significant health risks.

According to a 2017 survey from the American Medical Association, 92 percent of respondents reported care delays as a result of a private health plan’s use of prior authorization requirements.[1]

Impeded Patient Access to the Right Treatment at the Right Time

Another proposed change would allow Part D plans to exclude new formulations of some protected class treatments if the new formulation has the same active ingredient and does not provide a unique route of administration versus an older version of the drug. The letter to HHS expresses grave concerns that this change would hinder beneficiary access to the latest “medical breakthrough products.”

Furthermore, Part D plans could exclude any single-source drug or biologic within the protected classes from their formularies if the price of the drug increases beyond the rate of inflation. Such a change  could harm patients with cancer who need the right treatment at the right time.

Read the full letter

Given the potential harms that the proposed changes to Part D could inflict on Medicare beneficiaries, ASCO and its fellow signatories urge HHS to reject them. Such changes, while intended to cut costs and streamline access to care, could actually increase out-of-pocket costs for patients and limit their access to  protected class drugs.

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[1] American Medical Association. 2017 AMA Prior Authorization Physician Survey. Available at