Decisionmakers Must Address Unintended Consequences of Access Barriers in Implementing New Medicare Drug Pricing Policies

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The Autoimmune Association (AA) joined hundreds of other patient groups and stakeholders in filing comments in response to the Centers for Medicare and Medicaid Services’(CMS) initial draft guidance on the requirements and parameters for the new Medicare Drug Negotiation Program included in the Inflation Reduction Act (IRA).

Our comments emphasized the unique challenges that the more than 50 million autoimmune patients face in their day-to-day lives and the importance of having ready access to novel and innovative treatments to successfully manage their conditions and improve health and wellness. The IRA’s drug pricing provisions will have wide-ranging implications for not only Medicare beneficiaries, but for all autoimmune patients who stand to benefit from innovative therapies that are currently on the market, as well as those in the development pipeline. The letter strongly encourages regulators to remain vigilant of potential unintended consequences that could jeopardize future patient access to these therapies.

AA’s recommendations included:

  • Consideration of patient access issues beyond coverage requirements in the program to also address payer-imposed restrictions.

  • Adoption a broader definition of unmet medical need that reflects the diversity of patient preferences and needs.

  • Implementation of the program with maximum inclusivity of patients, families, and caregivers including allowing additional time to encourage broader community feedback.

AA also filed comments to CMS’s request for comments on prior authorizations policies. Our recent national polling and research found that 75% of health care consumers are concerned that prior authorization can delay or block patients’ access to treatment, and 71% are worried that PA will increase patient costs.

As CMS moves closer to implementing policies that impact the autoimmune community, AA and Let My Doctors Decide will continue to advocate for patients and their families by raising awareness of the harmful consequences of policies and regulations that could hinder patient access to much-needed medicines and therapies.

 AA’s letters to CMS can be found here and here.

Farheena Mustafa