WASHINGTON – Patients Rising, a non-profit organization advocating on behalf of patients with chronic and rare diseases, today released Principles for CMS on Harnessing the Power of Patient Involvement When Implementing the Inflation Reduction Act. 

The principles are a guideline to CMS’ decision-making as it launches the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act last year.

The group aims to mitigate additional problems with CMS’ new drug-negotiating authority. In March 2023, CMS failed to solicit comments on key aspects of the program, preventing patients and caregivers from weighing in. The principles are issued in response to CMS’ notice-and-comment period exemptions claims, with the goal of giving patients and caregivers across the country the ability to weigh in on negotiations, of which patients are the affected party.

“Patients best understand their illness and the value of their treatment. Just as we expect the FDA to listen to patients in the drug development and approval processes, it is imperative that CMS involve patients and caregivers in every aspect of the implementation of the IRA,” said MacKay Jimeson, Executive Director of the Patient Access & Affordability Project. “The principles released today encourage the development of a patient-centric culture at CMS to address medical inflation across the health system, eliminate unnecessary prior authorization and other utilization management practices, and ensure any savings from the IRA are delivered directly to patients rather than diverted to unrelated spending and subsidies.”

The principles focus on three key areas:

  • CMS must adopt a patients-first approach;
  • CMS must make patients the primary source for determining a medication’s value; and
  • CMS must increase transparency and remove access barriers.

To achieve these goals, the principles include specific recommendations that include prioritizing patient affordability and access to the highest quality of care, prohibiting the use of the quality-adjusted life year (QALY) when assessing pricing for patients, and an audit the U.S. health system to understand drivers of healthcare inflation.

“CMS’ decisions will have enormous impacts on patients and their ability to access affordable care, which is why it’s critical that the agency actively recruits patient and caregiver voices. Patients are, after all, the end-users of the healthcare system,” said Terry Wilcox, CEO of Patients Rising. “If CMS’ intentions are to truly help patients, then their feedback must be included in every step of the negotiation process.”