EACH/PIC Coalition

EACH/PIC Coalition Submits Comments from 23 Orgs to CMS on GUARD Model

The EACH/PIC Coalition submitted comments to the Centers for Medicare and Medicaid Services (CMS) on the proposed GUARD model, which would implement most favored nation (MFN) style pricing for Medicare Part D. The letter outlines that the demonstration would be unlikely to meaningfully lower what patients pay for their medications and urges for patient-centered reforms that would better address their needs.

The letter stated:

“The GUARD model relies on ‘most favored nation’ style pricing benchmarks to constrain drug costs. While such benchmarks may affect what Medicare pays, patient affordability is shaped by a broader set of factors, including insurance benefit design, formulary placement, utilization management, and cost-sharing requirements.”

“Because these patient-facing elements largely determine whether a drug therapy is affordable in practice, changes to underlying payment benchmarks alone are unlikely to meaningfully alter patients’ out-of-pocket experience. As a result, the GUARD model risks addressing system-level spending without resolving the affordability challenges patients consistently identify.”

“Even when payment reforms generate savings within the healthcare system, those savings do not automatically translate into lower costs for patients. In practice, patients’ financial experience is shaped by coverage rules and plan design decisions that operate independently of payment benchmarks. Without reforms that directly engage these drivers of patient cost burden, MFN-based approaches risk producing limited or uneven benefits for patients.”

“While we appreciate CMS’s interest in exploring new approaches, the GUARD demonstration is unlikely to meaningfully improve patient affordability. Any system-level savings achieved under the model may not translate into relief for patients without complementary reforms that directly address patient-facing barriers.”

“For these reasons, we respectfully urge CMS to withdraw the proposed GUARD demonstration and instead focus on patient-centered reforms that directly reduce out-of-pocket costs, protect access, and reflect the realities patients face in affording their medications.”

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