In a Bloomberg Law article, health care partner Margaux Hall discussed the Centers for Medicaid & Medicare Services revised guidance for the process of selecting the first 10 Medicare Part D drugs that will face government-negotiated prices starting in 2026.
Margaux notes that CMS has retained considerable discretion across various areas of importance to program implementation, and this is likely to draw concerns.
In the revised guidance, CMS stood by its definition of a “qualifying single source drug” to include all of the drug’s various dosage forms and strengths, including those that may be subject to different FDA-approved applications. Margaux said this was a topic that raised many legal and policy concerns from stakeholders, and those concerns remain.
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