Medicare Negotiation Final Guidance: No More ‘Gag’ Rules, But Other Changes Fall Short Of Hopes
CMS sends a warning to Medicare Part D plans that beneficiaries should have ‘meaningful’ formulary access to drugs with negotiated prices. However, the guidance does not broaden potential exclusions from negotiation for orphan drugs, to the disappointment of stakeholders.
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The final guidance on the Medicare drug price negotiation program also addresses complaints that the government may violate the uncompensated ‘takings’ clause of the Fifth Amendment of the US Constitution in the way it considers remaining patents and exclusivities for negotiated drugs.