CMS gives drugmakers no safe harbor when 340B entities withhold claim data
Issue
On November 9, 2026, CMS finalized its Medicare Drug Price Negotiation Program rule. A commenter asked to shield drugmakers when 340B covered entities refuse to share claim data.
CMS called that out of scope and set no safe harbors, but will weigh operational barriers when reviewing drugmaker compliance. Effective December 5, 2026. Its 340B discussion names no health center.
Sources for this story
Centers for Medicare & Medicaid Services (Medicare Drug Price Negotiation Program final rule, Federal Register document 2026-22792, 91 FR 72176)Part of
- 340B drug pricing
Manufacturer restrictions and data demands
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FQHC Talent. (2026, November 9). CMS gives drugmakers no safe harbor when 340B entities withhold claim data. Source: Centers for Medicare & Medicaid Services (Medicare Drug Price Negotiation Program final rule, Federal Register document 2026-22792, 91 FR 72176). Retrieved November 11, 2026, from https://www.fqhctalent.com/intel/cms-negotiation-final-rule-no-safe-harbor-340b-data-sharing-november-2026