Legal
HRSA Issues FQHC Scope of Project Manual Governing Provider Arrangements and 340B Operations
On August 11, 2026, HRSA released its Health Center Program Scope of Project Policy Manual, providing comprehensive guidance on what constitutes an FQHC's approved scope of project under Section 330 of the Public Health Service Act. The manual took effect immediately upon release. It addresses provider-patient relationships, arrangements with other providers, and 340B drug pricing program operations for federally qualified health centers. The guidance affects how FQHCs structure their service delivery, contractual relationships, and participation in federal programs, with implications for Medicaid managed care plans contracting with FQHCs and state agencies overseeing network adequacy.
Why it mattersThe manual's immediate effective date requires Medicaid managed care plans and state agencies to assess whether FQHC network providers' current arrangements and 340B operations comply with the new scope of project requirements, potentially affecting contract terms and network adequacy compliance.