HRSA’s New FQHC Scope Manual Changes How Health Centers Define Patients, Sites, Telehealth and 340B Eligibility

HRSA released the Health Center Program Scope of Project Policy Manual on August 11, 2026. The manual immediately replaced prior scope guidance contained in multiple Policy Information Notices and now serves as the primary policy text defining an FQHC's approved scope under Section 330 of the Public Health Service Act.

The manual consolidates prior guidance and adds new, operationally specific standards that affect who qualifies as a health center patient, when telehealth and co-located services are within scope, and how sites and relationships are treated for program purposes, including 340B drug pricing operations.

Patient-provider relationship redefined HRSA now specifies three conditions for an established patient: (1) an in-scope service is delivered on behalf of the health center, (2) the patient is located in or resides in the health center's service area at the time of the service, and (3) the health center maintains the visit record. Previously, HRSA guidance did not expressly define the patient-provider relationship in this way.

Operational consequence: services that were previously billed as FQHC visits may no longer qualify if any of those three elements are missing. Health centers should audit intake, documentation, and location verification practices to confirm that visit records reflect these elements.

The manual clarifies that whether a telehealth encounter is an in-scope service depends on the patient's physical location or residency at the time of the encounter. Specifically, the patient must be located in or reside in the health center's service area during the telehealth visit.

Operational consequence: telehealth policies and workflows must capture and retain the patient's physical location at the time of service. Change-in-scope requests that involve telehealth expansion will likely be measured against this geographic standard.

Sites, co-location and third-party arrangements HRSA defines scope components to include sites, services, service area and target population. The manual expands the concept of locations that count as part of the scope—explicitly calling out locations such as pharmacy sites—and adds criteria for adding sites, including rules for temporary sites opened for declared emergencies.

For contractor-operated, subrecipient-operated and co-located service sites, HRSA requires demonstration of independent operations, separate clinical and fiscal functions, retrievable patient records, board control and clear notice to patients. Separately, managing or staffing an employer-run clinic or a hospital department on behalf of another entity is treated as an "other line of business" that sits outside the health center program.

Operational consequence: arrangements that involve shared staffing or management may need restructuring or clear contractual and operational separations to preserve scope eligibility.

The manual's clearer standards on who counts as a patient, where services occur, and how co-located or contractor sites operate can change which drug dispensing events qualify for 340B pricing. HRSA cautions that if operational facts do not match the approved scope, health centers could face repayment risk for drugs that no longer qualify for 340B discounts.

Action steps for health centers and partners

• Review existing scope documentation and pending Change in Scope requests against the new manual.
• Update telehealth intake and documentation to capture patient location at time of service.
• Reassess co-location, contractor and subrecipient arrangements to ensure operational separation, retrievable records and board control where required.
• Align 340B policies and third-party administrator software with the clarified scope standards to reduce repayment risk.

The Scope Manual is effective immediately. HRSA also published extensive responses to public comments on the draft manual, which provide additional detail on HRSA's implementation rationale. Health centers with pending site additions or other change requests should assume HRSA will apply the revised standards when evaluating those requests.