On August 11, 2026, the Health Resources and Services Administration (“HRSA”) released its Health Center Program Scope of Project Policy Manual (“Scope Manual”), providing comprehensive guidance on what constitutes a health center’s approved scope of project under Section 330 of the Public Health Service Act. The Scope Manual became effective immediately upon release.
Federally Qualified Health Centers (“FQHCs”) and “look-alikes” cannot add a delivery site, new service category or expanded target population without prior approval from HRSA via the Change in Scope (“CIS”) process. The Scope Manual modernizes HRSA’s past approach by serving as the primary health center scope of project policy and replacing the separate scope of project policies previously set forth in Policy Information Notices (“PINs”). As a companion resource, HRSA also released its comprehensive responses to comments on the draft Scope Manual that was published in December 2024. This document contains an additional 85 pages of insight into HRSA’s thought process in adopting the Scope Manual.
For health centers, the new manual has immediate operational significance. In addition to consolidating past guidance, the Scope Manual provides further clarity on health center scope of project questions. In particular, the Scope Manual addresses several key areas of interest, including:
- Scope of Project: HRSA defines the components of a health center’s scope of project, including sites, services, service area and target population. These are generally the same five core elements included in the superseded guidance; however, the Scope Manual makes changes such as (i) clarifying that the criteria apply to locations, such as pharmacy sites, that would not have been “service sites” under the superseded guidance; and (ii) listing new criteria for adding sites, including specific criteria for temporary service sites opened in response to declared emergencies.
- Patient-Provider Relationship: HRSA clarifies that an individual becomes an established health center patient only when an in-scope service is delivered on behalf of the health center, the patient is located in or resides in the health center’s service area and the health center maintains the visit record. The superseded guidance did not expressly define what constitutes a patient-provider relationship.
- Telehealth Services: HRSA provides more detailed guidance on services delivered via telehealth and when these are within scope. In the published comments, HRSA addresses applicable geographic restrictions and clarifies that whether a patient may receive a service via telehealth as an in-scope service depends on the patient’s physical location or residency at the time of service. The Scope Manual provides that the patient must be located in or reside in the health center’s service area during the telehealth encounter.
- Co-Located Service Sites: HRSA clarifies the requirements for contractor-operated, subrecipient-operated and co-located service sites. In particular, a health center must demonstrate independent operations, separate clinical and fiscal functions, retrievable patient records, board control and clear notice to patients.
- Employer Clinics and Hospital Management: HRSA clarifies that managing or staffing an employer-operated clinic or hospital department on behalf of another entity is an “other line of business” outside the health center program scope. The superseded guidance used only non-health care examples such as operating a day care center when discussing other lines of business.
The Scope Manual’s revised standards for establishing a patient-provider relationship, determining when telehealth services are within scope and operating contractor, subrecipient and co-located service sites may each affect how an FQHC handles 340B drugs. Unless the FQHC appropriately incorporates any resulting operational changes into its 340B policies and third-party administrator software, it may face repayment risk for drugs that no longer qualify for 340B pricing.
Practical Takeaways
- The new Scope Manual highlights that what is within a health center’s scope increasingly turns on who the health center is acting for, where the patient is located and whether operational facts match the approved scope.
- Any new change-in-scope requests submitted to HRSA will most likely be evaluated under the revised standards, and health centers should review their current scope documentation to ensure compliance with the updated guidance.
- Health centers with pending requests to add new service sites should pay particular attention to the Scope Manual and applicable timelines.
- Hospitals and other providers with arrangements with health centers should also be aware of applicable terms related to staffing and co-location. Existing relationships may need to be reevaluated, especially if services provided in co-located or non-FQHC facilities were treated as FQHC services before the Scope Manual was released.
- Health centers should review their telehealth policies to determine in what instances telehealth services can be considered within their scope of service.
Health centers should also identify any impact that the patient-provider relationship, telehealth, contractor, subrecipient and co-location provisions of the Scope Manual may have on their handling of 340B drugs.
If you have any questions or would like assistance evaluating how the Scope Manual may affect your health center operations, please contact:
- James Junger at (202) 780-2989 or jjunger@hallrender.com;
- Andrew Heberling at (248) 457-7807 or aheberling@hallrender.com;
- Mara Wilber at (216) 538-1702 or mwilber@hallrender.com;
- Will Wurster at (317) 977-1494 or wwurster@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
