Health Center Program Compliance Frequently Asked Questions (FAQ)

If a health center needs to make a change to its scope of project, the health center must submit a CIS request through the Electronic Handbooks (EHBs). This allows HRSA to review and approve the change. There are two kinds of CIS requests:

• Formal- a formal CIS is for a significant change.
• Scope Adjustment- a scope adjustment is for a smaller change.

Formal CISs include:

• Add a new, additional, or specialty service to scope
• Delete an existing service from scope
• Add a new service site to scope
• Convert an existing administrative-only site to a service/administrative site or a service site
• Delete an existing service site from scope
• Convert an existing service site or service/administrative site to an administrative-only site
• Add a new target population

Scope Adjustments include:

• Update a required service
• Update an additional or specialty service
• Add an administrative-only site
• Delete an administrative-only site
• Update information about a site (such as hours of operation, months of operation, zip codes)
• Add, remove, or update other activities/locations

There are some updates to scope that are done by a health center through the self-update module within the EHBs. HRSA does not review these submissions.

Self-Updates include:

• Site name
• Service delivery site type (can only switch between administrative/service delivery site and service delivery site)
• Web URL
• Site phone number
• Site setting
• FQHC site National Provider Identification (NPI) number
• FQHC site Medicare billing number status
• FQHC site Medicare billing number

(Updated: 3/8/2023)

No, a change not listed under Formal CIS, Scope Adjustment CIS, or Self-Updates, as described in the "What is a Change in Scope (CIS) request?" FAQ, does not require the submission of a CIS into the Electronic Handbooks (EHBs).

Examples of changes that do not require HRSA approval may include, but are not limited to, hiring a new provider for a service already in scope or expanding in-scope services at other existing sites. For more information about scope, refer to the Scope of Project webpage.

(Updated: 3/8/2023)

A health center should submit a CIS request at least 60 days before the health center plans to implement the change.

(Updated: 3/8/2023)

1. Review PIN 2008-01: Defining Scope of Project & Policy for Requesting Changes (PDF - 224 KB) and PAL 2014-10: Updated Process for Change in Scope Submission, Review and Approval Timelines (PDF - 126 KB).
2. Use the sample forms and instructions found on the Scope of Project Resources webpage as a guide to complete the CIS.
3. Submit any questions through the BPHC Contact Form.
4. Complete and submit the official forms through the Electronic Handbooks (EHBs).

(Updated: 3/8/2023)

HRSA may take up to 60 days to review and approve a CIS, and HRSA may return any submission that needs corrections. Once a health center resubmits a CIS, HRSA may take another 60 days to review and approve it. In unique cases, HRSA may extend the review period beyond 60 days.

If HRSA approves a Formal CIS, the health center will receive a Notice of Award (NoA) or Notice of Look-Alike Designation (NLD). The health center then has 120 days to implement the change (for example, opening a health center site or beginning to provide a new health care service). When the change in scope is implemented by the health center, the health center must submit a Scope Verification task in the Electronic Handbooks (EHBs). Once HRSA accepts the verification, HRSA will issue a new NoA or NLD confirming the updates to the health center's scope of project.

Although HRSA does not issue a NoA or NLD for Scope Adjustment CISs or Self-Updates, the health center's scope of project updates in the EHBs. For additional information, refer to PAL 2014-10: Updated Process for Change in Scope Submission, Review and Approval Timelines (PDF - 126 KB).

(Updated: 3/8/2023)

A health center should refer to the Scope of Project Resources webpage to learn more about the CIS process. Some resources apply to all CIS requests; others are specific for changes to services, sites, target populations, or other activities.

(Updated: 3/8/2023)

At a minimum, HRSA considers the following factors to determine if a service or activity is provided on behalf of the health center: 

• The service or activity benefits the health center target population;
• Health center providers (specifically, employees, contractors, or volunteers) deliver in-scope services working under the direction of the health center;
• The health center pays for health center provider time using grant or non-grant funds included in the health center project total budget;
• Health center providers deliver in-scope services or carry out in-scope activities based on the health center’s policies and procedures;
• The health center governing board has control and authority over the activities and provision of all in-scope services, whether the activities take place at a health center site or at another location within the community; 
• For services provided through a contract or formal referral agreement, the health center’s governing board approves the contract or formal referral agreement;
• The health center establishes and maintains a patient record for all individuals served; and
• The health center bills for the services, as applicable. 

There may be other factors that indicate a service or activity is provided on behalf of the health center and within the health center scope of project. HRSA may need and request more information from health centers when assessing change-in-scope requests. 

Note: Certain changes for a health center’s scope of project require HRSA prior approval. For more information, refer to HRSA Health Center Program Scope of Project and HRSA’s Policy Information Notice (PIN) 2008-01: Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB). If you have questions about whether a service your health center provides or is planning to provide would be considered by HRSA to be in scope or if you have questions about change in scope requests, use the “Program Monitoring H80 / Change in Scope” section on the BPHC Contact Form.

(Updated: 11/1/2023)

 

A health center must contact HRSA as soon as possible but no later than 15 calendar days after initiating emergency response activities at the location. HRSA will determine on a case-by-case basis whether extraordinary circumstances justify an exception to the 15-day requirement.

A health center should use the BPHC Contact Form (preferred) or e-mail BPHCOHCPMHCESupport@hrsa.gov to submit a temporary service site request. To submit a request on the BPHC Contact Form, a health center awardee or look-alike should:

1. Go to the "Program Monitoring H80" section;
2. Select "General H80 Award;" and
3. Select "Temporary Site Request (Emergency Need)" in the dropdown menu.

If a health center is unable to access the BPHC Contact Form or to e-mail BPHCOHCPMHCESupport@hrsa.gov, a health center should contact Health Center Program Support at 1-877-464-4772.

To learn more about what a health center must submit to HRSA in the request, refer to PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF - 266 KB).

(Updated: 3/8/2023)

A health center must contact HRSA to request approval for an extension of time beyond 90 days. Otherwise, HRSA's approval of a temporary service site will automatically expire 90 days after the temporary service site's approved effective date, regardless of the issue date of formal documentation, and HRSA will administratively remove the temporary service site from the health center's scope of project.

A health center should use the BPHC Contact Form (preferred) or e-mail BPHCOHCPMHCESupport@hrsa.gov to submit an extension request. To request an extension using the BPHC Contact Form, a health center awardee or look-alike should:

1. Go to the "Program Monitoring H80" section;
2. Select "General H80 Award;" and
3. Select "Temporary Site Request (Emergency Need)" in the dropdown menu.

If a health center is unable to access the BPHC Contact Form or to e-mail BPHCOHCPMHCESupport@hrsa.gov, a health center should contact Health Center Program Support at 1-877-464-4772.

To learn more about temporary service site requests, refer to PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF - 266 KB).

(Updated: 3/8/2023)

Yes. While the COVID-19 PHE ended on May 11, 2023, the telehealth guidance HRSA issued during the PHE will be in effect until HRSA finalizes new policy guidance, which we anticipate releasing in draft this fall as part of the draft Scope of Project Policy Manual, or until December 31, 2025, whichever comes first.

Your health center may provide in-scope services via telehealth to people who have not received care at your health center before and who are not current patients of the health center. This includes triage services, including initial consultations. 

Telehealth visits are within the scope of project if:

• The person receives an in-scope required or additional health service;
• The provider documents the service in a patient medical record consistent with applicable standards of practice; and
• The provider is at a health center service site or at another location on behalf of the health center (for example, the provider’s home or an emergency operations center).

You should focus your health center’s telehealth services on patients and other people located in your health center’s service area or in adjacent areas.  HRSA recognizes that patients outside these areas may seek screenings and triage through telehealth. If your health center maintains services for the target populations in your health center’s service area, your health center may occasionally provide in-scope services through telehealth to people outside your health center’s service area or adjacent areas.

Refer to PAL 2020-01: Telehealth and Health Center Scope of Project (PDF - 176 KB) for more information.

Be aware that the telehealth reimbursement requirements of third-party payors, including Medicare, may be different from HRSA’s Health Center Program requirements.

(Updated: 10/08/2024)
 

In order to operate a SSP within your health center’s Health Center Program scope of project and use new or existing Health Center Program funds, your health center must request prior approval from HRSA via the HRSA Electronic Handbooks (EHBs). HRSA must review and approve the prior approval request before Health Center Program funding can be used to support proposed syringe service program costs, as allowable.

Your health center must submit all of the following items in the prior approval request:

• Documentation that your health center's state or local health department, in conjunction with the CDC, has determined that the jurisdiction your health center is located within "is experiencing, or is at risk for, a significant increase in hepatitis infections or an HIV outbreak due to injection drug use." You can find out if your health center is located in a jurisdiction that meets this determination of need requirement by referring to the Centers for Disease Control and Prevention Syringe Services Programs website.
• A letter signed by the health officer from the state, local, territorial, or tribal health department certifying that your health center’s SSP will operate in accordance with applicable law.
• Confirmation that your health center has substance use disorder (SUD) services (PDF - 315 KB) appropriately documented in your health center’s approved Health Center Program scope of project on Form 5A: Services Provided (PDF). If your health center does not currently have SUD services approved within its scope of project, you may submit a change in scope (CIS) request prior to submitting the prior approval request for the SSP. For more information on the CIS process, refer to the Scope of Project webpage.
• Confirmation that your health center will not use Health Center Program or any other federal grant dollars to purchase sterile syringes/needles for illegal drug injection.

For additional information, including guidance on the use of Health Center Program grant funds and other health center revenues to support the implementation of an SSP, refer to the latest HRSA Grants Policy Bulletin (PDF - 105 KB).

For technical assistance on the allowable uses of grant funds, contact your health center's Grants Management Specialist. For questions on the prior approval request, use the BPHC Contact Form (select "Program Monitoring H80," then select "Prior Approval").

Further federal guidance on SSPs is available at:

• Health Resources and Services Administration-Specific Implementation Guidance to Support Certain Components of Syringe Services Programs, 2016 (hiv.gov) (PDF - 329 KB)
• Syringe Services Programs (SSPs) | CDC
• Syringe Services Programs | HIV.gov

(Added: 5/26/2023)

Health centers can provide services to their patients and other residents of their service area at locations outside the health center, such as homeless encampments, parks, and under bridges. Providing care in this way enables individuals experiencing homelessness and others who may avoid medical treatment or face barriers to accessing medical treatment in traditional care settings to access care. We consider these activities to be in your scope of project if: 

1. You provide services documented on your Form 5A: Services Provided; 
2. Your health center providers (employees, volunteers, or contractors) deliver the services; and 
3. You document the services you provide in a health center patient record.

You can document that you provide services through street medicine in your health center’s scope of project by: 

• Ensuring that you have documented any services you provide through street medicine on your Form 5A: Services Provided (PDF - 63 KB); and
• Documenting these activities on Form 5C: Other Activities/Locations (PDF - 113 KB) by checking “Portable Clinical Care” in the list of Activity Types/Locations. 

See PIN 2008-01 – Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB) for additional information. 

You should ensure that you obtain appropriate informed consent prior to providing care. You should also have policies and procedures in place regarding what clinical services your staff can and cannot provide at the locations where you provide services through street medicine.

For information about FTCA requirements, refer to the FTCA Health Center Policy Manual (PDF - 406 KB), including sections C. Covered Activities, C.3 Provision of Services to Health Center Patients, and C.4 Covered Services to Non-Health Center Patients. Section C.4 reads in part: 

"Homeless Outreach - Health center staff travel to a shelter for homeless persons or a street location where homeless persons congregate, to conduct intake screening to determine those in need of clinic services. Health care services may be provided at the time of the intake activity or during subsequent clinic staff visits to that location."

We cannot provide general assurance of FTCA coverage in all situations, as such determinations are “fact specific.” If you have questions on how your health center’s specific street medicine model would be documented in your health center’s scope of project or covered by FTCA, please reach out to BPHC using the BPHC Contact Form. 

(Added: 12/23/2024)
 

This question relates to Serving Justice-Involved Individuals Reentering the Community and PIN 2024-05 (PDF - 482 KB).

Review the criteria in Section VI of PIN 2024-05 (PDF - 482 KB). If your health center meets these criteria, you may provide any of the services listed in Section VII of the PIN. 

You must have exclusive control and authority over the services provided to justice-involved individuals reentering the community (JI-R individuals). If facts (for example, language in your written agreement with the carceral authority) indicate your providers are acting on behalf of a third party and not your health center, we will consider these services and the carceral setting outside your health center’s scope of project. 

All services your health center provides must support transitions in care during the 90-calendar-day period prior to a JI-R individual’s scheduled or expected release. For JI-R individuals without an official expected or scheduled release date, this is for a period no longer than 90 calendar days.

(Added: 12/4/2024)
 

This question relates to Serving Justice-Involved Individuals Reentering the Community and PIN 2024-05 (PDF - 482 KB).

Your health center can provide transitional care services (consistent with those in Section VII of PIN 2024-05 (PDF - 482 KB)) in carceral settings including prisons, jails, juvenile justice facilities, or other carceral facilities operated by or on behalf of a state or local government.

You may not provide in-scope health center services to JI-R individuals in the care and custody of the federal government, even if they are in the same carceral setting as those in the care and custody of a state and/or local government.

(Added: 12/4/2024)

This question relates to Serving Justice-Involved Individuals Reentering the Community and PIN 2024-05 (PDF - 482 KB).

Yes. You must have a signed memorandum of agreement or understanding (MOA/MOU) with the carceral authority that operates the carceral setting where you will provide transitional care services. A carceral authority is the local or state government that is responsible for the care and custody of the JI-R individual.

(Added: 12/4/2024)
 

This question relates to Serving Justice-Involved Individuals Reentering the Community and PIN 2024-05 (PDF - 482 KB).

You can add transitional care in carceral setting (TCCS) locations through the Electronic Handbooks (EHBs) Scope Module. You should first review the criteria in PIN 2024-05 (PDF - 482 KB)  to ensure your change in scope request meets all PIN requirements. 

You will submit requests to add TCCS locations through a Change in Scope (CIS) Scope Adjustment request for an "Administrative-Only Site." Under “Scope Adjustment Request: Make minor adjustments or modifications to scope of project,” select “Add an Admin Only Site.” You cannot add TCCS locations as "Service Sites."

If we approve the CIS request for the TCCS location, we will not issue a notice of award (NoA) or notice of look-alike designation (NLD). However, the TCCS location will appear on your Form 5B in EHBs as an Administrative-Only Site which will serve as documentation that the location is within your scope of project. TCCS locations will not appear in Find a Health Center.

All services you provide at these TCCS locations must be within the list of allowable transitional care services in Section VII of PIN 2024-05 (PDF - 482 KB). These services must be within your approved scope of project (as documented on Form 5A: Services Provided) and, as with all in-scope services, you must make those services available to all residents of your service area. 

Use the following resources to prepare your health center’s CIS request:

• Guidance for Completing a Change in Scope Request to Add Transitional Care in Carceral Setting to Your Scope of Project (PDF - 248 KB)
• EHBs Quick Reference Guide for Transitional Care in Carceral Setting CIS Requests (PDF - 1 MB)

(Added: 12/20/2024)