Health Center Program Compliance Frequently Asked Questions (FAQ)

The Health Center Program Compliance Manual serves as a consolidated resource to assist health centers in understanding and demonstrating compliance with Health Center Program and Federal Tort Claims Act (FTCA) deeming requirements. The Health Center Program Compliance Manual increases clarity and consistency across the Health Center Program and serves as the foundation for HRSA's eligibility and compliance determinations.

The Health Center Program Compliance Manual applies to all Health Center Program award recipients, sub-recipients, and look-alikes. This includes health centers that are public agencies and health centers funded to serve only special populations (that is, individuals experiencing homelessness, residents of public housing, and migratory and seasonal agricultural workers).

The Health Center Program Compliance Manual is not intended to provide best or promising practices or performance improvement strategies. However, the Related Considerations sections of the Health Center Program Compliance Manual provide examples of areas where health centers have discretion when implementing a program requirement.

(Updated: 3/8/2023)

No, the Health Center Program Compliance Manual only supersedes the PINs and PALs listed in the Purpose section of the Compliance Manual. Refer to the Health Center Program PINs and PALs library for current PINs and PALs.

(Updated: 3/8/2023)

No, the Health Center Program Compliance Manual does not supersede the FTCA Health Center Policy Manual (PDF - 406 KB). Each of these documents has a distinct purpose.

The FTCA Health Center Policy Manual is the primary policy source for information about the FTCA program and focuses primarily on how FTCA relates to covered entities, individuals, and other situations. The FTCA Health Center Policy Manual does not focus on the requirements for FTCA deeming.

The Health Center Program Compliance Manual includes the requirements for FTCA deeming, including those that overlap with Health Center Program requirements. The requirements for FTCA deeming are also listed in the current Calendar Year Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers.

(Updated: 3/8/2023)

Yes, HRSA remains committed to reviewing the Health Center Program Compliance Manual routinely and to proposing updates for public comment, as appropriate.

(Updated: 3/8/2023)

HRSA conducts operational site visits for health centers at least once per period of performance. For health centers with a 1-year period of performance, the operational site visit generally takes place 2 - 4 months into the new period of performance. For health centers with a 3-year period of performance, the operational site visit takes place approximately 12-16 months into the new period of performance. However, HRSA may adjust the 12 to 16 month time period due to extenuating circumstances.

(Updated: 9/22/2023)

HRSA will continue the implementation of both virtual and in-person site visits throughout fiscal year 2023. HRSA will inform a health center prior to the site visit as to whether it will be a virtual or in-person visit.

(Updated: 3/8/2023)

The Site Visit Protocol (SVP) is like an "open book" test. It contains methodologies and questions that the HRSA site visit team uses and answers to assess health centers' compliance with program requirements.

Health centers should fully review methodologies and questions in the SVP to prepare for their site visit. Health centers may use the SVP to organize documents, samples, and other items reviewed during the site visit. Health centers may also use the SVP to prepare answers for the HRSA site visit team.

Health centers are also encouraged to review related Site Visit Resources when preparing for an upcoming site visit.

(Updated: 3/8/2023)

The Site Visit Protocol includes an Eligibility Requirements for Look-Alike Initial Designation Applicants section that the HRSA site visit team uses to assess eligibility for health centers seeking LAL ID.

To prepare for the site visit, applicants who seek LAL ID should fully review all eligibility requirements, methodologies, and questions in the SVP. LAL ID Applicants may use the SVP to organize documents according to the documents checklist, samples, and other items reviewed during the site visit. Applicants may also use the SVP to prepare answers for the HRSA site visit team.

The SVP is like an "open book" test. It contains methodologies and questions, including a specific methodology section about eligibility requirements for LAL ID, that the HRSA site visit team uses and answers to assess health centers' compliance with LAL ID eligibility and program requirements.

LAL ID health center applicants are encouraged to review the Health Center Program Look-Alike (LAL) Initial Designation (ID) Application Instructions and Resources, as well as Site Visit Resources and the Five Tips for a Successful Operational Site Visit video, when preparing for an upcoming site visit.

(Added: 5/26/2021)

Site visit teams, including consultants, are authorized representatives of HRSA and thus may review a health center's policies and procedures, financial or clinical records, and other relevant documents (any of which may include Personally Identifiable Information [PII]) in order to assess and verify compliance with Health Center Program requirements. Site visit teams are also subject to confidentiality standards, including HIPAA. Consultants who violate such standards are in violation of their contract and could be subject to Title 18, United States Code, Section 641. Health centers may request that HRSA staff or consultants sign additional confidentiality statements. If so, a health center should communicate this to the site visit team before the site visit to avoid any disruption or delay in the site visit process. In addition, health centers may remove PII from files, records, and other samples provided to the site visit team, so long as enough information remains for the site visit team to assess compliance.

(Updated: 7/1/2024)

The site visit team will consider all the information obtained during the site visit, including through document review, interviews, or samples. The team will document their findings as directed by the Site Visit Protocol (SVP), including any discrepancies, and provide them to HRSA. HRSA will then review the site visit findings, analyze any discrepancies, and make final compliance determinations.

(Updated: 3/8/2023)

The purpose of a site visit is to assess whether a health center demonstrates compliance with the statutory and regulatory requirements of the Health Center Program. During a site visit, consultants may offer or respond to a health center's request to share recommendations or technical assistance that fall outside the scope of the compliance review.

The site visit report will not record recommendations and technical assistance information requested by health centers or offered by site visit team members.

(Updated: 3/8/2023)

The health center selects all samples (for example, patient records). When the SVP allows for a range in the sample size, the health center should take into account its size and complexity when determining sample size. The health center should provide samples that are representative of its current Health Center Program project operations.

If the HRSA site visit team is unable to assess a Health Center Program requirement using the health center's sample, the team may complete additional sampling in coordination with the health center.

The site visit team will not review documents provided after the close of the first day of the site visit for the compliance assessment.

(Updated: 3/8/2023)

HRSA encourages health center staff to consider the health center's size and structure and relevancy of documents requested to the health center project. For example, a sample of contracts/agreements is only necessary if the health center delivers health services through contracts/agreements.

Refer to the Sampling Review Resource Guide as a helpful sampling resource.

(Updated: 3/8/2023)

A health center must provide the documents listed in each section of the Site Visit Protocol (SVP) to the site visit team. Health centers provide documents at least two weeks before the start of the site visit. HRSA may provide additional guidance on preparation or document submission before the site visit.

Health centers may submit confidential documents, such as patient records, in advance or review them with the site visit team at the time of the site visit. If a health center chooses to upload confidential documentation before the site visit, the health center must remove Personally Identifiable Information (PII). If the health center opts to provide these documents at the time of the site visit, the health center should inform the site visit team in order to account for this within the site visit schedule.

The site visit team will not review documents provided after the close of the first day of the site visit for the compliance assessment.

A Consolidated Documents Checklist (PDF - 561 KB) is available in the Site Visit Tools section of the SVP webpage to help health centers prepare.

HRSA also provides the site visit team with relevant documents before the visit, as noted in the Operational Site Visit Documents Provided by HRSA.

(Updated: 3/8/2023)

Yes, the name or title of a document may differ from that specified in the Site Visit Protocol. Health centers have discretion in how they name or title their documentation. The HRSA site visit team reviews documents to assess compliance with the program requirements. Compliance determinations are based on document content.

For example: Where the SVP asks the health center to provide a "board-approved policy," HRSA would assess compliance based on evidence of board approval and on the content of the document, regardless of whether the health center calls the document a "procedure" or "protocol" instead of a "policy."

Many demonstrating compliance elements allow for the review of "other documentation" to demonstrate compliance if health centers cannot demonstrate compliance in documents specifically listed in the SVP.

Certain terminology also may vary as long as it meets the intent of the demonstrating compliance element. For example, board meeting minutes may note that the board "accepted" a policy, and HRSA considers that terminology as equivalent to the board "approving" the policy.

(Updated: 3/8/2023)

Yes, the health center will conduct a live virtual tour for the site visit team of a service site (or, if the health center has multiple service sites, at least two service sites) using video-conferencing software and the health center's equipment (for example, phone, tablet, computer camera).

(Updated: 3/8/2023)

No, health centers will not be able to make "quick fixes" during the site visit to address non-compliance findings. Instead, health centers will be able to take advantage of the Compliance Resolution Opportunity (CRO) process and submit documentation through the Electronic Handbooks (EHBs) to demonstrate compliance. If the submission demonstrates compliance with each site visit finding, HRSA will not place a condition on the award or designation. HRSA designed this feature to be a uniform and efficient way to help health centers demonstrate compliance while maintaining the objectivity and integrity of the site visit review process.

(Updated: 3/8/2023)

Health centers must complete corrections to scope of project through the Electronic Handbooks (EHBs) Change in Scope (CIS) process. HRSA must review and approve CIS requests before they are effective. The site visit team will not consider documents provided after the close of the first site visit day in the compliance assessment.

More information on the CIS process is on the Scope of Project page.

(Updated: 3/8/2023)

No, a negative ("no") response to an individual Site Visit Protocol finding question under a demonstrating compliance element does NOT automatically indicate a health center has failed to demonstrate compliance with the element. Demonstration of compliance is based on the site visit team's compliance recommendation to HRSA and the comprehensive analysis of all information associated with the element. HRSA makes all final compliance determinations.

(Updated: 3/8/2023)

HRSA assesses the majority of the demonstrating compliance elements within the Health Center Program Compliance Manual during a site visit. The Site Visit Protocol (SVP) includes the specific demonstrating compliance elements that are assessed and states when a compliance element is not assessed via the site visit process. In addition, HRSA reviews health centers for compliance with the remaining demonstrating compliance elements through the Service Area Competition (SAC) and Renewal of Designation (RD) applications. Review the SVP and the Site Visit Resources for more information and to view all demonstrating compliance elements assessed during a site visit.

(Updated: 3/8/2023)

The site visit team will notify the health center of preliminary non-compliance findings during the site visit exit conference. A health center may use the Operational Site Visit (OSV) Exit Conference Tracking Resource (PDF - 268 KB) to track these findings.

(Updated: 3/8/2023)

No, HRSA does not permit recordings of any portion of any site visit. However, a health center is permitted to take notes during the site visit and the Operational Site Visit (OSV) Exit Conference Tracking Resource (PDF - 268 KB) is a helpful site visit resource. In addition, the health center will receive a final site visit report after the site visit.

(Updated: 3/8/2023)

No, HRSA will not shorten a period of performance as a result of site visit non-compliance findings. Site visits generally occur at the mid-point of a period of performance. HRSA makes period of performance determinations at the time of Service Area Competition (SAC) or Renewal of Designation (RD).

Consistent with current practice, HRSA may shorten a period of performance when a health center fails to adequately address conditions through the Progressive Action process or when HRSA determines that an immediate enforcement action is necessary. In such cases, HRSA may use available remedies, including terminating all or part of the federal award or designation before the health center's current period of performance end date. Refer to the Health Center Program Compliance Manual Chapter 2: Health Center Program Oversight for additional information.

(Updated: 3/8/2023)

No, the Site Visit Protocol is not policy guidance. The SVP is a standardized tool HRSA uses to support the assessment of health center compliance with Health Center Program requirements. The SVP is based upon and contains the demonstrating compliance elements from the Health Center Program Compliance Manual. The Health Center Program Compliance Manual is the streamlined and consolidated source for policy guidance developed to assist health centers in understanding and demonstrating compliance with Health Center Program and Federal Tort Claims Act (FTCA) deeming requirements.

(Updated: 3/8/2023)

Between the pre-site visit call and the issuance of the site visit report, contact the Federal Representative for site visit-related questions. Once the site visit report is sent to the health center, use the BPHC Contact Form to address any related questions.

(Updated: 3/8/2023)

HRSA remains committed to regular updates of the Site Visit Protocol and related resources. HRSA consistently collects feedback to ensure the SVP remains useful for the site visit process. HRSA encourages feedback through the post-site visit evaluation questionnaires and the BPHC Contact Form. To submit feedback on the SVP through the BPHC Contact Form, select "Site Visit Protocol General Inquiry" under the "Policy" section.

(Updated: 3/8/2023)

The Compliance Resolution Opportunity (CRO) is HRSA's process to support the timely resolution of areas of non-compliance cited during a site visit. The CRO provides health centers with an opportunity to address non-compliance findings before the health center's receipt of the final site visit report.

After the OSV has concluded, HRSA will process the draft site visit report. The health center will receive an Electronic Handbooks (EHBs) task titled "Urgent Site Visit Report Request." This task provides an opportunity for health centers to submit additional information and documentation on any areas of non-compliance identified through the site visit. When responding to the task in the EHBs, the health center should ensure any documents referenced in the response are attached to the submission. The health center will have 14 calendar days to submit a response to the non-compliance findings contained in the request. There will be no extensions or exceptions.

If HRSA determines that a health center has not demonstrated compliance after the CRO process has ended, HRSA will document such non-compliance in the final site visit report and will issue corresponding conditions to the health center through a Notice of Award or Notice of Look-alike Designation.

Refer to this resource for more information about the EHBs "Urgent Site Visit Report Request" task feature: Correspondence Resolution Opportunity for OSV Structured Technical Assistance Reports.

(Updated: 3/8/2023)

No, the CRO process begins after the site visit ends and HRSA processes the draft site visit report. The health center will receive an "Urgent Site Visit Report Request" task through the Electronic Handbooks (EHBs), which begins the CRO process.

(Updated: 3/8/2023)

HRSA develops and presents a final site visit report to the health center within 45 days after the site visit. The report will convey the final site visit findings and compliance decisions, including any non-compliance findings not resolved through the CRO.

For all areas of non-compliance indicated in the final site visit report, HRSA will issue a corresponding condition to the health center through a Notice of Award or Notice of Look-alike Designation. For more information and a full list of conditions, refer to the Progressive Action Conditions Library.

(Updated: 3/8/2023)

During the CRO process, a task titled "Urgent Site Visit Report Request" will be sent to the health center through the Electronic Handbooks (EHBs). This task will include a link to the draft site visit report that documents the consultants' narrative related to any non-compliance findings. (Note that the health center cannot make changes to the report.) Non-compliance findings documented in the report are based on the Health Center Program Compliance Manual, which is available to assist health centers in understanding how to demonstrate compliance with Health Center Program requirements. The health center's response to the task should include the documentation noted in the Progressive Action Conditions Library for the corresponding non-compliance findings.

(Updated: 3/8/2023)

Yes, if a health center submits a CRO response before the end of the 14 calendar day timeframe and the health center still has not demonstrated compliance for all or some of the non-compliance findings, HRSA sends a new "Urgent Site Visit Report Request" task to the health center for additional information and clarification on the remaining non-compliance findings. When a Project Director or Authorizing Official receives an "Urgent Site Visit Report Request" task, they should respond to this task via the Electronic Handbooks (EHBs) as soon as possible. This 14-day timeframe includes any back and forth submissions between HRSA and the health center; therefore, the health center should consider this timing when submitting documentation. HRSA will not provide a deadline extension beyond the 14 calendar days. HRSA will NOT consider information shared via methods other than the EHBs "Urgent Site Visit Report Request" task submission (for example, phone calls, e-mails) in its final compliance assessment.

(Updated: 3/8/2023)

All health center personnel registered with grant privileges in the Electronic Handbooks (EHBs) will receive copies of the "Urgent Site Visit Report Request" task, but only the Project Director or Authorizing Official will be able to submit a response to HRSA.

(Updated: 3/8/2023)

HRSA initiates the Compliance Resolution Opportunity (CRO) process when it sends an "Urgent Site Visit Report Request" task to the health center's Project Director through the EHBs. If the EHBs does not list the Project Director, the Federal Representative will select an Authorizing Official to whom to send the request. Such requests will appear in the EHBs Pending Tasks list as an "Urgent Site Visit Report Request" task. An EHBs-generated e-mail to either the Project Director or Authorizing Official will also notify the health center. The request will come from ‚"HRSA GEMS": oitgems@hrsa.gov. The health center can add this e-mail address to a "safe senders" or contacts list to avoid messages potentially going to a junk folder.

(Updated: 3/8/2023)

To prepare for a possible "Urgent Site Visit Report Request" task during the CRO process, health centers must ensure that the contact information (e-mail and phone number) in the EHBs for the Project Director is up-to-date and accurate to receive the task. The Federal Representative will initiate the EHBs "Urgent Site Visit Report Request" task. The request will come from "HRSA GEMS": oitgems@hrsa.gov. Health centers can add this e-mail address to a "safe senders" or contacts list to avoid messages potentially going to a junk folder.

(Updated: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Transportation services enable patients to access health center services when transportation would otherwise be a barrier to care (for example, providing transport vehicles, bus tokens or vouchers for public transportation, or linkages to other community transportation programs).

To accurately document the provision of patient transportation services on Form 5A: Services Provided, refer to the following:

• Column I (Directly): If a health center provides its own transportation service or directly pays for transportation that enables patients to access health center services, record such transportation services in Column I. For example, the health center operates a patient transport vehicle, the health center purchases bus tokens/vouchers, or the health center arranges/pays for taxis.
• Column II (Formal Written Contract/Agreement): If a health center pays for transportation via a contract/agreement with another organization/entity, record these types of contracts/agreements in Column II. For example, the health center pays for transportation through an account with an entity such as Uber Health or a county senior van, the health center contracts with a local taxi company, or the health center has another contract for public transportation.
• Column III (Formal Written Referral Arrangement): If a health center has an arrangement for transportation with another organization/entity but is not paying for the service, record these types of arrangements in Column III. For example, the health center coordinates with or connects patients to community transportation programs but does not pay for the service.

For more information, refer to the Service Descriptors for Form 5A: Services Provided (PDF - 315 KB).

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Nutrition education and counseling that are part of a primary care visit do not have to be listed separately on Form 5A: Services Provided because they are included within "General Primary Medical Care."

However, when nutrition education and counseling meet the definition for "Nutrition" in Service Descriptors for Form 5A: Services Provided (PDF - 315 KB) and are provided as a distinct service, then a health center would list "Nutrition" on Form 5A: Services Provided.

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Screening services are performed based on identified risk factors in the community or patient population. At a minimum, these services must include screenings for all of the following: cancer, communicable disease, cholesterol, and blood lead. For more information, refer to the Service Descriptors for Form 5A: Services Provided (PDF - 315 KB) for what, at a minimum, must be included as part of each required service.

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Yes, a health center is required to provide screening services to established patients and other individuals who present for and meet the criteria for screening, regardless of ability to pay. The provision of screening services should be based on identified risk factors in the patient population or community. Screening services include, but are not limited to, testing for HIV, Hepatitis B and C, and other sexually transmitted diseases/infections based on a patient's identified risk factors.

For more information on delivering services in the Health Center Program scope of project, refer to BPHC's Scope of Project page.

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

No, contracts/agreements or referral arrangements for enabling services do not need to include all of the provisions required for clinical services, such as documentation in the patient record or follow-up care. This is because enabling services, including transportation, translation, and outreach, are generally not documented in the patient record nor do they involve follow-up care; therefore, related provisions would not be included in the associated contract/agreement or referral arrangement.

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

If a health center contracts with an answering service that does not provide any clinical advice or medical triage, the service is not recorded on Form 5A: Services Provided for the purposes of after-hours coverage. In such cases, the answering service is not an actual health care service because the only role of the answering service is to connect a patient to an individual with the qualifications and training necessary to exercise professional judgment in assessing a health center patient's need for emergency medical care.

However, if a health center contracts with an answering service that provides medical triage or advice (for example, a nurse hotline), then "Coverage for Emergencies During and After Hours" is recorded in Column II of the health center's Form 5A: Services Provided. Refer to the Health Center Program Compliance Manual Chapter 7: Coverage for Medical Emergencies During and After Hours for additional information.

(Added: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Yes, if a service is not identified on Form 5A in Columns II or III, this would be a finding of scope inaccuracy. A health center should review its Form 5A for accuracy in preparation for an operational site visit to ensure all contracted or referral services are correctly recorded on Form 5A. Refer to the Health Center Self-Assessment Worksheet for Form 5A: Services Provided (PDF - 3 MB) in preparation for an operational site visit.

(Updated: 3/8/2023)

This question relates to Element a. Providing and Documenting Services within Scope of Project

Yes, if a contract/agreement is misclassified as a referral arrangement or vice versa, then the site visit team would review the documentation based on what the appropriate column should be. The site visit team would record any non-compliance findings related to provisions that may be lacking from the contract or arrangement in the site visit report.

(Updated: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials and Element e. Credentialing and Privileging Records

The site visit team will interview staff to determine how education and training is verified for LIPs. If the health center relies on the state licensing agency and does not conduct its own primary source verification, the health center would describe how the state licensing agency conducts primary source verification of education and training.

(Added: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials and Element d. Procedures for Review of Privileges

Yes, a health center, in accordance with its credentialing procedures, is required to credential individuals who supervise or train clinical staff (for example, Director of Nursing, Director of Pharmacy) at a health center but who do not provide any direct patient care.

If these supervisors provide patient care in addition to their supervisory or management roles or perform peer review of other health center providers, the health center is also required to privilege them in accordance with the health center's privileging procedures.

(Added: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials

"Other clinical staff" are clinical staff positions that do not require licensure or certification by the health center's state, territory, or jurisdiction. Examples of other clinical staff could include Medical Assistants or Community Health Workers.

Credentialing requirements apply to other clinical staff. A health center demonstrates compliance with credentialing requirements by ensuring that other clinical staff have the necessary education and training to perform the duties of their positions.

For a health center's credentialing process:

• The health center determines what constitutes necessary education and training for each type of other clinical staff and what sources to use to document education and training.
• The health center is not required to verify licensure or certification for other clinical staff because such licensure or certification does not exist.

(Added: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials and Element d. Procedures for Review of Privileges

No, a health center governing board is not required to approve credentialing or privileging procedures or individual provider credentials or privileges to demonstrate compliance with requirements in the Health Center Program Compliance Manual Chapter 5: Clinical Staffing.

(Added: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials

All health center staff classified as clinical by the health center are required to have documentation of basic life support training in their provider files.

Clinical staff include:

• Licensed independent practitioners (for example, Physician, Dentist, Physician Assistant, Nurse Practitioner);
• Other licensed or certified practitioners (for example, Registered Nurse, Licensed Practical Nurse, Registered Dietitian, Certified Medical Assistant); and
• Other clinical staff (for example, Medical Assistants or Community Health Workers in states, territories, or jurisdictions that do not require licensure or certification).

For more information, refer to the Health Center Program Compliance Manual Chapter 5: Clinical Staffing.

In addition, each service site in a health center's scope of project (as documented on Form 5B: Service Sites) is also required to have the clinical capacity to respond to emergencies, as demonstrated by having at least one staff member trained and certified in basic life support present at the site during regularly-scheduled hours of operation. For more information, refer to the Health Center Program Compliance Manual Chapter 7: Coverage for Medical Emergencies During and After Hours.

(Updated: 3/8/2023)

This question relates to Element c. Procedures for Review of Credentials and Element e: Credentialing and Privileging Records

HRSA does not define the specific type of basic life support training required to demonstrate compliance with the credentialing requirements in the Health Center Program Compliance Manual Chapter 5: Clinical Staffing. The health center defines what constitutes basic life support training, including the extent, type, and required documentation and whether there is variation based on provider type.

For example, certain licensed independent practitioners (LIPs) may have documentation of basic life support training included as part of their licensure/certification. In such cases, a health center may determine that such documentation satisfies this aspect of the credentialing process. For other provider types that do not have basic life support training as part of their licensure or certification, the health center ensures completion of separate or additional basic life support training. An example of training documentation could include a certificate of completion or course completion dates.

The health center also determines what role it plays in providing basic life support training for clinical staff. For example, some health centers may contract with an organization that provides periodic basic life support training for all staff. Other health centers may use online basic life support training classes or allow health center staff to independently complete relevant training.

(Updated: 3/8/2023)

This question relates to Element d. Procedures for Review of Privileges and Element e. Credentialing and Privileging Records

Fitness for duty is the ability to perform the duties of the job in a safe, secure, productive, and effective manner.

A health center determines how to assess and document fitness for duty for the purposes of privileging staff to provide clinical care. For example, a health center determines whether its fitness for duty verification procedures include a physical exam.

In addition, a health center determines whether privileging procedures for assessing fitness for duty vary between the initial granting and renewal of privileges.

HRSA assesses compliance by reviewing a health center's privileging procedures to ensure they address verification of fitness for duty. HRSA also assesses compliance by reviewing a health center's clinical staff files to ensure that the health center follows its privileging procedures.

For more information, refer to the Health Center Program Compliance Manual Chapter 5: Clinical Staffing. The Site Visit Protocol (SVP) resource Examples of Credentialing and Privileging Documentation provides common examples of credentialing and privileging documentation, although the examples are not exhaustive. Best practices in verifying fitness for duty are available through the Emergency Care Research Institute (ECRI) risk management resources.

(Added: 3/8/2023)

This question relates to Element e. Credentialing and Privileging Records

No, the Examples of Credentialing and Privileging Documentation resource is intended to complement the Site Visit Protocol by providing common examples of credentialing and privileging documentation methods and sources. This resource helps with the review of a health center's clinical staff file samples. The examples in the Examples of Credentialing and Privileging Documentation resource are not exhaustive.

The health center determines the specific documentation it uses to credential and privilege health center providers, as long as there is consistency with the Health Center Program Compliance Manual and the health center's own procedures.

(Updated: 3/8/2023)

This question relates to Element d. Multiple Sliding Fee Discount Schedules

Yes, a health center can have multiple SFDSs. However, if a health center has more than one SFDS, each SFDS would be based either on a service type or on a service delivery method.

• Examples of a SFDS based on service type: Having separate SFDSs for broad service types, such as medical and dental, or distinct subcategories of service types, such as preventive dental and additional dental services.

• Examples of a SFDS based on service delivery method: Having separate SFDSs for services provided directly by the health center and for services provided via formal written contract.

For each SFDS, eligibility for sliding fee discounts, including any nominal charges, would be applied uniformly to all patients and would be based solely on income and family size. In addition, the health center would evaluate the effectiveness of each SFDS, including any SFDSs based on current procedural terminology (CPT) codes, in reducing financial barriers to care.

In addition, each SFDS would be consistent with the SFDP requirements in the Health Center Program Compliance Manual Chapter 9: Sliding Fee Discount Program.

(Added: 3/8/2023)

This question relates to Element b. Sliding Fee Discount Program Policies and Element d. Multiple Sliding Fee Discount Schedules

A health center cannot establish different nominal charges within the same sliding fee discount schedule (SFDS).

However, if a health center has multiple SFDSs, a health center can establish a nominal charge for each SFDS.

Any nominal charge set up by the health center would be:

• A flat amount;
• Set at a level that is nominal from the perspective of the patient; and
• Not reflect the actual cost of the service being provided.

As a reminder, nominal charges are not "minimum fees," "minimum charges," or "co-pays."

Eligibility for sliding fee discounts, including any nominal charges, would be applied uniformly to all patients and would be based solely on income and family size.

(Added: 3/8/2023)

This question relates to Element d. Multiple Sliding Fee Discount Schedules

No, a health center cannot have different SFDSs that vary between in-scope health center sites.

However, health centers are permitted to take into account locally prevailing rates or charges, which may vary between sites (for example, at an urban site versus a rural site). Those rates or charges determine the fee schedules. The health center applies the SFDS to the fee schedules. Therefore, this may result in differences in the amounts charged to patients, depending on the site where they receive care.

For any SFDS, eligibility for sliding fee discounts, including any nominal charges, would be applied uniformly to all patients and would be based solely on income and family size.

For more information, refer to the Health Center Program Compliance Manual Chapter 16: Billing and Collections.

(Updated: 10/24/2023)

This question relates to Element d. Multiple Sliding Fee Discount Schedules

No, a health center cannot have different SFDSs that vary by special populations. Eligibility for sliding fee discounts, including any nominal charges, would be applied uniformly to all patients and would be based solely on income and family size. Eligibility for sliding fee discounts cannot be based on whether a patient is identified as being part of a "special population" or any other demographic category.

(Added: 3/8/2023)

This question relates to Element d. Multiple Sliding Fee Discount Schedules

No, a health center cannot have a different SFDS for telehealth services. However, if the locally prevailing charges or the actual costs for services delivered via telehealth differ from those delivered in-person, a health center may have different charges for those telehealth services on the center's fee schedule. The health center applies the SFDS to the fee schedule.

For example, when the cost of providing a primary health care visit through telehealth is less than an in-person visit, the health center may establish a lower charge for the telehealth primary care visit on the health center's fee schedule. If a health center has a percentage-based SFDS, the health center would apply that SFDS to the charge for the telehealth primary care visit, which would be the same SFDS percentage discount applied to an in-person primary care visit. This would result in a lower charge to the patient for the telehealth primary care visit.

As a reminder, nominal charges are set up to be a flat amount; nominal from the perspective of the patient; and not reflective of the actual cost of the service being provided. Therefore, nominal charges do not change based on the fee schedule.

For more information, refer to the Health Center Program Compliance Manual Chapter 16: Billing and Collections.

(Added: 3/8/2023)

This question relates to Element j. Sliding Fee for Column III Services

Whether the referral provider has to offer a discount that is equal to or greater than the health center's sliding fee discount depends on the discounts offered by the Column III referral provider. The referral provider does not have to use the same sliding fee discount schedule as the health center. Instead, a health center would demonstrate compliance with sliding fee discount program requirements for a Column III referral service through the following:

1. The health center ensures that the referral provider's sliding fee discount schedule (SFDS) meets all Health Center Program Compliance Manual Chapter 9: Sliding Fee Discount Program Element "c" requirements. In this case, the referral provider's discount does not have to be equal to or greater than the health center's sliding fee discount.

   For example: A health center provides a full discount to patients with incomes at or below 100 percent of the current Federal Poverty Guidelines (FPG) and, for patients with incomes above 100 percent but at or below 200 percent of the current FPG, the health center's SFDS includes four discount pay classes based on gradations in patient income levels.

   The health center has an arrangement with a referral provider who provides obstetrical services for health center patients. For patients with incomes at or below 100 percent of the current FPG, the referral provider applies a nominal charge. For patients with incomes above 100 percent but at or below 200 percent of the current FPG, the referral provider's SFDS includes three discount pay classes based on gradations in patient income levels.

   Although the referral provider's discounts may not be equal to or greater than the health center's sliding fee discounts, the referral provider's SFDS meets all Health Center Program SFDS requirements.

OR

2. When the referral provider does NOT offer a discount that meets all Health Center Program Compliance Manual Chapter 9: Sliding Fee Discount Program Element "c" requirements, the health center ensures both of the following:
   • The referral provider's discount offers individuals and families with incomes at or below 100 percent of the current FPG a full discount or a nominal charge for the referral provider's services. The referral provider's nominal charge does NOT have to be equal to or less than that of the health center, as long as the charge is nominal.
   • The referral provider's discount offers individuals and families with incomes above 100 percent of the current FPG and at or below 200 percent of the current FPG an equal or greater discount for the referral provider's services than if the health center's SFDS were applied to the referral provider's fee schedule. The referral provider is NOT required to have a SFDS that includes at least three discount pay classes between 100 and 200 percent of the current FPG.

   For example: A health center applies a nominal charge for patients with incomes at or below 100 percent of the current FPG and for patients with incomes above 100 percent but at or below 200 percent of the current FPG, the health center's SFDS includes four discount pay classes based on gradations in patient income levels. The health center has an arrangement with a referral provider who provides free diagnostic laboratory services for health center patients with incomes at or below 200 percent of the current FPG. Because health center patients are not paying for the diagnostic laboratory services, the health center has ensured that individuals with incomes above 100 percent and at or below 200 percent of the current FPG receive greater discounts than if the health center's SFDS were applied to the referral provider's fee schedule.

(Added: 3/8/2023)

This question relates to Element d. CEO Responsibilities

The HRSA Health Center Program regulations at 42 CFR Part 51c refer interchangeably to the PD and CEO. The title of the position may vary by health center. For the purpose of demonstrating compliance with Health Center Program requirements, the PD/CEO is the individual in the health center who:

• Is directly employed by the health center;
• Is selected by the health center's governing board;
• Reports to the health center's governing board; and
• Is responsible for overseeing other key management staff in carrying out the day-to-day activities necessary to fulfill the HRSA-approved scope of project.

Under the Uniform Administrative Requirements for HHS Awards at 45 CFR 75.2, the term "Principal Investigator/Program Director (PI/PD) means the individual(s) designated by the recipient to direct the project or program supported by the grant." The Health Center Program considers the PD/CEO to be synonymous with PI/PD. Therefore, the PD/CEO is the person responsible for the day-to-day management of the Health Center Program project.

If a health center has both a CEO position and a separately identified PD position, the health center would need to show that it is the PD for the Health Center Program project, and not the CEO, that fulfills all applicable requirements noted above. The health center also would need to provide documentation that the PD is directly employed by the health center.

(Updated: 3/8/2023)

This question relates to Element d. CEO Responsibilities

Yes, health centers are required to directly employ the PD/CEO. For the purpose of compliance with Health Center Program requirements, the health center's PD/CEO is an individual who:

• Is directly employed by the health center;
• Is selected by the health center's governing board;
• Reports to the health center's governing board; and
• Is responsible for overseeing other key management staff in carrying out the day-to-day activities necessary to fulfill the HRSA-approved scope of project.

For more information, refer to the Health Center Program Compliance Manual Chapter 11: Key Management Staff.

(Updated: 3/8/2023)

This question relates to Element d. CEO Responsibilities

To demonstrate compliance with the requirement for direct employment of the PD/CEO, a health center, including a public agency health center, as the Health Center Program awardee/designee of record, would directly employ the PD/CEO. Use of a co-applicant structure for meeting Health Center Program governance requirements does not alter this requirement. Please refer to related requirements in Health Center Program Compliance Manual Chapter 19: Board Authority on public agencies with co-applicants.

(Updated: 3/8/2023)

This question relates to Element d. CEO Responsibilities

Yes, the Health Center Program statutory requirement (Section 330(k)(3)(H)(ii) of the Public Health Service Act) that a health center directly employ its PD/CEO applies to any health center PD/CEO serving on an interim or permanent basis.

(Updated: 3/8/2023)

This question relates to Element e. HRSA Approval for Project Director/CEO Changes

Yes, in accordance with grants regulations (45 CFR 75.308(c)(1)(ii) and (iii)), a health center must request and receive prior approval from HRSA when there is a post-award change in the PD/CEO position, specifically when:

• There will be a change in the current health center PD/CEO. For example: a change due to dismissal, resignation, or retirement of the current PD/CEO; appointment of an interim PD/CEO for three months or more; appointment of a new permanent PD;
• The current health center PD/CEO will be absent from the project during any continuous period of three months or more; or
• The current PD/CEO will reduce time devoted to the project by 25 percent or more from the level that was approved at the time of award/designation.

Under the HHS Grants Policy Statement (GPS), a health center must provide written notification to the Grants Management Officer, and a request for prior approval must include all information noted in the GPS (refer to HHS GPS, p. II-56 (PDF)).

(Updated: 3/8/2023)

This question relates to Element e. HRSA Approval for Project Director/CEO Changes

A health center awardee can change its Project Director by submitting a prior approval through the EHBs, using the steps identified in this video.

A health center look-alike (LAL) should use the BPHC Contact Form to obtain guidance on how to change its Project Director in the EHBs.

(Added: 3/8/2023)

This question relates to Element a. Procurement Procedures

No, in a health center's financial management or procurement procedures, a simple reference to grants regulations at 45 CFR 75 Subpart E does not demonstrate compliance.

To demonstrate compliance with the Health Center Program Compliance Manual Chapter 12: Contracts and Subawards, a health center's procurement procedures would include specific information consistent with the standards set forth in grants regulations at 45 CFR Part 75 Subpart E, as well as any other federal mandates or related requirements for all procurements related to the federal award.

For additional assistance, refer to the HRSA Manage Your Grant website.

(Added: 3/8/2023)

This question relates to Element b. Records of Procurement Actions and Element c. Retention of Final Contracts

Yes, a health center lists all contracts that support the HRSA-approved scope of project that are paid for in whole or in part with federal award funds.

Federal award funds include the Health Center Program (H80) operating grant award as well as any supplemental funding awarded under section 330 of the PHS Act. Therefore, contracts using Health Center Program federal award funds include contracts that use supplemental award funds, such as Coronavirus-related supplemental awards (for example, H8C, H8D, H8E, or H8F awards) or other supplemental awards (for example, Primary Care HIV Prevention awards) as long as:

• The contracts are active; or
• The contracts had a period of performance that ended less than 3 years before the site visit.

If contracts funded in whole or in part by supplemental awards are among the five contracts that use the largest amounts of federal award funds, then those contracts would be reviewed as part of a site visit for the purpose of assessing compliance with contracting and procurement requirements. However, neither the health center nor consultants would single out supplemental-funded contracts or activities for review if they do not meet the SVP sampling criteria. Refer to the Sampling Review Resource Guide as a helpful sampling resource.

Note: Look-alike OSVs do not include a review of Contracts and Subawards or Conflict of Interest elements that are specific to Health Center Program federal award funds. In addition, look-alikes and awardees that receive other HRSA funding are subject to the specific requirements of those awards; however, the OSV does not assess compliance with those award requirements.

(Updated: 3/8/2023)

This question relates to Element a. Standards of Conduct and Element d. Adherence to Standards of Conduct

Yes, a health center board member can be a contractor or supplier to the health center and continue to serve on the board if the board member discloses the conflict of interest and does not participate in the selection process of any contract that has a conflict of interest. The health center determines the appropriate methods for board members to disclose real or apparent conflicts of interest.

For more information, refer to 45 CFR 75.327(c)(1), the HRSA Conflict of Interest Policy, and the Health Center Program Compliance Manual.

(Updated: 10/24/2023)

 

This question relates to Element a. Standards of Conduct

Yes, a board member is allowed to be employed by or contract with another health center, as long as:

• The board member does not have a real or apparent conflict of interest with the other health center;
• The board member complies with the methods of both health centers for disclosing real or apparent conflicts of interest;
• The board member complies with both health centers' standards of conduct when involved in the selection, award, or administration of contracts paid for in whole or in part by the Federal award; and
• The health center that employs or contracts with the board member follows standards of conduct related to procurements paid for in whole or in part by the Federal award.

Refer to Health Center Program Compliance Manual Chapter 13: Conflict of Interest and to Health Center Program Compliance Manual Chapter 20: Board Composition for additional requirements that may impact board members.

(Added: 3/8/2023)

This question relates to Element a. Standards of Conduct and Element d: Adherence to Standards of Conduct

No, when a site visit team assesses compliance with the Health Center Program Compliance Manual Chapter 13: Conflict of Interest, the site visit team does not review signed disclosure statements or forms from all health center staff and board members. If a health center identified a real or apparent conflict of interest for any procurement that occurred within the last three years and that was paid in whole or in part by the Federal award, the site visit team reviews all related written disclosures. These written disclosures (for example, board minutes documenting disclosures, standard forms to report disclosures) would be completed by employees, officers, board members, and agents of the health center.

(Updated: 3/8/2023)

This question relates to Element a. Fee Schedule for In-Scope Services and Element b. Bases for Fee Schedule

Yes, if a health center provides "new patient visits" that involve a greater intensity of services based on locally prevailing rates and actual health center costs, then the health center may create a separate fee in its fee schedule for those types of visits. However, a health center cannot have sliding fee discount schedules that are different for new versus established health center patients because sliding fee discounts would be applied uniformly to all patients and would be based only on income and family size.

(Added: 3/8/2023)

This question relates to Element i. Billing for Supplies or Equipment

No, dentures and eyeglasses are related to, but NOT included in, services (for example, dental care or vision care) as part of prevailing standards of care for the service. Therefore, these supplies are NOT subject to the Health Center Program sliding fee discount program requirements. In making dentures, eyeglasses, and other supplies accessible to their patient population, a health center determines how to charge its patients (for example, flat discounts, at cost, sliding fee discounts, bundled as part of a service). The health center would inform patients of any out-of-pocket charges prior to the time of service.

There are supplies and equipment (for example, casting materials, bandages), that ARE included in a service as part of prevailing standards of care and that do not have a separate charge on the health center's fee schedule. Therefore, the service as a whole, including the supplies and equipment, is discounted in accordance with the health center's sliding fee discount program.

For more information, refer to the Health Center Program Compliance Manual Chapter 9: Sliding Fee Discount Program and the Health Center Program Compliance Manual Chapter 16: Billing and Collections.

(Added: 3/8/2023)

This question relates to Element i. Billing for Supplies or Equipment

No, prescription drugs are supplies that are related to, but NOT included in, the service itself as part of prevailing standards of care for the service. Therefore, prescription drugs are NOT subject to the Health Center Program sliding fee discount program requirements. In making prescription drugs accessible to their patient population, a health center determines how to charge its patients (for example, flat discounts, at cost, sliding fee discounts, bundled as part of a service). The health center would inform patients of any out-of-pocket charges prior to the time of service.

All health centers are required to provide pharmaceutical services, which are separate from prescription drugs.

For more information, refer to the Health Center Program Compliance Manual Chapter 9: Sliding Fee Discount Program, the Health Center Program Compliance Manual Chapter 16: Billing and Collections, and the Service Descriptors for Form 5A: Services Provided (PDF - 315 KB).

(Added: 3/8/2023)

This question relates to Element b. Required Authorities and Responsibilities, Element d. Adopting, Evaluating, and Updating Health Center Policies, and Element e. Adopting, Evaluating, and Updating Financial and Personnel Policies

The Health Center Program Compliance Manual Chapter 19: Board Authority states which policies require board approval. Specifically, the health center board adopts, evaluates at least once every three years, and, as needed, approves updates to policies that support the following areas:

• Sliding Fee Discount Program;
• Quality Improvement/Assurance;
• Billing and Collections;
• Financial Management and Accounting Systems; and
• Personnel

While procedures are discussed in the Health Center Program Compliance Manual, they do not require approval by the governing board in order to demonstrate compliance with Health Center Program requirements.

The governing board of a health center is responsible for establishing and approving policies for health center operations, while the health center's staff is responsible for implementing and adhering to these policies through operating procedures.

Note: In cases where a public agency receives the Health Center Program award or designation and has established a co-applicant board, the public agency may establish and retain the authority to adopt and approve personnel policies and policies that support financial management and accounting systems.

(Updated: 3/8/2023)

This question relates to Element c. Exercising Required Authorities and Responsibilities

"Service utilization patterns" refers to the number of health care services and trends in the types of health care services patients access.

As part of its required authorities and responsibilities, a health center's governing board reviews service utilization patterns in order to evaluate health center performance and the health center's ability to meet patient needs.

For more information, refer to Health Center Program Compliance Manual Chapter 19: Board Authority.

(Added: 3/8/2023)

This question relates to Element c. Exercising Required Authorities and Responsibilities

No, the health center board is not required to approve progress reports (for example, BPRs, ACs, supplemental funding progress reports). A health center board may choose to approve progress reports, but it is not a requirement.

However, the health center board is required to approve the health center's annual budget and to monitor the health center's performance and progress, which are components of the BPR and AC. For more information, refer to Health Center Program Compliance Manual Chapter 19: Board Authority.

Note: A health center board is required to approve the Service Area Competition (SAC) or look-alike Renewal of Designation (RD) and all other competitive applications, including but not limited to applications for New Access Points (NAPs).

(Updated: 3/8/2023)

This question relates to Element b. Required Board Composition

The following costs are allowable if included in the health center budget that is approved by HRSA: The reasonable costs of meals provided to board members and staff participants during scheduled meetings if those costs are not already reimbursed to participants as per diem or otherwise, according to the health center’s established policies and procedures. 

In addition, as noted in the Health Center Program Compliance Manual Chapter 20: Board Composition, Footnote 6, both patient and non-patient health center board members may be reimbursed for reasonable expenses actually incurred by reason of their participation in board activities.

If a health center has questions about purchasing food for board meetings, they should contact the HRSA grants management specialist listed on the health center’s Notice of Award. 

(Added: 6/29/2023) 

HRSA primarily assesses a health center's compliance with Health Center Program requirements through operational site visit (OSV) findings and through the review of Service Area Competition (SAC) or Renewal of Designation (RD) applications.

When HRSA identifies non-compliance, a condition is placed on the health center award or look-alike designation.

HRSA encourages all health centers to use the Health Center Program Compliance Manual, Site Visit Protocol, and Site Visit Resources to resolve any active conditions and to prepare for upcoming SAC/RD applications and OSVs.

(Updated: 3/8/2023)

No, HRSA only assesses a health center's policies or procedures for compliance with the demonstrating compliance elements in the Health Center Program Compliance Manual. Although a health center may choose to include information in its policies or procedures that goes beyond what is required in the Health Center Program Compliance Manual, this additional information is not part of HRSA's compliance review.

(Updated: 3/8/2023)

Yes, the Health Center Program Compliance Manual lists the required timeframes for health centers to review or update policies and procedures. For example, in the Health Center Program Compliance Manual Chapter 19: Board Authority, the Compliance Manual specifies that at least once every three years, the health center board adopts, evaluates, and, as needed, approves updates to policies that support financial management and accounting systems and personnel policies.

However, if the Health Center Program Compliance Manual does not specify a timeframe, then the health center determines the appropriate interval for reviewing or updating its policies and procedures.

(Updated: 3/8/2023)

The Progressive Action process is a structured and time-phased approach for:

• Notifying health centers of failures to demonstrate compliance with the requirements in the Health Center Program Compliance Manual; and
• Receiving health center responses to identified conditions.

The Progressive Action phases are:

• Phase One: A Notice of Award (NoA) / Notice of Look-alike Designation (NLD) is issued with a condition detailing the specific areas where compliance with a requirement has not been demonstrated. Phase One gives the health center 90 days to either submit appropriate documentation that demonstrates compliance or, for a small number of conditions (refer to the Implementation Phase below), submit an adequate action plan outlining how the health center will demonstrate compliance with the program requirement.
• Phase Two: If the health center has not demonstrated compliance in Phase One, Phase Two gives the health center an additional 60 days to either submit appropriate documentation that demonstrates compliance or, for a small number of conditions (refer to the Implementation Phase below), submit an adequate action plan outlining how the health center will demonstrate compliance with the program requirement.
• Phase Three: If the health center has not demonstrated compliance in Phase Two, Phase Three gives the health center an additional 30 days to either submit appropriate documentation that demonstrates compliance or, for a small number of conditions (refer to the Implementation Phase below), submit an adequate action plan outlining how the health center will demonstrate compliance with the program requirement.
• Implementation Phase (for a small number of conditions): Gives the health center 120 days to implement the HRSA-approved action plan and submit appropriate documentation that demonstrates compliance with the program requirement.

(Added: 3/8/2023)

The Progressive Action Conditions Library is a list of conditions applied when a health center fails to demonstrate compliance with Health Center Program requirements.

Each demonstrating compliance element within the Health Center Program Compliance Manual has a matching progressive action condition. Each condition follows the Progressive Action policy outlined in the Health Center Program Compliance Manual Chapter 2: Health Center Program Oversight.

When HRSA determines a health center is not demonstrating compliance with one or more of the Health Center Program requirements, progressive action conditions are placed on the health center's award or look-alike designation. Each condition includes a description of the specific actions the health center can take to remove the condition.

(Updated: 3/8/2023)

The five progressive action conditions listed below allow for a 120-day progressive action implementation phase:

• Required and Additional Health Services-demonstrating compliance element "a": Providing and Documenting Services within Scope of Project
• Clinical Staffing-demonstrating compliance element "a": Staffing to Provide Scope of Services
• Sliding Fee Discount Program-demonstrating compliance element "I": Evaluation of the Sliding Fee Discount Program
• Board Authority-demonstrating compliance element "a": Maintenance of Board Authority Over Health Center Project
• Board Composition-demonstrating compliance element "f": Utilization of Special Population Input

For these progressive action conditions, a health center needs to submit either documentation that demonstrates compliance or an action plan outlining how compliance will be demonstrated. If an action plan is submitted by the health center and approved by HRSA, a 120-day "Implementation Phase" condition will be applied so that the health center can carry out the HRSA-approved action plan and submit appropriate documentation that demonstrates compliance.

Note: Progressive action conditions that allow for a 120-day implementation phase are NOT the same as a 120-day Compliance Achievement Plan (CAP) condition. A 120-day CAP condition is only applied if a health center is awarded a 1-year period of performance.

Health centers may refer to the language in individual conditions for more information.

(Updated: 3/8/2023)

A health center's future FTCA deeming determination may be impacted if the health center has one or more of the following conditions on its award at the time of the deeming determination:

• Clinical Staffing-demonstrating compliance element "c": Procedures for Review of Credentials
• Clinical Staffing-demonstrating compliance element "d": Procedures for Review of Privileges
• Clinical Staffing-demonstrating compliance element "e": Credentialing and Privileging Records
• Quality Improvement/Assurance-demonstrating compliance element "a": QI/QA Program Policies
• Quality Improvement/Assurance-demonstrating compliance element "b": Designee to Oversee QI/QA Program
• Quality Improvement/Assurance-demonstrating compliance element "c": QI/QA Procedures or Processes
• Quality Improvement/Assurance-demonstrating compliance element "d": Quarterly Assessments of Clinician Care
• Quality Improvement/Assurance-demonstrating compliance element "e": Retrievable Health Records
• Quality Improvement/Assurance-demonstrating compliance element "f": Confidentiality of Patient Information

Health centers also need to demonstrate compliance with the requirements related to risk management and claims management to receive FTCA deeming.

For more information on FTCA deeming requirements, refer to the Health Center Program Compliance Manual Chapter 21: Federal Tort Claims Act (FTCA) Deeming Requirements and to the FTCA Policies and Program Guidance website.

(Updated: 7/1/2024)

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)

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 - 1 MB)
• EHBs Quick Reference Guide for Transitional Care in Carceral Setting CIS Requests (PDF - 248 KB)

(Added: 12/20/2024)

The HRSA Bureau of Primary Health Care website is the central location with links to many technical assistance resources. Also, the HRSA Primary Health Care Digest is a weekly electronic newsletter containing updates and information of interest to the health center community. Sign up to receive it at HRSA Email Subscriptions. In addition, the Health Center Resource Clearinghouse is a one-stop location for training and technical assistance resources, including those available through the National Health Center Training and Technical Assistance Partners (NTTAPs).

(Updated: 3/8/2023)

Under certain circumstances HRSA allows Health Center Program awardees to carry over unobligated funding from the prior budget period without the need to submit a prior approval request. A health center may carry over UOBs resulting from Health Center Program awards made in fiscal year 2019 or beyond without prior approval except in the two scenarios as noted below. The unobligated balances may come from base operational funding or supplemental awards.

As part of HRSA's "Expanded Authority," a health center does not need to request prior approval from HRSA to carry over UOB that are 25 percent or less of the total amount awarded for the budget period.

Submission of a prior approval request is required to carry over UOB that exceeds 25 percent of the total award or to carry over UOB at the end of the award project period into a new project period.

This flexibility does not apply to other Health Center Program award recipients such as Primary Care Associations, National Cooperative Agreements, and Health Center Controlled Networks. These awardees need to submit a prior approval request to carry over UOB.

(Updated: 3/8/2023)

A health center can simply identify and request carryover from the prior Budget Period through the annual Federal Financial Report. When submitting the FFR in the Payment Management System, indicate in the comments/remarks area that your health center wishes to carry over all or a portion of the unobligated balance (UOB). Include the amount to be carried over, details regarding the source of the UOB, and your health center's plans for using the funds in the subsequent budget period. HRSA approval of the FFR indicates approval of the carryover request.

A health center will need to submit a prior approval request if it wants to carry over dollars in the following situations:

• If the total UOB of Health Center Program funds is more than 25 percent of the amount awarded for the budget period; or
• If the carryover is from a prior period of performance.

(Updated: 3/8/2023)

If a health center is requesting UOB from a prior period of performance, regardless of the amount, the health center must submit a Prior Approval request. Such requests are submitted through the Prior Approval Requests module in the Electronic Handbooks (EHBs), under the category of "Carryover of Unobligated Balances."

A health center must include an SF-424A: Budget Information form, a line item budget, and a narrative justification that addresses:

• The source of the funds and why they remain unobligated (i.e., where the UOB comes from and why it was not expended in the original budget period); and
• How the health center will use the carryover funds for the previously approved goals and objectives of the funding. For example: "$300,000 of UOB from the XXX Supplemental Services award will be used to complete activities A, B, and C, in accordance with the approved application. One-time funds of $80,000 made under the New Access Points award that remain unobligated for dental operatory equipment will be expended in the subsequent budget period once the operatory is renovated."

(Updated: 3/8/2023)

If a health center is requesting UOB that is more than 25 percent of the amount awarded for the current budget period, the health center must submit a Prior Approval request. Such requests are submitted through the Prior Approval Requests module in the Electronic Handbooks (EHBs), under the category of "Carryover of Unobligated Balances."

A health center must include an SF-424A: Budget Information form, a line item budget, and a narrative justification that addresses:

• The source of the funds and why they remain unobligated (i.e., where the UOB comes from and why it was not expended in the original budget period); and
• How the health center will use the carryover funds for the previously approved goals and objectives of the funding. For example: "$300,000 of UOB from the XXX Supplemental Services award will be used to complete activities A, B, and C, in accordance with the approved application. One-time funds of $80,000 made under the New Access Points award that remain unobligated for dental operatory equipment will be expended in the subsequent budget period once the operatory is renovated."

(Updated: 3/8/2023)

Any carryover funds, regardless of amount, must be used for the original approved purpose(s) of the award. Remember, in accordance with 45 CFR Part 75.403-405, a health center must use federal award funds only for allowable costs that are:

• Consistent with the terms and conditions of the federal award and the Federal Cost Principles (45 CFR Part 75 Subpart E);
• Allocable to the purposes of the Health Center Program project; and
• Reasonable.

HRSA reviews the use of federal funds through the single or program-specific audit conducted each year, in accordance with 45 CFR Part 75 Subpart F. For additional information on the management of federal funds, review the Health Center Program Compliance Manual. A health center's Grants Management Specialist can be contacted with questions about appropriate use of carryover funds.

(Updated: 3/8/2023)

No, an approved carryover request only allows funds from a prior budget/project period to be used in the current budget/project period. It does not increase the ongoing base level funding amount for a health center.

(Updated: 3/8/2023)