Required and Additional Health Services

Primary Reviewer: Clinical Expert

Secondary Reviewer: Fiscal Expert

Note: The Fiscal Expert also reviews the contracts/agreements and arrangements to support the Clinical Expert with the assessment of scope of project accuracy for element “a.”

Authority: Section 330(a)-(b), Section 330(h)(2), and Section 330(k)(3)(K) of the Public Health Service (PHS) Act; and 42 CFR 51c.102(h) and (j), 42 CFR 56.102(l) and (o), and 42 CFR 51c.303(l)

Health Center Program Compliance Manual Related Considerations

Document Checklist for Health Center Staff

  • For services delivered via Column I of the health center’s current Form 5A: Services Provided, provide a list of service sites to be toured. Sites selected are those where the majority of services are provided directly by the health center. If the health center has more than one service site, the list must include at least two health center service sites.
  • For health centers with Column II services, health center internal procedures that address documentation of information in the patient’s health center record for any contracted service(s) that occur at a location(s) other than a health center Form 5B in-scope site (for example, lab results, x-ray results).
  • For health centers with Column III services, operating procedures for tracking and managing referred services.
  • If a Column I service(s) cannot be verified through the site tours, provide documentation of service(s) provision in a current patient record.1
  • For services delivered via Column II of the health center’s current Form 5A (whether or not the service is also delivered via Column I and/or Column III):

    Contracts/Agreements:

    • At least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service.
    • To assist in the review, the health center should flag all relevant provisions within contracts/agreements related to:
      • How the service will be documented in the patient’s health center record; and
      • How the health center will pay for the service.

    Note: The same sample of contracts/agreements is to be utilized for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program. The sampling methodologies for Required and Additional Health Services are different from Contracts and Subawards and Conflict of Interest, although they may result in some overlap in the contracts/agreements.

    Patient Records:

    • Three to five health center patient records for patients who have received required and additional health services (as specified in the methodology under demonstrating compliance element “a”) in the past 24 months from a contracted provider(s)/organization(s).
  • For services delivered via Column III of the health center’s current Form 5A (whether or not the service is also delivered via Column I and/or Column II):

    Referral Arrangements:

    • At least one but no more than three written referral arrangements for EACH Required and EACH Additional Service.
    • To assist in the review, the health center should flag all relevant provisions within referral arrangements related to:
      • The manner by which referrals will be made and managed; and
      • The process for tracking and referring patients back to the health center for appropriate follow-up care (for example, exchange of patient record information, receipt of lab results).

      If these provisions are not present within the referral arrangements, provide additional documentation (for example, health center standard operating procedures) that contain those provisions.

    Note: The same sample of referral arrangements is to be utilized for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program.

    Patient Records:

    • Three to five health center patient records for patients who have received a required and additional service(s) (as specified in the methodology under demonstrating compliance element “a”) in the past 24 months from a referral provider(s)/organization(s). Ensure each record clearly documents the patient’s entire referral process, from initial referral to receipt of care and follow-up by the health center.
  • Sample of key health center documents (for example, materials/application used to assess eligibility for the health center’s sliding fee discount program, intake forms for clinical services, instructions for accessing after-hours services) translated for patients with limited English proficiency.

Note: Refer to the Sampling Review Resource Guide to assist in assembling the samples for Required and Additional Health Services.

Demonstrating Compliance

Select each element below for the corresponding text of the element, site visit team methodology, and site visit finding questions.

The health center provides access to all services included in its HRSA-approved scope of project2 (Form 5A: Services Provided) through one or more service delivery methods,3 as described below:4

  • Direct: If a required or additional service is provided directly by health center employees5 or volunteers, this service is accurately recorded in Column I on Form 5A: Services Provided, reflecting that the health center pays for and bills for direct care.
  • Formal Written Contract/Agreement:6 If a required or additional service is provided on behalf of the health center via a formal contract/agreement between the health center and a third party (including a subrecipient),7 this service is accurately recorded in Column II on Form 5A: Services Provided, reflecting that the health center pays for the care provided by the third party via the agreement. In addition, the health center ensures that such contractual agreements for services include:
    • How the service will be documented in the patient’s health center record; and
    • How the health center will pay for the service.
  • Formal Written Referral Arrangement: If access to a required or additional service is provided and billed for by a third party with which the health center has a formal referral arrangement, this service is accurately recorded in Column III on Form 5A: Services Provided, reflecting that the health center is responsible for the act of referral for health center patients and any follow-up care for these patients provided by the health center subsequent to the referral.8 In addition, the health center ensures that such formal referral arrangements for services, at a minimum, address:
    • The manner by which referrals will be made and managed; and
    • The process for tracking and referring patients back to the health center for appropriate follow-up care (for example, exchange of patient record information, receipt of lab results).

Site Visit Team Methodology

  • In conjunction with the CEO and/or other relevant staff, review the accuracy of the health center’s Form 5A: Services Provided.
  • Tour sites where the majority of services are provided directly by the health center (Column I) and interview clinical staff during the site tours.
    • If the health center has more than one service site, tour at least two service sites.
    • For any Column I services that cannot be verified through the site tour or through interview(s), review at least one patient record for each service directly provided by the health center (Column I).
  • Interview CMO and/or other clinical staff responsible for all service delivery methods (Columns I, II, and III).
  • For any service delivered via Column II (whether or not the service is also delivered via Column I and/or Column III):

    Review of Contracts/Agreements:

    • Review at least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service. For any required or additional service noted as a Column II service on Form 5A, review at least one written contract. If there is more than one contract for the same service, each contract should be included in the sample, up to a maximum of three contracts. For example:
      • Primary Care Services is listed in Column II. The health center maintains four separate contracts for individual contracted providers. The sample should include a maximum of three of these contracts for Primary Care Services.
      • Preventive Dental is listed in Column II. The health center maintains one contract for its preventive dental services. The sample should include one contract for Preventive Dental.
    • Review health center internal procedures that address documentation of information in the patient’s health center record for any contracted service(s) that occur at location(s) other than a health center Form 5B in-scope site (for example, lab results, x-ray results).
  • For any service delivered via Column II (whether or not the service is also delivered via Column I and/or Column III):

    Review of Patient Records:

    • Based on three Required Services and two Additional Services: Review three to five health center patient records for patients who have received these services in the past 24 months from a contracted provider(s)/organization(s). If the same patient has received more than one of these services, the same record can be used for assessing those services. If the health center delivers a service(s) through a subrecipient agreement(s), include patient records from all subrecipients, not to exceed a total of five subrecipients. For a health center with more than five subrecipients, select patient records from the subrecipients that receive the largest amounts of Health Center Program subaward funds.

      Note: For Column II Services provided by individual contractors who work at a health center Form 5B in-scope site, documentation in the patient record of the services provided would occur in the health center's own patient record system.

  • For any service delivered via Column III (whether or not the service is also delivered via Column I and/or Column II):

    Review of Referral Arrangements:

    • Review at least one but no more than three written referral arrangements for EACH Required and EACH Additional Service. For any required or additional service noted as a Column II service on Form 5A, review at least one written contract. If there is more than one referral arrangement for the same service, each written arrangement should be included in the sample, up to a maximum of three written arrangements. For example:
      • Intrapartum Services is listed in Column III. The health center maintains four separate arrangements for these services in various communities in their service area. The sample should include a maximum of three of these written arrangements for Intrapartum Care Services.
      • Diagnostic Laboratory Services is listed in Column III. The health center maintains one referral arrangement with a local hospital to provide these services. The sample should include one written arrangement for Diagnostic Laboratory Services.
  • For any service delivered via Column III (whether or not the service is also delivered via Column I and/or Column II):

    Review of Patient Records:

    • Based on three Required Services and two Additional Services: Review three to five health center patient records for patients who have received these services in the past 24 months from a referral provider(s)/organization(s). If the same patient has received more than one of these services, the same record can be used for assessing those services.

Notes

  • The same sample of contracts/agreements and referral arrangements is to be utilized for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program.
  • The sampling methodologies for Required and Additional Health Services are different from Contracts and Subawards and Conflict of Interest, although they may result in some overlap in the contracts/agreements.
  • The primary focus of this portion of the site visit is to validate the actual provision of the various required and additional services at the time of the Operational Site Visit and to ensure that Form 5A accurately reflects this current provision of services.
  • The sample provided by the health center should reflect the service(s) that the health center is currently providing.
  • If the site visit team finds that services reviewed in the sample differ from what is reflected on the health center’s Form 5A (for example, a contract or referral arrangement is provided in the sample but is not reflected on the health center's current 5A), the team will still proceed with reviewing the sample and note the discrepancies in their site visit findings. This includes noting if any services are not being conducted within the scope of project (i.e., are other lines of business).
  • When reviewing the provisions for enabling services (for example, transportation, translation, outreach) provided via Column II or III, compliance is demonstrated even if the related contracts or referral arrangements do not address all of the provisions (for example, documentation in the patient record, follow-up care) required for clinical services (for example, general primary medical care, preventive dental).
  • Any findings regarding the structure or availability of a health center’s sliding fee discount program (SFDP) as it relates to the services listed on Form 5A (for example, health center is providing an additional service directly, but the service is NOT discounted through the health center’s SFDP) will be assessed and documented under the Sliding Fee Discount Program section.
  • Follow-up from hospital admissions or hospital visits will be reviewed in the Continuity of Care and Hospital Admitting section.

Site Visit Findings

  1. FORM 5A, COLUMN I:
    • Are all services listed in Column I on the health center’s current Form 5A being provided by the health center directly?

      Response is: Yes, No, or Not Applicable

    Note: Select “Not Applicable” if the health center does not offer any services via Column I.

    If No, an explanation is required, including specifying any missing services.

  2. FORM 5A, COLUMN II:
    • Does the health center maintain formal written contracts/agreements for services listed in Column II on its current Form 5A?

      Response is: Yes, No, or Not Applicable

    • Do the health center’s contracts/agreements document how the health center will pay for the service(s)?

      Response is: Yes, No, or Not Applicable

    • Do the health center’s contracts/agreements or any supporting internal procedures document how information regarding the service(s) will be provided to the health center for inclusion in the patient’s health center record?

      Response is: Yes, No, or Not Applicable

    • Was the health center able to produce patient records from the past 24 months that document receipt of specific contracted services?

      Response is: Yes, No, or Not Applicable

    Note: Select “Not Applicable” for each of the above questions if the health center does not offer any services via Column II.

    If No OR Not Applicable was selected for any of the above, an explanation is required providing details on the specific service(s).

  3. FORM 5A, COLUMN III:
    • Does the health center maintain formal written referral arrangements for services listed in Column III on its current Form 5A?

      Response is: Yes, No, or Not Applicable

    • Do the health center’s formal written referral arrangements or other documentation (for example, health center standard operating procedures) include provisions that address the manner by which referrals will be made and managed as well as the process for tracking and referring patients back to the health center for appropriate follow-up care (for example, exchange of patient record information, receipt of lab results)?

      Response is: Yes, No, or Not Applicable

    • Is there documentation in the patient record of appropriate follow-up care and information that resulted from these referrals (for example, exchange of patient record information, receipt of lab results)?

      Response is: Yes, No, or Not Applicable

    Note: Select “Not Applicable” for each of the above questions if the health center does not offer any services via Column III.

    If No OR Not Applicable was selected for any of the above, an explanation is required providing details on the specific service(s).

  4. Considering the overall scope of project (i.e., all services on Form 5A across the various Columns), were services recorded on Form 5A consistent with how they were offered by the health center at the time of the site visit?

    Response is either: Yes or No

  5. If No: Has the health center submitted a Change in Scope request(s) to HRSA to correct all Form 5A inconsistencies?

    Response is either: Yes or No

    If Yes OR No, specify the inconsistency(ies) observed and whether the relevant Change in Scope request(s) has been submitted to HRSA to correct the accuracy of Form 5A.

Health center patients with limited English proficiency (LEP) are provided with interpretation and translation (for example, through bilingual providers, on-site interpreters, high quality video or telephone remote interpreting services) that enable them to have reasonable access to health center services.

Site Visit Team Methodology

  • Review Uniform Data System (UDS) patient demographic data.
  • Review sample of translated health center documents.
  • Review access to interpretation services (for example, on-site interpreter(s), contract(s) for interpretation services).
  • Interview health center clinical leadership and providers regarding patient language needs (for example, most common primary languages spoken by the patient population) and the role of cultural competency in the delivery of health center services (for example, training of front desk and clinical staff in cultural knowledge, attitudes, and beliefs of patient population).

Site Visit Findings

  1. Does the health center provide access to interpretation for health center patients with LEP?

    Response is either: Yes or No

    If No, an explanation is required.

  2. Was the health center able to provide an example of a key document (i.e., documents that enable patients to access health center services) currently in use that is translated into different languages for its patient population?

    Response is either: Yes or No

    If No, an explanation is required.

The health center makes arrangements and/or provides resources (for example, training) that enable its staff to deliver services in a manner that is culturally sensitive and bridges linguistic and cultural differences.

Site Visit Team Methodology

  • Review UDS patient demographic data.
  • Review sample of translated health center documents.
  • Review access to interpretation services (for example, on-site interpreter(s), contract(s) for interpretation services).
  • Interview health center clinical leadership and providers regarding patient language needs (for example, most common primary languages spoken by the patient population) and the role of cultural competency in the delivery of health center services (for example, training of front desk and clinical staff in cultural knowledge, attitudes, and beliefs of patient population).

Site Visit Findings

  1. Was the health center able to provide an example of how it delivers services in a manner that is culturally appropriate for its patient population (for example, culturally appropriate health promotion tools)?

    Response is either: Yes or No

    If No, an explanation is required.

 

Footnotes:

  • 1. Health centers may choose to provide samples of patient records prior to or during the site visit. If patient records will be provided during the site visit, this should be communicated prior to the site visit to avoid any disruption or delay in the site visit process.
  • 2. In accordance with 45 CFR 75.308 (Uniform Administrative Requirements: Revision of Budget and Program Plans), health centers must request prior approval from HRSA for a change in the scope or the objective of the project or program (even if there is no associated budget revision requiring prior written approval). This prior approval requirement applies, among other things, to the addition or deletion of a service within the scope of project. These changes require prior approval from HRSA and must be submitted by the health center as a formal Change in Scope request. Visit the Scope of Project website for further details, including the Form 5A Service Descriptors listed on Form 5A: Services Provided.
  • 3. The Health Center Program statute states in 42 U.S.C. 254b(a)(1) that health centers may provide services “either through the staff and supporting resources of the center or through contracts or cooperative arrangements.” The Health Center Program Compliance Manual utilizes the terms “Formal Written Contract/Agreement” and “Formal Written Referral Arrangement” to refer to such “contracts or cooperative arrangements.” For more information on documenting service delivery methods within the HRSA-approved scope of project on Form 5A: Services Provided, visit Form 5A Column Descriptors. Other Health Center Program requirements apply when providing services through contractual agreements and formal referral arrangements. Such requirements are addressed in other chapters of the Manual where applicable.
  • 4. See [Health Center Program Compliance Manual] Chapter 9: Sliding Fee Discount Program for more information on sliding fee discount program requirements and how they apply to the various service delivery methods.
  • 5. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), HRSA/BPHC utilizes Internal Revenue Service (IRS) definitions to differentiate contractors and employees. Typically, an employee receives a salary on a regular basis and a W-2 from the health center with applicable taxes and benefit contributions withheld.
  • 6. See [Health Center Program Compliance Manual] Chapter 12: Contracts and Subawards for more information on program requirements around contracting.
  • 7. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), services provided via “contract/formal agreement” are those provided by practitioners who are not employed by or volunteers of the health center (for example, an individual provider with whom the health center has a contract; a group practice with which the health center has a contract; a locum tenens staffing agency with which the health center contracts; a subrecipient organization). Typically, a health center will issue an IRS Form 1099 to report payments to an individual contractor. See the Federal Tort Claims Act (FTCA) Health Center Policy Manual (PDF - 406 KB) for information about eligibility for FTCA coverage for covered activities by covered individuals, which extends liability protections for eligible “covered individuals,” including governing board members and officers, employees, and qualified individual contractors.
  • 8. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), access to services provided via “formal referral arrangements” are those referred by the health center but provided and billed for by a third party. Although the service itself is not included within the HRSA-approved scope of project, the act of referral and any follow-up care provided by the health center subsequent to the referral are considered to be part of the health center’s HRSA-approved scope of project. For more information on documenting service delivery methods within the HRSA-approved scope of project on Form 5A: Services Provided, visit Form 5A Column Descriptors.