- What is the purpose of the Health Center Program Compliance Manual?
The Health Center Program Compliance Manual (Compliance Manual) serves as a streamlined and consolidated resource to assist health centers in understanding and demonstrating compliance with Health Center Program and Federal Tort Claims Act (FTCA) deeming requirements, and to increase clarity, transparency and consistency throughout the Health Center Program. HRSA staff use the Compliance Manual to determine health centers’ compliance with program requirements.
The Compliance Manual, which became effective upon its release in August 2017, applies to all Health Center Program award recipients, sub-recipients, and look-alikes. This includes health centers that are public entities and health centers funded to serve only special populations (i.e., individuals experiencing homelessness, residents of public housing, and/or migratory and seasonal agricultural workers).
- Does the Compliance Manual supersede all Policy Information Notices (PINs) and Program Assistance Letters (PALs)?
Appendix A of the Compliance Manual lists the Health Center Program non-regulatory policy issuances that remain in effect after release of the Compliance Manual. With the exception of these policies, the Compliance Manual supersedes other previous Health Center Program non-regulatory policy issuances (PINs, PALs, Regional Office Memoranda, Regional Program Guidance memoranda, and other non-regulatory materials) related to Health Center Program compliance or eligibility requirements.
- Is the FTCA Health Center Policy Manual superseded by the Compliance Manual?
The Compliance Manual does not supersede the FTCA Health Center Policy Manual. The FTCA Health Center Policy Manual focuses primarily on how FTCA relates to covered entities, individuals and situations. It does not focus on the requirements for deeming under the FTCA. Information on demonstrating compliance with the requirements for FTCA deeming is contained in the Health Center Program Compliance Manual as well as the annual FTCA deeming PAL. In addition, the Health Center Program Compliance Manual identifies those Health Center Program requirements that intersect with the requirements for deeming under the Health Center FTCA Program.
- When the Compliance Manual uses the term “would,” what does this mean?
The Compliance Manual uses the term “would” in the context of answering the question, “What is HRSA looking for when assessing a health center’s compliance?”
If a health center provides what is described in the Compliance Manual for a given Demonstrating Compliance element, then the health center would have demonstrated compliance with that element. In order to be assessed as in compliance with an overall program requirement area, a health center would need to demonstrate compliance with each Demonstrating Compliance element for that program requirement area.
- Are there specific timeframes associated with reviewing and updating health center policies or procedures? For example, how often are health centers expected to update and review their financial management and accounting systems or bylaws to meet requirements?
The Compliance Manual contains several specific timeframes for either updating or evaluating documents such as policies and/or for conducting other activities. These are the only cases where an assessment of compliance would be based on whether the health center met a specified timeframe and/or had updated documents. If the Compliance Manual does not specify a timeline, then the health center determines the appropriate interval for reviewing and updating the given document or activity.
- Does the Compliance Manual provide best or promising practices for health centers?
No, the Compliance Manual is not intended to address best or promising practices or performance improvement strategies undertaken by health centers. The Compliance Manual is a streamlined and consolidated resource to assist health centers in understanding and demonstrating compliance with Health Center Program requirements as well as requirements for deeming under the Health Center FTCA Program. However, the Related Considerations sections of the Compliance Manual provide examples of areas where health centers have discretion or that may be useful for health centers to consider when implementing a requirement.
- Where should a prospective health center or other stakeholder direct general questions about the Compliance Manual?
For general questions about the Compliance Manual, contact the Health Center Program Support or call 877-464-4772 from 7:00 a.m. to 8:00 p.m. ET, Monday through Friday (except federal holidays).
- Who should current Health Center Program award recipients and look-alikes contact with case-specific questions related to their grant or look-alike designation and the Compliance Manual?
Current Health Center Program award recipients and look-alikes should contact the HRSA staff identified on the Notice of Award (NOA) or Notice of Look-Alike Designation (NLD).
- Do HRSA-funded National Health Center Training and Technical Assistance Partners (NTTAPs) and Primary Care Associations (PCAs) assist health centers with achieving or maintaining compliance?
NTTAPs and PCAs provide training and technical assistance to existing and potential health centers to increase access to care, achieve operational excellence, improve health outcomes, and reduce health disparities. Although NTTAPs and PCAs do not have a direct role in health center compliance, they may assist health centers with improving quality and performance and are well-positioned to identify and disseminate best practices in health center operations that facilitate compliance.
- Where can I find information on the NTTAPs and PCAs training and technical assistance resources available to assist health centers with program operations?
The HRSA Primary Health Care Digest and the Bureau of Primary Health Care website provide various technical assistance resources and describe how health centers can access opportunities for technical assistance, including those available through NTTAPs and PCAs. The 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 here: https://public.govdelivery.com/accounts/USHHSHRSA/subscriber/new?topic_id=USHHSHRSA_118. The Health Center Resource Clearinghouse also provides a one-stop location for NTTAP , PCA, and other federal training and technical assistance resources to support health center quality operations. It can be reached at this link: https://www.healthcenterinfo.org/.
- [CLINICAL STAFFING] What qualifies as “documentation of basic life support training” as described in Chapter 5: Clinical Staffing, Demonstrating Compliance element “c”?
The health center determines what constitutes documentation of basic life support training. HRSA does not require clinical staff to have a specific type of documentation for basic life support training as part of the demonstrating compliance with element “c” of the Clinical Staffing chapter in the Health Center Program Compliance Manual. This documentation and the extent and type of basic life support training may also vary based on provider type. For example, certain licensed independent practitioners (LIPs) would have documentation of basic life support training included as part of their licensure/certification. Therefore, a health center may determine that such documentation satisfies this aspect of the credentialing process. In contrast, other provider types may not have basic life support training as part of their licensure or certification, and thus the health center would require separate or additional documentation of completion of basic life support training (e.g., a copy of certificate of completion of training, course completion dates, etc.).
- [CONFLICT OF INTEREST] Is a signed disclosure statement or form from each health center staff and board member required to demonstrate compliance with element a. Standards of Conduct in Chapter 13: Conflict of Interest?
No. When assessing this element during an Operational Site Visit (OSV), the reviewer will look at a "sample of written disclosures with respect to real or apparent conflicts of interest completed by officers, employees, board members and agents of the health centers." A review of these samples assesses whether the health center has a mechanism (e.g., a standard form) that health center staff and board members would be required to complete if and when a real or apparent conflict arises. Compliance determination relies on whether the OSV reviewer can observe that there are safeguards and processes in place should a conflict of interest arise for any procurement paid for in whole or in part by the federal award.
- [BOARD AUTHORITY] Is the Budget Period Progress Report (BPR)/Non-Competing Continuation (NCC) application an “Application” that would, based on the Compliance Manual Board Authority section, require board approval?
No. The BPR/NCC is essentially an annual progress report submitted to HRSA, the successful submission and approval of which prompts release of additional grant funds. As such, a health center board may, but is not required to, approve the BPR/NCC in the same way it would be required to approve the Service Area Competition (SAC) or other competing applications, such as New Access Point (NAP) or service expansion. However, HRSA does require the board to approve the health center’s annual budget and to monitor the health center’s performance and progress, which are components of the BPR/NCC.
- [BOARD AUTHORITY] Does the Compliance Manual specify which policies or procedures require board approval?
Yes, Chapter 19: Board Authority within the Compliance Manual specifies which policy areas require board approval in order to demonstrate compliance with Health Center Program requirements. Specifically, the health center board adopts, evaluates at least once every three years, and, as needed, approves updates to policies in or that support the following areas:
- Sliding Fee Discount Program
- Quality Improvement/Assurance
- Billing and Collections (those that address the waiving or reducing of amounts owed by patients due to inability to pay, and if applicable those that limit or deny services due to refusal to pay)
- Financial management and accounting systems and personnel
Note that the governing board of a health center is generally responsible for establishing and/or approving policies that govern health center operations, while the health center’s staff is generally responsible for implementing and ensuring adherence to these policies (including through operating procedures). Procedures do not require approval by the governing board in order to demonstrate compliance with Health Center Program requirements.
In addition to the policy areas outlined above that require board approval, health center governing boards have other required authorities and responsibilities (e.g., approving the selection of the health center’s Project Director/Chief Executive Officer (CEO), evaluating health center performance, approving health center services and the location and hours of operation of health center sites). For more information, please refer to the Health Center Program Compliance Manual Board Authority chapter.
- [FTCA DEEMING REQUIREMENTS] Do health centers have to include obstetrical training as part of their risk management training plans to demonstrate compliance with FTCA-deeming requirements?
FTCA-deemed health centers that provide obstetrical services through FTCA-deemed providers need to include obstetrical training as part of their risk management training plans to demonstrate compliance. This includes FTCA-deemed health centers that provide prenatal and postpartum care through FTCA-deemed providers, even if they do not provide labor and delivery services.
FTCA-deemed health centers that do not provide any obstetrical services, including prenatal, labor, delivery, and postpartum care, through FTCA-deemed providers (i.e., health centers that only provide obstetrical services through formal referral arrangements with other providers) are exempt from this requirement because the health centers would not have relevant clinical staff to train.