COVID-19 Frequently Asked Questions (FAQs)

Funding and Other Resources

Health centers may be eligible for relief through one or more of the following programs, subject to availability and continuation of funds:

The Small Business Administration's Paycheck Protection Program provided loans up to $10 million for non-profits with fewer than 500 employees to help prevent workers from losing their jobs and small businesses from shutting down due to economic losses caused by the COVID-19 public health emergency. The Paycheck Protection Program ended on May 31, 2021. Existing borrowers may be eligible for Paycheck Protection Program loan forgiveness. The Small Business Administration also offers additional COVID-19 relief.
The Small Business Administration's Economic Injury Disaster Loan Program provides financial assistance to small businesses or private, non-profit organizations that suffer substantial economic injury as a result of COVID-19, regardless of whether the applicant sustained physical damage. Organizations are eligible for grants up to $10,000 and loans up to $2 million.
The CARES Act Provider Relief Fund supports health care-related expenses or lost revenue attributable to COVID-19. For answers to specific questions, providers should call the toll-free Provider Support Line at 866-569-3522.
HHS established the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program. Visit the website for the most current information on the status of available funds for this program.
HHS established the HRSA COVID-19 Coverage Assistance Fund (CAF) to cover the costs of administering COVID-19 vaccines to patients whose health insurance does not cover vaccine administration fees, or whose insurance does but typically has patient cost-sharing. Visit the website for the most current information on the status of available funds for this program.
For information on how workers and employers can benefit from the protections and relief offered by the Emergency Paid Sick Leave Act and Emergency Family and Medical Leave Expansion Act, both part of the Families First Coronavirus Response Act, review information from the Department of Labor.

The following additional resources may also be helpful for health centers:

The National Association of Community Health Centers (NACHC) has a resource page with information on programs that may assist health centers in addressing cash flow and payroll concerns created by the COVID-19 pandemic.
The Small Business Administration has information on COVID-19 Relief Options.
Capital Link has COVID-19 funding sources and financing-related resources and tools.

This is not an exhaustive list, and health centers should review each resource to determine program eligibility and requirements. Please note that HRSA award recipients may not use Health Center Program grant funds for costs that are reimbursed or compensated by other federal or state programs that provide for such benefits. Health centers are also encouraged to reach out to other federal, state, and local partners for additional information and resources.

(Updated: 4/12/2022)

Program Oversight and Monitoring

In accordance with current Health Center Program billing and collections requirements, health centers must make every reasonable effort to collect appropriate reimbursement for their costs, including billing Medicare, Medicaid, CHIP, and other public and private insurance or assistance programs, as applicable. Health centers must apply their sliding fee discount schedules consistent with their established policies and procedures.

Health centers’ application of their sliding fee discount programs through their billing systems also should take into account any reimbursement from all third-party payors (including any/all reimbursements under any insurance policy or health plan, or under any federal or state health benefits program), including any associated patient cost sharing requirements (i.e., copayments, deductibles, coinsurance, or restrictions on balance billing).

Consistent with health centers’ billing and collections procedures, health centers should ascertain whether there are available reimbursement, funding, or compensation sources and any related cost sharing restrictions for COVID-19 related testing or treatment prior to billing patients. If there are any patient out-of-pocket costs, health centers should apply their sliding fee discounts, which are based on income and family size. If there are any applicable prohibitions on patient cost sharing, after submitting their claims for reimbursement to the applicable payor source(s), health centers should not charge patients for such costs.

Each health center is responsible for ensuring adherence to any terms and conditions that apply to specific reimbursement, funding, or compensation sources for COVID-19 related testing and treatment. These include but are not limited to reimbursement from the HRSA COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program and any funds received from the CARES Act Provider Relief Fund, which may include certain prohibitions regarding the balance billing of patients.

See the Health Center Program Compliance Manual for additional information on Health Center Program sliding fee discount requirements. For additional information on billing and patient cost sharing for health centers, see the Billing and Cost Sharing Overview for COVID-19 Vaccination, Testing, and Treatment resource.

(Updated: 6/21/2022)

Health centers are required to continue providing sliding fee discounts and maximizing reimbursement, and they must continue to ensure that no patient is denied service based on inability to pay. However, consistent with Health Center Program requirements, health centers have discretion to amend policies (with board approval) and/or modify operating procedures in response to the COVID-19 public health emergency, as long as such changes are consistent with applicable statutory, regulatory, and policy requirements. This includes the flexibility to adjust policies and operating procedures for billing and collections and/or sliding fee discounts based on the unique circumstances of the health center and patient population served. These flexibilities may include but are not limited to:

Offering additional billing options or payment methods (for example, payment plans, grace periods, mail-in options for payment) that address the need to limit in-person visits to the health center to reduce exposure for both patients and staff. The health center’s operating procedures for implementing these options or methods must ensure they are accessible to all patients regardless of income level or sliding fee discount pay class.
Eliminating nominal charges for individuals and families at or below 100% of the Federal Poverty Guidelines.
Revising the sliding fee discount schedule(s) to enhance effectiveness in reducing financial barriers to care. For example, health centers can adjust the percentages or reduce the amount of the fixed/flat fee used for discounting fees for patients with incomes between 100% and 200% of the Federal Poverty Guidelines.
Adjusting procedures to assess patient eligibility for sliding fee discounts to accommodate the circumstances of the patient population. For example, the health center may permit self-declaration of income and family size due to the limitations of providing in-person documentation during the COVID-19 public health emergency.
Expanding the specific circumstances the health center will consider when waiving or reducing fees or payments due to any patient’s inability to pay.

If health centers are discounting or waiving out of pocket costs, including co-pays for patients who have third-party coverage, such discounts may be subject to legal and contractual restrictions (i.e., any limitations that may be specified by applicable federal or state programs, or private payor contracts).

For more information, see Health Center Program Sliding Fee Discount Program requirements and Health Center Program Billing and Collections requirements.

(Added: 5/6/2020)

Providing Care During Emergencies

The U.S. Food and Drug Administration (FDA) has authorized several COVID-19 monoclonal antibody (mAb) therapeutic products for emergency use. When provided to eligible individuals, mAb therapeutics can shorten the duration of COVID-19 symptoms and reduce the risk of severe illness and hospitalization.

Sotrovimab is authorized for treatment of mild to moderate COVID-19 in certain patients, while EVUSHELD is authorized for pre-exposure prophylaxis in certain individuals. These products are available via a state/territory-coordinated distribution system. HHS will determine each state/territory’s weekly amount of products based on COVID-19 case burden and mAb utilization, and state/territorial health departments will identify which sites in their respective jurisdictions receive the product(s) and the amount each site receives. For questions about contacting your state/territorial health department, please contact covid19.therapeutics@hhs.gov.

Please note that as of January 24, 2022, the FDA has revised its Emergency Use Authorizations for REGEN-COV (casirivimab and imdevimab) and bamlanivimab/etesevimab to limit their use in the United States. Data show these products are unlikely to be effective against the omicron variant. These two mAb therapeutic products are therefore no longer being allocated to U.S. states and territories.

The HHS Office of the Assistant Secretary for Preparedness and Response, in partnership with the Johns Hopkins University Applied Physics Laboratory, has developed a COVID-19 Monoclonal Antibody Therapeutics Calculator for Infusion Sites (mAb calculator). This is a helpful resource for estimating the operational capacities of infusion sites and supports informed, cost-effective decision making to maximize health care resources. The mAb calculator can also be used to establish plans for reducing patient wait times and improving customer satisfaction.

The following resources may also be helpful for administration sites:

Additional information about mAb therapeutics can be found at PHE.gov/mAb and CombatCOVID.hhs.gov.

(Updated: 1/27/2022)

FTCA Requirements

The HHS Secretary issued a declaration of a national public health emergency regarding COVID-19 on January 31, 2020. As detailed in PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF - 184 KB): "HRSA recognizes that during an emergency, health centers are likely to participate in an organized state or local response, including by providing primary or preventive care services at temporary locations." Health centers may set up temporary sites that are “within the health center's service area or a county, parish, or other political subdivision adjacent to the health center's service area" (for in-scope services) with notification made to BPHC within 15 days. PAL 2020-05 (PDF - 184 KB) includes full details and requirements to ensure that the emergency response at temporary locations is considered part of the center's scope of project.

For purposes of FTCA coverage, patients served by covered individuals at temporary locations included in the covered entity's scope of project are considered the covered entity's patients. As such, the covered entity and its providers are covered by FTCA for services provided during the emergency at temporary locations." (See the FTCA Health Center Policy Manual (PDF) Section (I) F: A record of the services provided for each patient should be maintained.)

In addition, please see: Section (I) C.3 of the FTCA Health Center Policy Manual (PDF), Provision of Services to Health Center Patients, which states in part: "To meet the FTCA requirement of providing services to health center patients, a patient-provider relationship must be established. For the purposes of FSHCAA/FTCA coverage, the patient-provider relationship is established when: … Health center triage services are provided by telephone or in person, even when the patient is not yet registered with the covered entity but is intended to be registered."

Please also see the FTCA Health Center Policy Manual (PDF) Section (I) C.4 regarding Coverage in Certain Individual Emergencies.

Additionally, please see PAL 2017-07: Temporary Privileging of Clinical Providers by Federal Tort Claims Act (FTCA) Deemed Health Centers in Response to Certain Declared Emergency Situations (PDF - 286 KB).

For questions about FTCA as it relates to emergency events, please use the BPHC Contact Form or call for FTCA assistance at 877-464-4772, 8:00 a.m. to 5:30 p.m. ET, Monday-Friday (except federal holidays).

(Updated: 4/17/2020)

Chapter 5 of the Health Center Program Compliance Manual describes how health centers would demonstrate compliance with clinical staffing requirements, including the requirement that “the health center utilizes staff that are qualified by training and experience to carry out the activities of the center.”

PAL 2017-07, Temporary Privileging of Clinical Providers by Federal Tort Claims Act (FTCA) Deemed Health Centers in Response to Certain Declared Emergency Situations (PDF), provides Health Center FTCA Program-specific guidance for health centers wishing to use temporary credentialing and privileging processes during a declared emergency. The COVID-19 pandemic is such a declared emergency. As noted in PAL 2017-07, health centers may apply temporary credentialing and privileging processes for up to 90 days. By the end of the 90-day period, the health center must ensure standard credentialing and privileging is completed.

Health centers have some discretion in implementing these credentialing and privileging requirements. For example, each health center determines:

How credentialing will be implemented (for example, a health center may contract with a credentials verification organization to perform credentialing activities, or it may have its own staff conduct credentialing), including whether to have separate credentialing processes for licensed independent practitioners versus other provider types.
How it assesses clinical competence and fitness for duty of its staff (for example, regarding clinical competence, a health center may utilize peer review conducted by its own providers or may contract with another organization to conduct peer review).
What constitutes documentation of basic life support training. The extent and type of basic life support training may also vary based on provider type. For example, certain licensed independent practitioners would have documentation of basic life support training included as part of their licensure/certification.

As a reminder, per the terms and conditions of their award and designation, health centers are also responsible for maintaining their operations, in compliance with all other applicable federal, state, and local laws and regulations.

Please see HRSA’s Risk Management and Quality Improvement web page for information on additional technical assistance.

(Updated: 4/1/2021)

Continuous or permanent staffing of a hospital or hospital department to provide inpatient care to all hospital patients is not described by the authorizing statute for the Health Center Program, and FTCA coverage generally is not available for such care.

Health centers have discretion to enter into contractual arrangements with hospitals or may allow their providers to enter into arrangements with hospitals to provide hospital-based inpatient care outside the scope of their Health Center Program grants. However, FTCA coverage and other federal benefits directly associated with the Health Center Program would not apply. Providers providing continuous or permanent inpatient care in hospitals through such arrangements may have medical malpractice liability protection through the hospital or another source, and volunteer providers may be eligible for liability protections under federal and state law (including new legal protections for volunteer providers for COVID-19 emergency response via the CARES Act). Health centers should consult with private counsel for legal advice regarding these matters.

Please note that the Health Center FTCA Program regulations and the March 27, 2020, Determination of Coverage for COVID-19-Related Activities by Health Center Providers (PDF - 34 KB) provide for FTCA protection for deemed health centers in the circumstances described in those issuances. The March 27, 2020, Determination of Coverage indicates that health center providers may provide grant-supported health services “to prevent, prepare, or respond to COVID-19 (including but not limited to screening, triage, testing, diagnosis, and treatment)” to individuals who are not patients of the health center, whether at the health center or off-site, and whether in-person or through telehealth. This determination of coverage extends to local COVID-19 community-wide emergency response activities supported by the health center. The Health Center FTCA Program regulations also provide for liability protections for certain described individual emergency situations.

The Health Center Program provides grant support for the delivery of primary and preventive health care service to medically underserved populations and communities. Services provided through the Health Center Program generally consist of outpatient, ambulatory care services for health center patients. As provided for by statute, regulation, and determination of coverage, services may be provided to individuals who are not patients of the health center in limited circumstances.

(Added: 4/16/2020)

Yes. The definition of a “free clinic,” as established by the authorizing statute for the Free Clinics FTCA Program, requires that the entity not seek reimbursement for the health care that it provides. Section 233(o)(3) of title 42, United States Code, states in pertinent part: “the entity does not, in providing health services through the facility, accept reimbursement from any third-party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program).” In addition, 42 U.S.C. § 233(o)(2)(D) precludes a health care practitioner or free clinic from receiving “any compensation for [a health service] from the individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program).”

HRSA’s Provider Relief Fund frequently asked questions state the following:

The COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program provides reimbursements on a rolling basis directly to eligible providers for claims that are attributed to the testing and treatment of COVID-19 for uninsured individuals.

Health care providers who have conducted COVID-19 testing of uninsured individuals or provided treatment to uninsured individuals with a COVID-19 diagnosis for dates of service or admittance on or after February 4, 2020 may be eligible for claims reimbursement through the program as long as the service(s) provided meet the coverage and billing requirements established as part of the program.

Under the Free Clinics FTCA Program, an entity that accepts or receives reimbursement for the provision of health services from a third-party payor is not eligible to sponsor a provider deeming application, nor may the entity or the provider accept such compensation for the service provided. Accepting such reimbursement may therefore place at risk the availability of liability protections under this statute for the actions of the entity’s deemed providers. Free clinics should consult private counsel as needed for legal advice.

For additional information, see PIN 2011-02: Free Clinics Federal Tort Claims Act (FTCA) Program Policy Guide (PDF - 380 KB).

(Added: 5/20/2020)

Service Delivery

Temporary Sites

Testing

Health centers provide COVID-19 testing services to established health center patients and to other individuals who present to health center service sites and other locations at which the health center provides testing within the Health Center Program scope of project, and who meet criteria for COVID-19 testing, regardless of their ability to pay. COVID-19 testing criteria, whether for individuals with symptoms, exposure, or for asymptomatic individuals, should be informed by CDC guidelines on testing for SARS-CoV-19, as well as by state, tribal, or local public health guidance. If a health center does not have sufficient capacity to provide unlimited screening testing (e.g., limited PPE, testing supplies, or staff capacity), then the health center should make efforts to refer patients to other appropriate providers.

Reimbursement for COVID-19 screening tests is generally available through Medicare, Medicaid, or CHIP, and may be available through private insurance or other sources, subject to availability of funding. Pursuant to Health Center Program requirements, health centers should ascertain whether there is available reimbursement, funding (including H8E, H8F, and H80 grants), or compensation sources and any related cost sharing restrictions for COVID-19 testing prior to billing patients. If there are any patient out-of-pocket costs—for example, in the case of no or only partial coverage by private insurance—health centers should apply their sliding fee discounts, which are based on income and family size. If there are any applicable prohibitions on patient cost sharing, after submitting their claims for reimbursement to the applicable payor source(s), health centers should not charge patients for such costs, but may use H8E, H8F, or H80 funds to absorb any costs not covered by the payor source—for example if private insurance does not cover screening testing.

Health centers providing health services under the Health Center Program are required to comply with all Health Center Program requirements and all applicable federal, state, and local laws and regulations. Each health center is responsible for ensuring adherence to any terms and conditions that apply to specific reimbursement, funding, or compensation sources for COVID-19 related testing and treatment. For additional details on billing and reimbursement, see the question “Can health centers charge patients for COVID-19 testing and treatment?” in the Program Oversight and Monitoring section of this FAQ webpage.

Additional information is available from HRSA and CMS:

(Updated: 4/12/2022)

States regulate the practice of medicine and other health professions as part of their authority to establish laws and regulations to protect the health, safety, and general welfare of their citizens. Each health center is therefore responsible for maintaining its operations, including developing and implementing its own operating procedures, in compliance with all Health Center Program requirements and all other applicable federal, state, and local laws and regulations (42 CFR 51c.304(d)(3)(v)). This includes requirements regarding laboratory and personnel related to COVID-19 testing.

Health centers that provide COVID-19 testing must comply with their state’s clinical laboratory laws, including any personnel and training requirements for specimen collection and/or the performance of clinical laboratory testing.
Health centers must also comply with any applicable CLIA requirements, based on the complexity of the testing. See CLIA Laboratory Guidance During COVID-19 Public Health Emergency and additional updates from CMS.
Health centers must ensure that any clinical staff conducting specimen collection and testing are appropriately trained, qualified, and, if necessary, supervised, consistent with the health center’s credentialing and privileging procedures. This includes health centers that operate in states, territories, or jurisdictions that do not require licensure or certification for certain clinical staff (e.g., medical assistants) that may be involved in specimen collection.
If your state authorizes health practitioners (dentists, medical assistants, etc.) to provide services, including COVID-19 specimen collection, outside their usual areas of licensure/certification/practice, this should be documented in the health center’s credentialing files, along with fulfillment of any additional requirements for credentialing and privileging.

For specific questions regarding eligibility and applicability of FTCA coverage, see the FTCA Health Center Policy Manual (PDF - 406 KB), Section C. Covered Activities, and the March 27, 2020, Determination of Coverage for COVID-19-Related Activities by Health Center Providers (PDF - 34 KB)

(Added: 5/6/2020)

Vaccination

COVID-19 vaccination providers, including participating health centers, are required to report information on vaccine supply, vaccine administration, and vaccine adverse events. Reporting this information is critical to help stop the COVID-19 pandemic.

Health centers that provide vaccines must comply with the CDC COVID-19 Vaccination Program provider requirements regarding data and reporting:

COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration, and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., Immunization Information Systems (IIS)) as soon as practicable and no later than 72 hours after administration. For information on the required vaccine administration data reporting elements, please see the FAQs for Private and Public Healthcare Providers About Implementing the CDC COVID-19 Vaccination Program in Provider Practices.
All COVID-19 vaccination providers enrolled in jurisdictional immunization programs must report COVID-19 vaccine inventory daily into Vaccines.gov for allocations from jurisdictions. (Note: The Health Center COVID-19 Vaccine Program allocation should NOT be reported in Vaccines.gov.) In some jurisdictions, providers may report vaccine inventory to the jurisdiction’s IIS for the jurisdiction to upload into Vaccines.gov. If you have questions about the process for your jurisdiction, please contact your jurisdiction’s immunization program. For a list of Immunization Program Managers, please visit the Association of Immunization Managers website.
All health centers that participate in the Health Center COVID-19 Vaccine Program must report COVID-19 vaccine inventory daily into the VTrckS Provider Order Portal (VPoP) for the HRSA allocation ONLY. (Note: The jurisdictional-supplied allocation should NOT be reported in VPoP.) If you have questions about the process for the Health Center COVID-19 Vaccine Program, please submit them through the BPHC Contact Form or call 877-464-4772, option 2, 8 a.m. to 8 p.m. ET, Monday-Friday (except federal holidays).
Health care providers are required to report certain adverse events related to COVID-19 vaccines to the Vaccine Adverse Event Reporting System. COVID-19 vaccination providers are also required to report vaccine administration errors, regardless of whether the error led to an adverse event.

When documenting vaccine administration in medical record systems, please note:

For existing or established health center patients, health centers should follow their usual health documentation process and record the vaccination, as with all other services, in the patient’s health center medical record.
For individuals who are not established patients of the health center and who are not accessing other health center services beyond the COVID-19 vaccination, the health center may either record the vaccination within the health center's medical record system or create and maintain a separate record. At a minimum, the record created by the health center should identify the patient, the service provided, the location where the service was delivered, the name of the provider(s) delivering the service, and the date and time the service was delivered.
For both established patients and individuals who are not established patients, the health center must record all CDC-required vaccine administration data elements (if not already recorded in the vaccine recipient’s record) and report this required data to the relevant system for the jurisdiction noted in their provider agreement. More information is available from CDC.

While health centers may determine whether vaccination records will be documented using their existing medical record system (e.g., the health center’s electronic health record (EHR)) or if they will maintain a separate set of immunization records (e.g., use a shared jurisdictional record system), whatever system is used, this record keeping system must enable the health center to submit the required COVID-19 vaccination data into the IIS within the specified timeframes and align with the health center’s state or jurisdictional accepted reporting option.

As a reminder, the Health Center COVID-19 Vaccine Program is designed as a separate, direct allocation for health centers, distinct from any vaccine allocation that health centers are receiving from their state or jurisdiction. Therefore, health centers must track and report total inventory for the Health Center COVID-19 Vaccine Program separately from their state or jurisdictional allocation.

(Added: 5/20/2021)

The CDC maintains information and exercises oversight regarding the U.S. COVID-19 Vaccination Program. As indicated in CDC’s COVID-19 Vaccination Program Provider Enrollment: Guidance for Providers, health care providers that enroll as participating providers in the U.S. COVID-19 Vaccination Program must sign the CDC COVID-19 Vaccination Provider Agreement, which includes various requirements specific to the program. Of note, participating providers are required under the provider agreement not to seek payment from patients who receive COVID-19 vaccine doses, including additional doses and booster doses, purchased by the U.S. government.

However, enrolled providers may seek reimbursement for the administration of the vaccine from the patient’s public or private insurance company, or, for patients without insurance coverage, from the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program, subject to availability of funds. Health centers may also seek reimbursement under the HRSA COVID-19 Coverage Assistance Fund (CAF), subject to availability of funds, for the costs of administering COVID-19 vaccines to patients whose health insurance does not cover vaccine administration fees, or whose insurance does but typically has patient cost-sharing.

Consistent with section 330 requirements for in scope services, health centers that participate with the U.S. COVID-19 Vaccination Program should continue to make every reasonable effort to collect appropriate reimbursement for COVID-19 vaccine administration costs, including billing Medicare, Medicaid, CHIP, and other public and private insurance or assistance programs, as applicable.

However, consistent with the terms and conditions of the U.S. COVID-19 Vaccination Program, health centers cannot charge any fees to vaccine recipients, including individuals without insurance coverage or those who would otherwise have copays, for unreimbursed vaccine administration costs. Health centers may use HRSA Health Center Program operational funding, as well as COVID-19 supplemental funding (H80, H8E, or H8F funds), as necessary to support the administration of in-scope COVID-19 vaccinations. For additional information on billing and patient cost sharing for health centers, see the Billing and Cost Sharing Overview for COVID-19 Vaccination, Testing, and Treatment resource.

(Updated: 6/21/2022)

Health centers have discretion, consistent with applicable law, to determine which practitioners are qualified to administer vaccines. In addition, health centers that have enrolled in the CDC's U.S. COVID-19 Vaccination Program also must comply with all of the requirements of the CDC COVID-19 Vaccination Program Provider Agreement. The provider agreement includes provisions relating to completion of training, reporting and managing vaccine inventory, storing and handling vaccine, reporting of adverse events, and reporting of data on doses administered.

To further clarify, health centers that provide COVID-19 vaccinations must:

Familiarize themselves and comply with state and federal requirements relating to COVID-19 vaccination, including provider qualifications to administer COVID-19 vaccinations;
Comply with the health center's own credentialing and privileging procedures regarding provider qualifications to administer COVID-19 vaccinations; and
Document in the health center's credentialing files compliance with applicable provider qualification standards/requirements for administering COVID-19 vaccinations.

Health centers should be aware that the HHS Secretary has issued a declaration with amendments under the Public Readiness and Emergency Preparedness (PREP) Act relating to COVID-19 countermeasures, including authorized COVID-19 vaccines.

The declaration authorizes certain health care professionals who may not otherwise be permitted to administer COVID-19 vaccines to do so. These include pharmacists, pharmacy interns, and pharmacy technicians; health care professionals who are licensed in another state; and certain physicians, advanced practice registered nurses, registered nurses, or practical nurses whose license or certification has lapsed within the last five years, when they meet specified criteria and conditions.
The declaration also provides immunity from claims to covered person (as defined in the declaration) and individuals involved in the development, manufacture, testing, distribution, administration, and use of covered countermeasures for claims of loss caused, arising out of, relating to, or resulting from administration or use of the covered countermeasures when the conditions in the declaration are met.

For information regarding FTCA coverage for deemed health centers, see the FTCA Health Center Policy Manual (PDF); the March 27, 2020 Determination of Coverage for COVID-19-Related Activities by Health Center Providers (PDF); and other questions on this FAQ webpage.

(Updated: 2/19/2021)

Yes. Health centers may participate in community vaccination campaigns conducted in coordination with state, territorial, or local responses to the COVID-19 public health emergency, within their scope of project, if the health center is performing these activities on behalf of the health center.

Health center providers would demonstrate that they are acting on behalf of the health center when they provide in-scope services if they clearly identify themselves as health center staff, the health center compensates the work of health center providers, the health center maintains the vaccination records, and the health center bills for any administration fee associated with vaccination. Health centers should maintain documentation that identifies the date, place, and circumstances during which they provide such services.

Providing vaccinations on behalf of a third-party entity, for example as an independent contractor of a third party entity, would constitute another line of business, and would not be an in-scope activity. For more information on assessing whether services or activities are performed on behalf of the health center, review the Considerations for Health Center Scope of Project During the COVID-19 Public Health Emergency.

Additional practice considerations pertinent to in-scope activities include the following:

If health centers partner with other organizations conducting community-based immunization programs, they should make arrangements with those organizations, as necessary, to obtain timely documentation of immunizations administered by health center providers.
Health centers that participate in the CDC COVID-19 Vaccination Program must follow all COVID-19 vaccine and administration reporting requirements specified in the CDC COVID-19 Vaccination Program Provider Agreement.

Health centers without “Immunizations” listed as an activity on Form 5C: Other Activities/Locations (PDF - 103 KB) should, in advance of participating, submit a brief Scope Adjustment request via EHBs to add this activity to their scope of project. When completing the Form 5C Scope Adjustment request, select “Immunizations” as the “Activity”; under “Frequency” state “as needed”; and under “Activity Location” state “various locations within the community as appropriate to respond to vaccination needs.” Once approved by HRSA, this activity will be documented as in-scope on the health center’s Form 5C.

For information about liability protections relating to health center providers providing COVID-19 vaccines, please see the preceding question “What liability protections apply to health center providers when an individual who receives a vaccine has an adverse reaction?” on this FAQ webpage.

(Added: 2/1/2021)

Yes. The Health Center Program views providing COVID-19 vaccinations as an element of in-scope general primary care and immunization services, as reflected on Form 5A: Services Provided. Health centers may administer COVID-19 vaccinations within their scope of project to health center patients and to individuals who are not health center patients both at the health center and at locations within the community that are not a health center’s service sites, as documented on Form 5B or 5C as appropriate. These activities could include community-based events that are either conducted by the health center or in which the health center participates that take place on the grounds of or within locations such as community centers, senior centers, nursing homes, and skilled nursing facilities.

Health centers should review HRSA’s Considerations for Health Center Scope of Project During the COVID-19 Public Health Emergency for factors that are relevant to whether an activity is considered within scope of project in the context of the COVID-19 public health emergency. Health centers also may review HRSA’s Determination of Coverage for COVID-19-Related Activities by Health Center Providers under 42 U.S.C. § 233(g)(1)(B) and (C) (PDF), which clarifies eligibility for FTCA coverage for health center providers deemed as Public Health Service (PHS) employees through the Health Center FTCA Program and the Health Center VHP FTCA Program who provide grant-supported COVID-19 health services, including vaccine administration, to their patients and to individuals who are not patients of the health center.

As with all in-scope services, health centers should maintain appropriate health records and, where applicable, billing records for immunizations they provide, consistent with applicable standards of practice. Health centers that partner with other organizations conducting community-based immunization programs should maintain their own records to the extent practicable, and if unable to do so, should make arrangements with those organizations, as necessary, to obtain timely documentation of all individual immunizations administered by health center providers. Delivering health services on behalf of a third party entity is generally another line of business outside the scope of the Health Center Program project.

Health centers are also reminded that the Public Readiness and Emergency Preparedness (PREP) Act provides broad liability protection to administrators of COVID-19 vaccines, including boosters, who are authorized to administer vaccines under the PREP Act declaration covering COVID-19 tests, drugs, and vaccines. Please note that whether an activity is within the Health Center Program grant-supported scope of project does not affect the applicability of PREP Act protections.

For additional resources, health centers may wish to review CDC Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations.

Health centers may contact the state and/or local immunization program manager in their jurisdiction for more information about COVID-19 vaccines. A list of immunization program managers is available through the Association of Immunization Managers.

(Updated: 12/29/2021)

Sites recorded on Form 5B: Service Sites must be locations that meet the definition of a service site in PIN 2008-01: Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB). Specifically, these are locations where all of the following conditions are met:

Health center encounters are generated by documenting in the patients’ records face-to-face contacts between patients and providers;
Providers exercise independent judgment in the provision of services to the patient;
Services are provided directly by or on behalf of the grantee, whose governing board retains control and authority over the provision of the services at the location; and
Services are provided on a regularly scheduled basis (e.g., daily, weekly, first Thursday of every month). However, there is no minimum number of hours per week that services must be available at an individual site.

To determine whether locations where COVID-19 vaccination is being provided should be listed on Form 5B: Service Sites, a health center must determine if the location meets all site criteria above.

If a health center, on its own behalf, plans to provide vaccinations to individuals within the community at a location that is not an approved service site, such activity may be within the scope of project and documented on Form 5C: Other Activities/Locations. As described in PIN 2008-01 linked below, the criteria for activities to be included on Form 5C are those that (1) do not meet the definition of a service site, (2) are conducted on an irregular timeframe/schedule, and (3) offer a limited activity from within the full complement of health center activities included within the scope of project. However, providing vaccinations on behalf of a third-party entity constitutes another line of business, rather than an in-scope activity. Activities on behalf of third-party entities would not be reflected on Form 5C: Other Activities/Locations.

View additional information on Considerations for Health Center Scope of Project During the COVID-19 Public Health Emergency.

View PIN 2008-01: Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB), Section III.B.(g), for information about recording activities on Form 5C: Other Activities/Locations.

(Added: 1/11/2021)

Health centers should pursue all reasonable opportunities to vaccinate every eligible person who wants to be vaccinated, understanding that this may increase the likelihood that vaccine will be wasted. To increase vaccination while still mitigating vaccine wastage, health centers may consider:

Establishing and promoting standing vaccination days or half-days to increase the likelihood of large numbers of people presenting for vaccination on the same day.
Vaccinating family members or friends who accompany patients to medical visits, even if they do not have an appointment that day.
Contacting additional persons (e.g., from a waitlist) to use as many vaccine doses as possible.

Health centers should continue to prepare enough doses to meet daily scheduled or anticipated demand and administer vaccines in accordance with the manufacturer’s guidelines for multi-dose vials.

As a reminder, to be considered in scope, all vaccination activities must be provided on behalf of the health center through services and activities within their scope of project. For more information on assessing whether services or activities are performed on behalf of the health center, review the Considerations for Health Center Scope of Project During the COVID-19 Public Health Emergency.

In addition, to mitigate potential vaccine wastage, health centers may transfer vaccine doses received through the Health Center COVID-19 Vaccine Program from one health center to another health center, as long as both are part of the Health Center COVID-19 Vaccine Program. If no other health centers participating in the Health Center COVID-19 Vaccine Program are in need of vaccine, health centers may consider transferring vaccine to other eligible community partners. For more information see the question “Can a health center transfer vaccines allocated through the Health Center COVID-19 Vaccine Program to public health partners or other community organizations to support broader community vaccination efforts?” on this FAQ webpage.

For health centers that receive vaccine allocation from their state or jurisdiction, please refer to the state/jurisdiction guidelines regarding information on mitigating vaccine wastage.

(Updated: 6/11/2021)

Health Center COVID-19 Vaccine Program

Vaccines provided through the Health Center COVID-19 Vaccine Program are to be administered to established health center patients and other individuals (i.e., new patients) who present for such services. Vaccines from the Health Center COVID-19 Vaccine Program must be used for vaccination activities conducted on behalf of the health center. Some considerations for whether vaccination activities would be on behalf of the health center include but are not limited to:

The health center’s governing board retains control and authority over the activities/provision of any services, regardless of whether the activities take place at a health center site or at another location within the community;
The health center establishes and/or maintains a patient/vaccination record for all individuals served; and
The health center bills for the vaccine administrative fee, as applicable.

For more information on assessing whether services or activities are performed on behalf of the health center, review the Considerations for Health Center Scope of Project During the COVID-19 Public Health Emergency.

In addition, while HRSA encourages health centers to order only the quantity of vaccine doses they can reasonably administer themselves, HRSA recognizes that in some cases it may be appropriate for a health center to transfer existing vaccine doses to another health center or vaccine provider, including those not participating in the Health Center COVID-19 Vaccine Program.

If necessary to avoid wastage and to increase community-wide vaccination efforts, health centers that participate in the Health Center COVID-19 Vaccine Program may transfer vaccine doses to state, local, tribal, or territorial public health partners, or other health care providers, in accordance with the following requirements:

Transfers can only be made to other CDC-enrolled vaccine providers within the health center’s jurisdiction.
Both parties involved must update their inventory upon transfer. This means the health center will need to zero out the transferred doses in VPoP and the recipient organization will need to increase their inventory in their applicable reporting system (Vaccines.gov/VaccineFinder).
The provider receiving the transfer assumes responsibility for reporting vaccine administration in its state IIS. The health center will not report on the administration of any transferred doses in the Health Center COVID-19 Survey or in any other reporting systems.

Note that VTrckS will not be updated to change the ordering or delivery information. Further guidance regarding the vaccine transfer process is available in the Health Center Program Community.

Questions regarding restrictions on redistributing vaccine doses allocated to a health center from the state or other source outside of the Health Center COVID-19 Vaccine Program should be directed to the CDC and the state.

COVID-19 Frequently Asked Questions (FAQs)

Search FAQs:

Funding and Other Resources

Program Oversight and Monitoring

Providing Care During Emergencies

FTCA Requirements

Service Delivery

Temporary Sites

Testing

Vaccination

Health Center COVID-19 Vaccine Program

Health Center COVID-19 Therapeutics Program

UDS Reporting

Quality Improvement

Partnerships and Special Populations

Information Collection

HHS Mask Distribution Program

COVID-19 Frequently Asked Questions (FAQs)

Search FAQs:

Funding and Other Resources

What supplemental funding has HRSA awarded to support health centers in responding to the COVID-19 public health emergency?

What economic relief options are available beyond Health Center Program funding to address health center payroll, revenue, and other financial concerns due to the COVID-19 public health emergency?

What is the Provider Relief Fund and how is funding allocated?

Will HRSA provide fiscal year (FY) 2023 Service Area Competition or look-alike Renewal of Designation (RD) applicants with flexibilities similar to those offered to FY 2021 and FY 2022 SAC/RD applicants?

How can a health center determine if they are going to complete an FY 2023 SAC/RD or a Budget Period Progress Report (BPR)/Annual Certification (AC)?

Can a health center’s patient target be adjusted since fewer patients are being seen during the COVID-19 public health emergency?

Will HRSA provide waivers for 340B Drug Pricing Program eligibility or compliance requirements?

What impact has COVID-19 had on National Health Service Corps and Nurse Corps participants?

Can a health center use its own staff to undertake minor alteration/renovation work instead of a contractor?

Program Oversight and Monitoring

What are HRSA's expectations for health centers that are unable to demonstrate compliance with one or more requirements due to the COVID-19 public health emergency?

Can the health center governing board conduct required monthly meetings virtually instead of in-person?

Can health centers charge patients for COVID-19 related testing and treatment?

Can health centers amend or adjust their sliding fee discount programs and/or billing and collections policies or procedures to respond to logistical or access barriers during the COVID-19 public health emergency?

Can health centers have a separate sliding fee discount schedule for services provided via telehealth that differs from that used for the same service(s) provided in person?

What changes have been made to the Operational Site Visit (OSV) process?

Will HRSA continue to review and approve new look-alike initial designation (LAL ID) applications during the COVID-19 public health emergency?

Where can health centers find information and guidance about the HHS Office of Inspector General (OIG) enforcement areas related to the COVID-19 public health emergency?

From an accounting perspective, how should health centers record items such as masks, COVID-19 tests, or COVID-19 vaccines received for free from the federal government? Are they considered a federal grant, or are they a donation?

Providing Care During Emergencies

Is the COVID-19 public health emergency still in effect? Where can the latest status be found?

What are the Centers for Medicare & Medicaid Services (CMS) emergency preparedness requirements for health centers?

Is there specific guidance on COVID-19 infection control and prevention that health centers should follow?

How can health centers access the Strategic National Stockpile (SNS) to get Personal Protective Equipment (PPE) and additional supplies in response to the coronavirus?

Can health centers conduct COVID-19 contact tracing within their scope of project?

Can health centers participate in COVID-19 clinical research trials?

What should health centers do if there are new COVID-19 public health guidelines that impact the delivery of health center services, e.g., directives to cease non-emergency medical or dental services?

What can health centers do to support routine immunizations?

What do administration sites need to know about COVID-19 monoclonal antibody therapeutics?

How are health centers reimbursed for administering COVID-19 mAb therapeutics?

What do health centers need to know about oral antiviral therapeutics for COVID-19?

How can health centers equitably support people with disabilities in accessing information about the COVID-19 Response Programs for vaccines, at-home self-tests, and therapeutics?

What is the Health Center Program Community?

FTCA Requirements

What are the requirements for coverage under the Federal Tort Claims Act (FTCA) in light of the declaration of a national public health emergency?

How has the COVID-19 public health emergency impacted FTCA site visits?

Does FTCA coverage extend to telehealth visits with both established patients and non-health center patients?

During the declared COVID-19 emergency, do FTCA protections apply to health center providers who provide telehealth services to health center patients located across state lines?

Can the 90-day timeframe for temporary credentialing and privileging of volunteers and other health center staff brought on to provide COVID-19 vaccines be extended?

Can volunteer providers at a health center receive liability protections under the Health Center FTCA Program?

How does a health center submit a VHP deeming sponsorship application? Can a Primary Care Association (PCA) or another entity submit a VHP deeming sponsorship application on behalf of the health center?

Can someone who is employed by one health center volunteer at another health center?

Under the Free Clinics FTCA Program, if a deemed free clinic seeks reimbursement from the HRSA COVID-19 Uninsured Program, will it impact their providers’ eligibility for FTCA coverage?

Does HRSA have a particularized determination for health centers related to COVID-19 activities?

Does HRSA have a particularized determination for free clinics related to COVID-19 activities?

Does FTCA coverage apply to health center staff (employees and contractors) engaged in COVID-19 contact tracing activities in their community?

Does FTCA coverage apply to health center staff engaged in COVID-19 clinical research trials?

What are the FTCA requirements governing the administration of vaccines by nurses or others who are called out of retirement?

If health centers are considering drive-through vaccine clinics in fire stations or similar buildings, how can they ensure this activity is done on behalf of the health center and covered by FTCA? How will health centers add these temporary sites to scope?

Service Delivery

Can health centers reduce the delivery of some required or additional services (e.g., dental services, physical therapy) during the public health emergency?

Can health centers conduct COVID-19 screening, triage, or testing of health center and non-health center patients outside of the health center's service sites?

How can a health center determine if locations that conduct only COVID-19 testing are considered to be service sites (Form 5B) or are considered to be “Other Activities/Locations” (Form 5C)?

Can health centers decrease or increase the hours of operation at service sites during the public health emergency?

May health centers provide in-scope services through telehealth to individuals who are not current health center patients?

Can a health center use telehealth to provide services to a patient at a location that is not an in-scope service site? Can this occur if neither the health center provider nor the patient is at an in-scope service site (e.g. both the provider and patient are at their respective homes)?

Do health centers need to request a change in scope for a provider to deliver in-scope services via telehealth from their home or another site not on Form 5B, assuming all the criteria for doing so (see question above) are met?

Are there any new Health Insurance Portability and Accountability Act (HIPAA) flexibilities or considerations for providing telehealth visits using readily available technologies such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype?

Can health centers bill Medicare for telehealth services as distant site providers?

Is there current guidance on the reimbursement methodology for distant site telehealth visits under Medicare?

Are there resources available on state Medicaid coverage for telehealth services furnished by health centers as distant site providers?

What CMS flexibilities are available to health centers seeking Medicaid reimbursement for oral health services delivered through telehealth technology during the COVID-19 public health emergency?

During the COVID-19 public health emergency, can a health center utilize a provider to deliver care that is outside of their routine duties? For example, can the health center have an OB/GYN write orders for adult non-OB/GYN patients?

Temporary Sites

What is a “temporary site” for the purposes of scope of project?

Under what circumstances can health center services be delivered at a new location without HRSA approval?

Which health centers are eligible to add temporary sites based on the COVID-19 public health emergency?

How and when should health centers submit a change in scope request to add a temporary site due to an emergency?

Can health centers operate a “temporary site” longer than 90 days?

What CMS flexibilities are available to health centers that open temporary sites due to the COVID-19 public health emergency?

What action(s) do health centers need to take to close a temporary site or to request that a temporary site be converted to a permanent site?

Testing

What COVID-19 tests can health centers purchase or use?

Can health centers purchase and provide COVID-19 at-home self-swab specimen collection kits to their patients?

What is the HRSA COVID-19 Testing Supply Program?

Can health centers limit the availability of COVID-19 testing to individuals who are established health center patients?

Are health centers required to provide free COVID-19 screening testing for asymptomatic individuals who do not have known, suspected, or reported exposure?