COVID-19 Frequently Asked Questions (FAQs)

To date, HRSA has awarded approximately $9.3 billion to support HRSA-funded health centers and Health Center Program look-alikes in responding to COVID-19:

• On Tuesday, March 24, 2020, HRSA released $100 million in funding provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (PDF) (activity code H8C).
• On Wednesday, April 8, 2020 HRSA released more than $1.3 billion in funding provided by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PDF) (activity code H8D).
• On Thursday, May 7, 2020, HRSA released approximately $583 million in Expanding Capacity for Coronavirus Testing (ECT) funding provided by the Paycheck Protection Program and Health Care Enhancement Act (PDF) (PDF - 287 KB) (activity code H8E).
• On Thursday, July 9, 2020, HRSA released more than $17 million in Look-Alikes: Expanding Capacity for Coronavirus Testing (LAL ECT) funding provided by the Paycheck Protection Program and Health Care Enhancement Act (PDF) (activity code L1C).
• On Thursday, April 1, 2021, HRSA released more than $6.1 billion in funding provided by the American Rescue Plan Act (PDF) for health centers (activity code H8F).
• On Thursday, July 15, 2021, HRSA released nearly $144 million in funding provided by the American Rescue Plan Act (PDF) for Health Center Program look-alikes (activity code L2C).
• On Tuesday, September 28, 2021, HRSA released nearly $1 billion in funding provided by the American Rescue Plan Act (PDF) to support major health care construction and renovation projects at health centers (activity code C8E).

In fiscal year 2020, HRSA awarded nearly $12.9 million to support training and technical assistance to enhance health centers’ COVID-19 response:

• More than $5.8 million to 52 Primary Care Associations.
• Nearly $2.5 million to 21 National Training and Technical Assistance Partners.
• More than $4.5 million to 49 Health Center Controlled Networks.

In fiscal year 2021, HRSA awarded over $32 million in American Rescue Plan funding to support COVID-19 related training, technical assistance, and health information technology support:

• Approximately $16.3 million to 52 Primary Care Associations.
• Approximately $5.5 million to 21 National Training and Technical Assistance Partners.
• Approximately $10.5 million to 49 Health Center Controlled Networks.

For additional information, see the Coronavirus-Related Funding Frequently Asked Questions, the American Rescue Plan Funding for Health Centers Frequently Asked Questions, the American Rescue Plan Funding for Look-Alikes Frequently Asked Questions, and the American Rescue Plan – Health Center Construction and Capital Improvements Frequently Asked Questions.

(Updated: 10/7/2021)

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)

The Provider Relief Fund supports health care-related expenses or lost revenue attributable to COVID-19, and the Uninsured Program and Coverage Assistance Fund ensures uninsured and underinsured individuals can get services related to COVID-19. See HRSA’s Provider Relief webpage for details about these programs. For answers to specific questions, providers should call the toll-free Provider Support Line at 866-569-3522.

(Added: 10/26/2022)

Between April 2021 and September 2021, the Department of Defense in partnership with HHS provided a total of 5.1 million adult-sized masks and 7.4 million child-sized masks to HRSA-supported health centers for free distribution to patients, staff, and members of the community.

Health centers were directed to distribute masks free of charge and to develop a distribution plan consistent with their understanding of the needs of their patients, staff, and community. There was no reporting or tracking required in the distribution of the masks.

(Added: 7/19/2022)
 

Between January 2022 and June 2022, HRSA provided more than 18.6 million N95 masks from the HHS Strategic National Stockpile to HRSA-supported health centers for free distribution to patients, staff, and members of the community. This program also provided free N95 masks to Medicare-certified rural health clinics.

Health centers were directed to distribute masks free of charge to patients, staff, and any members of the community who requested them, with a maximum of three masks available for each individual. Participating health centers were expected to answer the biweekly Health Center COVID-19 Survey questions specific to the HRSA Health Center COVID-19 N95 Mask Program, which described the number of masks distributed, the method of distribution, and the populations served.

(Added: 7/19/2022)
 

Similar to the extensions granted in calendar year 2020 in recognition of the impact of the COVID-19 public health emergency, HRSA extended the periods of performance/designation of health centers in a two- or three-year period of performance/designation that ended or will end in FY 2022 or FY 2023. Health centers received an extension if:

• Their period of performance/designation ended or will end between October 1, 2021 and September 30, 2023, and
• They did not receive an extension in calendar year 2020, and
• They are not currently in a one-year period of performance/designation.

Health centers that received an extension in calendar year 2020 have completed an FY 2022 SAC or RD application, as appropriate.
For questions regarding the impact on the timing of Operational Site Visits, please contact your BPHC Point of Contact.

(Updated: 3/21/2022)
 

If your period of performance/designation (number 26 on your most recent H80 Notice of Award or number 6 on your most recent Notice of Look-Alike Designation) ends in FY 2023 (October 1, 2022 through September 30, 2023), you will complete an FY 2023 SAC. If your period of performance/designation does NOT end in FY 2023, you will complete an FY 2023 BPR/AC.

(Updated: 3/21/2022)
 

Adjustments to the patient target can only be made through the SAC application process, where you set your target for your upcoming period of performance (see the Patient Target FAQs); the patient target cannot be adjusted retroactively. HRSA is tracking progress toward meeting patient targets, as well as exploring ways to align patient targets more holistically with health center performance. We recognize the significant impacts of the COVID-19 public health emergency on health center operations and do not anticipate adjusting funding prior to any FY 2023 SAC announcements based on past performance relative to patient targets.

(Updated: 3/21/2022)

HRSA understands that many 340B Program stakeholders are concerned about the evolving impact of COVID-19. If a covered entity has a specific concern about 340B eligibility or compliance, they should contact the 340B Prime Vendor via email  or at 1-888-340-2787 (Monday-Friday, 9:00 a.m. to 6:00 p.m. ET). For more information, visit the HRSA Office of Pharmacy Affairs COVID-19 Resources webpage.

(Added: 3/25/2020)

Please see the National Health Service Corps and Nurse Corps: Coronavirus (COVID-19) Frequently Asked Questions for information about these programs and their response to COVID-19.

(Updated: 3/30/2020)

The preferred method for accomplishing construction development is by soliciting through a competitive bid process consistent with 45 CFR §75.326 - §75.333. However, awardees may consider using their own work force (force account) if they can demonstrate that it would be cost effective and that qualified personnel are available to accomplish the work. You will need to provide the following information to HRSA for review:

• Justification for accomplishing the construction work by force account rather than by contract;
• Estimate of force account costs based on expected work hours, hourly rates, and non-salary costs;
• Estimate of contract construction costs based on typical items of work, quantities of work, and estimated unit prices;
• Summary cost comparison between using force account and contract construction;
• Names and qualifications of personnel to be used on the force account;
• Statement by the awardee concerning their capability to perform the various tasks of design, supervision, inspections, and testing as required for the intended project work;
• Statement by the awardee on the availability of their personnel to integrate the project into their normal workload; and
• Schedule identifying critical tasks and dates for when each task will be completed.

Additional information related to force account labor (PDF) is available from BPHC.

(Added: 5/21/2020)

Health Center Program requirements form the foundation and support the core mission of the health center model of primary care. However, HRSA recognizes that during this public health emergency there may be certain requirements with which a health center cannot demonstrate compliance within the timeframe or specific manner indicated in the Compliance Manual. (For example, staff may be unable to complete basic life support (BLS) re-certification in accordance with the health center’s timeline in its credentialing and privileging procedures, the completion of the health center's needs assessment might be delayed to reflect more current data for an extended project period, or there could be a delay in the release of the health center’s regular patient satisfaction survey.) HRSA will consider the impact of the COVID-19 public health emergency on the ability of health centers to demonstrate compliance with Health Center Program requirements when making future compliance determinations.

In addition to compliance, each health center is responsible for maintaining its operations, in compliance with all other applicable federal, state, and local laws and regulation beyond HRSA’s authority. This includes but is not limited to those protecting public welfare, the environment, and prohibiting discrimination; state facility and licensing laws; state scope of practice laws; Centers for Medicare & Medicaid Services (CMS) Conditions for Coverage for FQHCs; and state Medicaid requirements. For information on any flexibilities or waivers of other requirements, consult the applicable agency.

Updated: 9/28/2021

Yes, as indicated in the Health Center Program Compliance Manual, where geography or other circumstances make monthly, in-person participation in board meetings burdensome, health centers may conduct monthly meetings by telephone or other means of electronic communication where all parties can both listen and speak to all other parties.

(Added: 3/19/2020)

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)

Health centers may not have a separate sliding fee discount schedule for telehealth. However, where the locally prevailing charges or the actual costs for services delivered via telehealth differ from those delivered in person, health centers may have different charges on a fee schedule. For example, if the cost of providing a primary health care visit through telehealth is less than an in-person visit, the health center may establish a separate, lower charge for the telehealth primary care visit on the fee schedule. The health center would then apply their sliding fee discount schedule to the charge for the telehealth visit, which would be the same sliding fee discount schedule applied to an in-person primary care visit. For more information, see Health Center Program Billing and Collections requirements.

(Added: 5/6/2020)

In response to the COVID-19 public health emergency, HRSA has suspended in‐person OSVs. As of summer 2022, HRSA continues to conduct OSVs virtually. Most aspects of the virtual OSV are the same as a traditional on-site OSV, but secure file sharing and video conferencing technology allow for remote access to documents and participants. HRSA will continue to use this virtual format until it is able to resume standard, on-site OSVs. Health centers due for a site visit will be contacted by HRSA to schedule and discuss the logistics of a virtual visit.

(Updated: 6/21/2022)

HRSA continues to welcome LAL ID applications on a rolling basis. For additional information, see the LAL ID technical assistance webpage.

To be designated as a look-alike, applicants must meet eligibility requirements and comply with all Health Center Program requirements at the time of application. LAL ID site visits are a critical part of the look-alike designation process. In order to continue processing LAL ID applications during the current public health emergency, HRSA is conducting virtual site visits for LAL ID applicants who successfully meet completeness and eligibility requirements. HRSA will continue using the standard review process to finalize designation or disapproval, with timeframe accommodations based on the impacts of the COVID-19 public health emergency.

(Updated: 9/30/2020)

The HHS OIG has issued FAQs on the Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 Public Health Emergency. Health centers are encouraged to review these FAQs regarding OIG’s administrative enforcement authorities, including the federal anti-kickback statute and civil monetary penalty provision prohibiting inducements to beneficiaries. OIG will continue to update the FAQs as additional responses become available. For specific inquiries, please contact OIGComplianceSuggestions@oig.hhs.gov.

(Added: 4/13/2021)

Items such as masks, COVID-19 tests, or COVID-19 vaccines that health centers receive for free from the federal government are considered to be in-kind donations and should be reported and accounted for by health centers accordingly. Please contact your Grants Management Specialist if you have any questions.

Related resources regarding in-kind reporting and valuation are available from the American Institute of Certified Public Accountants and the Financial Accounting Standards Board (PDF)

(Added: 9/14/2021)

A list of all public health emergency declarations is available from the HHS Office of the Assistant Secretary for Preparedness and Response. 

A public health emergency declaration lasts until the Secretary declares that the public health emergency no longer exists, or upon the expiration of the 90-day period beginning on the date the Secretary declared the public health emergency, whichever occurs first. The Secretary may extend the declaration for additional 90-day periods as long as the public health emergency continues to exist, or the Secretary may terminate the declaration whenever he determines that the public health emergency has ceased to exist.

(Updated: 3/3/2022)

The CMS Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers Final Rule outlines the expectations for health centers to develop and maintain an emergency preparedness communication plan and develop and maintain annual training and testing programs. Health centers must also coordinate with state and local health departments as part of their emergency management planning, preparedness, mitigation, and response efforts.

For information on how to coordinate with officials in your state regarding the state’s emergency preparedness or pandemic plan for the COVID-19 public health emergency, find your applicable point of contact.

(Added: 6/16/2020)

Health centers should refer to CDC Guidance for Healthcare Professionals about Coronavirus (COVID-19), which provides recommendations on caring for patients, protecting patients and workers, including infection control guidance for health care professionals, and facility guidance. In addition, health centers can contact their state, tribal, and/or local health departments for further guidance on patient safety and infection control and prevention. Lastly, health centers may wish to review the resources ECRI has developed through its COVID-19 Resource Center  and COVID-19 resources available through the Health Center Resource Clearinghouse.

(Updated: 7/28/2020)

If a health center's regular distributors are unable to fulfill orders for critical medical supplies such as PPE, the health center and/or the Primary Care Association should contact the local and/or state public health department for assistance. If the state is unable to provide supplies, state health officials — through the governor or his/her representative — may request federal assistance from the U.S. Department of Health and Human Services (HHS). Visit the HHS website for additional information and the current status of the SNS inventory.

(Updated: 4/29/2020)

As part of providing health services to their patients, health centers may have a role to play in COVID-19 contact tracing. Health center activities must be within the scope of section 330, should follow CDC and other applicable public health guidance, and should be coordinated as appropriate with federal, state, and local public health response efforts.

In providing care to patients with COVID-19, health centers should obtain information about the contacts of infected patients consistent with public health guidance, including guidance provided by the CDC. Health centers must report information on COVID-19 infections to federal, state, and local public health agencies consistent with applicable law (including laws relating to communicable disease reporting and privacy). In addition, in coordination with federal, state and local public health activities, health centers may notify identified contacts of infected health center patients of their exposure to COVID-19, consistent with applicable law (including laws relating to communicable disease reporting and privacy).

Health centers should be aware that activities other than those described above, as well as activities performed on behalf of a third party, including on behalf of a federal, state, or local public health agency, would constitute another line of business outside the scope of their Health Center Program project.

(Updated: 5/21/2020)

Health centers may participate in clinical research for COVID-19 vaccines and therapeutics within the Health Center Program scope of project incident to providing primary and approved additional health services to health center patients. Health centers that participate in such research must comply with all applicable laws and requirements, including but not limited to those pertaining to the protection of human research subjects (including requirements for informed consent and institutional review board approval) and ensuring privacy/confidentiality of patient health information. As the conduct of clinical research is highly regulated, health centers may wish to consult private legal counsel regarding applicable laws and requirements.

For more information regarding Health Center Program requirements related to patient safety and safeguarding the confidentiality of patient information, please review Chapter 10: Quality Improvement/Assurance (QI/QA) of the Health Center Program Compliance Manual. For information regarding health information privacy protection requirements, please review the HHS webpage on HIPAA for Professionals. For information on FTCA coverage for deemed health centers relating to clinical research, see Section C.5.5 Clinical research in the FTCA Health Center Policy Manual (PDF) and the question “Does FTCA coverage apply to health center staff engaged in COVID-19 clinical research trials?” in the FTCA section of this FAQ webpage.

Health centers can also support COVID-19 research for vaccines and therapeutics by encouraging patient participation in clinical research studies conducted by other organizations.

(Added: 10/23/2020)

Health centers should follow all applicable public health guidance from state and local public health authorities regarding the modification or cessation of the delivery of specific services. The following guidance is available from the federal government:

• CDC information regarding the latest clinical or testing guidance for COVID-19
• Centers for Medicare & Medicaid Services (CMS) information regarding Medicare and Medicaid services during the COVID-19 public health emergency.
• CDC guidance for providers in dental settings during the COVID-19 response
•  OSHA guidance on Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.

(Updated: 7/19/2021)

COVID-19 has led to a steep decline in routine immunizations, raising the risk for outbreaks and further strain on the nation’s health care system. Health centers play a critical role, as research shows the strongest predictor of whether a patient gets vaccinated is a recommendation from their health care professional.

To encourage patients and stakeholders to keep up with immunizations, the CDC has produced toolkits and resources to help health care professionals communicate with their patients about immunization. In addition, the CDC’s Interim Guidance for Immunization Services During the COVID-19 Pandemic can also help your health center plan for safe vaccine administration during the COVID-19 pandemic.

Health Center Program (H80), COVID-19 (H8C), CARES (H8D), and American Rescue Plan funds may be used to support the provision of routine immunizations—including influenza vaccines—provided such activities are within the health center’s scope of project. Health Center Program Expanded Capacity for Testing (ECT) (H8E) funds may not be used to support the provision of routine immunizations. More information about allowable uses of funding is available in the Other Uses of Funds section of the Health Center Program’s Coronavirus-Related Funding FAQs and the American Rescue Plan Funding for Health Centers FAQs.

(Updated: 7/19/2021)

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:

• Therapeutics Clinical Implementation Guide (PDF - 2 MB)
• COVID-19 Monoclonal Antibody Therapeutics Communications Toolkit

Additional information about mAb therapeutics can be found at COVID-19 Therapeutics and  CombatCOVID.hhs.gov.

(Updated: 1/27/2022)

During the COVID-19 public health emergency, Medicare will cover and pay for mAb therapies (when furnished consistent with their respective Emergency Use Authorizations) the same way it covers and pays for COVID-19 vaccines. For Federally Qualified Health Centers (FQHCs), that means mAb treatments are paid at 100% of reasonable cost through the Medicare cost report. FQHCs should include mAb treatment administration costs for patients enrolled in Medicare Advantage on the cost report as well. FQHCs may request lump sum payments in advance of cost report settlement from their Medicare Administrative Contractor for administering mAb therapies to Medicare beneficiaries.

MAb treatments are mandated treatments for Medicaid (PDF - 93 KB). Health centers should consult their state Medicaid program for reimbursement details.

For additional information on charging and discounting care for patients without insurance, see the question “Can health centers charge patients for COVID-19 related testing and treatment?” in the Program Oversight and Monitoring section of this FAQ webpage.

Health centers may also 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 mAb therapeutics to patients for whom this treatment is indicated. For additional information, see our Coronavirus-Related Funding FAQs or American Rescue Plan Funding for Health Centers FAQs.

(Updated: 4/12/2022)

The FDA has authorized two oral antiviral treatments – Lagevrio (molnupiravir) and Paxlovid – for emergency use in treating mild to moderate COVID-19. These products are available via a state/territory-coordinated distribution system, with state/territorial health departments identifying 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.

In order to ensure equitable access among the nation’s underserved communities and those disproportionately affected by COVID-19 and in support of the Biden-Harris Administration’s Test to Treat Initiative, a direct supply of oral antiviral treatments is also being provided to HRSA-supported health centers through the HRSA Health Center COVID-19 Therapeutics Program. After beginning incrementally in December 2021, this program is now open to all HRSA-funded health centers and Health Center Program look-alikes with pharmacy capacity. More information is available in the Health Center COVID-19 Therapeutics Program section of this FAQ webpage, including a list of resources under the question “What resources are available to educate health center staff about therapeutics?”

(Updated: 7/19/2022)

Health centers can support patients with disabilities who request assistance by referring them to the Disability Information and Access Line (DIAL). This is a helpline for people with disabilities funded by the HHS Administration for Community Living. Examples of how DIAL’s trained staff can assist include:

• Finding local vaccination locations and making appointments;
• Sharing information about therapeutics;
• Connecting callers to local services (such as accessible transportation) to address physical barriers to receive vaccinations, self-tests, or therapeutics; and
• Providing alternative accessible formats of at-home self-test instructions for the visually impaired and blind population.

(Added: 6/21/2022)
 

The Health Center Program Community is an online platform for COVID-19 Response Program participants (including vaccines, testing supplies, and therapeutics) to get answers, interact with other participating health centers, and access training and technical assistance resources. It is also being expanded as an information resource for additional topics related to the Health Center Program.

(Added: 6/21/2022) 

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 - 266 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 - 266 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)

Site visits are a critical part of the oversight and compliance process for deemed health centers. In response to the COVID-19 public health emergency, HRSA suspended in-person site visits temporarily and conducted virtual site visits beginning in November 2020. Beginning in August 2022, FTCA site visits may be conducted virtually or on-site, as determined by the program. Health centers selected for either type of site visit will be notified by HRSA staff. For additional information and resources, please visit the FTCA webpage. For questions, please email the FTCA site visit team at BPHCFTCASiteVisit@hrsa.gov, use the BPHC Contact Form, or call 877-464-4772, option 1.

(Updated: 6/21/2022)

When in-scope services are provided through telehealth on behalf of a deemed health center to either established patients or individuals who are not patients of the health center, and all other FTCA Program requirements are met, such services are eligible for liability protections under 42 U.S.C. 233(g)-(n), pursuant to 42 CFR 6.6 and the Determination of Coverage for COVID-19-Related Activities by Health Center Providers under 42 U.S.C. § 233(g)(1)(B) and (C) (the particularized determination for health center providers (PDF)).

The particularized determination clarifies eligibility for FTCA coverage during the COVID-19 pandemic for the provision of grant-supported health services by individuals who have been deemed as Public Health Service employees through the Health Center FTCA Program and the Health Center Volunteer Health Professional FTCA Program. It applies to 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 established or non-established patients of the health center, whether in person at the health center, offsite (including at offsite programs or events carried out by the health center), or via telehealth.

Health centers and providers are encouraged to consult with private counsel and/or consider the purchase of private malpractice insurance when undertaking activities that may not be within the health center’s scope of project.

(Updated: 6/2/2020)

Health Center FTCA Program regulations at 42 CFR Part 6 provide that coverage applies to “grant-related activities.” Therefore, a key determinant for FTCA coverage is whether the covered entity is providing services within the health center’s scope of project, under the Health Center Program authorizing statute.

PAL 2020-01: Telehealth and Health Center Scope of Project (PDF - 176 KB) highlights some of the relevant considerations for health centers in providing in-scope services through telehealth. Among other things, all providers must comply with applicable state requirements. If they do not—for example, if a provider uses a state license to provide services in a different state where doing so is unlawful under applicable state law—this may jeopardize eligibility for FTCA liability protection. However, some states may have temporarily amended their requirements for providing health care through telehealth to address the needs of the COVID-19 public health emergency.

Health centers that are uncertain of the applicable legal requirements for the provision of health services through telehealth across state lines should consult their private counsel for advice. HRSA cannot provide general assurance of FTCA coverage in all situations, as such determinations are fact-specific. As stated in the FTCA Health Center Policy Manual (PDF - 406 KB), “[w]hen FTCA matters become the subject of litigation, the Department of Justice and the federal courts assume significant roles in certifying or determining whether or not a given activity falls within the scope of employment for purposes of FTCA coverage.”

(Added: 4/8/2020)

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)

Yes, the 21st Century Cures Act (Pub. L. 114-255) extended liability protections to Volunteer Health Professionals (VHPs) for the performance of medical, surgical, dental, and related functions at health centers. For liability protections to apply under section 224(q) of the Public Health Service Act (42 U.S.C. § 233(q)), the volunteer must be a health care professional who is licensed or certified to provide clinical services. This would include Licensed Practical Nurses (LPNs) and Medical Assistants (MAs) who are licensed or certified. Volunteers who are not licensed or certified are not eligible for VHP coverage.

VHPs are not automatically eligible for liability protections under the Health Center FTCA Program. Deemed health centers must apply for such protections for their individual volunteers through a VHP deeming sponsorship application. See Program Assistance Letter (PAL) 2020-03: Calendar Year 2021 Volunteer Health Professional Federal Tort Claims Act (FTCA) Deeming Sponsorship Application Instructions (PDF - 183 KB). The deemed health center must submit to HRSA and receive approval of a VHP deeming sponsorship application for each individual volunteer.

Note: Statutory authority for the VHP Program is currently due to sunset on October 1, 2022, pursuant to Section 224(q)(6) of the Public Health Service Act (42 U.S.C. § 233(q)(6)).  Previously issued VHP Notices of Deeming Action are being amended to expressly reflect this statutory sunset date.  Future VHP Notices of Deeming Action for calendar year 2022 will also reflect the last date of coverage, which is September 30, 2022.  Absent legislative action to continue the program beyond the statutory sunset date, the program will end.

(Updated: 6/21/2022)

Health centers can complete a VHP deeming sponsorship application by accessing the Electronic Handbooks (EHBs) and going to the FTCA application section. The EHBs allow sponsoring health centers to submit multiple VHPs in one application submission. For assistance with this process, please 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).

Applications for VHP deeming must be submitted by the health center's Authorized Official. However, health centers may seek technical assistance in preparing and submitting such applications from PCAs and other third parties.

Note: Statutory authority for the VHP Program is currently due to sunset on October 1, 2022, pursuant to Section 224(q)(6) of the Public Health Service Act (42 U.S.C. § 233(q)(6)).  Previously issued VHP Notices of Deeming Action are being amended to expressly reflect this statutory sunset date.  Future VHP Notices of Deeming Action for calendar year 2022 will also reflect the last date of coverage, which is September 30, 2022.  Absent legislative action to continue the program beyond the statutory sunset date, the program will end.

(Updated: 6/21/2022)

Health centers and their providers are strongly encouraged to exercise caution, as FTCA liability protections may be placed at risk when a provider acts on behalf of more than one entity under circumstances that do not make it clear in what capacity the individual was acting at the time of an event that becomes the subject of a claim or lawsuit. Health centers are reminded that when FTCA matters become the subject of litigation, the U.S. Department of Justice and the federal courts assume significant roles in certifying or determining whether a given activity falls within the scope of employment for purposes of FTCA coverage. Health centers and providers are encouraged to consult with private counsel and/or consider the purchase of private malpractice insurance when individual providers wish to undertake activities on behalf of multiple entities and/or in multiple capacities.

(Added: 3/19/2020)

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. In responding to the declared public health emergency, otherwise qualified free clinic health care practitioners, employees, and contractors who have been deemed as Public Health Service employees for purposes of liability protections through the Free Clinics FTCA Program are eligible for such protections for screenings and triage activities relating to the diagnosis and treatment of COVID-19, as well as for other qualifying health services, provided to patients and other individuals seeking such services from the free clinic. These services may be provided at the free clinic or offsite, including at offsite programs or events carried out by the free clinic, which includes providing services on behalf of the free clinic at “drive-up” screening locations in the free clinic parking lot or in other nearby locations.

Free clinic providers located at the free clinic or in such other locations may also utilize telehealth to facilitate the delivery of services to free clinic patients and other individuals. All such contact must be appropriately documented in free clinic patient medical records. In addition, all other Free Clinics FTCA Program requirements remain applicable. For additional information, see Policy Information Notice 2011-02: Free Clinics Federal Tort Claims Act (FTCA) Program Policy Guide (PDF - 380 KB), and the Free Clinics FTCA Program website.

(Added: 3/27/2020)

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)

HRSA has issued a particularized determination for health center providers (PDF) that clarifies eligibility for FTCA coverage during the COVID-19 pandemic for the provision of grant-supported health services by individuals who have been deemed as Public Health Service employees through the Health Center FTCA Program and the Health Center VHP FTCA Program. It applies to 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 established or non-established patients of the health center, whether in person at the health center, offsite (including at offsite programs or events carried out by the health center), or via telehealth.

(Added: 3/31/2020)

HRSA has issued a particularized determination for free clinic providers (PDF) that clarifies eligibility for FTCA coverage during the COVID-19 pandemic for the provision of qualifying health services by individuals who have been deemed as Public Health Service employees through the Free Clinics FTCA Program. It applies to qualifying 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 established or non-established patients of the free clinic, whether in person at the free clinic, through responsive offsite programs or events carried out by the free clinic, or via telehealth.

(Added: 3/31/2020)

A deemed health center would be eligible for FTCA coverage for COVID-19 screening, triage, testing and diagnosis activities, including notifying identified contacts of infected health center patients of their exposure to COVID-19, consistent with applicable law (including laws relating to communicable disease reporting and privacy), as part of their scope of project and as reflected on Form 5A: Services Provided. These services are considered part of Required Services such as General Primary Medical Care, Screenings, and Diagnostic Laboratory.

Health centers participating in community-wide intervention efforts—which may include partnering with state and local health departments for contact tracing—would be operating within their scope of project, so long as the related services are conducted on behalf of the health center.

HRSA has issued a particularized determination (PDF - 34 KB) for health center providers that clarifies eligibility for FTCA coverage during the COVID-19 pandemic for the provision of grant-supported health services by individuals who have been deemed as Public Health Service employees through the Health Center FTCA Program and the Health Center VHP FTCA Program. The particularized determination applies to 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 established or non-established patients of the health center, whether in person at the health center, offsite (including at offsite programs or events carried out by the health center), or via telehealth."

For more information regarding eligibility and applicability of FTCA coverage, see the FTCA Health Center Policy Manual (PDF - 406 KB), Section B. Covered Individuals, and Section C. Covered Activities.

(Added: 5/6/2020)

Under FTCA Health Center Program regulations at 42 CFR 6.6(d), only acts and omissions related to the grant-supported activities of entities covered by FTCA are eligible for FTCA coverage. Acts and omissions related to services provided to individuals who are not patients of a deemed health center (“covered entity”) are eligible for coverage only in limited circumstances and after the Secretary makes certain required determinations.

Therefore, as explained in Section C.5.5 of the FTCA Health Center Policy Manual (PDF), clinical research in the context of patient care, conducted by covered individuals with covered entity patients, qualifies for FTCA coverage if it is within the approved scope of project of the covered entity and the scope of employment of the covered individuals with the covered entity. To the extent that research involves non-health center patients, it is not covered by FTCA.

(Added: 9/17/2020)

Through the Health Center FTCA Program regulations, HRSA has issued several examples of situations in which deemed health centers and their covered providers have liability protections for certain activities carried out by the deemed entity and its eligible personnel. Under 42 CFR 6.6(e)(4)(D):

(D) Immunization Campaigns: On behalf of the health center, health center staff conduct or participate in an event to immunize individuals against infectious illnesses. The event may be held at the health center, schools, or elsewhere in the community.

For additional information about FTCA Program requirements, please refer to the FTCA section of the Health Center Program website, which includes links to the FTCA Health Center Policy Manual (PDF), Annual Deeming Application PAL (PDF), and Annual VHP Deeming Application PAL (PDF - 183 KB), along with other resources that provide information and instructions regarding eligibility for liability protections for health center employees, board members, officers, contractors, and volunteers.

(Added: 8/20/2020)

For additional information in determining whether activities are performed on behalf of the health center, please review Considerations for Health Center Scope of Project and the COVID-19 Public Health Emergency. HRSA has a streamlined process outlined in PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF)

HRSA approval is required any time a health center will add a temporary site(s) in response to emergency events when the location would meet the service site definition as defined in PIN 2008-01: Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB). The information needed for this request must be submitted as soon as practicable but no later than 15 days after initiating emergency response activities. See also the FTCA Health Center Policy Manual (PDF), particularly Section (I)(C), and the Determination of Coverage for COVID-19-Related Activities by Health Center Providers (PDF).

(Added: 8/20/2020)

Health centers do not need to request HRSA prior approval via a change in scope in cases where they are temporarily closing a site due to the public health emergency. Health centers should ensure their patients are made aware of closures and where and how to seek care at other service delivery sites as appropriate.

If a health center determines that it will permanently close a site after the public health emergency, it must submit a change in scope for HRSA approval to delete the site.

(Added: 3/19/2020)

HRSA recognizes that during the declared emergency health centers may face staffing shortages and/or facility capacity limitations and may need to prioritize appointments and staffing to address the most urgent needs of patients. No change in scope is necessary if your health center is changing the level or intensity of certain services within the scope of project. If a health center permanently removes a service from its scope of project, a change in scope request to delete the service will need to be submitted for HRSA approval.

(Added: 3/17/2020)

Yes. COVID-19 screening, triage, or testing of health center patients performed on behalf of the health center are elements of general primary care and diagnostic laboratory services as reflected on Form 5A: Services Provided.

The Health Center Program views providing screenings, triage, and testing to any patient — including both established health center patients and individuals who are not established patients of the health center – at the health center, outside on its grounds, or elsewhere in the community as within the health center's scope of project (see 42 CFR 6.6 (e)(4)(i)(C)). This includes providing such screening, triage, or testing to patients in the parking lot of the health center or in other community locations.

(Updated: 6/18/2020)

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.

Health centers may be engaged in a variety of different COVID-19 testing activities (screening, triage, specimen collection, etc.). To determine whether COVID-19 testing should be categorized on Form 5B: Service Sites or Form 5C: Other Activities/Locations, a health center must determine if the location meets all site criteria above. If all site criteria are not met — particularly if testing is provided on an irregular timeframe/schedule (e.g., the health center provides testing for short periods of time at a variety of locations) — this would generally be considered portable clinical care and documented on Form 5C: Other Activities/Locations.

View additional information on considerations for health center scope of project during the COVID-19 public health emergency.

(Added: 7/8/2020)

HRSA recognizes that health centers may need to change the hours of operation of their service sites during the declared emergency. No change in scope is necessary if your health center is temporarily increasing or decreasing hours of operation at one or more sites. If a health center permanently changes the hours of operation at one or more sites, they should submit a scope adjustment (PDF) request for HRSA approval. As with any changes that may have impacts on access to care, health centers should ensure patients are made aware of changes to site hours of operation.

(Added: 4/7/2020)

As a result of the Secretary's declaration relating to the current COVID-19 public health emergency, health center providers may deliver in-scope services via telehealth to individuals who have not previously presented for care at a health center site and who are not current patients of the health center for the duration of this public health emergency. This includes triage services, including initial consultations. Telehealth visits are within the scope of project if:

• The individual receives an in-scope required or additional health service;
• The provider documents the service in a patient medical record consistent with applicable standards of practice; and
• The provider is physically located at a health center service site or at some other location on behalf of the health center (e.g., provider’s home, emergency operations center).

Health centers should focus services provided by telehealth on serving patients and other individuals located inside their service area or with areas adjacent to the covered entity’s service area. HRSA recognizes that patients outside these areas may seek health center screenings and triage by telehealth. Health centers that continue to maintain services for target populations in their service area and provide occasional in-scope services via telehealth to individuals outside these areas would be providing services within the Health Center Program scope of project for all such activities. Please review PAL 2020-01: Telehealth and Health Center Scope of Project (PDF) for more information.

(Added: 3/19/2020)

From a Health Center Program scope of project policy perspective, using telehealth to provide services to a patient at a location that is not an in-scope service site is allowable if:

1. The service being provided via telehealth is within the health center's approved scope of project (recorded on Form 5A);
2. The clinician delivering the service is a health center provider working on behalf of the health center; and
3. The individual receiving the service is a health center patient.

HRSA strongly encourages health centers that provide, or are planning to provide, health services via telehealth to consult with professional organizations, regulatory bodies, and private counsel to help assess, develop, and maintain written telehealth policies that are compliant with Health Center Program requirements; federal, state, and local requirements; and applicable standards of practice. HRSA also encourages health centers to consider the range of issues that would support successful implementation of telehealth. Please review PAL 2020-01: Telehealth and Health Center Scope of Project (PDF) for more information.

For questions about FTCA coverage, 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: 4/7/2020)

Health centers do not need to request a change in scope to deliver in-scope services via telehealth on behalf of the health center from the provider’s home or from another location that is not a Form 5B Service Site. In addition, health centers do not need to have "Home Visits" listed on their Form 5C: Other Activities/ Locations in order to provide in-scope services via telehealth.

For questions about FTCA coverage, 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).

(Added: 4/7/2020)

The HHS Office for Civil Rights issued a Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency on March 17, 2020, which indicates HHS will not impose penalties for noncompliance with regulatory requirements under HIPAA rules in connection with the good faith provision of telehealth during the COVID-19 emergency. There are also Frequently Asked Questions on telehealth (PDF - 414 KB) available.

Providers, including health centers, now have greater flexibility to provide telehealth using any non-public facing remote communication product that is available to communicate with patients (Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype). Note that according to this notification, Facebook Live, Twitch, and TikTok are not allowable applications. See the notification for additional details.

(Added: 3/25/2020)

During this emergency period, Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) are eligible to provide telehealth services to Medicare beneficiaries as distant site providers.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act revised the definition of a distant site in section 1834(m)(2)(A) of the Social Security Act to include FQHCs or RHCs that furnish a telehealth service to an eligible telehealth individual during the COVID-19 public health emergency period. Rural and site limitations are removed, so that telehealth services furnished during the emergency period can be provided regardless of the geographic location of the Medicare beneficiary, including if the patient is at home. Telehealth services include medical outpatient office visits, behavioral health services, and other visits currently eligible under the Medicare telehealth reimbursement policies.

Medicare telehealth services generally require an interactive audio and video telecommunications system that permits real-time communication between the practitioner and the patient. However, during the public health emergency, some telehealth services can be furnished using audio-only technology. For more information, please visit the following CMS resources:

• COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing (PDF - 1 MB)
• CMS Flexibilities to Fight COVID-19 (PDF - 2 MB) and
• CMS and Medicare Learning Network’s New and Expanded Flexibilities for RHCs and FQHCs During the COVID-19 Public Health Emergency (PDF - 200 KB) 

(Updated: 6/3/2020)

Medicare has provided guidance on the payment method for telehealth services furnished by FQHCs as distant sites during the emergency period. The CARES Act required the Centers for Medicare & Medicaid Services (CMS) to develop payment rates similar to the national average payment rates for comparable telehealth services under the Physician Fee Schedule (PFS). For services from January 27, 2020, through December 31, 2020, the rate was $92.03, which was the average amount for all PFS telehealth services on the telehealth list, weighted by volume for those services reported under the PFS. Effective January 1, 2021, the payment rate for distant site telehealth services was updated to $99.45. CMS has additional information (PDF - 200 KB) on the submission of claims and reimbursement.

(Updated: 7/19/2021)

States have the discretion to cover telehealth through Medicaid; no federal approval is needed for state Medicaid programs to reimburse for telehealth services in the same manner or at the same rate paid for face-to-face services, visits, or consultations. The Center for Connected Health Policy (a National Telehealth Resource Center) has published a summary of state telehealth responses to COVID-19 , including Medicaid coverage. For additional Medicaid information, please visit the State Medicaid & CHIP Telehealth Toolkit (PDF - 900 KB) located on the Medicaid telemedicine webpage and the COVID-19 resources for state Medicaid and CHIP agencies.

(Updated: 5/3/2021)

CMS has information (PDF - 2 MB) on flexibilities for telehealth reimbursements provided for state Medicaid and Children’s Health Insurance Program (CHIP) agencies. In particular, see the question on telehealth reimbursement flexibilities to cover teledentistry (page 73).

For additional training and technical assistance resources, visit the National Network for Oral Health Access (NNOHA), a HRSA-funded National Training and Technical Assistance Partner, for teledentistry resources. See also resources summarizing state telehealth responses to COVID-19, including Medicaid coverage, developed by the Center for Connected Health Policy (a National Telehealth Resource Center).

(Added: 6/9/2020)

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. If your state authorizes health practitioners to provide services 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.

(Added: 4/7/2020)

In response to emergency events, health centers can temporarily add sites (including tents, modular units, or trailers) that are not currently within the scope of project. These requests are not submitted through the EHBs; a health center simply provides key information via the BPHC Contact Form. Health centers may wish to review the Considerations for Health Center Scope of Project and the COVID-19 Public Health Emergency, prior to requesting the addition of a temporary site.

Temporary 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) as a location 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.

HRSA’s streamlined process for adding temporary sites during emergencies is described in PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF - 266 KB). We may contact you for additional information about your activities at the new locations so that HRSA can better determine if your request meets the criteria.

(Updated: 6/21/2022)

HRSA approval is not required for the provision of in-scope health center services at the following locations if these locations are already within your approved scope of project, i.e., documented on Form 5B or Form 5C, including but not limited to:

• A health center service site (on Form 5B), including any new modular units, tents, or trailers on the grounds of the 5B site;
• Mobile units (on Form 5B), including delivering in-scope services via mobile units at additional locations in the health center’s service area;
• Home visits (on Form 5C) to health center patients, including visiting health center patients in assisted living facilities and nursing homes; or
• Portable clinical care or health fairs (on Form 5C), where health center staff conduct clinical care or COVID-19 testing outside of health center sites (for example, conducting screenings, testing, or consultations in a parking lot or on the street to individuals experiencing homelessness). These activities may be coordinated with state or local health department or other community providers as long as these services are provided on behalf of the health center.

(Added: 3/30/2020)

As a result of the Secretary's declaration relating to the current COVID-19 public health emergency, HRSA considers all health centers impacted and “eligible” to submit change in scope requests to add temporary sites due to an emergency, if necessary.

(Updated: 3/24/2020)

HRSA approval is required anytime a health center will add a temporary site(s) in response to emergency events when the location would meet the service site definition as defined in Policy Information Notice (PIN) 2008-01: Defining Scope of Project and Policy for Requesting Changes (PDF - 224 KB). The information needed for this request must be submitted as soon as practicable but no later than 15 days after initiating emergency response activities. HRSA has a streamlined process outlined in PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events (PDF - 266 KB)

(Updated: 4/17/2020)

HRSA’s approval of the temporary service site will automatically expire 90 days after the temporary service site’s approved effective date. To request an extension to operate a temporary site beyond 90 days, use the BPHC Contact Form.

(Updated: 6/21/2022)

CMS has waived certain regulatory requirements for the duration of the COVID-19 public health emergency, providing flexibilities to assist Federally Qualified Health Centers, including Health Center Program awardees and look-alikes, in furnishing services at temporary locations. Updated information on these flexibilities is available from CMS (PDF - 172 KB).

During the public health emergency, additional flexibilities introduced by CMS include those related to:

• The physician supervision requirement for nurse practitioners (PDF - 508 KB) , to the extent permitted by state law;
• Telehealth services (PDF - 200 KB); and
• Medicare billing (PDF - 1 MB).

For information on how to coordinate with officials in your state regarding the state’s emergency preparedness or pandemic plan for the COVID-19 public health emergency, find your applicable point of contact.

(Added: 6/16/2020)

If you need to close a temporary service site, please use the BPHC Contact Form to request that the site be removed from your Form 5B. There is no need to submit a change in scope request.

To request that a temporary site be converted to a permanent site, you must submit a change in scope request. If HRSA approves the request, you must verify the site as operational. Only after you verify the site should you request to remove the temporary site from your Form 5B scope of project. For more information, see HRSA's Scope of Project webpage.

(Updated: 6/21/2022)

Health centers may purchase and use both diagnostic and antibody tests as part of their scope of project. The term "diagnostic test" generally refers to a molecular or antigen test, both of which can be used to diagnose infection with the SARS-CoV-2 virus. The terms "antibody test" or "serological test" generally refer to tests that detect antibodies to the SARS-CoV-2 virus. More information is available in the Food and Drug Administration’s FAQs on Testing for SARS-CoV-2. Health centers should consult with their state and local health departments for additional guidance on procuring and utilizing COVID-19 tests.

The following sites have resources and guidance on testing and specimen collection:

• FDA Guidance on Diagnostic Testing for SARS-CoV-2
• CDC Guidance on Evaluating and Testing Persons for COVID-19
• CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for COVID-19

For specific questions regarding eligibility and applicability of Federal Tort Claims Act 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).

(Updated: 5/19/2020)

Yes. Health Center Program funding may be used to support a wide-range of COVID-19 testing and testing-related in-scope activities, and this includes using these funds to support COVID-19 prevention and response by making available COVID-19 self-swab specimen collection kits to health center patients, consistent with FDA’s clearance, approval, or authorization of such kits.

Prescribing and providing access to at-home COVID-19 self-swab specimen collection kits to established health center patients is an available component of a health center’s general primary care for its patients when used consistent with FDA clearance, approval, or authorization. HRSA recommends that health centers follow CDC guidelines on COVID-19 testing and ensure compliance with all applicable FDA guidance for such testing.

Health centers that choose to make available to patients COVID-19 at-home self-swab specimen collection kits should:

• Ensure that they do so in compliance with the currently applicable FDA Emergency Use Authorization (EUA) for the specific test used.
• Follow the specific uses authorized within the applicable EUA, including any noted need for provider supervision of the specimen collection and any applicable limitations on use of the test. The FDA FAQ on Testing for SARS-CoV-2 provides more information on COVID-19 tests that are authorized for use with home specimen collection kits.
• Ensure appropriate follow-up, including on positive COVID-19 test results. Such follow-up may include, but is not limited to:
  • Guidance on self-monitoring for worsening symptoms
  • Steps for isolation to reduce risk of transmission
  • Making medically indicated referrals of patients
  • Providing connections to community-based support resources

For information on the availability of free at-home self-tests through the HRSA COVID-19 Testing Supply Program, visit the Expanding Access to COVID-19 Testing Supplies webpage.

(Updated: 12/23/2021)

The HRSA COVID-19 Testing Supply Program is a partnership between HHS and the Department of Defense that enables all HRSA-funded health centers and Health Center Program look-alikes, as well as Medicare-certified rural health clinics, to order free, FDA-authorized COVID-19 at-home self-tests for distribution at no cost to their patients and communities. In addition, participants may also obtain a limited supply of point-of-care rapid antigen testing analyzers and test strips through the program. For more information, visit the Expanding Access to COVID-19 Testing Supplies webpage.

(Updated: 3/3/2022)

Health centers should provide COVID-19 testing services to established patients and other individuals who present for such services and meet criteria for COVID-19 testing, regardless of ability to pay. Criteria for testing 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 test beyond its established patient population (e.g., limited Personal Protective Equipment (PPE), testing supplies, or staff capacity), then the center should make efforts to refer patients to other appropriate providers.

For PPE and testing supply needs, health centers should communicate and coordinate with state, tribal, and local health departments and Primary Care Associations in their state, in addition to reporting these needs in the HRSA Health Center COVID-19 Survey.

(Added: 7/7/2020)

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:

• HRSA COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured Program
• CARES Act Provider Relief Fund
• Coverage of COVID-19 testing under the Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act (PDF - 167 KB)
• Medicaid and CHIP Coverage and Reimbursement of COVID-19 Testing under the American Rescue Plan Act of 2021 (PDF - 227 KB)
   

(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)

The Centers for Medicare & Medicaid Services (CMS) issued a memorandum to laboratory surveyors providing guidance regarding the review of pathology slides, proficiency testing, alternate collection devices, and requirements for a CLIA certificate during the COVID-19 public health emergency.

Of note for health centers, CMS will be expediting review of applications for a CLIA certificate and will allow for testing to begin once a CLIA number has been assigned, as opposed to laboratories waiting for a hard copy paper certificate to come in the mail. CMS is also exercising enforcement discretion and will not enforce the requirement to have a separate certificate for laboratories that are located at a temporary testing site, provided that the designated primary site has such a certificate (using the address of the primary site) and the work being performed in the temporary testing site falls within the parameters of the primary site's certificate. A temporary testing site is where, at various intervals, an entity that is not at a fixed or permanent location performs laboratory testing.

In addition, CMS will permit a laboratory to extend its existing CLIA certificate to operate a COVID-19 temporary testing site in an off-site “designated overflow location” such as a school, church, or parking lot (with approval of local and state authorities). The temporary site is only permitted to perform tests, consistent with the existing certificate, and must be under the direction of the primary site/home base existing lab director.

(Added: 5/4/2020)

Health centers performing testing need to know whether a test system is waived, moderate, or high complexity for each test on their menu because this determines the applicable CLIA requirements. The complexity categorization or waiver status for a test may be printed in the manufacturer’s package insert or other instructions. The following FDA and CMS sites can help you determine the level of complexities for certain tests:

• FDA’s Searchable CLIA Database
• FDA’s Currently Waived Analytes
• FDA’s Emergency Use Authorization
• CMS' CLIA Testing Requirements for SARS-CoV-2 (includes infographic) (PDF - 1 MB)

(Added: 5/6/2020)

Health centers should coordinate with state and local health departments and Primary Care Associations in their state to support their ability to identify alternatives for lab processing capacity.

(Added: 5/6/2020)

For information on the availability of free at-home self-tests and point-of-care testing supplies through the HRSA COVID-19 Testing Supply Program, visit the Expanding Access to COVID-19 Testing Supplies webpage. For other testing supply and equipment needs, health centers should communicate and coordinate with state, tribal, and/or local health departments and their state or regional Primary Care Associations. If those channels are unable to provide support, health centers can reach out to HHS Resource Coordination to request assistance.

In addition, health centers should continue to report these needs in the Health Center COVID-19 Survey. The data provided in these surveys provides critical information regarding the impact of COVID-19 on health center operations, patients, and staff, which HRSA shares with other agencies and partners. The data is also used to better understand trends that influence health center training and technical assistance, funding, and other resource needs.

(Updated: 3/3/2022)

Health centers considering testing of persons with possible COVID-19 should coordinate with state and local health departments on reporting requirements for both positive and negative cases. The following CDC sites have resources on testing, reporting, and specimen collection:

• COVID-19 Testing and Reporting by Laboratories: Q & A
• Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for COVID-19

(Added: 5/6/2020)

A sentinel surveillance system utilizes a limited network of reporting sites to rapidly signal trends, identify outbreaks, and monitor the burden of disease such as COVID-19. Health centers may provide COVID-19 testing data to sentinel surveillance systems consistent with applicable law.

For more information on surveillance activities that support the COVID-19 response, please see CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again (PDF - 40 KB).

(Added: 6/16/2020)

Patients can contact their local health center to find out about availability of COVID-19 vaccine appointments. To find your local health center, please use HRSA's Find a Health Center tool.

In addition, states or territories can provide information on other vaccine locations. More information is available from the CDC.

(Updated: 2/25/2021)

In accordance with the CDC's U.S. COVID-19 Vaccination Program, in order to receive and administer COVID-19 vaccine, constituent products, and ancillary supplies, vaccination provider facilities/organizations must enroll in the U.S. COVID-19 Vaccination Program coordinated through their jurisdiction's immunization program. Enrolled COVID-19 vaccination providers must be credentialed/licensed in the jurisdiction where vaccination takes place, and they must sign and agree to the conditions in the CDC COVID-19 Vaccination Program Provider Agreement.

Health centers may contact the state and/or local immunization program manager in their jurisdiction for information on how to become a COVID-19 vaccine provider. A list of immunization program managers is available through the Association of Immunization Managers.

To ensure our nation's underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated against COVID-19, HRSA and CDC launched the Health Center COVID-19 Vaccine Program. As of April 7, 2021, HRSA and CDC have invited all HRSA-funded health centers and Health Center Program look-alikes to access vaccines through the program, if they wish to join and have the necessary capabilities. More information is available in the Health Center COVID-19 Vaccine Program section of this FAQ webpage.

(Updated: 4/22/2021)

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)

Since no out-of-pocket costs are charged directly to individuals who receive a COVID-19 vaccination, including additional doses and booster doses, health centers do not need to assess eligibility for the sliding fee discount program if the only service being delivered is the COVID-19 vaccination.

However, if individuals present for other in-scope health center services (for example, a routine primary care visit), health centers are required to continue assessing eligibility for and providing applicable sliding fee discounts and maximizing reimbursement, and they must continue to ensure that no patient is denied service based on inability to pay.

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. Participating providers are required 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 charge a fee for the administration of the vaccine. More information is available in the preceding question “What considerations apply to health centers’ billing for COVID-19 vaccination?” on this FAQ webpage.

(Updated: 12/13/2021)

The Centers for Medicare and Medicaid Services (CMS) has information regarding provider reimbursement for the administration of COVID-19 vaccines. In addition, Federally Qualified Health Centers may request lump sum payments for administering COVID-19 vaccines in advance of cost report settlement. CMS will pay you for COVID-19 vaccines and administration at 100% reasonable cost, as is done for influenza and pneumonia vaccines. Contact your Medicare Administrative Contractor or view the April 1 edition of the CMS Medicare Learning Network Connects newsletter for more information.

(Updated: 4/19/2021)

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)

The reporting requirements for COVID-19 vaccines are the same for those authorized under emergency use or fully approved. Health care providers who administer COVID-19 vaccines are required by law to report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event.
• Serious adverse events, regardless of whether the reporter thinks the vaccine caused the adverse event. FDA defines serious adverse events as:
  • Death;
  • A life-threatening event;
  • Inpatient hospitalization or prolongation of existing hospitalization;
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
  • A congenital anomaly/birth defect; or
  • An important medical event that based on appropriate medical judgment may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
• Cases of Multisystem Inflammatory Syndrome.
• Cases of COVID-19 that result in hospitalization or death.

The following resources contain additional information:

• Guidance on reporting adverse events to VAERS
• Vaccine administration errors and deviations
• COVID-19 Vaccine: Quick Reference Guide for Healthcare Professionals (PDF - 97 KB)

(Added: 3/30/2022)

Health centers that have been deemed as federal employees through the Health Center FTCA Program are eligible for liability protection for grant-supported activities by “covered providers” and deemed volunteer health professionals. Deemed health centers that receive a claim or a legal summons and complaint involving the administration of a vaccination should promptly provide such documentation to the HHS OGC General Law Division, as described in the Health Center FTCA Policy Manual (PDF), Section II. Claims and Lawsuits.

Pursuant to the Public Readiness and Emergency Preparedness (PREP) Act, the Secretary of HHS has also issued a declaration (and amendments) concerning medical countermeasures against COVID-19, which declared that COVID-19 vaccines are also covered countermeasures for the purposes of liability protection under the PREP Act. If all requirements set forth in the Secretary’s declaration are met, a covered person is immune from liability except for “willful misconduct” with respect to all claims for loss caused by, arising out of, relating to, or resulting from the manufacture, testing, development, distribution, administration, and use of a COVID-19 vaccine.

An individual who sustains a covered serious physical injury or death as a direct result of the administration or use of a covered countermeasure (or estates and survivors of such individual) may be eligible for certain benefits under the Countermeasures Injury Compensation Program (CICP), which is administered by HRSA. Information about the CICP and filing a claim are available toll-free at 1-855-266-2427, or at the CICP website.

(Added: 1/5/2021)

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)

If a health center does not have “Immunizations” listed as an activity on its Form 5C: Other Activities/Locations (PDF - 103 KB), it must submit a brief Scope Adjustment request via EHBs to add this activity to its scope of project. When completing the Form 5C Scope Adjustment, 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.

(Added: 1/21/2021)

Health centers provide COVID-19 vaccinations to established patients and other individuals who present for such services (i.e., new patients) and meet criteria for vaccination, regardless of an individual’s ability to pay.

If a health center does not have sufficient capacity to vaccinate individuals beyond its established patient population (e.g., due to limited Personal Protective Equipment (PPE), supplies, or staff capacity), the health center should refer patients to other appropriate providers. For PPE and supply needs, health centers should communicate and coordinate with state, tribal, and local health departments and Primary Care Associations in their state, in addition to reporting these needs to HRSA through the HRSA Health Center COVID-19 Survey.

(Updated: 4/22/2021)

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)

You may provide COVID-19 vaccinations as part of routine primary care visits or with other in-scope services. However, in accordance with the CDC COVID-19 Vaccination Program Provider Agreement requirements, you may not:

• Require additional medical or other services during the visit as a condition for getting a COVID-19 vaccination;
• Charge patients for an office visit or other fee if COVID-19 vaccination is the only medical service given; or
• Balance bill for COVID-19 vaccinations.

As a reminder, if you provide other in-scope services (e.g., a routine primary care visit) in addition to the COVID-19 vaccination, you must assess eligibility for and provide applicable sliding fee discounts and also maximize reimbursement from third-party payor sources for the other primary care services provided. You must also ensure that you do not deny a patient any service based on their inability to pay. You can find specific information about billing for the administration of COVID-19 vaccinations in the question “What considerations apply to health centers’ billing for COVID-19 vaccination?" on this FAQ webpage.

(Added: 4/13/2021)

Your health center’s engagement in COVID-19 testing, treatment, and/or vaccine administration provides critical opportunities to connect people to essential health center services.

HRSA encourages you to engage with individuals who present for testing or vaccination to promote awareness of other health center services. This is an opportunity to support entry into care for those who lack a primary care medical home and/or to offer enrollment assistance with Medicaid, CHIP, and other affordable insurance options, including those available through the Marketplace special enrollment period.

(Added: 4/13/2021)

As a trusted community partner, your health center plays an important role in strengthening COVID-19 vaccine confidence among your patient population. As part of your routine delivery of primary care services, HRSA encourages you to offer patient-centered and culturally appropriate:

• Education about COVID-19 vaccines (see the CDC’s Vaccinate with Confidence resource);
• Information about how to make an appointment for a COVID-19 vaccine when ready; and
• Enabling services that reduce barriers to COVID-19 vaccine access, such as transportation or translation.

As a reminder, in accordance with the CDC COVID-19 Vaccination Program Provider Agreement requirements, you must administer the COVID-19 vaccine with no out-of-pocket cost to patients for the vaccine and may not require additional medical or other services during the visit as a condition for getting a COVID-19 vaccination.

(Added: 4/13/2021)

There is no federal legal requirement for parent or caregiver consent for COVID-19 vaccination, or any other vaccination. However, states and territories may have laws and regulations regarding consent for vaccination of minors. Health centers must administer COVID-19 vaccines according to applicable state and territorial vaccination laws and guidance, including those related to consent. Health centers should contact their state, tribal, and/or local health departments for further guidance. More information and resources are available from the CDC on COVID-19 Vaccines for Children and Teens.

(Updated: 11/4/2021)

Following the Biden-Harris Administration's COVID-19 Action Plan  announced on September 9, CMS announced  the publication of the interim final rule with comment period, Medicare and Medicaid Programs: Omnibus COVID-19 Health Care Staff Vaccination, on November 5. This emergency regulation requires COVID-19 vaccination of staff across Medicare and Medicaid-certified health care facilities to protect the health and safety of patients. The rule details the requirements that apply to Federally Qualified Health Centers as well as other CMS facility types. For more information, view CMS’ frequently asked questions (PDF - 313 KB).

(Added: 11/5/2021)

To ensure our nation's underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated against COVID-19, HRSA and the Centers for Disease Control and Prevention (CDC) launched the Health Center COVID-19 Vaccine Program on February 9, 2021, to directly allocate a limited supply of COVID-19 vaccine to select HRSA health centers.

(Added: 2/19/2021)

In the first phase of the program, beginning in February 2021, 250 HRSA-funded health centers were invited to participate. The health centers invited for participation in the initial phase served populations disproportionately affected by COVID-19, including a significant number of people experiencing homelessness, migrant/seasonal agricultural workers, residents of public housing, and those with limited English proficiency, and included at least one health center in each state or territory.

In the second phase, beginning in March 2021, HRSA and CDC invited an additional 700 health centers to participate, increasing the total number of invited health center participants to 950. In selecting these health centers, HRSA again focused on reaching communities disproportionately hit by the pandemic, including those that served high proportions of low-income and minority patients, provided services to rural/frontier populations, operated Tribal/Urban Indian Health Programs, and/or utilized mobile vans to deliver services.

In the third phase, beginning in April 2021, HRSA invited all remaining HRSA-funded health centers and Health Center Program look-alikes with the necessary capabilities to access vaccines through the program.

In order to participate in the Health Center COVID-19 Vaccine Program, health centers must complete and submit the required Conditions of Participation agreement and Readiness Assessment and obtain a VTrckS PIN for each proposed site. If you are interested in participating in the Health Center COVID-19 Vaccine Program or want to renew your participation, please use the BPHC Contact Form to let us know.

(Updated: 6/21/2022)

Yes, HRSA has invited all HRSA-funded health centers and Health Center Program look-alikes to access vaccines through the program, if they wish to join and have the necessary capabilities.

(Updated: 4/7/2021)

To participate in the Health Center COVID-19 Vaccine Program, health centers must agree to a Conditions of Participation agreement, which includes:

1. Enrollment in and compliance with the CDC's U.S. COVID-19 Vaccination Program;
2. Accurate completion and approval of the HRSA Health Center COVID-19 Vaccine Program Readiness Assessment;
3. Data reporting (i.e., required vaccine supply and administration data reported to state/jurisdictions, as required in the CDC COVID-19 Vaccine Provider Agreement, as well as to the Health Center COVID-19 Survey and addendum); and
4. Other requirements (i.e., administer COVID-19 vaccines provided through the program to established health center patients and other individuals who present for such services (i.e., new patients) as capacity permits; ensure timely administration of all COVID-19 vaccine doses received through the program).

HRSA and the CDC will work with state and jurisdictional public health officials, Primary Care Associations, and health centers to assess and support health center readiness and capacity to participate in the program.

(Updated: 3/26/2021)

Yes, timely completion of the Health Center COVID-19 Survey and the addendum to the survey is mandatory for health centers participating in the Health Center COVID-19 Vaccine Program.

(Added: 2/19/2021)

HRSA has established policies and practices to maximize the impact and effectiveness of the Health Center Vaccine Program within the program’s weekly national vaccine allocation. In an effort to ensure equitable access to vaccines for all program participants, HRSA has instituted vaccine ordering caps at the site and health center level. This policy ensures that enrolled health centers will continue to have access to vaccine each week.

Participating health centers are encouraged to order the type and amount of vaccine that they are able to store and administer to meet the needs of the populations served, and to ensure that they can administer their full weekly vaccine order within 7 days. Each week, HRSA reviews health centers’ vaccine order requests, along with other allocation, inventory, and administration data, to develop final orders within the program’s total vaccine allocation.

The Health Center COVID-19 Vaccine Program is designed as a separate, direct allocation for health centers. The program is intended to supplement — not supplant — existing vaccine distributions that health centers are receiving from states.

(Updated: 5/3/2021)

Yes, a health center can receive shipment at one or more locations and then transfer or divide doses to any of their sites that meet the following three requirements:

1. The site is within the health center’s scope of project and has the appropriate capacity to administer vaccine;
2. The site has an established CDC COVID-19 Vaccination Program Provider Agreement in place; and
3. The site has been onboarded in VPoP.

Pre-approval is not required from HRSA to transfer vaccines to another health center site. However, the transfer should be documented in VPoP using the transfer tab. Health centers must report transferred inventory at the site to which the vaccine was transferred.

(Added: 4/27/2021)

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:

1. Transfers can only be made to other CDC-enrolled vaccine providers within the health center’s jurisdiction.
2. 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).
3. 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.

(Updated: 6/11/2021)

The intent of the Health Center COVID-19 Vaccine Program is to ensure underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated against COVID-19.

Health centers are to ensure timely administration of all COVID-19 vaccine doses provided through the program to established health center patients and other individuals who present for such services (i.e., new patients) and meet criteria for vaccination, regardless of an individual’s ability to pay.

If a health center does not have sufficient capacity to vaccinate individuals beyond its established patient population (e.g., due to limited Personal Protective Equipment (PPE), supplies, or staff capacity), the health center should refer patients to other appropriate providers.

(Added: 3/10/2021)

The CDC’s Advisory Committee on Immunization Practices has recommended that people whose immune systems are moderately to severely compromised receive an additional dose of mRNA COVID-19 vaccine at least four weeks after completion of their initial two-dose mRNA series. See the statement from CDC.

Health centers participating in the Health Center COVID-19 Vaccine Program should continue to order the type and amount of vaccine that they are able to store and administer to meet the needs of the populations served, and to ensure that they can administer their full weekly vaccine order within 7 days. Additional doses for immunocompromised individuals—like all vaccine doses—must be administered in accordance with the latest CDC guidance and FDA Emergency Use Authorization for the vaccine.

We added a question in the main part of the Health Center COVID-19 Survey to understand how many patients (by race and ethnicity) have received an additional dose, as well as questions in the addendum to understand how many staff and how many patients (by race, ethnicity, and special population) have received an additional dose allocated through the Health Center COVID-19 Vaccine Program. These new questions first appeared in the survey sent on Friday, September 10.

(Updated: 9/14/2021)

Patients can contact their local health center to find out about availability of COVID-19 vaccine appointments. To find your local health center, please use HRSA's Find a Health Center tool.

(Added: 2/19/2021)

The HRSA Health Center COVID-19 Therapeutics Program provides health centers with a direct allocation of oral antiviral treatments for the outpatient treatment of mild to moderate COVID-19. In order to ensure equitable access among the nation’s underserved communities and those disproportionately affected by COVID-19 and in support of the Biden-Harris Administration’s Test to Treat Initiative, this program provides an additional supply of oral antiviral treatments directly to HRSA-supported health centers, supplementing state/jurisdictional allocations.

The HRSA Health Center COVID-19 Therapeutics Program began incrementally in December 2021 at approximately 200 health centers. These initial participants were selected because they have pharmacy capacity and specialize in caring for particularly underserved and disproportionately affected populations (for example, a significant number of people experiencing homelessness, migratory/seasonal agricultural workers, residents of public housing, people 65 or older, and those with limited English proficiency), or have reported significant COVID-19 testing activity in the biweekly Health Center COVID-19 Survey.

On March 7, 2022, the program expanded its reach by doubling the number of invited health centers to over 400, and on March 28, 2022, the program became open to all health centers and Health Center Program look-alikes with pharmacy capacity.

If you are interested in participating in the HRSA Health Center COVID-19 Therapeutics Program or want to renew your participation, please use the BPHC Contact Form to let us know.

(Updated: 7/19/2022)

Yes, the program became open to Health Center Program look-alikes with pharmacy capacity, in addition to all HRSA-funded health centers with pharmacy capacity, on March 28, 2022.

(Updated: 3/29/2022)

Yes, health centers may order oral antiviral treatments through separate allocations from their state/jurisdiction. The HRSA Health Center COVID-19 Therapeutics Program allocation is not meant to replace participating health centers’ current state allocations. The program supplements state/jurisdictional COVID-19 therapeutics allocations to ensure equitable access by providing an additional supply directly to populations served by HRSA-supported health centers.

(Updated: 3/29/2022)

To identify participating health centers and coordinate the distribution of therapeutics, states may contact the HHS Office of the Assistant Secretary for Preparedness and Response at COVID19.Therapeutics@hhs.gov.

(Added: 1/21/2022)

Health centers must dispense therapeutics in accordance with the FDA’s Emergency Use Authorization (EUA) conditions of use and in accordance with federal clinical guidance. Please visit the NIH COVID-19 Treatment Guidelines for up-to-date, evidence-based recommendations on the management of COVID-19. In addition to the relevant FDA and NIH guidance, please follow all applicable state, local, or health center policies and guidelines.

(Added: 1/21/2022)

• COVID-19 Therapeutics
• NIH COVID-19 Treatment Guidelines
• COVID-19 Treatment Guidelines Panel’s Statement on Prioritization of Anti-SARS-CoV-2 Therapies for the Treatment and Prevention of COVID-19 When There Are Logistical or Supply Constraints
• Side-by-Side Overview of Outpatient Therapies Authorized for Treatment of Mild-Moderate COVID-19
• FDA fact sheet on Merck’s Lagevrio (molnupiravir)
• FDA fact sheet on Pfizer’s Paxlovid

(Updated 7/19/2022)

Yes, for 2021 UDS reporting, COVID-19 temporary sites that meet HRSA’s site criteria (as listed on Form 5B (PDF)) are included in the health center’s scope of project. Services that occur at these sites are counted in UDS reporting. For additional information on temporary sites, refer to the Temporary Sites category above. For additional information on how to count COVID-19 tests in the UDS report, see the question below.

(Updated: 11/30/2021)

Staff reporting is based on full-time equivalents (FTE), in alignment with the guidance provided in the 2021 UDS Manual (PDF - 4 MB). If an employee was being paid while on leave, they are to be counted in the FTEs reported in Table 5. If an employee was on unpaid leave, furloughed, or laid off during the reporting year, any portion of the year where they were not being paid by the health center or not employed by the health center should not be included in Table 5. Staff providing services outside the scope of the health center project are also not to be included. For additional information, see the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 11/30/2021)

Volunteer health care providers and their services at health centers during the pandemic should be reported as specified in Appendix B in the 2021 UDS Manual (PDF - 4 MB).

(Updated: 11/30/2021)

The number of patients served and visits associated with COVID-19 and associated respiratory illnesses diagnoses are collected in the 2021 UDS on Table 6A. This table also collects the number of patients served and visits associated with COVID-19 testing and COVID-19 vaccination. Additional details are included in the 2021 UDS Manual (PDF - 4 MB) and the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

For additional information regarding which patient visits are countable, see the question “What patient visits for COVID-19 tests and vaccinations are counted in the 2021 UDS report?” in this FAQ webpage.

(Updated: 6/21/2022)

Countable patient visits, for the purposes of UDS reporting, are documented individual, face-to-face or virtual contacts between a patient and a licensed or credentialed provider who exercises independent, professional judgment in providing services. Countable patients are those that receive at least one such visit during the reporting year.

If an individual is tested (i.e., a specimen is collected) for COVID-19 or receives a COVID-19 vaccine, but there is no follow-up treatment provided by the health center, then this patient and encounter are not counted in the annual UDS patient and visit tables. A test or vaccination alone does not count as a UDS visit.

If the health center provides an individual with additional services that meet the criteria of visit and patient for the purposes of UDS reporting, as mentioned above (see also page 20 of the 2021 UDS Manual (PDF - 4 MB)), that individual is considered a patient for UDS reporting. Their visit and the associated care would be reported in the 2021 UDS.

For additional information, see the UDS Countable Visit Guidance and FAQ (PDF - 258 KB) and the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 6/17/2022)

For 2021 UDS reporting, health centers should report the count of patients who received at least one dose of COVID-19 vaccine and the count of visits in which vaccine was administered on Table 6A, Line 24b. Do not include vaccines administered to health center patients while participating in clinical trials.

Health centers should only include patients who had a countable UDS visit during 2021. If the only service the individual received from the health center was administration of a vaccine, do not report this activity anywhere in the UDS. Please note: All COVID-19 vaccinations should still be reported as part of the Health Center COVID-19 Survey, per the COVID-19 Data Collection Survey Tool User Guide.

For additional information, see the UDS Countable Visit Guidance and FAQ (PDF - 258 KB) and the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 6/17/2022)

For UDS reporting, virtual visits are those that use interactive, synchronous audio and/or video telecommunication systems permitting real-time communication between a provider and a patient. With the Centers for Medicare & Medicaid Services expansion of telehealth, virtual visits may now be conducted with a patient in any location – including the patient’s home – for the duration of the COVID-19 public health emergency. If a virtual visit meets the criteria listed above, it is countable for purposes of UDS reporting. Virtual check-ins, used to determine whether an established patient requires a visit, and e-visits, which are portal communications with established patients, would not be counted for UDS reporting.

For additional information, see the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 06/17/2022)

Yes, as long as they are allowable UDS case management visits or patient and community education visits as defined in the 2021 UDS Manual (PDF - 4 MB) (Instructions for Table 5: Staffing and Utilization section) and meet the UDS definition of virtual visits.

(Updated: 11/30/2021)

Yes, if a telehealth visit meets the CQM’s denominator and/or numerator specifications as directed by the measure steward, as well as the UDS’ virtual visit definition, it may be counted.

The UDS defines virtual visits as those that use interactive, synchronous audio and/or video telecommunication systems permitting real-time communication between the provider and a patient. For a list of the CQM measure stewards, refer to Appendix G: UDS CQMs and National Programs Crosswalk, in the 2021 UDS Manual (PDF - 4 MB). Measurement specifications are available from the Electronic Clinical Quality Improvement Resource Center. For additional information. For additional information, see Telehealth Impact on 2021 UDS Clinical Measure Reporting (PDF - 656 KB) and the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 11/30/2021)

BPHC recognizes the essential work being performed by health centers during the COVID-19 pandemic, while continuing to provide routine, preventive, and chronic disease care to patients. We recommend you document as much information in your systems as possible, and then work with your Health Center Program UDS Reviewer during the 2021 UDS data reporting and review period to help explain any changes resulting from the pandemic. For additional information, see the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 11/30/2021)

To the extent that health centers receive non-monetary donations, the current rules apply for counting the estimated reasonable acquisition cost of donations on Table 8A, as specified in the 2021 UDS Manual (PDF - 4 MB).

(Updated: 11/30/2021)

Health Center Program awardees should report drawdowns of the following COVID-19 supplemental funding on Table 9E:

• Coronavirus Preparedness and Response Supplemental Appropriations Act (activity code H8C) on Line 1l.
• Coronavirus Aid, Relief, and Economic Security (CARES) Act (activity code H8D) on Line 1m.
• Expanding Capacity for Coronavirus Testing (activity code ECT) on Line 1n.
• American Rescue Plan on Line 1o.
• Other COVID-19 related funding from BPHC on Line 1p.

Table 9D, Line 8c should be used to reflect charges, collections, and adjustments associated with testing and treatment of uninsured patients with suspected or diagnosed COVID-19. Table 9E, Line 3b should be used to reflect funds received through the Provider Relief Fund and drawn down during 2021. For additional information, see the UDS Novel Coronavirus Disease (COVID-19) Reporting webpage.

(Updated: 11/30/2021)

Losses themselves are not directly reported as a line item in the UDS report, but are observable through comparisons with other financial data reported. For HRSA guidance regarding lost revenue, refer to the Coronavirus-Related Funding Frequently Asked Questions (FAQ).

(Updated: 11/30/2021)

AAAHC is performing survey activities while following COVID-19 precautions. Prior to their survey, each health center should conduct an internal gap analysis to evaluate their readiness and implement an action plan to address any gaps. Please visit the AAAHC website or the TJC website for further updates and additional resources.

(Updated: 6/21/2022)

AAAHC, TJC, and NCQA are assessing each health center’s circumstances as surveys are scheduled. Health centers that are currently recognized and/or accredited are strongly encouraged to submit their Notice of Intent three to six months prior to their expiration date. Health centers should coordinate with their respective recognition/accreditation organizations to ensure they have the most accurate information regarding expiration dates, renewal requirements, and COVID-19 process updates. Information on submitting a Notice of Intent is available from HRSA.

For more information:

• Contact AAAHC via email.
• Contact TJC via email or call 630-792-5900.
• Contact NCQA online or call 888-275-7585.

(Updated: 6/21/2022)

PCA and NTTAP awardees are encouraged to reach out to their Project Officer to discuss any impact to their approved work plans. Changes to the work plan will be considered on a case-by-case basis. If changes need to be made, your Project Officer will send a Request for Information (RFI) through the EHBs for you to outline and provide a detailed description of any new activities you intend to modify or propose. If changes will require a budget revision, please work with you Project Officer to determine the appropriate steps.

(Added: 3/24/2020)

PCAs can facilitate the sharing of important information with health centers through electronic alerts, can conduct outreach to increase awareness and participation in various regional/state pandemic or emergency event planning and response activities, and can learn from the health centers what issues they face and what assistance may be needed.

PCAs have established mechanisms to engage with health centers in collecting critical information during and after an emergency situation. In addition, PCAs can work to ensure that health centers are included in COVID-19 response plans by tapping into regional/state pandemic planning and response activities. Many PCAs play active roles in the state as coordinators, managers, and disseminators of real-time information during emergencies. For information on how to coordinate with officials in your state regarding the state’s emergency preparedness or pandemic plan, PCAs can help identify the appropriate state point of contact. For questions about Medicare emergency preparedness requirements, PCAs may also contact the applicable state survey agency for guidance or assistance.

To inform HRSA’s COVID-19 emergency response efforts, PCAs are expected to regularly communicate with and encourage health centers to complete the Health Center COVID-19 Survey. HRSA shares national and state-level COVID-19 survey data summary reports with each PCA to support targeted technical assistance to the health centers in each state.

(Updated: 6/21/2022)

HCCNs have established platforms to engage with health centers to collect critical information during and after emergency situations, such as the COVID-19 pandemic. HCCNs can:

• Facilitate important and timely information sharing with health centers through electronic alerts;
• Assist health centers considering how to expand their telehealth services;
• Conduct outreach with health centers in their networks to share challenges and lessons learned from the use of telemedicine and virtual care technologies amongst health centers; and
• Work to ensure that health centers are integrated in regional and state response plans by coordinating with Primary Care Associations (PCAs) on planning and response activities.

Additionally, HCCNs coordinate with the Office of the National Coordinator for Health Information Technology (ONC), the Centers for Medicare and Medicaid Services (CMS), the Health Information and Technology, Evaluation and Quality (HITEQ) Center, and HRSA’s Federal Office of Rural Health Policy (FORHP) to provide training and technical assistance on hardware and/or software, provider education, workflows, patient education, billing and coding, cybersecurity, remote provider education, and policy interpretation.

(Updated: 6/21/2022)

HRSA is asking health centers and Health Center Program look-alikes to fill out a biweekly survey to help track the number of patients who have undergone COVID-19 testing, initiated and completed vaccinations, along with other critical information about clinic operations during the pandemic. Each health center and look-alike will receive an electronic survey every other Friday afternoon from BPHCanswers@hrsa.gov.

A COVID-19 Data Collection Survey Tool User Guide is available to assist you in completing the survey. If you have additional questions, please use the BPHC Contact Form or call 877-464-4772, option 2, 8:00 a.m. to 8:00 p.m. ET, Monday-Friday (except federal holidays).

Please note: Participants in the Health Center COVID-19 Vaccine Program will also receive an addendum containing additional questions that will be used to track vaccine administration, evaluate the impact of the program, and identify training and technical assistance needs. Completion of all data reporting elements in the biweekly Health Center COVID-19 Survey and the addendum is required as a condition of participation in the Health Center COVID-19 Vaccine Program.

(Updated: 6/17/2022)

Please report on your experiences from the past two weeks. For more detailed instructions, see the COVID-19 Data Collection Survey Tool User Guide.

(Updated: 7/6/2021)

The survey is sent to the Project Director listed in EHBs, but that person can also forward their unique link to anyone in the organization who can report. If you need to add additional points of contact to the survey, please use the BPHC Contact Form or call 877-464-4772, 8:00 a.m. to 8:00 p.m. ET, Monday-Friday (except federal holidays).

(Updated: 4/8/2020)

The information collection surveys are open Friday afternoons through Tuesdays at 11:59 p.m. your local time. If you miss a deadline, please wait until the next survey – and remember to report information for that two-week period only.

Please note: For participants in the Health Center COVID-19 Vaccine Program, timely completion of all data reporting elements in the biweekly Health Center COVID-19 Survey and the addendum is required as a condition of participation in the program.

(Updated: 7/6/2021)

Yes. The survey includes an opportunity to provide additional information, comments, or challenges you are experiencing due to COVID-19.

(Updated: 4/8/2020)

HRSA uses the information collected from the Health Center COVID-19 Survey to help track health center and look-alike capacity and the impact of COVID-19 on operations, patients, and staff. Survey results are also used to better understand training and technical assistance, funding, and other resource needs. HRSA shares this information with other agencies and partners.

In addition, HRSA will use the information collected from participants in the Health Center COVID-19 Vaccine Program to assess participants’ capacity to administer vaccine, to monitor progress, to evaluate the impact of the program in order to inform subsequent vaccine allocations, and to identify training and technical assistance needs.

(Updated: 2/25/2021)

The COVID-19 pandemic is a continually evolving situation. Therefore, how long HRSA will collect this information is yet to be determined. HRSA will continue to assess the situation and evaluate the information collected, and we will make adjustments as appropriate.

(Updated: 7/28/2020)

PCAs are expected to regularly communicate with and encourage health centers in completing the Health Center COVID-19 Survey. HRSA shares national and state-level COVID-19 data summary reports with each PCA to support targeted technical assistance to the health centers in each state.

HRSA discontinued its separate survey for PCAs following July 14, 2021.

(Updated: 7/19/2021)