HRSA Answers Your COVID-19 Questions

July 20, 2020 5:21 pm

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The COVID-19 pandemic has had enormous global impact. There isn’t a part of our lives that remains unscathed. Every aspect of our lives be it the daily routine we used to follow, the places we used to go to, the way we manage our finances, our professional lives, our career track, our familial relationships, everything has been changed or modified or in some cases changed irrevocably due to the pandemic. 

In the initial stages of the pandemic, people truly believed that this won’t be a serious issue, any infections are fringe events, and even if it does affect people, it would be curable. Because of this lethargic response, the providers faced a PPE crisis, N-95 mask shortage, hand sanitizer shortage, hoarding, unemployment, evictions & the list of consequential problems keeps on growing. Now, we are way past all that, people have begun to understand how serious the problem is and have finally begun to grasp the gravity of the pandemic.

The government finally following through on getting serious about the pandemic have initiated several emergency responses and action plans. One such widely known action plan is the expansion of the 1335 waiver which enabled easier access to telemedicine and wider coverage for telemedicine & telehealth. As virtual services began to surge and it became one of the useful tools for providers and healthcare professionals to combat the pandemic. Automation of coverage trackers and digital wearables saw a similar rise to prominence. While people are obviously aware of the life-saving benefits of these services, one can not ignore the way telemedicine and telehealth has aided us economically. It has helped medical practices by offsetting the revenue losses caused due to the pandemic and it has also helped healthcare-support industries like medical coding & billing and RCM service companies. Considering these benefits and coupled with the government and private payor backing the tech, providers have been able to easily transition to telemedicine, which enabled them to get a better handle on the pandemic. Understanding the positive impact of just one of the action plans to expand telemedicine services is enough to make one understand why such action plans are important and why they need to be enacted on time.

Even Though, the people and especially the healthcare community have gotten a handle on the pandemic situation, there are still numerous doubts and questions and everyone is forced to play it by ear. Most prominent of these questions can be summed up more or less as these, What is the government doing? How are relief packages being distributed? How is the healthcare sector being supported? How are the providers & healthcare professionals being cared for? Basically anything related to testing and How long will any of the relaxation imposed will last? 

The department of Health Resources & Service Administration (HRSA) have taken it upon themselves, as part of their emergency response to answer some of the common questions that we might have, which include the aforementioned ones as well. The below listed FAQ can be sorted as questions belonging to any of these 10 categories:

  • Funding & other resources
  • Program oversight & monitoring
  • Providing care during emergencies
  • The requirements for Federal Tort Claims Act (FTCA)
  • Funding & other resources
  • Service delivery
  • Temporary site project
  • Everything related to testing
  • UDS reporting
  • Quality improvement
  • Community programs, engagement and responsibility

If you do not have your questions answered you can always get them answered through any of the below listed means:

You can submit your questions to through the Health Center Program Support Onilne

877-464-4772

Option 2, 7:00 a.m. to 8:00 p.m. ET, Monday-Friday (except federal holidays)

Just comment your question below in the comment section and I will definitely get them answered for you

Funding & Other Resources

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

  • On Tuesday, March 24, HRSA announced the release of $100 million in fiscal year 2020 funding provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020.
  • On Wednesday, April 8, HRSA announced the release of more than $1.3 billion in fiscal year 2020 funding provided by the Coronavirus Aid, Relief, and Economic Security (CARES) Act
  • On Thursday, May 7, HRSA announced the release of approximately $583 million in fiscal year 2020 Expanding Capacity for Coronavirus Testing (ECT) funding provided by the Paycheck Protection Program and Health Care Enhancement Act
What economic relief options are available beyond Health Center Program funding to address health center payroll, revenue and other financial concerns due to the COVID-19 public health emergency?
  • For information on how workers and employers will 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 updated information from the Department of Labor.
  • For information on how workers and employers will 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 updated information from the Department of Labor.
  • The CARES Act Provider Relief Fund supports health care-related expenses or lost revenue attributable to COVID-19 and ensures uninsured Americans can get testing and treatment for COVID-19. Additionally, starting May 6, 2020, health care providers who have conducted testing or provided treatment for uninsured patients on or after February 4, 2020, can request claims reimbursement electronically. Providers generally will be reimbursed at Medicare rates, subject to available funding. See additional information in the questions below.
  • Justification for accomplishing the construction work by force account rather than by contract
  • The Federal Communications Commission’s COVID-19 Telehealth Program provides $200 million in telehealth funding for health care providers responding to the COVID-19 pandemic. Hospitals and health centers can apply for up to $1 million, with applications accepted on an ongoing basis.
  • 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 Small Business Administration’s Paycheck Protection Program provides 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.
  • For information on how workers and employers will 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 updated information from the Department of Labor.
What is the Provider Relief Fund & how is funding allocated?

The CARES Act Provider Relief Fund supports health care-related expenses or lost revenue attributable to COVID-19 and ensures uninsured Americans can get testing and treatment for COVID-19. See the CARES Act Provider Relief Fund webpage for details about current and future allocations. For answers to specific questions, providers should call the toll-free Provider Support Line at 866-569-3522

What is the claims reimbursement process for COVID-19 testing and treatment of uninsured patients?

HHS will provide claims reimbursement to health care providers who have conducted COVID-19 testing or provided treatment for uninsured individuals with a COVID-19 diagnosis on or after February 4, 2020. Providers can begin the process to file claims for reimbursement at the HRSA COVID-19 Uninsured Program Portal

Is there flexibility regarding the use of equipment or supplies purchased using Health Center Program supplemental funding (e.g.,SUD-MH or IBHS) to respond to COVID-19? For example, can staff use laptops purchased with IBHS funding for telework or telepsychiatry equipment to support COVID-19 assessments?

Yes. Health center awardees have flexibility in the use of the equipment and supplies purchased with previously awarded supplemental funding to support other in-scope activities at their health center. The requirements for use and disposition of equipment and supplies acquired under the Health Center Program award are governed by the Uniform Administrative Requirements at 45 CFR §75.320 and §75.321.

For health centers scheduled to submit a fiscal year (FY) 2021 Service Area Competition (SAC) or Renewal of Designation (RD), what flexibilities will HRSA provide?

FY 2021 Health Center SACs:

  • 1-year project period: Based on statutory requirements, health centers in a current 1-year project period will still complete an FY 2021 SAC. HRSA released the FY 2021 SAC Notice of Funding Opportunity in mid-June, approximately one month later than usual.
  • 2-year or 3-year project period: To provide flexibility during the COVID-19 pandemic response, HRSA is extending the project periods of the majority of health centers scheduled to complete a SAC in FY 2021. Health centers whose current 2-year or 3-year project period ends in FY 2021 will receive a 12-month extension with funds and will complete a Budget Period Progress Report (BPR) rather than a SAC in FY 2021.

FY 2021 Look-Alike RDs:

  • 1-year designation period: Look-alikes with a current 1-year designation period will still complete an FY 2021 RD. HRSA expects to release the FY 2021 RD instructions in early July, approximately one month later than usual.
  • 3-year designation period: Look-alikes with a current 3-year designation period will receive a 12-month extension and complete an FY 2021 Annual Certification (AC) rather than an RD.

If a health center will complete an FY 2021 Budget Period Progress Report (BPR) or Annual Certification (AC), what flexibilities will HRSA provide?

HRSA is in the process of streamlining the BPR and AC to reduce the time it will take health centers to complete the submissions. HRSA expects to release these documents in July and August, respectively.

Will future SAC funding be tied to achievement of patient targets?

HRSA does not anticipate making adjustments based on achievement of patient targets to service area funding with the FY 2021 SAC. HRSA is also exploring ways to align the FY 2022 and future SAC Notice of Funding Opportunities more holistically with health center performance

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

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 HRSA BPHC exit disclaimer or at 1-888-340-2787 (Monday-Friday, 9:00 a.m. to 6:00 p.m. ET).

Can health centers accelerate the drawdown of their grant funds as a needed response to the COVID-19 emergency?

HRSA is aware that many health centers are experiencing budget challenges associated with COVID-19. Health centers may draw grant funding from the Payment Management System (PMS) for expenses in alignment with the health center’s financial and operational policies and procedures and the approved grant budget. Acknowledging that this is an unprecedented time, health centers should consider the pace of their spending to ensure they have sufficient funds to avoid any funding shortfall.

As a reminder, advance payments to a Health Center Program awardee must be limited to the minimum amounts needed and be timed to be in accordance with the actual, immediate cash requirements of the awardee in carrying out the purpose of the approved program or project (per the Uniform Administrative Requirements at 45 CFR 75.305).

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

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:

  • Schedule identifying critical tasks and dates for when each task will be completed.
  • 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

Program Oversight & Monitoring

Will HRSA allow health centers additional time to respond to active, unresolved Progressive Action conditions?

In April 2020, HRSA determined that, due to the declared COVID-19 public health emergency and its impact on health center operations, the due dates for responses to Progressive Action conditions would be extended an additional 90 days. HRSA is now resuming the Progressive Action process. Accordingly, further extensions of Progressive Action condition due dates will NOT be provided.

Progressive Action conditions and compliance assessments are an important part of the Health Center Program monitoring and oversight process. HRSA is resuming Progressive Action condition progression and enforcement for those health centers with active conditions based on the extended due date reflected in EHBs. HRSA is providing advance public notice of resumed Progressive Action condition activity through this updated FAQ, and health centers with active conditions will also be notified through EHBs.

Health centers are encouraged to continue to submit documentation to demonstrate compliance by the condition submission due date. Project Officers remain available to provide guidance in line with the Health Center Program Compliance Manual and Progressive Action Conditions Library for any health centers with questions on active conditions.

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

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, 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.

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

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.

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

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.

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

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: 

  • Expanding the specific circumstances the health center will consider when waiving or reducing fees or payments due to any patient’s inability to pay.
  • 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.
  • 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.

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).

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

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.

Will BPHC conduct scheduled Operational Site Visits (OSV) or other site visits as scheduled?

Given the importance of health centers in the local, state, and national response efforts, as well as CDC guidance, BPHC will postpone most site visits planned through at least September 30, 2020. This decision is made in consideration of the potential impact to health center operations during the COVID-19 outbreak, BPHC staff and consultants, as well as the need for staff to be available for immediate mission critical assignments. OSVs and other site visits are an important part of the Health Center Program monitoring and oversight process; therefore, BPHC will reschedule the postponed OSVs and all other site visits as soon as is practical.

While the majority of BPHC’s OSVs scheduled through September 30 are postponed, there are health centers with extenuating circumstances (e.g., 1-year project periods, other emergent issues) that may require an OSV or other technical assistance or assessment visit prior to September 30. In these cases, BPHC will contact the health center to schedule a visit.

Will the deadlines for diabetes action plans for reporting be extended?

As health centers’ 2020 OSVs are being postponed, diabetes action plans and related reporting are also being postponed for the next quarterly submission. Health centers with active diabetes action plans from 2019 OSVs, or action plans associated with forthcoming 2020 OSVs, should work with their Project Officer to discuss a timeframe for quarterly diabetes action plan reporting that is feasible for the health center.

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

HRSA continues to welcome LAL ID applications on a rolling basis. Please note that to support an application system update, the EHBs application module for LAL IDs will shut down July 21 and reopen August 14, when applications will again be accepted. 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 OSVs 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 plans to conduct virtual LAL ID site visits for those applicants who successfully meet completeness and eligibility requirements. HRSA will continue using the standard review process to finalize designation or disapproval, with timeframe accommodations made based on the impacts of the COVID-19 public health emergency.

Will HRSA still require health centers to submit tri-annual reports for fiscal year 2019 Integrated Behavioral Health Services (IBHS) supplemental funding?

No. HRSA will shift from collecting IBHS tri-annual progress reports to monitoring health centers‘ progress at increasing new and/or existing patients receiving substance use disorder and/or mental health services through the submission of 2020 Uniform Data System (UDS) reports.

What if a health center has not yet reported the required addition of 0.5 FTE to support IBHS activities? Will the health center still receive IBHS year-two funding?

HRSA plans to provide year-two funding to all IBHS recipients this spring. For health centers that reported less than 0.5 FTE in their January 2020 progress report, HRSA is extending the due date of the 0.5 FTE requirement by 12 months to April 30, 2021. Health centers will be required to submit to HRSA a completed IBHS Staffing Impact Form that demonstrates a total of 0.5 FTE in substance use disorder and/or mental health personnel supported by fiscal year 2019 IBHS supplemental funding prior to April 30, 2021. Additional information will be included in the Notice of Award that provides year-two IBHS funding.

Providing Care During Emergencies

What are the CMS emergency preparedness requirements for health centers?

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.

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

Health centers should refer to the CMS Guidance for Infection Control and Prevention of Coronavirus Disease (COVID- 19) in Outpatient Settings, which provides recommendations to mitigate transmission, including screening, restricting visitors, cleaning and disinfection, and possible closures. Guidance relating to supply scarcity and FDA recommendations are also included. In addition, health centers should monitor the CDC website for information and resources, and should contact their state, local, or territorial health departments or authorities for further guidance on patient safety and infection control and prevention. Health centers may also wish to review the resources ECRI has developed through its COVID-19 Resource Center.

How can health centers access the Strategic National Stockpile (SNS) to get PPE and additional supplies in response to COVID-19?

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). 

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

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.

What can health centers do to counter stigma towards certain groups during the COVID-19 outbreak?

Health centers are encouraged to review the CDC guidelines around reducing stigma. They describe actions health centers can take, such as maintaining the privacy and confidentiality of those seeking care, raising awareness of COVID-19 without increasing fear, and sharing accurate information about how the virus spreads.

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

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:

  • OSHA guidance on joint recommendations issued by OSHA and HHS for all employers on preparing to reopen workplaces for COVID-19
  • CDC information regarding the latest clinical or testing guidance for COVID-19
  • CMS information regarding Medicare and Medicaid services during the COVID-19 public health emergency.
  • OSHA guidance for dentistry workers and employers 

The Requirements For Federal Tort Claims Act (FTCA)

What are the requirements for coverage under the FTCA in light of the declaration of a national public health emergency?

HHS Secretary Alex Azar issued a declaration of a national public health emergency regarding COVID-19 on January 31. As detailed in PAL 2020-05: Requesting a Change in Scope to Add Temporary Service Sites in Response to Emergency Events: “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 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 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, 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 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

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

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). 

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. 

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

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 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, “when 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.”

Where can health centers find FTCA guidelines related to credentialing and privileging during a declared emergency?

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 for guidance  

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

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. The deemed health center must submit to HRSA and receive approval of a VHP deeming sponsorship application for each individual volunteer.

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

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 contact Health Center Program Support online 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.

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

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.

Will a deemed health center’s providers remain covered by liability protections under the FTCA if they are directed to provide continuous or permanent services to non-health center inpatients at a local hospital as part of a community-wide emergency response during the declared COVID-19 public health emergency?

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 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.

Are free clinic healthcare practitioners, employees and individual contractors who provide screenings, triage and other health services to individuals in vehicles within the free clinic’s parking lot (or near the free clinic site) eligible for coverage through HRSA’s Free Clinics FTCA Program?

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.

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

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).”

  • 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.
  • 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.

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.

Will HRSA issue a particularized determination for health centers related to COVID-19 activities, similar to the particularized determination that was issued during the H1N1 emergency?

HRSA has issued a particularized determination 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. 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.

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

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 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.”

Will COVID-19 affect calendar year (CY) 2021 FTCA health center deeming application deadlines?

Due to the ongoing COVID-19 pandemic, HRSA is extending the CY 2021 deeming application cycle deadline from May 14, 2020, to July 13, 2020. Health centers are strongly encouraged to complete and submit their applications as soon as possible, which will ensure all Notice of Deeming Actions are issued well in advance of December 31, 2020. Health centers that apply early will receive an expedited review.

The EHBs will begin accepting applications on April 13, 2020, with applications due on or before July 13, 2020. Health centers will be able to submit supplemental deeming applications for sponsored VHPs who were not included on their redeeming application beginning on July 31, 2020.

Service Delivery

Do health centers need prior approval from HRSA to temporarily close a site due to COVID-19?

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.

Can health centers reduce the delivery of some required or additional services during the public health emergency?

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 the 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.

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

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.

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

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 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.

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

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 provider documents the service in a patient medical record consistent with applicable standards of practice 
  • 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 

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.

Can a health center use telehealth to provide services to a patient at a location that is not an in-scope service site? Can this occur if neither the health center provider nor the patient is at an in-scope service site?

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:

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

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.

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

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.

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

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  revises 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:

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

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

Medicare has provided new guidance on the payment method for telehealth services furnished by FQHCs as distant sites during the emergency period. The CARES Act requires 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). CMS has set that rate at $92.03, which is the average amount for all PFS telehealth services on the telehealth list, weighted by volume for those services reported under the PFS. For telehealth services furnished between January 27, 2020, and June 30, 2020, FQHCs will be reimbursed for telehealth services based on their Prospective Payment System (PPS) rate. These claims will be automatically reprocessed in July when the claims system is updated with the new telehealth payment rate. After July 1, 2020, through the end of the COVID-19 public health emergency, FQHCs will use a specific G code (G2025) and will be paid at the $92.03 rate.

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

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 quick reference guide that summarizes state telehealth responses to COVID-19, including Medicaid coverage.

During COVID-19 public health emergencies, can a health center utilize a provider to deliver care that is outside of their routine duties

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.

Temporary Site Project

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

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 the project. These requests are not submitted through the EHBs; a health center simply provides key information to their Project Officer by email or phone.

HRSA has received a few temporary service site requests that reflect locations that do not typically meet the definition or criteria of a service site, such as hotels, fitness centers, sports arenas, or churches. Your Project Officer may contact you for additional information about your activities at these locations so HRSA can better determine if your request meets the criteria. 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 as a location where all of the following conditions are met:

  • 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 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

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

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:

  • 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 departments or other community providers as long as these services are provided on behalf of the health center.
  • Home visits (on Form 5C) to health center patients, including visiting health center patients in assisted living facilities and nursing homes
  • Mobile units (on Form 5B), including delivering in-scope services via mobile units at additional locations in the health center’s service area
  • A health center service site (on Form 5B), including any new modular units, tents, or trailers on the grounds of the 5B site

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

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.

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

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. 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.

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

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, contact your Project Officer by email or phone.

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

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.

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

  • Medicare billing
  • Telehealth services
  • The physician supervision requirement for nurse practitioners, to the extent permitted by state law

Everything Related To Testing

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

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:

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

What types of health center clinical staff can perform COVID-19 testing and are there any specific Health Center Program or FTCA requirement related to this?

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.

  • 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.
  • 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 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 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.

What flexibilities do health centers have under the Clinical Laboratory Improvement Amendments (CLIA) program during the COVID-19 public health emergency?

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.

How do health centers know if a specimen collected from a COVID-19 test can be processed on site as opposed to sending to a reference lab?

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:

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

If there are delays or backlogs in processing COVID-19 tests, what alternatives are available to health centers?

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.

What information are health centers required to report to state and local health departments for COVID-19 tests?

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:

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

May health centers contribute COVID-19 testing data to sentinel surveillance systems?

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. 

UDS Reporting

For the purpose of Uniform Data System (UDS) reporting, do health centers report on services at temporary sites that are added to address the COVID-19 pandemic?

Yes, for 2020 UDS reporting, COVID-19 temporary sites that meet HRSA’s site criteria (as listed on Form 5B) 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.

Do case management visits and patient and community education visits that are provided to health centers via telehealth during the COVID-19 pandemic count in 2020 UDS reports?

Yes, as long as they are allowable UDS case management visits or patient and community education visits as defined in the 2020 UDS Manual (Instructions for Table 5: Staffing and Utilization section) and meet the UDS definition of virtual visits.

How do health centers report staff during the COVID-19 pandemic in 2020 UDS?

Staff reporting is based on full-time equivalents (FTE), in alignment with the guidance provided in the UDS Manual. If an employee is being paid while on leave, they are to be counted in FTEs. If they are on unpaid leave, furloughed, or no longer employed, they are not counted for this purpose. Staff providing services outside the scope of the health center project are not to be included.

How will COVID-19 tests and virtual visits be counted in the 2020 UDS report?

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 screened, or tested (i.e., a specimen is collected) for COVID-19, and there is no follow-up treatment provided by the health center, then this patient and visit are not counted for purposes of annual UDS reporting.

If the health center provides an individual with additional services that meet the criteria mentioned above (see also page 22 of the UDS Manual), that individual is considered a patient for UDS reporting. Their visit and the associated care would be reported in the 2020 UDS.

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.

Quality Improvement

Will COVID-19 affect health centers’ eligibility for Quality improvement Awards (QIAs), considering the challenging patients may face?

Since HRSA will use 2019 UDS data to make determinations for the fiscal year 2020 QIAs, there is no immediate impact of COVID-19 on determination criteria for these awards. For future QIA determinations, HRSA will examine different options in response to shifts in patient utilization and related quality of care indicators.

Will health centers receive communications from accrediting/recognition bodies regarding changes to any current guidance or impacts to their accreditation/recognition?

The Accreditation Association for Ambulatory Health Care (AAAHC) and The Joint Commission (TJC) will keep health centers apprised of changes to the current guidance and impacts to their accreditation. If TJC is your accrediting body, please contact Brittnay Hull, TJC account executive, at (630) 792-5216 or bhull@jointcommission.org with specific questions. If AAAHC is your accrediting body, please contact Mona Sweeney, AAAHC Assistant Director of Accreditation Services, at (847) 324-7487 or msweeney@aaahc.org with specific questions.

If you need additional support or have any concerns with your accreditation and PCMH recognition (TJC, AAAHC, or National Committee for Quality Assurance) please reach out to the HRSA APCMH Initiative and you will receive a response within 24 hours. To make sure you receive the response, please add “BPHCAnswers@hrsa.gov” to your address book. 

What should health centers do if recognition/accreditation through AAAHC, TJC or the National Committee for Quality Assurance (NCQA) is due to expire soon and it was dependent on a survey review?

AAAHC, TJC, and NCQA are providing extensions for health centers affected by survey postponements and assessing each health center’s circumstances. HRSA will reach out to AAAHC, TJC, and NCQA on behalf of health centers and request extensions, and will follow up with impacted health centers.

NCQA health centers expiring between March 1 and June 30, 2020 will receive a 60-day extension due to COVID-19. HRSA will be revisiting and providing additional support to health centers with expiration dates beyond June as the situation evolves. Health centers transitioning to the 2017 standards will be contacted by NCQA six months before their expiration date to provide guidance.

If a health center chooses to continue to pursue PCMH recognition at this time and is actively undergoing check-ins, they are able to show evidence from any time in the past year. So even if things are temporarily not done according to policy, the health center may still show the policy was routinely implemented before this time.

Community Programs, Engagement & Responsibility

What options are available for PCAs and National Training & Technical Assistance Partners (NTTAPs) if activities are cancelled or postponed?

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 your Project Officer to determine the appropriate steps.

How can health centers contribute to community awareness and education to lessen the severity and impact of a COVID-19 outbreak?

As part of their ongoing health education services, health centers can and should inform and raise awareness among their patients and the community of COVID-19 preventive measures; how to recognize symptoms of COVID-19 infection; and what to do if and when they or a member of their family gets sick. Health centers should provide information in a culturally appropriate manner to accommodate people with limited English proficiency. School-based health centers should participate with school administrations in educating students and parents about COVID-19 and appropriate preventive and treatment measures.

How can PCAs assist in ensuring that states integrate health centers in COVID-19 planning and response and in supporting health centers during the COVID-19 pandemic?

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 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.

How can Health Center Controlled Networks (HCCNs) help health centers shift towards increased telehealth services and meet reporting requirements during the COVID-19 pandemic?

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:

  • Work to ensure that health centers are integrated in regional and state COVID-19 response plans by coordinating with Primary Care Associations (PCAs) on planning and response activities.
  • Facilitate important and timely information sharing with health centers through electronic alerts
  • Assist health centers considering the expansion of telehealth services; Conduct outreach with health centers in their networks to increase awareness of the benefits of telehealth, and share challenges and lessons learned amongst health centers

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.

HRSA will work with HCCNs in the coming months to revise HCCN work plans, if needed, so that these activities can be counted under their existing grants.

How can health centers address the unique needs of special populations, such as migratory & seasonal agricultural workers, residents of public housing and homeless populations, relative to COVID-19 ?

Health centers provide comprehensive services to address the unique health needs of their target population, as well as supportive and enabling services that promote access and quality of care—such as translation, case management, outreach, patient education, and transportation. These services are even more critical for at-risk, vulnerable populations during emergencies.

Health centers may employ and intensify existing outreach services to ensure that the needs of their target populations are being addressed as appropriate. Mobile vans and temporary locations could be established for education and treatment services. Health centers that serve special populations routinely deliver services in areas where these patients live and/or work.

Health centers should work with their Primary Care Associations and National Training and Technical Assistance Partners for technical assistance resources and best practices related to addressing special population needs during the COVID-19 pandemic.

A note from us @BillingParadise    

We at BillingParadise and our clients especially, can attest to the fact that telemedicine systems are a must have contingency during a crisis and during more normal times it definitely benefits the community as a whole. Keeping this in mind, we offer telemedicine platforms that are tailored to your needs and practice. We also provide end-to-end support services for telemedicine related billing and coding with open access to our RCM experts.

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