One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of funding for COVID-19 services during the public health emergency.
The HRSA uninsured program has paid approximately $18 billion in claims, including approximately $11.4 billion for testing, $5.85 billion for treatment and $1.6 billion for vaccines.1
Over the last few weeks, the HRSA stopped accepting claims for COVID-19 testing and treatment claims, as well as for COVID-19 vaccination claims.2
The program was funded by federal legislation, including the Families First Coronavirus Response Act; the Coronavirus Aid, Relief and Economic Security Act; the Coronavirus Response and Relief Supplemental Appropriations Act; and the American Rescue Plan of 2021. The program provided reimbursement for health care providers who rendered COVID-19 testing, treatment and vaccine services to uninsured individuals.
The massive amount of money paid to providers via the HRSA uninsured program renders the program ripe for government auditing and oversight to ensure compliance with federal requirements.In particular, providers were required to agree to the program’s terms and conditions which include potential post-reimbursement audit review.3 Additionally, the U.S. Department of Health and Human Services’ Office of Inspector General work plan includes an audit of the HRSA uninsured program to determine whether claims for COVID-19 testing and treatment complied with federal requirements.4
The OIG initially announced an expected issue date for the audit of fiscal year 2021 but has since changed the date to fiscal year 2022.
Government Enforcement and Potential Liability for Noncompliance
To receive reimbursement from the program, providers enrolled and attested to the program’s terms and conditions, and noncompliance may subject a provider to administrative, civil or criminal liability.
In addition to the terms and conditions, program guidance has been in the form of information posted on HRSA’s website, including frequently asked questions.5 It is unclear whether or to what extent the Centers for Medicare & Medicaid Services guidance applies to the program.
CMS guidance is referenced several times in program material, and there is a strong implication that HHS, the parent agency for both CMS and HRSA, may require participating providers to comply with some CMS regulations and guidance.
Importantly, the program FAQs state that HRSA has a program to identify overpayments and collect overpaid funds from future claims payment. The FAQs also set forth a process for providers who self-identify overpayments to return the funds.
There has been limited enforcement related to the HRSA uninsured program to date, but OIG and the U.S. Department of Justice press releases reveal government attention on COVID-19 fraud generally,6 and press articles suggest attention on the program specifically and signal the potential for more enforcement to come.
In this article, we describe the HRSA uninsured program’s requirements and some risks that providers may face, including the potential penalties that may result from noncompliance with program requirements.
Claims Must Be for Medically Necessary Services
Providers were required to certify that all items and services for which reimbursement is sought are medically necessary. HHS, the U.S. Department of Labor and the U.S. Department of the Treasury issued guidance interpreting the FFCRA provision requiring payers to cover COVID-19 testing services and clarifying that payers are not required to provide coverage for screening tests or tests for employment purposes.7
While it is unclear whether the departments’ guidance would apply to the program, it is likely, and by submitting claims to HRSA for tests that are not medically necessary, providers may be subject to government scrutiny.
At least one provider has entered into a settlement agreement with OIG after disclosing alleged violations of the Civil Monetary Penalties Law for allegedly presenting claims to the HRSA uninsured program for services rendered to patients without a COVID-19 primary diagnosis.
Patients Must Be Uninsured
The program is intended to reimburse for claims for uninsured patients only, and providers must certify that to the best of its knowledge, patients identified on each claim form were uninsured at the time the service was rendered.
With the speed at which providers began offering COVID-19 testing and treatment services to address the significant need during the public health emergency, providers may not have put in place proper procedures to determine patients’ insurance status. Failure to take measures to determine whether patients are uninsured may expose providers to liability for failure to comply with the program terms and conditions.
Provider May Not Balance Bill Patients
Providers were required to certify that they would not engage in balance billing or charge any type of cost sharing for services provided to uninsured individuals for which reimbursement is sought from the HRSA uninsured program.
Likewise, providers that charged a fee to uninsured individuals for testing prior to signing the terms and conditions had to communicate with the uninsured individual that they do not owe any money for the services, and return any payment already made to the uninsured individual.
HRSA guidance does not speak to remediation following instances in which providers balance bill patients after signing the terms and conditions. Consequently, providers may be subject to government enforcement.
Providers May Not Seek Reimbursement for Expenses Reimbursed by Other Sources
Providers certified that they would not use program reimbursement for expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse.
Instances of potential noncompliance with this requirement may be discovered via data analysis, including for those who received other sources of federal COVID-19 relief funding including from the provider relief fund or the Paycheck Protection Program.
The HRSA uninsured program has provided a critical source of reimbursement for providers rendering COVID-19-related services to uninsured individuals. However, noncompliance with the program’s requirements may expose providers to liability for administrative, civil or criminal fines.
Providers who participated in and submitted claims to the program should assess their operations to ensure they were in compliance with the terms and conditions and program guidance. Likewise, providers that detect noncompliance with program requirements should look into remediation.
This article was originally published by Law360 and is reprinted here by permission.
3 https://www.hrsa.gov/sites/default/files/hrsa/provider-relief/uninsured-program-terms-and-conditions-6- 21.pdf