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Law360 (August 4, 2020, 8:04 PM EDT) -- Clinical laboratories aren't violating federal anti-fraud laws when they dole out free COVID-19 antibody tests to Medicare and Medicaid patients who are already getting other important blood tests, the Office of Inspector General for the U.S. Department of Health and Human Services said Tuesday.
The HHS watchdog responded to health care providers' questions about whether they should be concerned about potential compliance issues related to the coronavirus pandemic, like giving out antibody tests that determine whether a person was exposed to the virus, saying the agency has been flexible in its enforcement activities.
"In the current public health emergency resulting from the outbreak of the COVID-19, the health care industry must focus on delivering needed patient care," the watchdog said. "We are committed to protecting patients by ensuring that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns."
Among the questions was whether a clinical lab, seeking to promote awareness about donations of COVID-19 blood plasma, can provide free antibody testing to Medicare and Medicaid beneficiaries who are undergoing other blood tests. While that arrangement would normally put the lab at risk of violating the federal anti-kickback statute and could result in substantial civil penalties, the OIG said there's little chance for enforcement action.
"The proposed arrangement offers the possibility of substantial public health benefits through the identification of additional potential convalescent plasma donors and valuable public health information and data and would pose a sufficiently low risk of fraud and abuse," the OIG said, adding that the lab would still have to ensure that it's not providing patients, or the doctors ordering the tests, with anything of value.
The tests also need to occur as part of another medically necessary blood test and must be approved by the U.S. Food and Drug Administration, the OIG said.
In another scenario addressed by the watchdog, clinical labs shouldn't be concerned about violating the federal anti-kickback statute by billing Medicare or Medicaid for costs associated with retail pharmacies conducting COVID-19 tests.
As long as payments for the services are fair market value and the retail pharmacy isn't submitting claims to reimburse it for services that the laboratory has already covered, then providers are well-situated to avoid an enforcement action, the OIG said.
The OIG cautioned that all of its responses are "informal feedback" and don't bind any other federal agency.
"Any favorable answer will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under federal criminal law," the OIG said.
--Editing by Steven Edelstone.
For a reprint of this article, please contact reprints@law360.com.
