On August 4, 2020, the Office of Inspector General of Health & Human Services (OIG) used a new website resource to share informal guidance on the ability of laboratories to provide free COVID-19 antibody testing to Medicare beneficiaries. For the specific situation, the requestors indicated that the clinical lab would provide free COVID-19 antibody testing to patients—including federal healthcare program beneficiaries—in conjunction with other medically necessary blood tests performed by the lab. The lab indicated that it would not charge any patient or other payors for the COVID-19 antibody tests offered in conjunction with other paid lab tests. The requestors also indicated that the purpose of the arrangement had a public health focus as it was intended to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which can be used for certain experimental convalescent plasma therapy treatments for COVID-19.
This type of arrangement normally implicates the Federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements Civil Monetary Penalty (CMP), but the OIG found that the proposed arrangement offers the possibility of substantial public health benefits because it would identify potential convalescent plasma donors. The OIG was further assured that the arrangement would pose a sufficiently low risk of fraud and abuse so long as the arrangement includes the following safeguards: (1) the physicians ordering the lab tests, including the free COVID-19 antibody tests, would not receive any payments or anything else of value from the lab in connection with the free antibody testing program; (2) the patients receiving the lab tests would not receive any payments or anything of value, other than the free COVID-19 antibody test, from the lab in connection with the free antibody testing program; (3) the tests would be offered only to patients receiving other medically necessary blood tests as part of a medically necessary exam or treatment; (4) no payor (patient, commercial insurance company, federal healthcare program, or otherwise) would be billed for or pay any costs in connection with the COVID-19 antibody tests; and (5) the antibody tests are cleared or approved by the U.S. Food and Drug Administration (FDA) or are subject to an FDA-issued Emergency Use Authorization.
As background, the OIG implemented an interim advisory process in recognition of the healthcare community’s urgent need to deliver patient care during the COVID-19 Public Health Emergency. This process ensures that healthcare providers have the regulatory flexibility necessary to address enforcement questions as it pertains to COVID-19 related services. Specifically, the OIG is allowing members of the healthcare community to submit questions via email regarding application of AKS and CMP provisions prohibiting inducements to beneficiaries, instead of submitting through the formal and lengthy advisory opinion process. Therefore, questions regarding how the OIG would view an arrangement that is directly connected to the Public Health Emergency and could implicate the AKS or CMP can be submitted electronically to OIGComplianceSuggestions@oig.hhs.gov.
So far, the OIG has responded to eleven inquiries using this informal process, including the free antibody testing inquiry. And with its antibody testing response, the OIG shows a willingness to weigh the public health benefit against strict prohibitions that would ordinarily not be approved through its formal advisory opinion process. That said, it is important to keep in mind that questions submitted using this process will not receive the full scrutiny or immunity offered under the formal advisory opinion process, and the informal feedback furnished on this site does not bind or obligate HHS, the U.S. Department of Justice, or any other federal agency. Because the facts presented via email are not certified, any favorable answer by the OIG will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under federal criminal law. OIG guidance on this site is only applicable to situations involving COVID-19 and only for the duration of the Public Health Emergency. Nonetheless, the informal guidance is helpful and allows the healthcare community to make informed decisions on solutions that otherwise might be completely foreclosed under the letter of the law.
When submitting a request, submitters should provide sufficient facts to allow for an understanding of the key parties and terms of the arrangement at issue. The OIG is posting their responses on its COVID-19 Portal FAQ titled “FAQs—Application of OIG’s Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”: https://oig.hhs.gov/coronavirus/authorities-faq.asp