On August 4, 2020, the Office of Inspector General for the United States Department of Health and Human Services (OIG) updated its FAQs regarding the application of OIG’s administrative enforcement authorities to arrangements directly connected to the ongoing COVID-19 public health emergency.  

By way of brief background, on April 3, 2020, the OIG announced that it would not impose administrative sanctions under its exclusion and civil monetary penalty (CMP) authorities for violations of the Anti-Kickback Statute (AKS) with respect to certain arrangements related to the COVID-19 pandemic.  The details of that announcement were covered in a prior Chilivis Grubman blog post that can be accessed here.

On August 4, the OIG updated its website to answer the following frequently asked question:  “Can clinical laboratories offer free COVID-19 antibody testing to Federal health care program beneficiaries who are contemporaneously receding other medically necessary blood tests during the COVID-19 public health emergency?”

The OIG began by noting that:

Providing free laboratory testing to Federal health care program beneficiaries implicates the [AKS] because the clinical laboratory would be providing something of value for free to beneficiaries who could self-refer to the laboratory for items and services reimbursable by a Federal health care program. The proposed arrangement also implicates the Beneficiary Inducements CMP because the free COVID-19 antibody testing could reasonably influence a Medicare or State health care program beneficiary to select—or to cause his or her physician to select—the clinical laboratory for other medically necessary blood testing that is reimbursable by Medicare or a State health care program, in order to qualify for the free COVID-19 antibody testing.

The OIG went on to state, however, that because the proposed arrangement “offers the possibility of substantial public health benefits,” the OIG would not impose sanctions so long as the following safeguards were put into place:

  1. the physicians ordering the tests would not receive any payments or anything else of value from the laboratory in connection with the free antibody testing program; 
  2. the patients receiving the tests would not receive any payments or anything of value, other than the free COVID-19 antibody test, from the laboratory 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, including the patient, a commercial insurance company, or a Federal health care program, 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 FDA or are subject to an FDA-issued Emergency Use Authorization.

The attorneys at Chilivis Grubman represent heathcare providers of all types and sizes in connection with regulatory matters and government investigations.  If you need assistance with such a matter, please contact us today.