OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ permitting labs to offer free COVID-19 antibody tests; and on July 29, 2020, it published an FAQ allowing oncology practices to offer free lodging where lodging facilities have closed and patients otherwise would have qualified for free or reduced lodging.

Free COVID Antibody Tests

OIG states that a clinical laboratory may provide free COVID-19 antibody testing to patients, including federal healthcare program beneficiaries, who are contemporaneously undergoing other medically necessary blood tests at the lab. Although providing free lab testing to federal healthcare program beneficiaries implicates the federal anti-kickback statute (AKS) and the Beneficiary Inducements CMP, OIG believes the proposed arrangement offers substantial public health benefits by identifying additional potential convalescent plasma donors and providing valuable public health data through reporting antibody testing results to public health agencies.

OIG identified several safeguards labs should implement to minimize risk of fraud and abuse: (1) the physicians ordering the laboratory tests cannot receive payments or anything else of value from the laboratory in connection with the free antibody testing program; (2) the patients receiving the laboratory tests cannot receive 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 should be offered only to patients receiving other medically necessary blood tests; (4) no payor, including the patient, a commercial insurance company, or a federal healthcare program, should be billed for or pay any costs in connection with the COVID-19 antibody tests; and (5) the antibody tests are approved by the FDA or are subject to an FDA Emergency Use Authorization.

Free Oncology Lodging

In certain circumstances, federal healthcare program beneficiaries with cancer who are receiving chemotherapy or radiation treatment qualify for free or discounting housing at nonprofit lodging facilities near treatment sites while their treatment is ongoing. In its FAQ, OIG recognizes that some of these facilities have closed as a result of COVID-19, causing some cancer patients to travel longer distances from their homes to receive medically necessary cancer treatment. If an oncology practice wishes to offer free or discounted lodging to financially needy patients who have qualified for free or discounted lodging at a nonprofit facility that is now closed as a result of COVID-19, OIG believes that an oncology practice’s provision of free or discounted lodging to these patients presents a low risk of fraud and abuse if certain conditions are met.

OIG identified the following safeguards to minimize the risk of fraud and abuse in providing such lodging: (1) the patient resides at least 50 miles from the treatment site; (2) the patient is an established patient of the oncology practice who has already scheduled chemotherapy or radiation treatment prior to the offer of free or discounted lodging; (3) the patient’s physician determines that free or discounted lodging would facilitate access to care while the patient is receiving chemotherapy or radiation treatment; (4) the oncology practice reasonably believes that the patient would have qualified for free or discounted housing during treatment at a nonprofit lodging facility that is closed as a result of the COVID-19 public health emergency; (5) the remuneration is in-kind, such as a direct payment to a hotel or motel for the appropriate number of nights; (6) the hotel or motel is located in close proximity to the treatment site; (7) the practice does not advertise the availability of free or discounted housing or otherwise use the availability of this remuneration for patient recruitment; and (8) the lodging is provided during the COVID-19 public health emergency.

The new FAQs are published as part of OIG’s ongoing effort to ensure healthcare providers have the regulatory flexibility necessary to respond to COVID-19 concerns. Providers should note that, unlike OIG’s advisory opinion process, OIG’s published FAQs are “informal feedback” that do not bind or obligate the HHS, the DOJ, or any other agency. OIG’s FAQs also do not have any effect on any other federal, state, or local statute, rule, regulation, or other law that may be applicable to a certain question answered.

All of the OIG FAQs regarding COVID-19, including these two most recent FAQs, can be found here.