As the pandemic continues, health care providers, suppliers and managed care organizations are turning to incentive programs in an effort to boost COVID-19 vaccination rates. These programs offer various rewards, such as food and beverages or the chance to win free trips, cruises, groceries, event tickets or large cash prizes, to individuals who receive their COVID-19 vaccine. Recently, the Office of the Inspector General (“OIG”) issued Frequently Asked Questions (the “FAQ”), available here, regarding application of the OIG’s administrative enforcement authority to various measures designed to combat COVID-19. In the FAQ, the OIG addresses the offer of incentives and rewards, including cash, cash equivalents or in-kind incentives or rewards, to COVID-19 vaccine recipients as a means of encouraging COVID-19 vaccinations. As stated in the FAQ, the OIG has taken the position that for the limited duration of the public health emergency, a health care provider, supplier or managed care organization offering or providing a reward or incentive in connection with a beneficiary receiving one or both doses of the COVID-vaccine is sufficiently low risk under the Federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”), provided that the safeguards outlined below are met.
Analysis
In view of the fact that Medicare and other Federal health care programs reimburse for COVID-19 vaccine administration, the offer or provision of rewards and incentives to beneficiaries of these programs who receive the vaccine could potentially implicate the AKS and the CMPL provisions prohibiting inducements to Federal health care beneficiaries.
The OIG recognizes that these incentives and rewards may improve the feasibility of achieving widespread vaccine administration, which is imperative to the COVID-19 pandemic response. As such, in the limited context of providing a reward or incentive to COVID-19 vaccine recipients, the OIG views such arrangements as sufficiently low risk under the AKS and CMPL provided that health care providers, suppliers and managed care organizations wishing to offer such incentives utilize the following safeguards:
- The incentive or reward must be furnished in connection with receiving a required dose of a COVID-19 vaccine (which could include either one or two doses, depending on vaccine type);
- The vaccine must be authorized or approved by the Food and Drug Administration as a COVID-19 vaccine and administered in accordance with all applicable Federal and State rules and regulations, as well as all conditions applicable to the vaccine provider’s receipt of vaccine supply from the Federal government;
- The incentive or reward must not be tied to or contingent upon any other arrangement or agreement between the entity offering the incentive and the Federal health care program beneficiary;
- The incentive or reward must not be conditioned on the vaccine recipient’s past or anticipated future use of other items or services that are reimbursable, in whole or in part, by Federal health care programs;
- The incentive or reward must be offered without regard to the vaccine recipient’s insurance coverage (or lack thereof), unless the incentive or reward is being offered by a managed care organization and eligibility is limited to its enrollees; and
- The incentive or reward must be provided during the COVID-19 public health emergency.
Practical Takeaways
Health care providers, suppliers and managed care organizations seeking to create an incentive or reward program for COVID-19 vaccine recipients should take care to follow the above safeguards to limit risk of violating the AKS or CMPL. Note that the EEOC also recently issued helpful guidance aimed at employers seeking to offer incentives for COVID-19 vaccinations, which we have summarized here. As noted in the FAQ, the OIG did not give any opinion on the utility or merits of any particular type of incentive or reward, and instead limited its opinion to the OIG’s administrative enforcement authority generally. As a result, organizations have some flexibility in the type of vaccine incentives they offer, provided that such incentives comply with the six safeguards outlined in the FAQ.
If you have any questions or would like additional information about this topic, please contact:
- Julie Lappas at (317) 977-1490 or jlappas@wp.hallrender.com;
- Jennifer Skeels at 317.977.1497 or jskeels@wp.hallrender.com;
- Megan Culp at (317) 429-3644 or mculp@wp.hallrender.com; or
- Your primary Hall Render contact.
Special thanks to James Kiai, law clerk, for his assistance with the preparation of this alert.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
