OIG Provides Additional Guidance Regarding Application of Administrative Enforcement Authorities to Arrangements Directly Connected to the COVID-19 PHE

King & Spalding

On May 24, 2021, OIG provided additional guidance in the form of an FAQ as to whether an offer or provision of cash, cash-equivalent, or in-kind incentives or rewards to Federal health care program beneficiaries who receive COVID-19 vaccinations during the PHE violate OIG’s administrative enforcement authorities (the May 2021 FAQ Guidance).

OIG typically expresses concerns regarding the provision of anything of value to Federal health care program beneficiaries intended to induce the utilization of reimbursable items or services-remuneration. In the May 2021 Guidance, OIG states that it is aware that healthcare providers and entities are offering “incentives and rewards” to individuals who receive the COVID-19 vaccine. Such rewards include food, concert tickets, and cash. OIG acknowledges that “certain incentives and rewards may promote broader access to and uptake of COVID-19 vaccinations.”

In the limited context of the COVID-19 PHE, OIG states that an arrangement whereby a provider, supplier, or managed care organization offers a Federal healthcare program beneficiary receiving the COVID-19 vaccine dose a reward or incentive, is a “low risk” arrangement under the Federal Anti-Kickback Statute and the civil monetary penalty laws (CMP Laws) if the following safeguards are met:

  1. the incentive or reward is 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);

  2. the vaccine is authorized or approved by the FDA as a COVID-19 vaccine and is administered in accordance with all other applicable Federal and State rules and regulations and the conditions for the provider or supplier receiving vaccine supply from the Federal government;

  3. the incentive or reward is not tied to or contingent upon any other arrangement or agreement between the entity offering the incentive or reward and the Federal health care program beneficiary;

  4. the incentive or reward is not conditioned on the 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;

  5. the incentive or reward is offered without taking into account the insurance coverage of the patient (or lack of insurance coverage) unless the incentive or reward is being offered by a managed care organization and eligibility is limited to its enrollees; and

  6. the incentive or reward is provided during the COVID-19 public health emergency.

OIG also emphasized that incentives and rewards currently offered to Federal health care program beneficiaries who receive the COVID-19 vaccine and are paid for by entities that are not affiliated or connected with any health care industry stakeholder have minimal risk under the Federal Anti-Kickback Statute, and to the extent it is implicated, the CMP Laws. OIG is continuing to accept additional inquiries regarding the application of its administrative enforcement authorities.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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