Addiction Policy News

New Rules on Safe Harbor Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

December 2, 2020

 

 

On December 2nd 2020, the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) released a final rule that amends the safe harbors to the Federal anti-kickback statute (AKS) and the civil monetary penalty (CMP) rules regarding beneficiary inducements. Of note for addiction medicine professionals, the final rule does not expand the patient engagement and support safe harbor to include cash and cash-equivalent (gift card) payments offered as part of contingency management interventions or other programs to motivate beneficial behavioral changes, despite advocacy from leading addiction treatment organizations, including ASAM, to do so.

 

OIG recognized that research shows that contingency management interventions are the most effective currently available treatment for stimulant use disorders, and that substance use disorder treatment programs utilizing contingency management often involve payments to the patient in the form of the opportunity to earn vouchers, gift cards, or even, in some models, cash in exchange for desired prosocial behaviors or meeting specified goals. However, after weighing the potential benefits of contingency management with the potential risks to program integrity, OIG decided not to expand the patient engagement and support safe harbor to include cash and cash-equivalent payments offered as part of contingency management interventions.

 

This does not mean that all such cash or cash-equivalent payments are unlawful, but they would be subject to case-by-case analysis under the Federal AKS and Beneficiary Inducements CMP. OIG emphasized that in-kind remuneration and certain limited-use gift cards offered as part of contingency management interventions could receive protection under the patient engagement and support safe harbor if all safe harbor conditions are satisfied. Importantly, gifts or in-kind benefits cannot exceed a retail value of $15 per item or $75 in aggregate per beneficiary per year. Gifts that implicate the Beneficiary Inducements CMP that exceed these dollar limits are not prohibited but are analyzed on a case-by-case basis for compliance under the statute.  This nominal value guidance applies only to in-kind items and services and not to the value of incentive payments in the form of cash or cash equivalents, and it applies only to the Beneficiary Inducements CMP and not to the Federal AKS. The Federal AKS may constrain the ability of individuals or entities to offer contingency management program incentives of any value to Federal health care program beneficiaries, depending on the facts of the arrangement. 

 

However, OIG notes, with respect to contingency management program incentives – whether above or below $75 in value:
• In-kind remuneration in connection with such programs can fit in the patient engagement and support safe harbor, which protects certain limited-use gift cards, if all safe harbor conditions are met (including the $500 annual cap).
• If a contingency management incentive that implicates the Federal AKS, Beneficiary Inducements CMP, or both does not satisfy an existing safe harbor or exception (as applicable), that does not mean that such incentive automatically violates the statutes and is illegal. Contingency management incentive arrangements that do not comply with a safe harbor must be analyzed on a case-by-case basis for compliance with the Federal AKS and Beneficiary Inducements CMP.
• Incentives that are included in a service covered by a Federal health care program (i.e., the coverage includes the incentive itself) would not implicate the Federal AKS or the Beneficiary Inducements CMP, provided that the applicable billing and coverage rules are followed including collection of any applicable patient cost-sharing obligations.
• Incentives offered as part of a CMS-sponsored model may qualify for protection.


With respect to cash or cash-equivalent incentives, OIG generally remains concerned about heightened fraud and abuse risk. Its oversight and enforcement experience suggests that cash incentives can result in medical identity theft and misuse of patients’ Medicare numbers, lead to inappropriate utilization (in the form of medically unnecessary items and services), and cause improper patient steering (including patients selecting a provider because the provider offers the most valuable incentives and not because of the quality of care the provider furnishes). It has thus precluded cash or cash equivalents from protection under this safe harbor in recognition of the critical need to protect vulnerable patients from fraud.

 

Still, arrangements involving cash or cash equivalents used to promote adherence or healthy behavior modification do not necessarily violate the Federal AKS; they would need to be evaluated under the AKS on a case-by-case basis, including the intent of the parties. Parties may seek an OIG advisory opinion if they want assurance that their arrangement(s) comply with the statutes or would not be subject to OIG administrative enforcement sanctions, but having an advisory opinion is not mandatory. 

 

As always, ASAM encourages members to consult legal counsel for advice on complying with all federal and state laws.

 

Read the Rule here.

Read the AMA summary of the Anti-Kickback Statute and Stark Law Final Rules here