HHS OIG Approves Substance Use Recovery Incentive Program – Food, Drugs, Healthcare, Life Sciences

On March 2, 2022, the Office of the Inspector General of the Department of Health and Human Services (“HHS”) (the “OIG”) issued a new advisory opinion (“AO 22-04“) related to a program through which the applicant would provide certain individuals with access to digital emergency management (“CM”) and related tools to treat substance use disorders (“Program”). BIG has indicated that it will not impose administrative penalties under the Anti-Kickback Statute (“AKS”) or the Civil Monetary Penalty Act (“CMPL”).

The applicant, a digital health company, proposes a program that uses smartphone technology and smart debit cards to implement CM for people with substance use disorders, addressing aspects of these disorders “in a way that conventional advice and medication often cannot.” Applicant makes this technology available to individuals who meet certain requirements through contracts with various entities, such as health plans, addiction treatment providers, employee assistance programs, research and other processing providers (“clients”).

Individuals (“Members”) are clients or self-referrals and undergo a structured interview using the American Society of Addiction’s Medicine Continuum Screening Tool prior to participating in the program . The applicant’s enrollment specialist, under the direction of a licensed clinical supervisor, determines the type of services and frequency of recovery coaching using an evidence-based automated algorithm. The program’s technology schedules the expected target behavioral health events, objectively validates whether each expected event has occurred, and if so, quickly disburses the exact, protocol-specified incentive to the member using ( where applicable) a schedule for progressive reinforcement.

The program is not limited to treatments or services reimbursable by the federal government; it also includes, among other features, support groups, medication reminders, and checking for appointment attendance. For those that include federally reimbursable services, the applicant has indicated that these services can be provided by a client. Program incentives are provided to members via a “smart debit card”. The card includes “abuse and relapse protections (for example, it cannot be used in bars, liquor stores, casinos, or certain other locations, or to convert credit to cash at ATMs vending machines or gas stations)”, and allows the Applicant to monitor usage. Incentives are capped at $200/month and $599/year; individual incentives are usually relatively small, between $1 and $3.

The applicant receives fees from clients on a fixed monthly basis, per eligible active member, or on a pay-for-performance model, in which the applicant is paid when a member achieves certain agreed-upon abstinence goals. The applicant has certified that the overall fee is consistent with fair market value and does not vary based on the volume or value of business generated under federal health care programs. Instead, fees are based on service configurations purchased and the intensity of behavioral targets expected for each member, as well as whether a member is low or high risk, whether in treatment or no.

The OIG concluded that two compensation streams potentially involved AKS and CMPL. First, customers pay the requestor a fee to provide services, some of which could induce a member to receive a federally billable service. Second, some of the fees clients pay to the applicant are passed on to members as CM inducements to achieve certain behavioral health goals, some of which may involve services that might be billable to federal health care programs (e.g., a counseling session) by an individual supplier or supplier, who could be a Client. The OIG has raised long-standing concerns about the offering of inducements intended to induce recipients to obtain federally reimbursable items and services, as such inducements could present significant risks of fraud and abuse. .

The OIG concluded that the program poses minimal risk of fraud and abuse and declined to impose penalties, providing four justifications –

  1. The applicant has certified that the program is research-based and has provided evidence that MC is a “highly effective and cost-effective treatment for people with substance use disorders”. Therefore, the OIG has determined that, combined with the other safeguards present in the arrangement, the claimant’s program incentives are “part of a protocol-based, evidence-based treatment program rather than an incentive to to seek, or a reward for requesting, special treatment reimbursable by the federal government. »

  2. Incentives offered under the program have a relatively low value and cap, and are largely unrelated to federally payable services, especially since the applicant is not registered and does not charge federal health care programs for program services. Therefore, the OIG has determined that the risk that the incentives “encourage overuse of federally reimbursable services is low”.

  3. Plaintiff’s client base is not limited to entities that have an interest in inducing the receipt of federally reimbursable services. While the OIG has recognized that there may be instances where an inducement may be provided to receive a federally chargeable service, the fees do not vary based on the volume or value of federally chargeable services, and customers do not have control of the program. Therefore, the OIG has determined that there is a low risk of an entity becoming a client to “generate business or reward referrals”.

  4. Although the incentives loaded onto a chip-based debit card function as cash equivalents, the OIG found that the safeguards included in the arrangement were sufficient to mitigate the risk of fraud and abuse. The applicant, who does not charge for federal health care programs or have an incentive to induce overuse, determines the services an individual needs and the incentives attached to them. In addition, the chip debit card has “anti-relapse protections”, which can signal a possible need for intervention. Therefore, the OIG has concluded that remuneration in the form of a chip-based debit card presents a sufficiently low risk.

AO 22-04 reflects HHS’s ongoing goals of increasing flexibility around treatments for substance use disorders. Just two weeks before, HHS announcement two grant programs, totaling $25.6 million, to expand access to drug treatments for opioid use disorders and prevent prescription drug abuse. In a press release, HHS Secretary Xavier Becerra reportedly said, “At HHS, we are committed to solving the overdose crisis, and one of the ways we are doing that is by expanding access to treatment. drugs and other effective and proven treatments human resource-based prevention and intervention strategies HHS’ “National Tour to Strengthen Mental Health” aims to “hear directly from Americans across the country about the challenges they face and to engage with local leaders to strengthen mental health and crisis care in our communities”, focusing on three aspects: mental health, suicide and substance abuse. Further flexibilities should be anticipated in these areas as and as the Tour continues.

Anyone looking for treatment options for substance abuse should call the SAMHSA National Helpline at 800-662-HELP (4357) or visit
findtreatment.gov. If you or someone you know is struggling with suicidal thoughts, please call the National Suicide Prevention Lifeline at 800-273-TALK (8255), or text the Crisis Text Line (text HELLO to 741741).

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

Ryan H. Bowman