On March 2, 2022, the Division of Well being and Human Providers (“HHS”) Workplace of the Inspector Normal (the “OIG”) issued a brand new advisory opinion (“AO 22-04”) associated to a program by way of which the Requestor would supply sure people entry to digital contingency administration (“CM”) and associated instruments to deal with substance use issues (“Program”). The OIG suggested that it could not impose administrative sanctions underneath the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Financial Penalty Legislation (“CMPL”).
The Requestor, a digital well being firm, presents a Program that makes use of smartphone and sensible debit card expertise to implement CM for people with substance use issues, addressing features of those issues “in ways in which typical counseling and drugs usually can’t.” The Requestor makes this expertise accessible to people who meet sure necessities by way of contracts with a wide range of entities, akin to well being plans, habit therapy suppliers, worker help applications, analysis establishments, and different therapy suppliers (“Clients”).
People (‘Members”) are Buyer- or self-referred, and are topic to a structured interview utilizing the American Society of Habit Medication Continuum Triage software earlier than participation within the Program. The Requestor’s enrollment specialist, underneath the steerage of a licensed scientific supervisor, determines the kind of providers and frequency of restoration teaching utilizing an evidence-based, automated algorithm. The Program expertise establishes the schedule of anticipated goal behavioral well being occasions, objectively validates whether or not every anticipated occasion has occurred, and, if it has, promptly disburses the precise, protocol-specified incentive to the Member, utilizing (the place applicable) a progressive reinforcement schedule.
The Program will not be restricted to remedies or federally reimbursable providers; it additionally consists of, amongst different options, help teams, medicine reminders, and appointment attendance verification. For those who do embody federally reimbursable providers, the Requestor suggested that such providers could also be furnished by a Buyer. Incentives from the Program are offered to Members through a “sensible debit card.” The cardboard consists of “abuse and anti-relapse protections (e.g., it can’t be used at bars, liquor shops, casinos, or sure different places nor can it’s used to transform credit score to money at ATMs or fuel stations)”, and permits the Requestor to watch use. Incentives are capped at $200/month and $599/12 months; particular person incentives are usually comparatively small, at $1-$3.
The Requestor receives charges from Clients on both a flat month-to-month foundation, per eligible, energetic Member, or a pay-for-performance mannequin, by which Requestor is paid upon a Member attaining sure agreed-upon targets for abstinence. The Requestor licensed that the mixture charges are according to honest market worth and don’t range based mostly on the amount or worth of enterprise generated underneath federal well being care applications. As a substitute, charges are based mostly on the service configurations being bought and the depth of behavioral targets which might be deliberate for every Member, in addition to whether or not a member is low- or high-risk, and in or out of therapy.
OIG concluded that two stream of remuneration doubtlessly implicate the AKS and CMPL. First, Clients pay Requestor a price to offer providers, a few of which may incentivize a Member to obtain a federally billable service. Second, a number of the charges Clients pay to Requestor get handed on to Members as CM Incentives for attaining sure behavioral well being targets, a few of which can contain providers that might be billable to Federal well being care applications (e.g., a counseling session) by a selected supplier or provider, which might be a Buyer. OIG famous its longstanding considerations regarding the provide of incentives meant to induce beneficiaries to acquire federally reimbursable objects and providers, as such incentives may current vital dangers of fraud and abuse.
The OIG concluded that the Program presents a minimal threat of fraud and abuse and declined to impose sanctions, offering 4 justifications –
- The Requestor licensed that the Program relies in analysis, and offered proof that CM is a “extremely efficient, cost-efficient therapy for people with substance use issues.” Subsequently, the OIG determined that, taken along with the opposite safeguards current within the Association, the incentives within the Requestor’s Program function “a part of a protocol-driven, evidence-based therapy program reasonably than an inducement to hunt, or a reward for having sought, a selected federally reimbursable therapy.”
- The incentives provided by way of the Program have a comparatively low worth and a cap, and largely are unrelated to any federally payable providers, particularly because the Requestor will not be enrolled in and doesn’t invoice to federal well being care applications for Program providers. Subsequently, the OIG decided that the chance of the incentives “encouraging overutilization of federally reimbursable providers is low.”
- The Requestor’s Buyer base will not be restricted to entities which have an incentive to induce receipt of federally reimbursable providers. Whereas the OIG acknowledged that there could also be situations the place an incentive could also be given for receiving a federally billable service, the charges don’t range based mostly on quantity or worth of any federally reimbursable providers, and the Clients don’t have management of the Program. Subsequently, the OIG decided that the chance is low an entity would grow to be a Buyer to “generate enterprise or reward referrals.”
- Though the incentives loaded onto a wise debit card perform as money equivalents, the OIG discovered the safeguards included within the Association ample to mitigate fraud and abuse considerations. The Requestor, which doesn’t invoice federal well being care applications or have an incentive to induce overutilization, determines what providers a person wants and what incentives are connected. Moreover, the sensible debit card has “anti-relapse protections”, which may sign attainable want for intervention. Subsequently, the OIG concluded that the remuneration within the type the sensible debit card is sufficiently low threat.
AO 22-04 displays HHS’s continued goals to extend flexibility round substance use dysfunction remedies. Simply two weeks earlier than, HHS introduced two grant applications, totaling $25.6 million, to develop entry to medication-assisted therapy for opioid use dysfunction and stop the misuse of pharmaceuticals. In a press launch, HHS Secretary Xavier Becerra is quoted as saying, “At HHS we’re dedicated to addressing the overdose disaster, and one of many methods we’re doing that is by increasing entry to medication-assisted therapy and different efficient, evidenced-based prevention and intervention methods.” HHS’ “Nationwide Tour to Strengthen Psychological Well being” is meant to “hear straight from People throughout the nation in regards to the challenges they’re dealing with, and have interaction with native leaders to energy the psychological well being and disaster care in our communities”, centered on three features: psychological well being, suicide, and substance use. Additional flexibilities must be anticipated in these areas because the Tour continues.
Anybody looking for therapy choices for substance misuse ought to name SAMHSA’s Nationwide Helpline at 800-662-HELP (4357) or go to findtreatment.gov. When you or anybody you already know is fighting ideas of suicide, please name the Nationwide Suicide Prevention Lifeline at 800-273-TALK (8255), or textual content the Disaster Textual content Line (textual content HELLO to 741741).