Wednesday, August 3, 2022
HomeHealth LawHHS OIG Indicators Off on Substance Use Restoration Incentive Program

HHS OIG Indicators Off on Substance Use Restoration Incentive Program

On March 2, 2022, the Division of Well being and Human Providers (“HHS”) Workplace of the Inspector Basic (the “OIG”) issued a brand new advisory opinion (“AO 22-04”) associated to a program by means of which the Requestor would offer 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 below the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Financial Penalty Legislation (“CMPL”).

The Requestor, a digital well being firm, affords 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 standard counseling and drugs usually can not.” The Requestor makes this expertise obtainable to people who meet sure necessities by means of contracts with a wide range of entities, resembling 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 Drugs Continuum Triage software earlier than participation within the Program. The Requestor’s enrollment specialist, below the steerage of a licensed medical 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 shouldn’t be restricted to therapies or federally reimbursable providers; it additionally consists of, amongst different options, assist teams, treatment reminders, and appointment attendance verification. For people who do embrace federally reimbursable providers, the Requestor suggested that such providers could also be furnished by a Buyer. Incentives from the Program are supplied 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 or not it’s used to transform credit score to money at ATMs or gasoline stations)”, and permits the Requestor to watch use. Incentives are capped at $200/month and $599/yr; 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, wherein Requestor is paid upon a Member attaining sure agreed-upon targets for abstinence. The Requestor licensed that the mixture charges are in line with honest market worth and don’t fluctuate primarily based on the quantity or worth of enterprise generated below federal well being care applications. As an alternative, charges are primarily based on the service configurations being bought and the depth of behavioral targets which can 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 payment to offer providers, a few of which might incentivize a Member to obtain a federally billable service. Second, a few 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 specific supplier or provider, which might be a Buyer. OIG famous its longstanding issues regarding the provide of incentives supposed to induce beneficiaries to acquire federally reimbursable gadgets and providers, as such incentives might 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 –

  1. The Requestor licensed that the Program relies in analysis, and supplied proof that CM is a “extremely efficient, cost-efficient therapy for people with substance use issues.” Due to this fact, 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 relatively than an inducement to hunt, or a reward for having sought, a specific federally reimbursable therapy.”
  2. The incentives supplied by means of the Program have a comparatively low worth and a cap, and largely are unrelated to any federally payable providers, particularly because the Requestor shouldn’t be enrolled in and doesn’t invoice to federal well being care applications for Program providers. Due to this fact, the OIG decided that the danger of the incentives “encouraging overutilization of federally reimbursable providers is low.”
  3. The Requestor’s Buyer base shouldn’t 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 fluctuate primarily based on quantity or worth of any federally reimbursable providers, and the Clients wouldn’t have management of the Program. Due to this fact, the OIG decided that the danger is low an entity would turn into a Buyer to “generate enterprise or reward referrals.”
  4. Though the incentives loaded onto a sensible debit card operate as money equivalents, the OIG discovered the safeguards included within the Association ample to mitigate fraud and abuse issues. 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. Due to this fact, the OIG concluded that the remuneration within the kind the sensible debit card is sufficiently low threat.

AO 22-04 displays HHS’s continued goals to extend flexibility round substance use dysfunction therapies.  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 instantly from Individuals 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 needs to be anticipated in these areas because the Tour continues.

Anybody in search of therapy choices for substance misuse ought to name SAMHSA’s Nationwide Helpline at 800-662-HELP (4357) or go to Should you or anybody you realize 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).



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