On March 2, 2022, the Division of Well being and Human Providers (“HHS”) Workplace of the Inspector Common (the “OIG”) issued a brand new advisory opinion (“AO 22-04”) associated to a program by means 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 beneath the Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Financial Penalty Regulation (“CMPL”).
The Requestor, a digital well being firm, presents a Program that makes use of smartphone and sensible debit card know-how to implement CM for people with substance use issues, addressing facets of those issues “in ways in which standard counseling and medicines usually can not.” The Requestor makes this know-how accessible to people who meet sure necessities by means of contracts with quite a lot of entities, equivalent to well being plans, habit therapy suppliers, worker help packages, analysis establishments, and different therapy suppliers (“Prospects”).
People (‘Members”) are Buyer- or self-referred, and are topic to a structured interview utilizing the American Society of Habit Medication Continuum Triage device earlier than participation within the Program. The Requestor’s enrollment specialist, beneath the steering of a licensed scientific supervisor, determines the kind of companies and frequency of restoration teaching utilizing an evidence-based, automated algorithm. The Program know-how 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 acceptable) a progressive reinforcement schedule.
The Program will not be restricted to therapies or federally reimbursable companies; it additionally contains, amongst different options, help teams, medicine reminders, and appointment attendance verification. For those who do embrace federally reimbursable companies, the Requestor suggested that such companies could also be furnished by a Buyer. Incentives from the Program are offered to Members through a “sensible debit card.” The cardboard contains “abuse and anti-relapse protections (e.g., it can’t be used at bars, liquor shops, casinos, or sure different areas nor can or not it’s used to transform credit score to money at ATMs or fuel stations)”, and permits the Requestor to observe 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 Prospects on both a flat month-to-month foundation, per eligible, lively Member, or a pay-for-performance mannequin, during which Requestor is paid upon a Member reaching sure agreed-upon targets for abstinence. The Requestor licensed that the mixture charges are according to truthful market worth and don’t fluctuate primarily based on the quantity or worth of enterprise generated beneath federal well being care packages. As a substitute, 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 probably implicate the AKS and CMPL. First, Prospects pay Requestor a charge to offer companies, a few of which might incentivize a Member to obtain a federally billable service. Second, among the charges Prospects pay to Requestor get handed on to Members as CM Incentives for reaching sure behavioral well being targets, a few of which can contain companies that could possibly be billable to Federal well being care packages (e.g., a counseling session) by a specific supplier or provider, which could possibly be a Buyer. OIG famous its longstanding issues regarding the provide of incentives supposed to induce beneficiaries to acquire federally reimbursable gadgets and companies, as such incentives might current vital dangers of fraud and abuse.
The OIG concluded that the Program presents a minimal danger 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.” 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 quite than an inducement to hunt, or a reward for having sought, a specific federally reimbursable therapy.”
- The incentives supplied by means of the Program have a comparatively low worth and a cap, and largely are unrelated to any federally payable companies, particularly because the Requestor will not be enrolled in and doesn’t invoice to federal well being care packages for Program companies. Due to this fact, the OIG decided that the danger of the incentives “encouraging overutilization of federally reimbursable companies is low.”
- The Requestor’s Buyer base will not be restricted to entities which have an incentive to induce receipt of federally reimbursable companies. 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 companies, and the Prospects do not need management of the Program. Due to this fact, the OIG decided that the danger 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 operate as money equivalents, the OIG discovered the safeguards included within the Association adequate to mitigate fraud and abuse issues. The Requestor, which doesn’t invoice federal well being care packages or have an incentive to induce overutilization, determines what companies a person wants and what incentives are connected. Moreover, the sensible debit card has “anti-relapse protections”, which might sign potential want for intervention. Due to this fact, the OIG concluded that the remuneration within the kind the sensible debit card is sufficiently low danger.
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 packages, totaling $25.6 million, to increase entry to medication-assisted therapy for opioid use dysfunction and forestall the misuse of prescribed drugs. 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 concerning the challenges they’re dealing with, and interact with native leaders to power the psychological well being and disaster care in our communities”, centered on three facets: psychological well being, suicide, and substance use. Additional flexibilities must be anticipated in these areas because the Tour continues.
Anybody searching for therapy choices for substance misuse ought to name SAMHSA’s Nationwide Helpline at 800-662-HELP (4357) or go to findtreatment.gov. For those who or anybody you recognize is combating 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).