OIG Approves Payments to Contingency Management Patients

Contingency administration (CM) is a type of intervention therapy program that incentivizes sufferers with substance use issues to watch sure circumstances—corresponding to non-use of medication or alcohol confirmed through urine drug screening or breathalyzer take a look at, and even drug remedy adherence—in alternate for one thing of financial worth.  Adherence is commonly tracked and confirmed by people who present the motivation fee by digital well being applied sciences—together with apps that may be downloaded to the affected person’s sensible cellphone or which are already downloaded to a smart phone provided to the patient as a part of a CM program.  Whereas many contend that CM is an effective, evidence-based treatment, sure authorized boundaries restrict, and infrequently stop, its widespread adoption and use.  When there may be the potential for sufferers to obtain objects and companies payable by Federal well being care packages (FHCPs), CM incentives are topic to scrutiny below the Federal anti-kickback statute (AKS) and the Beneficiary Inducements CMP.  A latest advisory opinion issued by the USA Division of Well being and Human Providers (HHS), Workplace of Inspector Common (OIG), accepted a digital well being firm’s provide to offer money equivalents to sufferers collaborating in a CM program.  This favorable consequence continues to reveal OIG’s flexibility however regulatory precedent or steering showing on the contrary.

The OIG’s Historic Place

The AKS, 42 U.S.C. § 1320a-7b, typically prohibits the providing or provision of remuneration—together with the switch of something of worth, immediately or not directly, overtly or covertly, in money or in variety—in alternate for the referral of an merchandise or service payable below an FHCP.  Whereas the AKS is criminally enforceable, the OIG may impose administrative sanctions, together with civil financial penalties, assessments, and/or exclusion, for violating the AKS.  The Beneficiary Inducements CMP, 42 U.S.C. § 1320a-7a(a)(5), additionally prohibits the providing or transferring of remuneration—together with the switch of things and companies without spending a dime or for aside from truthful market worth—to a Medicare or State well being care program beneficiary that the individual is aware of or ought to know is more likely to affect that beneficiary’s number of a specific supplier, practitioner, or provider for the order or receipt of an merchandise or service payable by the Medicare or State well being care program.  Just like the AKS, the OIG might provoke administrative proceedings towards the individual providing or transferring the remuneration.

As early as 2002 and as highlighted in recent guidance, OIG has defined its longstanding considerations referring to the providing of incentives meant to induce beneficiaries to acquire federally reimbursable objects and companies when these incentives have been money or money equivalents.  Nevertheless, by its advisory opinion course of, OIG has blessed sure preparations when money equivalents have been supplied or supplied to beneficiaries.  For instance, in October, 2008, the OIG allowed a non-profit group that gives outpatient therapy companies for sufferers with psychoactive substance abuse dependence to supply incentives within the type of $5–$10 present playing cards to encourage these sufferers to stick to their therapy plans, which embody urine drug screening and counseling classes.  After which, in December, 2020, the OIG decided to not impose any sanctions on a federally certified well being middle’s proposal to supply $20 present playing cards to sufferers to incentivize them to attend re-scheduled, preventative and early intervention care appointments even when the association wouldn’t fulfill an exception below the Beneficiary Inducements CMP.  The OIG’s most recent advisory opinion highlights, once more, its flexibility for the availability of money equivalents, significantly within the CM context.

Advisory Opinion 22-04

In Advisory Opinion 22-04, the OIG blessed an Association referring to a program by which a digital well being firm (Requestor) gives sufferers with substance use issues (Members) entry to digital CM and associated instruments to deal with substance use issues (Program) and which is funded by prospects that would embody Members’ well being care suppliers or suppliers (Prospects).  Members are held accountable for reaching their customized behavioral well being objectives by the Program’s options: (1) appointment and drugs reminders that embody verification mechanisms, (2) drug, alcohol, and tobacco testing, (3) cognitive behavioral remedy modules, (4) surveys and assessments, (5) licensed restoration teaching, (6) licensed household companions for important others and members of the family, and (7) day by day digital help teams moderated by licensed restoration coaches and household companions.

Whereas every reward is usually small ($1–$3), the full rewards can, within the mixture, embody money equivalents of as much as $200 monthly, with a $599 per yr cap, that are loaded onto a wise debit card within the Member’s possession (CM Incentives).  Nevertheless, Members are restricted from utilizing the funds at bars, liquor shops, casinos, or sure different areas.  The funds can’t even be transformed to money at ATMs or gasoline stations.  These “abuse and anti-relapse protections” are managed by Requestor such that entry to the aforementioned varieties of transactions can be blocked.

Prospects, which might embody Members’ well being care suppliers or suppliers, pay charges to Requestor on both month-to-month or pay-for-performance bases—the latter being premised on sure abstinence-based targets for Members.  Whatever the foundation, the combination charges are truthful market worth, don’t fluctuate with the amount or worth of referrals or enterprise in any other case generated, however do fluctuate primarily based on the service configurations bought by Prospects and the depth of the targets deliberate for every Member.  For instance, Prospects pay a decrease month-to-month charge for a Member’s smoking cessation or alcohol moderation, and a better month-to-month charge for a Member’s alcohol or different substance use issues.  The price differential for Prospects relies on the digital interface with Members: Members obtain text-based teaching just for smoking cessation or alcohol moderation, whereas Members obtain text-based teaching, in addition to video and voice-based teaching for alcohol or different substance use issues.  Requestor displays Members’ exercise within the Program and solely payments Prospects the charges and solely rewards Members money equivalents when these Members have achieved their particular behavioral well being objectives.

Based mostly on its evaluation of the Association, OIG decided that there are two streams of prohibited remuneration: (1) Prospects pay Requestor a charge to offer companies, a few of which might incentivize a Member to obtain a federally billable service, and (2) a number of the charges Prospects pay to Requestor get handed on to Members as CM Incentives for reaching sure behavioral well being objectives, a few of which can contain companies that might be billable to FHCPs by a specific supplier or provider, which might be a Buyer.

However these streams of remuneration taking the type of money equivalents and never being protected by an AKS regulatory protected harbor or by an exception to the Beneficiary Inducements CMP, the OIG nonetheless concluded that the Association introduced a minimal danger of fraud and abuse primarily based on a totality of the underlying details and circumstances.  The OIG highlighted 4 particular causes.  First, the OIG defined that the CM Incentives within the Program are a part of a nationally-recognized, protocol-driven, evidence-based therapy program, slightly than an inducement to hunt, or a reward for having sought, a specific federally reimbursable therapy.  Second, the OIG concluded that the chance of the CM Incentives encouraging overutilization of federally reimbursable companies is low as a result of the Requestor doesn’t invoice any FHCP for companies furnished by the Program and the CM Incentive quantities are comparatively low and never, by and huge, related to federally payable companies.  Third, the OIG reasoned that the chance {that a} Buyer would pay Requestor’s charges to generate enterprise or reward referrals of federally reimbursable companies is low as a result of the Requestor’s Buyer base just isn’t solely made up of people or entities which have incentives to induce Members to obtain federally reimbursable companies, the charges paid by Prospects don’t fluctuate with the amount or worth of any federally reimbursable companies, and the Program just isn’t pushed or established by the Prospects.  Lastly, the OIG was snug with the remuneration within the type of the sensible debit card—a money equal.  The OIG particularly reasoned that such type of remuneration is sufficiently low danger as a result of the Association’s safeguards, which embody anti-relapse protections, outweigh and mitigate the fraud and abuse dangers the CM Incentives in any other case carry, primarily based on the OIG’s enforcement expertise.

Key Takeaways

This favorable advisory opinion seems in line with the OIG’s place referring to the availability of money equivalents to beneficiaries as an incentive to obtain objects and companies that could be payable below FHCPs.  Nevertheless, this stance seems to be inconsistent with sure of the OIG’s preamble explanations concerning the availability of such money equivalents within the context of the brand new regulatory protected harbor referring to affected person engagement instruments and helps furnished by a value-based enterprise to a affected person in a goal inhabitants.  Because the OIG defined, the protected harbor was created “to enhance high quality, well being outcomes, and effectivity”—recognizing “the necessary position that digital well being expertise plans in advancing [HHS’s] objectives in reference to the Regulatory Dash, together with enhancing the coordination and administration of affected person care.”  85 Fed. Reg. 77684, 77688, 77782 (Dec. 2, 2020).  The protected harbor protected remuneration in alternate for therapy or follow-up care plan adherence, as long as the incentives didn’t take the type of money or money equivalents, together with debit playing cards, rebate checks, and most present playing cards.  See, e.g.id. at 77781, 77782–3, 77789–90, 77791.  The OIG notably decided these types of remuneration to not be protected below the brand new protected harbor as a result of its “longstanding concern in regards to the fraud and dangers inherent” in offering them, irrespective of its historically-favorable advisory opinion strategy concerning the identical and though sure commenters urged the OIG to permit a majority of these rewards due to their confirmed profit below evidence-based methodologies.  Id. at 77789, 77790.  Nonetheless, the OIG didn’t totally shut the door to money equivalents (and even money) for the advantage of future requestors of advisory opinions.  The OIG appears to acknowledge that sure CM interventions for substance abuse issues developed by help from different authorities companies, together with the Nationwide Institutes of Well being, might be helpful—clarifying that any proposal to offer remuneration is in the end analyzed on a case-by-case foundation, as is out there below the OIG’s advisory opinion course of.  Id. at 77790, 77791.

As expertise expands and the regulatory panorama within the well being care business evolves, the Agency is out there to offer compliance recommendation and steering for suppliers, digital well being firms, and others as they contemplate coming into the market, progress alternatives, or submitting advisory opinions to the OIG in regards to the dangers concerned with taking such actions.

© 2022 Proskauer Rose LLP.
Nationwide Legislation Overview, Quantity XII, Quantity 101

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OIG Approves Payments to Contingency Management Patients

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