OIG Permits Healthcare Group’s Smartphone Mortgage Program For Telehealth Companies | McGuireWoods LLP

On April 22, 2022, the US Division of Well being and Human Companies Workplace of Inspector Basic (OIG) issued a positive advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare group loaning smartphones to advertise telehealth care that it gives to underserved populations. The Advisory Opinion gives context for healthcare organizations which will equally need to mortgage out smartphones to sufferers to help such sufferers in acquiring reimbursed telehealth providers, which in any other case could possibly be thought-about renumeration to induce referrals and federal Anti-Kickback Statute (AKS) and Beneficiary Inducements Civil Financial Penalty (CMP) repercussions.

The OIG concluded that whereas the proposed association might implicate the AKS, the OIG wouldn’t impose sanctions as a result of the association met a collection of safeguards, such that the OIG decided that the association posed a comparatively low threat of fraud and abuse. As with all OIG advisory opinions, the OIG’s conclusions apply solely to the proposed association. It’s, nevertheless, informative for these evaluating related smartphone or telehealth mortgage preparations.

The Association

The Advisory Opinion addresses an association the place the requester, a federally certified well being heart (FQHC), loans limited-use smartphones to current sufferers of the group. Such smartphones will enable such sufferers to entry telehealth providers from the requesting FQHC. As proposed, the sufferers can have the precise to maintain the smartphones, however provided that the affected person obtained at the least one service from the group within the prior 24-month interval, no matter whether or not the service was telehealth associated.

Beneath the AKS, the OIG concluded that the association didn’t fulfill a secure harbor. Nevertheless, underneath the Beneficiary Inducements CMP, the OIG concluded the association did meet the “Promotes Entry to Care Exception,” (42 USC § 1320a-7a(i)(6)(F)) which requires that the objects enhance the beneficiary’s skill to acquire providers payable by Medicare or Medicaid, and pose a low threat of hurt to Medicare and Medicaid beneficiaries and Medicare and Medicaid applications by being unlikely to skew medical choice making, unlikely to extend prices by over utilization or inappropriate and never elevating affected person security or quality-of-care issues. In concluding this to be the case, the OIG additionally articulated that these identical safeguards recommend there’s minimal threat of fraud and abuse underneath the AKS, too. These safeguards, and key elements, embody:

  1. The OIG believes {that a} smartphone mortgage association can promote entry to care. Within the info of the association, 94% of the requesting FQHC’s sufferers reported incomes at or under 200% of the federal poverty tips and, due to this fact, the association eliminated some socioeconomic limitations for accessing telehealth providers. Moreover, the association solely offered telephones to sufferers who didn’t have already got a tool able to operating telehealth software to entry the providers. Not less than throughout the COVID-19 public well being emergency when Medicare and Medicaid each pay for telehealth providers, such a mortgage promotes entry to vital telehealth care (though, as famous within the Advisory Opinion, such logic will seemingly proceed post-pandemic assuming telehealth reimbursement continues).
  2. The OIG believes {that a} smartphone poses a low threat of hurt by being (1) unlikely to intrude with medical choice making and (2) unlikely to extend prices to Federal well being care applications or beneficiaries. The association didn’t seem to battle with these necessities primarily as a result of the sufferers didn’t already personal smartphones and merely holding a loaned gadget wouldn’t essentially result in important extra care. Beneath the association, the sufferers should obtain just one service inside a 24-month interval to stay eligible for the smartphone mortgage. The OIG didn’t imagine such interval is more likely to improve prices to Federal well being care applications or beneficiaries, as an FQHC would seemingly present at the least one service to such sufferers over a big time frame as a main entrance to the healthcare system. Probably, a extra specialised supplier of care would have a unique end result because it could possibly be seen as driving extra providers to proceed to obtain the loaned telephone.
  3. The OIG believes that use of smartphones doesn’t elevate important affected person security or quality-of-care issues. The OIG didn’t discover the association to have these issues and, as a substitute, believes it promotes affected person security and quality-of-care by permitting sufferers to obtain well being care providers with out coming into bodily contact with suppliers and different workers throughout the COVID-19 pandemic . OIG did acknowledge that in-person visits might enable for a better high quality of affected person care in lots of circumstances, however the OIG didn’t imagine that the association would recommend that the requesting FQHC would make the most of such “telehealth providers when doing so might pose affected person security or quality-of-care issues.” Different suppliers searching for to reflect this Advisory Opinion might need to have procedures to make sure telehealth is simply offered when warranted for the situation.
  4. The smartphones’ funding additionally decreased the probability of abuse. OIG favorably cited that this association obtained funding from the Federal Communications Fee (FCC) and an area charity. The OIG believed that this would scale back dangers underneath the AKS as neither the FCC or the charity obtain monetary curiosity when sufferers obtained providers from the FQHC, and due to this fact such help didn’t current extra issues. Additional, the truth that the healthcare group complied with all necessities imposed in reference to the funding additionally confirmed much less threat of fraud and abuse in line with the OIG.
  5. Limiting the smartphones’ performance additionally scale back the probability of abuse. The smartphones within the association had restricted performance. Ie, the smartphones have been “locked” in a means that restricted use to solely making/receiving calls, sending/receiving textual content messages, utilizing the offered telehealth purposes, and viewing the affected person’s medical information. A affected person couldn’t obtain extra purposes or surf the web on the telephone. The OIG had beforehand favorably mentioned locking telephones (eg, Advisory Opinion 19-02) to cut back the probability of fraud and abuse because the affected person has much less instruments from the gadget. Right here, nevertheless, the requestor nonetheless allowed the sufferers to make/obtain calls and ship/obtain textual content messages. The requestor licensed to the OIG that it had a goal (along with telehealth) to fight social isolation throughout the COVID-19 pandemic public well being emergency (PHE). The OIG famous that for the reason that program was not restricted to the PHE, that such social isolation might have to be reconsidered in different applications. Right here, nevertheless, the sufferers needed to safe funding for their very own voice and information providers and due to this fact entry to such issues weren’t regarding sufficient to the OIG that it might result in overutilization or inappropriate utilization.


The OIG concluded that the proposed association might generate prohibited remuneration underneath the AKS if the requisite intent have been current, however the OIG wouldn’t impose administrative sanctions as a result of this particular association would current a low threat of fraud and abuse for the explanations mentioned above. Different healthcare suppliers who need to develop related applications and can need to look to the OIG’s steerage for related structuring concepts. In so doing, suppliers ought to be cautioned that the OIG had particular factual causes for permitting this initiative and nonetheless expressed that AKS threat was doable if the requisite intent underneath the regulation was current. Accordingly, it is very important train warning and to assemble acceptable safeguards when loaning smartphones or different expertise to sufferers.

Additional, though the OIG utilized the identical evaluation underneath the “Promotes Entry to Care Exception” of the Beneficiary Inducements CMP to the AKS evaluation on this occasion, the OIG indicated that the AKS evaluation might differ. This leaves one other door open for the OIG to attract a unique conclusion in future. Please contact one of many authors for added info on this advisory opinion or different associated compliance issues.

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