The Workplace of the Inspector Basic (“OIG”) just lately issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the supply of restricted use smartphones by a federally certified well being heart (“FQHC”) to present, low-income sufferers (the “Association”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”) and was not more likely to generate remuneration prohibited below the federal Civil Financial Penalties Regulation prohibiting inducements to well being care program beneficiaries (“Beneficiary Inducement CMP”).
The FQHC served predominantly low-income people together with Medicare and Medicaid beneficiaries and provided telehealth providers to its sufferers via a telehealth utility, which could possibly be downloaded onto a smartphone.
The FQHC obtained funding from the Federal Communications Fee (“FCC”) and an area charity to supply smartphones and sure knowledge providers to its sufferers. The FCC funding was meant to facilitate the flexibility of healthcare suppliers to obtain telecommunication providers and related gadgets for the aim of creating telehealth providers accessible to sufferers through the ongoing COVID-19 public well being emergency (“PHE”).
The FQHC loaned the smartphones on a first-come, first-serve foundation to present sufferers who didn’t possess a smartphone able to working the telehealth utility. Sufferers eligible for this system have been required to have obtained no less than one service from the FQHC within the previous 24 months and reported earnings ranges at 200 % or beneath the Division of Well being and Human Providers federal poverty pointers. The Association was restricted to three,000 smartphone gadgets and didn’t prolong to new sufferers.
Along with the supply of loaned gadgets, the FQHC made no-cost voice and knowledge providers accessible to sufferers for as much as 14 months after which sufferers have been required to pay straight for these providers. The smartphones have been accessible to be utilized solely to make or obtain cellphone calls, ship or obtain textual content messages, obtain telehealth providers through the FQHC’s utility, and/or view affected person medical data. The smartphones couldn’t be used for downloading functions or searching the web, and any affected person who now not obtained providers from the FQHC was required to return the smartphone.
The Federal Anti-Kickback Statute
The AKS makes it a legal offense to knowingly and willfully supply, pay, solicit, or obtain something of worth (in money or in-kind) to induce the referral of a person for any merchandise or service reimbursable below a federal well being care program. Violation of the AKS can lead to a most high-quality of $100,000, 10 years imprisonment, or each, per violation.
The OIG discovered that, whereas the association didn’t fall inside the protected harbor provisions of the AKS, the safeguards of the Association introduced not more than a minimal danger of fraud and abuse below the AKS for the next causes:
- Neither the FCC nor the native charity that offered funding to the FQHC had a monetary curiosity in any sufferers deciding on the FQHC for providers;
- The FQHC reported that it had adopted all the funding necessities imposed by the FCC and the native charity; and
- There was no help to counsel that the smartphones can be utilized by the FQHC to inappropriately enhance the utilization of federally reimbursable providers regardless of the FQHC’s intent to proceed to allow sufferers to make the most of the smartphones after the PHE expired.
Beneficiary Inducement CMP
The Beneficiary Inducement CMP imposes civil financial penalties on any individual that transfers or presents a free merchandise or service 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 the beneficiary’s number of a supplier, practitioner, or provider, for the order or receipt of any service which is paid for by Medicare or a state well being care program. However, the supply of an merchandise or service that “promotes entry to care and poses a low danger of hurt to sufferers and Federal well being care applications” is an exception (the “Promotes Entry to Care Exception”).
Promote Entry to Care
In assessing whether or not the FQHC’s provision of free smartphones and knowledge promoted entry to care below the Association, the OIG concluded that the Association improved the flexibility of Medicare and Medicaid beneficiaries to entry telehealth providers through the PHE for the next causes:
- Given that almost all of the FQHC’s sufferers reported incomes at or beneath 200% of the federal poverty pointers, the supply of limited-use smartphones might scale back socio-economic obstacles to accessing telehealth providers;
- Distant affected person monitoring and cell well being functions offered healthcare suppliers with the flexibility to ship high quality well being care on to sufferers, no matter location; and
- The Association was restricted to sufferers who didn’t have already got a tool able to working the applying required to entry telehealth providers from the FQHC.
Danger of Hurt
The OIG concluded that the Association posed a low danger of hurt by evaluating the chance that the renumeration interfered with scientific decision-making, elevated prices to federal well being care applications or beneficiaries via overutilization or inappropriate utilization, and raised affected person security or quality-of-care considerations. In reaching this conclusion, the OIG highlighted the next options of the Association:
- The Association was unlikely to intrude with scientific decision-making as a result of there was no info to help that using smartphones by sufferers adversely impacted the scientific decision-making of medical professionals offering providers to the FQHC’s sufferers;
- The danger for overutilization or inappropriate utilization was low as a result of:
- The association was restricted to present sufferers who already had the smartphones;
- The sufferers obtained no less than one service from the FQHC inside the prior 12 months;
- The smartphones had restricted performance; and
- Sufferers have been required to straight pay for voice and knowledge providers after the preliminary provision of providers; and
- The Association didn’t pose affected person security or quality-of-care considerations on the premise that using telehealth providers through the PHE promoted affected person security by lowering bodily contact with suppliers, employees and different sufferers and that the FQHC didn’t present telehealth providers when doing so posed dangers to affected person security or quality-of-care.
Lastly, it is very important be aware that the OIG discovered that, within the occasion that this system didn’t meet the Promotes Entry to Care exception, it might not impose administrative sanctions below the Beneficiary Inducement CMP after the PHE expired primarily based upon the above-referenced options of the Association.
The Advisory Opinion supplies useful perception to healthcare suppliers contemplating preparations meant to reinforce entry to telehealth providers through the PHE and past. Healthcare entities desirous about implementing comparable applications ought to be conscious that Advisory Opinions are restricted to their details and binding solely with respect to the requesting events. Skilled regulatory counsel ought to be consulted for steering on particular preparations upfront of implementation.
 Part 11128A(a)(7) of the Social Safety Act (“SSA”).
 Part 1128(a)(5) of the SSA.
 94% of sufferers of the FQHC have been famous to have incomes are at or beneath 200% of the federal
 The FCC offered 85% and the native charity offered 15% of the funding obtained by the
FQHC to buy the smartphones.
 42 U.S.C. § 1320a-7b(b).
 Part 1128A(i)(6)(F) of the SSA.