On March 24, 2023, the Workplace of Inspector Basic (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), by which it determined to not impose sanctions on an Association to supply pay as you go present playing cards to sufferers for sure preventative screening exams (the “Association”).
As a part of the Association, a laboratory and its mother or father firm (the “Corporations”) would offer a pay as you go card, equivalent to a Visa or Mastercard present card, of as much as $75 to sure people to encourage these people to return the pattern assortment equipment related to an FDA-approved colorectal most cancers screening take a look at (the “Take a look at”). Within the Opinion, the OIG decided that it might not impose administrative sanctions beneath the Anti-Kickback Statute (“AKS”)[1] or the Beneficiary Inducements prohibition within the Civil Financial Penalties Legislation (“CMP”)[2] for the Association.
FOCUS ON THE FACTS: Evaluate of Particular Safeguards Beneath the Association
In its evaluation, as all the time, the OIG relied closely on the particular information of the Association. Particularly, the OIG famous that the Take a look at have to be prescribed by a well being care supplier appearing inside the scope of their prescribing authority (the “Prescriber”). The Take a look at equipment is then mailed to the affected person’s dwelling. The affected person should acquire their very own stool pattern and ship the Take a look at equipment again to the laboratory. As such, the Prescriber doesn’t management whether or not the Take a look at equipment pattern is distributed to the laboratory – that step is inside the affected person’s management.
Subsequent, the Corporations licensed they’d implement sure safeguards associated to the Association, together with the next:
- The Present Card could be mailed solely to these sufferers who return the Take a look at equipment by a specified deadline.
- They might advise sufferers that the Present Card might not be used for gadgets or providers supplied by the Corporations.
- Every affected person could be restricted to receiving one Present Card per 36-month interval, a time interval that aligns with Medicare’s protection for the Take a look at, which is as soon as each 36 months.
- The Corporations would implement processes to make sure that the recipient of the Present Card had not already acquired a Present Card within the prior 36-month interval.
- The Corporations wouldn’t have interaction in every other patient-focused promotion of the Association, equivalent to direct-to-consumer ads on third-party web sites or ads in newspapers, on tv or radio, or in magazines in reference to the Association.
- The Corporations wouldn’t promote or market the Association to Prescribers or supply or pay any remuneration to Prescribers in reference to the Association.
THE OIG’S ANALYSIS:
The OIG suggested that the Association would implicate the Beneficiary Inducements CMP and AKS due to the supply and switch of remuneration to Medicare sufferers, doubtlessly ensuing within the buy of laboratory providers in reference to the Take a look at. Nevertheless, the OIG concluded that it might not impose administrative sanctions on the Corporations in reference to the Association beneath both regulation based mostly on the fact-specific evaluation outlined under.
Evaluate of the Proposed Association Beneath Federal AKS
At a excessive degree, the OIG concluded that the Association presents a minimal threat of fraud and abuse beneath the AKS. Notably, the OIG cited to its prior opinion on preventative care providers, noting that:
“From an anti-kickback perspective, the chief concern is whether or not an association to induce sufferers to acquire preventive care providers is meant to induce different enterprise payable by a Federal well being care program. Related components in making this analysis would come with, however not be restricted to: the character and scope of the preventive care providers; whether or not the preventive care providers are tied straight or not directly to the availability of different gadgets or providers and, in that case, the character and scope of the opposite providers; the idea on which sufferers are chosen to obtain the free or discounted providers; and whether or not the affected person is ready to afford the providers.”
Accordingly, the OIG decided that the Association is unlikely to result in improperly elevated prices or overutilization as a result of the Take a look at prescription is restricted in a number of methods. For instance, the Take a look at is restricted to sufferers aged 45-75-years-old and every affected person might solely get hold of one prescription each 36-months. Moreover, as a result of Present Playing cards are solely supplied to sufferers who return the Take a look at, moderately than to all sufferers who obtain a Take a look at, Prescribers will be unable to anticipate whether or not the Corporations would supply or present the Present Card to sufferers for which the take a look at was ordered.
Second, the Association would profit sufferers and the Medicare program by selling compliance with a advisable screening take a look at. Notably, over thirty p.c of sufferers who acquired a Take a look at weren’t returning their pattern. Lastly, the OIG famous that the listed safeguards set forth by the Corporations cut back the chance of fraud and abuse.
Beneficiary Inducements CMP and the Preventative Care Exception
When analyzing the Beneficiary Inducements CMP, the OIG centered on the exception to the definition of “remuneration” beneath part 1128A(i)(6)(D) of the Social Safety Act, excluding incentives given to people to advertise the supply of preventive care the place the supply of such providers aren’t tied (straight or not directly) to the availability of different providers reimbursed in entire or partially by Medicare or an relevant State well being care program. (the “Preventive Care Exception”).
The OIG opined that the Present Card beneath the Association would fulfill this exception as a result of the Present Card promoted the supply of a preventative screening take a look at and the Present Card would neither be an instrument convertible to money, nor, on this specific case, disproportionately massive in relationship to the worth of the preventive care service. Whereas the OIG made a word that $75 could also be too massive in different contexts, it thought of the advantages to beneficiaries and the long run well being care prices anticipated to be prevented on account of the Exams when evaluating the proportionality on this occasion.
FINAL THOUGHTS:
Present playing cards and different various types of remuneration stay on the OIG’s radar and topic to scrutiny. Notably, the OIG lately revealed an FAQ discussing the way it differentiates between “money,” “money equivalents,” and “in-kind” present playing cards.
Whereas the Opinion supplies some flexibility, you will need to word that the OIG highlighted that its opinion is, as all the time, particular to the information introduced within the Corporations’ Association right here. Notably, the OIG acknowledged:
“We respect that the Present Card might current the chance for sufferers to obtain useful remuneration that would induce them to buy federally reimbursable providers and warning that if any of the foregoing information have been totally different, we probably would attain a special conclusion with respect to the chance introduced by this kind of association beneath the Federal anti-kickback statute, no matter whether or not the association satisfies an exception to the Beneficiary Inducement CMP.”
Accordingly, related preparations have to be rigorously reviewed to make sure compliance with relevant regulation. When you’ve got additional questions associated to this submit, attain out to a member of Sheppard Mullin’s Healthcare Crew.
FOOTNOTES
[1] 42 U.S.C. § 1320a–7b(b).
[2] 42 U.S.C. § 1320a–7a(a)(5).
