This article first appeared on LinkedIn on June 1, 2021 as part 2 in a multi-part series. Part 3 will follow in a future post. It is republished here with permission of the author.
Providers, including marketers, are tempted to give patients and potential patients free items and services. While providers usually have good intentions, they must comply with applicable requirements. As Part 1 of this series indicates, there are two applicable federal statutes: the anti-kickback statute (AKS) and the civil monetary penalties law (CMPL). Part 1 also makes it clear that there are a number of exceptions or “safe harbors. If providers can meet the requirements of an applicable safe harbor or exception, they can give patients and potential patients free items and services that would otherwise violate applicable requirements.
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services, the primary enforcer of fraud and abuse prohibitions, announced that;
effective on December 7, 2016; the limits on free items and services given to beneficiaries increased. Specifically, according to the OIG, items and services of nominal value may be given to patients or potential patients that have a retail value of no more than $15 per item or $75 in the aggregate per patient on an annual basis. The previous limits were $10 per item or $50 in the aggregate per patient on an annual basis.
Under section 1128A(a)(5) of the Social Security Act, persons who offer or transfer to Medicare and/or Medicaid beneficiaries any remuneration that they know or should know is likely to influence beneficiaries’ selection of particular providers or suppliers of items or services payable by the Medicare or Medicaid Programs may be liable for civil money penalties for up to $10,000 for each wrongful act. “Remuneration” includes waivers of copayments and deductibles, and transfers of items or services for free or for other than fair market value.
In the Conference Committee report that accompanied the enactment of these requirements, Congress expressed a clear intent to permit inexpensive gifts of nominal value given by providers to beneficiaries. In 2000, the OIG initially interpreted “inexpensive” or “nominal value” to mean a retail value of no more than $10 per item or $50 in the aggregate per patient an annual basis.
The OIG also expressed a willingness to periodically review these limits and adjust them based on inflation. Consequently, effective on December 7, 2016, the OIG increased the limits of items and services of nominal value that may be given by providers and suppliers to beneficiaries to a retail value of no more than $15 per item or $75 in the aggregate per patient on an annual basis. Providers may not, however, give cash or cash equivalents.
These amounts may still seem paltry to many providers. According to the OIG, providers who see that patients need items worth more than these limits should establish relationships with charitable organizations that can provide items and/or services that are not subject to these limits. In other words, work together to meet the needs of patients!