OIG Report: A Review of the 2022 OIG Advisory Opinions

When it comes to navigating the complex health care fraud and abuse laws, it helps to know your history. To that end, we have developed this summary of the advisory opinions issued by the U.S. Department of Health and Human Services Office of Inspector General (the “OIG”) in 2022. This summary, alongside previously issued advisory opinions, can be referenced when beginning to consider the fraud and abuse implications of various health care arrangements.

OIG Advisory Opinions

The OIG is the office tasked with enforcement of several sections of the Social Security Act (the “Act”), including those sections related to the commission of acts described in the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and the Beneficiary Inducements Civil Monetary Penalty (42 U.S.C. § 1320a-7a(b)(5)). In connection with this enforcement role, the OIG regularly issues advisory opinions in response to inquiries about proposed or existing health care arrangements. In such opinions, the OIG describes the arrangement and provides legal analysis of whether the arrangement may be in violation of the Act. While the OIG’s advisory opinions are limited in scope to the facts and circumstances provided by each requestor and cannot be relied upon by any other person or entity, they are helpful for gaining an understanding of how the OIG might respond to similar facts and circumstances. This makes them a particularly useful tool when planning and structuring various health care arrangements.

Relevant Laws

The following laws are discussed in the 2022 OIG advisory opinions. Additional health care fraud and abuse laws not discussed in the opinions include the Physician Self-Referral (Stark) Law, the False Claims Act, the Program Fraud Civil Remedies Act, and more.

1. The Anti-Kickback Statute

The Anti-Kickback Statute (the “AKS”) makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, the referral of an individual to a person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable under a Federal health care program. 42 U.S.C. § 1320a-7b(b). For purposes of the AKS, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind. 42 U.S.C. § 1320a-7b(b)(1). Any definitive conclusion regarding the existence of an AKS violation requires consideration of all the facts and circumstances of the arrangement as implemented, including a party’s intent. The determination of a party’s intent is a necessary element to prove that the AKS has been violated.

Violation of the AKS constitutes a felony punishable by a maximum fine of $100,000, imprisonment up to ten years, or both. See 42 U.S.C. § 1320a-7b(b). Conviction will also lead to exclusion from Federal health care programs, including Medicare and Medicaid. 42 U.S.C. § 1320a-7(a)(3). When a person violates the AKS, the OIG may also initiate administrative proceedings to impose civil monetary penalties and to exclude such person from Federal and State health care programs. 42 U.S.C. § 1320a-7a(a).

2. The Beneficiary Inducements Civil Monetary Penalty

The Beneficiary Inducements Civil Monetary Penalty (the “BI CMP”) provides for the imposition of civil monetary penalties against any person who offers or transfer remuneration to a Medicare or State health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program. 42 U.S.C. § 1320a-7a(a)(5). For purposes of the BI CMP, “remuneration” includes transfers of items or services for free or for other than fair market value. 42 U.S.C. § 1320a-7a(i)(6). Unlike the AKS, the determination of a party’s intent is not a necessary element to prove that the BI CMP has been violated.

When a person offers or transfers prohibited remuneration under the BI CMP, the OIG may initiate administrative proceedings to impose civil monetary penalties on such person. 42 U.S.C. § 1320a-7a(a). The OIG also may initiate administrative proceedings to exclude such person from Federal and State health care programs. Id.

3. Other Civil Monetary Penalties

42 U.S.C. § 1320a-7a(a)(6) provides for the imposition of civil monetary penalties against any person who arranges or contracts (by employment or otherwise) with an individual or entity that the persons knows or should know is excluded from participation in a Federal health care program, for the provision of items or services for which payment may be made under such a program.

Similar to the BI CMP, when a person violates this section the OIG may initiate administrative proceedings to impose civil monetary penalties and to exclude such person from Federal and State health care programs. 42 U.S.C. § 1320a-7a(a).

The 2022 OIG Advisory Opinions

In 2022, the OIG issued twenty-one advisory opinions. The new opinions covered a wide range of health care providers and entities, including physicians, nurses, hospitals, children’s hospitals, home health agencies, medical device companies, pharmaceutical manufacturers, and more. The OIG noted in almost all of these opinions (20) that prohibited remuneration under the AKS or the BI CMP may be generated by the proposed arrangements. However, in only two instances (Advisory Opinions Nos. 22-09 and 22-14) did the OIG caution the requestors that certain aspects of the arrangements would pose more than a minimal risk to fraud and abuse under the AKS. In both opinions, the OIG acknowledged that, under the AKS, the proposed arrangements would constitute grounds for the imposition of sanctions only if the requisite intent were present. The OIG did not find grounds to impose sanctions under the BI CMP in any proposed arrangements discussed in the 2022 advisory opinions.

Last year, the OIG also modified two existing opinions:

• In Advisory Opinion No. 22-10, the OIG modified Advisory Opinion No. 15-14 to include supplemental submissions and a proposed modification from the requestor. The OIG determined that, while the modification would generate prohibited remuneration under both the AKS and the BI CMP, the OIG would not impose administrative sanctions on the requestor.
• On June 1, 2022, the OIG posted a Notice of Modification of OIG Advisory Opinion 20-02 in response to a proposed modification from the requestor. The OIG determined that the proposed modification does not affect the conclusion reached in Advisory Opinion 20-02, and that (i) while the modified arrangement would generate prohibited remuneration under the AKS, the OIG would not impose administrative sanctions on the requestor, and (ii) the modified arrangement does not constitute grounds for the imposition of sanctions under the BI CMP.

Click on the image below to download a summary with a brief description of each advisory opinion issued by the OIG in 2022 and the corresponding outcome under the relevant health care fraud and abuse laws:

Takeaways

For guaranteed protection from OIG enforcement actions under the AKS, health care arrangements should be designed to fit within one of the statutory exceptions or safe harbors found at 42 U.S.C. § 1320a-7b(b)(3)(A) and 42 C.F.R. § 1001.952(o), respectively. Similarly, there are certain exceptions for the BI CMP found at 42 U.S.C. § 1320a-7a(i)(6). However, just because an arrangement cannot fit neatly within an exception or safe harbor does not mean that the OIG will impose administrative sanctions.

As the majority of the advisory opinions issued in 2022 suggest, the fact that a health care arrangement may generate prohibited remuneration under the AKS or the BI CMP alone may not constitute grounds for the imposition of administrative sanctions. The OIG did not find grounds to impose sanctions under the BI CMP in any proposed arrangements discussed in the 2022 advisory opinions. In only two opinions did the OIG caution the requestors that certain aspects of the arrangements would pose more than a minimal risk to fraud and abuse under the AKS. Even then, the OIG acknowledged that, under the AKS, the proposed arrangements would constitute grounds for the imposition of sanctions only if the requisite intent were present. Therefore, when designing a health care arrangement that does not meet an exception or safe harbor, health care professionals should remain mindful of the intent behind the offer or transfer of any prohibited remuneration.

Nyemaster Goode’s Health Care practice group is available to answer questions about health care fraud and abuse laws, seeking OIG advisory opinions, and OIG administrative proceedings.