The Workplace of Inspector Normal (“OIG”) throughout the U.S. Division of Well being and Human Providers (“HHS”) is liable for detecting and stopping fraud, waste, and abuse in federal well being care applications. The OIG has authority to implement the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Financial Penalty regulation (“CMPL”). One of many ways in which the OIG makes use of its enforcement authority is thru the issuance of advisory opinions. 

Upon request from well being care suppliers and others, the OIG periodically points advisory opinions in regards to the software of fraud and abuse legal guidelines to current or proposed enterprise preparations. Whereas advisory opinions should not binding, the OIG has a celebration that receives a positive advisory opinion is protected against OIG-imposed administrative sanctions, offered that the association is carried out in accordance with the information submitted to the OIG.

In 2022, the OIG issued 21 new advisory opinions relating to preparations and modified two of its current opinions. Nearly all of the advisory opinions concerned preparations that the OIG decided would generate prohibited remuneration, however introduced minimal threat of fraud and abuse. Whereas the OIG cautioned that a number of proposed preparations introduced greater than a minimal threat of fraud and abuse, it indicated that it might solely impose sanctions because of violations of the AKS below two of the preparations.

This put up offers an evidence of the OIG’s evaluate course of, a abstract of the OIG’s 2022 advisory opinions, and an outline of the OIG’s new FAQ course of.

OIG Evaluate Course of

Requesting an advisory opinion from the OIG requires the requestor to explain an current or proposed association, present related information, and certify that each one info offered is true and correct to one of the best of the requestor’s information. As soon as the OIG has accomplished its evaluate, it points an advisory opinion that gives steering on how the proposed or current association might implicate the AKS or CMPL.

The OIG usually offers the requestor with a possibility to debate the advisory opinion earlier than it’s issued, in order to facilitate the OIG’s evaluate and evaluation of the association. Moreover, the requestor is afforded the chance to withdraw the request for an advisory opinion earlier than it’s issued. Nevertheless, advisory opinions that aren’t withdrawn are required by regulation to be made obtainable to the general public.

Abstract of 2022 OIG Advisory Opinions

For ease of reference, we have now included for every advisory opinion the important thing information of the proposed association, the OIG’s evaluation, and its final dedication within the [].

OIG’s New FAQs Course of

Along with its current advisory opinion course of, on March 23, 2023, the OIG a to permit stakeholders to submit questions and obtain suggestions from the OIG on points historically reserved for the advisory opinion course of. The OIG already offers FAQs relating to advisory opinions, self-disclosures, company integrity agreements, and exclusions. In the beginning of the COVID-19 public well being emergency (“PHE”), the OIG additionally carried out COVID-19 FAQs to offer non-binding steering explaining the OIG’s view on sure preparations which might be straight linked to the PHE and implicate the OIG’s administrative enforcement authorities.

Via its new course of, the OIG has expanded the subjects it considers for FAQs submitted by the well being care neighborhood. Particularly, the brand new FAQ subjects the OIG will think about embody: (1) common questions relating to AKS and the OIG’s administrative enforcement authorities, (2) inquiries relating to the final software of the AKS and CMPL to a sort of association that will implicate these statutes, (3) questions relating to compliance issues, and (4) the . Moreover, the OIG can even evaluate and think about common questions lined by sure of its , particularly advisory opinions, exclusions, and its whistleblower safety coordinator operate.

The OIG has supplied that when “acceptable and helpful,” it can problem formal, non-binding suggestions in response to chose inquiries relating to the above-described subjects in an FAQ response. Along with the brand new FAQ course of, stakeholders are reminded that they’ll use the OIG advisory opinion course of to hunt a proper, binding authorized opinion about an association that implicates or might implicate the AKS or CMPL.

FOOTNOTES

HHS-OIG Advisory Opinion FAQs, obtainable at (final visited Apr. 10, 2023).

Id.