The HHS Office of the Inspector General (OIG) has recently delivered an ‘unfavorable’ advisory opinion in relation to a proposed joint venture concerning interoperative neuro monitoring (IONM). Details of the advisory opinion were published in August, shedding light on certain aspects regarding compliance in joint ventures.
While some of the specifics remain undisclosed, the central reason for the OIG’s disapproval appears to stem from concerns of potential fraud and abuse. In determining its opinion, the OIG would’ve likely assessed whether the joint venture could lead to violations under the Anti-Kickback Statute or the exclusion authorities of the Social Security Act.
For legal professionals working within this space, this sends a timely reminder about the importance of rigorously examining all aspects of planned joint ventures for potential violations and conflicts. Legal experts from Saul Ewing LLP, who reviewed the OIG analysis, suggest that all parties considering joint ventures should conduct a thorough assessment of compliance, in order to avoid similar unfavorable opinions from the OIG.
The OIG frequently issues advisory opinions to provide legal guidance on the applicability of regulatory sanctions. This recent opinion concerning IONM provides a significant guideline, especially for health-sector business entities preparing to enter into joint ventures. As always, these guidelines should be considered within the framework of the specific legal circumstances. Parties involved in joint ventures should seek comprehensive legal advice to ensure that their future operations remain compliant with all relevant statutes and regulations.