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Alexa Chronister

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The Department of Health and Human Services Office of Inspector General (OIG) recently released Advisory Opinion 25-04, concluding that a medical device manufacturer’s proposal to pay for third-party compliance screening and monitoring services required or requested by its hospital and surgery center customers could violate the federal Anti-Kickback Statute (AKS) if the requisite intent were present.

Under the proposed arrangement, the manufacturer would engage a third-party company to conduct compliance screening and monitoring, including initial and ongoing screenings for exclusion from Federal health care programs and evaluating the manufacturer’s compliance with other legal requirements, such as compliance with Medicare Advantage plan requirements. In exchange for these services, the manufacturer would pay the company an annual subscription fee on a per-customer basis for each customer that requested to receive the monitoring reports. The manufacturer estimated that, based on its existing customer base, it would pay approximately $450,000 in fees annually to the company.  

OIG concluded that the proposed arrangement implicates the AKS and does not satisfy a safe harbor. Based on its facts and circumstances analysis, and acknowledging that there may be ways to structure such an arrangement that would not raise the same concerns, OIG concluded that the payment by the manufacturer to the company for these services, which are services the manufacturer’s customers would otherwise have to obtain, was not low risk enough for OIG to issue a favorable opinion. OIG’s decision reinforces its longstanding position that when a manufacturer or other party pays for a service that relieves a health care provider of a duty or financial obligation the provider otherwise would have to satisfy, that payment may constitute prohibited remuneration under the AKS.Continue Reading OIG Issues Unfavorable Opinion to Device Manufacturer

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) released Advisory Opinion 25-03, offering a favorable review of a proposed telehealth arrangement involving a management support organization (MSO) and a professional corporation (PC). These parties (Requestors) proposed to enter into agreements with third-party telehealth platforms consisting of MSOs providing management services to telehealth providers (Platform MSOs) and affiliated professional telehealth entities that employ clinicians (Platform PCs).

Under the proposal, Requestors would lease clinicians from the Platform PCs and obtain certain administrative services from the Platform MSOs, including marketing, accounting, administrative support, and IT services. The Requestors sought OIG’s review of the proposed structure with the aim to expand access to in-network telehealth services, particularly for patients in underserved and rural areas. The Requestor PC would credential the leased clinicians and enroll them under its existing payor contracts. These clinicians would then provide services to Platform patients under Requestor PC’s in-network plans.

OIG ultimately concluded that while the arrangement implicates the federal Anti-Kickback Statute (AKS), it falls within a safe harbor protection. Thus, the payments between the parties do not constitute prohibited remuneration. The opinion offers important insight into how OIG continues to evaluate evolving telehealth and care coordination models under federal fraud and abuse laws.Continue Reading OIG Issues Favorable Advisory Opinion 25-03 Regarding Telehealth Arrangement

In February 1971, at the tail end of Richard Nixon’s first term, his Secretary of Health, Education and Welfare, Elliot Richardson, approved a directive that was printed in the Federal Register as a Statement of Policy on “Public Participation in Rulemaking”.

The statement asserted that the Department of Health Education and Welfare (the precursor to the current Department of Health and Human Services [HHS]) would NOT exempt from full notice and comment rulemaking any rules relating to public property, loans, grants, benefits or contracts. The Department made this decision even though it was permitted to exempt these rules by the text of the Administrative Procedure Act (APA). Additionally, the policy statement urged the agency to only sparingly use a “good cause” exemption from notice and comment that was also included in the text of the APA.Continue Reading Elimination of the Richardson Waiver Means Changes . . . But To What End?