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.

OIG’s Analysis

The AKS prohibits offering or receiving remuneration to induce referrals for items or services reimbursable by federal healthcare programs. Because Requestor PC would pay platform entities for both the leased clinicians’ services and other administrative services, the proposed arrangement implicates the AKS. However, Requestors certified that the proposed arrangement would comply with all requirements of the AKS safe harbor for personal services and management contracts and outcomes-based payment arrangements set out in 42 C.F.R. § 1001.952(d)(1).

OIG examined whether the arrangement satisfied each of the safe harbor’s requirements and confirmed that Requestors certified compliance. Specifically, the agreement would: be set out in writing, signed by the parties, have a term of at least 1 year, and specify all services provided by the parties. Further, the methodology for determining the fee would be set in advance and it would be consistent with fair market value, not determined by the volume or value of referrals. Importantly, Requestor PC would pay for the services provided regardless of whether it is ultimately reimbursed by a payor. As OIG noted, this reduces the risk that the fee would be linked to the volume or value of referrals.

Finally, Requestors certified that the arrangement would not involve the counseling or promotion of any activity that violates State or Federal law, and that the scope of services would not exceed what is reasonably necessary to achieve a legitimate business purpose. Ultimately, OIG concluded that the arrangement would not involve prohibited remuneration and therefore would not trigger sanctions under the AKS.

Key Takeaways

  • Complex, Multi-Entity “Friendly PC” Structure: OIG endorsed a telehealth arrangement involving multiple MSOs and affiliated provider entities, emphasizing that these models can be structured to comply with federal fraud and abuse laws.
  • Significant Market Reach: The Platform PC reportedly holds over 400 payor contracts covering 80% of commercial and 65% of Medicare Advantage patients, giving the arrangement significant potential for impact.
  • Affirmative Safe Harbor Protection: While many OIG advisory opinions simply decline to impose sanctions, here OIG affirmatively concluded that the arrangement meets the AKS safe harbor criteria.

Limited Scope, but Broader Implications: While OIG advisory opinions only bind the requesting party, this opinion demonstrates OIG’s openness to compliant digital health and care coordination models when structured with appropriate safeguards.

Reed Smith will continue to monitor developments in federal fraud and abuse enforcement and advisory opinions. If you have any questions about this advisory opinion or its implications, please contact the health care lawyers at Reed Smith.