On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management support organization and a physician-owned professional corporation (the Requestors) would enter into an arrangement involving the leasing of clinical employees and provision of certain administrative services related to payor contracting to support the delivery of telehealth services through online platforms. OIG determined that the proposal was protected by a safe harbor under the federal anti-kickback statute (AKS), and therefore the fees payable between the parties thereunder did not constitute prohibited remuneration under the AKS.

Background

Parties Involved

The Requestors include a management support organization that provides non-clinical support services (Requestor MSO), and a physician-owned professional corporation that maintains provider network participation contracts with commercial, Medicare Advantage, and Medicaid plans (Requestor PC) but does not otherwise employ or engage with clinical staff.

Proposed Telehealth Services Platform Arrangement

Under the proposal (Proposed Arrangement), the Requestors would contract with third-party online telehealth platforms – comprised of management services organizations that furnish management services to telehealth providers (Platform MSOs) and telehealth provider entities (Platform PCs) to lease clinicians from the Platform PCs and obtain certain administrative services from the Platform MSOs. According to the Advisory Opinion, the Proposed Arrangement is intended to expand access to in-network services for patients of the Platform PCs, many of whom are “negatively impacted by limited access to insurance-covered telehealth services furnished by Platform PCs” especially in underserved and rural areas. The Requestor PC would credential the clinicians leased from the Platform PCs, and such leased clinicians would furnish services to their patients under Requestor PC’s contracted plans. In conjunction with this clinical arrangement, the Platform MSOs would provide ancillary administrative services to Requestor PC, including accounting (which OIG characterizes as including the collection of patient cost-sharing amounts for services rendered), marketing, administrative support (e.g., support for scheduling of clinical visits), and IT services (e.g., provision of a HIPAA-compliant online platform for receipt of synchronous telehealth services). Requestor PC would pay hourly fees for the leased clinicians and an administrative fee for the non-clinical administrative services, which would be consistent with fair market value for the services rendered as determined by a third-party valuation consultant.

As part of their request for the Advisory Opinion, Requestor MSO and Requestor PC certified that the Proposed Arrangement would meet all conditions of the AKS safe harbor for personal services and management contracts and outcomes-based payment arrangements, including by noting that the methodology for determining the fees would be set in advance and not take into account volume/value of any referrals or other business generated between the parties. Additionally, the fees would be payable regardless of whether Requestor PC was reimbursed by a payor for the visit.

OIG Analysis

Federal Anti-Kickback Statute

The OIG explained that because the Requestor PC offers and pays remuneration to the Platform PC and/or Platform MSO for services rendered, the AKS is implicated whenever the Platform PC refers a patient to Requestor PC.  The OIG therefore evaluated whether the Proposed Arrangement could violate the AKS, which prohibits offering, paying, accepting, or soliciting remuneration in exchange for referrals of items or services paid for by federal programs, or in exchange for the purchasing, leasing, ordering of, or arranging for the order of any good, facility, service, or item reimbursed under a federal health care program. Remuneration under the AKS can include anything of value, and violators of the AKS are subject to criminal and civil sanctions, including imprisonment, fines, civil monetary penalties, and exclusion from federal health care programs.

AKS Safe Harbor Requirements and Further Structural Safeguards

The broad scope of the AKS is subject to certain statutory and regulatory safe harbors, which establish protections from scrutiny thereunder for arrangements that meet all required criteria of a safe harbor. As OIG notes, safe harbor compliance “is voluntary” and “arrangements that do not comply with a safe harbor are evaluated on a case-by-case basis.”

In this Advisory Opinion, OIG affirmed that the Proposed Arrangement satisfies the requirements of the “personal services and management contracts and outcomes-based payment arrangements” safe harbor codified at 42 C.F.R. § 1001.952(d), after reviewing the key elements of the Proposed Arrangement and the criteria necessary to comply with such safe harbor.

OIG described the following structural safeguards of the Proposed Arrangement that are compliant with the safe harbor:

• The Proposed Arrangement will be memorialized in a written agreement signed by the parties, will have a term of at least one year, and the agreement will clearly describe the duties of, and services provided by all parties involved;
• The payments—both for the services of the leased clinicians from each Platform PC, and for the administrative services provided by Platform MSO—are fixed in advance and in line with fair market value, not determined based on volume or value of any referrals or other business generated between the parties, and are payable regardless of whether the Requestor PC is reimbursed by payors for services rendered; and
• The Proposed Arrangement would be commercially reasonable even if no referrals resulted from the Proposed Arrangement, the services contracted for are reasonably necessary to accomplish the purpose of the Proposed Arrangement, and the parties are not involved in counseling or promoting any business activity that would violate federal or state law.

The OIG cautioned that this Advisory Opinion is limited to the Proposed Arrangement only, and does not cover additional arrangements or referrals outside of the Proposed Arrangement that may exist between the Platform PC, Platform MSO, Requestor PC and Requestor MSO. The OIG further cautioned that the Advisory Opinion is binding only on the Department of Health and Human Services and not on other government agencies (e.g., the Department of Justice).

Takeaways

The Advisory Opinion is notable for the complexity of the Proposed Arrangement and potentially broad scope of its impact given the reported scope of Platform PC’s payor contracting activities (exceeding 400 payor contracts that cover 80% of all commercially covered lives and 65% of Medicare Advantage covered lives). The Advisory Opinion also acknowledges the role played by management services and support organizations in connection with care delivery, and particularly telehealth services delivered in connection with the Proposed Arrangement. The Advisory Opinion’s conclusion is also noteworthy because OIG did not determine that the arrangement could result in prohibited remuneration, but OIG would exercise discretion not to pursue it due to safeguards present, as OIG often concludes in Advisory Opinions under the AKS. OIG instead went further and determined that there was no prohibited remuneration because it met the safe harbor. It accordingly may provide a potential model for other management services and care delivery organizations to consider for arrangements. We will continue to monitor any guidance or additional advisory opinions that OIG issues on these topics.

This article was co-authored by Ivy Miller