Q1 2026 Roundup: HHS-OIG Advisory Opinions

Between January 1 and March 31, 2026, the U.S. Department of Health and Human Services’s Office of Inspector General (HHS-OIG) issued five advisory opinions (Nos. 26-01 through 26-05). All five were favorable determinations by OIG and focus heavily on operational and transactional realities facing healthcare providers and life sciences companies, especially ambulatory surgery centers (ASCs), a frequent focus of ASC compliance; urgent care operators, management services organizations (MSOs); and clinical research sites.

While an advisory opinion from OIG technically only binds the requesting party, the docket of Q1 2026 advisory opinions still can provide a useful blueprint for complying with the federal Anti-Kickback Statute (AKS), a cornerstone of healthcare fraud and abuse enforcement, and for structuring physician succession, shared management models, vendor discounting, and patient financial support.

Across the first quarter, OIG took a consistent, practical approach to fraud and abuse risk, built on three main premises:

Astute readers know that healthcare arrangements do not necessarily have to satisfy all prongs of applicable AKS safe harbors. Indeed, several of the Q1 arrangements failed to do so. Rather than issuing adverse opinions, OIG evaluated the total clinical and commercial context. Where the setup prevents improper incentives, OIG exercised discretion to not impose penalties under Sections 1128(b)(7) and 1128A(a)(7) of the Social Security Act.

In evaluating pricing and discount arrangements, OIG repeatedly emphasized how Medicare pays for the underlying services. When those items or services are paid through set, bundled rates (e.g., ASC facility fees or global surgical fees), there is little financial reason to order unnecessary services or run up federal costs.

For physician-owned facilities and MSO structures, OIG focused on revenue isolation. Arrangements were permitted when the referring providers received no direct financial gain from ancillary volume and retained total clinical discretion over what they ordered.

Issued March 4, 2026, AO 26-04 addresses a single-specialty ASC wholly owned by its founding physician (Physician A) who sought to properly structure a retirement and estate plan. The plan had several phases: gifting equity interests to a non-physician spouse, giving fair market value (FMV) purchase options to two physician children in the same medical specialty, and permitting the ASC to sell minority shares to outside physician investors at FMV.

Gifted equity fails to meet the ASC safe harbor (42 C.F.R. § 1001.952(r)). Nonetheless, OIG approved the arrangement based on a few strong safeguards:

• Physician A agreed to completely retire from clinical practice, resign all administrative and governance posts, and refrain from directing or influencing patient referrals.
• Payments to the non-referring family members remain strictly proportional to their equity ownership.
• Future physician investors must pay a verified FMV price without regard to past or expected referral volume.

AO 26-04 establishes a workable healthcare succession planning framework for physician founders seeking to exit clinical practice, a sensitive physician practice transition, without being pushed into a fire sale to private equity or hospital health systems.

Issued March 4, 2026, AO 26-03 reviews a proposal by a medical technology manufacturer, a life sciences and medical device company, to sell intraocular lenses (IOLs) and surgical packs to ASCs at a discount, as long as affiliated eye practices buy the vendor’s practice management software at full price.

Because the price reduction required an affiliated practice to sign a separate software contract, it failed the Discount Safe Harbor (42 C.F.R. § 1001.952(h)). OIG still approved the arrangement because money moved in the opposite direction from a typical kickback. The referring physicians paid for the software out of pocket, while the recipient ASC realized the supply savings. Because Medicare reimburses cataract procedures through fixed facility and professional fees, the cheaper supplies could not increase program billing or encourage improper clinical volume.

Issued February 12, 2026, AO 26-02 evaluates an MSO, a common corporate practice of medicine (CPOM) structure, that manages several urgent care centers and proposed to operate an independent clinical diagnostic laboratory through a separate subsidiary. The lab would accept specimen referrals from the providers working at those urgent care sites.

OIG affirmed that the arrangement generated no prohibited remuneration under the AKS because strict operational barriers were present:

• Urgent care clinicians maintained full freedom to select outside laboratories without pressure from quotas, tracking, or EHR ordering defaults.
• Laboratory facilities remained physically separate from the clinical urgent care centers.
• The MSO certified that none of the lab’s revenue would be paid, credited, or passed back to the urgent care providers.

OIG warned that sham lab joint ventures are still an active prosecution target, but with careful MSO compliance and genuine operational separation, MSOs can run their own ancillary diagnostic services.

In two separate advisory opinions, OIG evaluated beneficiary cost-sharing relief under AKS and the Beneficiary Inducements Civil Monetary Penalty (CMP) law:

• AO 26-01 (issued January 15, 2026): A lab manufacturer waived patient copayments, a form of patient cost-sharing support, for its stool-based RNA colorectal cancer test exclusively for commercially insured individuals. OIG accepted the carve-out structure because the test had minimal federal program coverage, the waiver applied uniformly to all commercial patients, and the providers who ordered it received no compensation.
• AO 26-05 (March 11, 2026): A device manufacturer covered out-of-pocket Medicare deductibles and copays for patients enrolled in a CMS-approved Category B Investigational Device Exemption (IDE) trial for a heart failure implant. OIG determined that the subsidies would generate prohibited remuneration under both AKS and the Beneficiary Inducements CMP, but concluded the fraud and abuse risk was sufficiently low to decline sanctions. OIG pointed to several things: the subsidies were a reasonable way to promote study enrollment and retention, the risk of overuse was low, the trial ran under a CMS-approved Category B IDE protocol with review board oversight, and the subsidies were never advertised to prospective participants.

Taken together, these two advisory opinions rest on different findings. In AO 26-01, the waiver covered only commercial patients and the test has little federal coverage. Because OIG decided there was no remuneration at all, neither the AKS nor the Beneficiary Inducements CMP was implicated.

In AO 26-05, OIG determined that the subsidies were remuneration but still approved the plan by using its enforcement discretion, based on the low risk of fraud and abuse rather than any lack of remuneration.

Document Founder Exits: Healthcare groups using equity transfers for succession must strip retiring partners of all management control, board seats, and patient-direction authority, and document fair market value support for every ownership transfer.

Maintain MSO Firewalls: Ancillary ventures managed by common MSOs require strict EHR neutrality and accounting firewalls that prevent ancillary lab or imaging earnings from subsidizing clinical salaries under the Anti-Kickback Statute and Stark Law.

Leverage Fixed Reimbursement Schedules: Tying discounts to bundled or capitated payment lines builds a strong defense against claims of overuse.

Disclaimer: This industry insight is for general information only, is not legal advice, and does not create an attorney-client relationship.