The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a favorable advisory opinion on March 9, 2026, regarding a proposed discount arrangement between a medical technology manufacturer and ambulatory surgery centers (ASCs). The arrangement allows for discounts on intraocular lenses (IOLs) and surgical supplies used in cataract surgery, contingent on affiliated physician practices purchasing the manufacturer’s software.
The opinion, designated Advisory Opinion 26-03, addresses a proposal where the manufacturer would offer discounts to ASCs on conventional IOLs and phacoemulsification packs – single-case packs of disposable supplies used during cataract surgery – if a related physician practice purchases and subscribes to the company’s web-based software platform. The software is designed as a configurable digital planning tool for cataract surgery and is not directly billed to federal healthcare programs.
While the arrangement does not qualify for protection under the federal Anti-Kickback Statute’s (AKS) discount safe harbor, HHS-OIG determined the risk of fraud and abuse was sufficiently low to warrant a favorable opinion. According to the agency, the proposed arrangement would not increase costs to federal healthcare programs or lead to overutilization of services.
HHS-OIG’s analysis found that cataract surgeries have set facility and professional service fees. The discounted supplies would be included in the facility fee, while the software remains at full price and is not separately billable. This means federal healthcare programs would pay the same amount regardless of the products used during the surgery.
The agency also determined the arrangement poses a low risk of interfering with clinical decision-making. The software is compatible with various electronic health record and diagnostic equipment brands, and its output provides manufacturer-agnostic reports usable for selecting IOLs from any manufacturer. The manufacturer does not include marketing or clinical decision support directing providers to specific products.
HHS-OIG noted that the arrangement does not present an inappropriately high risk of steering or unfair competition. Both ASCs and practices will consider factors like price, quality, and convenience when selecting products and software. The agency emphasized that the physician practice must purchase the software at full price for the ASC to receive discounts, reducing the risk of inappropriate influence.
The opinion follows a recent favorable HHS-OIG advisory opinion concerning pharmaceutical manufacturing discounting, indicating a potential trend toward greater flexibility in evaluating market access arrangements. However, HHS-OIG reiterated its position that discounts conditioned on services, rather than purchases, generally fall outside the AKS discount safe harbor.
The manufacturer, a distributor of medical technology products in fields including ophthalmology and microsurgery, sought clarification on whether the proposed arrangement would trigger sanctions under the AKS. The agency concluded that while the arrangement could technically generate prohibited remuneration under the AKS if the requisite intent were present, it would not impose administrative sanctions given the low risk of fraud and abuse.
HHS-OIG cautioned that the opinion is limited to the specific proposed arrangement and that different circumstances could lead to a different conclusion. The agency also required the manufacturer to certify that the arrangement would not increase costs to federal healthcare programs or result in overutilization, and to provide ASCs with invoices reflecting the discounts received.
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