#Market Access: Another Favorable Medical Products Advisory Opinion from HHS-OIG Signals New Flexibilities

On March 9, 2026, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), posted a favorable advisory opinion, Advisory Opinion 26-03, addressing a medical technology manufacturer and distributor’s proposal to offer a discount to certain ambulatory surgery centers (ASCs) on intraocular lenses (IOLs) and other surgical supplies used to perform cataract surgery, if an affiliated physician group practice (a “Practice”) purchases the manufacturer’s software product, which can be used at both the ASC and the physician practice. Although HHS-OIG concluded that the proposed arrangement fell outside the federal Anti-Kickback Statute (AKS) discount safe harbor, the agency issued a favorable opinion, determining that the arrangement presented sufficiently low AKS risk.

 

The opinion is notable for approving a discount arrangement that is conditioned on a service and due to the fact that the bundled discount offer is made to two buyers where one party’s purchase triggers a discount on products purchased by a different, commonly owned party.

 

This advisory opinion follows another recent favorable HHS-OIG advisory opinion addressing pharmaceutical manufacturing discounting, including market share and bundled arrangements (see earlier Sidley Update here).

 

 

The requestor is a medical technology manufacturer and distributor offering products in several medical fields, including ophthalmology and microsurgery. Among its product offerings are diagnostic tools used by ophthalmic surgeons as well as IOLs, Phaco Packs (single per-case packs of disposable supplies used in cataract surgery), and a web-based software platform (the “Software”) that serves as a configurable digital planning tool for cataract surgery. The Software is not separately billable to federal health care programs (FHCPs).

 

Under the proposed arrangement, the requestor would offer discounts to ASCs on its conventional IOLs and Phaco Packs contingent on a Practice — with ophthalmic surgeons who perform cataract surgery at the ASC — purchasing and subscribing to the Software. Specifically, the requestor would offer the ASC either an upfront, volume-based discount or a post-sale, volume-based rebate on the ASC’s standard purchase price for its Phaco Packs and conventional IOLs if a Practice purchased and entered into a subscription agreement for the Software. Neither the Practice nor the ASC would receive any discount on the Software subscription price regardless of the volume or value of items purchased by the ASC.

 

To be eligible for the offer, the Practice and the ASC must share at least one common direct owner, as certified through an ownership certification form. The requestor would enter into separate written agreements with the Practice (covering the Software purchase and subscription) and the ASC (covering the IOL consignment arrangement, Phaco Pack purchases, and any applicable discounts), with the agreements being coterminous. The requestor certified that it would provide ASCs with invoices reflecting the discounts received and that the ASC agreement would require the ASC to properly disclose and appropriately reflect the discounts in FHCP claims.

 

Importantly, the requestor also certified several features of the Software that HHS-OIG relied on in its analysis, including that the Software is agnostic to the brand of electronic health record and diagnostic equipment used by the surgeon or ASC, meaning it is compatible with competitors’ equipment; the Software’s output is a manufacturer-agnostic report of patient measurements, usable for the selection of any manufacturer’s IOL; and the Software does not include any marketing or clinical decision support directing a provider to particular products.

 

 

As a threshold matter, HHS-OIG determined that the discounts offered under the proposed arrangement do not qualify for protection under the AKS discount safe harbor for two reasons. First, the safe harbor does not protect the offer of a single, bundled discount arrangement to more than one buyer that requires one party (the Practice) to make a full-price purchase in order for a different party (the ASC) to qualify for a discount on other products. Second, to be eligible for the discounts, the ASC must effectively secure the participation of a commonly owned Practice to purchase the Software. HHS-OIG concluded that, because the Practice participation condition requires the Practice to perform a service to obtain the discount, it is expressly outside the safe harbor’s definition of “discount”. HHS-OIG also took the opportunity to reiterate its long-held view that the agency generally does not find price reductions conditioned on performing a service to be low risk under the AKS.

 

Despite the arrangement’s failure to meet the discount safe harbor, HHS-OIG concluded that the AKS risk was sufficiently low to warrant a favorable opinion based on several factors:

 

No Increased Costs to Federal Health Care Programs or Overutilization. HHS-OIG found that the proposed arrangement should not increase costs to FHCPs or result in overutilization. Cataract surgeries involve set facility fees and set professional services fees. The discounted items (Phaco Packs and IOLs) would be included in the facility fee paid by FHCPs, while the Software, which is not included in either fee, would remain at full price. Neither the Software nor the discounted items are separately billable. FHCPs, therefore, pay the same amount regardless of which products and services are used for the surgery.

 

Low Risk of Interference with Clinical Decision-Making. HHS-OIG found that the arrangement presents a low risk of interference with clinical decision-making. The discounted Phaco Packs are not specific to any particular IOL, the discounted IOLs do not require use of any particular Phaco Pack, and the Software functions regardless of the brand of electronic health record, diagnostic equipment, Phaco Pack, or conventional IOL used. While a surgeon with common ownership in the ASC could receive an indirect benefit from the discounted items, HHS-OIG reasoned that the cost of these items is only one factor a surgeon might consider when choosing a product. Additionally, the Practice must invest in the Software, which is an additional expense to the Practice that would not act as a financial incentive distorting clinical decision-making.

 

No Inappropriately High Risk of Steering or Unfair Competition. HHS-OIG concluded that the arrangement does not present an inappropriately high risk of steering or unfair competition. HHS-OIG reasoned that, as rational economic actors, both ASCs and Practices will consider a variety of factors (including price, quality, and convenience) in their selection of products and software platforms. Critically, HHS-OIG also assessed the risk of steering from the Practice to the ASC, noting that the referral source (the Practice) must purchase the Software at full price for the ASC (the referral recipient) to receive discounts on items included in its Facility Fee. HHS-OIG stated that if the opposite were true (i.e., if an ASC were paying full price for an item or service that resulted in the Practice (a referral source) receiving discounts or other remuneration), the risk of inappropriate steering would be much higher, and HHS-OIG may have reached a different conclusion.

 

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Advisory Opinion 26-03 follows HHS-OIG’s long-standing guidance regarding discount safe harbor requirements, including restating its position that conditioning a discount on services, rather than purchases, fall outside the safe harbor’s definition of a “discount”. However, the opinion demonstrates HHS-OIG’s willingness to look beyond the safe harbor and evaluate the totality of the facts and circumstances of a proposed arrangement using prudential factors. This opinion highlights the importance of implementing robust safeguards that demonstrate that an arrangement will not increase FHCP program costs, will not distort clinical decision-making, and will not create inappropriate steering dynamics. More broadly, it is another recent signal from HHS-OIG that properly structured market access arrangements that fall outside a safe harbor may nevertheless present a low risk of fraud and abuse.