Alerts3.17.26
HHS-OIG Issues Favorable Advisory Opinion on Discount Arrangement Between Medical Technology Manufacturer and Ambulatory Surgery Centers
Highlights
- The U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG) released Advisory Opinion No. 26-03, a favorable opinion addressing a proposed arrangement involving a medical technology manufacturer and distributor. Under the proposal, the company would offer certain ambulatory surgery centers a discount on intraocular lenses and other surgical supplies used to perform cataract surgery, contingent on affiliated physician practices purchasing the requestor’s software product. The opinion concludes that the arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (AKS), if the requisite intent were present, but that OIG would not impose administrative sanctions given the low risk of fraud and abuse.
- HHS-OIG found the arrangement favorable because the requestor certified that the proposed arrangement should not increase costs to federal healthcare programs or result in overutilization, presents a low risk of interference with clinical decision making, and does not present an inappropriately high risk of steering or unfair competition.
- Despite the favorable result, HHS-OIG cautioned that this opinion is limited in scope to this proposed arrangement and that in slightly different circumstances, it may have reached a different conclusion.
The medical technology manufacturer and distributor (the requestor) offers products in numerous fields, including ophthalmology and microsurgery. These products include diagnostic tools needed to evaluate whether a patient requires cataract surgery, medical equipment, conventional or premium implants (e.g., IOLs), and surgical supplies to perform cataract surgery generally packaged in a single-case pack called a phacoemulsification pack (phaco pack), with one pack utilized per surgery.
Keep Up to Date in a Changing World
Do you want to receive more valuable insights directly in your inbox? Visit our subscription center and let us know what you’re interested in learning more about.
