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# OIG Backs Manufacturer-Sponsored Patient Tests
- URL: https://www.fdaweb.com/oig-backs-manufacturer-sponsored-patient-tests/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161409

The HHS Inspector General (IG) has issued an advisory opinion that favorably addressed a drug manufacturer’s program to provide free antibody testing to determine whether it would be appropriate to prescribe the manufacturer’s product. Attorneys **Dominick DiSabatino** and **Audrey Mercer** (Sheppard) write in an online [post](https://www.sheppard.com/insights/blogs/oig-issues-favorable-opinion-on-manufacturer-sponsored-patient-testing-program?ref=fdaweb.com) on their firm’s *FDA Law Update* that the opinion “offers practical lessons for pharmaceutical and biotech companies contemplating similar arrangements.”

The post says the manufacturer in question contracted with a third-party laboratory to provide the testing at no cost to eligible patients. It says the IG concluded that although the arrangement would generate prohibited remuneration under the federal anti-kickback statute if the requisite intent were present, the IG would refrain from imposing sanctions on the manufacturer. The IG further concluded, the attorneys say, that the arrangement does not generate prohibited remuneration under the beneficiary inducements civil monetary penalty.

“The opinion reinforces a now well-established principle in OIG’s advisory opinion jurisprudence: manufacturer-sponsored diagnostic testing programs can be structured to satisfy both the anti-kickback statute and the beneficiary inducement civil monetary penalty, provided the program is designed with genuine diagnostic intent and rigorous structural separation from the manufacturer’s commercial operations,” the attorneys conclude.