On June 10, 2026, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 26-14 (AO 26-14), another favorable advisory opinion (its fourth in as many years) involving sponsored tests.
On Monday, February 26, 2024, BioMarin Pharmaceutical, Inc. (“BioMarin”) disclosed in its annual filing that the company recently received a subpoena from the U.S. Department of Justice (DOJ) requesting certain documents regarding BioMarin’s sponsored testing programs relating to two of its products, VIMIZIM and NAGLAZYME.[1] BioMarin also stated that the company “produced documents in response to the subpoena and are cooperating fully, but there is no assurance that such sponsored testing programs, or [BioMarin’s] other operations or programs, will not be ...
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- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing