by David M. Traskey, Colleen R. Pierson | Feb 19, 2025
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
by David M. Traskey, Andrew Z. Ko | Feb 19, 2025
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
by David M. Traskey, Vanessa A. Giunta | Feb 19, 2025
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
by David M. Traskey, Colleen R. Pierson | Feb 19, 2025
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
by David M. Traskey, Andrew Z. Ko | Feb 19, 2025
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).