HHS OIG Opinion Raises Questions On Free Drug Offers

By Jeffrey Mittleman and Andrew Namkung (November 28, 2018, 4:12 PM EST) -- In remarkable fashion, the U.S. Department of Health and Human Services Office of the Inspector General posted Advisory Opinion 18-14 on Nov. 16, 2018, an unfavorable opinion on a proposal to provide a free specialty drug to hospitals for use in the inpatient setting. Specifically, the requestor is a marketer of a particular drug that is one of two currently FDA-approved drugs that can treat a particular form of infantile epilepsy syndrome. Due to the nature of this condition, initial treatment must, and typically does, begin in an inpatient hospital setting, then continued and tapered after the patient has been discharged. According to the requestor, many hospitals often refuse or are unable to stock the drug for a variety of reasons, including inventory risk and the fact that government programs and other insurers do not separately reimburse for the drug when administered in the inpatient setting. This often delays a patient's access to the drug, which may have adverse consequences....

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