Bass, Berry & Sims attorney Shannon Wiley provided insight for an article in Law360 Healthcare Authority outlining the potential legal risks for drug manufacturers associated with direct-to-consumer (DTC) drug sales through the TrumpRx program.
While the Department of Health and Human Services Office of Inspector General (OIG) issued a bulletin in late January noting the “low risk” of violations to anti-kickback laws that drugmakers face if they sell drugs directly to consumers, many in the industry still have questions. “Given the OIG’s long-standing prohibition on the use of copay coupons for drugs reimbursed by federal healthcare program, the bulletin provides valuable guidance to clarify the prohibition does not extend to these cash pay transactions,” noted Shannon.
“Without a clearly defined safe harbor in place, manufacturers may still be hesitant to move forward,” Shannon added.
Shannon did signify that the program “may usher in a new generation of direct-to-patient drug access,” as consumers become more comfortable “ordering everything on their phone and having it delivered to their door.”
The full article, “Legal Risks Complicate Drugmakers’ TrumpRx Participation,” was published by Law360 Healthcare Authority on February 3 and is available online (subscription required). Shannon co-authored content on this topic, “OIG Issues New Guidance on DTC Drug Sales and AKS Risk,” issued on January 30.