Nevada Department of Health and Human Services to Exercise Enforcement Discretion for Required Reports under Drug Pricing Transparency LawJune 26, 2018
As we previously reported, Nevada enacted a law on June 15, 2017 addressing drug prices. S.B. 539 imposed new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”) related to diabetes treatments and health care provider payments (also see related posts here and here). Manufacturers of prescription drugs determined by the Nevada Department of Health and Human Services (“NDHHS”) to be “essential for treating diabetes” in Nevada are required to make certain annual disclosures regarding costs, expenses, profits, rebates, and financial assistance data, as well as the wholesale acquisition cost (“WAC”) related to such products. Pursuant to S.B. 539, PBMs must also submit annual reports regarding rebates for essential diabetes drugs. Finally, patient advocacy groups are required to report certain payments from pharmaceutical manufacturers, PBMs, and other third parties.
Under the statute, the submission deadline for the first manufacturer report is July 1, 2018. However, on June 7, 2018, NDHHS issued a notice that it would not take enforcement action on any reports required under S.B. 539 until January 15, 2019. Specifically, NDHHS stated (on its website):
NDHHS will not proceed with any enforcement action for reports made during the first six months. NDHHS expects that all entities will work in good faith during the six month period, but wants to ensure that manufacturers, sales representatives, pharmacy benefit managers, and non-profit organizations have ample opportunity to come into compliance with the statutes and regulations by January 15, 2019 before any enforcement action will be taken. NDHHS anticipates that information regarding [WAC] should be available during the summer of 2018 but may further extend deferment of enforcement action if needed.
A NDHHS staff person informed us unofficially that the Department intends to issue guidance and forms related to manufacturer reporting in the near future. We will continue to update our readers on developments in Nevada and other states that have enacted laws related to drug pricing.