California and Nevada Agencies Move Ahead with Drug Price Transparency Rule Making
The working draft of the regulations primarily mirror the statute, except that the draft proposes that the quarterly reports on drug cost increases be due one month after the end of the quarter (e.g., the report on cost increases from January 1 to March 31 would be due April 30). The preliminary working draft is not draft regulations or final regulations, and OSHPD’s website indicates that there will be an open rulemaking period with a public forum for comment in July 2018.
The Nevada Department of Health and Human Services adopted implementing regulations for the Nevada drug transparency law on May 31, 2018. As with the proposed regulations, the final regulations focus on (a) the process for a manufacturer to submit a designation that an element of the annual report is a confidential trade secret, and (b) the DHHS process for notifying manufacturers of any request for records designated confidential.
At this time, none of the other states that have passed drug price transparency laws have released any implementing regulations.
The Arent Fox Health Care Group regularly monitors developments regarding the evolving prescription drug price regulatory environment, as well as other issues affecting the pharmaceutical industry. If you have any questions regarding this topic, please contact Stephanie Trunk, Rachel Yount, or Erin Atkins in our Washington, DC office, Thomas Jeffry in our Los Angeles office, or the Arent Fox professional who regularly handles your matters.
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