Proposed Regulations Implementing California’s Drug Price Transparency Law Available for Public Comment
The proposed regulations are available here.
As with the preliminary draft of the regulations, which were discussed on Health Care Counsel Blog in June, the proposed regulations state that the quarterly reports on drug cost increases would 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 proposed regulations also includes a section under which manufacturers may appeal penalty assessments by filing a request for a hearing. OSHPD also released format and file specifications for submission of prescription drug reports.
Comments on the proposed regulations are due by 5pm on August 29, 2018. OSHPD has also scheduled a public hearing on the proposed regulations on August 29, 2018, in Sacramento.
Arent Fox's 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 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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