State Issues Proposed Rules on SB 17 Implementation
July 17, 2018
By Brett Johnson
On Friday, July 13, California’s Office of Statewide Health Planning and Development (OSHPD) posted for public comment (available here) its official rulemaking package for implementing Senate Bill 17 in California.
SB 17 requires manufacturers to provide a 60-day advance notice of certain price increases to all California public agency purchasers, health insurers, and pharmacy benefit managers (PBM). It also requires further reporting to OSHPD on those drugs, as well as reporting on new drugs with an initial list price of over $670 per month, which is the Medicare Part D specialty drug threshold.
The law’s advance notice provisions officially took effect on Jan. 1, 2018. Additional quarterly reporting and reporting on new drugs by manufacturers is required beginning Jan. 1, 2019.
The officially proposed rules do not differ substantially from previous drafts released – with the most notable difference being the addition of sections covering penalties and appeals. The penalties and appeals process discussed, however, are consistent with the guidance provided by OSHPD at the April 11, 2018, Data Submitter Workshop (summary available here).
Comments are due to OSHPD by 5:00pm on August 29, 2018, with a public hearing set for 2:00pm that day in OSHPD’s building at 2020 West El Camino Avenue, Sacramento, CA 95833.
CLSA will be soliciting input from our membership in preparation of official written and oral comments. If there is any further information we can provide in the meantime, please contact Brett Johnson, Senior Director of Policy & Regulatory Affairs at firstname.lastname@example.org, or Oliver Rocroi, Senior Director of State Government Relations at email@example.com.