Prescription Drug (CTRx)
Public hearing for comment on proposed regulations for Prescription Drug Pricing (SB 17) will be held August 29th
Register for Notifications
Register for purchaser advance notice or download the list of registered purchasers.Learn more
Register for Rx Purchaser Notifications
Register to receive 60-day advance notice of a specified increase in the wholesale acquisition cost of a prescription drug from prescription drug manufacturers.
Current List of Registered Rx Purchasers
Download the list of registered prescription drug purchasers for the purpose of 60-day advance notice of a specified increase in the wholesale acquisition cost of a prescription drug, as required by Senate Bill 17. This list will be updated weekly or as needed to include all current registrants.
SB 17 Overview
Senate Bill (SB) 17 (Chapter 603, Statutes of 2017)
The implementation plan outlined below describes the provisions of SB 17 involving OSHPD. There are also provisions that will be implemented by the Department of Managed Health Care and the California Department of Insurance.
Beginning January 1, 2018, SB 17 requires OSHPD to make available a registry of public and private purchasers for purposes of the 60-day advance notice requirement for specified increases in the wholesale acquisition cost of a prescription drug. Public and private purchasers may register with OSHPD beginning December 1, 2017 on this website.
Beginning January 1, 2019, drug manufacturers must notify OSHPD within three days of introducing a new drug at a wholesale acquisition cost that exceeds the specified threshold. Within 30 days of this notification, manufacturers must submit additional information to OSHPD. OSHPD will publish this information on its website quarterly.
Beginning after January 1, 2019, drug manufacturers are required to submit to OSHPD information on the rationale for cost increases for existing drugs that fall under the reporting requirement. OSHPD will collect this information beginning April 2019 and publish on its website within 60 days of receipt from each manufacturer on a quarterly basis.
August 29, 2018
Conduct public hearing for comment.
September – December 2018
Release preliminary information reporting requirements and information collection format to drug manufacturers and share with stakeholders.
January 1, 2019
Formally adopt regulations
Begin collecting information related to new prescription drugs from drug manufacturers. OSHPD to publish this information quarterly on its website beginning Spring 2019.
Begin collecting first quarter 2019 prescription drug cost increase information for existing drugs from drug manufacturers.
By June 2019
Publish first quarter 2019 drug cost increase information for existing drugs on OSHPD website.
Rulemaking and Public Comment
The rulemaking period has opened for the CTRx (SB 17) proposed regulations and public comment is being accepted. The proposed regulations can be found on the OSHPD Laws and Regulations webpage. A public hearing will be held August 29 from 2-3pm at the OSHPD Sacramento office at 2020 West El Camino Avenue, Sacramento, CA 95833. (Agenda)
OSHPD conducted a workshop March 15, 2018 focused on eliciting feedback from data users on the information OSHPD will publish per the provisions of SB 17. OSHPD conducted a second workshop on April 11, 2018 focused on eliciting feedback from data submitters on the requirements for data that OSHPD will collect per the provisions of Senate Bill 17. The materials from both these workshops are available below.
DATA USER WORKGROUP
March 15th, 2018, 1-5pm
2020 W. El Camino Avenue, Sacramento, CA 95833
DATA SUBMITTER WORKGROUP
April 12th, 2018, 1-5pm
2020 W. El Camino Avenue, Sacramento, CA 95833
What is Senate Bill 17?
SB 17 (Hernandez, Statutes of 2017) seeks to increase prescription drug cost transparency by:
- Requiring advance notification to public and private purchasers before a significant prescription drug wholesale acquisition cost increase occurs, and making public certain information associated with the increase.
- Requiring the provision of information about the impact to health care plans and insurers of cost increases.
What is happening now?
Drug manufacturers must now provide notice to specified purchasers 60 days in advance of the planned effective date of an increase in the wholesale acquisition cost of certain prescription drugs when that increase is greater than 16%, including the proposed increases and the cumulative increases that occurred within the previous two calendar years prior to the current year. In 2019, manufacturers must provide additional information to the Office of Statewide Health Planning and Development (OSHPD) after raising the WAC of a prescription drug above a certain level, and must provide information regarding new prescription drugs introduced to market above a specified wholesale acquisition cost threshold. OSHPD will publish this information quarterly on its website.
What is OSHPD’s publishing schedule?
OSHPD will publish quarterly on its website information from drug manufacturers related to new prescription drugs beginning in spring of 2019. Beginning in June of 2019, OSHPD will publish quarterly on its website prescription drug WAC increase information for existing prescription drugs.
Are prescription drug purchasers required to register with OSHPD?
No. Registration is purely voluntary. However, specified prescription drug purchasers must register with OSHPD in order to receive advance notice of specified prescription drug wholesale acquisition cost increases.
I reimburse prescription drug manufacturers, but I am not a direct purchaser. Am I eligible to register for advance notice?
Yes. State purchasers, licensed health care service plans, health insurers holding a valid outstanding certificate of authority from the Insurance Commissioner, and pharmacy benefit managers as defined in subdivision (j) of Section 4430 of the Business and Professions Code that purchase or reimburse for prescription drugs are eligible to register for advance notice from manufacturers.
Will OSHPD issue regulations regarding the purchaser registration and manufacturer advance notice?
Yes. Over the next year, OSHPD will promulgate regulations. For up-to-date information regarding the upcoming SB 17 rulemaking process, please visit the OSHPD website and/or sign up for CTRx Informational Announcements.
Does a prescription drug manufacturer need to report to OSHPD all cost increases for a given quarter in a one-time report? Is there an indefinite quarterly reporting requirement for each drug cost increase above the specified threshold?
Specific prescription drug cost increase reporting requirements will be addressed during the outreach and rulemaking process. OSHPD welcomes and encourages stakeholder participation throughout the process of developing regulations for SB 17.
When must manufacturers begin notifying OSHPD of introduction of a new prescription drug to market at a wholesale acquisition cost exceeding the threshold set for a specialty drug under Medicare Part D program?
The new drug reporting requirements of SB 17 take effect January 1, 2019.
When does OSHPD plan to make available a form for manufacturers to report required cost increase and new drug information to OSHPD?
The format for reporting prescription drug cost increase and new drug information to OSHPD will be addressed during the outreach and rulemaking process. OSHPD anticipates that it will make available to manufacturers the prescribed format on or before January 1, 2019. OSHPD welcomes and encourages stakeholder participation throughout the process of developing regulations for SB 17.
I am aware that there is an active lawsuit challenging the constitutionality of SB 17. Do I need to comply with SB 17 while the lawsuit is active?
Yes. Unless a court issues an order preventing OSHPD from implementing SB 17, you must comply with law. No order is in place at the present time.