Rules affected: OAR OAR 836-053-0473, 836-200-0500, 836-200-0505, 836-200-0510, 836-200-0515, 836-200-0520, 836-200-0525, 836-200-0530, 836-200-0535, 836-200-0540, 836-200-0545, 836-200-0550, 836-200-0555, 836-200-0560
Need for Rules:
The Prescription Drug Price Transparency Act (2018 Oregon House Bill 4005, enrolled at 2018 Oregon Laws, Chapter 7) directs the Department of Consumer and Business Services (DCBS) to establish a reporting program for prescription drug manufacturers and health insurance carriers to increase the transparency of prescription drug pricing in Oregon. This program will be known as the Oregon Prescription Drug Price Transparency program. The law directs DCBS to engage in rulemaking to define key terms and timelines, and empowers DCBS to establish fees, adopt a schedule of civil penalties for violations and adopt any other rules necessary for carrying out the provisions of Section 2 of the law.
The proposed rule establishes:
- Definitions for key terms including “new prescription drug,” “net annual increase,” “one month supply” and “course of treatment” that clarify the circumstances when a report is required;
- Form, manner and content requirements for reports from drug manufacturers;
- DCBS’s supervisory expectations of participating drug manufacturers, including good faith standards;
- Timelines for DCBS to request additional information relating to drug manufacturer reports, and for manufacturers’ responses;
- DCBS’s process for adjudicating trade secret claims from drug manufacturers;
- Timelines for DCBS to make drug manufacturer reports publicly available, subject to applicable trade secret exemptions;
- DCBS’s process for receiving notices from consumers about prescription drug price increases;
- Establishing an annual $400 fee for drug manufacturers, as well as an additional surcharge fee for manufacturers that file reports with DCBS;
- Adopting a schedule of civil penalties for drug manufacturer violations; and
- Requirements for information on drug pricing to be provided by health insurance carriers in rate filings.
The proposed rules are necessary to ensure that the program is administered in a fair and equal manner for all participating drug manufacturers and health insurance carriers, to minimize the administrative burden and cost of the program for the state and the industry, and to achieve the program’s purpose of providing notice and disclosure of information relating to the cost and pricing of prescription drugs in order to provide accountability for prescription drug pricing.
Filed: December 28, 2018
Public hearing: January 22, 2019, 10:00 a.m.
Last day for public comment: February 1, 2019, 5 p.m.
Documents