Rules affected: OAR 836-200-0545, 836-200-0555
Need for Rules:
The Prescription Drug Price Transparency Act (2018 Oregon House Bill 4005, enrolled at 2018 Oregon Laws, Chapter 7) directed the Department of Consumer and Business Services (DCBS) to establish the Oregon Prescription Drug Price Transparency Program. In March, 2019, DCBS adopted OARs 836-200-0500 to 836-200-0560 to implement the new law’s reporting requirements for drug manufacturers.
The Act and the administrative rules implementing it require prescription drug manufacturers to file annual reports for each drug with price increases above a specified threshold, and to file reports no later than 30 days after the introduction of new drugs with a price in excess of $670. These reports are required to cover a range of data elements and comply with a variety of form and manner requirements specified in OAR 836-200-0530. The law specifies that drug manufacturers’ annual price increase reports are due to DCBS by July 1st for the first year of the program in 2019, and by March 15th in subsequent years.
The law requires DCBS to make drug manufacturer filings available to the public on its website, but prohibits DCBS from disclosing trade secret information, provided the public interest does not require disclosure of the information. The timeline for public disclosure of drug manufacturer filings and related materials is specified by OAR 836-200-0545.
The law gives DCBS the authority to set fees for drug manufacturers to pay for the department’s expenses associated with the drug manufacturer reporting program. These fees are established by OAR 836-200-0555, including a $400 annual fee and an additional surcharge fee for manufacturers that file reports that is calculated based on the number of reports filed and the revenue required to administer the drug price transparency program.
The proposed rules make minor adjustments to OARs 836-200-0545 and 836-200-0555 to allow for more efficient and effective administration of the Oregon Prescription Drug Price Transparency Program:
- The proposed amendments to OAR 836-200-0545 establish a regular quarterly schedule for public disclosure of drug manufacturer filings. This change will eliminate unnecessary administrative work associated with tracking hundreds of separate deadlines for public disclosure of new drug filings, which may be filed with DCBS at any time of year. It will also establish clearer timeframes to enable interested stakeholders and members of the public to plan for public disclosures related to the program.
- The proposed amendments to OAR 836-200-0555 provide clarification regarding which filings will be subject to the surcharge assessment each year. The current rule does not provide specific allowance for DCBS to take the time necessary to reconcile accounts and bill manufacturers, so this clarification is necessary to establish clear expectations and equitable treatment of drug manufacturers that file reports. The proposed amendments also clarify the process that will be used to calculate the amount of the surcharge assessment.
Filed: November 25, 2019
Public hearing: January 8, 2020, 9:00a
Last day for public comment: January 8, 2020, 5 p.m.
Documents