OSPIRG helped pass several bills in 2021; two of them are in rulemaking, a process that provides guidance from state agencies to the entities affected by the statute on how the law will be implemented and how entities can adhere to it. The first bill, SB 763, requires the licensure and ethics education of pharmaceutical sales representatives. The second, HB 2362, requires early notice and approval from state agencies for consolidation of health care entities. I am part of both rulemaking advisory committees (or RACs), the group that works with state agencies to provide feedback on the rules before they are adopted. Here's a quick description and the links to the feedback I provided on the rules for these bills.
For SB 763, the rules describe licensing requirements, reporting requirements for licensees, license renewals, education and continuing education requirements for licensees, prohibited conduct for licensees, and penalties. My goal was to ensure licensing and reporting requirements included information that state agencies can use to extrapolate information about the pharmacuetical industry, such as what contact sales representatives have with health care providers and what prescription samples or gifts are given during marketing meetings. The drafts of the rules were overall very good, and my comments are mostly to push back on feedback from industry representatives on the RAC.
For HB 2362, the rules are much more technical. The definitions alone cover the entities required to provide notice and get approval, as well as guidelines for more complicated regulations covered by the rules such as what constitutes "control" over a health care entity. The rules further define what transactions are covered and which are not, emergency exceptions and procedures, exemptions, procedures and forms for giving notice of a transaction (including the information that entities must disclose), and procedures for the reviews of a transaction. The rules also cover confidentiality, post-approval monitoring, and information needed for reporting and evaluation of the oversight program.
These rules are very technical, so my goal was to ensure that health care mergers and acquisitions were reviewed based on the effects of those transactions on the local community - on the cost and competition within the region the transaction takes place. I also wanted to ensure that state agencies will be able to monitor the effects of a transaction after it takes place, and that the information needed to evaluate the oversight program will be available. It was also important to keep the emergency exemptions only to true emergencies so that the exemption provisions are not abused. Finally, I aimed to keep the review procedures transparent and thorough to accomplish the goals of the legislation: to prevent mergers that raise costs for patients.
Rulemaking is an important part of implementing a law after a bill passes. Most rulemaking committees in Oregon welcome public comment at the end of the meetings, and are open to the public. After the RACs are concluded, the rules are posted temporarily for further public comment before they become final and effective. Anyone can submit comments on these rules, and it is helpful for state agencies to know that you care about these issues, so keep an eye out - these two sets of rules will be posted before the new year!