WSR 22-02-015
PREPROPOSAL STATEMENT OF INQUIRY
DEPARTMENT OF HEALTH
[Filed December 27, 2021, 12:56 p.m.]
Subject of Possible Rule Making: Chapter 246-945 WAC, rules pertaining to medication assistance and the settings in which medication assistance occurs. The pharmacy quality assurance commission (commission) and department of health (department) are filing jointly to consider adopting new rules to reinstate rules on medication assistance as permitted under chapter 69.41 RCW.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.005, 69.41.010(15), and 69.41.075.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The commission completed a nearly three-year process in July 2020 to update and consolidate all rules under its authority, resulting in the creation of chapter 246-945 WAC. Although this process included extensive work with interested parties, it was brought to the commission's attention, once the new chapter was published, that the repeal of chapter 246-888 WAC resulted in unintended disruptions for medication assistance in the community-based and in-home care settings permitted under chapter 69.41 RCW.
Medication assistance under chapter 69.41 RCW lacks the detail needed to develop and implement training, policies, procedures, and regulations. RCW 69.41.010(15) does not provide the level of specificity needed by the broad range of entities charged with implementation and oversight of community-based or in-home care settings and requires that "such other means" of medication assistance are established in rule by the department. The commission also has rules on patient-owned medications (WAC 246-945-440), but they do not apply to community-based and in-home care settings and do not adequately cover the concerns communicated to the commission by the impacted parties.
The commission and the department will consider adopting rules to provide further definitions for terms used such as "enabler," and establish those "other means of medication assistance as defined by rule adopted by the department." These rules are intended to help impacted individuals retain their independence and live in the least restrictive setting, such as their own home, longer by providing means and guidance for medication assistance.
Emergency rules pertaining to this issue are currently in effect under WSR 21-23-098, filed November 17, 2021. The emergency rules have been in effect since July 20, 2021, with the filing of WSR 21-15-108. The commission and the department intend to keep emergency rules in effect until permanent rules are formalized as necessary.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The Washington state department of social and health services believes additional specificity is needed by the entities that are charged with implementation and oversight. Medication assistance under chapter 69.41 RCW lacks the detail needed to develop and implement training, policies, procedures, and regulations.
Process for Developing New Rule: Collaborative.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Joshua Munroe, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-2987, fax 360-236-2321, TTY 711, email PharmacyRules@doh.wa.gov.
Additional comments: Rule development takes place in open public meetings prior to a formal rule proposal and comment period. All rule-making notices are mailed via GovDelivery. To receive notices, interested persons may sign up by going to https://public.govdelivery.com/accounts/WADOH/subscriber/new. After signing up, please click open the box labeled "Health Systems Quality Assurance." Next, click open the box labeled "Health Professions," then check the boxes next to either "Pharmacy Commission Meeting and Agenda" and/or "Pharmacy Commission Newsletter."
December 27, 2021
Teri Ferreira, RPh
Pharmacy Quality Assurance Chair
and Kristin Peterson, JD
Deputy Secretary
Policy and Planning