WSR 19-21-143

PROPOSED RULES

DEPARTMENT OF HEALTH

(Medical Quality Assurance Commission)

[Filed October 22, 2019, 9:29 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 19-15-007.

Title of Rule and Other Identifying Information: WAC 246-919-865 (physicians) Patient notification, secure storage, and disposal and 246-918-815 (physician assistants) Patient notification, secure storage, and disposal, the Washington medical commission (commission) is proposing amendments to establish requirements, and clarifications, for patient notification and refusal when prescribing opioid drugs as directed by SSB 5380 (chapter 314, Laws of 2019).

Hearing Location(s): On December 12, 2019, at 3:00 p.m., at the Department of Health, Town Center 2, Room 145, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2397, Security Desk.

Date of Intended Adoption: December 12, 2019.

Submit Written Comments to: Amelia Boyd, P.O. Box 47866, Olympia, WA 98504-7866, email https://fortress.wa.gov/doh/policyreview, by December 5, 2019.

Assistance for Persons with Disabilities: Contact Amelia Boyd, phone 800-525-0127, TTY 360-833-6388 or 711, email medical.rules@wmc.wa.gov, by December 5, 2019.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: SSB 5380 requires the commission, along with the dental quality assurance commission, podiatric medical board, board of osteopathic medicine and surgery, and nursing care quality assurance commission to adopt or amend rules establishing additional patient notification and right to refuse requirements.

Sections 8 and 9 of SSB 5380 direct the commission to adopt or amend the opioid prescribing rules by January 1, 2020, to establish the requirement for allopathic physicians and physician assistants to notify patients of their right to refuse an opioid prescription or order and to document any refusal.

Section 17 of SSB 5380 adds a new section to chapter 69.50 RCW requiring the prescribing practitioner, prior to the first opioid prescription, to discuss with the patient risks of opioids, pain management alternatives to opioids, and provide the patient a written copy of the warning language. The rules are amended to include pain management alternatives in the patient notification.

In addition, the proposed rule clarifies situations where the notification requirements would not apply. Specifically, notification requirements that would not apply to emergent care, situations where pain represents a significant health risk, procedures involving administration of medications, when a patient is unable to grant or revoke consent, or for medication assisted treatment for substance use disorders because SSB 5380 only applies to prescriptions and these exemptions clarify settings in which direct administration is occurring.

The intent of SSB 5380 is to reduce the number of people who inadvertently become addicted to opioids and, consequently, reduce the burden on opioid treatment programs.

Reasons Supporting Proposal: The proposed rules are necessary to expand patient notification related to opioid prescribing requirements for allopathic physicians and allopathic physician assistants. The proposed rules provide a necessary framework and structure for safe, consistent opioid prescribing practice consistent with the directives of SSB 5380. The goal is to reduce the number of people who inadvertently become addicted to opioids and, consequently, reduce the burden on opioid treatment programs.

Statutory Authority for Adoption: RCW 18.71.017, 18.71.810, 18.71A.810.

Statute Being Implemented: RCW 69.50.314, 18.71.810, 18.71A.810.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington medical commission, governmental.

Name of Agency Personnel Responsible for Drafting: Amelia Boyd, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2727; Implementation and Enforcement: Melanie de Leon, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2755.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Amelia Boyd, P.O. Box 47866, Olympia, WA 98504-7866, phone 360-236-2727, TTY 360-833-6388 or 711, email medical.rules@wmc.wa.gov.

This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:

Is exempt under RCW 19.85.025(3) as the rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect; and rule content is explicitly and specifically dictated by statute.

Explanation of exemptions: The language in this proposal is largely dictated by statute. The language exempting certain settings is a clarification that settings in which direct administration is occurring are exempt from these rules as they are not relating to the issuance of a prescription.

The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. WAC 246-919-865 (1)(e) contains exemptions to the new requirements of law, which are not part of the law, in settings where complying with the law would be overly burdensome or impossible for providers. The commission determined the proposed rules do not impose more-than-minor costs on businesses in the industry. These rules impact providers only.

October 21, 2019

Melanie de Leon

Executive Director