WSR 19-21-083

PROPOSED RULES

DEPARTMENT OF HEALTH

(Board of Osteopathic Medicine and Surgery)

[Filed October 14, 2019, 1:43 p.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 19-15-006.

Title of Rule and Other Identifying Information: WAC 246-853-675 (osteopathic physicians) Patient notification, secure storage, and disposal and 246-854-255 (osteopathic physician assistants) Patient notification, secure storage, and disposal. The board of osteopathic medicine and surgery (board) is proposing amendments to establish patient notification, documentation, counseling requirements, and right to refuse an opioid prescription or order for any reason, when prescribing opioid drugs, as directed by SSB 5380 (chapter 314, Laws of 2019), codified as RCW 18.57.810 and 18.57A.810. The board is also proposing clarifications of when notification is not required.

Hearing Location(s): On December 6, 2019, at 9:00 a.m., at the Department of Health, Creekside at Centerpointe, Suite 310, Room 309, 20425 72nd Avenue South, Kent, WA 98032.

Date of Intended Adoption: December 6, 2019.

Submit Written Comments to: Tracie Drake, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2901, by November 27, 2019.

Assistance for Persons with Disabilities: Contact Tracie Drake, phone 360-236-4766, fax 360-236-2901, TTY 360-833-6388 or 711, email osteopathic@doh.wa.gov, by November 27, 2019.

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

Sections 5 and 6 of SSB 5380, codified as RCW 18.57.810 and 18.57A.810, direct the board to adopt or amend the opioid prescribing rules by January 1, 2020, to establish the requirement for osteopathic physicians and osteopathic 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, codified as RCW 69.50.317, requires 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 proposed rules are amended to include pain management alternatives in the patient notification.

In addition, the proposed rules clarify situations where the notification requirements would not apply. Specifically, notification requirements 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. These exemptions are included 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 restate patient notification and patient right to refuse related to opioid prescribing requirements for osteopathic physicians and osteopathic physician assistants, and to clarify situations when notification is not required. 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 18.57.005.

Statute Being Implemented: RCW 18.57.810, 18.57A.810, and 69.50.317.

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

Name of Proponent: Washington state board of osteopathic medicine and surgery, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Tracie Drake, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4766.

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 Tracie Drake, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4766, fax 360-236-2901, TTY 360-833-6388 or 711, email Osteopathic@doh.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 rule content is explicitly and specifically dictated by statute.

Explanation of exemptions: Except for exemptions in WAC 246-853-675 (3)(d) and 246-854-255 (3)(d), all proposed changes are dictated by statute.

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 246-853-675 (3)(d) and 246-854-255 (3)(d) contain 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 board determined the proposed rules do not impose more-than-minor costs on businesses in the industry. These rules impact providers only.

October 14, 2019

Renee Fullerton

Executive Director