DEPARTMENT OF HEALTH

(Podiatric Medical Board)

[Filed October 22, 2019, 1:09 p.m.]

Preproposal statement of inquiry was filed as WSR 19-16-019.

Title of Rule and Other Identifying Information: WAC 246-922-675 Patient notification, secure storage, and disposal, the podiatric medical board (board) is proposing amendments to establish requirements for patient notification and refusal when prescribing opioid drugs as directed by SSB 5380 (chapter 314, Laws of 2019).

Hearing Location(s): On December 5, 2019, at 1:00 p.m., at the Department of Health, Creekside at CenterPoint, Suite 310, Room 307, 20425 72nd Avenue South, Kent, WA 98032.

Date of Intended Adoption: December 5, 2019.

Submit Written Comments to: Susan Gragg, 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 Susan Gragg, phone 360-236-4941, fax 360-236-2901, TTY 360-833-6388 or 711, email podiatric@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 dental quality assurance commission, board of osteopathic medicine and surgery, Washington medical commission, and nursing care quality assurance commission to adopt or amend rules establishing additional patient notification and right to refuse requirements.

Section 3 of SSB 5380, codified as RCW 18.22.810, directs the board to adopt or amend their opioid prescribing rules by January 1, 2020, to establish the requirement for podiatric physicians 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 rule is amended to include pain management alternatives in the patient notification.

In addition, the proposed rule restates when the notification requirements do not apply, as outlined in RCW 69.50.317. The amendment also restates the requirement, also in RCW 69.50.317, that the patient's parent or guardian must be included in the discussion if the patient is under eighteen years of age or is not competent.

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 purposed rules are necessary to be consistent with the directives of SSB 5380 for rule making.

Statutory Authority for Adoption: RCW 18.22.005 and 18.22.015.

Statute Being Implemented: RCW 18.22.810 and 69.50.317.

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

Name of Proponent: Washington state podiatric medical board, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Susan Gragg, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4941.

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 Susan Gragg, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4941, fax 360-236-2901, TTY 360-833-6388 or 711, email podiatric@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.

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. The proposed rule does not impose more-than-minor costs on businesses. Minor costs may be imposed on individual providers.

AMENDATORY SECTION(Amending WSR 18-20-085, filed 10/1/18, effective 11/1/18)

WAC 246-922-675Patient notification, secure storage, and disposal.

(1) The podiatric physician shall provide information to the patient educating them of risks associated with the use of opioids, including the risk of dependence and overdose, as appropriate to the medical condition, the type of patient, and the phase of treatment. The podiatric physician shall document such notification in the patient record.

(2) Patient notification must occur, at a minimum, at the following points of treatment:

(a) The first issuance of a prescription for an opioid; and

(b) The transition between phases of treatment, as follows:

(i) Acute nonoperative pain or acute perioperative pain to subacute pain; and

(ii) Subacute pain to chronic pain.

(3) Patient notification must also include information regarding:

(a) Pain management alternatives to opioid medications as stated in WAC 246-922-680;

(b) The safe and secure storage of opioid prescriptions; ((and

(b)))(c) The proper disposal of unused opioid medications including, but not limited to, the availability of recognized drug take-back programs; and

(d) The patient's right to refuse an opioid prescription or order for any reason. In accordance with RCW 18.22.810, if a patient indicates a desire not to receive an opioid, the podiatric physician must document the patient's request and avoid prescribing or ordering opioids, unless the request is revoked by the patient.

(4) ((The patient notification requirements in this section shall be deemed fulfilled by providing board-approved patient education information.))If a patient is under eighteen years old or is not competent, the discussion required in subsections (1) through (3) of this section must include the patient's parent, guardian, or the person identified in RCW 7.70.065, unless otherwise provided in law.

(5) As required in RCW 69.50.317 of the Uniform Controlled Substances Act, any practitioner who writes the first prescription for an opioid during the course of treatment to any patient must discuss a written copy of the warning language provided by the department under RCW 43.70.765.

(6) This section does not apply to:

(a) Opioid prescriptions issued for the treatment of pain associated with terminal cancer or other terminal diseases, or for palliative, hospice, or other end-of-life care or where the practitioner determines the health, well-being, or care of the patient would be compromised by the requirements of this section and documents such basis for the determination in the patient's health care record; or

(b) Administration of an opioid in an inpatient or outpatient treatment setting.

(7) To fulfill the requirements in this section, a podiatric physician may designate any individual who holds a credential issued by a disciplining authority under RCW 18.130.040 to provide the notification.