DEPARTMENT OF HEALTH

(Board of Naturopathy)

[Filed July 2, 2018, 12:11 p.m.]

Preproposal statement of inquiry was filed as WSR 13-22-059.

Title of Rule and Other Identifying Information: Amending WAC 246-836-210 Authority to use, prescribe, dispense and order and new WAC 246-836-212 Nonsurgical medical cosmetic procedures, the board of naturopathy (board) is proposing an amendment to an existing rule and proposing to add a new section of rule to address the practice of nonsurgical cosmetic procedures performed by naturopathic physicians.

Hearing Location(s): On September 7, 2018, at 1:00 p.m., at the Department of Health, Town Center 2 (TC2), Room 145, 111 Israel Road S.E., Tumwater, WA 98501.

Date of Intended Adoption: September 7, 2018.

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 August 31, 2018.

Assistance for Persons with Disabilities: Contact Susan Gragg, phone 360-236-4941, TTY 360-833-6388 or 711, email susan.gragg@doh.wa.gov, by August 31, 2018.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board is proposing an amendment to an existing rule and proposing to add a new section of rule to clarify the practice of nonsurgical cosmetic procedures performed by naturopathic physicians, and adds training and practice requirements for those naturopathic physicians who choose to perform them.

Reasons Supporting Proposal: The proposed rule is necessary to set minimum standards for the performance of nonsurgical cosmetic procedures by naturopathic physicians and ensure that naturopathic physicians performing these procedures apply the same, consistent standard of good medical practice as a similar, prudent health care practitioner.

Statutory Authority for Adoption: RCW 18.36A.160.

Statute Being Implemented: Chapter 18.36A RCW.

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

Name of Proponent: Washington state board of naturopathy, 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 susan.gragg@doh.wa.gov.

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. No small business economic impact statement is required because although the proposed rules do have a more-than-minor cost, that cost is a one-time cost, is only for those practitioners choosing to perform the nonsurgical cosmetic procedures, and will be more than offset by the expected new revenue that will come in to providers through being able to offer these additional health care services. The cost of the one-time training is expected to be approximately $1,700; this is more than the threshold of $1,138 but the new expected income would be a new on-going revenue stream. The cost impact threshold is calculated as follows: Payroll-based threshold for an average establishment in this NAICS code 621399 (Offices of All Other Miscellaneous Health Practitioners) that would be affected by these proposed rules is $1,138 (103,873*1000/913)*(0.01) = $1,138 where 108,873*1000 is Annual payroll and 913 is Total Establishments for this NAICS.

AMENDATORY SECTION(Amending WSR 12-13-104, filed 6/20/12, effective 7/21/12)

WAC 246-836-210Authority to use, prescribe, dispense and order.

(1) Naturopathic medical practice includes the prescription, administration, dispensing, and use of:

(a) Nutrition and food science, physical modalities, minor office procedures, homeopathy, hygiene, and immunizations/vaccinations;

(b) Contraceptive devices;

(d) Legend drugs as defined under RCW 69.41.010 ((with the exception of Botulinum Toxin (commonly known as, among other names, Botox, Vistabel, Dysport, or Neurobloc) and inert substances used for cosmetic purposes)); and

(e) Codeine and testosterone products that are contained within Schedules III, IV, and V in chapters 69.50 RCW and 246-887 WAC.

(2) In accordance with RCW 69.41.010(13), all prescriptions must be hand-printed, typewritten, or generated electronically.

(3) Prior to being allowed to administer, prescribe, dispense, or order controlled substances, a naturopathic physician must meet the requirements in WAC 246-836-211 and have obtained the appropriate registration issued by the Federal Drug Enforcement Administration.

(4) Naturopathic physicians may not treat malignancies except in collaboration with a practitioner licensed under chapter 18.57 or 18.71 RCW.

WAC 246-836-212Nonsurgical medical cosmetic procedures.

(1) Prior to performing a nonsurgical cosmetic procedure, a naturopathic physician must establish a physician/patient relationship which includes, but is not limited to:

(a) Taking a history;

(b) Performing an appropriate physical examination;

(d) Recommending appropriate treatment;

(e) Obtaining the patient's informed consent;

(f) Providing instructions for emergency and follow-up care; and

(g) Preparing an appropriate medical record.

(2) The naturopathic physician is responsible for:

(a) The safety of the patient;

(b) Performing the nonsurgical medical cosmetic procedure in accordance with standard medical practice; and

(3) Prior to being allowed to prescribe and administer botulinum toxins (commonly known as, among other names, Botox, Vistabel, Dysport, or Neurobloc) and inert substances consistent with naturopathic scope of practice used for cosmetic purposes, naturopathic physicians must be appropriately trained in aesthetic injectable techniques. Such training must:

(a) Be obtained through a certifying body or organization that is:

(i) Accredited or nationally recognized;

(ii) A recognized entity as defined in WAC 246-836-080;

(iii) Part of a council on naturopathic medical education (CNME) accredited residency; or

(iv) Conducted through in-person training substantially equivalent to those trainings in (a)(i) through (iii) of this subsection by a qualified individual holding an active license that includes the authority to prescribe and administer botulinum toxins and inert substances.

(b) Be a combination of hands-on training and training in pharmacology that pertains to aesthetics and must also include:

(i) Criteria for the selection and treatment of patients;

(ii) Indications and contraindications for each procedure;

(iii) Preprocedural and postprocedural care;

(iv) Recognition and acute management of potential complications; and

(v) Infectious disease control.